Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products, 24714-24759 [2011-9865]
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Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 321, 332, and 381
[Docket No. FSIS–2008–0039]
RIN 0583–AD37
Cooperative Inspection Programs:
Interstate Shipment of Meat and
Poultry Products
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is amending
the Federal meat and poultry products
inspection regulations to establish a
new voluntary cooperative program
under which State-inspected
establishments with 25 or fewer
employees will be eligible to ship meat
and poultry products in interstate
commerce. In participating States, Stateinspected establishments selected to
take part in this program will be
required to comply with all Federal
standards under the Federal Meat
Inspection Act (FMIA) and the Poultry
Products Inspection Act (PPIA). These
establishments will receive inspection
services from State inspection personnel
that have been trained in the
enforcement of the FMIA and PPIA.
Meat and poultry products produced
under the program that have been
inspected and passed by designated
State personnel will bear an official
Federal mark of inspection and will be
permitted to be distributed in interstate
commerce. FSIS will provide oversight
and enforcement of the program.
DATES: Effective Date: July 1, 2011.
FOR FURTHER INFORMATION CONTACT:
Daniel Engeljohn, Assistant
Administrator, Office of Policy and
Program Development, Room 350–E,
Jamie L. Whitten Building, 1400
Independence Avenue, SW.,
Washington, DC 20250; Telephone (202)
720–2709, Fax (202) 720–2025.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
The Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601, et seq.) and the
Poultry Products Inspection Act (PPIA)
(21 U.S.C. 451, et seq.) (‘‘the Acts’’)
require that FSIS protect the public by
ensuring that meat and poultry products
are safe, wholesome, and accurately
labeled. The Acts require Federal
inspection and provide for Federal
regulation of meat and poultry products
prepared for distribution in commerce
for use as human food.
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Cooperative State inspection
programs. Section 661 of the FMIA and
454 of the PPIA authorize FSIS to
cooperate with State agencies in
developing and administering their own
meat or poultry products inspection
programs for the inspection and
regulation of products that are produced
and sold solely within the State (21
U.S.C. 661 & 454). These cooperative
State inspection programs are required
to operate in a manner and with
authorities ‘‘at least equal to,’’ but not
necessarily identical to, the provisions
set out in the FMIA and PPIA (21 U.S.C.
661 (a)(1) & 454 (a)(1)). The ‘‘at least
equal to’’ standard is a concept that
requires that State MPI Programs
operate in a manner that is at least as
effective as those standards adopted for
the Federal inspection program. The
Acts provide for FSIS to contribute up
to 50 percent of the cost of the
cooperative State inspection programs,
as long as the State programs are
effectively enforcing requirements that
are ‘‘at least equal to’’ the Federal
program (21 U.S.C. 661 (a)(3) & 454
(a)(3)).
Section 11015 of Title XI of The Food,
Conservation, and Energy Act of 2008
(‘‘the 2008 Farm Bill’’), enacted on June
18, 2008, amended the Acts to establish
a new cooperative inspection program
under which certain State-inspected
establishments will be eligible to ship
meat and poultry products in interstate
commerce (Pub. L. 110–246, 112 Stat.
1651; 21 U.S.C. 683 and 472). The
amendments to the Acts provide that
the Secretary of Agriculture (FSIS by
delegation), ‘‘in coordination with the
appropriate State agency of the State in
which the establishment is located,’’
may select State-inspected
establishments with 25 or fewer
employees to ship meat and poultry
products in interstate commerce (21
U.S.C. 683 (b) and 472(b)). Inspection
services for these establishments must
be provided by State inspection
personnel that have ‘‘undergone all
necessary inspection training and
certification to assist the Secretary with
the administration and enforcement of
[the Acts]’’ (21 U.S.C. 683(a)(2) and
472(a)(2)). Meat and poultry products
inspected and passed by the State
inspection personnel would bear a
‘‘Federal mark, stamp, tag, or label of
inspection’’ and would be permitted to
be shipped in interstate commerce (21
U.S.C. 683(b)(1) and 472(b)(1)).
The law provides for the Secretary to
‘‘designate an employee of the Federal
government’’ to ‘‘provide oversight and
enforcement’’ of the program (21 U.S.C.
683(d)(1) and 472 (d)(1)). If the Federal
employee finds that an establishment
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selected for the program is in violation
of the Acts, he or she is required to
‘‘deselect the selected establishment or
suspend inspection at the selected
establishment’’ (21 U.S.C. 683(d)(3)(c)
and 472(d)(3)(c)). The law requires that
any selected establishment that FSIS
‘‘determines to be in violation of any
requirement of the Act, be transitioned
to be a Federal establishment’’ (21 U.S.C.
683(h) and 472(g)).
The law provides that FSIS is to
reimburse a State for costs related to the
inspection of establishments in the State
selected for the program ‘‘in an amount
of not less than 60 percent of eligible
State costs’’ (21 U.S.C. 683(c) and
472(c)). The law also states that FSIS
‘‘may provide grants to appropriate State
agencies to assist the appropriate State
agencies in helping establishments
covered by this Act to transition to
selected establishments’’ (21 U.S.C.
683(g) and 472(f)). The law is to take
effect ‘‘on the date on which the
Secretary, after providing a period of
public comment (including through the
conduct of public meetings or hearings),
promulgates final regulations to carry
out [section 11015]’’ (21 U.S.C. 683 (j)(1)
and 472((i)(1)).
Proposed rule. On September 16,
2009, FSIS published proposed
regulations to implement the new
cooperative interstate shipment program
(‘‘Cooperative Inspection Programs:
Interstate Shipment of Meat and Poultry
Products,’’ 74 FR 47648).
FSIS held two public meetings by
teleconference on October 27, 2009, and
November 4, 2009, to solicit comments
on the proposed regulations (74 FR
54493). The comment period for the
proposed rule was scheduled to close on
November 16, 2009, but, in response to
comments, was extended to December
16, 2009.
In developing this final rule, FSIS
considered all comments submitted in
response to the September 2009
proposed rule, as well as those provided
at the two teleconferences held in
October and November 2009. Based on
its analysis of the issues, and on
information provided by the comments,
FSIS made certain changes to the
proposed regulations. Those changes are
summarized below and are discussed in
detail in the Agency’s responses to
comments.
For a more detailed discussion of
section 11015 of the 2008 Farm Bill and
FSIS’s proposed implementing
regulations, refer to the September 16,
2009, proposed rule.
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II. Summary of Amendments to the
Proposed Rule To Implement the
Cooperative Interstate Shipment
Program
In this rulemaking, FSIS is finalizing,
with some changes, the provisions in
the September 2009 proposed rule.
Specifically, the Agency is amending
the proposal to:
• Revise the standards for
determining an establishment’s average
number of employees for purposes of
the cooperative interstate shipment
program to exclude employees whose
duties do not involve handling the meat
or poultry products produced by the
establishment (9 CFR 332.3(b)(1) and (2)
and 9 CFR 318.513(b)(1) and (2));
• Revise the standards for
determining the average number of
employees for purposes of the
cooperative interstate shipment program
to include uncompensated volunteers
who are involved in handling the meat
or poultry products produced by the
establishment (9 CFR 332.3(b)(6) and
381.515(b)(6));
• Allow States that have existing
cooperative agreements for a State MPI
program to submit a request to enter
into an agreement with FSIS for a
cooperative interstate shipment program
before the States have identified
establishments to recommend for the
cooperative interstate shipment program
(9 CFR 332.4(b)(1) and 381.514(b)(1));
• Identify factors that will be
considered to determine the frequency
with which the FSIS selected
establishment coordinator (SEC) will
visit selected establishments under his
or her jurisdiction (9 CFR 332.7(a) and
381.517(a));
• Give establishments that were
deselected from the cooperative
interstate shipment program because
they are located in a State whose
agreement for the program was
terminated the option to either revert
back to operating under the cooperative
State MPI program or obtain a Federal
grant of inspection (9 CFR 332.11(a) and
381.521(a));
• Allow establishments that were
deselected from the cooperative
interstate shipment and successfully
transitioned to become Federal
establishments to revert back to the
State MPI program after successfully
operating as a Federal establishment for
a year (9 CFR 332.11(b) and 381.521(b));
• Allow establishments selected to
participate in the cooperative interstate
shipment program to operate under both
the State MPI program for the State
where the establishment is located and
the new cooperative interstate shipment
program. State-inspected establishments
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that operate under both programs must
maintain an appropriate separation of
time or space between operations (9
CFR 332.13 and 381.523);
• Allow selected establishments that
are in full compliance with the
requirements of the cooperative
interstate shipment program to
voluntarily end their participation in
the program and revert back to the State
MPI program (9 CFR 332.14 and
381.514);
• Codify the definition of ‘‘eligible
State costs’’ to include those costs that
a State has justified and FSIS has
approved as necessary for the State to
provide inspection services to selected
establishments in the State (9 CFR
321.3(b) and 381.187(b)).
III. Comments and Responses
FSIS received approximately 90
separate comment letters in response to
the September 2009 proposed
regulations and approximately 5000
identical comment letters submitted by
a consumer advocacy organization on
behalf of private citizens. Comments
submitted by consumer advocacy
organizations, private citizens, State
farm bureaus, trade associations
representing meat processors, and a
labor union representing food and
commercial workers expressed general
support for the proposed regulations.
Comments submitted by an association
of State meat and food inspection
directors, an association of State
Departments of Agriculture, several
State Departments of Agriculture and
other State agencies, farm and
agriculture advocacy organizations,
Congress members providing comments
on behalf of the State of Wisconsin, and
private citizens expressed support for
the concept of a cooperative interstate
shipment program but objected to
several provisions in FSIS’s proposed
implementing regulations. Other
comments submitted by FSIS inspection
personnel, small federally-inspected
establishments, and one consumer
advocacy organization opposed any
program that would permit Stateinspected meat and poultry products in
interstate commerce.
Following is a discussion of these
comments and FSIS’s responses.
A. Development of the proposed rule
Comment: Several comments
criticized FSIS for not consulting with
State officials during the development
of the proposed regulations. The
comments stated that several States and
organizations of State officials had
offered to form an advisory committee
to assist FSIS in developing the
proposed regulations to implement the
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cooperative interstate shipment
program. As noted by the comments,
FSIS determined that such a request was
not practical due to the regulatory
constraints and the statutory time-line
for implementing this program. The
comments encouraged FSIS to work
closely with State inspection officials to
develop final regulations to make the
program as workable as possible. One
comment said that creating an
environment where state regulators and
federal regulators work together
consistently will provide the stability
the program needs to be successful for
all involved.
Some comments suggested that FSIS
use this rulemaking as an opportunity to
encourage more State involvement in
addressing the nation’s food safety
problem. The comments encouraged
FSIS to accord considerable weight to
comments submitted by States with
exemplary food safety inspection
histories and State-inspected
establishments that likewise have
exemplary histories when the Agency
finalizes the proposed rule.
Response: FSIS appreciates the States’
willingness to participate in the
development and implementation of the
new cooperative interstate shipment
program. In developing this final rule,
FSIS carefully considered the comments
and suggestions submitted by the States
and, as a result, the Agency made
certain revisions to the proposed
regulations. FSIS will work closely with
the States as the Agency moves forward
to implement the cooperative interstate
shipment program established in this
final rule.
Comment: A few comments stated
that the teleconference format for the
two public meetings that were held in
October and November of 2009 was not
an appropriate way to generate
comments on the proposed cooperative
interstate shipment program. One
comment noted that there were few
comments presented during the
teleconferences, which the commenter
believed may be related to the format of
the public meeting. One comment said
that both teleconferences occurred on
the same dates and times when FSIS
was offering webinars for small and very
small plant operators, which presented
a conflict for those interested in
participating in both meetings. Another
comment complained that, although the
commenter had registered for the
teleconference and has a confirmation
passcode to participate, the commenter
was not allowed to speak during the
meeting.
Response: FSIS chose the
teleconference format for the public
meetings to provide individuals with
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easier access to the meeting, particularly
those who may lack the resources or
time to attend a meeting in person. FSIS
will consider the comments submitted
on this issue to determine how it can
improve its use of the teleconference
format to conduct public meetings in
the future.
B. General Support for and General
Opposition to the Proposed Rule
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1. Support for the Proposed Regulations
Comment: Comments submitted by
consumer advocacy organizations,
private citizens, State farm bureaus,
trade associations representing meat
processors, and a labor union
representing food and commercial
workers expressed general support for
FSIS’s proposed regulations to
implement the cooperative interstate
shipment program. Some of these
comments said that the language in
Section 11015 of the 2008 Farm Bill
reflects an agreement reached through
negotiations between various national
consumer organizations, the National
Association of State Departments of
Agriculture, the National Farmers
Union, the American Federation of
Government Employees, and the United
Food and Commercial Workers Union.
According to these comments, the
language in section 11015 was carefully
crafted to meet the desire of some Stateinspected meat plants to enlarge their
area of sales while assuring that all meat
and poultry sold across state lines meet
federal inspection standards. The
comments commended FSIS for writing
proposed regulations that closely adhere
to both the intent and specific language
of the legislation.
One comment noted that the program
established in the proposed regulations
builds on existing State inspection
programs and includes important
enhancements that can lead to stronger
State inspection programs. The
comment approved of the fact that, like
the statute, the proposed regulations
would not permit ‘‘regulatory forum
shopping.’’
Response: FSIS agrees that the
proposed regulations are consistent with
both the intent and language of the
enabling legislation. The Agency also
agrees that the program established in
the proposed regulations will
complement the existing State
inspection programs.
2. Support Interstate Shipment but not
the Program Proposed by FSIS
Comment: Comments submitted by an
organization of State Agriculture
Departments, an organization of State
meat inspection program Directors,
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several State Departments of
Agriculture, State agencies, farm and
agriculture advocacy organizations, and
private citizens expressed support for
the concept of a cooperative interstate
shipment program but had concerns
about FSIS’s proposed regulations to
implement the program. Many of these
comments stated that, instead of
allowing for the interstate shipment of
state inspected products, FSIS’s
proposed regulations essentially set up
another Federal inspection system
under more stringent and inflexible
provisions than the current Federal
system. According to the comments,
FSIS’s proposed program fails to remove
unnecessary barriers for small
establishments to sell their specialty
products across State lines. The
comments asserted that the proposed
regulations will create a regulatory
system that is too burdensome for either
establishments or State inspection
programs, which likely means that few
will take advantage of the program.
To support these assertions, the
comments noted that, when FSIS issued
the proposed rule, the Agency estimated
that approximately 60% (16 of 27) of the
States with existing State MPI programs
and approximately 200–600
establishments were interested in
participating in the new cooperative
interstate shipment program. The
comments stated that after FSIS issued
the proposed rule, an internal poll
conducted by an organization of State
official indicates that only 2 of these 27
States, each with only a handful of
establishments, now find the
cooperative interstate shipment
proposed by FSIS to be even potentially
viable. According to the comments,
without a drastic revision of the
proposed regulations and active FSIS
participation in cooperation with the
State partners, the program is unlikely
to succeed.
Response: After careful consideration
of all comments submitted in response
to the 2009 proposed rule, FSIS
modified the proposed regulations to
provide some added flexibility for
establishments selected to participate in
the cooperative interstate shipment
program. For example, under this final
rule, selected establishments that are in
full compliance with the program will
be permitted to voluntarily end their
participation in the program. This final
rule will also permit selected
establishments to operate under both
the cooperative interstate shipment
program and the State’s MPI program if
they maintain an appropriate separation
of time or space between operations.
The Agency believes that these
modifications, which are discussed in
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more detail in the Agency’s response to
comments, will provide additional
incentive for some establishments to
participate in the program.
3. Oppose any Program That Would
Allow Interstate Shipment of StateInspected Product
Comment: Comments submitted by
FSIS inspection personnel, small
federally-inspected meat and poultry
processing establishments, and a
consumer advocacy organization
objected to any program that would
permit state-inspected meat and poultry
products to be shipped in interstate
commerce. According to many of these
comments, meat and poultry products
produced in State-inspected
establishments do not undergo the same
level of inspection as products
produced in Federal-inspected facilities,
and many State MPI programs are not
truly ‘‘at least equal to’’ the Federal
inspection program. A few comments
referenced a 2006 Office of Inspector
General Audit Report of State-inspected
meat and poultry programs that the
comments said found that some Stateinspected facilities had failed to operate
in a sanitary manner and that FSIS had
not provided consistent oversight of
existing State MPI programs.
Response: As required by law, the
cooperative interstate shipment program
established under this final rule will
operate under the same standards
imposed under the Federal inspection
program. Thus, meat and poultry
products produced in State-inspected
establishments selected for the
cooperative interstate shipment program
will undergo the same level of
inspection as products produced in
federally-inspected facilities.
With respect to the comment that
many State MPI programs are not truly
‘‘equal to’’ the Federal inspection
program, each year the FSIS OPEER
Federal State Audit Branch reviews the
State cooperative MPI programs and
their requirements to verify that each
State program ‘‘at least equal to’’ the
Federal program. These comprehensive
reviews consist of an annual review of
the State MPI program’s self assessment
submission and an on-site review to
verify the State’s self-assessment
submission. The onsite reviews are
scheduled at a minimum, once every
three years.
Based on the self assessment
documents received during FY 2009,
FSIS determined that all of the 27 State
MPI programs provided adequate
documentation to support that they
have implemented and can maintain
MPI programs ‘‘at least equal to’’ the
Federal program. FSIS determined that
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all of the 11 State MPI programs
reviewed on-site were enforcing
requirements ‘‘at least equal to’’ those
imposed under the Federal Acts.
In its 2006 audit of the FSIS’s
cooperative State MPI programs, the
OIG provided recommendations to
strengthen FSIS’s review of these
programs. FSIS provided management
decisions in response to the 2006 OIG
audit recommendations, which were
accepted by OIG. The Agency has
implemented the 2006 management
decisions.
Comment: One comment stated that
State-inspected establishments should
not be allowed to ship products
interstate because the States do not have
the money or staff to provide the
inspection that the Federal government
does. Another comment maintained that
Federal inspectors undergo more
extensive training than State inspection
personnel and, therefore, unlike State
inspectors, are continuously expanding
their knowledge bases.
Response: As discussed in greater
detail below, to qualify for the
cooperative interstate shipment
program, States with cooperative State
MPI programs will need to demonstrate
that they have staffing sufficient to
conduct the same inspection activities
in establishments operating under the
cooperative interstate shipment program
that FSIS conducts in official Federal
establishments. The States will also
need to demonstrate that the designated
State personnel have been properly
trained in Federal inspection
methodology. FSIS will not enter into
an agreement for a cooperative interstate
shipment program with States that are
unable to meet these conditions.
Comment: One comment submitted
by a consumer advocacy organization
said that while the commenter does not
support State-inspected meat and
poultry for either intrastate or interstate
commerce, it understands that Congress
amended the FMIA and PPIA to
establish the cooperative interstate
shipment program, and that FSIS is
required to develop regulations to
implement the law. The comment urged
the Agency to put into place a system
whereby establishments that participate
in the program are held to the identical
Federal standards and practices as those
establishments under Federal inspection
and that the Agency maintain strict
oversight of such a program.
Response: The cooperative interstate
shipment program established in these
final regulations will be a State
inspection program under which
designated State-personnel enforce
Federal food safety standards. As
required by law, FSIS will provide
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oversight and enforcement of the
program.
Comment: Several comments
submitted by FSIS inspection personnel
and small federally-inspected meat and
poultry processors maintained that
instead of establishing cooperative
interstate shipment program, FSIS
should require that State-inspected
establishments that desire to ship their
meat and poultry products in interstate
commerce come under Federal
inspection.
One comment submitted by a small
federally-inspected establishment
explained that as a small company, it
decided to obtain a Federal grant of
inspection as an investment for the
future of its business. The comment
noted that the establishment did this to
allow for interstate sales of its products
and that the same option is available
today for any company willing to make
a similar investment. The comment
asserted that to provide for a level
playing field, all small companies that
want to sell their products across state
lines should be required to go through
the same process and obtain a Federal
grant of inspection.
Response: Section 11015 of the 2008
Farm Bill amended the FMIA and PPIA
to establish the cooperative interstate
shipment program. The amendments
require that FSIS issue final regulations
to implement the new program. Once
the new program becomes effective,
small State-inspected establishments
that are interested in selling meat or
poultry products across State lines will
have the option to operate as a selected
establishment under the cooperative
interstate shipment program or as an
official Federal establishment. An
establishment that ships products across
States lines must comply with all
Federal standards regardless of the
inspection program that it chooses to
operate under.
Comment: One comment said that the
cooperative interstate shipment program
is not necessary because the Talmadge/
Aiken program serves the same purpose.
Response: The Talmadge-Aiken
program and the cooperative interstate
shipment program serve different
purposes. Under the Talmadge-Aiken
program, FSIS enters into a separate
agreement with a State agency for the
State program to conduct meat, poultry,
or egg products inspection or other
regulatory activities on behalf of FSIS.
Establishments that participate in the
Talmadge-Aiken program operate under
a Federal grant of inspection. Under the
cooperative interstate shipment
program, FSIS enters into a separate
agreement with a State agency to
enforce Federal food safety standards at
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State-inspected establishments.
Establishments that participate in the
cooperative interstate shipment program
are not Federal establishments operating
under a Federal grant of inspection.
Comment: Comments submitted by a
few FSIS inspection personnel opposed
the proposed cooperative interstate
shipment stated because the
commenters believe that the program
will result in a reduction in the Federal
inspection force. The comments stated
that under such a program, small
federally-inspected establishments will
want to drop their Federal grant of
inspection and produce products under
State-inspection, thereby taking jobs
that would otherwise belong to Federal
employees and giving them to State
employees.
Response: Under the law and
implementing regulations,
establishments that operate under the
Federal inspection program are
ineligible to participate in the
cooperative interstate shipment
program. The new program is limited to
certain small and very small Stateinspected establishments. Thus, the
cooperative interstate shipment program
will have little effect on Federal
inspection personnel.
Comment: One comment objected to
allowing the interstate shipment of
state-inspected products because,
according to the comment, FSIS will no
longer have control or jurisdiction over
some meat and poultry products in
interstate commerce. The comment
noted that a State’s jurisdiction is
limited to the State’s borders. The
comment asked what would happen if
product produced by a State-inspected
establishment is implicated in a food
safety issue resulting in a recall.
Response: Under the law, FSIS is
responsible for providing oversight and
enforcement of the cooperative
interstate shipment program. Therefore,
if an establishment operating under the
cooperative interstate shipment program
distributes meat or poultry products that
present a food safety hazard or that need
to be recalled for other reasons, FSIS
will coordinate with the State MPI
program to ensure that such product is
removed from commerce. FSIS will be
responsible for the overall coordination
of the recall and for verifying that
recalled product that has been shipped
interstate has been removed from
commerce.
C. Establishment Participation—
Conditions for Eligibility and Standards
for Determining Average Number of
Employees
The proposed rule prescribed
conditions that State-inspected
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establishments would be required to
meet to become eligible to participate in
the cooperative interstate shipment
program. Consistent with the law,
among these proposed conditions were
that an establishment be in compliance
with all Federal inspection
requirements under the FMIA, PPIA,
and their implementing regulations, and
that the establishment employ, on
average, no more than 25 individuals.
The proposed rule also included
proposed standards for determining the
average number of employees, which,
for the most part, reflect applicable
methods used by the Small Business
Administration (SBA) to calculate the
number of employees for a small
business concern. FSIS received several
comments on the proposed conditions
for establishment eligibility and the
proposed standards for determining the
average number of employees.
1. Compliance With Federal Standards
Comment: Some comments agreed
that State-inspected establishments
should be required to comply with
Federal standards to be eligible for the
cooperative interstate shipment
program. The comments stated that
many small and very small
establishments have managed to
conform to, and operate successfully
under, the requirements of the Federal
inspection system. Two comments
noted that data obtained from FSIS’s
PBIS in 2007 show that 51 percent
(2,878 of 5,603) of all federallyinspected establishments have 10 or
fewer employees and 80% have 50 or
fewer employees.
The comments also noted that all
establishments that prepare or process
meat and poultry products have always
had the opportunity to ship their
products in interstate commerce
provided that they apply for and receive
a Federal grant of inspection. The
comments stated that small and very
small establishments now under Federal
inspection have invested time and
money to comply with all Federal
regulations and to operate under Federal
standards. The comments asserted that
while the new cooperative interstate
shipment program is intended to offer
establishments operating under their
State inspection program an opportunity
to broaden their distribution, any
establishment that ships meat or poultry
products in interstate commerce can
and should meet Federal food safety
standards.
Other comments stated that requiring
that State-inspected establishments
comply with Federal food safety
standards in order to be eligible for the
cooperative interstate shipment program
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will establish unfair barriers for small
plants to participate in the program. The
comments urged FSIS to provide small
State-inspected establishments with
greater flexibility in achieving food
safety standards. One comment from a
small State-inspected establishment
stated that it cannot afford Federal
inspection. The comment noted that
establishments operating under the
State MPI system are required to adhere
to very strict food safety standards but,
unlike the Federal system, State
inspection personnel are also available
to help the small and very small
establishments with education and
training.
Response: The amendments to the
Acts in section 11015 of the 2008 Farm
Bill require that State-inspected
establishments be in compliance with
all Federal standards in order to be
eligible for the cooperative interstate
shipment program. The provisions in
the Acts that establish the cooperative
interstate shipment program define an
‘‘eligible establishment’’ as an
establishment that is in compliance
with both ‘‘* * * the State inspection
program of the State in which the
establishment is located’’ and ‘‘[the
FMIA or PPIA], including the rules and
regulations issued under [the FMIA or
PPIA]’’ (21 U.S.C. 472(a)(3) and
683(a)(3)).
The Senate Conference Committee
report on the bill that established the
cooperative interstate shipment program
also makes clear that establishments
selected for the program ‘‘* * * must
fully follow [the FMIA or PPIA], its
regulations, notices, directives and
policies just as would be required of a
Federal establishment’’ (S. Rep. No. 220,
110th Cong., 1st Sess. (2007), pp. 211–
214). Thus, requiring that Stateinspected establishments comply with
Federal food safety standards to become
eligible to participate in the cooperative
interstate shipment program is
consistent with both the language and
intent of section 11015 of the 2008 Farm
Bill.
FSIS’s Office of Outreach, Employee
Education, and Training (OOEET) will
provide technical resources,
information, and guidance to small and
very-small State establishments that are
interested in becoming eligible to
participate in the cooperative interstate
shipment program.
2. Determining Average Number of
Employees
a. Proposed standard: All individuals,
both supervisory and non-supervisory,
employed by the establishment on a
full-time, part-time, or temporary basis
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are to be counted when calculating the
total number of employees.
Comment: Several comments stated
that for purposes of the cooperative
interstate shipment program, an
establishment’s average number of
employees should be based only on
those directly involved in the
preparation or processing of meat and
poultry products. The comments noted
that many small and very small
establishments conduct operations other
than the processing of meat or poultry
products, such as grocery stores,
convenience stores, or other retail
outlets. According to the comments,
employees that do not perform duties
related to the meat or poultry processing
operations of the business should not be
included when calculating the average
number of employees.
One comment suggested that FSIS
consider basing the ‘‘value’’ associated
with the employee on the workers
compensation code that the employer
designates. The commenter said that it
could give FSIS a simple way of
determining which workers are
associated with the meat processing part
of the business and which employees
offer other roles for the company, such
as administrative workers or retail
clerks.
Other comments said that all
establishment personnel, including
those not involved in the actual
production of meat and poultry
products, should be counted when
calculating the average number of
employees. One comment noted that the
law specifically states that supervisory
and nonsupervisory employees are to be
counted when calculating the average
number of employees. The comment
maintained that this indicates that if
Congress had intended to exclude
certain employees from the calculation,
it would have expressly stated so in the
law. The comment urged FSIS to require
that temporary and part-time
employees, regardless of their position
in the establishment, be counted when
determining the average number of
employees.
Response: Although the law limits
participation in the cooperative
interstate shipment program to Stateinspected establishments that employ,
on average, 25 or fewer employees, it
does not distinguish between employees
involved in an establishment’s meat or
poultry processing operations from
those that are not. Counting all
individuals employed by the
establishment would ensure that
participation in the cooperative
interstate shipment program is limited
to very small and certain small
establishments. Counting only
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employees directly involved in the
preparation or processing of meat and
poultry products would create a more
flexible standard that would expand the
number of potentially eligible
establishments to include those that
have a small number of employees that
work in meat or poultry processing but
a larger number of employees that work
in other areas of their business.
The 2008 amendments to the Acts
give FSIS the authority to define
‘‘average number of employees’’ for
purposes of the cooperative interstate
shipment program, but they also make
clear that the program is intended for
State-inspected establishments that
employ a limited number of individuals.
Therefore, FSIS is adopting a standard
for calculating the average number of
employees that provides some flexibility
for establishments that conduct
operations other than meat or poultry
processing, but that also clearly
distinguishes those employees that are
to be counted for purposes of the
interstate shipment program from those
that are not.
Therefore, instead of counting all
individuals employed by the
establishment as proposed, under this
final rule, an establishment’s average
number of employees will be calculated
by counting all individuals employed by
the establishment, excluding the
employees that do not come into contact
with the meat or poultry products
produced by the establishment. For
example, if the owner of a gas station
produces beef jerky and sells it at the
gas station, the employees that are
involved in producing the jerky, as well
as those that work as cashiers and sell
the product, will be counted. The
mechanics that work on the cars,
however, will not be. Employees that
perform solely administrative functions
and that do not handle meat or poultry
products will also not be counted.
When an establishment conducts
multiple operations, it is sometimes
difficult to distinguish employees
associated with the meat or poultry
operations from those that are not. For
example, an individual employed as a
cashier at an establishment’s deli
operations may also slice and package
meat or poultry products produced by
the establishment. The standard
adopted in this final rule clearly
distinguishes employees whose duties
are associated with the meat or poultry
products produced by an establishment
from those that are not. It also ensures
that the cooperative interstate shipment
program will remain limited to certain
small and very small establishments, as
intended.
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b. Proposed standard: Part-time and
temporary employees are to be counted
the same as full-time employees.
Comment: Several comments, most
submitted by consumer advocacy
organizations and one submitted by a
food and commercial workers union,
agreed with the proposed standard to
count part-time and temporary workers
as full-time workers for purposes of
qualifying for the cooperative interstate
shipment program. The comments noted
that most very small establishments
have few full-time employees, and many
do not operate every day. The comments
maintained that counting part-time and
temporary employees the same as full
time employees is an effective means to
assure the cooperative interstate
shipment program serves the entities it
was intended to serve. According to the
comment, failing to count part-time and
temporary employees in the average
number of employees would permit
substantially larger entities to
participate in a program that was
designed to serve very small local
establishments.
Some of these comments noted that
during negotiations with the States,
consumer advocacy groups reluctantly
agreed to the States’ request for a
program with a 25 employee limit.
According to the comment, none of the
groups involved in the negotiations ever
agreed to anything larger than 25
employees. The comments said that the
primary reason that many consumer
advocacy organizations had opposed the
House interstate shipment bill was
because the bill contained a 50
employee limit, which, according to the
comment, would have expanded the
number of establishments in the new
cooperative program far beyond what
was intended. One comment stated that,
although the program’s 25 employee
limit is reasonable, the commenter
would have preferred a limit of 10
employees, which is similar to the
current FSIS definition for very small
establishments.
Several other comments, most
submitted by State Departments of
Agriculture and other State agencies,
disagreed with the proposed standard to
count part-time and temporary workers
as full time employees. The comments
stated that such a standard seems
excessive and does not provide an
accurate depiction of an establishment’s
actual number of employees.
The comments noted that many small
establishments in small towns hire parttime employees who work as little as a
few hours a week. According to the
comments, to count such employees as
full-time would contradict and undercut
the rural development intentions of the
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24719
enabling legislation. One comment
stated that in some rural areas,
especially those with small and very
small establishments, meat processing
has a seasonal component that provides
part-time seasonal work for rural
residents. The comments noted that
during each part of the day, an
establishment may have only 25
employees on site, even if the total
number of part-time and fulltime
employees employed overall during the
day exceeds 25.
The comments suggested that parttime and temporary workers be counted
on the basis of ‘‘full-time equivalents’’ or
‘‘FTEs,’’ i.e., based on the ratio of their
work-hours to those of a full-time yearround employee. The comments said
that part-time and temporary employees
should be grouped together and counted
based on the number of hours they work
each week during the year, with 40
hours per week being considered an
FTE. Several comments suggested
formulas for calculating the number of
employees based on FTEs.
Response: After considering the
comments, FSIS has decided to adopt
the proposed standard to count
temporary and part time employees the
same as full-time employees. For
purposes of its regulatory programs,
FSIS defines small and very small
establishments based on SBA criteria. A
standard that counts part-time and
temporary workers the same as full-time
workers reflects the SBA methods for
calculating the average number of
employees for a small business concern
and is thus consistent with FSIS’s
overall approach for defining small and
very small establishments.1
As noted by the comments, several
very small establishments have few fulltime employees, and many do not
operate every day. A standard that is
based on the SBA criteria that counts
part-time and temporary employees the
same as full time employees allows
these establishments to hire seasonal
workers while ensuring that only very
small and certain small establishments
are eligible to participate in the
program.
Comment: Several comments stated
that the standards for determining the
average number of employees need to
allow for more flexibility in counting
temporary seasonal workers. The
comments noted that small and very
small establishments often have
fluctuation in their employees during
certain parts of the year, such as during
1 See 13 CFR 121.105 and 121.106 for SBA
methods to calculate the number of employees of
a business concern where the size standard in
number of employees.
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holiday and hunting seasons, and that
the term ‘‘seasonal’’ will have different
meanings in different areas of the
country. Some comments noted some
establishments hire extra employees to
help with seasonal activities that are not
related to the processing of amenable
species, such as processing game meat
or for busy times in their retail shops
around holidays.
The comments suggested that
seasonal employees be counted based
on FTE. As an example, the comments
explained that a seasonal employee who
works full-time for 3 months would be
a 25% FTE and should be counted as
one quarter of an employee.
One comment asserted that seasonal
employees should not be counted at all
when calculating the average number of
employees. The comment suggested that
the final rule define a seasonal
employee as an employee that works for
the establishment ninety or fewer days
in a calendar year.
Response: When Congress amended
the FMIA and PPIA to establish the
cooperative interstate shipment
program, it intended for FSIS to
interpret the term average ‘‘…to provide
some flexibility to these selected plants
that require seasonal employees for
certain parts of the year, as long as the
increase in employees are [sic]
manageable by the establishment and
the increase in employees does not
undermine food safety standards’’ (S.
Rep. No. 220, 110th Cong., 1st Sess., pp.
211–214 (2007)).
As discussed below, under the
proposed rule, selected establishments
may temporarily employ more than 25
employees during busy seasons, as long
as the average number of employees
continues to be 25 and the number of
employees does not exceed 35. Thus, a
standard that counts temporary seasonal
employees the same as full-time
employees will allow selected
establishments to hire seasonal
employees while ensuring that the
number of employees remains
manageable by the establishment, as
Congress intended.
FSIS disagrees with the comment that
stated that seasonal employees should
not be counted at all. Such an approach
would be inconsistent with the language
and intent of the statute.
c. Proposed standard: The total
number of employees cannot exceed 35
at any given time, regardless of the
average number of employees.
Comment: Some comments stated that
the proposed standard that provides that
the total number of employees can never
exceed 35 individuals at any given time,
regardless of the average number of
employees, is a reasonable upper limit
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for selected establishments to remain
eligible to participate in the program.
One comment stated that such a limit is
reasonable if FSIS does not count parttime and temporary employees the same
as full time.
Other comments asserted that FSIS
should not limit the number of
employees working at a selected
establishment at any given time if the
establishment maintains an average of
25 employees or fewer. The comments
stated that while section 11015 of the
2008 Farm Bill requires that the average
number of employees not exceed 25, the
law does not prohibit a selected
establishment from ever, over the course
of a year, having more than 35
employees.
The comments stated that in many
small establishments there may be
‘‘spikes’’ in employee numbers during
busy periods, but the overall average
number of employees is under 25. The
comments asserted that, as written, the
proposed rule excludes such
establishments from participating in the
interstate shipment program. According
to the comments, section 11015 was not
intended to exclude these
establishments. The comments
suggested that FSIS revise the proposed
rule to ensure that these establishments
remain eligible for the program.
One comment disagreed with the
proposed 35 employees limit because,
according to the comment, allowing
selected establishment to have 35
employees during seasonal shifts
represents, at minimum, a 40% increase
in establishment personnel. The
comment argued that the higher number
of employees represents a huge increase
in production that could overwhelm a
very small establishment’s production
systems, which could result in
contaminated food entering commerce.
The comment noted that if an
establishment routinely employs 5
people and then increases this number
to 10 or 20 during a certain timeframe,
it will have a 100% or 400% increase
in employees. The comment maintained
that this level of increase is not
manageable and is not what Congress
intended.
The comment suggested that instead
of limiting the total number of
employees to 35 at any given time, FSIS
should cap at 20% the increase in the
number of employees that an
establishment may use during a
seasonal shift. The comment
acknowledged that the commenter does
not have data to support this number,
but stated that it stands to reason that
a sudden increase in production could
significantly affect the dynamics within
an establishment and overwhelm the
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system. According to the comment,
small and very small establishments
have HACCP plans for a production
process at a certain level that would not
necessarily support a significantly
higher level of production. The
comment pointed out that FSIS did not
provide any data to support the
proposed 35 employee cap.
