Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products, 47648-47669 [E9-21952]
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules
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
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AGENCY: Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
SUMMARY: The Food Safety and
Inspection Service (FSIS) is proposing
regulations to implement 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), as well as with all State
standards. 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.
FSIS is proposing these regulations in
response to the Food, Conservation, and
Energy Act, enacted on June 18, 2008.
Section 11015 of the law amended the
FMIA and PPIA to provide for these
cooperative programs.
DATES: Submit comments on or before
November 16, 2009.
ADDRESSES: FSIS invites interested
persons to submit comments on this
proposed rule. Comments may be
submitted by either of the following
methods:
Federal eRulemaking Portal: Go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments.
Mail, including floppy disks or CD–
ROM’s, and hand- or courier-delivered
items: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety
and Inspection Service, Room 2–2127
George Washington Carver Center, 5601
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Sunnyside Avenue, Beltsville, MD
20705.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2008–0039. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to: https://
www.regulations.gov.
Docket: For access to background
documents or comments received, go to
the FSIS Docket Room at the address
listed above between 8:30 a.m. and 4:30
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Philip Derfler, 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
A. Federal-State Cooperative Inspection
Programs
FSIS has been delegated the authority
to carry out the functions of the
Secretary of Agriculture as provided in
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.). These statutes
mandate that FSIS protect the public by
ensuring that meat and poultry products
are safe, wholesome, unadulterated, and
properly labeled and packaged.
The FMIA and the PPIA (‘‘the Acts’’)
provide for FSIS to cooperate with State
agencies in developing and
administering their own meat or poultry
inspection programs (21 U.S.C. 661 and
454). The FMIA and the PPIA restrict
each cooperative State meat or poultry
products inspection program to the
inspection and regulation of products
that are produced and sold within the
State (21 U.S.C. 661(a)(1) and 454(a)(1)).
Under section 661 of the FMIA and
section 454 of the PPIA, cooperative
State inspection programs are required
to operate in a manner and with
authorities ‘‘at least equal to’’ the
provisions set out in the Acts (21 U.S.C.
661(a)(1) and 454(a)(1)).
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) and
454(a)(3)). States that have enacted a
mandatory State meat or poultry
inspection law must apply to FSIS to
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enter into a cooperative State inspection
program agreement with the Agency.
If a State is unable or unwilling to
continue to operate a cooperative State
inspection program on an ‘‘at least equal
to’’ basis, FSIS designates the State as
not having an ‘‘at least equal to’’
program by publishing this designation
in the Federal Register. After the
expiration of thirty days of such
publication, the State establishments are
subject to Federal inspection (21 U.S.C.
661(c)(1) and 454(c)(1)).
The Talmadge-Aiken Act authorizes
the Secretary of Agriculture to enter into
cooperative arrangements with State
departments of agriculture and other
State agencies to assist the Secretary in
the enforcement of relevant Federal
laws and regulations to the extent and
in the manner appropriate to the public
interest (7 U.S.C. 450). Pursuant to the
Talmadge-Aiken Act, 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. FSIS provides 50 percent funding
to the State programs for these services.
B. The Food, Conservation, and Energy
Act of 2008
On June 18, 2008, Congress enacted
The Food, Conservation, and Energy Act
of 2008 (also referred to as ‘‘the 2008
Farm Bill’’) (Pub. L. 110–246, 112 Stat.
1651). Section 11015 of Title XI of the
2008 Farm bill amended the FMIA to
add a new title V—‘‘Inspections by
Federal and State Agencies,’’ which
contains a new section 501, ‘‘Interstate
Shipment of Meat Inspected by Federal
and State Agencies for Certain Small
Establishments (122 Stat. 2124; codified
at 21 U.S.C. 683). Section 11015 also
amended the PPIA to add a new section
31, ‘‘Interstate Shipment of Poultry
Inspected by Federal and State Agencies
for Certain Small Establishments’’ (122
Stat. 2127; codified at 21 U.S.C. 472).