One comment stated that FSIS should
not allow more than 25 employees in
selected establishments at any given
time. The comment noted that section
11015 requires that establishments that
consistently employ more than 25
employees but fewer than 35 employees
transition to Federal establishments
within three years of the enactment
date. The comment stated that this
provision indicates that Congress
recognized that establishments that ship
product in interstate commerce and that
have more than 25 employees should be
under Federal inspection.
Response: While the 2008
amendments to the Acts do not
specifically prohibit selected
establishments from ever having more
than 35 employees, the Senate report
described above indicates that Congress
intended that there be some limits on
the number of employees working at a
selected establishment at any given
time.
As explained in the preamble to the
proposed rule, FSIS proposed that the
number of employees working in a
selected establishment never exceed 35
at any given time because the law
allows FSIS to select for the cooperative
interstate shipment program
establishments that employed more than
25 but fewer than 35 employees as of
June 18, 2008, the date the law was
enacted (21 U.S.C. 683(b)(3)(B) and
472(b)(3)(B)). To remain in the program,
these establishments must employ fewer
than 25 employees on average 3 years
after the effective date of this final rule.
Thus, while Congress did not intend to
‘‘* * * routinely allow selected
establishments to employ above 25 or
more employees,’’ the fact that the law
provides for some selected
establishments to initially employ up to
35 individuals demonstrates that a
temporary increase in the number of
employees of up to 35 individuals, as
long as the average number of
employees remains 25 or fewer, is
consistent with the language and intent
of the Acts.
As noted above, when Congress
established the cooperative interstate
shipment program, it intended to
provide some flexibility to
establishments that require seasonal
employees to meet consumer demands
for certain parts of the year. The 20%
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cap on the increase in the number of
employees suggested by one of the
comments would greatly restrict the
number of temporary workers that a
selected establishment would be
allowed to hire during busy seasons. For
example, an establishment that regularly
employs five employees on average
would be permitted to hire only one
temporary employee during its busy
seasons. Many small and very small
establishments operate on an
intermittent or seasonal basis and are
accustomed to adjusting their operations
to temporarily increase production
without undermining food safety
standards. FSIS has concluded that
restricting the increase in employees to
20% is unlikely to provide the
flexibility that many very small selected
establishments will need to meet
seasonal demands for their products.
d. Proposed standards: Volunteers
who receive no compensation are not
considered employees.
Comment: One comment disagreed
with the proposed standard that
provides that volunteers are not
considered employees. The comment
stated as a food safety measure,
uncompensated volunteers who are
engaged in meat or poultry product
processing should be considered
employees for the purpose of the
cooperative interstate shipment
program.
Response: FSIS agrees with this
comment and has revised the standards
for counting employees to include as
employees, volunteers that perform
duties that involve handling the meat or
poultry products produced by the
establishment.
D. State Participation: ‘‘The Same as’’
Standard for Inspection Services
Provided to Selected Establishments
The proposed regulations provide that
States interested in establishing an
agreement for a cooperative interstate
shipment program are required to
submit a request for such an agreement
to FSIS through the FSIS district office
that covers the State. The proposed rule
also provided that, in their requests,
States are required to include
documentation to demonstrate that they
are able to provide the necessary
inspection services to selected
establishments in the State and conduct
any related activities that would be
required under a cooperative interstate
shipment program. The preamble to the
proposed rule explained that to meet
this requirement, the statute requires
that States demonstrate that the
inspection service that they provide to
selected establishments in the State will
be ‘‘the same as,’’ rather than ‘‘at least
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equal to’’ those provided under the
Federal inspection program. FSIS
received a significant number of
comments on the proposed ‘‘same as’’
standard.
1. Support for ‘‘the same as’’ Standard
Comments submitted by consumer
advocacy organizations, meat processor
trade associations whose members
mainly operate under the Federal
inspection system, a union representing
food and commercial workers, two pork
producer trade associations, and some
private citizens expressed support for
the proposed ‘‘same as’’ standard.
Comment: The comments that
supported the proposed ‘‘same as’’
standard agreed that the language and
intent of the enabling statute require
that the cooperative interstate shipment
program operate under standards that
are the ‘‘same as’’ the Federal inspection
system and not the ‘‘at least equal to’’
standard that applies to State MPI
programs. The comments believed that
all meat and poultry products shipped
in interstate commerce should be
required to comply with uniform
Federal food safety standards rather
then multiple State standards. The
comments stated that it is especially
important for State-inspected
establishments that participate in the
new program to be in compliance with
all Federal standards because the meat
and poultry products produced by these
establishments will bear a Federal mark
of inspection.
One comment stated that requiring
that selected establishments that
voluntarily request the opportunity to
participate in a cooperative interstate
shipment program operate in a manner
that is the ‘‘same as’’ federally-inspected
establishments is not only consistent
with the provisions and intent of the
law, but also ensures that the food safety
standards established in the FMIA,
PPIA, and their implementing
regulations are applied uniformly to all
meat and poultry products that are
distributed in interstate commerce. The
comment encouraged FSIS to retain the
proposed ‘‘same as’’ standard to first and
foremost ensure the safety of meat and
poultry products distributed in
interstate commerce, but also to ensure
equity in the marketplace. The comment
added that this fundamental
proposition, that the playing field be
level for all companies engaging in
interstate commerce, was a critical
element in securing passage of the
statutory provisions that authorized the
cooperative interstate shipment
program. The comment asserted that the
program must not provide an unfair
advantage to small companies that will
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24721
not, or cannot, make the commitments
necessary to comply with Federal food
safety requirements.
Two comments stated that requiring
that State-inspected products produced
under the cooperative interstate
shipment program comply with all
Federal requirements is essential for
maintaining domestic and international
markets for U.S. meat and poultry
products. Other comments said that
consumers expect that products carrying
the Federal mark of inspection comply
with Federal standards for meat and
poultry inspection. The comments
stated that establishments that are not
held to all aspects of the Federal
requirements should not be entitled to
apply the Federal mark of inspection on
their products.
One comment that supported the
‘‘same as’’ standard noted that although
establishments operating under a State
MPI inspection program receive
inspection services that are ‘‘at least
equal to’’ the Federal inspection
program, the methodology employed by
FSIS is a critical part of the effectiveness
of the Federal food safety system. The
comment asserted that, as such, it is
essential for States that participate in
the cooperative interstate shipment
program to follow Federal inspection
methodology when providing
inspection services to selected
establishments.
Response: FSIS agrees that the ‘‘same
as’’ standard is consistent with the
language and intent of the statutes. The
issues raised by the comments
demonstrate why it is important for the
cooperative interstate shipment program
to operate under standards that are ‘‘the
same as’’ those imposed under the
Federal meat and poultry products
inspection programs.
2. Opposed to ‘‘same as’’ standard
Several comments submitted by State
Departments of Agriculture and other
State agencies, as well as organizations
representing these entities, objected to
the proposed ‘‘same as’’ standard. Some
farm and rural community advocacy
organizations, cattle producer
organizations, a trade association
representing small meat processors, and
an animal welfare advocacy
organization also opposed the proposed
standard.
Comment: Several comments that
objected to the proposed ‘‘same as’’
standard claimed that such a standard is
not authorized by law. These comments
asserted that the Acts, as amended by
the 2008 Farm Bill, do not contain any
language that would require that the
inspection services that States provide
to selected establishments be ‘‘the same
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as’’ or ‘‘identical to’’ the inspection
services provided under the Federal
program. The comments maintained
that such an interpretation is an
extrapolation of the language that does
not exist in the statute.
The comments noted that under the
2008 Farm Bill amendments, the term
‘‘eligible establishment’’ refers to an
establishment that is ‘‘in compliance
with’’ the Acts. The comments also
noted that these amendments authorize
the SEC to ‘‘ensure that selected
establishments are operating in a
manner that is consistent with * * *’’
the Acts (21 U.S.C. 472(d)(3)(A),
683(d)(3)(A)). The comments argued
that these provisions indicate that if
Congress had intended to require that
the State program be ‘‘the same as’’ or
‘‘identical to’’ to the Federal program, it
would have specifically said so in the
statute.
The comments also noted that the
2008 Farm Bill did not amend the
provisions in the FMIA and PPIA that
provide for cooperative State MPI
programs that are ‘‘at least equal’’ to the
Federal program. According to the
comments, the fact that Congress did
not amend these provisions
demonstrates that State programs that
are ‘‘at least equal to’’ the Federal
program are in compliance with the
Acts.
Response: The language in the FMIA
and PPIA, as amended by the 2008 Farm
Bill, is clear: Congress provided that the
cooperative interstate shipment program
would operate under standards that are
‘‘the same as’’ those imposed under the
Federal program.
The 2008 amendments to the FMIA
and PPIA provide that to be eligible for
the cooperative interstate shipment,
State-inspected establishments must be
in compliance with both the State’s MPI
program and ‘‘* * * the requirements of
this chapter, including the rules and
regulations issued under this chapter’’
(21 U.S.C. 472(a)(3) and 683(a)(3)). As
used in the statutes, the term ‘‘this
chapter’’ refers to the FMIA at 21 U.S.C
Chapter 12, and the PPIA at 21 U.S.C.
Chapter 10. The 2008 amendments also
require that the State personnel
designated to provide inspection
services under the program undergo
‘‘* * * all necessary training and
certification to assist * * * in the
administration and enforcement of this
chapter, including the rules and
regulations issued under this chapter’’
(21 U.S.C. 472(a)(2) and 683(a)(2)). The
2008 amendments allow a meat or
poultry product inspected by designated
State personnel to bear a Federal mark
of inspection and be shipped in
interstate commerce if the product
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‘‘* * * qualifies for the mark * * *
under the requirements of this chapter’’
(21 U.S.C. 472(b)(1)(A) and
683(b)(1)(A)).
The Senate Conference Committee
report on the bill that established the
cooperative interstate shipment program
provides that ‘‘* * * establishments
selected for the [cooperative interstate
shipment] program * * * must fully
follow [the FMIA or PPIA], its
regulations, notices, directives and
policies just as would be required of a
Federal establishment’’ (S. Rep. No. 220,
110th Cong., 1st Sess. (2007), pp. 211–
214). The report also provides that
‘‘* * * [t]he inspection personnel of the
State that will inspect the selected
establishment must have undergone all
the necessary training to carry out the
requirement of [the Acts], [their]
regulations, notices directives and
policies, just as required of a Federal
inspector.’’
Thus, both the statute and the
Committee report make clear that
Congress intended for the cooperative
interstate shipment program to operate
under standards that are ‘‘the same as’’
those imposed under the Federal
inspection program.
FSIS agrees with the comments that
stated that the 2008 Farm Bill did not
amend the provisions in the FMIA and
PPIA that provide for cooperative State
MPI programs that are ‘‘at least equal’’ to
the Federal program. However, FSIS
disagrees that this means that State
programs that are ‘‘at least equal to’’ the
Federal program are in compliance with
all requirements of the Acts for
purposes of the cooperative interstate
shipment program. Under the FMIA and
PPIA, establishments operating under
an ‘‘at least equal to’’ State MPI program
are permitted to produce meat or
poultry products solely for distribution
within the State where the
establishment is located (21 U.S.C.
454(a)(1) and 661(a)(1)). Thus, State
programs that are ‘‘at least equal to’’ the
Federal program are in compliance with
the Acts only if the establishments
operating under these programs prepare
and ship products solely for use within
the State where they are located.
Comment: One comment asked
whether the proposed rule requires that
a State’s entire MPI program must be
‘‘identical to’’ the Federal program for
the State to qualify for the cooperative
interstate shipment program.
Response: No, a State’s entire MPI
program does not need to be identical to
the Federal program for the State to
qualify for the cooperative interstate
shipment program. To qualify for the
program, a State must demonstrate that
the inspection services that it will
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provide to selected establishments in
the State will be ‘‘the same as’’ those
provided under the Federal inspection
program. States that participate in the
cooperative interstate shipment program
may continue to operate an ‘‘at least
equal to’’ State MPI program for
establishments that produce meat and
poultry products solely for distribution
within the State.
Comment: Several comments stated
that the interstate shipment program’s
legislative history demonstrates that
Congress intended for the program to
operate under the ‘‘at least equal’’
standard required for the existing
cooperative State MPI programs.
According to the comments, the
conference reports for the House and
Senate versions of interstate shipment
legislation indicate that Congress
adopted the Senate version of the bill
because the House version would have
required that States implement meat
and poultry inspection programs
‘‘identical to’’ the Federal inspection
system. The comments maintained that
the legislative intent was to provide
current State facilities with a viable
route to ship State product interstate.
The comments said that the requirement
for State plants to be ‘‘identical to’’ or
‘‘same as’’ a federal plant radically
deviates from this.
Response: The comments are correct
in that Congress did adopt the Senate
version of the legislation that
established the cooperative interstate
shipment program. However, FSIS
disagrees that the Senate version was
adopted to permit State-inspected
establishments operating under an ‘‘at
least equal to’’ standard to ship meat and
poultry products in interstate
commerce.
Section 11103 of the House version of
the 2008 Farm Bill would have
amended the FMIA and PPIA to replace
the existing ‘‘at least equal to’’
cooperative State MPI program with a
new program that would have
authorized FSIS to approve, and enter
into cooperative agreement with, only
those State MPI programs that adopt
standards identical to those imposed
under the Federal program (H. Rep.
110–256, 110th Cong., 1st Session, pp.
184–191). Under the House version, all
State-inspected establishments would
have been required to comply with
Federal standards, the State mark of
inspection would have been deemed an
official mark, and all State-inspected
establishments would have been
allowed to ship meat or poultry
products in interstate commerce.
The Senate bill, which was the
version adopted in the 2008 Farm Bill,
supplements, but does not replace, the
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existing State MPI programs. The Senate
version provides an option under which
State-inspected establishments that
have, on average, 25 or fewer
employees, will be permitted to ship
their meat or poultry products in
interstate commerce. Under the Senate
version, State-inspected establishments
are required to comply with all Federal
standards to be eligible to participate in
the cooperative interstate shipment
program, and designated State
personnel must be trained to enforce
Federal food safety standards. Under the
Senate version, State-inspected
establishments that choose not to
participate in the cooperative interstate
shipment program may continue to
operate under the ‘‘at least equal to’’
State MPI program and ship their
products within the States where they
are located.
Comment: Some comments claimed
that in the past, FSIS itself concluded
that it was unrealistic for States to
maintain MPI programs that are ‘‘the
same as’’ or ‘‘identical to’’ FSIS’s
program. The comments noted that in
2003, the Agency provided an option for
the States to claim that their meat and
poultry inspection programs were ‘‘same
as’’ or ‘‘identical to’’ FSIS inspection as
part of the Agency’s annual review in
which it verifies that State MPI
programs are ‘‘equal to’’ the Federal
program. The comments said that in
2006, FSIS reached the conclusion that
it was logistically impossible for State
programs to maintain a true ‘‘same as’’ or
‘‘identical to’’ status, so the Agency
removed this option from the State Self
Assessment Manual forms. The
comments asserted that if only a few
years ago FSIS acknowledged that it is
impossible for State MPI programs to be
the ‘‘same as’’ Federal programs,
proposing such a standard now will
effectively prevent States from
qualifying for a cooperative interstate
shipment program.
Response: FSIS has stated that ‘‘at
least equal to’’ does not require that
States operate their cooperative MPI
programs in a manner that is ‘‘the same
as’’ or ‘‘identical to’’ the FSIS program or
does not prohibit States from
establishing safeguards that the States
believe to be more effective than those
employed by FSIS. The law does not
require that the cooperative State MPI
programs operate under standards
‘‘identical to’’ the Federal program.
As noted above, the cooperative
interstate shipment program will
supplement the existing State MPI
programs, not replace them. Thus, while
States that participate in the cooperative
interstate shipment program will need
to provide the same inspection services
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to selected establishments that FSIS
provides to federally-inspected
establishments, States may also
continue to operate their cooperative
State MPI programs in a manner that is
‘‘at least equal to’’ the Federal program.
Comment: Several comments noted
that a foreign country must demonstrate
that its inspection system is
‘‘equivalent’’ to the U.S. inspection
system before FSIS will permit
establishments located in the foreign
country to import meat and poultry
products into the United States. These
comments asserted that requiring that
States operate their cooperative
interstate shipment programs under
standards that are the ‘‘same as’’ those
required under the Federal program
subjects the States to a stricter and less
flexible standard than the standard
applied to foreign countries. One
comment maintained that while the
commenter does not support the
equivalent standard for foreign facilities,
there is no justification for
discriminating against domestic
establishments under the jurisdiction of
State inspection programs by requiring
that they meet more rigid standards than
those imposed on foreign
establishments.
Response: The equivalence standard
applied to imported meat and poultry
products and the ‘‘same as’’ standard
applied to meat and poultry products
produced under the cooperative
interstate shipment program reflect the
relevant provision in the FMIA and
PPIA. The FMIA and PPIA require that
FSIS treat as equivalent to a U.S.
requirement alternative measures
proposed by an exporting country if the
country provides scientific evidence or
other information, in accordance with
risk assessment methodologies agreed to
by FSIS and the exporting country, to
demonstrate that the alternative
measure achieves the level of protection
that is appropriate for the United States
(21 U.S.C. 620(e)(1)(B), 466(d)(2)(A)).
These provisions reflect the U.S.
Government’s obligation under the
World Trade Organization (WTO)
Agreement on the Application of
Sanitary and Phytosanitary Measures
(the SPS Agreement) to accept the
sanitary measures of an exporting
Member country as equivalent if the
exporting member demonstrates that its
sanitary measures attain the same level
of protection (Article 4.1, ‘‘Agreement
on the Application of Sanitary and
Phytosanitary Measures). FSIS evaluates
foreign food regulatory systems for
equivalence through document reviews,
on-site audits, and port-of-entry
reinspection of products at the time of
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importation (9 CFR part 327 and 381
subpart T).
Comment: Several comments asserted
that it is unnecessary to require that the
inspection services that States provide
to selected establishments be the ‘‘same
as’’ inspection services provided under
the Federal program because most States
have incorporated the Federal
requirements into their State MPI
programs. The comments stated that,
according to FSIS’s 2008 report on its
review of the State MPI programs, these
State programs have demonstrated that
they can implement the Federal laws
and regulations in a manner that is ‘‘at
least equal to,’’ and thus, ‘‘in compliance
with’’ the Federal standards without
operating under a program that is ‘‘the
same as’’ the Federal inspection program
because of the smaller staff size and
other administrative aspects of the State
programs.
Response: As noted throughout this
document, the 2008 amendments to the
Acts require that the inspection services
that States provide to selected
establishments be ‘‘the same as’’ those
provided under the Federal inspection
program. The Senate report also makes
clear that State inspection personnel are
‘‘* * * to carry out the Federal
requirements of the [the Acts], [their]
regulations, notices directives and
policies, just as required of a Federal
inspector’’ (S. Rep. No. 110–220, 110th
Cong., 1st Sess. (2007), pp 211–214).
Thus, FSIS disagrees that State
programs that have implemented the
Federal laws and regulations in a
manner that is ‘‘at least equal to’’ the
Federal inspection program are ‘‘in
compliance with’’ the Federal standard
for purposes of the cooperative
interstate shipment program. The law
clearly requires that the inspection
services that designated State personnel
provide to selected establishments in
States participating in the cooperative
interstate shipment program be ‘‘the
same as’’ those provided under the
Federal program.
Comment: Several comments claimed
that under the ‘‘at least equal to’’
standard, some States have
implemented requirements for food
safety and consumer protection that are
stricter than those provided for under
the Federal Acts. According to these
comments, many States have processes
for the review and evaluation of product
labels that do more than FSIS’s generic
label process to ensure that the labels of
meat and poultry products properly
inform consumers about the product, its
weight and its ingredients. The
comments also noted that while FSIS
currently does not have the authority to
levy civil penalties for violations of the
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Federal Acts, many States have the
authority to impose civil penalties
against violators of State meat and
poultry inspection laws. Some
comments stated that while FSIS allows
the slaughter and sale of up to 20,000
farm raised chickens annually to
restaurants and retail markets without
benefit of inspection, many State
programs do not permit this activity.
The comment claimed that requiring
States to operate their MPI programs in
a manner that is ‘‘identical to’’ the
Federal program could force the States
to lower their standards.
One comment stated that some states
impose humane handling and slaughter
requirements that go above and beyond
those required by Federal law. Another
comment said that some States have
stricter cold storage requirements than
FSIS.
Response: As discussed above, the
cooperative interstate shipment program
established in this final rule
supplements rather than replaces the
existing State MPI programs. States that
participate in the cooperative interstate
shipment program may continue to
operate their ‘‘at least equal to’’ State
MPI programs for meat and poultry
products produced and sold solely
within the State. Thus, this final rule
does not affect requirements for
labeling, civil fines, poultry inspection,
humane handling, or cold storage that
States have adopted as part of their
cooperative State MPI programs.
Comment: In the preamble to the
proposed rule, FSIS explained that to
qualify for a cooperative interstate
shipment program, States will need to
demonstrate that they have the authority
under State law to provide the necessary
inspection services to selected
establishments in the State (74 FR
47652). Some comments noted that if
the final regulations require that
inspection services provided to selected
establishments be the ‘‘the same as’’
those provided under the Federal
inspection system, many States will not
be able to immediately change their
laws to make them identical to the
Federal inspection laws.
One comment noted that the ability of
States interested in the new program to
change their rules and adopt FSIS
regulations will depend on the process
the State program must follow in order
to make those changes. Other comments
noted that each State has its own
legislative process and some State
legislatures do not meet every year. One
comment noted that, although the State
programs are ‘‘equal to’’ the Federal
inspection system, the terminology and
precise phrasing in the laws and
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regulations differ, and that State
administrative systems vary.
Response: As discussed above, the
cooperative interstate shipment program
supplements the existing State MPI
programs. Therefore, States are not
required to amend all State inspection
laws to make them identical to the
Federal requirements. States interested
in participating in the cooperative
interstate shipment program will need
to demonstrate that they have the
necessary legal authority to enforce
Federal food safety standards in selected
establishments in the State.
As noted by the comments, State laws
and regulations differ, and each State
has its own legislative process. Some
States may already have the necessary
legal authority to participate in the
cooperative interstate shipment
program, while others may need to
make legislative changes to provide for
any additional authority that they may
need.
Comment: Some comments asserted
that the main focus of any program that
provides for the interstate shipment of
State-inspected products should be on
the safety of the products produced in
the selected establishments, not on
administrative procedures for the
inspection program. According to the
comments, if States are required to
operate their cooperative interstate
shipment programs in a manner that is
the ‘‘same as’’ the Federal program, the
focus of these programs will be on the
administrative procedures of the State
instead of food safety. The comments
stated that regulatory requirements can
be met through different means and that
it is not practical or effective for a State
program to operate under the exact same
procedures prescribed in the Federal
system.
The comments suggested that an
effective alternative would be to allow
States to work within the existing ‘‘equal
to’’ framework to develop food safety
activities focused on problems specific
to their establishments. The comments
stated that the ‘‘at least equal to’’
standard is well accepted and has been
effective in ensuring that State MPI
inspection programs are comparable to
the Federal program.
Response: As explained above, the
law does not provide for the cooperative
interstate shipment program to operate
within the existing ‘‘at least equal to’’
framework. Under the 2008
amendments to the Acts, meat or
poultry produced in selected
establishments are permitted to bear a
Federal mark of inspection and be
shipped in interstate commerce only if
designated State personnel find that
such product qualify for a Federal mark
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(21 U.S.C. 683(b)(1)(a) and 472(b)(1)(a)).
While products that are inspected and
passed under a State’s ‘‘at least equal’’
MPI program qualify for a State mark,
these products are not eligible for a
Federal mark.
Comment: Some comments
complained that FSIS’s proposed
regulations would require that States
maintain two separate inspection
systems, one that is ‘‘identical to’’ the
Federal program and one that is ‘‘equal
to’’ the Federal program. The comments
said that adding an entirely new State
inspection system to comply with the
‘‘same as’’ standard will add an extra
layer of cost for the States. According to
the comments, many States would need
to hire additional laboratory staff to
perform different methodology and
complete documentation the same as
FSIS. The comments also said that
States would need funds to train
inspectors and purchase Federal
computers, and that overall State
administrative costs would increase
because office staff, accountants,
supervisors, and managers would need
to manage two systems. One comment
urged FSIS to fully consider the impact
that the ‘‘same as’’ standard will have on
the administrative aspects of the State
inspection programs.
Response: In the Preliminary
Regulatory Impact Analysis (PRIA) to
the proposed interstate shipment rule,
FSIS acknowledged that States that
choose to participate in the cooperative
interstate shipment program may need
to make certain modifications to their
inspection program to provide
inspection services to selected
establishments in the State (74 FR
47657). The Agency also acknowledged
that the inspection costs under the new
program may differ from the costs of the
existing State MPI program. As required
by law, if Congress provides the
necessary funding for the cooperative
interstate shipment program, FSIS will
reimburse States for costs related to the
inspection of selected establishments in
the State in an amount not less than 60
percent of eligible State cost. FSIS has
updated its analysis of the State costs in
the Final Regulatory Impact Analysis
(FRIA) for this final rule.
As noted by the comments, the
cooperative interstate shipment program
established in the proposed rule may
require that States maintain two
separate inspection programs, one that
is ‘‘the same as’’ the Federal program and
one that is ‘‘equal to’’ the Federal
program. States that enter into
cooperative agreements under the
Talmadge-Aiken program to provide
Federal inspection services to Federal
establishments on behalf of FSIS are
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also required to maintain two separate
inspection systems—one under the
cooperative State ‘‘at least equal to’’ MPI
program and the other under the
cooperative Talmadge-Aiken program.
Thus, FSIS does not believe that the cost
to administer two separate cooperative
inspection programs will prevent States
that are interested in participating in the
cooperative interstate shipment program
from doing so.
3. ‘‘Same as’’ Computer Systems and
Forms
In the preamble to the proposed rule,
FSIS explained that to qualify for a
cooperative interstate shipment
program, the Agency expects States to
demonstrate that they can provide the
necessary equipment for State personnel
to provide the same inspection services
to selected establishment that FSIS
provides to official establishments,
including computers and supplies for
collecting regulatory product samples
(74 FR 47652).
Comment: A number of comments
said that this statement could be
interpreted to mean that State programs
must obtain and use the same
computers and computer programs that
are used by FSIS personnel. The
comments requested that FSIS clarify its
expectations with regard to the type of
computers and information systems the
States will need to have in place to
qualify for a cooperative interstate
shipment program.
Some of these comments noted that
many States currently use State-issued
laptops computers and have developed
systems that have been determined
‘‘equal to’’ FSIS to track and report
inspection activities and other required
data. One comment noted that some
States have developed their own datadriven systems that mimic the Federal
System, but that also allow State
program personnel access to State
licensing information and to view and
conduct other inspection activities in
facilities that are not related to meat and
poultry. According to the comment,
States with their own information
systems are able to tailor FSIS
inspection activities, which are geared
towards use in larger establishments, to
be effective in very small
establishments.
Response: To qualify for the
cooperative interstate shipment
program, States will need to have
computer programs and information
systems that are ‘‘the same as’’ those
used by FSIS to administer the Federal
inspection program. Assuming that
Congress provides the necessary
funding, FSIS will allow States that do
not have the necessary information
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systems to purchase from the Agency
federally-procured computers and the
necessary computer programs. FSIS will
reimburse the States for 60% of their
eligible costs to obtain the necessary
computers and software. FSIS does not
intend to reimburse more than 60% of
the States’ costs unless Congress directs
it, and provides the money for it to do
so.
Comment: Some comments stated that
if FSIS expects States to have
information systems that are identical to
those used under the Federal system,
some States will need to maintain two
computer systems to participate in the
program because the Federal computer
system does not allow any State
program loads, and the Federal systems
cannot be operated on a computer other
than a federally-sourced computer. One
comment noted that federally-procured
computers generally cost more than
State-procured ones, and the Federal
computers would only be used on a
limited basis by State personnel that
work in selected establishments.
Response: As noted above, to provide
the necessary inspection services under
the cooperative interstate shipment
program, States that participate in the
program will need to use computer
programs that are ‘‘the same as’’ those
used by FSIS to administer the Federal
inspection program. Thus, if the Federal
computer programs cannot be operated
on State-sourced computers, the State
may need to purchase new computers
from FSIS. As a result, some States will
need to maintain two computer systems
to participate in the cooperative
interstate shipment program.
Comment: One comment asked if
states participating in the cooperative
interstate shipment program will have
access to all of the Federal data
programs, like eADRS, Assurance Net
and FSIS intranet. Another comment
stated that FSIS did not explain how
requiring that States have identical
computer systems in order to participate
in the cooperative interstate shipment
program will further food safety and
compliance with the Acts.
Response: States that participate in
the cooperative interstate shipment
program will have access to the
computer programs that are necessary to
provide inspection services that are ‘‘the
same as’’ those provided under the
Federal program. The computer systems
used by States to administer the
cooperative interstate shipment program
need to be ‘‘the same as’’ those used
under the Federal program to ensure
that selected establishments are meeting
all food safety standards that are ‘‘the
same as’’ rather than ‘‘at least equal to’’
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standards imposed under the Federal
program.
Comment: Some comments asked
whether the forms used by States
operating under a cooperative interstate
shipment need to be identical to the
Federal forms that FSIS uses under its
inspection program. According to one
comment, State inspection programs
frequently do not have access to Federal
forms and, therefore, most have
developed their own forms. The
comment stated that, if States are
required to maintain forms that are
identical to the Federal forms, many
States will need to manage two different
sets of documentation to participate in
the cooperative interstate shipment
program.
Response: To provide the necessary
inspection services to selected
establishments participating in the
cooperative interstate shipment
program, States will need to use forms
that are the same as those used under
the Federal inspection program. FSIS’s
OOEET will assist the States to obtain
the necessary forms.
4. ‘‘Same as’’ Training for Designated
State Personnel
The preamble to the proposed rule
stated that to qualify for a cooperative
interstate shipment program, States will
need to demonstrate that designated
State personnel have been properly
trained in Federal inspection
methodology (74 FR 7652). The
preamble also explained that FSIS offers
training courses in Federal inspection
methodology to State inspection
personnel and that States that are
interested in participating in a
cooperative interstate shipment program
will be responsible for making
arrangements for their inspection
personnel to attend these courses.
Comment: Several comments stated
that FSIS-sponsored training is costly,
lengthy, and almost always requires
travel out of State for extended periods
of time. The comments suggested that,
instead of requiring designated State
personnel to attend FSIS training, the
Agency should allow States to provide
training that is ‘‘equal to’’ FSIS’s training
program. The comments explained that
such training would include equivalent
content as FSIS training but could be
administered by the individual States,
other State programs, FSIS or other
qualified entities.
Response: The law does not provide
for training that is ‘‘equal to’’ FSIS’s
training program or that includes
equivalent content. The 2008
amendments to the Acts require that
designated State personnel under go
‘‘* * * all necessary inspection training
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and certification to assist the [FSIS
Administrator] in the administration
and enforcement of [the Acts], including
rules and regulations issued under [the
Acts]’’ (21 U.S.C. 683(a)(2)and 472(a)(2)).
As stated in the Senate Committee
report, this means that the designated
State personnel ‘‘* * * must have
undergone all the necessary training to
carry out the requirements of [the Acts],
[their] regulations, notices, directives
and policies, just as required of a
Federal inspector’’ (S. Rep. No. 220,
110th Cong., 1st Sess. (2007), pp. 211–
214) Thus, the law clearly requires that
the training in Federal inspection
methodology provided to designated
State personnel be ‘‘the same as’’ the
training provided to FSIS inspection
personnel.
As noted in the preamble to the
proposed cooperative interstate
shipment rule, FSIS offers training
courses in Federal inspection
methodology to State inspection
personnel. FSIS’s OOEET will
coordinate with States participating in
the cooperative interstate shipment
program to provide the necessary
training for designated State personnel.
Comment: Some comments stated that
many States conduct their own training
courses, which are subject to oversight
by FSIS. The commenters noted that
these State courses often present the
identical material that FSIS presents in
its training courses. The comments
suggested that FSIS consider these State
courses as acceptable training for
designated State personnel.
Response: Although some States may
be providing training that includes the
same content as the training provided
by FSIS, designated State personnel will
need to complete FSIS-sponsored
training for the State to qualify for the
cooperative interstate shipment
program. FSIS-sponsored training
courses will ensure that designated
State personnel receive the necessary
training to carryout the requirements of
the Federal Acts, ‘‘just as required of a
Federal inspector,’’ as intended by
Congress.
Comment: One comment asked
whether State personnel will need to
complete their training before the State
begins its cooperative interstate
shipment program. Some comments
stated that State programs cannot afford
the travel costs associated with sending
already trained state inspectors to
additional training. One comment
suggested that FSIS make any required
training for State inspectors available
through on-line courses at no charge to
the States. Two comments asked
whether FSIS would be covering
training and training-related expenses.
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Response: As noted above, the
preamble to the proposed rule explained
that to qualify for the program, States
would need to demonstrate, among
other things, that designated State
personnel have been properly trained in
Federal inspection methodology. This
means that when a State submits a
request to FSIS for a cooperative
interstate shipment program, the State
must demonstrate either that its
designated State personnel have
completed the necessary training in
Federal inspection methodology or that
such personnel will have completed
such training before they begin to
provide inspection services to selected
establishments in the State.
As previously noted, FSIS currently
offers courses in Federal inspection
methodology to State inspection
personnel. States that are interested in
participating in a cooperative interstate
shipment program will be responsible
for making arrangements for their
inspection personnel to attend these
courses. FSIS’s OOEET will coordinate
with the States to help make the
necessary training available to
designated personnel in the State. For
example, if a State has a significant
number of designated personnel that
need to be trained Federal inspection
methodology, FSIS could arrange to
conduct training courses at a location
within the State so that all designated
State personnel can attend.
As it does for training costs associated
with the State MPI program, FSIS will
reimburse States for any eligible training
costs associated with the cooperative
interstate shipment program, including
necessary travel costs. However, instead
of reimbursing the State for 50% of the
eligible costs, FSIS will reimburse 60%
of a State’s eligible costs associated with
training designated State personnel.
As discussed above, for a State to
qualify for the cooperative interstate
shipment program, its designated State
personnel will need to attend FSISsponsored training in person. Thus,
FSIS will not be providing the required
training through on-line courses as
suggested by the comment. The Agency
may, however, make supplemental
training materials available on-line.
5. ‘‘Same as’’ Laboratory Testing and
Analysis
The preamble to the proposed rule
explained that to qualify for an
interstate shipment program, States will
need to demonstrate that the laboratory
services that they intend to use to
analyze regulatory product samples
from selected establishments are
capable of conducting the same
chemical, microbiological, physical, and
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pathology testing as are required under
the Federal meat and poultry products
inspection programs (74 FR 47652). The
preamble also explains that FSIS’s
Office of Public Health Science (OPHS)
will provide laboratory audit assistance
to the State to verify that the
methodologies used by a State’s
laboratory services to analyze samples
from selected establishments are
capable of producing the same results as
the methodologies used by FSIS
laboratories.
Comment: Some comments agreed
that State-inspected establishments
participating in the cooperative
interstate shipment program should be
subject to the same regulatory sampling
programs as those established in the
Federal inspection program. One
comment stated that positive results on
pathogen and residue testing on
products produced in selected
establishments should lead to the same
regulatory actions that federallyinspected establishments are subjected
to.
Two comments stated that they were
encouraged by the requirements for
regulatory sampling and laboratory
analysis described in the proposed rule.
The comments stated that a robust
residue, microbiological, and
pathological analysis capability will
assure accuracy of these test results,
which, according to the comments, is
essential for maintaining foreign
markets.
Response: The comments present
valid reasons for requiring that the
selected establishments participating in
the cooperative interstate shipment
program be subject to the same
regulatory sampling required under the
Federal program.
Comment: Several comments
requested that FSIS clarify its
expectations with regard to the
laboratory services used by States to
analyze samples under the cooperative
interstate shipment program. Many
comments specifically asked whether
FSIS expects these laboratories to be
(International Organization for
Standards) ISO accredited. Several
comments expressed concern that if
FSIS requires laboratories that analyze
samples for the cooperative interstate
shipment program to be ISO accredited,
some laboratories will have to abandon
perfectly acceptable procedures, or
possibly more up-to-date procedures, to
perform the methodology executed at
the FSIS laboratories. The comments
also said that some states would need to
hire additional personnel to perform the
increased paperwork with no additional
benefit in the quality or quantity of tests
performed.
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Response: The laboratory services that
States use to analyze samples collected
under the cooperative interstate
shipment must be capable of producing
the same results as FSIS’s laboratories.
Therefore, to demonstrate that the
laboratory services used by a State are
sufficient for the State to qualify for the
cooperative interstate shipment
program, the State will need to show
that the laboratory is accredited by an
internationally recognized organization
that accredits food testing laboratories
against the ISO 17025 ‘‘General
Requirements for the Competence of
Testing and Calibration Laboratories’’
and AOAC ‘‘Guidelines for Laboratories
Performing Food Microbiological and
Chemical Analyses of Food and
Pharmaceuticals Testing’’ written by the
Analytical Laboratory Accreditation
Criteria Committee (ALACC). The
assessment body that FSIS uses, the
American Association for Laboratory
Accreditation (A2LA), is the sole
organization that incorporates ALACC
into their program requirements. State
labs would need to use A2LA or another
accrediting body that incorporates
ALACC and is a signatory and in good
standing to the Mutual Recognition
Arrangements of the International
Laboratory Accreditation Cooperation
(ILAC).
The laboratory will also need to use
the protocols for analytical tests
required for FSIS regulatory activities
on meat and poultry products described
in the FSIS Chemistry, Microbiological,
and Pathology Laboratory Guidebooks.
However, if the laboratory that a State
intends to use to analyze samples for the
cooperative interstate shipment program
is unable to follow an FSIS method as
written, the State may submit a
justification to FSIS that: (1) Explains
why the laboratory is unable to follow
the FSIS methodology and (2) describes
the modifications that the laboratory
intends to make to the FSIS
methodology. FSIS will evaluate the
State’s justification to determine
whether the modification of FSIS
methodology is minimal and
supportable through validation or other
evidence. FSIS will allow a State to use
the modified method if the Agency
determines that methodology is
consistent with the original FSIS
protocol and the State’s method is
capable of achieving results that are
consistent with the corresponding FSIS
method.
To assist the States in developing
laboratory services that are ‘‘the same
as’’ those provided under the Federal
inspection program, FSIS is adopting a
‘‘phased in’’ approach for the States to
become ISO 17025 accredited. OPHS
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has developed a Quality Assurance (QA)
checklist based on ISO 17025 and
ALACC criteria. It is not as extensive as
ISO 17025, but contains minimum QA
practices that laboratories should follow
to be able to defend their results. The
checklist is included as an appendix in
FSIS’s guidance for ‘‘at least equal to’’
State MPI programs. States that use
services from laboratories that are not
ISO 17025 accredited but that can
demonstrate that the laboratories meet
the laboratory criteria in the FSIS QA
checklist will be permitted to
participate in the cooperative interstate
shipment program if they agree to
actively seek and obtain ISO
accreditation within two years.
However, if the laboratory fails to
actively seek or does not obtain the
necessary accreditation, FSIS will
terminate the State’s cooperative
agreement for the interstate shipment
program.
FSIS is developing materials to assist
States whose laboratory services are
pursuing ISO accreditation to meet the
requirements to become accredited.
States may also use an outside
laboratory to analyze samples collected
under the cooperative interstate
shipment program if the outside
laboratory has the necessary
accreditation.
States that currently use laboratories
with active ISO 17025 accreditations
will need to submit the necessary
documentation for FSIS to verify that
the laboratories are ISO accredited and
meet ALACC food laboratory
requirements as assessed by an
appropriate accreditation body. To
remain eligible for the programs, States
will need to demonstrate, through
documented third-party audits or other
appropriate documentation, that their
laboratories are maintaining their
accreditation and are continuing to use
methods described in FSIS Laboratory
Guidebooks.
Comment: One comment asserted that
instead of conducting the same number
and type of sampling that is conducted
under FSIS’s sampling programs, the
Agency should allow States to develop
sampling programs that reflect the same
number of samples over the broad
spectrum of meat products produced
under the cooperative interstate
shipment program. According to the
comment, States may very well conduct
more sampling or more comprehensive
sampling than Federal programs. The
comment also suggested that FSIS
provide States with production data to
guide them in selecting the same
number or more samples based on the
same volumes under FSIS inspection
programs.
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Response: To qualify for the
cooperative interstate shipment program
States must, at a minimum, collect and
analyze the same number and type of
regulatory product samples from
selected establishments as are collected
and analyzed under FSIS’s inspection
sampling program. If they have met the
sampling requirements provided for in
FSIS’s regulatory sampling programs,
States may collect additional samples or
conduct additional analyses if they
choose to do so. FSIS will provide
guidance to States in determining the
appropriate number of samples that they
will need to collect to be the same as the
Federal regulatory sampling program.
Comment: Some comments noted that
establishing a national laboratory
program to analyze samples collected
under the cooperative interstate
shipment program would be more
economically viable than requiring that
each State program conduct a laboratory
program that is ‘‘the same as’’ FSIS’s.
According to the comments, it is
economically unreasonable for States to
set up and maintain equipment
necessary for running extremely rare
samples.
Response: States that do not have the
laboratory capability to conduct the
necessary sampling and analyses
required under the cooperative
interstate shipment program are
permitted to submit samples collected
under the cooperative interstate
shipment program to an outside
laboratory that does. The States may
rely on the sample results obtained from
an outside laboratory if the State, in
coordination with FSIS’s OPHS, has
verified that the laboratory has the
necessary accreditation and is capable
of producing the same results obtained
by FSIS’s laboratories.
Comment: One comment stated that
the level of oversight that FSIS intends
to have over State laboratories under the
cooperative interstate shipment program
is unnecessary. The comment suggested
that, if FSIS intends to oversee the
analysis of samples collected from
selected establishments, it should offer
to analyze all samples from eligible
establishments at FSIS laboratories at no
cost to the State program.
Response: FSIS does not intend to
oversee the analysis of samples
collected from selected establishments.
The Agency intends to consult with the
States to verify that the laboratories that
States use to analyze samples from
selected establishments are capable of
producing the same results as FSIS’s
laboratories.
Comment: One comment included a
number of questions that the commenter
requested FSIS address before the
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Agency issues the final rule to
implement the cooperative interstate
shipment program. The questions are as
follows:
• Will the kidney inhibition swab
(KIS) test for detecting antimicrobial
drug residues be required in
establishments selected for the program,
or will other tests be acceptable?
• If KIS is necessary, will every
facility be required to have an incubator,
or can samples be sent to the state
laboratory, requiring only one
incubator?
• If an establishment decides to
participate in both the cooperative
program and the state inspection
program, would the sampling program
required by FSIS be sufficient, or would
they also have to participate in the
State’s sampling program?
• Could the selected establishments
be put into the FSIS sampling program,
with FSIS sending sample requests and
supplies, and the samples analyzed at
Federal labs?
• What process must be followed if a
state’s laboratory wants to request audit
help?
• Will the recommendations of the
auditor be the official required
adjustments the lab must make to allow
the state to participate in the program?
Response: As noted above, the
laboratory services that a State uses to
analyze samples under the cooperative
interstate shipment program must use
methods that are capable of producing
results that are ‘‘the same as’’ those
obtained from the methods used by
FSIS’s laboratories. Therefore, the KIS
test for detecting antimicrobial drug
residues used by FSIS is the acceptable
test. Samples may be sent to and
analyzed by the State laboratory if FSIS
has evaluated and approved any minor
modifications to the procedures
described in the FSIS Laboratory
Guidebooks.
If an establishment participates in
both the cooperative interstate shipment
program and the cooperative State MPI
program, the sampling conducted under
the cooperative interstate shipment
program must be ‘‘the same as’’ the
sampling conducted under the Federal
program, while the samples collected
under the State MPI program must meet
standards that are ‘‘at least equal to’’ the
Federal program.
States that participate in the
cooperative interstate shipment program
are responsible for scheduling,
collecting and analyzing samples
required under the program. FSIS will
not collect or analyze regulatory
samples for the cooperative interstate
shipment program.
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The SEC assigned to the State will
facilitate the process for the State to
obtain the necessary audit assistance
from FSIS’s OPHS. As noted above,
OPHS will provide guidance and advice
on laboratory accreditation
requirements. However, the laboratories
themselves will be responsible for
obtaining the necessary ISO
accreditation.
6. Related Activities
Comment: Some comments requested
that FSIS clarify what States need to do
to demonstrate they are able to ‘‘conduct
any related activities that would be
required under a cooperative interstate
shipment program,’’ as required under
the proposed regulations. The
comments said that the final rule must
specifically describe the ‘‘related
activities’’ required under the
cooperative agreement or else the
Agency should remove this statement.
One comment said that requiring that
States conduct ‘‘related activities’’ adds
requirements for a State program that
are outside of what is authorized by the
enabling statute, and is both unclear and
unnecessary. The comment said that
FSIS should not be attempting to
impose ancillary requirements on the
States through the cooperative
agreement process. According to the
comment, the State’s ability to provide
inspection service to selected
establishments in accordance with the
statute is all that is authorized and,
therefore, all that is necessary.
Response: The term ‘‘related
activities’’ refers to any activities that are
necessary to ensure that the inspection
services provided to selected
establishments are ‘‘the same as’’ the
inspection services provided to Federal
establishments. Such activities include,
but are not limited to, scheduling,
collecting and analyzing regulatory
samples, issuing export certificates for
establishments that will be exporting
products to foreign countries, and
verifying that selected establishments
are humanely handling livestock in
connection with slaughter.
E. Additional Conditions for State
Participation
In addition to requiring that a State’s
requests for an interstate shipment
program include documentation to
demonstrate that it is capable of
providing the necessary inspection
services to selected establishments in
the State, the proposed regulations also
require that, in its request, the State
must agree to: (1) Provide FSIS with
access to the results of all laboratory
analyses conducted on product samples
from selected establishments in the
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State; (2) inform the SEC for the State of
any laboratory results that indicate that
a product produced in a selected
establishment may be adulterated or
may otherwise present a food safety
concern; and (3) if necessary, cooperate
with FSIS to transition selected
establishments in the State that have
been deselected from a cooperative
interstate shipment program to become
official establishments (proposed 9 CFR
332.4(b)(3) and 381.187(b)(3)).
The proposed regulations also provide
that when States submit their requests
for an interstate shipment program, they
must include a list of establishments
that have requested to participate in the
program and that the State recommends
for initial selection into the program
(proposed 9 CFR 332.4(b)(1) and
381.187(b)(1)).
Comment: Two comments suggested
that FSIS remove the provision in the
proposed regulations that requires that
States give FSIS access to the results of
all laboratories analyses conducted at
selected establishments. The comments
stated that such a requirement is
unnecessary because the States are also
required to notify the SEC of results that
indicate that a product produced in a
selected establishment may be
adulterated or may otherwise present a
food safety hazard.
Response: Although the States are
required to notify the SEC of laboratory
results that indicate that a product
produced in a selected establishment
may be adulterated or present a food
safety hazard, the SEC or other FSIS
personnel also need to have access to
the results of the laboratory analyses
conducted on products produced in
selected establishments to verify that
these establishments are operating in a
manner that complies with the Acts.
Comment: One comment stated that,
as written, the proposed requirement
that States give FSIS ‘‘access’’ to all
laboratory results could be interpreted
as requiring that FSIS have electronic
access, via a particular system, to the
results of testing conducted by State
programs. According to the comment,
when an integrated electronic system for
data sharing is developed, funded, and
implemented, State programs will share
laboratory results with FSIS
electronically. The comment maintained
that the cooperative interstate shipment
program should not unintentionally
limit the methods by which analytical
results are shared with FSIS before an
electronic system is fully operational.
Response: The regulations do not
prescribe the methods by which States
are required to share their analytical
results with FSIS. States may share
analytical results with FSIS
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electronically or they may provide hard
copies. The only requirement is that
they give FSIS access to these results
upon request.
Comment: One comment said that the
proposed requirement that the State
notify the SEC when laboratory results
indicate that a product from a selected
establishment may be ‘‘adulterated or
may otherwise present a food safety
concern’’ is overly broad and redundant.
The comment asserted that any product
that presents a food safety concern is, by
definition, adulterated. The comment
suggested that FSIS delete the phrase
‘‘may otherwise present a food safety
concern’’ in the final regulations.
Response: There may be instances in
which a product presents a food safety
concern but it is unclear as to whether
the product is adulterated under the
FMIA or PPIA. For example, a
preliminary laboratory result may
indicate that a product that has been
distributed in commerce is
contaminated with a pathogen but the
laboratory needs to complete the
analysis to confirm these results. The
SEC needs to be made aware of these
situations to verify that the
establishment and States have
responded to the preliminary result in a
manner that complies with the Federal
Acts and implementing regulations.
Comment: One comment stated that,
instead of requiring that a State’s
request for a cooperative interstate
shipment program include a list of
establishments that have submitted
requests to participate in the program
and that the State recommends for the
program, the final regulations should
permit States to submit a request for a
cooperative interstate shipment program
before they have identified
establishments interested in being
selected for the program. According to
the comment, this would allow the State
and Federal programs to work out any
issues with their relationship before
offering the program to establishments.
Response: FSIS agrees with this
comment. The Agency has modified the
regulations to require that a State’s
request for a cooperative interstate
shipment program include a list of
establishments that have submitted a
request to participate in the program, if
any. This will allow States to request an
agreement for a cooperative interstate
shipment program before they have
identified establishments interested in
participating in the program. However,
FSIS will only reimburse States for 60%
of their eligible costs to administer the
program if, after entering into a
cooperative agreement, establishments
in the State are selected for, and
participate in, the program.
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Comment: A few comments stated
that, in addition to verifying that States
have sufficient authority, resources,
personnel, training, sampling capability
and laboratory capacity to provide the
necessary inspection services to selected
establishments in the State, FSIS will
also need to monitor budget issues in
participating States on an ongoing basis
to ensure that States continue to have
sufficient resources to participate in the
program. The comments noted that
many State governments are under
financial duress and have had to make
budget cuts in their State inspection
programs. One comment said that even
though FSIS is required to reimburse
States for at least 60% of their eligible
costs associated with the cooperative
interstate shipment program, the
Agency will need to verify that States
interested in participating in the new
program will be able to meet Federal
inspection regulatory requirements
during these hard economic times.
Response: States that enter into an
agreement with FSIS for a cooperative
interstate shipment program will be
required to prepare annual budgets to
cover the costs for the cooperative
interstate shipment program, maintain
complete accounting records, and
conduct all other financial
accountability activities just as they do
for the State MPI program. FSIS will
terminate a State’s agreement for a
cooperative interstate shipment program
if the State does not have sufficient
finances to comply with all aspects of
the cooperative interstate shipment
program.
F. Selection Process
Under the proposed regulations,
State-inspected establishments that are
interested in participating in the
cooperative interstate shipment program
must apply for the program through
their State (proposed 9 CFR 332.5(a)(1)
and 381.515(a)(1)). If a State determines
that an establishment operating under
the State’s meat or poultry products
inspection program qualifies for
selection into a cooperative interstate
shipment program, and the State is able
and willing to provide the necessary
inspection services to the establishment,
the State is to submit its evaluation of
the establishment through the FSIS
District Office that covers the State (74
FR 47653). The proposed rule provides
that the FSIS Administrator, in
coordination with the State, will decide
whether to select the establishment for
the program (proposed 9 CFR 332.5(b)
and 381.151(b)).
Comment: Some comments said that
the State inspection program is the
government entity best suited to begin
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24729
the process of selecting establishments
for the cooperative interstate shipment
program. According to the comments
the States, not the FSIS Administrator,
should be responsible for selecting
establishments to participate in the
program. The comments suggested that
after initiating the selection process, the
State program could collaborate with
the FSIS SEC, who can visit the
establishments that are under
consideration for selection into the
cooperative interstate shipment
program.
Response: FSIS agrees that the States
are best suited to begin the process of
determining which establishments in
the State are eligible for selection to the
cooperative interstate shipment
program. Therefore, the proposed rule
requires that establishments interested
in participating in the cooperative
interstate shipment program apply for
the program through the State in which
they are located (proposed 9 CFR
332.5(a) and 381.515(a). After the State
recommends establishments for the
program, the law requires that the FSIS
Administrator coordinate with the State
to select establishments for the program
(21 U.S.C. 683(b)(1) and 472(b)(1)).
Comment: One comment argued that
the regulations do not need to include
a process for selecting establishments to
participate in the cooperative interstate
shipment program because
establishments operating under the
State MPI programs are already under
an inspection system that provides for
food safety in a manner that is ‘‘at least
equal to’’ the Federal inspection
program. According to the comment,
there is no need for selection because
the entire State program has already
been approved.
Response: The law requires that the
FSIS Administrator, in coordination
with the State, select establishments to
participate in the new cooperative
interstate shipment program (21 U.S.C.
683(b) and 472(b)). There is nothing in
the law to indicate that establishments
operating under the existing State MPI
programs have already been approved
for the cooperative interstate shipment
program. Therefore, these final
regulations include procedures for
selecting establishments for the
program.
Comment: One comment suggested
that the final rule require that selected
establishments undergo an on-site
review by FSIS at least 30 days before
they become eligible to participate in
the cooperative interstate shipment
program. The comment noted that such
a review would help to guarantee that
selected establishments that wish to
ship their meat products in interstate
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commerce are in compliance with
Federal law.
Response: The preamble to the
proposed rule explained that, as part of
the selection process, the SEC assigned
to a State, in coordination with the
State, will verify that each
establishment in the State that has
applied to participate in a cooperative
interstate shipment program is in
compliance with all Federal standards
(74 FR 47653). To verify such
compliance, the SEC will coordinate
with the State to conduct on-site
reviews of each establishment that has
applied, and that the State recommends,
for selection into the program.
Comment: One comment said that
FSIS should better explain how
establishments may be selected for the
cooperative interstate shipment
program.
Response: The preamble to the
proposed rule provides a detailed
description of the proposed selection
process. FSIS is adopting that process in
this final rule.
As proposed, State-inspected
establishments that are interested in
participating in a cooperative interstate
shipment program will be required to
apply for the program through the State
agency that administers the State MPI
program. States are responsible for
establishing their own application
procedures. The State will then evaluate
the establishment to determine whether
it qualifies for selection. To qualify for
selection to the cooperative interstate
shipment program, an establishment
must:
• Have the appropriate number of
employees;
• Not be ineligible for a cooperative
interstate shipment program 2;
• Be in compliance with all
requirements under the State inspection
program; and
• Be in compliance with all Federal
meat or poultry products inspection
requirements.
If a State determines that an
establishment operating under the
State’s MPI program qualifies for
selection into a cooperative interstate
shipment program, and the State is able
and willing to provide the necessary
inspection services to the establishment,
the State is to submit its evaluation of
the establishment through the FSIS
2 Examples of establishments that are ineligible
for the cooperative interstate shipment program
include official Federal establishments,
establishments located in a State that has a State
MPI program, establishments in violation of the
FMIA or PPIA, establishments that are the subject
of a transition to become a Federal plant, and
establishments located in a State without a State
MPI program.
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District Office that covers the State. The
FSIS Administrator, in coordination
with the State, will then decide whether
to select the establishment for the
program.
In deciding whether to select an
establishment that the State has
recommended for the cooperative
interstate shipment program, the
Administrator will consider whether the
establishment qualifies for the program
and whether the Agency has the
resources that it needs to provide the
required oversight of the establishment
if it is selected for the program. Before
an establishment can be selected, the
SEC, in coordination with the State,
must verify, through record reviews and
on-site visits, that the establishment is
in compliance with all Federal
inspection requirements under the
FMIA, PPIA, and their implementing
regulations in title 9, chapter III, of the
CFR.
G. Mark of Inspection and Official
Number
The proposed regulations require that
inspection services for selected
establishments be provided by
designated State personnel, and that
articles prepared or processed in a
selected establishment that have been
inspected and passed by designated
personnel bear an official Federal mark
of inspection (proposed 9 CFR 332.6(c)
and 381.516(c)). The proposed
regulations also require that the Federal
mark contain a selected establishment
number assigned to the establishment
by the State. The proposal provides that
the number must include, as a suffix,
the abbreviation for the State in which
the establishment is located, as well as
the abbreviation ‘‘SE’’ for selected
establishment (e.g. ‘‘38SETX’’ as a
number for a selected establishment in
Texas). If the establishment processes
poultry products, the suffix must also
contain a ‘‘P,’’ (e.g., 38 SEPND for a
selected poultry establishment in North
Dakota) (proposed 9 CFR 332.5(c) and
381.515(c)). The proposed regulations
also state that States that fail to assign
an establishment number to selected
establishments in the State and report
the number to the SEC for the State will
not qualify to participate in the program
(proposed 9 CFR 332.5(d) and
381.515(d)).
Comment: Some comments expressed
concern that allowing State-inspected
meat and poultry products to bear a
Federal mark of inspection will make it
difficult to maintain the integrity of the
Federal mark. One comment stated that
the integrity of the Federal mark will be
diminished if a State-inspected product
distributed in interstate commerce is
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recalled or found to be adulterated.
Another comment said that allowing
State-inspected products to bear a
Federal mark of inspection is
misleading because consumers that see
a Federal mark of inspection on the
label of a meat or poultry product will
think that the product is the same as all
other federally-inspected products. The
comment noted that the FMIA and PPIA
both prohibit labeling that is false or
misleading.
Response: Under the 2008
amendments to the Acts, meat and
poultry products produced under the
cooperative interstate shipment that
designated State personnel have
determined are in compliance with all
Federal standards are required to bear a
‘‘Federal mark, stamp, tag, or label of
inspection’’ (21 U.S.C. 472(b)(1) and
683(b)(1)). Thus, requiring that articles
prepared or processed in a selected
establishment that have been inspected
and passed by designated personnel
bear an official Federal mark is
consistent with the law. Such a
requirement will not diminish the
integrity of the Federal mark or be
misleading to consumers, as suggested
by the comments, because all meat and
poultry products that bear the Federal
mark will have been produced under
Federal standards.
Comment: Some comments
maintained that it is not necessary to
require that the meat and poultry
products produced under the
cooperative interstate shipment program
bear a Federal mark of inspection
because States that have MPI
cooperative agreements already provide
State marks. A State Department of
Agriculture and a State agency
commented that many State-inspected
establishments prefer that their products
bear the State mark of inspection. The
comments claimed that requiring that
selected establishments apply a Federal
mark and identify the State in the
establishment number is unacceptable
to most plant owners. Another comment
argued that requiring that a Federal
mark of inspection be applied to
products that have been inspected by a
State inspector under a cooperative
State meat inspection program is
counterintuitive and does not
accomplish the goal of providing for
interstate shipment of State-inspected
products.
Response: The 2008 amendments to
the Acts require that meat and poultry
products produced under the
cooperative interstate shipment program
bear a Federal mark of inspection.
As noted above, under the proposed
regulations, the Federal mark is required
to contain a selected establishment
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number assigned to the establishment
by the State. The selected establishment
number is required to include, as a
suffix, the abbreviation for the State in
which the establishment is located, as
well as the abbreviation ‘‘SE’’ for
selected establishment (e.g. ‘‘38SETX’’ as
a number for a selected establishment in
Texas). If the establishment processes
poultry products, the suffix must also
include a ‘‘P’’ before State abbreviation
(e.g., 38 SEPND for a selected poultry
establishment in North Dakota). Thus,
although meat and poultry products
produced in selected establishments
will not bear a State mark of inspection,
the State in which the product was
produced can be readily identified by
referencing the selected establishment
number that is required to appear inside
the Federal mark.
Comment: Some comments agreed
that products produced in selected
establishments should bear a Federal
mark of inspection but also suggested
that such products be allowed to bear a
State mark if the establishment so
chooses. According to the comments,
many State-inspected establishments
believe that compliance with their State
inspection program requirements along
with the Federal standards provides a
marketing advantage and that
appearance of the State mark may add
value to State-inspected products sold
in interstate commerce. One comment
noted that because their State mark of
inspection is an outline of the State,
selected establishments in the State
could use the State mark to promote
their products interstate.
Response: It is not necessary for meat
or poultry products that have been
processed or prepared in selected
establishments to bear both a State and
Federal mark because the product’s
State-of-origin can be identified by the
selected establishment number that is
required to appear in the Federal mark.
Moreover, allowing products produced
under Federal standards to bear both a
Federal and State mark of inspection
may be misleading to consumers and
foreign trade partners because the law
prohibits interstate shipment of
products produced under State MPI
programs. Allowing both Federal and
State marks could also be confusing to
consumers and make it difficult for
them to identify products potentially
implicated in outbreaks or subject to
recall.
Selected establishments that were
interested in using the State mark to
market meat or poultry products
produced under the cooperative
interstate shipment program could use
labeling statements information to
identify where the product was
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produced instead, provided that the
statement is truthful and not
misleading. For example, the label of a
meat product produced in a selected
establishment in Texas, could contain
the statement ‘‘prepared in Texas,’’ if the
statement is presented in a manner that
is truthful and not misleading to
consumers.
Comment: Some comments suggested
that instead of requiring that States
assign a new official State establishment
number to selected establishment, FSIS
should allow establishments that
participate in the cooperative interstate
shipment program to retain their official
State number in conjunction with the
suffix ‘‘SE.’’
Response: There is nothing in the
proposed rule that would prevent a
State from allowing establishments
selected for the cooperative interstate
shipment program to retain their official
State number, provided that the suffix
‘‘SE’’ is added to original State
establishment number. The ‘‘SE’’ suffix
is necessary to make clear that the
establishment associated with the
number is a selected establishment.
Comment: One comment noted that
the proposed regulations identify the
‘‘SE’’ that is required to appear as part
of a selected establishment’s official
State number as a suffix. The comment
stated that the ‘‘SE’’ designation is, in
fact, a prefix.
Response: FSIS refers to the ‘‘SE’’
along with the State abbreviation as a
‘‘suffix’’ because these abbreviations
follow the number assigned to the
selected establishment.
Comment: One comment objected to
the provision in the proposed
regulations that provide that a State that
fails to assign an official State number
to the selected establishments in the
State and inform the SEC will be
disqualified from participating in the
cooperative interstate shipment
program. The comment believed that
disqualification is an overly harsh
penalty for what may be a simple
omission. The comment suggested that
in the final rule, FSIS replace the
statement that failure to assign an
official number ‘‘will disqualify the
State’’ to ‘‘may disqualify the State.’’
Response: As explained in the
preamble to the proposed rule, full
compliance by a State with the
requirements for assigning official
establishment numbers to
establishments selected for the
cooperative interstate shipment program
is essential if the program is to succeed
(74 FR 57654). FSIS will give States that
inadvertently fail to assign a proper
establishment number to a selected
establishment an opportunity to take
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24731
corrective actions to comply with the
regulations. However, failure to comply
with the establishment number
requirements in this final rule will
disqualify a State from participating in
the cooperative interstate shipment
program.
Comment: Several comments
submitted by State Departments of
Agriculture and State agencies
requested that in the final rule FSIS
make clear that it will permit selected
establishments to produce products
under both the cooperative interstate
shipment program and the State MPI
program. The comments noted that FSIS
allows establishments with both a
Federal grant and State grant of
inspection to operate as both a Federal
plant and a State plant if they maintain
an appropriate separation by time or
space between the State and Federal
operations and that the products are
appropriately marked. The comments
noted that in a letter to the National
Association of State Departments of
Agriculture (NASDA) dated September
15, 2009, the Deputy Secretary of
Agriculture said that FSIS expects to
apply a similar policy to selected
establishments that are interested in
continuing to produce certain products
solely for distribution in the State under
the State MPI program. The comments
maintained that allowing for this type of
flexibility will benefit rural America
and is necessary for the success of the
new program.
One comment said that if the final
rule permits selected establishments to
produce products under both the State
MPI program and the cooperative
interstate shipment program, FSIS
should allow these establishments to
continue to apply the State mark to
products that are not produced under
the cooperative interstate shipment
program.
Response: FSIS has considered these
comments and has decided to revise the
proposed regulations to allow selected
establishments to conduct operations
under both the cooperative interstate
shipment program and the State MPI
program if those establishments
implement and maintain written
procedures for complete physical
separation of product and process for
each operation by time or space. An
establishment may provide for
separation by space by conducting its
State MPI operations in an area that is
physically separate from the area in
which it conducts operations under the
cooperative interstate shipment
program. Alternatively, an
establishment may conduct each
operation in the same area provided that
the separation in space is sufficient to
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ensure that potential food safety
hazards, such as microbiological
pathogens, if present, are not likely
spread from one area to another through
aerosolization, air ducts, air currents,
employees, or other means and that
there is no co-mingling of product.
Establishments that chose to conduct
both operations in the same area must
clearly identify and distinguish the
State MPI operation from the
cooperative interstate shipment
operation. For example, the
establishment might designate certain
employees on a given day to work
exclusively on the State MPI operations
and have these employees wear white
clothing, and designate other employees
to work exclusively on the cooperative
interstate shipment operations and have
these employees wear yellow clothing.
The establishment could also color-code
knives and other equipment associated
with each operation.
In addition to separation by space, an
establishment may conduct the State
MPI operations and cooperative
interstate shipment operations at
separate times if the establishment’s
procedures for separation address cleanup between operations. Establishments
that conduct both operations in the
same facility and on the same
equipment, and that separate the
operations by time, will need to fully
clean and sanitize the facilities and
equipment in between operations as set
out in their Sanitation SOPs.
Establishments that conduct
operations under both the State MPI
program and the cooperative interstate
shipment program will also need to
establish written procedures to ensure
that product produced under the State
MPI program will not become comingled with product produced under
the cooperative interstate shipment
program. The procedures will need to
ensure that products produced under
each program are appropriately
identified as State MPI product or
cooperative interstate shipment
products, and that each product bears
the appropriate mark of inspection.
Establishment will also need to
maintain physical separation of product
produced under the State MPI program
from products produced under the
cooperative interstate shipment program
throughout the process, either through
the use of separate facilities or by
designated areas for holding or storing
products produced under separate
operations.
The meat or poultry products
produced when the establishment is
operating under the State MPI program
will be required to bear the State mark
of inspection and will only be permitted
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to be distributed within the State. Meat
or poultry products produced when the
establishment is operating under the
cooperative interstate shipment program
will be required to bear a Federal mark
and may be shipped in interstate
commerce.
H. Oversight and Enforcement—
Selected Establishment Coordinator
The preamble to the proposed rule
explained that the statute requires that
FSIS appoint a ‘‘state coordinator’’ to
‘‘provide oversight and enforcement’’ of
the cooperative interstate shipment
program and ‘‘to oversee the training
and inspection activities’’ of State
personnel designated to provide
inspection services to selected
establishments (74 FR 47654). When
FSIS issued the proposed rule, the
Agency explained that the ‘‘state
coordinator’’ required by statute would
be referred to as the ‘‘selected
establishment coordinator’’ (SEC) in the
proposed regulations to avoid confusion
with the ‘‘State coordinator’’ under the
Talmadge-Aiken program, which is a
State employee. In the preamble to the
proposed rule, FSIS also explained that
the Agency had tentatively decided that
the SEC would be an employee of the
FSIS Office of Field Operations (OFO)
and would be assigned to an FSIS
district office.
1. SEC Definition and FSIS Program
Area
Comment: One comment stated that
the codified text in the final rule should
clarify that the term ‘‘selected
establishment coordinator’’ as used in
the implementing regulations is
synonymous with the term ‘‘state
coordinator’’ under the statute. The
comment said that there should not be
both a State coordinator and an SEC.
Response: As noted in the preamble to
the proposed rule, the term ‘‘State
coordinator’’ is often used to refer to a
State employee under the TalmadgeAiken program. Therefore, to make clear
that the ‘‘State coordinator’’ for the
cooperative interstate shipment program
is an FSIS employee, this final rule
identifies that employee as the FSIS
‘‘selected establishment coordinator’’ in
the codified text. The codified text in
the final rule does not provide for both
a State coordinator and an SEC.
Comment: Some comments stated
that, instead of being under the direct
supervision of an FSIS District Manager,
as FSIS tentatively decided in the
proposed rule, the SEC should be under
the direct supervision of the Secretary of
Agriculture as provided under the
statute.
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Other comments agreed with FSIS’s
tentative determination that the SECs
operate out of the district offices. One
comment noted that the SEC is a Federal
employee. The comment stated that, as
such, it is appropriate that the SEC be
stationed at the district office and report
to a District Manager and ultimately,
FSIS headquarters. The comment
asserted that the SEC should not be
stationed at the State meat and poultry
inspection agency, but should maintain
frequent communication with State
agency officials.
Response: The Secretary of
Agriculture has delegated the
administration and enforcement of the
cooperative interstate shipment program
to FSIS. Since the SEC will be an FSIS
employee that operates out of the FSIS
district office, it is appropriate for the
SEC to be under the direct supervision
of the FSIS District Manager.
Comment: Several comments were
concerned about the Agency’s tentative
decision to assign the SEC to an FSIS
district office. According to the
comments, FSIS district offices are not
always consistent in their interpretation
and enforcement of the Agency’s
policies. The comments stated that
administering the cooperative interstate
shipment program from different district
offices will make it difficult for FSIS to
implement and enforce the program in
a consistent manner. The comment
suggested that, instead of assigning
SECs to multiple district offices, FSIS
should designate a single entity within
the Agency to implement and enforce
the cooperative interstate shipment
program.
Some comments suggested that FSIS
create a branch in OPEER, similar to the
Federal/State Audit Branch (FSAB), or
assign the FSAB to administer, review,
and enforce the cooperative interstate
shipment program. The comments noted
that the OPEER/FSAB is already
responsible for verifying that the State
MPI programs are operating in a manner
that is ‘‘equal to’’ the Federal standards,
and States now spend a considerable
amount of time providing information to
OPEER/FSAB. The comments stated
that allowing a centralized Agency
branch, such as the OPEER/FSAB, to
administer and enforce the cooperative
interstate shipment program will
promote consistency in the program by
providing the FSIS SECs, the State
programs, and selected establishments
with a single point of contact for
guidance, policy implementation, and
enforcement.
Response: The FSIS SEC is required to
provide ‘‘oversight and enforcement’’ of
the cooperative interstate shipment
program and ‘‘to oversee the training
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and inspection activities’’ of State
personnel designated to provide
inspection services to selected
establishments (21 U.S.C. 683(d)(1) and
472(d)(1)). As noted above, when FSIS
issued the proposed rule, it had
tentatively decided that the SEC would
be an employee of the FSIS Office of
Field Operations (OFO) assigned to an
FSIS District Office. Because OFO has
expertise in management and
enforcement of Federal inspection
standards, FSIS is affirming that
decision. The SEC will be an OFO
employee assigned to an FSIS district
office as proposed.
As noted by the comments, the
OPEER/FSAB is responsible for
conducting comprehensive audits of
Federal and State MPI programs.
OPEER/FSAB verifies that State MPI
programs are operating in a manner that
is ‘‘at least equal to’’ the Federal
program. Although OPEER/FSAB will
not have direct oversight and
enforcement of the cooperative
interstate shipment program, once the
cooperative interstate shipment program
is fully implemented, the OPEER/FSAB
will be responsible for auditing that
program to verify that it is operating in
a manner that is ‘‘the same as’’ the
Federal inspection program.
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2. Number of SECs per State
In the preamble to the proposed rule,
FSIS explained that the number of
States in an FSIS district assigned to an
SEC will likely depend on several
factors, including, but not limited to: (1)
The number of States and selected
establishments, if any, that participate
in the cooperative interstate shipment
program; (2) the location of each
selected establishment; (3) the number
of State inspection personnel providing
inspection services to selected
establishments in a State; (4) the
complexity of the operations conducted
at each selected establishment; and (5)
the schedule of operations for each
selected establishment (74 FR 47654).
The preamble also noted that the
number of States assigned to an SEC
would also need to be based on
consideration of the most effective
allocation of available Agency
resources.
In the PRIA to the proposed rule, FSIS
also estimated that 13 full-time
equivalent FSIS employees would be
needed to perform the SEC functions for
the 16 States expected to participate in
the cooperative interstate shipment
program (74 FR 47660). If 400
establishments participate in the new
program, the Agency estimated each
SEC will be responsible for 31
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establishments in a geographicallylimited area.
Comment: Several comments, most
submitted by consumer advocacy
organizations, stated that 13 SECs to
oversee cooperative interstate shipment
programs in 16 States is not sufficient to
provide adequate oversight of the new
program. The comments urged FSIS to
assign a separate SEC to each State that
participates in the program. The
comments asserted that to effectively
verify that selected establishments
operating in a manner consistent with
the Acts, the SECs need to be spending
most of their time in these
establishments rather than driving from
state-to-state. One comment said that
when the provisions of the law were
negotiated, the parties understood that
there was to be one SEC per State.
Other comments questioned whether
the Agency’s estimate of one SEC for 31
establishments is adequate to ensure
that these establishments are operating
in a manner that complies with the
Acts. The comments stated that FSIS
must provide enough flexibility to
reduce the number of establishments
covered by an SEC if circumstances
warrant.
One comment expressed concern over
the statement in the proposed rule that
‘‘[t]he number of States assigned to an
SEC would also need to be based on
consideration of the most effective
allocation of available Agency
resources.’’ The comment stated this
sentence demonstrates that there is
reason to be concerned that the new
program may not receive adequate
resources to best protect public health
and safety. The comment maintained
that there should be at minimum one
SEC per participating State and that the
SEC’s sole function should be oversight
and enforcement of the program, unless
the State has so few participating
establishments that a full-time SEC is
not warranted.
Response: As noted in the preamble to
the proposed rule, the number of SECs
needed to provide effective oversight of
the cooperative interstate shipment
program will depend on several factors,
all of which are intended to ensure that
there is sufficient Federal oversight of
the program. FSIS agrees with the
comments that stated that the SECs
should be spending most of their time
overseeing activities in selected
establishments, and the Agency intends
to structure the SEC’s assignment in a
manner that will, to the greatest extent
possible, limit the time spent traveling
between selected establishments. In
some instances, this will require that an
SEC cover selected establishments
located in different States, particularly
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24733
in States with selected establishments
located near the State borders.
As noted above, FSIS estimated that
there would be one SEC for 31
establishments in a geographicallylimited area. This number is an estimate
and assumes a certain level of
participation by State-inspected
establishments that employed fewer
than 35 employees when the 2008 Farm
Bill was enacted. The actual number of
establishments assigned to an SEC will
depend on a number of factors,
including the complexity of the
operations conducted at the selected
establishments and the schedule of
operations for each selected
establishment.