These new sections supplement the
existing cooperative State meat and
poultry inspection programs by
establishing a new cooperative program
under which certain State-inspected
establishments would be permitted to
ship meat and poultry products in
interstate commerce.
The new law provides that the
Secretary of Agriculture, ‘‘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 interstate (Sec. 501(b)
and Sec. 31(b)). Inspection services for
these establishments must be provided
by State inspection personnel that have
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‘‘undergone all necessary inspection
training and certification to assist the
Secretary with the administration and
enforcement of [the FMIA or PPIA]’’
(Sec. 501(a)(2) and Sec. 31(a)(2)). Meat
and poultry products inspected and
passed by these State inspection
personnel would bear a ‘‘Federal mark,
stamp, tag, or label of inspection’’ (Sec.
501(b)(1) and Sec. 31(b)(1)). The law
provides for the Secretary to ‘‘designate
an employee of the Federal
government’’ to ‘‘provide oversight and
enforcement’’ of the program (Sec.
501(d)(1) and Sec. 31(d)(1)).
The law is to take effect ‘‘on the date
on which the Secretary * * *
promulgates final regulations to carry
out [section 11015]’’ (Sec. 501(j)(1) and
Sec. 31(i)(1)). The law requires that the
Secretary promulgate final regulations
‘‘not later than 18 months after the date
of enactment’’ (Sec. 501(j)(2) and Sec.
31(i)(2)).
FSIS is issuing this proposed rule to
implement section 11015 of the 2008
Farm Bill. Following is a summary of
the provisions of section 11015 that are
addressed in this proposed rule.
Selected establishments. The law
applies to certain establishments that
are already operating under a
cooperative State meat or poultry
inspection program. The law defines an
‘‘eligible establishment’’ as ‘‘an
establishment that is in compliance
with * * * the State inspection program
of the State in which the establishment
is located’’ and the Acts, including the
rules and regulations issued under the
Acts (Sec. 501(a)(3) and Sec. 31(a)(3)). A
‘‘selected establishment’’ is defined as
‘‘an establishment that is authorized by
the Secretary, in coordination with
* * * the appropriate State agency of
the State in which the establishment is
located * * * to ship [meat or poultry]
items in interstate commerce’’ (Sec.
501(a)(5) and Sec. 31(a)(5)).
The law prohibits the Secretary from
selecting an establishment for interstate
shipment that ‘‘on average, employs
more than 25 employees (including
supervisory and nonsupervisory
employees), as defined by the
Secretary’’ (Sec. 501(b)(2)(A) and Sec.
31(b)(2)(A)). The law also prohibits the
selection of establishments that
currently ship interstate, as well as
certain former and future Federal
establishments (Sec. 501(b)(2)(B), Sec.
501(b)(2)(C), Sec. 31(b)(2)(B), and Sec.
31(b)(2)(C)).
Transition to a Federal establishment.
The law permits the Secretary to select
establishments with ‘‘more than 25
employees but less than 35 employees’’
to participate in the program (Sec.
501(b)(3)(B)(i) and Sec. 31(b)(3)(B)(i)).
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However, if selected, these
establishments must transition to
Federal establishments ‘‘beginning on
the date that is 3 years after the effective
date’’ if they consistently employ, on
average, more than 25 employees (Sec.
501(b)(3)(B)(ii) and Sec. 31(b)(3)(B)(ii)).
The law authorizes the Secretary to
develop a procedure to transition
certain selected establishments to a
Federal establishment (Sec. 501(b)(3)(A)
and Sec. 31(b)(3)(A)). The law also
requires that ‘‘[a]ny selected
establishment that the Secretary
determines to be in violation of any
requirement of the Act, be transitioned
to a Federal establishment’’ (Sec. 501(h)
and Sec. 31(g)).