3. Frequency of SEC Visits
As required under the statute, the
proposed regulation provided that the
FSIS SEC is to visit each selected
establishment in the State on a regular
basis to verify that these establishments
are operating in a manner that is
consistent with the Acts and the
implementing regulations (proposed 9
CFR 332.7(a) and 318.517(a)). In the
preamble to the proposed rule, FSIS
noted that the SEC’s frequency of visits
and oversight activities for each selected
establishment will need to reflect the
type of operations conducted by a
selected establishment, as well as the
establishment’s production processes
(74 FR 47654). The Agency requested
comments on how frequently the SEC
should visit each establishment under
his or her jurisdiction.
Comment: Several comments said
that, since the law requires that the
SECs file quarterly reports on the status
of the selected establishment under
their jurisdiction, they should visit each
selected establishment at least quarterly.
Some comments stated that requiring
that the SEC visit selected
establishments more often than once a
quarter would seem overly burdensome
and ineffective. One comment suggested
that FSIS modify the proposed
regulation to read that the SEC will
visit, ‘‘each selected establishment in the
State on a regular basis, but no less
frequently than quarterly, to verify that
the establishment is operating in a
manner that is consistent with the Act.’’
One comment stated that requiring
quarterly or bi-annual visits will allow
the SECs to both cover their assigned
establishments and conduct the day-today operations of managing the program
for their region. The comment said that
if a problem arises, the SEC can visit the
establishment more frequently. The
comment suggested that SECs also rely
on State inspection personnel to advise
them if additional visits are needed.
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Many comments stated that the
frequency of the SEC’s visits should be
based on the performance of the
establishment. The comments noted that
the number of visits may need to be
higher when the program is first
implemented while the State inspection
personnel gain experience with the
program’s regulatory requirements. Two
comments suggested that initially, the
visits should be weekly and that
subsequent visits should be based on
the establishment’s performance.
One comment said that the final
regulations should clearly state that the
frequency of the SEC’s visits shall be
based on the performance of the
establishment’s food safety control
systems. The comment maintained that
such a statement will ensure judicious
use of FSIS resources and create an
additional incentive for the
establishment to effectively operate
their food safety control systems.
One comment stated that the SEC
should visit selected establishments no
more frequently than FSIS front line
supervisors typically visit federallyinspected establishments in their
circuit. Another comment said that the
SECs will need to visit selected
establishments quite frequently to
ensure that they are in compliance with
Federal standards. One comment stated
the goal in determining how frequently
SECs should visit establishments under
their jurisdiction should be to provide a
statistically relevant sample to check on
the level of compliance and
performance of inspections by state
inspectors.
One comment suggested that in
addition to prescribing the frequency of
SEC visits, the final regulations should
specify that the SEC’s visits to selected
establishments are to occur at different
times and be unannounced.
Response: The comments submitted
on this issue indicate that there is a
general lack of consensus on how
frequently the SEC should visit selected
establishments in the States. As noted
above, some comments suggested that
the SEC conduct quarterly or even biannual visits, while others suggested
that the SEC visit each selected
establishment at least weekly.
The 2008 amendments to the Acts do
not specify how frequently the SECs are
to visit selected establishments, but they
do provide that the SEC ‘‘* * *shall
visit selected establishments with a
frequency that is appropriate to ensure
that selected establishments are
operating in a manner that is consistent
with this Chapter (including regulations
and policies under this Chapter (21
U.S.C. 683(d)(3)(a) and 472(d)(3)(a)).
The Senate Committee report that
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explains this provision states that ‘‘[i]t is
the Committee’s intent that the [SEC]
inspect selected establishments
frequently each month’’ (S. Rep. No.
110–20, 110th Cong., 1st Sess. (2007),
pp 211–214)).
Therefore, after considering the
comments on this issue, as well as the
language in both the statute and the
Senate Committee report, FSIS has
decided not to prescribe how frequently
SECs are to visit selected establishments
under their jurisdiction. Instead, the
Agency is revising the proposed rule to
clarify that the frequency with which
the SEC will visit selected
establishments under the SEC’s
jurisdiction will be based on a number
of factors, including the complexity of
the operations conducted at the selected
establishment, the establishment’s
schedule of operations, and the
establishment’s performance under the
cooperative interstate shipment
program. The Agency has concluded
that such an approach will ensure that
the number of SEC visits reflects the
appropriate level of oversight needed for
each selected establishment.
FSIS agrees with the comments that
noted that the number of SEC visits may
need to be higher when the program is
first implemented in order for the State
personnel to gain experience in
enforcing Federal food safety standards.
FSIS also intends to schedule some
unannounced SEC visits to selected
establishments, as suggested by the
comments. However, the SEC will also
conduct scheduled visits to selected
establishments to give State personnel
the opportunity to prepare to discuss
issues related to their role in enforcing
Federal standards.
Although FSIS is not prescribing a
specific minimum number of SEC visits,
based on the statement in the Senate
Committee report, FSIS has concluded
that bi-annual or quarterly visits to
selected establishments, as suggested by
some comments, are most likely not
frequent enough to carry out the intent
of the statutes.
Comment: One comment stated that
the provision in the proposed rule that
allows the SEC, in consultation with the
District Manager, to designate qualified
FSIS personnel to visit a selected
establishment on behalf of the SEC is an
appropriate use of Agency resources.
The comment said that assigning other
designated FSIS personnel to visit
establishments on behalf of the SEC
makes sense from a practical and
financial standpoint. The comment
stated that FSIS could use inspection
personnel who are already out in the
field to conduct visitations to check
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compliance on a more frequent basis
than sending the SEC into the field.
Response: FSIS agrees that providing
for qualified FSIS personnel to visit
selected establishment on behalf of the
SEC is an appropriate use of Agency
resources.
4. SEC Duties—Oversight
Comment: Some comments supported
the level of Federal oversight provided
for in the proposed regulations as
necessary to maintain the safety and
security of all meat and poultry
products distributed in interstate
commerce. One of the comments stated
that any cooperative interstate shipment
program must be federally driven and
that FSIS must be in charge.
Other comments complained that the
proposed rule would give the SEC an
excessive and unnecessary level of
Federal oversight over the cooperative
interstate shipment program. The
comments stated that FSIS currently
evaluates ‘‘at least equal to’’ State MPI
programs through reviews of State selfassessment and through an on-site
evaluation of the State’s program every
three years. The comments asserted that
this evaluation methodology has proven
effective for assuring that State
programs are in compliance with
Federal requirements. The comments
said that FSIS should, to the extent
allowed by statute, consider using this
same method for evaluating a State’s
performance under the new cooperative
interstate shipment program.
Response: FSIS disagrees with the
comments that stated that the proposed
rule would give the SEC an excessive
and unnecessary level of Federal
oversight over the cooperative interstate
shipment program. As noted throughout
this document, under the Acts, as
amended by the 2008 Farm Bill, the
FSIS Administrator is required to
designate an FSIS employee as an SEC
for each State to ‘‘provide oversight and
enforcement of the program’’ and to
‘‘oversee the training and inspection
activities’’ of the designated State
personnel providing inspection services
to a selected establishment. (21 U.S.C.
683(d)(1) and 472(d)(1)). The Acts also
require that the SEC visit selected
establishments as frequently as
necessary to ensure that these
establishments are operating in a
manner consistent with the Federal Acts
(21 U.S.C. 683(d)(3) and 472(d)(3)).
Thus, the level of Federal oversight that
the proposed rule provides for the
cooperative interstate shipment program
reflects the level of oversight that is
required by law.
FSIS disagrees with the comments
that suggested that the Agency use
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OPEER/FSAB’s evaluation methodology
to oversee a State’s performance under
the new cooperative interstate shipment
program. As noted by the comments, the
OPEER/FSAB conducts comprehensive
audits of the State MPI programs to
verify that States are enforcing laws and
regulations that ‘‘are at least equal to’’ to
requirements of the Federal Acts. The
evaluation methodology used by the
OPEER/FSAB is designed to provide a
comprehensive annual assessment of
the State MPI programs rather than
continuous Federal oversight and
enforcement of these programs. Thus,
this methodology would not provide the
necessary level of oversight that the
Acts require for the cooperative
interstate shipment program.
Comment: Some comments expressed
concern that the proposed rule would
give ‘‘de facto constant regulatory
oversight authority’’ to the FSIS SEC.
The comments stated that this would
basically give State personnel working
in selected establishments two
supervisors. According to the
comments, this chain-of-command will
create confusion and needless
redundancy.
One comment said that the SEC needs
to work with the States to coordinate
Federal oversight of the program to
reduce the burden on the selected
establishments to the extent possible.
The comments stated that the program
should not become one in which both
Federal and State officials are routinely
inspecting the same facilities.
Another comment agreed with the
provision in the proposed rule that
stated that the SEC’s role is limited to
oversight and enforcement of the
program. The comment also agreed that
the State program should continue to be
responsible for the direct supervision of
designated State personnel.
Response: The proposed rule makes
clear that inspection services for
selected establishments participating in
the cooperative interstate shipment
program must be provided by
designated personnel, who will be
under the direct supervision of a State
employee (proposed 9 CFR 332.6(b) and
381.516(b)). Although the SEC will be
responsible for overseeing the
inspection activities of the designated
personnel, the State program will
continue to be responsible for the direct
supervision of all designated State
personnel. Thus, the comment that
stated that the proposed rule would give
State personnel working in selected
establishments two supervisors is
inaccurate.
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5. SEC Duties—Enforcement
The proposed regulation gave the SEC
the authority to initiate any appropriate
enforcement action provided for in the
FSIS rules of practice in 9 CFR part 500
if the SEC determines that a selected
establishment under his or her
jurisdiction is operating in a manner
that is inconsistent with the Acts
(proposed 9 CFR 332.9(b) and
381.189(b)). As noted in the preamble,
such actions include regulatory control
actions, withholding actions, and
suspensions (74 FR 47655).
Comment: Some comments supported
the proposed enforcement provisions.
One comment stated that it is
appropriate for the SECs to have the
same authority to initiate enforcement
actions with respect to selected
establishments as FSIS inspection
personnel are authorized to do with
federally-inspected establishment. The
comment also supported the proposed
requirement that selected
establishments provide FSIS officials
with ‘‘access to all establishment records
required under the Act and the
implementing regulations in this
chapter.’’
Some comments said that the
proposed rule’s enforcement provisions
go beyond what is authorized under the
statute and will result in duplicative
efforts. The comments asserted that the
designated State personnel, not the SEC,
should be responsible for initiating
enforcement action in selected
establishments.
Response: Under the proposed rule,
designated State personnel are
responsible for providing the necessary
inspection services to selected
establishments in the State. The SEC is
responsible for verifying that the
designated personnel are providing
inspection services in compliance with
the Acts.
In the preamble to the proposed rules,
FSIS explained that to verify that
designated personnel are providing the
necessary inspection services, the SEC
for the establishment, in coordination
with the State, will verify that the
designated personnel are correctly
applying Federal inspection
methodology, making decisions based
upon the correct application of this
methodology, accurately documenting
their findings, and, when authorized to
do so, implementing enforcement
actions in accordance with the FSIS
Rules of Practice in 9 CFR part 500 (74
FR 47655). Thus, the proposed rule
makes clear that, as part of their
inspection activities, designated State
personnel are responsible for initiating
enforcement actions in selected
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24735
establishments if such personnel
determine that an enforcement action is
authorized under 9 CFR part 500.
The 2008 amendments to the Acts
provide that if the SEC determines that
any selected establishment is in
violation of any requirement of the Acts,
the SEC is required to: (1) Immediately
notify the Administrator and (2)
‘‘deselect’’ the establishment or suspend
inspection at the establishment (21
U.S.C. 683(d)(3)(C) and 472(d)(3)(C)). As
explained in the preamble to the
proposed rule, in adopting this
language, Congress intended that the
SEC ‘‘* * * shall be provided all the
tools necessary * * * to prevent or
control any food safety issue that would
harm human health’’ (S. Rep. No. 220,
110th Cong., 1st Sess., at 211 (2007)).
Therefore, to ensure that the SEC has
the appropriate authority to address any
food safety issues as required by the
statutes, the proposed rule authorizes
the SEC to initiate any appropriate
enforcement action provided for in 9
CFR part 500 if he or she determines
that a selected establishment under his
or her jurisdiction is operating in a
manner that is inconsistent with the
Acts or their implementing regulations.
Thus, under the proposed rule,
designated State personnel are
responsible for taking appropriate
enforcement action for violations of
Federal food safety standards in selected
establishments when such actions are
authorized under 9 CFR part 500. The
SEC covering a selected establishment is
also authorized to take any necessary
enforcement actions if the SEC
identifies the need to take such action
when conducting oversight activities at
a selected establishment.
Comment: One comment agreed with
the proposed enforcement provisions
and stated that selected establishments
should be subject to Food Safety
Assessments (FSAs) just as federallyinspected establishments are. The
comment also maintained that NRs
issued to selected establishments and
other enforcement action should be
made available through the Freedom of
information Act (FOIA).
Response: States that participate in
the cooperative interstate shipment
program will need to conduct
comprehensive FSAs in order to
properly enforce Federal food safety
standards. As discussed in the preamble
to the proposed rule, the SEC will also
be authorized to conduct an FSA, or to
request that an FSIS Enforcement,
Investigation, and Analysis Officer
(EIAO) conduct an FSA, if the SEC in
consultation with the District Manager
determines that such action would help
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determine whether the establishment is
operating in compliance with the Acts.
Any records that the States and
selected establishment are required to
provide to FSIS to allow the Agency to
provide the necessary oversight and
enforcement of the cooperative
interstate shipment program, including
NRs issued to selected establishments,
will be made available to the public
through the FOIA if the records are not
subject to an exemption under the
FOIA.
Comment: One comment stated that
the final rule needs to specify an
appeals process for non-compliances to
ensure that all establishments that
participate in the program understand
the process and their rights.
Response: The proposed rule
provided that selected establishments
participating in the cooperative
interstate shipment program would be
subject to the notification and appeal
procedures set out in 9 CFR part 500
(proposed 9 CFR 332.9(b) and
381.519(b)). Thus, the proposed rule did
provide for an appeals process for noncompliances.
6. SEC Duties—Quarterly Reports
As provided for in the law, the
proposed rule provides that the SEC is
to prepare a report on a quarterly basis
that describes the status of each selected
establishment under the SEC’s
jurisdiction (proposed 9 CFR 332.8 and
381.518).
Comment: Some comments requested
clarification on the type of information
the SECs will be required to include in
their quarterly reports. One comment
asked whether the quarterly reports will
include the SEC’s assessment of the
performance of the designated State
personnel or of the selected
establishments. One comment stated
that the quarterly report should include
the SEC’s assessment of the State
program’s performance in providing
inspection services to selected
establishments and not be limited to the
performance of the designated
personnel.
Response: The proposed rule
provided that the SEC quarterly report
will: (1) Include the SEC’s assessment of
the performance of the designated
personnel in conducting inspection
activities at selected establishments and
(2) identify the selected establishments
that the SEC has verified are in
compliance with all Federal
requirements, those that have been
deselected, and those that are
transitioning to become Federal
establishments (proposed 9 CFR
332.8(b) and 381.518(b). Thus, the
quarterly report includes the SEC’s
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assessment of the performance of both
the selected establishments and the
designated State personnel.
The designated personnel’s ability to
provide inspection services to selected
establishments in a manner that
complies with Federal standards reflects
the State’s ability to administer the
cooperative interstate shipment
program. Thus, the quarterly report will
reflect the SEC’s assessment of the State
program’s performance in providing
inspection services to selected
establishments.
Comment: One comment asserted that
the SEC’s do not need to visit selected
establishments on a quarterly basis to
complete the quarterly report. The
comment stated that SECs will be able
to determine the status of selected
establishments based on routine reports
and other documentation submitted by
designated State personnel. Another
comment stated that requiring an
assessment on a quarterly basis would
establish a burdensome Federal
oversight process for States that
participate in the program.
Response: As discussed above, the
2008 amendments to the Acts require
that SECs visit selected establishments
with a frequency that is appropriate to
ensure that selected establishments are
operating in a manner that is consistent
with the Federal Act. There is nothing
in the law to indicate that the SEC is to
determine the status of selected
establishments based on routine reports
and other documentation submitted by
designated State personnel, as suggested
by the comments.
FSIS disagrees with the comment that
stated that requiring an assessment on a
quarterly basis would establish a
burdensome Federal oversight process
for States that participate in the
program. As noted above, the 2008
amendments to the Acts require that the
SECs prepare a quarterly report.
Comment: Some comments asked
whether the State MPI programs would
have a role in preparing the quarterly
reports. One comment asked whether
the States will receive copies of the
quarterly reports from the SECs.
Response: The proposed rule provides
that the SEC, in coordination with the
State, will verify that selected
establishments in the State are receiving
the necessary inspection services from
designated State personnel and that
these establishments are eligible, and
remain eligible, to participate in the
cooperative interstate shipment program
(proposed 9 CFR 332.8(b) and
381.517(b)). Although the SEC is
responsible for preparing the quarterly
reports, the SEC will coordinate with
the State to assess the status of selected
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establishments under the SEC’s
jurisdiction. FSIS will provide the State
copies of the SEC’s quarterly reports on
the status of selected establishments in
the State upon request.
I. Deselection and Transition To Become
Federal Establishment
The proposed regulations provide that
the FSIS Administrator will ‘‘deselect’’ a
selected establishment that becomes
ineligible to participate in the
cooperative interstate shipment program
(proposed 9 CFR 332.10(a) and
381.520(a)). The preamble to the
proposed rule explained that an
establishment could become ineligible
for the program for various reasons,
such as hiring additional employees or
for violating the Federal Acts (74 FR
47656). The preamble also noted that
establishments located in a State whose
cooperative interstate shipment program
was terminated would also be ineligible
for the program. Consistent with the
statute, the proposed regulations require
that a deselected establishment be
transitioned to become a Federal
establishment (proposed 9 CFR 332.11
and 381.521).
1. Establishment Deselection
Comment: One comment requested
that FSIS provide more specific
information on the circumstances in
which an establishment will be
deselected for non-compliance with the
Acts. The comment asked whether a
non-compliance report (NR) or a Notice
of Intended Enforcement (NOIE) could
result in deselection. According to the
comment, NRs and NOIEs can
sometimes be subjective depending on
the inspection program personnel
writing them. The comment encouraged
FSIS and State inspection program
directors to work with selected
establishments that have noncompliances or enforcement actions
against them to help those
establishments come back into
compliance and successfully continue
within the program. The comment also
asked FSIS to provide proper oversight
and training to the SECs to ensure that
the standards for non-compliances and
enforcement actions are applied
consistently across the country.
Response: As noted above, under the
proposed rule, the SEC is authorized to
initiate any appropriate enforcement
actions authorized under the Agency’s
Rules of Practice in 9 CFR part 500,
which include, among others, regulatory
control actions, withholding actions,
and suspensions (proposed 332.9(b) and
381.189(b)). The proposed regulations
provide that if inspection at a selected
establishment is suspended for any of
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the reasons specified in 9 CFR 500.3 or
500.4, the Agency will provide an
opportunity for the establishment to
implement corrective actions and
remain in the cooperative interstate
shipment program or the Agency will
move to deselect the establishment
(proposed 9 CFR 332.9(c) and
381.519(c)).
The proposed rule provides that the
decision to deselect a selected
establishment under a suspension will
be made on a case-by-case basis
(proposed 9 CFR 332.9(d) and
381.519(d)). The proposed rule also
states that in making this decision the
FSIS Administrator, in consultation
with the State, will consider, among
other factors: (1) The non-compliance
that led to the suspension; (2) the
selected establishment’s compliance
history; and (3) the corrective actions
proposed by the establishment
(proposed 9 CFR 332.9(d) and
381.519(d)). Thus, under certain
conditions, the proposed rule does
authorize the FSIS Administrator to
coordinate with the States to help
selected establishments with noncompliances come back into compliance
and successfully continue within the
program.
FSIS will provide the SECs with the
training they need to oversee and
enforce the cooperative interstate
shipment program in a manner that is
consistent with the law and these
implementing regulations.
Comment: One comment asserted that
the State, not the SEC, should initiate
deselection of a selected establishment.
The comment noted that some States
have not incorporated 9 CFR part 500
into their State laws or regulations. The
comment suggested that instead of
referencing 9 CFR part 500, the final
regulations should give States the
authority to take ‘‘appropriate
enforcement action’’ against selected
establishments when necessary.
Response: Consistent with the law,
under the proposed regulations,
designated State personnel are required
to provide inspection services in
compliance with the Federal Acts and
implementing regulations. Part of the
designated personnel’s inspection
duties involves taking appropriate
enforcement actions when authorized to
do so. The FSIS Rules of Practice in 9
CFR part 500 identify the conditions
under which inspection personnel are
authorized to take enforcement actions
and include the criteria for when those
actions are warranted. Thus, unless they
follow the procedures prescribed in the
FSIS Rules of Practice, designated State
personnel will be unable to properly
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enforce Federal standards in selected
establishments.
Because States are responsible for
providing inspection services to
selected establishments participating in
the cooperative interstate shipment
program, the States may recommend
that an establishment be deselected
from the program if the State determines
that the establishment is not complying
with the requirements of the program.
FSIS is likely to accept the State’s
recommendation.
2. Deselected Establishments To Become
Official Establishment
Comment: Some comments supported
the provisions in the proposed rule that
require that establishments that become
ineligible for the cooperative interstate
shipment program be transitioned to
become Federal establishments. These
comments said that such a requirement
is necessary to prevent establishments
from attempting to move into and out of
the program with no long-term
commitment.
Several comments stated that
requiring that a deselected
establishment transition to become a
Federal establishment is a disincentive
for establishments to participate in the
program and could force deselected
establishments that choose not to come
under Federal regulation out of
business. One comment suggested that
instead of requiring that deselected
establishments transition to become
Federal establishments, FSIS should
allow them to implement corrective
actions and revert back to State
inspection.
Response: The 2008 amendments to
the Acts authorize the Agency to
establish a procedure to transition
selected establishments that employ, on
average, more than 25 employees to
become Federal establishments (21
U.S.C. 683(b)(3)(A) and 472(b)(3)(A)).
The 2008 amendments also require that
selected establishments that the
Administrator determines to be in
violation of any provision of the Acts be
transitioned to become Federal
establishments in accordance with the
procedure developed to transition
selected establishments that employ
more than 25 employees (21 U.S.C.
683(h) and 472(g)). Thus, requiring that
deselected establishments be
transitioned to become Federal
establishments is necessary to
implement the law. The law does not
authorize FSIS to allow deselected
establishments to revert back to the
State MPI program without transitioning
to become a Federal establishment, even
if such establishments implement
corrective actions.
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24737
Comment: Many comments stated that
FSIS should allow establishments that
have been deselected and successfully
transitioned to become Federal
establishments to revert back to the
State MPI program if they choose. The
comments stated that if FSIS is
concerned that establishments might
find it advantageous to periodically
switch from under one jurisdiction to
under another, the Agency could
establish a reasonable time period, such
as one-year, before an establishment that
has transitioned to become a Federal
establishment could revert back to a
State’s jurisdiction. One comment
suggested that FSIS give establishments
that have successfully transitioned to
become Federal establishments the
option to either revert to the State MPI
program or be reselected for the
cooperative interstate shipment
program.
Response: After considering these
comments, FSIS has decided to amend
the proposed regulations to allow
establishments that were deselected
from the cooperative interstate shipment
and that have successfully transitioned
to become Federal establishments to
revert back to the cooperative State MPI
program after operating as a Federal
establishment for one year.
As noted above, the 2008
amendments to the Acts require that
establishments that are in violation of
the Acts be transitioned to Federal
establishments. The amendments also
authorize FSIS to deselect and transition
to Federal establishments selected
establishments that consistently employ
more than 25 employees on average.
However, the statutes are silent on
whether establishments that have
successfully transitioned to become
Federal establishments must remain in
the Federal program or whether they
can later revert back to the State
program. Therefore, FSIS has
determined that the law does not
prohibit such an action.
Allowing deselected establishments
that have successfully transitioned to
become Federal establishments to revert
back to the State MPI program will
provide flexibility for establishments to
determine which inspection system
(Federal or State) best meets their needs.
In addition, requiring that deselected
establishments operate under Federal
inspection for a year will promote food
safety by ensuring that these
establishments can perform in
accordance with Federal standards
before reverting back to the State
program.
The statutes provide that the
Administrator, in coordination with the
States, shall not select for the
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cooperative interstate shipment
program, an establishment that is a
Federal establishment (21 U.S.C. 683
(b)(2)(C)(i), 683(b)(2)(F)). Thus, FSIS
does not believe that the law would
allow establishments that have been
deselected from the cooperative
interstate shipment program and
transitioned to become a Federal
establishment to be re-selected for the
program at a later date.
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3. Establishments Deselected for
Exceeding Employee Threshold
Comment: A few comments suggested
that FSIS allow selected establishments
that were deselected and transitioned to
become Federal establishments because
they now have more than 25 employees
on average to revert back to the State
MPI program at a later date if they
reduce their average number of
employees to fewer than 25. One of
these comments noted that it is not
inconceivable that a selected
establishment could quickly exceed its
employee-based eligibility threshold,
forcing it to transition to an official
Federal establishment, only to later
discover that it does not desire to
maintain the larger operation. The
comment stated that in such case, the
establishment should not be prohibited
from reverting back to State jurisdiction
or from participating in the cooperative
interstate shipment program if it
reduces its average number of
employees to fewer than 25.
One comment stated that selected
establishments that have more than 25
employees on average should be
required to transition to become Federal
establishments, and that once they have
transitioned, they should not be
permitted to revert back to the State MPI
program. The comment stated that
selected establishments should
anticipate that as they grow and add
additional employees beyond the 25
employee limit, they will be
transitioned to the Federal inspection
system. The comment stated that it is
essential that establishments not be
permitted to ‘‘forum shop’’ for regulatory
oversight. According to the comment, if
establishments are meeting the
requirements of the new program and
are succeeding, there should be no
reason why the establishments that
outgrow this special program should not
operate under Federal inspection.
One comment asked whether an
establishment that was deselected
because its average number of
employees exceeded 25 rather than for
food safety violations will remain
ineligible to participate in the program
in the future.
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Response: As discussed above, FSIS
has decided to amend the proposed rule
to allow deselected establishments that
have been transitioned to become
Federal establishments to revert back to
the State MPI program after successfully
operating as a Federal establishment for
one year. This amendment will apply to
establishments that have been
deselected for exceeding the average
number of employees limit regardless of
whether they reduce their average
number of employees to fewer than 25
or not.
As noted above, because the law
prohibits Federal establishments from
being selected for the cooperative
interstate shipment program, FSIS does
not believe that it should permit
establishments that have been
deselected from the program and
transitioned to become Federal
establishments to be re-selected for the
program at a later date, regardless of the
reason for the deselection.
Deselection and State Operations
Comment: One comment stated that if
the final regulations resulting from the
proposal allow selected establishments
to produce some products under State
inspection and other products under the
cooperative interstate shipment
program, FSIS must make clear that the
provision that requires that deselected
establishments transition to become
Federal establishments only applies to
operations conducted under the
cooperative interstate shipment
program. The comment asserted that
selected establishments that produce
certain products under a State MPI
program should be permitted to
continue these operations without
transitioning to become a Federal
establishment if the establishment is
deselected from the cooperative
interstate shipment program.
Response: The requirements
associated with the cooperative
interstate shipment program only apply
to operations that State-inspected
establishments conduct as part of that
program. Thus, deselected
establishments that conduct operations
under both the cooperative interstate
shipment program and the cooperative
State MPI program will be required to
transition the operations subject to the
cooperative interstate shipment program
to become a Federal establishment.
These establishments may continue to
produce products under the State MPI
program if they maintain an appropriate
separation by time or space between
operations.
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4. Voluntary Withdrawal
Comment: Several comments
requested that FSIS give selected
establishments that continue to be
eligible for the cooperative interstate
shipment program the option to
voluntarily leave the program and revert
back to operating under the State MPI
program. The comments noted that after
being selected for the cooperative
interstate shipment program, some
establishments may find that their
businesses have changed such that they
no longer need to ship their products
interstate. The comments asserted that it
makes no sense to force establishments
that are in full compliance with the
program’s requirements but that no
longer need to participate in the
program to become Federal
establishments.
Most of the comments that requested
that selected establishments be
permitted to voluntarily leave the
cooperative interstate shipment program
and revert back to their State MPI
programs also said that FSIS should
allow these establishments to re-enter
the program at a later date. These
comments acknowledged that the rules
should prohibit State-inspected
establishments from freely moving into
and out of the program and suggested
that the final regulations prescribe a
waiting period that establishments that
voluntarily leave the program must
comply with before they may re-apply
for the program. Most comments
suggested a one-year waiting period,
and one suggested a five year wait. One
comment asked whether an
establishment that voluntarily leaves the
program will be allowed to re-apply for
the program if it comes under new
ownership at a later date.
Response: FSIS has considered these
comments and has concluded that it
would not be inconsistent with the law
to allow a selected establishment that is
in full compliance with the cooperative
interstate shipment program to
voluntarily leave the program and
operate under a State grant of
inspection.
The 2008 amendments to the Acts
require that any establishment selected
for the cooperative interstate shipment
program that is in violation of any
requirement of the Federal Acts be
‘‘transitioned to a Federal
establishment’’ (21 U.S.C. 683(h) and
472(g)). However, the statutes do not
address situations in which an
establishment that is in full compliance
with the Federal Acts elects to
voluntarily withdraw from the program
for business reasons, e.g., the
establishment is in compliance with all
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Federal standards but has been unable
to establish a market for its products
outside of the State. FSIS has concluded
that allowing these establishments to
voluntarily end their participating in the
cooperative interstate shipment program
will give them the flexibility they need
to determine which inspection program
can best meet their business needs.
FSIS has also decided to permit
establishments that have voluntarily left
the cooperative interstate shipment
program to apply for and be re-selected
for the program at a later date. Allowing
these establishments to be re-selected
for the program presents little concern
about regulatory forum shopping
because they would be leaving the
program for business reasons and not
because they are having difficulty
meeting Federal food safety standards.
In addition, establishments that
voluntarily withdraw from the
cooperative interstate shipment program
would need to re-apply through the
State and be re-selected by the FSIS
Administrator in coordination with the
State in order participate in the program
again at a later date. Both FSIS and the
States are unlikely to select an
establishment that has a history of
applying for and then withdrawing from
the program. Therefore, FSIS has
decided that the one-year waiting period
suggested by the comment is a
reasonable amount of time for
establishments that voluntarily leave the
program to wait before they may reapply for the program. Such a policy
will give establishments that are in full
compliance with the program flexibility
to re-apply for the program if, at a later
date, they find that there may be a
market for their products in other States.
Comment: One comment
recommended that FSIS distinguish
between selected establishments that
want to withdraw completely from the
program, and those that want to
withdraw temporarily and resume
operations under the program at a later
date. According to the comment, such a
distinction is necessary because many
very small establishments operate on a
seasonal basis or part of the year. The
comment stated that the final
regulations should include a process in
which entities that operate on a seasonal
basis could apply for a temporary
withdrawal from the program. The
comments said that the process could be
similar to the process used by Federal
establishments to apply for a temporary
withdrawal of inspection.
One comment stated that it is not
uncommon for very small
establishments to operate infrequently
or in response to local consumer
demands. The comment noted that State
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MPI programs are generally able to offer
a great amount of flexibility in
providing inspection services to these
small establishments upon request. The
comment recommended that FSIS
provide for this type of practice in the
final regulations implementing the
cooperative interstate shipment
program. The comment also stated that
the decision to provide infrequent or
sporadic inspection should be the
State’s.
Response: As explained above,
selected establishments that are in
compliance with the cooperative
interstate shipment will be permitted to
voluntarily withdraw from the program.
However, if these establishments want
to resume operations as a selected
establishment, they will need to reapply and be re-selected for the program
by the FSIS Administrator in
coordination with the States.
On the other hand, selected
establishments that operate on a
seasonal basis may also request a
voluntary suspension of inspection from
the State to cover times when the
establishment does not operate. Selected
establishments that are granted a
voluntary suspension will not need to
re-apply for selection to resume
operations under the cooperative
interstate shipment program. As
suggested by the comment, the decision
to provide infrequent or sporadic
inspection in response to a request from
a selected establishment will be the
State’s.
Comment: One comment suggested
that FSIS consider implementing an
open enrollment period during which
State-inspected establishments could get
in or out of the interstate shipment
program without penalties, so long as
they are qualified for the program. The
comment said that FSIS could limit the
number of times that establishments are
allowed to make such changes. The
comment claimed that such a program
would give State-inspected
establishments the option to take
advantage of the program when it
worked best for their business.
Response: The proposed regulations
specified how State-inspected
establishments that are interested in
participating in the cooperative
interstate shipment program are to
apply for the program, and FSIS is
amending the proposed regulations to
allow selected establishments that are in
compliance with the program to
voluntarily end their participation.
Therefore, FSIS has concluded that it is
unnecessary to establish an open
enrollment period in which Stateinspected establishments that qualify for
the cooperative interstate shipment
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24739
program could enter or withdraw from
the program.
The proposed regulations require that
State-inspected establishments that are
interested in participating in the
cooperative interstate shipment program
apply for the program through the State
in which the establishment is located
(proposed 9 CFR 332.5(a)(1) and
381.515(a)(1)). The preamble to the
proposed rule makes clear that States
participating in the cooperative
interstate shipment program will
develop their own application
procedures (74 FR 47653). Thus, Stateinspected establishments that are
interested in participating in the
cooperative interstate shipment program
will follow their State’s application
procedures to request that they be
selected for the program.
As explained above, an establishment
that has been selected for the
cooperative interstate shipment program
and that is in compliance with all of the
programs requirements may voluntarily
end its participation at any time. Such
establishments will be permitted to reapply for the program after a waiting
period of one year.
5. Termination of State’s Cooperative
Agreement
Comment: Several comments asserted
that selected establishments that
become ineligible for the cooperative
interstate shipment program because
their State’s agreement for the program
was terminated should not be required
to transition to become Federal
establishments. Instead, the comments
suggested that FSIS give these
establishments the option of either
applying for a Federal grant or reverting
back to the State MPI program. The
comments said that establishments that
are deselected because the State
agreement is terminated have no control
over the circumstances under which
they were deselected and, therefore, it is
unfair to require that they become
Federal establishments.
A few comments asked FSIS to
consider the impact of requiring that
selected establishments transition to
Federal establishments if the State’s
agreement for a cooperative interstate
shipment program is terminated.
According to the comments, such a
requirement could affect the future
viability of some of these
establishments. The comments said that
it would be devastating to local markets
if deselected establishments had to shut
down because they are not allowed to
revert back to the State MPI program.
Response: The 2008 amendments to
the Acts do not require that
establishments that are no longer
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eligible to participate in the cooperative
interstate shipment program because
they are located in a State whose
agreement for such a program was
terminated transition to become Federal
establishments. Therefore, FSIS is
amending the proposed rule to give
these establishments the option to either
revert back to the State MPI inspection
program or obtain a Federal grant of
inspection.
If a State’s agreement for a cooperative
interstate shipment program is
terminated, some establishments that
were operating under the cooperative
interstate shipment program may be
willing to forgo interstate shipment and
revert back to the State MPI program
because they prefer to receive
inspection services from State
personnel. Other establishments may
prefer to continue to market their
products interstate under a Federal
grant of inspection. It only seems fair to
give establishments that are in
compliance with the requirements of the
program, but that become ineligible
because of a situation that is beyond
their control, the option of transitioning
to become a Federal establishment or
reverting back to the State program.
Comment: One comment stated that
the decision to terminate a State’s
agreement for a cooperative interstate
shipment program should not be taken
lightly or without considering
circumstances unique to the State and
its selected establishments. The
comment suggested that FSIS revise the
provision in proposed rule that states:
‘‘If the State fails to develop a corrective
action plan, or the selected
establishment coordinator for the State
determines that the corrective action
plan is inadequate, the Administrator
will terminate the agreement for the
cooperative interstate shipment program
* * *’’ to change ‘‘will’’ to ‘‘may.’’ The
comment stated that this revision will
provide an appropriate degree of
flexibility for the Administrator in
deciding whether to terminate an
agreement for a cooperative interstate
shipment program.
Response: The proposed regulation
provides that if the SEC determines that
designated State personnel are
providing inspection services to
selected establishments in the State in a
manner that is inconsistent with the
Federal Acts and implementing
regulations, the Administrator will
provide an opportunity for the State to
develop and implement a corrective
action plan to address inspection
deficiencies identified by the SEC
(proposed 9 CFR 332.7(c) and
381.517(c)). The SEC will advise the
State on the issues that the State needs
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to address to ensure that the corrective
action plan adequately addresses the
deficiencies identified by the SEC.
However, if the State fails to develop a
corrective action plan that adequately
addresses the issues identified by the
SEC, FSIS believes that the
Administrator has no choice but to
terminate the cooperative agreement.
Therefore, the Agency is not changing
‘‘will’’ terminate the agreement to ‘‘may’’
terminate the agreement, as suggested
by the comment.
7. Transition Procedures
Comment: The proposed regulations
provide that if a selected establishment
is deselected, FSIS will coordinate with
the State where the establishment is
located to develop and implement a
plan to transition the establishment to
become an official establishment. One
comment stated that FSIS needs to
clearly state the procedures needed to
transition a selected establishment to
become a Federal establishment to
ensure that all States and establishments
that are interested in participating in the
program agreement fully understand all
of the requirements and potential
consequences of deselection.
Response: The 2008 amendments to
the Acts authorize FSIS to develop a
procedure to transition selected
establishments to become Federal
establishments if they employ more
than 25 employees on average, or if the
Administrator determines that they are
in violation of any provision of the Acts
(21 U.C.S. 683(b), 683(h), 472(b) and
472(h)). In the preamble to the proposed
rule, the Agency explained that it was
not prescribing specific procedures to
transition selected establishments to
become official establishments because
the actions needed to successfully make
such a transition are likely to depend on
the reason the establishment was
deselected (74 FR 47656). As an
example, FSIS noted that an
establishment that was deselected for
violating the Acts would likely need to
develop a corrective action plan to
transition to an official establishment,
while an establishment that was
deselected for hiring additional
employees would not.
Therefore, consistent with the
proposal, FSIS has decided to not
prescribe specific procedures to
transition selected establishments to
become Federal establishments, as
suggested by the comment. As was
proposed, if a selected establishment is
deselected from the cooperative
interstate shipment program, FSIS will
coordinate with the State where the
establishment is located to develop and
implement a plan to transition the
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establishment. As noted in the
preamble, at a minimum, such a plan
will include: (1) Adding the
establishment to an FSIS circuit; (2)
replacing the establishment’s State
establishment number with a Federal
number; and (3) replacing the
designated personnel with FSIS
personnel.
Comment: One comment noted that in
the proposed rule FSIS outlined some
general procedures that would be
necessary to transition a selected
establishment to become a Federal
establishment (e.g., changing the
establishment number and replacing
state personnel with FSIS inspection
personnel) but that the Agency also
explained it would collaborate with the
States to implement specific transition
procedures on a case-by-case basis. The
comments stated that while this
approach may be appropriate in dealing
with individual establishments in a
State, FSIS should develop specific
procedures for instances when the
State’s agreement for a cooperative
interstate shipment program is
terminated.
Response: As discussed above, under
this final rule, establishments that are
no longer eligible to participate in a
cooperative interstate shipment because
they are located in a State whose
agreement for such a program was
terminated will have the option to either
revert back to the State MPI inspection
program or obtain a Federal grant of
inspection. Selected establishments that
choose to operate under Federal
inspection will need to transition to
become a Federal establishment. FSIS
will coordinate with the State where the
establishment is located to develop and
implement a plan for the establishment
to obtain a Federal grant of inspection.
Selected establishments that choose to
revert to the State MPI program will
need to obtain a State grant of
inspection through the State in which
they are located.
J. Federal Contribution, Technical
Assistance, and Transition Grants
1. Federal Contribution 60% State Costs
As noted in the preamble to the
proposed rule, the statute requires that
the Federal contribution for inspection
services provided by States that enter
into an agreement for a cooperative
interstate shipment program be at least
60% of eligible State costs. In the
preamble, FSIS also explained that the
Agency had tentatively concluded that
eligible State costs are those costs that
a State has justified and FSIS has
approved as necessary for the State to
provide inspection services to selected
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establishments in the State (74 FR
47650). The Agency requested
comments on whether it should codify
this definition or any other
requirements related to State
reimbursement for eligible costs in the
final rule.
Comment: Comments submitted by
both State Departments of Agriculture
and consumer advocacy organizations
stated that FSIS should codify
requirements related to reimbursement
of States for at least 60% of their eligible
costs associated with the cooperative
interstate shipment program. According
to some comments, codifying these
requirements would provide both States
and FSIS personnel with consistent
guidance on the level of reimbursement
and requirements for receiving payment
under the program. The comments also
said that codifying the reimbursement
requirements will prevent ad hoc
interpretations and inequitable
reimbursement policies over time.
Some comments requested that FSIS
more clearly define ‘‘eligible costs.’’ The
comments specifically asked whether
the following State costs would be
considered eligible costs under the final
rule: (1) Federal Indirect Cost
Reimbursement to pay for office and
administrative support services; (2) rent
for computers, (3) administrative offices
and field staff offices; and (4) fees
associated with information technology
and laboratory services.
One comment supported the proposed
definition of eligible State costs as those
direct costs that a State has justified and
FSIS has approved as necessary for the
State to provide inspection services to
selected establishments in the State. The
comment argued that these are Federal
taxpayer dollars that should be spent on
Federal programs. The commenter
stated that it understands that the law
requires FSIS to reimburse States not
less than 60% of eligible State costs but,
according to the comment, such
reimbursement should be confined to
direct costs only. The comment asserted
that costs that fall under Federal
Indirect Cost Reimbursement definitions
should not be included.
Response: To be reimbursed for 60%
of their eligible costs to administer the
cooperative interstate shipment
program, States will need to follow the
same financial accountability and
budget submission requirements needed
to receive the maximum 50% Federal
reimbursement under the cooperative
State MPI program. These requirements
include, but are not limited to, the
administrative rules for Federal grants
and cooperative agreements prescribed
in USDA’s Uniform Administrative
Requirements for Grants and
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Cooperative Agreements to State and
Local Governments regulations (7 CFR
part 3016), as well as the principles
provided in the Office of Management
and Budget’s (OMB) circular A–87 ‘‘Cost
Principles for State, Local, and Indian
and Tribal Governments’’ (2 CFR Part
225); OMB circular A–102, ‘‘Grants and
Cooperative Agreements with State and
Local Governments’’; and OMB circular
A–133, ‘‘Audits of States, Local
Governments, and Non-Profit
Organizations’’.
FSIS will only reimburse 60% of a
State’s costs to administer the
cooperative interstate shipment program
if the State can justify that the costs are
necessary to provide inspection services
to selected establishments in the State
and that the costs are allowable under
the applicable Federal cost principles or
other terms and conditions of the
cooperative agreement. To make this
clear, FSIS is codifying the definition of
eligible State costs that it had tentatively
decided on in the proposed rule. Thus,
9 CFR 321.3 and 381.187 of this final
rule provide that for purposes of the
cooperative interstate shipment
program, eligible State costs are those
costs that a State has justified and FSIS
has approved as necessary for the State
to provide inspection services to
selected establishments in the State.
The Federal requirements and
procedures for the financial
administration and operation of
cooperative State agreements are
described in FSIS Directive 3300.1
‘‘Fiscal Guidance for Cooperative
Inspection Programs’’. These
requirements and procedures apply to
all cooperative inspection program
agreements, including agreements for
the cooperative interstate shipment
program. FSIS will update directive
3300.1 to specifically address the
cooperative interstate shipment
program.
Comment: One comment asked
whether a State’s administrative costs to
begin an interstate shipment program
will be eligible for at least 60%
reimbursement from FSIS. The
comment also asked whether there is
anything in the program that would
prohibit a State from charging an
establishment a fee to participate in the
program to help cover the State’s
additional costs. Another comment
asked whether the final rule will require
that States submit separate financial
reports for inspection costs associated
with the State MPI program and for
costs associated with the cooperative
interstate shipment program.
Response: As noted above, FSIS will
only reimburse 60% of a State’s costs to
administer the cooperative interstate
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24741
shipment, including the administrative
costs to begin the program, if the State
can justify that the costs are necessary
to provide inspection services to
selected establishments in the State and
that the costs are allowable under the
applicable Federal cost principles or
other terms and conditions of the
cooperative agreement. The 2008
amendments to the Acts are silent on
whether a State may charge an
establishment a fee to participate in the
cooperative interstate shipment
program. The proposed rule provides
that States are responsible for
developing their own procedures for
establishments to apply to be selected
for the cooperative interstate shipment
program.
The agreement between FSIS and a
State for a cooperative interstate
shipment program is separate from the
cooperative State MPI agreement.
Therefore, States that participate in the
cooperative interstate shipment program
will be required to submit separate
financial reports for inspection costs
associated with the State MPI program
and for costs associated with the
cooperative interstate shipment
program. The States must also clearly
document the time and cost that they
spent to provide administrative support
for the State MPI program versus the
time and cost needed to provide
administrative support for the
cooperative interstate shipment
program.
Comment: Some comments supported
the requirement that Federal
reimbursement for the cooperative
interstate shipment program be in an
amount of not less than 60% of eligible
State costs. The comments urged FSIS to
provide more funding if, and when, the
budget allows.
One comment stated that in order for
the program to succeed, it is critically
important for FSIS, the Obama
Administration, and Congress to commit
sufficient resources to carry out the
program. The comment stated that
under no circumstances should FSIS be
required to absorb these resources from
its existing budget.
One comment stated that the higher
the Federal contribution, the more likely
it is that State programs will be able to
participate in the interstate shipment
program. The comment encouraged
FSIS to be creative in finding ways to
increase the Federal contribution to the
program. The comment noted that cash
infusions are the best way to support the
program, but that other contributions,
such as equipment (including
computers discussed above) and
services (including training and
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laboratory services), would also be
helpful.
Response: FSIS agrees that the success
of the cooperative interstate shipment
program will depend on the level of
funding that Congress provides for the
Agency to administer the program.
2. Technical Assistance and Outreach
As required by the statute, FSIS
established the Office of Outreach
Employee Education and Training
(OOEET) to provide ‘‘outreach,
education, and training to certain small
and very small establishments’’ and to
provide ‘‘grants to States to provide
outreach, technical assistance,
education, and training to certain small
and very small establishments’’ (21
U.S.C. 683(f)).
In the preamble to the proposed rule,
FSIS explains that the Agency fulfilled
this requirement by establishing the
Office of Outreach Employee Education
and Training (OOEET). OOEET is
responsible for directing outreach,
education, and training programs for
FSIS to ensure public health and food
safety through both inspection and
enforcement activities. FSIS received
several comments and suggestions on
how OOEET should provide outreach
and technical assistance to support the
cooperative interstate shipment
program. FSIS has included a general
description of these comments below.
However, OOEET’s outreach and
assistance activities were not
specifically addressed in the proposed
rule. Thus, these comments are outside
the scope of this rulemaking.
Comment: Some comments
encouraged OOEET to work with other
Federal agencies to assist establishments
that are interested in participating in the
cooperative interstate shipment program
to acquire grants or loans to fund
modifications that they may need to
make to their facilities in order to
comply with Federal standards. The
comments noted that in the preamble to
the proposed rule, FSIS estimated that
establishments that need to make
structural modifications or perform new
construction could incur costs in the
range of $15,000 to $30,000. The
comments said that the States should
not be expected to fund these costs.
A few comments suggested that FSIS
use USDA’s ‘‘Know Your Farmer, Know
Your Food’’ initiative to provide
information about USDA grant and loan
programs to help small and very small
facilities upgrade their infrastructure.
The consumer advocacy organization
Food and Water Watch submitted
identical comment letters on behalf of
5,083 private citizens. The comment
letters supported FSIS’s proposed
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regulation implementing the
cooperative interstate shipment
program. The comments also suggested
that FSIS take a number of actions to
ensure that the change to the new
program goes smoothly and is feasible
for States and small establishments.
Three comments reference a report
issued by Food and Water Watch
entitled ‘‘Where’s the Local Beef?’’ The
comments stated that the report
provides a number of recommendations
that FSIS should consider for the
technical assistance required under the
statute. The comments encouraged FSIS
to consider these recommendations.
One comment stated that to ensure
that States and establishments receive
the assistance that they need to
participate in the program, the
Administration must budget, and
Congress must appropriate, adequate
funding for outreach and training
activities. The comment said that, in
particular, OOEET will need sufficient
resources to conduct workshops,
training sessions, and other activities to
ensure that small and very small
establishments in the new program
understand the requirements they are
expected to meet.
Response: As noted above, the issues
raised by these comments are outside
the scope of this rulemaking. However,
the Agency will take them into
consideration when it implements this
final rule.
3. Transition Grants
Under the statute, FSIS is authorized
to provide ‘‘transition grants’’ to States to
assist the States in helping Stateinspected establishments transition to
selected establishments (21 U.S.C.
683(g) and 472(f)). In the proposed rule,
FSIS explained that it has tentatively
decided to define transition grants as
funds that a State participating in a
cooperative interstate shipment program
must use to reimburse selected
establishments in the State for the cost
to train one individual in individual in
HACCP requirements for meat and
poultry products and associated training
in the development of Sanitation SOPs.
FSIS received several comments on
the proposed definition of transition
grants.
Comment: Some comments supported
FSIS’ tentative conclusion to use its
transition grant authority to reimburse
States for the costs of HACCP training
for establishment employees as an
appropriate use of these funds.
According to one comment, FSIS has
already created a division to provide
technical assistance for small and very
small establishments, i.e., OOEET, so it
is not necessary to provide transition
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grants to the States to use for
duplicative outreach services.
Other comments said that the
proposed transition grant definition is
too narrow, unnecessarily restrictive,
and does not reflect the fact that training
may be more urgently needed in other
areas essential to food safety, such as
microbiological sampling, process
control, validation, determination of
HACCP Critical Limits, or use of
modern monitoring techniques. The
comments suggested that FSIS revise the
definition to allow the funds to be used
to provide outreach, technical
assistance, education, and training that
establishments may need to become
selected establishments and maintain
this designation.
Other comments stated that while
HACCP training is an appropriate use of
transition grants, it should not be the
only use permitted for these funds. The
comments asserted that transition grants
could be used in some States for
relevant state and local agencies to
convene workshops and listening
sessions on the application of local,
State and Federal food safety regulations
on small and very small processing
establishments. The comments asserted
that these workshops could generate
approaches to improve and streamline
food safety regulations, including
HACCP requirements, to ensure that
they are appropriate for achieving food
safety standards in smaller facilities.
A few comments stated that FSIS
should permit transition grant funds to
be used for tangible items, such as
facility upgrades or other one-time start
up costs for establishments to become
eligible for the cooperative interstate
shipment program. One comment said
that, if necessary FSIS could limit the
amount it would provide to States to
reimburse selected establishments to
$5,000 per establishment, which was
the Agency’s estimated cost to train an
individual in HACCP.
Two comments submitted by animal
welfare advocacy organizations stated
that, in addition to HACCP training,
FSIS should also allow States to use
transitions grant funds to reimburse
selected establishments for their costs to
train personnel in humane handling and
humane slaughter.
Response: The comments indicate
that there is a general lack of consensus
on the appropriate use of transition
grant funds. Therefore, because the
comments offered no compelling reason
to change it, FSIS is adopting the
proposed definition of transition grant
as funds that a State participating in a
cooperative interstate shipment program
must use to reimburse selected
establishments in the State for the cost
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to train one individual in HACCP
requirements for meat and poultry
products and associated training in the
development of Sanitation SOPs.
FSIS has very limited authority for
and experience in administering grants
for financial assistance outside the
scope of cooperative inspection
programs, and its food safety focus
suggests that it would be of limited
value for the Agency to gain such
experience. Other USDA agencies, such
as Rural Development and the National
Institute for Food and Agriculture
provide loans and grants of the kind that
might be useful for establishments that
may need to make modifications to their
facilities to become eligible for the
cooperative interstate shipment
program. FSIS will coordinate with
these other USDA agencies in
developing and publicizing such
programs, but will defer to them as
USDA’s loan and grant program
specialists.
A limited grants program to provide
Federal funds to States so that they may
reimburse selected establishments for
HACCP training is, however, consistent
with FSIS’s authorities and capabilities.
It will help to ensure that
establishments that participate in the
cooperative interstate shipment program
are able to comply with Federal food
safety standards. Limiting the use of
transition grants to HACCP training for
one individual will ensure that the costs
associated with these grants are limited,
predictable, and simple to monitor.
Comment: One comment requested
that FSIS provide more details on the
transition grants. The comment noted
that while funds from transition grants
will be available to help establishments
with the costs of training on HACCP and
SSOPs, some establishments are likely
to have already completed the necessary
HACCP training. For those
establishments, the comment asked
whether States could use transition
grant funds to reimburse the
establishment’s costs to send an
employee to advanced HACCP training
courses or to send another employee for
training in basic HACCP and SSOPs.
The comment also asked if the grant
includes all costs associated with the
training, from travel costs to the cost of
registration or materials.
Response: The proposed rule requires
that States use transition grant funds to
reimburse selected establishments for
their costs to train one individual in
HACCP requirements for meat and
poultry products as required under 9
CFR 417.7 of the HACCP regulations
and associated training in the
development of Sanitation SOPs. These
regulations require that the individual
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successfully complete a course of
instruction in the application of the
seven HACCP principles to meat or
poultry product processing. Thus,
transition grant funds may be used to
reimburse the costs associated with the
basic training required to comply with
9 CFR 417.7, which does not include
advanced HACCP training. The
transition grant would include any costs
that the establishment can demonstrate
were necessary to provide HACCP
training to one individual.
K. Potential Benefits
FSIS received several comments on
the potential benefits of allowing small
and very small State-inspected
establishments to ship meat and poultry
products in interstate commerce.
Following is a general description of
these comments categorized by potential
benefit.
1. Expand Markets for Small
Establishments
Several comments said that allowing
State-inspected products to ship meat
and poultry products interstate will
benefit small and very small Stateinspected establishment by providing
new markets for their products. The
comments also stated that, as small
processors expand their markets,
consumers will also benefit from an
increase in product choice.
2. Rural Development
Some comments stated that, if
implemented correctly, the cooperative
interstate shipment program will
provide opportunities for rural
development. One comment said that a
workable cooperative interstate
shipment program will stimulate small
business sales, expand rural
development and jobs, and increase
local tax bases, strengthening the
stability of rural communities. Another
comment noted that increasing the
market opportunities for small
processors is important to rural
development because it will help to
maintain and increase jobs in the rural
areas where many of these small
processors are located.
3. Small Farmers and Livestock
Producers
Several comments stated that
allowing State-inspected processing
plants to ship products interstate will
benefit small farmers and local livestock
and poultry producers by providing
them with access to processing plants
that can sell meat and poultry products
across State lines. The comments noted
that farmers rely on processing plants to
sell their products to consumers, and
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that allowing interstate shipment of
State-inspected products will help
family farmers raising livestock and
poultry, as well as small processing
plants, to increase their access to larger
markets.
One commenter had conducted a
survey of farmers across the country in
spring 2009 to identify barriers to local
food marketing. The comment noted
that by far, the number one barrier
mentioned was access to processing
plants for meat, poultry, and valueadded crops.
Several comments said that, in
addition to expanding markets for local
livestock and poultry producers,
allowing small State-inspected
processing plants to ship products
interstate will also benefit these local
producers by reducing travel costs that
many must incur to send their livestock
to a federally-inspected establishment.
One comment said that a producer in
central Wyoming estimated that he
could save almost $220,000 per year if
he could have his animals processed
locally in a state-inspected
establishment. Some comments noted
that many small livestock and poultry
producers prefer to have their products
processed in small State-inspected
establishments, but that for some of
these producers, the closest small
processing establishment may be
located across State lines.
Some comments stated that the
cooperative interstate shipment program
could benefit cattle producers by
increasing the demand for beef. The
comment said that allowing stateinspected establishments to ship
interstate will provide many smaller
packing plants with an opportunity to
expand into new markets. According to
the comment, growth and new
opportunities for these smaller plants
means that they will have the
opportunity to buy more cattle from
producers. The comment asserted that
this further demand for cattle will
provide more competition in the market
and will potentially provide more
opportunities for cattlemen.
One comment stated that the
increased market opportunities for small
processors will be passed on to livestock
and poultry producers, which will lead
to increased on-farm revenues.
A few comments stated that the
proposed cooperative interstate
shipment program will offer
independent family farmers and niche
producers whose operations use
humane and sustainable animal
agricultural practices greater
opportunity to market their products to
a broader range of consumers. One
comment believed that the proposed
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rule has the potential to benefit small
organic livestock operations. According
to the comment, it is often difficult for
these producers to find local slaughter
or processing facilities.
One comment stated that the
proposed interstate shipment program
has the potential to benefit not only
family farmers but the animals they
raise by reducing the stress associated
with long transport times to slaughter.
Some comments stated that the
proposed rule will enhance the USDA’s
‘‘Know Your Farmer, Know Your Food’’
initiative by helping to break down
structural barriers that have inhibited
local food systems from thriving.
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4. Protect Public Health
One comment stated that the
proposed program will protect public
health by facilitating traceback of Stateinspected products that may be the
subject of a recall.
Response: FSIS agrees that these
comments all identify potential benefits
associated with the cooperative
interstate shipment program.
L. Interstate Shipment and Humane
Handling of Livestock
Comment: A few comments noted that
the proposed rule did not mention the
Federal Humane Methods of Slaughter
Act (HMSA). One comment stated that,
while the FMIA incorporates the HMSA
by reference, it is imperative that FSIS
make clear in the final rule’s codified
text that establishments must be in
compliance with the HMSA and all
State humane handling requirements to
be eligible for the cooperative interstate
shipment program.
One comment stated that in May
2008, the commenter published a report
on the enforcement of humane slaughter
laws in the United States. The comment
explained that the report included
results from a series of public records
requests that the commenter made to the
30 States accredited to administer the
Federal humane slaughter laws (the 27
States with cooperative agreements for
State MPI programs and 3 States with
cooperative programs for custom
plants).
Based on this report, the comment
concluded that most states that operate
meat inspection programs are not
enforcing the HMSA at state-inspected
establishments. The comment said that
small state-inspected establishments are
probably less likely to have staff and
management with training in humane
handling and slaughter as Federal
establishments, and that small stateinspected establishments are also
probably less likely to have specialized
equipment for proper animal handling
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or a facility design that promotes
humane handling and slaughter.
Response: To qualify for the
cooperative interstate shipment
program, establishments will need to
comply with, and States will need to
enforce, standards that are ‘‘the same as’’
those imposed under the Federal Acts
and implementing regulations. As noted
by the comments, the FMIA
incorporates the HMSA by reference.
Therefore, selected establishments must
comply with, and participating States
must enforce, humane handling
procedures that are ‘‘the same as’’ those
imposed under the HMSA and FSIS’s
implementing regulations.
Because the FMIA incorporates the
HMSA, it is not necessary to include
additional requirements to implement
the HMSA in the regulations
implementing the cooperative interstate
shipment program.
Comment: One comment suggested
that as part of its outreach efforts to
small and very small establishments,
FSIS include training in the humane
handling of livestock and poultry during
slaughter and processing. One comment
suggested that FSIS grade and identify
establishments based on how humanely
they raise their livestock.
Response: These comments are
outside the scope of the proposed rule.
M. Miscellaneous Comments
Comment: A few comments noted that
many small and very small
establishments process bison, elk, and
other species that are not amenable to
the Federal Acts. The comments asked
whether FSIS would address the
processing of these species in the final
rule implementing the cooperative
interstate shipment program. One
comment asked whether the final
regulations will permit selected
establishments to continue to slaughter
non-amenable species under the State
inspection program. The comment also
asked whether the ‘‘same as’’ standard
proposed for the cooperative interstate
shipment program will affect Stateinspected operations related to nonamenable species.
Response: The cooperative interstate
shipment program does not cover
operations for the processing of bison,
elk, and other species that are not
amenable to the FMIA or PPIA.
However, as discussed above, this final
rule will allow State-inspected
establishments to operate under both
the State MPI program and the
cooperative interstate shipment
program. Under this final rule, selected
establishments may continue to
slaughter and process non-amenable
species under the State inspection
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program as long as they maintain an
appropriate separation of time or space
between these operations and the
operations conducted under the
cooperative interstate shipment
program. Because operations associated
with non-amenable species are not
eligible for the cooperative interstate
shipment program, these operations are
not affected by the ‘‘same as’’ standard
required for the program.
Comment: One comment stated that
FSIS must make clear in the final rule
that state-inspected horse slaughter
facilities are not eligible to participate in
the new cooperative interstate shipment
program. The comment noted that
currently there are no such facilities in
operation in the United States, but
expressed concern that providing
certain state-inspected establishments
access to the interstate market may
encourage some small establishments to
initiate new horse slaughter operations.
The comment stated that Congress has
made its intent clear that Federal
funding must not be used to inspect
such facilities, and FSIS must not allow
establishments to use the cooperative
interstate shipment program to
circumvent the law.
The comment also stated that any
attempt by FSIS to regulate horse
slaughter facilities must comply with
the National Environmental Policy Act,
42 U.S.C. 4231 et seq., and cited
Humane Society of the United States v.
Johanns (520 F.Supp.2d 8 (D.D.C. 2007))
to support this statement. The comment
asserted that unless FSIS makes clear
that the final rule does not encompass
horse slaughter, the Agency will need to
prepare an Environmental Impact
Statement or Environmental Assessment
before finalizing the rule to avoid a
potential violation of a federal court
order.
Response: As noted by the comment,
the FY 2010 Agriculture, Rural
Development, Food and Drug
Administration, and Related Agencies
Appropriations Act prohibits the use of
appropriated funds and user fees to pay
the salaries of expenses of personnel to
inspect horses prior to slaughter for
human food (Pub. L. 111–80, § 739).
FSIS will comply with these and any
future restrictions on the use of
appropriated funds as it implements the
cooperative interstate shipment
program.
Comment: One comment suggested
that, when developing the final rule to
implement the cooperative interstate
shipment program, FSIS should review
its data on FSAs, NRs, suspensions,
HACCP deviations, number of lab tests,
and laboratory results to compare FSIS
regulatory oversight of very small State-
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inspected establishments with large and
small establishments. According to the
comment, this information may help
identify specific areas of concern that
the Agency should address in the final
rule.
Response: FSIS believes that this final
rule provides the appropriate level of
Federal oversight required under the
2008 amendments to the Acts. The data
identified by the comment will be
useful to FSIS in overseeing the
program.
Comment: One comment asked
whether the labels for products
produced in establishments selected to
participate in the cooperative interstate
shipment program will be granted
expedited review so that they can begin
to operate under the new program more
quickly. The comment also asked
whether such labels would be approved
by the FSIS Labeling and Program
Delivery Division (LPDD). The comment
stated that it would be disappointing if
an establishment’s ability to participate
in the cooperative interstate shipment
program was delayed because of the
label approval process.
Response: The labels of meat and
poultry products produced under the
cooperative interstate shipment program
will be subject to FSIS’ prior label
approval system to ensure that such
labels comply with Federal labeling
requirements. The SEC for the State
where a selected establishment is
located will coordinate with the State to
facilitate the label submission process.
The SEC will also verify that the labels
applied to meat and poultry products
produced under the cooperative
interstate shipment program have been
evaluated and approved by LPDD,
except for generically approved labeling
authorized for use in Title 9 of the Code
of Federal Regulations (CFR), §§ 317.5
and 381.133. Because the labels of meat
and poultry products produced in
selected establishments are required to
bear a Federal mark, it is essential that
these labels comply with all Federal
labeling requirements.
Comment: One comment requested
that FSIS explain whether, under the
final rule, E. coli O157:H7 would be
considered an adulterant if detected on
an intact muscle cut of beef. The
comment asserted that if E. coli
O157:H7 is only considered an
adulterant if it is detected in a ground
beef sample, selected establishments
whose operations are limited to further
processing will be subject to
enforcement action, i.e., deselection, for
upstream contamination over which
they have no control.
Two comments suggested that in the
final rule, FSIS add a provision to
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ensure that selected establishments
whose operations are limited to further
processing are not subject to
enforcement actions for product
contamination that originated in an
upstream slaughter facility.
Response: These comments address
issues associated with FSIS’s existing
policies with respect to E. coli O157:H7.
They are outside the scope of this
rulemaking.
Comment: One comment stated that
processors and regulatory staff have
been trained to recognize ‘‘shall’’ as an
indication of mandatory requirements.
The comment inserted suggested
revisions to the proposed codified text,
such as replacing ‘‘will’’ with ‘‘shall.’’
According to the comment, the
suggested revisions are needed to make
clear which provisions of the
regulations are mandatory.
Response: This is the only comment
to make these suggested revisions. FSIS
believes that the language in the
codified text clearly articulates the
requirements associated with the
cooperative interstate shipment
program.
Comment: One comment noted that
throughout the proposed regulations
FSIS uses the terms such as ‘‘in
compliance with the Acts’’ or
‘‘consistent with the Acts.’’ The
comment stated that since State meat
and poultry inspection programs
already comply with the FMIA and
PPIA, FSIS needs to make clear that
most references to ‘‘the Act’’ in the
proposed regulation are intended to
refer to the new legislation, i. e., Title
V of these Acts. According to the
comment, Section 11015 of the 2008
Farm Bill did not amend the existing
sections of FMIA and PPIA, but rather
created a new section in each of these
Acts. The comment suggested that FSIS
revise ‘‘in compliance with the Acts’’ to
‘‘in compliance with this Act’’ to make
this clear.
Response: In the final codified text,
‘‘this Act’’ was changed to ‘‘this chapter.’’
As used in the statutes, ‘‘this chapter’’
means the FMIA and PPIA, not section
11015 of the 2008 Farm Bill (see 21
U.S.C.A. 683 and 472, Historical and
Statutory Notes, References in Text).
Thus, the terms ‘‘in compliance with the
Acts’’ or ‘‘consistent with the Acts’’
better reflect the intent of the statutes
than ‘‘in compliance with this Act’’
meaning section 11015 of the 2008 Farm
Bill.
Executive Order 12866 and Regulatory
Flexibility Act
This final rule has been reviewed
under Executive Order 12866. It has
been determined to be significant, but
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24745
not economically significant for
purposes of E.O. 12866 and, therefore,
has been reviewed by the Office of
Management and Budget (OMB).
Currently, 27 States administer
cooperative State meat or poultry
inspection (MPI) programs. These States
have approximately 1,873
establishments that would be eligible to
apply for selection into the new
cooperative interstate shipment
program. However, because
participation in the new program is
voluntary, FSIS will not know how
many States and establishments will
apply to participate until this final rule
becomes effective and establishments
are selected for the program.
In the proposed rule’s Preliminary
Regulatory Impact Analysis (PRIA),
FSIS explained that information
obtained through the Agency’s outreach
activities indicated that, as of July 2008,
about 170 establishments in sixteen
States had approached the State MPI
programs to express interest in the new
cooperative interstate shipment
program. These sixteen States have in
total 1,133 establishments that could
potentially be eligible for the new
program. However, more recent Agency
outreach activities conducted after the
proposed rule was published indicate
that there now may be only four States
interested in participating in the
cooperative interstate shipment
program.3 The four States that have
recently expressed interest in the
program are North Dakota, Ohio,
Wisconsin, and Vermont. According to
the State Directors of these four States,
the total number of establishments in
these States that might participate is
between 27 and 102, and the actual
number will depend on the language of
the final rule. This finding is consistent
with information provided in the public
comments submitted in response to the
proposed rule that indicated that the
participation number we estimated in
the proposed rule was too high.
Therefore, we have adjusted the budget
impact downward by incorporating the
new information.
Expected Benefits of the Proposed
Action
State-inspected establishments
selected to participate in the new
cooperative interstate shipment program
will be permitted to ship and sell their
meat and poultry products in interstate
and foreign commerce. Thus, this final
3 These four States have each signed an agreement
with the Agency to conduct a comparative analysis
to determine what the States would need to do to
meet the ‘‘same as’’ requirements for the cooperative
interstate shipment program. FSIS provided funds
for the States to conduct the assessment.
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rule will benefit these establishments by
opening new markets for their products.
This final rule will also benefit
consumers by generating more product
choices, as more products can be
shipped to new markets. In addition,
requiring that products produced under
the cooperative interstate shipment
program bear a Federal inspection
legend that includes an official State
selected establishment inspection
number will allow consumers to
identify that these products were
produced under the cooperative
interstate shipment program if such
products are ever the subject of an
investigation or recall.
States that participate in the program
will benefit because the law requires
that FSIS reimburse them for at least
60% of their eligible costs related to
inspection of selected establishments in
the State. FSIS provides up to 50% of
the costs to provide inspection under
the existing cooperative State MPI
programs. States are likely to benefit
from the 10% increase in
reimbursement for the cooperative
interstate shipment program because, as
explained below, for many States, the
costs to administer the new program are
not expected to greatly exceed the costs
to administer the State MPI programs.
The Agency received several
comments that identified additional
potential benefits of allowing small and
very small State-inspected
establishments to ship meat and poultry
products in interstate commerce. These
benefits include:
1. Rural development: Allowing
certain small and very small Stateinspected establishments to ship their
products across State lines may
stimulate small business sales, expand
rural development and jobs, and
increase local tax bases, strengthening
the stability of rural communities,
where many of these small
establishments are located.
2. Benefits for small farmers and
livestock producers: Allowing Stateinspected processing plants to ship
products in interstate commerce will
benefit small farmers and local livestock
and poultry producers by providing
them with access to processing plants
that can sell meat and poultry products
across State lines. It will also benefit
local producers by reducing travel costs
that many must incur to send their
livestock to a federally-inspected
establishment, as the closest small
processing establishment may be
located across State lines.
participate in the cooperative interstate
shipment program, a State-inspected
establishment must be in compliance
with: (1) The State-inspection program
of the State in which the establishment
is located and (2) the FMIA or PPIA, and
their implementing regulations. Before
State-inspected establishments can be
selected to participate in a cooperative
interstate shipment program, they will
need to apply for selection into the
program and demonstrate that they
comply with both State and Federal
requirements.
Thus, an establishment that chooses
to apply for selection into the program
will incur one-time start-up costs
associated with filing an application,
training employees, meeting regulatory
performance standards, obtaining label
approval, and implementing a food
safety system that complies with all
Federal requirements (e.g. Sanitation
SOP and HACCP requirements).
In addition, to qualify for a
cooperative interstate shipment
program, some State-inspection
establishments may need to invest in
structural modifications to their
facilities in order to comply with
Federal standards. Based on information
obtained through FSIS’ outreach
activities with the States in 2008, in the
PRIA of the proposed rule, the Agency
estimated that the cost for Stateinspected establishments to fully
comply with Federal standards, as
required by the law, will range from
$1,500 to $50,000. FSIS did not receive
any comments or new information in
response to the proposed rule to suggest
changes to these estimates.
According to most State Directors, the
cost to very small establishments that do
not need to make structural
modifications to their facilities is likely
to be in the range of $5,000 to $10,000.
If the establishments need to make
structural modifications or perform new
construction, the estimated range would
be about $15,000 to $30,000.4 However,
because the cooperative interstate
shipment program is a voluntary
program, establishments that choose to
incur the costs associated with
participating in the program will most
likely do so because they anticipate that
such participation will provide an
overall net benefit for them.
Looking at the potential for the
establishments to experience new
(incremental) burden or expenses due to
State inspection under the proposed
cooperative interstate shipment
Expected Costs of the Proposed Action
1. Costs to the participating
establishments. To be eligible to
4 Note that under this final rule, establishments
selected for the program will be eligible to be
reimbursed the cost to train one employee in
HACCP and Sanitation SOPs.
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program, FSIS believes that there will be
essentially no change. FSIS is aware that
the cooperative State MPI programs are
not identical to the Federal inspection
program. FSIS anticipates that States
may need to modify their existing
inspection procedures when providing
inspection services to selected
establishment in the State to ensure that
these establishments receive inspection
services that are ‘‘the same as’’ those
required under the Federal program.
However, since the State programs are
required to be ‘‘at least equal to’’ the
Federal inspection programs now, FSIS
anticipates that changes that States will
need to make to provide inspection to
selected establishments will largely be
procedural, and there will not be any
particular increase or decrease in overall
State effort that would change the
burden of the inspection regimen on the
establishments.
2. Costs to the participating States.
States that choose to participate in the
program will be required to pay 40
percent of the eligible costs related to
inspection of establishments in the State
that are selected for the program. Under
the current cooperative program, the
States are paying 50 percent of the
eligible inspection costs. Although the
inspection costs under the new program
may be different from the costs under
the existing program, the States’ share of
40 percent or less is unlikely to be
higher than its current share.
One area the States will have to
address is the laboratory services that
they will be using to analyze samples
collected under the cooperative
interstate shipment program. To
demonstrate that the laboratory services
used by a State are sufficient for the
State to qualify for the cooperative
interstate shipment program, the State
will need to show that the laboratory is
accredited by an internationally
recognized organization that accredits
food testing laboratories against the ISO
17025 ‘‘General requirements for the
competence of testing and calibration
laboratories’’ and AOAC ‘‘Guidelines for
Laboratories Performing Food
Microbiological and Chemical Analyses
of Food and Pharmaceuticals Testing’’
written by the Analytical Laboratory
Accreditation Criteria Committee
(ALACC). The assessment body that
FSIS uses, the American Association for
Laboratory Accreditation (A2LA), is the
sole organization that incorporates
ALACC into their program
requirements. State labs would need to
use A2LA or another accrediting body
that incorporates ALACC and is a
signatory and in good standing to the
Mutual Recognition Arrangements of
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the International Laboratory
Accreditation Cooperation (ILAC).
Currently three State labs are ISO
17025 accredited—Minnesota, North
Carolina, and Florida (FL does not have
a State MPI program), four States are
actively seeking ISO 17025
accreditation—Ohio, Wisconsin, North
Dakota, and Vermont, and four States
use commercial labs that are ISO
accredited.
States that use laboratories that do not
use the methods described in FSIS’s
Laboratory Guidebooks may incur costs
to adopt such methods to analyze
samples under the cooperative interstate
shipment program. If a test or product
described in the FSIS Guidebook is not
commercially available, FSIS will assist
the laboratory in developing an
appropriate alternative method.