Federal-State coordination. Under the
law, the Secretary is authorized to
designate a Federal employee as ‘‘State
coordinator’’ for each State to ‘‘provide
oversight and enforcement’’ of the
interstate shipment program and to
‘‘oversee the training and inspection
activities’’ of the State personnel
providing inspection services to
selected establishments (Sec. 501(d)(1)
and Sec. 31(d)(1)). The law provides
that if the State coordinator determines
that a selected establishment under the
State coordinator’s jurisdiction is in
violation of the Acts, the State
coordinator must ‘‘immediately notify
the Secretary of the violation’’ and
‘‘deselect the selected establishment or
suspend inspection at the selected
establishment’’ (Sec. 501(d)(3)(C) and
Sec. 31(d)(3(C)).
This proposed rule refers to the ‘‘State
coordinator’’ established in section
11015 of the 2008 Farm Bill as the FSIS
‘‘selected establishment coordinator’’ to
maintain consistency with the other
terminology in this proposed rule and to
make clear that the ‘‘State coordinator’’
is a Federal employee. The term ‘‘State
coordinator’’ is often used to refer to a
State employee under the TalmadgeAiken program, so FSIS has tentatively
decided not to use this term in these
proposed regulations.
Federal reimbursement of State costs.
The law requires that the Secretary
‘‘reimburse a State for costs related to
the inspection of selected
establishments * * * in an amount of
not less than 60 percent of eligible State
costs’’ (Sec. 501(c) and Sec. 31(c)).
Inspection training division. The law
amended the FMIA to provide that not
later than 180 days after the effective
date of section 11015 of the 2008 Farm
Bill, the Secretary shall establish in
FSIS an inspection training division to
provide outreach, education, and
training to, and provide grants to
appropriate State agencies to provide
outreach, technical assistance,
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education, and training to small and
very small establishments (as defined by
the Secretary) (Sec. 501(f)). FSIS
implemented this provision by
establishing an Office of Outreach,
Education and Training. A substantive
part of the program’s function is to
provide training, education, and
outreach services to small and very
small plants.
Transition grants. The law permits the
Secretary to provide grants to States to
assist them in helping establishments
operating under a cooperative State
meat or poultry inspection program
transition to selected establishments
(Sec. 501(g) and Sec. 31(f)).
II. The Proposed Rule
A. General
FSIS is proposing to amend 9 CFR
part 321 of the Federal meat inspection
regulations and 9 CFR part 381, subpart
R, of the poultry products inspection
regulations to add new sections that
describe the cooperative interstate
shipment program established in section
11015 of the 2008 Farm Bill. FSIS is also
proposing to add a new 9 CFR part 332
to the Federal meat inspection
regulations and a new 9 CFR part 381,
subpart Z, to the poultry products
inspection regulations that prescribe the
conditions under which States and
establishments operating under a Stateinspection program will be permitted to
participate in a cooperative interstate
shipment program.
When FSIS completes the rulemaking
process and issues a final rule, the
Federal meat and poultry products
regulations will provide for three
separate cooperative State meat and
poultry products inspection programs:
(1) Cooperative State meat or poultry
products inspection programs under the
FMIA and PPIA; (2) cooperative
agreements for State programs to
conduct meat or poultry products
inspection or other regulatory activities
on behalf of the Agency under the
Talmadge-Aiken Act; and (3)
cooperative programs for the interstate
shipment of State-inspected meat and
poultry products under the FMIA and
PPIA as amended by section 11015 of
the 2008 Farm Bill.
The proposed regulations to
implement section 11015 are described
in detail below.
B. Description of Cooperative
Programs—9 CFR Part 321 and 9 CFR
Part 381, Subpart R
9 CFR part 321 of the Federal meat
inspection regulations and 9 CFR part
381, subpart R, of the poultry products
inspection regulations describe
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cooperative meat and poultry products
inspection programs authorized under
the FMIA, PPIA, and the TalmadgeAiken Act. These regulations reference
the legal authority for each cooperative
inspection program and provide a
general description of each program.
FSIS is proposing to amend part 321
and part 381, subpart R, to add a new
§ 321.3 and a new § 381.187 to describe
the cooperative interstate shipment
program established under section
11015 of the 2008 Farm Bill.