To assist the States in developing
laboratory services that are ‘‘the same
as’’ those provided under the Federal
inspection program, FSIS is adopting a
‘‘phased in’’ approach for the States to
become ISO 17025 accredited. FSIS’s
Office of Public Health Science (OPHS)
intends to provide advice and answer
questions from State labs as they seek
ISO accreditation. FSIS estimates the
cost for a State lab to obtain the
necessary accreditation to be ‘‘the same
as’’ to be somewhere between $28,000
and $350,000. These costs reflect the
costs associated with purchasing
additional equipment, hiring additional
staff (QC manager for Chemistry, QC
manager for Microbiology, Document
Control Clerk, and additional analysts,)
the initial application fee to apply for
ISO 17025 accreditation, the annual fee
to maintain accreditation, and the
accrediting body’s assessment fee.
States that choose to participate in the
interstate shipment program may need
to make certain modifications to their
State inspection programs to provide
inspection services to selected
establishments in a manner that is ‘‘the
same as’’ the Federal inspection
program. However, most States that
have implemented State meat and
poultry products inspection (MPI)
programs have incorporated the Federal
requirements into their programs.5
Thus, State costs to train State
personnel are likely to be minimal
because many State personnel have
received training in Federal inspection
methodology as part of the State MPI
program. In addition, as noted above,
FSIS offers training courses in Federal
inspection methodology to State
inspection personnel. FSIS’s OOEET
will coordinate with States participating
in the cooperative interstate shipment
program to provide the necessary
training for designated State personnel.
States may incur some costs
associated with the processing and
evaluation of applications submitted by
establishments requesting to be selected
for the cooperative interstate shipment
program. However, because the States
will develop their own application
procedures, FSIS is unable to estimate
these costs with any certainty.
FSIS anticipates that States may need
to revise their State inspection
procedures when providing inspection
services to selected establishments in
the State to ensure that these inspection
services are ‘‘the same as’’ those
provided under the Federal program.
However, since the cooperative State
MPI programs are required to be ‘‘at least
equal’’ to the Federal inspection
programs now, FSIS anticipates that
changes will largely be procedural, and
there will not be any particular increase
or decrease in overall State effort or
cost. FSIS has no basis on which to
assume anything else.
Expected FSIS Budgetary Effects
The new cooperative interstate
shipment program that we are
implementing in this final rule is
expected to have budgetary effects on
FSIS. This section discusses the
baseline costs and activities, i.e., what is
happening now before the cooperative
interstate shipment program option is
available, and then lays out the
incremental effects on FSIS. The PRIA
in the proposed rule presented a
baseline scenario outlining the Agency’s
spending for the Federal-State
cooperative inspection programs for FY
2009 through 2014 in case the
cooperative interstate shipment program
option is not enacted (see table below).6
We did not receive any data or comment
in response to the proposed rule to
suggest changes to these numbers.
TABLE 1—BASELINE: COST FEDERAL STATE COOP PROGRAM WITH NO CHANGE
2010
(Budget)
FSIS level costs, fiscal year
2011
2012
2013
2014
Total 5-year
FSIS costs ........................................................................
Reimburs. to States .........................................................
$15.3
50.3
$15.9
52.1
$16.5
54.1
$17.1
56.2
$17.8
58.4
$82.5
271.1
Total ..........................................................................
65.7
68.0
70.5
73.3
76.1
353.6
FSIS Staff Years ..............................................................
29
29
29
29
29
....................
Federal reimbursement ....................................................
State program spending ..................................................
$50.3
50.3
$52.1
52.1
$54.1
54.1
$56.2
56.2
$58.4
58.4
$271.1
271.1
Total MPI program ....................................................
100.7
104.2
108.1
112.4
116.7
542.1
Number of plants .............................................................
1,873
1,873
1,873
1,873
1,873
....................
3.9
4.1
1.6
3.9
4.1
1.6
....................
....................
....................
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Economic Assumptions from OMB for the 2010 Budget
State & Local Exp, % .......................................................
FSIS Civilian pay, % ........................................................
Non-Pay Expenditure, % .................................................
5 Based on Agency’s most recent (FY 2009) review
of the 27 States’ self-assessment reports (including
the State Laboratory Activity Tables) by the Federal
State Audit Branch, Internal Control and Audit
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3.1
5.1
0.8
3.5
4.1
1.2
Division of the Office of Program Evaluation,
Enforcement, and Review.
6 For details, including assumptions, for the
baseline scenario, please see the proposed rule
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3.8
4.1
1.4
‘‘Cooperative Inspection Programs: Interstate
Shipment of Meat and Poultry Products,’’
September 16, 2009, 74 FR 47658–47659.
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Interstate Scenario
To evaluate this scenario, we must
estimate the number of establishments
and States that will seek to participate
and be selected for the new cooperative
interstate shipment program. Then we
will discuss the likely incremental
changes in activity that could
reasonably suggest any changes in cost
or burden for FSIS, the States, or
establishments.
As noted above, in the proposed rule,
through its outreach activities, FSIS had
identified sixteen States that expressed
an interest in the new cooperative
interstate shipment program. These
States have a total of 1,133
establishments that could potentially be
eligible for the new program. Because
participation in the cooperative
interstate shipment program is
voluntary, the Agency could not
estimate with certainty the number of
eligible establishments that will choose
to participate. Therefore, in the
proposed rule, for illustration purposes,
the Agency estimated the costs for three
scenarios: 200, 400 and 600
establishments.
However, comments received in
response to the proposed rule suggested
that the Agency overestimated both the
number of States and establishments
that were interested in participating in
the program. The most recent Agency
outreach activities confirmed this
assertion. As of November 2010, only
four States (North Dakota, Ohio,
Wisconsin, and Vermont) expressed
interest in participating and, according
to the State Directors, about 27 to 102
establishments may apply for selection
into the program through these four
States. Therefore, we revised the three
scenarios to be (1) 27 establishments in
four States participating from FY 2011
through 2014, (2) 102 establishments
from four States from FY 2011 through
2014, and (3) 102 establishments from 4
States in FY 2011, then the participation
increases to 200 establishments from all
27 eligible States in FY 2012 through
2014. The Agency understands that
there are many other possible scenarios.
Nevertheless, it is difficult to determine
with any certainty which scenarios are
more likely to occur than others; and the
farther out (in terms of fiscal years) the
projection, the greater the uncertainty.
These three scenarios are for illustration
purposes only as the number of
participating States and establishments
can go up or down depending on the
perception of the final rule, the
experience of the program once it starts,
and other socio-economic factors.
We started with the change in Federal
costs for the program caused by the new
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statutory reimbursement level. For the
cooperative interstate shipment program
the law requires that FSIS reimburse
States for their eligible costs related to
the inspection of selected
establishments in the State in an
amount not less than 60 percent of
eligible State costs. Under the existing
law, FSIS may reimburse a State for up
to 50 percent of eligible State costs to
administer and enforce the cooperative
State MPI. This analysis projects the
effects of the different reimbursement
rate on FSIS fiscal requirements
assuming no change in State level
activity over the baseline. FSIS assumes
that States will not change their level of
activity associated with selected
establishments in the cooperative
interstate shipment program as
discussed above.
To calculate this figure, FSIS
estimated average per establishment
spending for the cooperative interstate
shipment program for the
establishments in four States. For FY
2011, the estimated additional State
reimbursement for inspection of an
establishment selected for the
cooperative interstate shipment program
compared to the reimbursement for an
establishment operating under the
cooperative State MPI program, is
$12,415 (per establishment)in North
Dakota, $5,283 in Ohio, $16,123 in
Wisconsin, and $3,314 in Vermont.7
This and analogous figures are reflected
in the tables below in the ‘‘Total grants
to States’’ line for the 27, 102, and 102–
200 establishment scenarios.
Under section 11015 of the 2008 Farm
Bill, FSIS is required to oversee the
inspection activities of State personnel
designated to provide inspection to
selected establishments in the State.
FSIS will incur costs associated with
providing the necessary oversight. FSIS
also expects to incur new costs for
outreach and training. This will result
in increased demand for FSIS staff and
resources. In summary, this includes
state coordinators, Deputy District
Managers (DDM), outreach and training
staff, and lab analysts to certify State
laboratories, transition grants to hone
establishment staff skills with HACCP
and SOPs, and associated operating
expenses and travel expenses.
The statute requires FSIS to appoint a
Federal employee to be a State
Coordinator. As explained earlier in this
document, the State Coordinator
prescribed by the statute is referred to
7 For methodology of calculating this please see
74 FR 47659–47660.
To summarize, for each State we took the
allocation for FY 2010 under the cooperative State
MPI program, divided by the number of
establishments, and then multiplied it by 1.2.
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as the ‘‘selected establishment
coordinator’’ (SEC) in this proposed
rule. The SEC is required by statute to
visit selected establishments with a
frequency that is appropriate to ensure
that such establishments are operating
in a manner that is consistent with the
FMIA and PPIA, including regulations
and policies there under and to: (1)
Provide oversight and enforcement of
the program, and (2) oversee the training
and inspection activities of Statepersonnel designated to provide
inspection services to the selected
establishments. SECs will further
provide quarterly reports on each
selected establishment under his or her
jurisdiction to document their level of
compliance with the requirements of the
Acts.
We estimate that 2 to 3 full-time
equivalent FSIS employees will be able
to perform the SEC functions for the 4
States interested in participating in the
cooperative interstate shipment
program. It is expected that early in the
program the SEC time will initially
focus on outreach and start-up activities
(including establishment selection) and
shift over until it is more completely the
oversight activities stipulated in the
Acts.
In the start-up period, in addition to
SEC outreach efforts, FSIS expects to
incur costs for outreach and training,
and administration from OOEET for the
small and very small establishments
that are considering the cooperative
interstate shipment program, that decide
to apply for the program, and for those
who are selected to participate in the
program. OOEET will conduct face-toface workshops in every State to provide
information to establishment owners
and operators about the requirements of
the new cooperative interstate shipment
program. These workshops will not only
educate the interested owners and
operators about the requirements, they
will also help them meet the
requirements. This allocation will cover
the cost of developing, printing, and
shipping the workshop materials, as
well as the cost of traveling Agency
personnel to conduct the workshops,
and the cost of meeting space. The cost
is reflected in the tables below in the
‘‘Training/Outreach’’ line. The reason
these costs do not change between the
scenarios of 27 and 102 is because the
information will be provided in a
classroom. Costs are expected to be
largely the same whether attendance is
high or low. Also, note that these costs
drop sharply for each subsequent year
as the cooperative interstate shipment
program specific effort changes to
operating training for establishments
selected to participate in the program.
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In the start-up period, transition grant
authority under 9 CFR 332.12 and 9 CFR
381.522 will be used to provide States
funds to reimburse selected
establishments in the State for their
costs to train one individual in HACCP
and associated training in Sanitation
SOP requirements. The Agency
estimates that the cost of training each
establishment specialist will average
about $5,000, including staff time and
travel necessary for the training. Since
this is a new expense necessary to
implement the cooperative interstate
shipment program and since statute
authorizes it without State matching
funds, these costs will be entirely new
costs for FSIS that are part of ‘‘Total
grants to States’’ in Table 2 below. This
training will only be needed in the startup period and, accordingly, appears
only in FY 2011 in Table 2 for all three
scenarios, and again in FY 2012 in the
102–200 establishments scenario when
more establishments participate.
SECs are likely to be supervised by
Deputy District Managers (DDMs) at the
equivalent of about 1 DDM per 300
establishments. This is similar to the
ratio of DDM effort used to manage
frontline FSIS supervisors in the Federal
programs. For the four States scenario,
though, since the numbers of
establishments are less than 300, there
will be one DDM. This is reflected in the
‘‘DDM’’ line of the tables below.
FSIS estimates that two laboratory
staff will be needed to complete
periodic audits of the State inspection
program laboratory systems and
otherwise coordinate with the
laboratories to ensure the sampling and
testing programs are ‘‘the same as’’ the
Federal program. We anticipate that the
program needs two lab staff regardless
of how many establishments eventually
participate because most of the labs
typically have a chemistry residue
program and a microbiology program.
This is reflected in the ‘‘Lab staff’’ line
of the tables below.
Travel costs are included on the
‘‘Travel—SC & lab staff’’ line in the
tables below. The SECs will need to
travel a fair amount to complete their
duties and the lab staff will need to
travel some. Travel for SECs and lab
staff starts in FY 2011.
As noted above, early in the program
the SEC’s duties will initially focus on
outreach and start-up activities and later
will shift to the oversight activities
stipulated in the Acts. Thus, we project
about $6,150 for travel for each SEC in
the first year and $6,300 per year for
subsequent years.8
For the lab staff we based our trips to
the State program laboratories on one
audit of each laboratory to make an
initial assessment, so that would be one
trip to the labs for each of the 4 States.
Because most of the labs typically have
a chemistry residue program and a
microbiology program, two lab-auditors
will go on each trip—one chemist and
one microbiologist. These labs would
also need a follow-up the next year and
then we would make a judgment as to
whether there needed to be annual visits
after that. We based the number of
audits on the figures that we had
regarding the number of States that will
participate. Each trip ran about $1,500
for each auditor.
Finally, there are the normal
operating expenses associated with field
operations including office space,
communications costs, information
technology costs (such as laptop
computers), other equipment, and office
supplies. FSIS estimates $3,500 per new
staff for laptop, LincPass, and Black
Berries. These costs are generally stable
over time, although they inflate and, of
course, are a little higher in the start-up
year. These costs are found in the
‘‘Equipment and admin’’ line of the
tables below.
Table 2, below, summarizes the
incremental costs to FSIS to operate the
new cooperative interstate shipment
program in the three scenarios: 27, 102
and 102-to-200 establishments.
TABLE 2—COOPERATIVE INTERSTATE SHIPMENT PROGRAM COST ESTIMATES—THREE SCENARIOS ($ MILLIONS)
Fiscal year
2011
2012
2013
2014
4-Year
Interstate Program—Summary of Incremental Cost Estimates
Costs if 27 establishments .......................................................................
Costs if 102 establishments .....................................................................
Costs if 102, then 200 establishments ....................................................
1.09
1.94
1.94
0.95
1.43
4.22
0.83
1.34
4.40
0.87
1.40
4.58
3.74
6.11
15.14
Interstate Program with 27 Establishments
Number of establishments .......................................................................
Total grants to States * ............................................................................
Total salaries & benefits ..........................................................................
DDM .........................................................................................................
State coordinator (SC) .............................................................................
Lab staff ...................................................................................................
Operating expenses .................................................................................
Travel–SC & lab staff ...............................................................................
Training/Outreach ....................................................................................
Equipment and admin ..............................................................................
27
0.28
0.51
0.09
0.16
0.25
0.31
0.02
0.21
0.07
27
0.15
0.53
0.10
0.17
0.26
0.26
0.02
0.19
0.07
27
0.15
0.55
0.10
0.17
0.27
0.12
0.03
0.04
0.07
27
0.16
0.58
0.11
0.18
0.29
0.12
0.03
0.04
0.07
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
Total ..................................................................................................
1.09
0.95
0.83
0.87
3.74
102
0.50
0.61
0.10
0.25
0.26
102
0.52
0.63
0.10
0.26
0.27
102
0.54
0.67
0.11
0.27
0.29
....................
....................
....................
....................
....................
....................
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Interstate Program with 102 Establishments
Number of establishments .......................................................................
Total grants to States * ............................................................................
Total salaries & benefits ..........................................................................
DDM .........................................................................................................
State coordinator (SC) .............................................................................
Lab staff ...................................................................................................
102
0.99
0.59
0.09
0.24
0.25
8 The PRIA stated that the estimated travel cost
per SEC’s in subsequent years would be $630. This
was a technical error and should have read $6,300.
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TABLE 2—COOPERATIVE INTERSTATE SHIPMENT PROGRAM COST ESTIMATES—THREE SCENARIOS ($ MILLIONS)—
Continued
Fiscal year
2011
2012
2013
2014
4-Year
Operating expenses .................................................................................
Travel–SC & lab staff ...............................................................................
Training/Outreach ....................................................................................
Equipment and admin ..............................................................................
0.36
0.03
0.21
0.12
0.30
0.3
0.19
0.11
0.18
0.03
0.05
0.11
0.18
0.03
0.05
0.11
....................
....................
....................
....................
Total ..................................................................................................
1.94
1.43
1.34
1.40
6.11
Interstate Program with 102, then 200 Establishments
Number of establishments .......................................................................
Total grants to States * ............................................................................
Total salaries & benefits ..........................................................................
DDM .........................................................................................................
State coordinator (SC) .............................................................................
Lab staff ...................................................................................................
Operating expenses .................................................................................
Travel–SC & lab staff ...............................................................................
Training/Outreach ....................................................................................
Equipment and admin ..............................................................................
102
0.99
0.59
0.09
0.24
0.25
0.36
0.03
0.21
0.12
200
1.64
2.25
0.16
1.83
0.26
0.82
0.09
1.40
0.36
200
1.20
2.35
0.17
1.91
0.27
0.85
0.10
1.12
0.38
200
1.25
2.45
0.18
1.98
0.29
0.89
0.10
0.35
0.39
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
Total ..................................................................................................
1.94
4.22
4.40
4.58
15.14
* Note ‘‘Total grants to States’’ includes funding for Transition Grants to help establishments train one person in HACCP and SOPs per
§ 332.12 and § 381.522.
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Effect on Small Entities—Regulatory
Flexibility Analysis
Pursuant to section 605(b) of the
Regulatory Flexibility Act, 5 U.S.C.
605(b), the FSIS Administrator certifies
that this rule will not have a significant
economic impact on a substantial
number of small entities. This
certification is based primarily on the
fact that (1) the program is voluntary,
and (2) the rule will benefit very small
and certain small establishments that
operate under cooperative State MPI
programs. Based on FSIS’s HACCP
(Hazard Analysis and Critical Control
Points) size definitions, very small
establishments have fewer than 10
employees or generate less than $2.5
million in annual sales; small
establishments have 10 or more but
fewer than 500 employees and generate
more than $2.5 million in annual sales;
and establishments having 500 or more
employees are large establishments.
Thus, very small State-inspected
establishments and small Stateinspected establishments that have
fewer than 25 employees on average
will be eligible to participate in the
cooperative interstate shipment
program.
This final rule will benefit very small
and certain small establishments that
operate under cooperative State MPI
programs. Under section 11015, Stateinspected establishments that employ
on average 25 or fewer employees
would be permitted to be selected to
participate in a cooperative interstate
shipment program. The law also permits
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the Secretary to select State-inspected
establishments that employ, on average,
more than 25 but less than 35
employees to participate in the program.
However, to remain in the program,
these establishments must employ, on
average, 25 or fewer employees three
years after the regulations implementing
the new cooperative interstate shipment
program become effective. FSIS
provides for the selection of Stateinspected establishments that employ,
on average, more than 25 but fewer than
35 employees in the implementing
regulations. Thus, this rule will benefit
these very small and small Stateinspected establishments by allowing
them to ship meat and poultry products
in interstate and foreign commerce,
thereby opening new markets for their
products.
Currently, 27 States administer
cooperative State meat or poultry
inspection (MPI) programs. These States
have approximately 1,873
establishments that would be eligible to
apply for selection into the new
cooperative interstate shipment
program. As mentioned earlier in the
preamble to this final rule, the Agency’s
most recent outreach activities indicate
that four States may be interested in
participating in the program and the
number of establishments in these
States that might participate is between
27 and 102. However, because
participation in the new program is
voluntary, FSIS will not know how
many States and establishments will
apply to participate until this final rule
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becomes effective and establishments
are selected for the program.
As discussed above, costs to the
participating establishments are likely
to be small. An establishment that
chooses to apply for selection into the
program will incur one-time start-up
costs associated with filing an
application, training employees,
meeting regulatory performance
standards, obtaining label approval, and
implementing a food safety system that
complies with all Federal requirements
(e.g. Sanitation SOP and HACCP
requirements). In addition, to qualify for
a cooperative interstate shipment
program, some State-inspection
establishments may need to invest in
structural modifications to their
facilities in order to comply with
Federal standards. Based on information
obtained through FSIS’ outreach
activities with the States in 2008, in the
PRIA of the proposed rule, the Agency
estimated that the cost for Stateinspected establishments to fully
comply with Federal standards, as
required by the law, will range from
$1,500 to $50,000. Looking at the
potential for the establishments to
experience new (incremental) burden or
expenses due to State inspection under
the proposed cooperative interstate
shipment program, FSIS believes that
there will be essentially no change. FSIS
did not receive any comments or new
information in response to the proposed
rule to suggest changes to these
estimates.
Because the cooperative interstate
shipment program is a voluntary
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Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Rules and Regulations
program, establishments that choose to
incur the costs associated with
participating in the program will most
likely do so because they anticipate that
such participation will provide an
overall net benefit for them.
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts
State and local laws and regulations that
are inconsistent with this rule; (2) has
no retroactive effect; and (3) does not
require administrative proceedings
before parties may file suit in court
challenging this rule.
sroberts on DSK69SOYB1PROD with RULES
E-Government Act
FSIS and USDA are committed to
achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et
seq.) by, among other things, promoting
the use of the Internet and other
information technologies and providing
increased opportunities for citizen
access to government information and
services, and for other purposes.
Executive Order 13175
This final rule has been carefully
evaluated for potential tribal
implications in accordance with
Executive Order 13175, ‘‘Consultation
and Coordination with Indian Tribal
Governments.’’ FSIS has concluded
based on its evaluation that this final
rule will not have any direct or
substantial effects on Indian Tribes, on
the relationship between the Federal
Government and Indian Tribes, or on
the distribution of power or
responsibilities between the Federal
Government and Indian Tribes. This
final rule implements the Congressional
enactment providing that States with
approved MPI programs, that is State
established and administered meat or
poultry inspection programs, approved
by FSIS pursuant to the Federal meat
and poultry inspection laws, may now
be eligible in their discretion to
participate in the cooperative interstate
shipment program established by this
final rule. Accordingly, because this
program is only authorized under law
and this rule is for States with approved
MPI programs, there are no significant
tribal implications. Nonetheless, FSIS
will include Tribes and intertribal
organizations, involved in or interested
in the meat and poultry sectors, in the
Agency’s outreach efforts associated
with implementation and
administration of this final rule. In
addition, if and when a State, with an
MPI program approved by FSIS, satisfies
the requirements of this final rule and
enters into an agreement with FSIS
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regarding a cooperative interstate
shipment program, FSIS will conduct
outreach to Tribes and intertribal
organizations to ensure that they are
fully aware of the cooperative interstate
shipment program in that State, and to
ensure that meat or poultry
establishments on Tribal lands have the
opportunity to participate in the
approved State interstate shipment
program if they are interested in doing
so.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture
(USDA) prohibits discrimination in all
its programs and activities on the basis
of race, color, national origin, gender,
religion, age, disability, political beliefs,
sexual orientation, and marital or family
status. (Not all prohibited bases apply to
all programs.)
Persons with disabilities who require
alternative means for communication of
program information (Braille, large
print, audiotape, etc.) should contact
USDA’s Target Center at 202–720–2600
(voice and TTY).
To file a written complaint of
discrimination, write USDA, Office of
the Assistant Secretary for Civil Rights,
1400 Independence Avenue, SW.,
Washington, DC 20250–9410 or call
202–720–5964 (voice and TTY). USDA
is an equal opportunity provider and
employer.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
ensure that the public and in particular
minorities, women, and persons with
disabilities, are aware of this final rule,
FSIS will announce it on-line through
the FSIS Web page located at https://
www.fsis.usda.gov/regulations/
2011_Interim_&_Final_Rules_Index.
FSIS also will make copies of this
Federal Register publication available
through the FSIS Constituent Update,
which is used to provide information
regarding FSIS policies, procedures,
regulations, Federal Register notices,
FSIS public meetings, and other types of
information that could affect or would
be of interest to our constituents and
stakeholders. The Update is
communicated via Listserv, a free e-mail
subscription service consisting of
industry, trade, and farm groups,
consumer interest groups, allied health
professionals, scientific professionals,
and other individuals who have
requested to be included. The Update
also is available on the FSIS Web page.
Through Listserv and the Web page,
FSIS is able to provide information to a
much broader, more diverse audience.
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24751
In addition, FSIS offers an e-mail
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at
https://www.fsis.usda.gov/
news_&_events/email_subscription/.
Options range from recalls to export
information to regulations, directives
and notices. Customers can add or
delete subscriptions themselves, and
have the option to password protect
their accounts.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995,
the information collection and
recordkeeping requirements included in
this rule were submitted for approval to
the Office of Management and Budget
(OMB) when the proposed rule was
published. OMB preapproved the
information collection; the OMB Control
number is 0583–0144.
The estimated number of respondents
in the preapproved information
collection reflects the number of States
and establishments that FSIS estimated
would participate in the cooperative
interstate shipment program when the
Agency issued the proposed rule. FSIS
believes that it overestimated the
participation by States and
establishments in the proposed rule.
However, the Agency’s final estimated
hours of paperwork burden per
respondent is the same as the estimate
provided in the proposed rule.
Title: ‘‘Cooperative Inspection
Programs: Interstate Shipment of Meat
and Poultry Products.’’
Type of collection: New.
Abstract: FSIS has reviewed the
paperwork and recordkeeping
requirements in this final rule in
accordance with the Paperwork
Reduction Act. Under this final rule,
FSIS is requiring certain information
collection and recordkeeping activities.
States that are interested in
participating in the cooperative
interstate shipment program are
required to submit a request for an
agreement to establish such a program
through the appropriate FSIS District
Office. In their requests, States must: (1)
Identify establishments in the State that
the State recommends for initial
selection into the program, if any; (2)
include documentation to demonstrate
that the State is able to provide
necessary inspections services to
selected establishments in the State and
conduct any related activities that
would be required under a cooperative
interstate shipment program; and (3)
agree to comply with certain conditions
to assist with enforcement of the
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Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Rules and Regulations
program. States that have entered into
an agreement with FSIS for a
cooperative interstate shipment program
must submit, through the FSIS district
office, an evaluation of each Stateinspected establishment that has
applied, and that the State recommends
be selected, for the cooperative
interstate shipment program.
Under this final rule, State inspected
establishments selected to participate in
the cooperative interstate shipment
program will be required to develop and
maintain the same records that are
required under the Acts and their
implementing regulations. Selected
establishment will also be required to
give the FSIS selected establishment
coordinator (SEC) access to all
establishment records required under
the Acts and implementing regulations.
Most States that have cooperative State
meat or poultry products inspection
(MPI) programs have incorporated the
Federal standards into their programs.
Thus, most establishments selected to
participate in the interstate shipment
program are currently required to
maintain records that comply with
Federal standards. However,
establishments located in States that
have implemented recordkeeping
requirements that are ‘‘at least equal to’’
but not identical to Federal
requirements will need to modify their
recordkeeping procedures to comply
with Federal standards. All selected
establishments will be required to give
the FSIS SEC access to their records
upon request.
Estimate of Burden: When it proposed
these regulations, FSIS estimated that 16
of the 27 States that currently have
agreements for cooperative State meat or
poultry products inspection programs
will prepare and submit a request to
FSIS to establish a cooperative interstate
shipment program. The Agency also
estimated that approximately 400
establishments will apply for the
program. Thus, FSIS estimated that each
of the 16 States mentioned above will
need to prepare and submit, on average,
25 evaluations for the State-inspected
establishments that have applied for,
and that the State recommends, for
selection into the program, for an
estimated total of 400 evaluations.
FSIS estimates that it will take
approximately 40 hours for each State to
prepare and submit a request to
establish a cooperative interstate
shipment program, for a total burden of
640 hours. The Agency estimates that it
will take each State approximately 24
hours to prepare an evaluation of a
State-inspected establishment’s
qualifications to be selected for a
cooperative interstate shipment
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18:58 Apr 29, 2011
Jkt 223001
program, for a total burden of 9,600
hours.
FSIS estimates that if all of the 400
establishments that apply are selected
for the program, approximately 100 of
these establishments will need to
modify their recordkeeping procedures
to come into compliance with Federal
standards. The extent to which these
establishments will need to modify their
recordkeeping procedures will depend
on requirements under the State
inspection program. Because
recordkeeping requirements under the
State inspection program must be ‘‘at
least equal to’’ the Federal requirements,
these modifications should be minor.
FSIS estimates that it will take
approximately 16 hours for each
establishment that is currently
maintaining records under State
standards to review and revise its
recordkeeping procedures, and about 5
minutes for each establishment to file
these records, for a total burden of
approximately 1608 hours.
All of the estimated 400
establishments that participate in the
program will be required to give the SEC
access to all records required under the
Federal Acts. FSIS estimates that it will
take each establishment approximately
15 minutes to assist the SEC to locate
the necessary records for review on the
initial visit, for a total burden of 100
hours. FSIS estimates that these
establishments will need to spend and
approximately 5 minutes to assist the
SEC locate records for review for each
subsequent visit. If the SEC visits each
selected establishment at least once a
month, the total burden per
establishment per year will be 1 hour,
for a total estimated annual burden of
400 hours.
Respondents: State agencies that
administer cooperative State meat and
poultry products inspection programs
and State-inspected establishments
selected to participate in a cooperative
interstate shipment program.
Estimated number of respondents:
416 (16 States and 400 State-inspected
establishments).
Estimated number of responses per
respondent: One request to establish a
cooperative interstate shipment program
per State and 25 evaluations of Stateinspected establishments per State, on
average.
A one-time modification of records for
each selected establishment whose
recordkeeping does not comply with all
Federal standards. One initial SEC visit
in which each selected establishment
will need to provide the SEC with
access to all required records. Each
establishment selected for the program
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will need to provide the FSIS access to
its records on an ongoing basis.
Estimated Total Annual Burden on
Respondents: 11,848 hours to establish
and implement the cooperative
interstate shipment program in 16
States. Once the program has been
implemented, an estimated annual
burden of 400 hours for selected
establishments to provide the SEC
access to establishment records on-going
basis.
Copies of this information collection
assessment can be obtained from John
O’Connell, Paperwork Reduction Act
Coordinator, Food Safety and Inspection
Service, USDA, 1400 Independence
Avenue, SW., Room 3532 South
Building, Washington, DC 20250.
Proposed Regulations
List of Subjects
9 CFR Part 321
Grant programs-agriculture,
Intergovernmental relations, Meat
inspection.
9 CFR Part 332
Grant programs-agriculture,
Intergovernmental relations, Meat
inspection.
9 CFR Part 381
Grant programs-agriculture,
Intergovernmental relations, Poultry and
poultry products.
For the reasons discussed in the
preamble, FSIS is amending 9 CFR
Chapter III as follows:
PART 321—COOPERATION WITH
STATES AND TERRITORIES
1. The authority citation for part 321
is revised to read as follows:
■
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
2. Section 321.3 is added to read as
follows:
■
§ 321.3 Cooperation of States for the
interstate shipment of carcasses, parts of
carcasses, meat, and meat food products.
(a) The Administrator is authorized
under 21 U.S.C. 683(b) to coordinate
with States that have meat inspection
programs as provided in § 321.1 of this
part to select certain establishments
operating under these programs to
participate in a cooperative program to
ship carcasses, parts of carcasses, meat,
and meat food products in interstate
commerce. A cooperative program for
this purpose is called a ‘‘cooperative
interstate shipment program.’’
(b) Establishments selected to
participate in a cooperative interstate
shipment program described in this
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332.10 Deselection of ineligible
establishments.
332.11 Transition to official establishment.
332.12 Transition grants.
332.13 Separation of operations.
332.14 Voluntary withdrawal.
PART 332—SELECTED
ESTABLISHMENTS; COOPERATIVE
PROGRAM FOR INTERSTATE
SHIPMENT OF CARCASSES, PARTS
OF CARCASSES, MEAT, AND MEAT
FOOD PRODUCTS
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section must receive inspection services
from designated State personnel that
have been trained in the enforcement of
the Act. If the designated personnel
determine that the carcasses, parts of
carcasses, meat, and meat food products
prepared in establishments selected to
participate in the cooperative interstate
shipment program comply with all
requirements under the Act, these items
will bear an official Federal mark of
inspection and may be shipped in
interstate commerce. The Administrator
will assign an FSIS ‘‘selected
establishment coordinator,’’ who will be
an FSIS employee, to each State that
participates in a cooperative interstate
shipment program to provide Federal
oversight of the program and
enforcement of the program’s
requirements. The Federal contribution
for inspection services provided by
States that enter into a cooperative
interstate shipment program under this
section will be at least 60 percent of
eligible State costs. Eligible State costs
are those costs that a State has justified
and FSIS has approved as necessary for
the State to provide inspection services
to selected establishments in the State.
(c) Part 332 of this subchapter
prescribes conditions under which
States and establishments may
participate in the cooperative interstate
shipment program.
(d) The Administrator will terminate
a cooperative interstate shipment
agreement with a State if the
Administrator determines that the State
is not conducting inspection at selected
establishments in a manner that
complies with the Act and the
implementing regulations in this
chapter.
■ 3. Part 332 is added to read as follows:
§ 332.3 Requirements for establishments;
ineligible establishments.
Sec.
332.1 Definitions.
332.2 Purpose.
332.3 Requirements for establishments;
ineligible establishments.
332.4 State request for cooperative
agreement.
332.5 Establishment selection; official
number for selected establishments.
332.6 Commencement of a cooperative
interstate shipment program; inspection
by designated personnel and official
mark.
332.7 Federal oversight of a cooperative
interstate shipment program.
332.8 Quarterly reports.
332.9 Enforcement authority.
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Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
§ 332.1
Definitions.
Cooperative interstate shipment
program. A cooperative meat inspection
program described in § 321.3 of this
subchapter.
Cooperative State meat inspection
program. A cooperative State-Federal
meat inspection program described in
§ 321.1 of this subchapter.
Designated personnel. State
inspection personnel that have been
trained in the enforcement of the Act
and any additional State program
requirements in order to provide
inspection services to selected
establishments.
Interstate commerce. ‘‘Interstate
commerce’’ has the same meaning as
‘‘commerce’’ under § 301.2 of this
subchapter.
Selected establishment. An
establishment operating under a State
cooperative meat inspection program
that has been selected by the
Administrator, in coordination with the
State where the establishment is
located, to participate in a cooperative
interstate shipment program.
§ 332.2
Purpose.
This part prescribes the conditions
under which States that administer
cooperative State meat inspection
programs and establishments that
operate under such programs may
participate in a cooperative interstate
shipment program.
(a) An establishment that operates
under a cooperative State meat
inspection program may apply to
participate in a cooperative interstate
shipment program under this part if:
(1) The establishment employs on
average no more than 25 employees
based on the standards described in
paragraph (b) of this section, or
(2) The establishment employed more
than 25 employees but fewer than 35
employees as of June 18, 2008. If
selected to participate in a cooperative
interstate shipment program, an
establishment under this paragraph
must employ on average no more than
25 employees as of July 1, 2014, or it
must transition to become an official
establishment as provided in § 332.11 of
this part.
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24753
(b) An establishment that has 25 or
fewer employees based on the following
standards is considered to have 25 or
fewer employees on average for
purposes of this part.
(1) All individuals, both supervisory
and non-supervisory, employed by the
establishment on a full-time, part-time,
or temporary basis whose duties involve
handling the meat or meat food
products prepared by the establishment
are counted when calculating the total
number of employees.
(2) All individuals employed by the
establishment from a temporary
employee agency, professional
employee organization, or leasing
concern whose duties involve handling
the meat or meat food products
prepared by the establishment are
counted when calculating the total
number of employees.
(3) The average number of employees
is calculated for each of the pay periods
for the preceding 12 calendar months.
(4) Part-time and temporary
employees are counted the same as fulltime employees.
(5) If the establishment has not been
in business for 12 months, the average
number of employees is calculated for
each of the pay periods in which the
establishment has been in business.
(6) Volunteers who receive no
compensation are not considered
employees unless their duties involve
handling the meat or meat food
products prepared by the establishment.
(7) The total number of employees can
never exceed 35 individuals at any
given time, regardless of the average
number of employees.
(c) The following establishments are
ineligible to participate in a cooperative
interstate shipment program:
(1) Establishments that employ more
than 25 employees on average (except as
provided under paragraph (a)(2) of this
section);
(2) Establishments operating under a
Federal-State program as provided in
§ 321.2 of this subchapter as of June 18,
2008;
(3) Official establishments;
(4) Establishments that were official
establishments as of June 18, 2008, but
that were re-organized on a later date by
the person that controlled the
establishment as of June 18, 2008;
(5) Establishments operating under a
cooperative State meat inspection that
employed more than 35 employees as of
June 18, 2008, that were reorganized on
a later date by the person that controlled
the establishment as of June 18, 2008;
(6) Establishments that are the subject
of a transition under § 332.11 of this
part;
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(7) Establishments that are in
violation of the Act; and
(8) Establishments located in States
without a cooperative State meat
inspection program.
(9) Establishments located in a State
whose agreement for a cooperative
interstate shipment program was
terminated by the Administrator as
provided in § 321.3(d) of this
subchapter.
(d) An establishment that meets the
conditions in paragraph (a) of this
section and that is not an ineligible
establishment under paragraph (c) of
this section may apply for selection into
a cooperative interstate shipment
program through the State in which the
establishment is located.
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§ 332.4 State request for cooperative
agreement.
(a) State participation in a cooperative
interstate shipment program under this
part is limited to States that have
implemented cooperative State meat
inspection programs.
(b) To request an agreement for a
cooperative interstate shipment program
under this part, a State must submit a
written request to the Administrator
through the FSIS District Office for the
FSIS District in which the State is
located. In the request the State must:
(1) Identify establishments in the
State that have requested to be selected
for the program that the State
recommends for initial selection into
the program, if any;
(2) Demonstrate that the State is able
to provide the necessary inspection
services to selected establishments in
the State and conduct any related
activities that would be required under
a cooperative interstate shipment
program established under this part; and
(3) Agree that, if the State enters into
an agreement with FSIS for a
cooperative interstate shipment
program, the State will:
(i) Provide FSIS with access to the
results of all laboratory analyses
conducted on product samples from
selected establishments in the State;
(ii) Notify the selected establishment
coordinator for the State of the results
of any laboratory analyses that indicate
that a product prepared in a selected
establishment may be adulterated or
may otherwise present a food safety
concern; and
(iii) When necessary, cooperate with
FSIS to transition selected
establishments in the State that have
been deselected from a cooperative
interstate shipment program to become
official establishments.
(c) If the Administrator determines
that a State that has submitted a request
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to participate in a cooperative interstate
shipment program qualifies to enter into
a cooperative agreement for such a
program, the Administrator and the
State will sign a cooperative agreement
that sets forth the terms and conditions
under which each party will cooperate
to provide inspection services to
selected establishments located in the
State.
(d) After the Administrator and a
State have signed an agreement for a
cooperative interstate shipment program
as provided in paragraph (c) of this
section, the Administrator will:
(1) Appoint an FSIS employee as the
FSIS selected establishment coordinator
for the State and
(2) Coordinate with the State to select
establishments to participate in the
program as provided in § 332.5(b) of this
part.
§ 332.5 Establishment selection; official
number for selected establishments.
(a) An establishment operating under
a cooperative State meat inspection
program will qualify for selection into a
cooperative interstate shipment program
if the establishment:
(1) Has submitted a request to the
State to be selected for the program;
(2) Has the appropriate number of
employees under § 332.3(a) of this part;
(3) Is not ineligible to participate in a
cooperative interstate shipment program
under § 332.3(c) of this part;
(4) Is in compliance with all
requirements under the cooperative
State meat inspection program; and
(5) Is in compliance with all
requirements under the Act and the
implementing regulations in this
chapter.
(b) To participate in a cooperative
interstate shipment program, an
establishment that meets the conditions
in paragraph (a) of this section must be
selected by the Administrator, in
coordination with the State where the
establishment is located.
(c) If an establishment is selected to
participate in a cooperative interstate
shipment program as provided in
paragraph (b) of this section, the State
is to assign the establishment an official
number that reflects the establishment’s
participation in the cooperative
interstate shipment program and advise
the FSIS selected establishment
coordinator for the State of the official
number assigned to each selected
establishment in the State. The official
number assigned to every selected
establishment must contain a suffix,
e.g., ‘‘SE,’’ that identifies the
establishment as a selected
establishment and that identifies the
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State, e.g., ‘‘SETX,’’ for ‘‘selected
establishment Texas.’’
(d) Failure of the State to comply with
paragraph (c) of this section will
disqualify the State from participation
in the cooperative interstate shipment
program.
§ 332.6 Commencement of a cooperative
interstate shipment program; inspection by
designated personnel and official mark.
(a) A cooperative interstate shipment
program will commence when the
Administrator, in coordination with the
State, has selected establishments in the
State to participate in the program.
(b) Inspection services for selected
establishments participating in a
cooperative interstate shipment program
must be provided by designated
personnel, who will be under the direct
supervision of a State employee.
(c) Carcasses, parts of carcasses, meat,
and meat food products prepared in a
selected establishment and inspected
and passed by designated State
personnel must bear an official Federal
mark, stamp, tag, or label of inspection
in the appropriate form prescribed in
part 312 of this subchapter that includes
the information specified in § 332.5(c) of
this part.
(d) Carcasses, parts of carcasses, meat,
and meat food products prepared in a
selected establishment that comply with
the conditions in paragraph (c) of this
section may be distributed in interstate
commerce.
§ 332.7 Federal oversight of a cooperative
interstate shipment program.
(a) The FSIS selected establishment
coordinator for a State that has entered
into an agreement for a cooperative
interstate shipment program will visit
each selected establishment in the State
on a regular basis to verify that the
establishment is operating in a manner
that is consistent with the Act and the
implementing regulations in this
chapter. The frequency with which the
SEC will visit selected establishments
under the SEC’s jurisdiction will be
based on factors that include, but are
not limited to, the complexity of the
operations conducted at the selected
establishment, the establishment’s
schedule of operations, and the
establishment’s performance under the
cooperative interstate shipment
program. If necessary, the selected
establishment coordinator, in
consultation with the District Manager
that covers the State, may designate
qualified FSIS personnel to visit a
selected establishment on behalf of the
selected establishment coordinator.
(b) The selected establishment
coordinator, in coordination with the
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State, will verify that selected
establishments in the State are receiving
the necessary inspection services from
designated personnel, and that these
establishments are eligible, and remain
eligible, to participate in a cooperative
interstate shipment program. The
selected establishment coordinator’s
verification activities may include:
(1) Verifying that each selected
establishment employs, and continues
to employ, 25 or fewer employees, on
average, as required under § 332.3(a) of
this part, unless the establishment is
transitioning to become an official
establishment;
(2) Verifying that the designated
personnel are providing inspection
services to selected establishments in a
manner that complies with the Act and
the implementing regulations in this
chapter;
(3) Verifying that that the State
staffing levels for each selected
establishments are appropriate to carry
out the required inspection activities;
and
(4) Assessing each selected
establishment’s compliance with the
Act and implementing regulations
under this chapter.
(c) If the selected establishment
coordinator determines that designated
personnel are providing inspection
services to selected establishments in
the State in a manner that is
inconsistent with the Act and the
implementing regulations in this
chapter, the Administrator will provide
an opportunity for the State to develop
and implement a corrective action plan
to address inspection deficiencies
identified by the selected establishment
coordinator. If the State fails to develop
a corrective action plan, or the selected
establishment coordinator for the State
determines that the corrective action
plan is inadequate, the Administrator
will terminate the agreement for the
cooperative interstate shipment program
as provided in § 321.3(d) of this chapter.
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§332.8
Quarterly reports.
(a) The selected establishment
coordinator will prepare a report on a
quarterly basis that describes the status
of each selected establishment under his
or her jurisdiction.
(b) The quarterly report required in
paragraph (a) of this section will:
(1) Include the selected establishment
coordinator’s assessment of the
performance of the designated
personnel in conducting inspection
activities at selected establishments and
(2) Identify those selected
establishments that the selected
establishment coordinator has verified
are in compliance with the Act and
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implementing regulations in this
chapter, those that have been deselected
under § 332.10 of this part, and those
that are transitioning to become official
establishments under § 332.11 of this
part.
(c) The selected establishment
coordinator is to submit the quarterly
report to the Administrator through the
District Manager for the State where the
selected establishments identified in the
report are located.
§ 332.9
Enforcement authority.
(a) To facilitate oversight and
enforcement of this part, selected
establishments operating under a
cooperative interstate shipment program
must, upon request, give the FSIS
selected establishment coordinator or
other FSIS officials access to all
establishment records required under
the Act and the implementing
regulations in this chapter. The
Administrator may deselect any selected
establishment that refuses to comply
with this paragraph.
(b) Selected establishment
coordinators may initiate any
appropriate enforcement action
provided for in part 500 of this chapter
if they determine that a selected
establishment under their jurisdiction is
operating in a manner that is
inconsistent with the Act and the
implementing regulations in this
chapter. Selected establishments
participating in a cooperative interstate
shipment program are subject to the
notification and appeal procedures set
out in part 500 of this chapter.
(c) If inspection at a selected
establishment is suspended for any of
the reasons specified in § 500.3 or
§ 500.4 of this chapter, FSIS will:
(1) Provide an opportunity for the
establishment to implement corrective
actions and remain in the cooperative
interstate shipment program, or
(2) Move to deselect the establishment
as provided in § 332.10 of this part.
(d) The decision to deselect a selected
establishment under a suspension will
be made on a case-by-case basis. In
making this decision, FSIS, in
consultation with the State where the
selected establishment is located, will
consider, among other factors:
(1) The non-compliance that led to the
suspension;
(2) The selected establishment’s
compliance history; and
(3) The corrective actions proposed by
the selected establishment.
§ 332.10 Deselection of ineligible
establishments.
(a) The Administrator will deselect a
selected establishment that becomes
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24755
ineligible to participate in a cooperative
interstate shipment program for any
reason listed under § 332.3(c) of this
part.
(b) An establishment that has been
deselected must transition to become an
official establishment as provided in
§ 332.11 of this part.
§ 332.11 Transition to official
establishment.
(a) If an establishment is deselected
from a cooperative interstate shipment
program as provided in § 332.10 of this
part, FSIS, in coordination with the
State where the establishment is
located, will develop and implement a
plan to transition the establishment to
become an official establishment.
Except that an establishment that was
deselected from a cooperative interstate
shipment program because it is located
in a State whose agreement for such a
program was terminated may either
transition to become an official
establishment or transition to become a
State-inspected establishment under the
cooperative State meat inspection
program.
(b) An establishment that has been
deselected from a cooperative interstate
shipment program and successfully
transitioned to become an official
establishment may withdraw from the
Federal inspection program and resume
operations under the cooperative State
meat inspection program after operating
as an official establishment in full
compliance with the Act for a year.
§ 332.12
Transition grants.
(a) Transition grants are funds that a
State participating in a cooperative
interstate shipment program under this
part may apply for to reimburse selected
establishments in the State for the cost
to train one individual in the seven
HACCP principles for meat or poultry
processing as required under § 417.7 of
this chapter and associated training in
the development of sanitation standard
operating procedures required under
part 416 of this chapter.
(b) A State participating in a
cooperative interstate shipment program
that receives a transition grant must use
grant funds to reimburse the training
costs of one employee per each selected
establishment in the State. Any other
use of such funds is prohibited.
§ 332.13
Separation of operations.
A selected establishment may conduct
operations under the cooperative State
meat inspection program if the
establishment implements and
maintains written procedures for
complete physical separation of product
and process for each operation by time
or space.
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Voluntary withdrawal.
A selected establishment that is in full
compliance with the requirements in
this part may voluntarily end its
participation in a cooperative interstate
shipment program and operate under
the cooperative State meat inspection
program. Establishments that
voluntarily end their participation in
the cooperative may re-apply for the
program after operating under the
cooperative State meat inspection
program for one year.
PART 381—POULTRY PRODUCTS
INSPECTION REGULATIONS
■
4. The authority citation for part 381
continues to read as follows:
■
Authority: 7 U.S.C. 138f, 450; 21 U.S.C.
451–470; 7 CFR 2.7, 2.18, 2.53.
5. Add § 381.187 to subpart R to read
as follows:
■
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§ 381.187 Cooperation of States for the
interstate shipment of poultry products.
(a) The Administrator is authorized
under 21 U.S.C. 472(b) to coordinate
with States that have poultry products
inspection programs as provided in
§ 381.185 of this subpart to select
certain establishments operating under
these programs to participate in a
cooperative program to ship poultry
products in interstate commerce. A
cooperative program for this purpose is
called a ‘‘cooperative interstate
shipment program.’’
(b) Establishments selected to
participate in a cooperative interstate
shipment program described in this
section must receive inspection services
from designated State personnel that
have been trained in the enforcement of
the Act. If the designated personnel
determine that the poultry products
prepared in establishments selected to
participate in the cooperative interstate
shipment program comply with all
requirements under the Act, these items
will bear an official Federal mark of
inspection and may be shipped in
interstate commerce. The Administrator
will assign an FSIS ‘‘selected
establishment coordinator,’’ who will be
an FSIS employee, to each State that
participates in a cooperative interstate
shipment program to provide Federal
oversight of the program and
enforcement of the program’s
requirements. The Federal contribution
for inspection services provided by
States that enter into a cooperative
interstate shipment program under this
section will be at least 60 percent of
eligible State costs. Eligible State costs
are those costs that a State has justified
and FSIS has approved as necessary for
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the State to provide inspection services
to selected establishments in the State.
(c) Subpart Z, of this part 381
prescribes conditions under which
States and establishments may
participate in the cooperative interstate
shipment program.
(d) The Administrator will terminate
a cooperative interstate shipment
agreement with a State if the
Administrator determines that the State
is not conducting inspection at selected
establishments in a manner that
complies with the Act and the
implementing regulations in this
chapter.
6. Add subpart Z to read as follows:
Subpart Z—Selected Establishments;
Cooperative Program for Interstate
Shipment of Poultry Products
Sec.
381.511 Definitions.
381.512 Purpose.
381.513 Requirements for establishments;
ineligible establishments.
381.514 State request for cooperative
agreement.
381.515 Establishment selection; official
number for selected establishments.
381.516 Commencement of a cooperative
interstate shipment program; inspection
by designated personnel and official
mark.
381.517 Federal oversight of a cooperative
interstate shipment program.
381.518 Quarterly reports.
381.519 Enforcement authority.
381.520 Deselection of ineligible
establishments.
381.521 Transition to official establishment.
381.522 Transition grants.
381.523 Separation of operations.
381.524 Voluntary withdrawal.
Subpart Z—Selected Establishments;
Cooperative Program for Interstate
Shipment of Poultry Products
§ 381.511
Definitions.
Cooperative interstate shipment
program. A cooperative poultry
products inspection program described
in § 381.187 of this part.
Cooperative State poultry products
inspection program. A cooperative
State-Federal poultry products
inspection program described in
§ 381.185 of this part.
Designated personnel. State
inspection personnel that have been
trained in the enforcement of the Act
and any additional State program
requirements in order to provide
inspection services to selected
establishments.
Interstate commerce. ‘‘Interstate
commerce’’ has the same meaning as
‘‘commerce’’ under § 381.1 of this part.
Selected establishment. An
establishment operating under a State
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cooperative poultry products inspection
program that has been selected by the
Administrator, in coordination with the
State where the establishment is
located, to participate in a cooperative
interstate shipment program.
§ 381.512
Purpose.
This subpart Z prescribes the
conditions under which States that
administer cooperative State poultry
products inspection programs and
establishments that operate under such
programs may participate in a
cooperative interstate shipment
program.
§ 381.513 Requirements for
establishments; ineligible establishments.
(a) An establishment that operates
under a cooperative State poultry
products inspection program may apply
to participate in a cooperative interstate
shipment program under this subpart if:
(1) The establishment employs on
average no more than 25 employees
based on the standards described in
paragraph (b) of this section, or
(2) The establishment employed more
than 25 employees but fewer than 35
employees as of June 18, 2008. If
selected to participate in a cooperative
interstate shipment program, an
establishment under this paragraph
must employ on average no more than
25 employees as of July 1, 2014, or it
must transition to become an official
establishment as provided in § 381.521
of this subpart.
(b) An establishment that has 25 or
fewer employees based on the following
standards is considered to have 25 or
fewer employees on average for
purposes of this subpart.
(1) All individuals, both supervisory
and non-supervisory, employed by the
establishment on a full-time, part-time,
or temporary basis whose duties involve
handling the poultry products prepared
by the establishment are counted when
calculating the total number of
employees.
(2) All individuals employed by the
establishment from a temporary
employee agency, professional
employee organization, or leasing
concern whose duties involve handling
the poultry products prepared by the
establishment are counted when
calculating the total number of
employees.
(3) The average number of employees
is calculated for each of the pay periods
for the preceding 12 calendar months.
(4) Part-time and temporary
employees are counted the same as fulltime employees.
(5) If the establishment has not been
in business for 12 months, the average
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number of employees is calculated for
each of the pay periods in which the
establishment has been in business.
(6) Volunteers who receive no
compensation are not considered
employees unless their duties involve
handling the poultry products prepared
by the establishment.
(7) The total number of employees can
never exceed 35 individuals at any
given time, regardless of the average
number of employees.
(c) The following establishments are
ineligible to participate in a cooperative
interstate shipment program:
(1) Establishments that employ more
than 25 employees on average (except as
provided under paragraph (a)(2) of this
section);
(2) Establishments operating under a
Federal-State program as provided in
§ 381.186 of this part as of June 18,
2008;
(3) Official establishments;
(4) Establishments that were official
establishments as of June 18, 2008, but
that were re-organized on a later date by
the person that controlled the
establishment as of June 18, 2008;
(5) Establishments operating under a
cooperative State poultry products
inspection program that employed more
than 35 employees as of June 18, 2008,
that were reorganized on a later date by
the person that controlled the
establishment as of June 18, 2008;
(6) Establishments that are the subject
of a transition under § 381.521 of this
subpart;
(7) Establishments that are in
violation of the Act; and
(8) Establishments located in States
without a cooperative State poultry
products inspection program.
(9) Establishments located in a State
whose agreement for a cooperative
interstate shipment program was
terminated by the Administrator as
provided in § 381.187(d) of this part.
(d) An establishment that meets the
conditions in paragraph (a) of this
section and that is not an ineligible
establishment under paragraph (c) of
this section may apply for selection into
a cooperative interstate shipment
program through the State in which the
establishment is located.
sroberts on DSK69SOYB1PROD with RULES
§ 381.514 State request for cooperative
agreement.
(a) State participation in a cooperative
interstate shipment program under this
subpart is limited to States that have
implemented cooperative State poultry
products inspection programs.
(b) To request an agreement for a
cooperative interstate shipment program
under this subpart, a State must submit
a written request to the Administrator
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18:58 Apr 29, 2011
Jkt 223001
through the FSIS District Office for the
FSIS District in which the State is
located. In the request the State must:
(1) Identify establishments in the
State that have requested to be selected
for the program that the State
recommends for initial selection into
the program, if any;
(2) Demonstrate that the State is able
to provide the necessary inspection
services to selected establishments in
the State and conduct any related
activities that would be required under
a cooperative interstate shipment
program established under this subpart;
and
(3) Agree that, if the State enters into
an agreement with FSIS for a
cooperative interstate shipment
program, the State will:
(i) Provide FSIS with access to the
results of all laboratory analyses
conducted on product samples from
selected establishments in the State;
(ii) Notify the selected establishment
coordinator for the State of the results
of any laboratory analyses that indicate
that a product prepared in a selected
establishment may be adulterated or
may otherwise present a food safety
concern; and
(iii) When necessary, cooperate with
FSIS to transition selected
establishments in the State that have
been deselected from a cooperative
interstate shipment program to become
official establishments.
(c) If the Administrator determines
that a State that has submitted a request
to participate in a cooperative interstate
shipment program qualifies to enter into
a cooperative agreement for such a
program, the Administrator and the
State will sign a cooperative agreement
that sets forth the terms and conditions
under which each party will cooperate
to provide inspection services to
selected establishments located in the
State.
(d) After the Administrator and a
State have signed an agreement for a
cooperative interstate shipment program
as provided in paragraph (c) of this
section, the Administrator will:
(1) Appoint an FSIS employee as the
FSIS selected establishment coordinator
for the State and
(2) Coordinate with the State to select
establishments to participate in the
program as provided in § 381.515(b) of
this subpart.
§ 381.515 Establishment selection; official
number for selected establishments.
(a) An establishment operating under
a cooperative State poultry products
inspection program will qualify for
selection into a cooperative interstate
shipment program if the establishment:
PO 00000
Frm 00045
Fmt 4701
Sfmt 4700
24757
(1) Has submitted a request to the
State to be selected for the program;
(2) Has the appropriate number of
employees under § 381.513(a) of this
subpart;
(3) Is not ineligible to participate in a
cooperative interstate shipment program
under § 381.513(c) of this subpart;
(4) Is in compliance with all
requirements under the cooperative
State poultry products inspection
program; and
(5) Is in compliance with all
requirements under the Act and the
implementing regulations in this
chapter.
(b) To participate in a cooperative
interstate shipment program, an
establishment that meets the conditions
in paragraph (a) of this section must be
selected by the Administrator, in
coordination with the State where the
establishment is located.
(c) If an establishment is selected to
participate in a cooperative interstate
shipment program as provided in
paragraph (b) of this section, the State
is to assign the establishment an official
number that reflects the establishment’s
participation in the cooperative
interstate shipment program and advise
the FSIS selected establishment
coordinator for the State of the official
number assigned to each selected
establishment in the State. The official
numbers assigned to every selected
establishment must contain a suffix,
e.g., ‘‘SE,’’ that identifies the
establishment as a selected
establishment; that includes the letter
‘‘P,’’ which identifies the establishment
as a poultry establishment; and that
identifies the State, e.g., ‘‘SEPND,’’ for
‘‘selected establishment poultry North
Dakota.’’
(d) Failure of a State to comply with
paragraph (c) of this section will
disqualify the State from participation
in the cooperative interstate shipment
program.
§ 381.516 Commencement of a
cooperative interstate shipment program;
inspection by designated personnel and
official mark.
(a) A cooperative interstate shipment
program will commence when the
Administrator, in coordination with the
State, has selected establishments in the
State to participate in the program.
(b) Inspection services for selected
establishments participating in a
cooperative interstate shipment program
must be provided by designated
personnel, who will be under the direct
supervision of a State employee.
(c) Poultry products processed in a
selected establishment and inspected
and passed by designated State
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02MYR3
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Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Rules and Regulations
personnel must bear an official Federal
mark, stamp, tag, or label of inspection
in the appropriate form prescribed in
subpart M of this part that includes the
information specified in § 381.515(c) of
this subpart.
(d) Poultry products processed in a
selected establishment that comply with
the conditions in paragraph (c) of this
section may be distributed in interstate
commerce.
sroberts on DSK69SOYB1PROD with RULES
§ 381.517 Federal oversight of a
cooperative interstate shipment program.
(a) The FSIS selected establishment
coordinator for a State that has entered
into an agreement for a cooperative
interstate shipment program will visit
each selected establishment in the State
on a regular basis to verify that the
establishment is operating in a manner
that is consistent with the Act and the
implementing regulations in this
chapter. The frequency with which the
SEC will visit selected establishments
under the SEC’s jurisdiction will be
based on factors that include, but are
not limited to, the complexity of the
operations conducted at the selected
establishment, the establishment’s
schedule of operations, and the
establishment’s performance under the
cooperative interstate shipment
program. If necessary, the selected
establishment coordinator, in
consultation with the District Manager
that covers the State, may designate
qualified FSIS personnel to visit a
selected establishment on behalf of the
selected establishment coordinator.
(b) The selected establishment
coordinator, in coordination with the
State, will verify that selected
establishments in the State are receiving
the necessary inspection services from
designated personnel, and that these
establishments are eligible, and remain
eligible, to participate in a cooperative
interstate shipment program. The
selected establishment coordinator’s
verification activities may include:
(1) Verifying that each selected
establishment employs, and continues
to employ, 25 or fewer employees, on
average, as required under § 381.513(a)
of this part, unless the establishment is
transitioning to become an official
establishment;
(2) Verifying that the designated
personnel are providing inspection
services to selected establishments in a
manner that complies with the Act and
the implementing regulations in this
chapter;
(3) Verifying that that the State
staffing levels for each selected
establishments are appropriate to carry
out the required inspection activities;
and
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18:58 Apr 29, 2011
Jkt 223001
(4) Assessing each selected
establishment’s compliance with the
Act and implementing regulations in
this chapter.
(c) If the selected establishment
coordinator determines that designated
personnel are providing inspection
services to selected establishments in
the State in a manner that is
inconsistent with the Acts and the
implementing regulations in this
chapter, the Administrator will provide
an opportunity for the State to develop
and implement a corrective action plan
to address inspection deficiencies
identified by the selected establishment
coordinator. If the State fails to develop
a corrective action plan, or the selected
establishment coordinator for the State
determines that the corrective action
plan is inadequate, the Administrator
will terminate the agreement for the
cooperative interstate shipment program
as provided in § 381.187(d) of this part.
§ 381.518
Quarterly reports.
(a) The selected establishment
coordinator will prepare a report on a
quarterly basis that describes the status
of each selected establishment under his
or her jurisdiction.
(b) The quarterly report required in
paragraph (a) of this section will:
(1) Include the selected establishment
coordinator’s assessment of the
performance of the designated
personnel in conducting inspection
activities at selected establishments and
(2) Identify those selected
establishment that the selected
establishment coordinator has verified
are in compliance with the Act and
implementing regulations in this
chapter, those that have been deselected
under § 381.520 of this subpart, and
those that are transitioning to become
official establishments under § 381.521
of this subpart.
(c) The selected establishment
coordinator is to submit the quarterly
report to the Administrator through the
District Manager for the State where the
selected establishments identified in the
report are located.
§ 381.519
Enforcement authority.
(a) To facilitate oversight and
enforcement of this subpart, selected
establishments operating under a
cooperative interstate shipment program
must, upon request, give the FSIS
selected establishment coordinator or
other FSIS officials access to all
establishment records required under
the Act and the implementing
regulations in this chapter. The
Administrator may deselect any selected
establishment that refuses to comply
with this paragraph.
PO 00000
Frm 00046
Fmt 4701
Sfmt 4700
(b) Selected establishment
coordinators may initiate any
appropriate enforcement action
provided for in part 500 of this chapter
if they determine that a selected
establishment under their jurisdiction is
operating in manner that is inconsistent
with the Act and the implementing
regulations in this chapter. Selected
establishments participating in a
cooperative interstate shipment program
are subject to the notification and
appeal procedures set out in part 500 of
this chapter.
(c) If inspection at a selected
establishment is suspended for any of
the reasons specified in § 500.3 or
§ 500.4 of this chapter, FSIS will:
(1) Provide an opportunity for the
establishment to implement corrective
actions and remain in the cooperative
interstate shipment program, or
(2) Move to deselect the establishment
as provided in § 381.520 of this subpart.
(d) The decision to deselect a selected
establishment under a suspension will
be made on a case-by-case basis. In
making this decision, FSIS, in
consultation with the State where the
selected establishment is located, will
consider, among other factors:
(1) The non-compliance that led to the
suspension;
(2) The selected establishment’s
compliance history; and
(3) The corrective actions proposed by
the selected establishment.
§ 381.520 Deselection of ineligible
establishments.
(a) The Administrator will deselect a
selected establishment that becomes
ineligible to participate in a cooperative
interstate shipment program for any
reason listed under § 381.513(c) of this
subpart.
(b) An establishment that has been
deselected must transition to become an
official establishment as provided in
§ 381.521 of this subpart.
§ 381.521 Transition to official
establishment.
(a) If an establishment is deselected
from a cooperative interstate shipment
program as provided in § 381.520 of this
subpart, FSIS, in coordination with the
State where the establishment is
located, will develop and implement a
plan to transition the establishment to
become an official establishment.
Except that an establishment that was
deselected from a cooperative interstate
shipment program because it is located
in a State whose agreement for such a
program was terminated may either
transition to become an official
establishment or transition to become a
State-inspected establishment under the
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cooperative State poultry products
inspection program.
(b) An establishment that has been
deselected from a cooperative interstate
shipment program and successfully
transitioned to become an official
establishment may withdraw from the
Federal inspection program and resume
operations under the cooperative State
poultry products inspection program
after operating as an official
establishment in full compliance with
the Act for a year.
§ 381.522
Transition grants.
§ 381.523
sroberts on DSK69SOYB1PROD with RULES
(a) Transition grants are funds that a
State participating in a cooperative
interstate shipment program under this
subpart may apply for to reimburse
selected establishments in the State for
the cost to train one individual in the
seven HACCP principles for meat or
VerDate Mar<15>2010
18:58 Apr 29, 2011
poultry processing as required under
§ 417.7 of this chapter and associated
training in the development of
sanitation standard operating
procedures required under part 416 of
this chapter.
(b) A State participating in a
cooperative interstate shipment program
that receives a transition grant must use
grant funds to reimburse the training
costs of one employee per each selected
establishment in the State. Any other
use of such funds is prohibited.
Jkt 223001
Separation of operations.
A selected establishment may conduct
operations under the cooperative State
poultry products inspection program if
the establishment implements and
maintains written procedures for
complete physical separation of product
PO 00000
Frm 00047
Fmt 4701
Sfmt 9990
24759
and process for each operation by time
or space.
§ 381.524
Voluntary withdrawal.
A selected establishment that is in full
compliance with the requirements in
this part may voluntarily end its
participation in a cooperative interstate
shipment program and operate under
the cooperative State poultry products
inspection program. Establishments that
voluntarily end their participation in
the cooperative may re-apply for the
program after operating under the
cooperative State poultry products
inspection program for one year.
Done at Washington, DC, on: March 31,
2011.
Alfred V. Almanza,
Administrator.
[FR Doc. 2011–9865 Filed 4–29–11; 8:45 am]
BILLING CODE P
E:\FR\FM\02MYR3.SGM
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Agencies
[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Rules and Regulations]
[Pages 24714-24759]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9865]
[[Page 24713]]
Vol. 76
Monday,
No. 84
May 2, 2011
Part III
Department of Agriculture
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Food Safety and Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 321, 332, and 381
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Product; Final Rule
Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Rules and
Regulations
[[Page 24714]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 321, 332, and 381
[Docket No. FSIS-2008-0039]
RIN 0583-AD37
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to establish a
new voluntary cooperative program under which State-inspected
establishments with 25 or fewer employees will be eligible to ship meat
and poultry products in interstate commerce. In participating States,
State-inspected establishments selected to take part in this program
will be required to comply with all Federal standards under the Federal
Meat Inspection Act (FMIA) and the Poultry Products Inspection Act
(PPIA). These establishments will receive inspection services from
State inspection personnel that have been trained in the enforcement of
the FMIA and PPIA. Meat and poultry products produced under the program
that have been inspected and passed by designated State personnel will
bear an official Federal mark of inspection and will be permitted to be
distributed in interstate commerce. FSIS will provide oversight and
enforcement of the program.
DATES: Effective Date: July 1, 2011.
FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant
Administrator, Office of Policy and Program Development, Room 350-E,
Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington,
DC 20250; Telephone (202) 720-2709, Fax (202) 720-2025.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.)
(``the Acts'') require that FSIS protect the public by ensuring that
meat and poultry products are safe, wholesome, and accurately labeled.
The Acts require Federal inspection and provide for Federal regulation
of meat and poultry products prepared for distribution in commerce for
use as human food.
Cooperative State inspection programs. Section 661 of the FMIA and
454 of the PPIA authorize FSIS to cooperate with State agencies in
developing and administering their own meat or poultry products
inspection programs for the inspection and regulation of products that
are produced and sold solely within the State (21 U.S.C. 661 & 454).
These cooperative State inspection programs are required to operate in
a manner and with authorities ``at least equal to,'' but not
necessarily identical to, the provisions set out in the FMIA and PPIA
(21 U.S.C. 661 (a)(1) & 454 (a)(1)). The ``at least equal to'' standard
is a concept that requires that State MPI Programs operate in a manner
that is at least as effective as those standards adopted for the
Federal inspection program. The Acts provide for FSIS to contribute up
to 50 percent of the cost of the cooperative State inspection programs,
as long as the State programs are effectively enforcing requirements
that are ``at least equal to'' the Federal program (21 U.S.C. 661
(a)(3) & 454 (a)(3)).
Section 11015 of Title XI of The Food, Conservation, and Energy Act
of 2008 (``the 2008 Farm Bill''), enacted on June 18, 2008, amended the
Acts to establish a new cooperative inspection program under which
certain State-inspected establishments will be eligible to ship meat
and poultry products in interstate commerce (Pub. L. 110-246, 112 Stat.
1651; 21 U.S.C. 683 and 472). The amendments to the Acts provide that
the Secretary of Agriculture (FSIS by delegation), ``in coordination
with the appropriate State agency of the State in which the
establishment is located,'' may select State-inspected establishments
with 25 or fewer employees to ship meat and poultry products in
interstate commerce (21 U.S.C. 683 (b) and 472(b)). Inspection services
for these establishments must be provided by State inspection personnel
that have ``undergone all necessary inspection training and
certification to assist the Secretary with the administration and
enforcement of [the Acts]'' (21 U.S.C. 683(a)(2) and 472(a)(2)). Meat
and poultry products inspected and passed by the State inspection
personnel would bear a ``Federal mark, stamp, tag, or label of
inspection'' and would be permitted to be shipped in interstate
commerce (21 U.S.C. 683(b)(1) and 472(b)(1)).
The law provides for the Secretary to ``designate an employee of
the Federal government'' to ``provide oversight and enforcement'' of
the program (21 U.S.C. 683(d)(1) and 472 (d)(1)). If the Federal
employee finds that an establishment selected for the program is in
violation of the Acts, he or she is required to ``deselect the selected
establishment or suspend inspection at the selected establishment'' (21
U.S.C. 683(d)(3)(c) and 472(d)(3)(c)). The law requires that any
selected establishment that FSIS ``determines to be in violation of any
requirement of the Act, be transitioned to be a Federal establishment''
(21 U.S.C. 683(h) and 472(g)).
The law provides that FSIS is to reimburse a State for costs
related to the inspection of establishments in the State selected for
the program ``in an amount of not less than 60 percent of eligible
State costs'' (21 U.S.C. 683(c) and 472(c)). The law also states that
FSIS ``may provide grants to appropriate State agencies to assist the
appropriate State agencies in helping establishments covered by this
Act to transition to selected establishments'' (21 U.S.C. 683(g) and
472(f)). The law is to take effect ``on the date on which the
Secretary, after providing a period of public comment (including
through the conduct of public meetings or hearings), promulgates final
regulations to carry out [section 11015]'' (21 U.S.C. 683 (j)(1) and
472((i)(1)).
Proposed rule. On September 16, 2009, FSIS published proposed
regulations to implement the new cooperative interstate shipment
program (``Cooperative Inspection Programs: Interstate Shipment of Meat
and Poultry Products,'' 74 FR 47648).
FSIS held two public meetings by teleconference on October 27,
2009, and November 4, 2009, to solicit comments on the proposed
regulations (74 FR 54493). The comment period for the proposed rule was
scheduled to close on November 16, 2009, but, in response to comments,
was extended to December 16, 2009.
In developing this final rule, FSIS considered all comments
submitted in response to the September 2009 proposed rule, as well as
those provided at the two teleconferences held in October and November
2009. Based on its analysis of the issues, and on information provided
by the comments, FSIS made certain changes to the proposed regulations.
Those changes are summarized below and are discussed in detail in the
Agency's responses to comments.
For a more detailed discussion of section 11015 of the 2008 Farm
Bill and FSIS's proposed implementing regulations, refer to the
September 16, 2009, proposed rule.
[[Page 24715]]
II. Summary of Amendments to the Proposed Rule To Implement the
Cooperative Interstate Shipment Program
In this rulemaking, FSIS is finalizing, with some changes, the
provisions in the September 2009 proposed rule. Specifically, the
Agency is amending the proposal to:
Revise the standards for determining an establishment's
average number of employees for purposes of the cooperative interstate
shipment program to exclude employees whose duties do not involve
handling the meat or poultry products produced by the establishment (9
CFR 332.3(b)(1) and (2) and 9 CFR 318.513(b)(1) and (2));
Revise the standards for determining the average number of
employees for purposes of the cooperative interstate shipment program
to include uncompensated volunteers who are involved in handling the
meat or poultry products produced by the establishment (9 CFR
332.3(b)(6) and 381.515(b)(6));
Allow States that have existing cooperative agreements for
a State MPI program to submit a request to enter into an agreement with
FSIS for a cooperative interstate shipment program before the States
have identified establishments to recommend for the cooperative
interstate shipment program (9 CFR 332.4(b)(1) and 381.514(b)(1));
Identify factors that will be considered to determine the
frequency with which the FSIS selected establishment coordinator (SEC)
will visit selected establishments under his or her jurisdiction (9 CFR
332.7(a) and 381.517(a));
Give establishments that were deselected from the
cooperative interstate shipment program because they are located in a
State whose agreement for the program was terminated the option to
either revert back to operating under the cooperative State MPI program
or obtain a Federal grant of inspection (9 CFR 332.11(a) and
381.521(a));
Allow establishments that were deselected from the
cooperative interstate shipment and successfully transitioned to become
Federal establishments to revert back to the State MPI program after
successfully operating as a Federal establishment for a year (9 CFR
332.11(b) and 381.521(b));
Allow establishments selected to participate in the
cooperative interstate shipment program to operate under both the State
MPI program for the State where the establishment is located and the
new cooperative interstate shipment program. State-inspected
establishments that operate under both programs must maintain an
appropriate separation of time or space between operations (9 CFR
332.13 and 381.523);
Allow selected establishments that are in full compliance
with the requirements of the cooperative interstate shipment program to
voluntarily end their participation in the program and revert back to
the State MPI program (9 CFR 332.14 and 381.514);
Codify the definition of ``eligible State costs'' to
include those costs that a State has justified and FSIS has approved as
necessary for the State to provide inspection services to selected
establishments in the State (9 CFR 321.3(b) and 381.187(b)).
III. Comments and Responses
FSIS received approximately 90 separate comment letters in response
to the September 2009 proposed regulations and approximately 5000
identical comment letters submitted by a consumer advocacy organization
on behalf of private citizens. Comments submitted by consumer advocacy
organizations, private citizens, State farm bureaus, trade associations
representing meat processors, and a labor union representing food and
commercial workers expressed general support for the proposed
regulations. Comments submitted by an association of State meat and
food inspection directors, an association of State Departments of
Agriculture, several State Departments of Agriculture and other State
agencies, farm and agriculture advocacy organizations, Congress members
providing comments on behalf of the State of Wisconsin, and private
citizens expressed support for the concept of a cooperative interstate
shipment program but objected to several provisions in FSIS's proposed
implementing regulations. Other comments submitted by FSIS inspection
personnel, small federally-inspected establishments, and one consumer
advocacy organization opposed any program that would permit State-
inspected meat and poultry products in interstate commerce.
Following is a discussion of these comments and FSIS's responses.