The amendments to the FMIA in
section 501 of section 11015 of the 2008
Farm Bill have been codified at 21
U.S.C. 683, and the amendments to the
PPIA in section 31 have been codified
at 21 U.S.C. 472 (122 Stat. 2124, 2127).
Therefore, proposed § 321.3(a) provides
that under 21 U.S.C. 683(b), FSIS is
authorized to coordinate with States
that have cooperative State meat
inspection programs to select certain
establishments operating under these
programs to ship carcasses, parts of
carcasses, meat, and meat food products
in interstate commerce. Similarly,
proposed § 381.187(a) provides that
under 21 U.S.C. 472(b), FSIS is
authorized to coordinate with States
that have cooperative State poultry
products inspection programs to select
certain establishments operating under
these programs to ship poultry products
in interstate commerce. Proposed
§§ 321.3(a) and 381.187(a) both explain
that this type of cooperative program is
called a ‘‘cooperative interstate
shipment program.’’
Proposed §§ 321.3(b) and 381.187(b)
contain a general description of the
cooperative interstate shipment program
and make clear that the Federal
contribution for inspection services
provided by States that have entered
into such a program will be at least 60
percent of eligible State costs. Under the
FMIA and PPIA, FSIS is required to
contribute up to 50 percent of the cost
of a cooperative State meat or poultry
products inspection program (21 U.S.C.
661(a)(3) and 454(a)(3)). Thus, States
that participate in the new cooperative
interstate shipment program will receive
additional reimbursement for costs
related to inspection of selected
establishments in the State.
As required under the statute, the
Federal contribution for inspection
services provided by States that enter
into a cooperative interstate shipment
program under this proposal will be at
least 60 percent of eligible State costs.
When the program is implemented,
FSIS does not intend to reimburse States
for more than 60 percent of their eligible
costs unless Congress directs it, and
provides the money for it, to do so.
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To be reimbursed under this proposed
rule, States will be expected to submit
their budgets for their cooperative
interstate shipment programs to FSIS for
approval prior to receiving Federal
funds. States will also be expected to
submit a separate justification for any
costs related to the cooperative
interstate shipment program that were
not included in their initial budget
request. FSIS will also need to approve
a State’s request for additional funds
before the Agency will reimburse the
State for not less than 60% of the cost.
FSIS has tentatively decided that, for
purposes of this proposed rule, eligible
State costs will be 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 Agency
requests comments on whether the final
rule resulting from this proposal should
codify this definition or any other
requirements related to State
reimbursement for eligible costs related
to inspection of selected establishments.
Proposed §§ 321.3(c) and 381.187(c)
identify 9 CFR part 332 and 9 CFR part
381, subpart Z, as the regulations that
prescribe conditions under which States
and establishments may participate in
the cooperative interstate shipment
program. Proposed §§ 321.3(d) and
381.187(d) provide that the
Administrator will terminate an
agreement for a cooperative interstate
shipment program with a State if the
Administrator determines that the State
is not conducting inspection at selected
establishments in a manner that
complies with the Acts and their
implementing regulations.
C. Requirements for a Cooperative
Interstate Shipment Program—9 CFR
Part 332 and 9 CFR 381 Subpart Z
1. General
FSIS is proposing to amend title 9,
Chapter III, Subchapter A of the Code of
Federal Regulations (CFR) to add a new
part 332 titled ‘‘Selected
Establishments; Cooperative Program for
Interstate Shipment of Carcasses, Parts
of Carcasses, Meat, and Meat Food
Products,’’ and to add to part 381 a new
subpart Z titled ‘‘Selected
Establishments; Cooperative Program for
Interstate Shipment of Poultry
Products.’’ The regulations in the
proposed new part 332 and the
proposed new subpart Z prescribe the
requirements for a cooperative interstate
shipment program.