A. Development of the proposed rule
Comment: Several comments criticized FSIS for not consulting with
State officials during the development of the proposed regulations. The
comments stated that several States and organizations of State
officials had offered to form an advisory committee to assist FSIS in
developing the proposed regulations to implement the cooperative
interstate shipment program. As noted by the comments, FSIS determined
that such a request was not practical due to the regulatory constraints
and the statutory time-line for implementing this program. The comments
encouraged FSIS to work closely with State inspection officials to
develop final regulations to make the program as workable as possible.
One comment said that creating an environment where state regulators
and federal regulators work together consistently will provide the
stability the program needs to be successful for all involved.
Some comments suggested that FSIS use this rulemaking as an
opportunity to encourage more State involvement in addressing the
nation's food safety problem. The comments encouraged FSIS to accord
considerable weight to comments submitted by States with exemplary food
safety inspection histories and State-inspected establishments that
likewise have exemplary histories when the Agency finalizes the
proposed rule.
Response: FSIS appreciates the States' willingness to participate
in the development and implementation of the new cooperative interstate
shipment program. In developing this final rule, FSIS carefully
considered the comments and suggestions submitted by the States and, as
a result, the Agency made certain revisions to the proposed
regulations. FSIS will work closely with the States as the Agency moves
forward to implement the cooperative interstate shipment program
established in this final rule.
Comment: A few comments stated that the teleconference format for
the two public meetings that were held in October and November of 2009
was not an appropriate way to generate comments on the proposed
cooperative interstate shipment program. One comment noted that there
were few comments presented during the teleconferences, which the
commenter believed may be related to the format of the public meeting.
One comment said that both teleconferences occurred on the same dates
and times when FSIS was offering webinars for small and very small
plant operators, which presented a conflict for those interested in
participating in both meetings. Another comment complained that,
although the commenter had registered for the teleconference and has a
confirmation passcode to participate, the commenter was not allowed to
speak during the meeting.
Response: FSIS chose the teleconference format for the public
meetings to provide individuals with
[[Page 24716]]
easier access to the meeting, particularly those who may lack the
resources or time to attend a meeting in person. FSIS will consider the
comments submitted on this issue to determine how it can improve its
use of the teleconference format to conduct public meetings in the
future.
B. General Support for and General Opposition to the Proposed Rule
1. Support for the Proposed Regulations
Comment: Comments submitted by consumer advocacy organizations,
private citizens, State farm bureaus, trade associations representing
meat processors, and a labor union representing food and commercial
workers expressed general support for FSIS's proposed regulations to
implement the cooperative interstate shipment program. Some of these
comments said that the language in Section 11015 of the 2008 Farm Bill
reflects an agreement reached through negotiations between various
national consumer organizations, the National Association of State
Departments of Agriculture, the National Farmers Union, the American
Federation of Government Employees, and the United Food and Commercial
Workers Union. According to these comments, the language in section
11015 was carefully crafted to meet the desire of some State-inspected
meat plants to enlarge their area of sales while assuring that all meat
and poultry sold across state lines meet federal inspection standards.
The comments commended FSIS for writing proposed regulations that
closely adhere to both the intent and specific language of the
legislation.
One comment noted that the program established in the proposed
regulations builds on existing State inspection programs and includes
important enhancements that can lead to stronger State inspection
programs. The comment approved of the fact that, like the statute, the
proposed regulations would not permit ``regulatory forum shopping.''
Response: FSIS agrees that the proposed regulations are consistent
with both the intent and language of the enabling legislation. The
Agency also agrees that the program established in the proposed
regulations will complement the existing State inspection programs.
2. Support Interstate Shipment but not the Program Proposed by FSIS
Comment: Comments submitted by an organization of State Agriculture
Departments, an organization of State meat inspection program
Directors, several State Departments of Agriculture, State agencies,
farm and agriculture advocacy organizations, and private citizens
expressed support for the concept of a cooperative interstate shipment
program but had concerns about FSIS's proposed regulations to implement
the program. Many of these comments stated that, instead of allowing
for the interstate shipment of state inspected products, FSIS's
proposed regulations essentially set up another Federal inspection
system under more stringent and inflexible provisions than the current
Federal system. According to the comments, FSIS's proposed program
fails to remove unnecessary barriers for small establishments to sell
their specialty products across State lines. The comments asserted that
the proposed regulations will create a regulatory system that is too
burdensome for either establishments or State inspection programs,
which likely means that few will take advantage of the program.
To support these assertions, the comments noted that, when FSIS
issued the proposed rule, the Agency estimated that approximately 60%
(16 of 27) of the States with existing State MPI programs and
approximately 200-600 establishments were interested in participating
in the new cooperative interstate shipment program. The comments stated
that after FSIS issued the proposed rule, an internal poll conducted by
an organization of State official indicates that only 2 of these 27
States, each with only a handful of establishments, now find the
cooperative interstate shipment proposed by FSIS to be even potentially
viable. According to the comments, without a drastic revision of the
proposed regulations and active FSIS participation in cooperation with
the State partners, the program is unlikely to succeed.
Response: After careful consideration of all comments submitted in
response to the 2009 proposed rule, FSIS modified the proposed
regulations to provide some added flexibility for establishments
selected to participate in the cooperative interstate shipment program.
For example, under this final rule, selected establishments that are in
full compliance with the program will be permitted to voluntarily end
their participation in the program. This final rule will also permit
selected establishments to operate under both the cooperative
interstate shipment program and the State's MPI program if they
maintain an appropriate separation of time or space between operations.
The Agency believes that these modifications, which are discussed in
more detail in the Agency's response to comments, will provide
additional incentive for some establishments to participate in the
program.
3. Oppose any Program That Would Allow Interstate Shipment of State-
Inspected Product
Comment: Comments submitted by FSIS inspection personnel, small
federally-inspected meat and poultry processing establishments, and a
consumer advocacy organization objected to any program that would
permit state-inspected meat and poultry products to be shipped in
interstate commerce. According to many of these comments, meat and
poultry products produced in State-inspected establishments do not
undergo the same level of inspection as products produced in Federal-
inspected facilities, and many State MPI programs are not truly ``at
least equal to'' the Federal inspection program. A few comments
referenced a 2006 Office of Inspector General Audit Report of State-
inspected meat and poultry programs that the comments said found that
some State-inspected facilities had failed to operate in a sanitary
manner and that FSIS had not provided consistent oversight of existing
State MPI programs.
Response: As required by law, the cooperative interstate shipment
program established under this final rule will operate under the same
standards imposed under the Federal inspection program. Thus, meat and
poultry products produced in State-inspected establishments selected
for the cooperative interstate shipment program will undergo the same
level of inspection as products produced in federally-inspected
facilities.
With respect to the comment that many State MPI programs are not
truly ``equal to'' the Federal inspection program, each year the FSIS
OPEER Federal State Audit Branch reviews the State cooperative MPI
programs and their requirements to verify that each State program ``at
least equal to'' the Federal program. These comprehensive reviews
consist of an annual review of the State MPI program's self assessment
submission and an on-site review to verify the State's self-assessment
submission. The onsite reviews are scheduled at a minimum, once every
three years.
Based on the self assessment documents received during FY 2009,
FSIS determined that all of the 27 State MPI programs provided adequate
documentation to support that they have implemented and can maintain
MPI programs ``at least equal to'' the Federal program. FSIS determined
that
[[Page 24717]]
all of the 11 State MPI programs reviewed on-site were enforcing
requirements ``at least equal to'' those imposed under the Federal
Acts.
In its 2006 audit of the FSIS's cooperative State MPI programs, the
OIG provided recommendations to strengthen FSIS's review of these
programs. FSIS provided management decisions in response to the 2006
OIG audit recommendations, which were accepted by OIG. The Agency has
implemented the 2006 management decisions.
Comment: One comment stated that State-inspected establishments
should not be allowed to ship products interstate because the States do
not have the money or staff to provide the inspection that the Federal
government does. Another comment maintained that Federal inspectors
undergo more extensive training than State inspection personnel and,
therefore, unlike State inspectors, are continuously expanding their
knowledge bases.
Response: As discussed in greater detail below, to qualify for the
cooperative interstate shipment program, States with cooperative State
MPI programs will need to demonstrate that they have staffing
sufficient to conduct the same inspection activities in establishments
operating under the cooperative interstate shipment program that FSIS
conducts in official Federal establishments. The States will also need
to demonstrate that the designated State personnel have been properly
trained in Federal inspection methodology. FSIS will not enter into an
agreement for a cooperative interstate shipment program with States
that are unable to meet these conditions.
Comment: One comment submitted by a consumer advocacy organization
said that while the commenter does not support State-inspected meat and
poultry for either intrastate or interstate commerce, it understands
that Congress amended the FMIA and PPIA to establish the cooperative
interstate shipment program, and that FSIS is required to develop
regulations to implement the law. The comment urged the Agency to put
into place a system whereby establishments that participate in the
program are held to the identical Federal standards and practices as
those establishments under Federal inspection and that the Agency
maintain strict oversight of such a program.
Response: The cooperative interstate shipment program established
in these final regulations will be a State inspection program under
which designated State-personnel enforce Federal food safety standards.
As required by law, FSIS will provide oversight and enforcement of the
program.
Comment: Several comments submitted by FSIS inspection personnel
and small federally-inspected meat and poultry processors maintained
that instead of establishing cooperative interstate shipment program,
FSIS should require that State-inspected establishments that desire to
ship their meat and poultry products in interstate commerce come under
Federal inspection.
One comment submitted by a small federally-inspected establishment
explained that as a small company, it decided to obtain a Federal grant
of inspection as an investment for the future of its business. The
comment noted that the establishment did this to allow for interstate
sales of its products and that the same option is available today for
any company willing to make a similar investment. The comment asserted
that to provide for a level playing field, all small companies that
want to sell their products across state lines should be required to go
through the same process and obtain a Federal grant of inspection.
Response: Section 11015 of the 2008 Farm Bill amended the FMIA and
PPIA to establish the cooperative interstate shipment program. The
amendments require that FSIS issue final regulations to implement the
new program. Once the new program becomes effective, small State-
inspected establishments that are interested in selling meat or poultry
products across State lines will have the option to operate as a
selected establishment under the cooperative interstate shipment
program or as an official Federal establishment. An establishment that
ships products across States lines must comply with all Federal
standards regardless of the inspection program that it chooses to
operate under.
Comment: One comment said that the cooperative interstate shipment
program is not necessary because the Talmadge/Aiken program serves the
same purpose.
Response: The Talmadge-Aiken program and the cooperative interstate
shipment program serve different purposes. Under the Talmadge-Aiken
program, FSIS enters into a separate agreement with a State agency for
the State program to conduct meat, poultry, or egg products inspection
or other regulatory activities on behalf of FSIS. Establishments that
participate in the Talmadge-Aiken program operate under a Federal grant
of inspection. Under the cooperative interstate shipment program, FSIS
enters into a separate agreement with a State agency to enforce Federal
food safety standards at State-inspected establishments. Establishments
that participate in the cooperative interstate shipment program are not
Federal establishments operating under a Federal grant of inspection.
Comment: Comments submitted by a few FSIS inspection personnel
opposed the proposed cooperative interstate shipment stated because the
commenters believe that the program will result in a reduction in the
Federal inspection force. The comments stated that under such a
program, small federally-inspected establishments will want to drop
their Federal grant of inspection and produce products under State-
inspection, thereby taking jobs that would otherwise belong to Federal
employees and giving them to State employees.
Response: Under the law and implementing regulations,
establishments that operate under the Federal inspection program are
ineligible to participate in the cooperative interstate shipment
program. The new program is limited to certain small and very small
State-inspected establishments. Thus, the cooperative interstate
shipment program will have little effect on Federal inspection
personnel.
Comment: One comment objected to allowing the interstate shipment
of state-inspected products because, according to the comment, FSIS
will no longer have control or jurisdiction over some meat and poultry
products in interstate commerce. The comment noted that a State's
jurisdiction is limited to the State's borders. The comment asked what
would happen if product produced by a State-inspected establishment is
implicated in a food safety issue resulting in a recall.
Response: Under the law, FSIS is responsible for providing
oversight and enforcement of the cooperative interstate shipment
program. Therefore, if an establishment operating under the cooperative
interstate shipment program distributes meat or poultry products that
present a food safety hazard or that need to be recalled for other
reasons, FSIS will coordinate with the State MPI program to ensure that
such product is removed from commerce. FSIS will be responsible for the
overall coordination of the recall and for verifying that recalled
product that has been shipped interstate has been removed from
commerce.
C. Establishment Participation--Conditions for Eligibility and
Standards for Determining Average Number of Employees
The proposed rule prescribed conditions that State-inspected
[[Page 24718]]
establishments would be required to meet to become eligible to
participate in the cooperative interstate shipment program. Consistent
with the law, among these proposed conditions were that an
establishment be in compliance with all Federal inspection requirements
under the FMIA, PPIA, and their implementing regulations, and that the
establishment employ, on average, no more than 25 individuals. The
proposed rule also included proposed standards for determining the
average number of employees, which, for the most part, reflect
applicable methods used by the Small Business Administration (SBA) to
calculate the number of employees for a small business concern. FSIS
received several comments on the proposed conditions for establishment
eligibility and the proposed standards for determining the average
number of employees.
1. Compliance With Federal Standards
Comment: Some comments agreed that State-inspected establishments
should be required to comply with Federal standards to be eligible for
the cooperative interstate shipment program. The comments stated that
many small and very small establishments have managed to conform to,
and operate successfully under, the requirements of the Federal
inspection system. Two comments noted that data obtained from FSIS's
PBIS in 2007 show that 51 percent (2,878 of 5,603) of all federally-
inspected establishments have 10 or fewer employees and 80% have 50 or
fewer employees.
The comments also noted that all establishments that prepare or
process meat and poultry products have always had the opportunity to
ship their products in interstate commerce provided that they apply for
and receive a Federal grant of inspection. The comments stated that
small and very small establishments now under Federal inspection have
invested time and money to comply with all Federal regulations and to
operate under Federal standards. The comments asserted that while the
new cooperative interstate shipment program is intended to offer
establishments operating under their State inspection program an
opportunity to broaden their distribution, any establishment that ships
meat or poultry products in interstate commerce can and should meet
Federal food safety standards.
Other comments stated that requiring that State-inspected
establishments comply with Federal food safety standards in order to be
eligible for the cooperative interstate shipment program will establish
unfair barriers for small plants to participate in the program. The
comments urged FSIS to provide small State-inspected establishments
with greater flexibility in achieving food safety standards. One
comment from a small State-inspected establishment stated that it
cannot afford Federal inspection. The comment noted that establishments
operating under the State MPI system are required to adhere to very
strict food safety standards but, unlike the Federal system, State
inspection personnel are also available to help the small and very
small establishments with education and training.
Response: The amendments to the Acts in section 11015 of the 2008
Farm Bill require that State-inspected establishments be in compliance
with all Federal standards in order to be eligible for the cooperative
interstate shipment program. The provisions in the Acts that establish
the cooperative interstate shipment program define an ``eligible
establishment'' as an establishment that is in compliance with both ``*
* * the State inspection program of the State in which the
establishment is located'' and ``[the FMIA or PPIA], including the
rules and regulations issued under [the FMIA or PPIA]'' (21 U.S.C.
472(a)(3) and 683(a)(3)).
The Senate Conference Committee report on the bill that established
the cooperative interstate shipment program also makes clear that
establishments selected for the program ``* * * must fully follow [the
FMIA or PPIA], its regulations, notices, directives and policies just
as would be required of a Federal establishment'' (S. Rep. No. 220,
110th Cong., 1st Sess. (2007), pp. 211-214). Thus, requiring that
State-inspected establishments comply with Federal food safety
standards to become eligible to participate in the cooperative
interstate shipment program is consistent with both the language and
intent of section 11015 of the 2008 Farm Bill.
FSIS's Office of Outreach, Employee Education, and Training (OOEET)
will provide technical resources, information, and guidance to small
and very-small State establishments that are interested in becoming
eligible to participate in the cooperative interstate shipment program.
2. Determining Average Number of Employees
a. Proposed standard: All individuals, both supervisory and non-
supervisory, employed by the establishment on a full-time, part-time,
or temporary basis are to be counted when calculating the total number
of employees.
Comment: Several comments stated that for purposes of the
cooperative interstate shipment program, an establishment's average
number of employees should be based only on those directly involved in
the preparation or processing of meat and poultry products. The
comments noted that many small and very small establishments conduct
operations other than the processing of meat or poultry products, such
as grocery stores, convenience stores, or other retail outlets.
According to the comments, employees that do not perform duties related
to the meat or poultry processing operations of the business should not
be included when calculating the average number of employees.
One comment suggested that FSIS consider basing the ``value''
associated with the employee on the workers compensation code that the
employer designates. The commenter said that it could give FSIS a
simple way of determining which workers are associated with the meat
processing part of the business and which employees offer other roles
for the company, such as administrative workers or retail clerks.
Other comments said that all establishment personnel, including
those not involved in the actual production of meat and poultry
products, should be counted when calculating the average number of
employees. One comment noted that the law specifically states that
supervisory and nonsupervisory employees are to be counted when
calculating the average number of employees. The comment maintained
that this indicates that if Congress had intended to exclude certain
employees from the calculation, it would have expressly stated so in
the law. The comment urged FSIS to require that temporary and part-time
employees, regardless of their position in the establishment, be
counted when determining the average number of employees.
Response: Although the law limits participation in the cooperative
interstate shipment program to State-inspected establishments that
employ, on average, 25 or fewer employees, it does not distinguish
between employees involved in an establishment's meat or poultry
processing operations from those that are not. Counting all individuals
employed by the establishment would ensure that participation in the
cooperative interstate shipment program is limited to very small and
certain small establishments. Counting only
[[Page 24719]]
employees directly involved in the preparation or processing of meat
and poultry products would create a more flexible standard that would
expand the number of potentially eligible establishments to include
those that have a small number of employees that work in meat or
poultry processing but a larger number of employees that work in other
areas of their business.
The 2008 amendments to the Acts give FSIS the authority to define
``average number of employees'' for purposes of the cooperative
interstate shipment program, but they also make clear that the program
is intended for State-inspected establishments that employ a limited
number of individuals. Therefore, FSIS is adopting a standard for
calculating the average number of employees that provides some
flexibility for establishments that conduct operations other than meat
or poultry processing, but that also clearly distinguishes those
employees that are to be counted for purposes of the interstate
shipment program from those that are not.
Therefore, instead of counting all individuals employed by the
establishment as proposed, under this final rule, an establishment's
average number of employees will be calculated by counting all
individuals employed by the establishment, excluding the employees that
do not come into contact with the meat or poultry products produced by
the establishment. For example, if the owner of a gas station produces
beef jerky and sells it at the gas station, the employees that are
involved in producing the jerky, as well as those that work as cashiers
and sell the product, will be counted. The mechanics that work on the
cars, however, will not be. Employees that perform solely
administrative functions and that do not handle meat or poultry
products will also not be counted.
When an establishment conducts multiple operations, it is sometimes
difficult to distinguish employees associated with the meat or poultry
operations from those that are not. For example, an individual employed
as a cashier at an establishment's deli operations may also slice and
package meat or poultry products produced by the establishment. The
standard adopted in this final rule clearly distinguishes employees
whose duties are associated with the meat or poultry products produced
by an establishment from those that are not. It also ensures that the
cooperative interstate shipment program will remain limited to certain
small and very small establishments, as intended.
b. Proposed standard: Part-time and temporary employees are to be
counted the same as full-time employees.
Comment: Several comments, most submitted by consumer advocacy
organizations and one submitted by a food and commercial workers union,
agreed with the proposed standard to count part-time and temporary
workers as full-time workers for purposes of qualifying for the
cooperative interstate shipment program. The comments noted that most
very small establishments have few full-time employees, and many do not
operate every day. The comments maintained that counting part-time and
temporary employees the same as full time employees is an effective
means to assure the cooperative interstate shipment program serves the
entities it was intended to serve. According to the comment, failing to
count part-time and temporary employees in the average number of
employees would permit substantially larger entities to participate in
a program that was designed to serve very small local establishments.
Some of these comments noted that during negotiations with the
States, consumer advocacy groups reluctantly agreed to the States'
request for a program with a 25 employee limit. According to the
comment, none of the groups involved in the negotiations ever agreed to
anything larger than 25 employees. The comments said that the primary
reason that many consumer advocacy organizations had opposed the House
interstate shipment bill was because the bill contained a 50 employee
limit, which, according to the comment, would have expanded the number
of establishments in the new cooperative program far beyond what was
intended. One comment stated that, although the program's 25 employee
limit is reasonable, the commenter would have preferred a limit of 10
employees, which is similar to the current FSIS definition for very
small establishments.
Several other comments, most submitted by State Departments of
Agriculture and other State agencies, disagreed with the proposed
standard to count part-time and temporary workers as full time
employees. The comments stated that such a standard seems excessive and
does not provide an accurate depiction of an establishment's actual
number of employees.
The comments noted that many small establishments in small towns
hire part-time employees who work as little as a few hours a week.
According to the comments, to count such employees as full-time would
contradict and undercut the rural development intentions of the
enabling legislation. One comment stated that in some rural areas,
especially those with small and very small establishments, meat
processing has a seasonal component that provides part-time seasonal
work for rural residents. The comments noted that during each part of
the day, an establishment may have only 25 employees on site, even if
the total number of part-time and fulltime employees employed overall
during the day exceeds 25.
The comments suggested that part-time and temporary workers be
counted on the basis of ``full-time equivalents'' or ``FTEs,'' i.e.,
based on the ratio of their work-hours to those of a full-time year-
round employee. The comments said that part-time and temporary
employees should be grouped together and counted based on the number of
hours they work each week during the year, with 40 hours per week being
considered an FTE. Several comments suggested formulas for calculating
the number of employees based on FTEs.
Response: After considering the comments, FSIS has decided to adopt
the proposed standard to count temporary and part time employees the
same as full-time employees. For purposes of its regulatory programs,
FSIS defines small and very small establishments based on SBA criteria.
A standard that counts part-time and temporary workers the same as
full-time workers reflects the SBA methods for calculating the average
number of employees for a small business concern and is thus consistent
with FSIS's overall approach for defining small and very small
establishments.\1\
---------------------------------------------------------------------------
\1\ See 13 CFR 121.105 and 121.106 for SBA methods to calculate
the number of employees of a business concern where the size
standard in number of employees.
---------------------------------------------------------------------------
As noted by the comments, several very small establishments have
few full-time employees, and many do not operate every day. A standard
that is based on the SBA criteria that counts part-time and temporary
employees the same as full time employees allows these establishments
to hire seasonal workers while ensuring that only very small and
certain small establishments are eligible to participate in the
program.
Comment: Several comments stated that the standards for determining
the average number of employees need to allow for more flexibility in
counting temporary seasonal workers. The comments noted that small and
very small establishments often have fluctuation in their employees
during certain parts of the year, such as during
[[Page 24720]]
holiday and hunting seasons, and that the term ``seasonal'' will have
different meanings in different areas of the country. Some comments
noted some establishments hire extra employees to help with seasonal
activities that are not related to the processing of amenable species,
such as processing game meat or for busy times in their retail shops
around holidays.
The comments suggested that seasonal employees be counted based on
FTE. As an example, the comments explained that a seasonal employee who
works full-time for 3 months would be a 25% FTE and should be counted
as one quarter of an employee.
One comment asserted that seasonal employees should not be counted
at all when calculating the average number of employees. The comment
suggested that the final rule define a seasonal employee as an employee
that works for the establishment ninety or fewer days in a calendar
year.
Response: When Congress amended the FMIA and PPIA to establish the
cooperative interstate shipment program, it intended for FSIS to
interpret the term average ``[hellip]to provide some flexibility to
these selected plants that require seasonal employees for certain parts
of the year, as long as the increase in employees are [sic] manageable
by the establishment and the increase in employees does not undermine
food safety standards'' (S. Rep. No. 220, 110th Cong., 1st Sess., pp.
211-214 (2007)).
As discussed below, under the proposed rule, selected
establishments may temporarily employ more than 25 employees during
busy seasons, as long as the average number of employees continues to
be 25 and the number of employees does not exceed 35. Thus, a standard
that counts temporary seasonal employees the same as full-time
employees will allow selected establishments to hire seasonal employees
while ensuring that the number of employees remains manageable by the
establishment, as Congress intended.
FSIS disagrees with the comment that stated that seasonal employees
should not be counted at all. Such an approach would be inconsistent
with the language and intent of the statute.
c. Proposed standard: The total number of employees cannot exceed
35 at any given time, regardless of the average number of employees.
Comment: Some comments stated that the proposed standard that
provides that the total number of employees can never exceed 35
individuals at any given time, regardless of the average number of
employees, is a reasonable upper limit for selected establishments to
remain eligible to participate in the program. One comment stated that
such a limit is reasonable if FSIS does not count part-time and
temporary employees the same as full time.
Other comments asserted that FSIS should not limit the number of
employees working at a selected establishment at any given time if the
establishment maintains an average of 25 employees or fewer. The
comments stated that while section 11015 of the 2008 Farm Bill requires
that the average number of employees not exceed 25, the law does not
prohibit a selected establishment from ever, over the course of a year,
having more than 35 employees.
The comments stated that in many small establishments there may be
``spikes'' in employee numbers during busy periods, but the overall
average number of employees is under 25. The comments asserted that, as
written, the proposed rule excludes such establishments from
participating in the interstate shipment program. According to the
comments, section 11015 was not intended to exclude these
establishments. The comments suggested that FSIS revise the proposed
rule to ensure that these establishments remain eligible for the
program.
One comment disagreed with the proposed 35 employees limit because,
according to the comment, allowing selected establishment to have 35
employees during seasonal shifts represents, at minimum, a 40% increase
in establishment personnel. The comment argued that the higher number
of employees represents a huge increase in production that could
overwhelm a very small establishment's production systems, which could
result in contaminated food entering commerce. The comment noted that
if an establishment routinely employs 5 people and then increases this
number to 10 or 20 during a certain timeframe, it will have a 100% or
400% increase in employees. The comment maintained that this level of
increase is not manageable and is not what Congress intended.
The comment suggested that instead of limiting the total number of
employees to 35 at any given time, FSIS should cap at 20% the increase
in the number of employees that an establishment may use during a
seasonal shift. The comment acknowledged that the commenter does not
have data to support this number, but stated that it stands to reason
that a sudden increase in production could significantly affect the
dynamics within an establishment and overwhelm the system. According to
the comment, small and very small establishments have HACCP plans for a
production process at a certain level that would not necessarily
support a significantly higher level of production. The comment pointed
out that FSIS did not provide any data to support the proposed 35
employee cap.
One comment stated that FSIS should not allow more than 25
employees in selected establishments at any given time. The comment
noted that section 11015 requires that establishments that consistently
employ more than 25 employees but fewer than 35 employees transition to
Federal establishments within three years of the enactment date. The
comment stated that this provision indicates that Congress recognized
that establishments that ship product in interstate commerce and that
have more than 25 employees should be under Federal inspection.
Response: While the 2008 amendments to the Acts do not specifically
prohibit selected establishments from ever having more than 35
employees, the Senate report described above indicates that Congress
intended that there be some limits on the number of employees working
at a selected establishment at any given time.
As explained in the preamble to the proposed rule, FSIS proposed
that the number of employees working in a selected establishment never
exceed 35 at any given time because the law allows FSIS to select for
the cooperative interstate shipment program establishments that
employed more than 25 but fewer than 35 employees as of June 18, 2008,
the date the law was enacted (21 U.S.C. 683(b)(3)(B) and 472(b)(3)(B)).
To remain in the program, these establishments must employ fewer than
25 employees on average 3 years after the effective date of this final
rule. Thus, while Congress did not intend to ``* * * routinely allow
selected establishments to employ above 25 or more employees,'' the
fact that the law provides for some selected establishments to
initially employ up to 35 individuals demonstrates that a temporary
increase in the number of employees of up to 35 individuals, as long as
the average number of employees remains 25 or fewer, is consistent with
the language and intent of the Acts.
As noted above, when Congress established the cooperative
interstate shipment program, it intended to provide some flexibility to
establishments that require seasonal employees to meet consumer demands
for certain parts of the year. The 20%
[[Page 24721]]
cap on the increase in the number of employees suggested by one of the
comments would greatly restrict the number of temporary workers that a
selected establishment would be allowed to hire during busy seasons.
For example, an establishment that regularly employs five employees on
average would be permitted to hire only one temporary employee during
its busy seasons. Many small and very small establishments operate on
an intermittent or seasonal basis and are accustomed to adjusting their
operations to temporarily increase production without undermining food
safety standards. FSIS has concluded that restricting the increase in
employees to 20% is unlikely to provide the flexibility that many very
small selected establishments will need to meet seasonal demands for
their products.
d. Proposed standards: Volunteers who receive no compensation are
not considered employees.
Comment: One comment disagreed with the proposed standard that
provides that volunteers are not considered employees. The comment
stated as a food safety measure, uncompensated volunteers who are
engaged in meat or poultry product processing should be considered
employees for the purpose of the cooperative interstate shipment
program.
Response: FSIS agrees with this comment and has revised the
standards for counting employees to include as employees, volunteers
that perform duties that involve handling the meat or poultry products
produced by the establishment.
D. State Participation: ``The Same as'' Standard for Inspection
Services Provided to Selected Establishments
The proposed regulations provide that States interested in
establishing an agreement for a cooperative interstate shipment program
are required to submit a request for such an agreement to FSIS through
the FSIS district office that covers the State. The proposed rule also
provided that, in their requests, States are required to include
documentation to demonstrate that they are able to provide the
necessary inspection services to selected establishments in the State
and conduct any related activities that would be required under a
cooperative interstate shipment program. The preamble to the proposed
rule explained that to meet this requirement, the statute requires that
States demonstrate that the inspection service that they provide to
selected establishments in the State will be ``the same as,'' rather
than ``at least equal to'' those provided under the Federal inspection
program. FSIS received a significant number of comments on the proposed
``same as'' standard.
1. Support for ``the same as'' Standard
Comments submitted by consumer advocacy organizations, meat
processor trade associations whose members mainly operate under the
Federal inspection system, a union representing food and commercial
workers, two pork producer trade associations, and some private
citizens expressed support for the proposed ``same as'' standard.
Comment: The comments that supported the proposed ``same as''
standard agreed that the language and intent of the enabling statute
require that the cooperative interstate shipment program operate under
standards that are the ``same as'' the Federal inspection system and
not the ``at least equal to'' standard that applies to State MPI
programs. The comments believed that all meat and poultry products
shipped in interstate commerce should be required to comply with
uniform Federal food safety standards rather then multiple State
standards. The comments stated that it is especially important for
State-inspected establishments that participate in the new program to
be in compliance with all Federal standards because the meat and
poultry products produced by these establishments will bear a Federal
mark of inspection.
One comment stated that requiring that selected establishments that
voluntarily request the opportunity to participate in a cooperative
interstate shipment program operate in a manner that is the ``same as''
federally-inspected establishments is not only consistent with the
provisions and intent of the law, but also ensures that the food safety
standards established in the FMIA, PPIA, and their implementing
regulations are applied uniformly to all meat and poultry products that
are distributed in interstate commerce. The comment encouraged FSIS to
retain the proposed ``same as'' standard to first and foremost ensure
the safety of meat and poultry products distributed in interstate
commerce, but also to ensure equity in the marketplace. The comment
added that this fundamental proposition, that the playing field be
level for all companies engaging in interstate commerce, was a critical
element in securing passage of the statutory provisions that authorized
the cooperative interstate shipment program. The comment asserted that
the program must not provide an unfair advantage to small companies
that will not, or cannot, make the commitments necessary to comply with
Federal food safety requirements.
Two comments stated that requiring that State-inspected products
produced under the cooperative interstate shipment program comply with
all Federal requirements is essential for maintaining domestic and
international markets for U.S. meat and poultry products. Other
comments said that consumers expect that products carrying the Federal
mark of inspection comply with Federal standards for meat and poultry
inspection. The comments stated that establishments that are not held
to all aspects of the Federal requirements should not be entitled to
apply the Federal mark of inspection on their products.
One comment that supported the ``same as'' standard noted that
although establishments operating under a State MPI inspection program
receive inspection services that are ``at least equal to'' the Federal
inspection program, the methodology employed by FSIS is a critical part
of the effectiveness of the Federal food safety system. The comment
asserted that, as such, it is essential for States that participate in
the cooperative interstate shipment program to follow Federal
inspection methodology when providing inspection services to selected
establishments.
Response: FSIS agrees that the ``same as'' standard is consistent
with the language and intent of the statutes. The issues raised by the
comments demonstrate why it is important for the cooperative interstate
shipment program to operate under standards that are ``the same as''
those imposed under the Federal meat and poultry products inspection
programs.
2. Opposed to ``same as'' standard
Several comments submitted by State Departments of Agriculture and
other State agencies, as well as organizations representing these
entities, objected to the proposed ``same as'' standard. Some farm and
rural community advocacy organizations, cattle producer organizations,
a trade association representing small meat processors, and an animal
welfare advocacy organization also opposed the proposed standard.
Comment: Several comments that objected to the proposed ``same as''
standard claimed that such a standard is not authorized by law. These
comments asserted that the Acts, as amended by the 2008 Farm Bill, do
not contain any language that would require that the inspection
services that States provide to selected establishments be ``the same
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as'' or ``identical to'' the inspection services provided under the
Federal program. The comments maintained that such an interpretation is
an extrapolation of the language that does not exist in the statute.
The comments noted that under the 2008 Farm Bill amendments, the
term ``eligible establishment'' refers to an establishment that is ``in
compliance with'' the Acts. The comments also noted that these
amendments authorize the SEC to ``ensure that selected establishments
are operating in a manner that is consistent with * * *'' the Acts (21
U.S.C. 472(d)(3)(A), 683(d)(3)(A)). The comments argued that these
provisions indicate that if Congress had intended to require that the
State program be ``the same as'' or ``identical to'' to the Federal
program, it would have specifically said so in the statute.
The comments also noted that the 2008 Farm Bill did not amend the
provisions in the FMIA and PPIA that provide for cooperative State MPI
programs that are ``at least equal'' to the Federal program. According
to the comments, the fact that Congress did not amend these provisions
demonstrates that State programs that are ``at least equal to'' the
Federal program are in compliance with the Acts.
Response: The language in the FMIA and PPIA, as amended by the 2008
Farm Bill, is clear: Congress provided that the cooperative interstate
shipment program would operate under standards that are ``the same as''
those imposed under the Federal program.
The 2008 amendments to the FMIA and PPIA provide that to be
eligible for the cooperative interstate shipment, State-inspected
establishments must be in compliance with both the State's MPI program
and ``* * * the requirements of this chapter, including the rules and
regulations issued under this chapter'' (21 U.S.C. 472(a)(3) and
683(a)(3)). As used in the statutes, the term ``this chapter'' refers
to the FMIA at 21 U.S.C Chapter 12, and the PPIA at 21 U.S.C. Chapter
10. The 2008 amendments also require that the State personnel
designated to provide inspection services under the program undergo ``*
* * all necessary training and certification to assist * * * in the
administration and enforcement of this chapter, including the rules and
regulations issued under this chapter'' (21 U.S.C. 472(a)(2) and
683(a)(2)). The 2008 amendments allow a meat or poultry product
inspected by designated State personnel to bear a Federal mark of
inspection and be shipped in interstate commerce if the product ``* * *
qualifies for the mark * * * under the requirements of this chapter''
(21 U.S.C. 472(b)(1)(A) and 683(b)(1)(A)).
The Senate Conference Committee report on the bill that established
the cooperative interstate shipment program provides that ``* * *
establishments selected for the [cooperative interstate shipment]
program * * * must fully follow [the FMIA or PPIA], its regulations,
notices, directives and policies just as would be required of a Federal
establishment'' (S. Rep. No. 220, 110th Cong., 1st Sess. (2007), pp.
211-214). The report also provides that ``* * * [t]he inspection
personnel of the State that will inspect the selected establishment
must have undergone all the necessary training to carry out the
requirement of [the Acts], [their] regulations, notices directives and
policies, just as required of a Federal inspector.''
Thus, both the statute and the Committee report make clear that
Congress intended for the cooperative interstate shipment program to
operate under standards that are ``the same as'' those imposed under
the Federal inspection program.
FSIS agrees with the comments that stated that the 2008 Farm Bill
did not amend the provisions in the FMIA and PPIA that provide for
cooperative State MPI programs that are ``at least equal'' to the
Federal program. However, FSIS disagrees that this means that State
programs that are ``at least equal to'' the Federal program are in
compliance with all requirements of the Acts for purposes of the
cooperative interstate shipment program. Under the FMIA and PPIA,
establishments operating under an ``at least equal to'' State MPI
program are permitted to produce meat or poultry products solely for
distribution within the State where the establishment is located (21
U.S.C. 454(a)(1) and 661(a)(1)). Thus, State programs that are ``at
least equal to'' the Federal program are in compliance with the Acts
only if the establishments operating under these programs prepare and
ship products solely for use within the State where they are located.
Comment: One comment asked whether the proposed rule requires that
a State's entire MPI program must be ``identical to'' the Federal
program for the State to qualify for the cooperative interstate
shipment program.
Response: No, a State's entire MPI program does not need to be
identical to the Federal program for the State to qualify for the
cooperative interstate shipment program. To qualify for the program, a
State must demonstrate that the inspection services that it will
provide to selected establishments in the State will be ``the same as''
those provided under the Federal inspection program. States that
participate in the cooperative interstate shipment program may continue
to operate an ``at least equal to'' State MPI program for
establishments that produce meat and poultry pr