2. Definitions and Purpose
Proposed §§ 332.1 and 381.511 define
the terms ‘‘cooperative interstate
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shipment program,’’ ‘‘cooperative State
meat inspection program,’’ ‘‘cooperative
State poultry products inspection
program,’’ ‘‘selected establishment,’’
and ‘‘designated personnel.’’ Terms
used in the proposed regulations that
are defined in 9 CFR 301.2 and 9 CFR
381.1 retain their same meaning.
Under proposed §§ 332.1 and 381.511,
‘‘cooperative interstate shipment
program,’’ ‘‘cooperative State meat
inspection program,’’ and ‘‘cooperative
poultry products inspection program’’
are defined by providing a crossreference to the description of these
cooperative programs in 9 CFR part 321
and 9 CFR part 381 subpart R, described
above. Under this proposal, ‘‘selected
establishment’’ is defined as ‘‘an
establishment operating under a State
cooperative [meat or 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.’’
FSIS is proposing to define
‘‘designated personnel’’ as ‘‘State
inspection personnel that have been
trained in the enforcement of the Acts
and any additional State program
requirements in order to provide
inspection services to selected
establishments.’’
In addition to proposing new
definitions, proposed §§ 332.1 and
381.511 make clear that the term
‘‘interstate commerce,’’ as used in the
proposed regulations has the same
meaning as ‘‘commerce’’ under 9 CFR
301.2 and 381.1. The regulations in 9
CFR 301.2 and 381.1 define
‘‘commerce’’ as ‘‘[c]ommerce between
any State, any Territory, or the District
of Columbia, and any place outside
thereof * * *.’’ Thus, under this
proposal, State-inspected
establishments that are selected to
participate in a cooperative interstate
shipment program will be permitted to
distribute and sell meat or poultry
products across State lines and to export
these products to foreign countries.
Proposed §§ 332.2 and 381.512 state
that the purpose of part 332 and part
381, subpart Z, is to prescribe the
conditions under which States that
administer cooperative State meat or
poultry products inspection programs
and establishments that operate under
such programs may participate in a
cooperative interstate shipment
program.
3. Requirements for Establishments
The proposed regulations in §§ 332.3
and 381.513 prescribe conditions that
establishments operating under a
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cooperative State meat or poultry
products inspection program must
comply with in order to apply to
participate in a cooperative interstate
shipment program. Proposed §§ 332.3
and 381.513 also describe
establishments that are ineligible to be
selected for such a program.
Number of employees. Under
proposed §§ 332.3(a)(1) and
381.513(a)(1), an establishment
operating under a cooperative State
meat or poultry products inspection
program may apply to participate in a
cooperative interstate shipment program
if the establishment employs, on
average, no more than 25 employees.
Standards for determining the average
number of employees for purposes of
this proposal are described in proposed
§§ 332.3(b) and 381.513(b) below.
Under proposed §§ 332.3(a)(2) and
381.513(a)(2), establishments that
employed more than 25 but fewer than
35 employees as of June 18, 2008, are
also permitted to apply for a cooperative
interstate shipment program. However,
§§ 332.3(a)(2) and 381.513(a)(2) provide,
reflecting the amended FMIA and PPIA,
that if selected, these establishments
must employ, on average, 25 or fewer
employees as of the date three years
from the date that the final rule
resulting from this proposal becomes
effective. If they do not, proposed
§§ 332.3(a)(2) and 381.513(a)(2) require
that they be deselected from the
program and transition to become
official establishments.
Standards for determining number of
employees. Proposed §§ 332.3(b) and
381.513(b) establish standards for
determining whether an establishment
employs, on average, 25 or fewer
employees for purposes of this proposed
rule. FSIS developed these proposed
standards to carry out Congress’ intent
that ‘‘[t]he term ‘average’ should be
interpreted to provide some flexibility
to these selected establishments 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
* * * does not undermine food safety
standards’’ (S. Rep. No. 220, 110th
Cong., 1st Sess., at 211 (2007)).
For the most part, the proposed
standards in §§ 332.3(b) and 381.513(b)
reflect applicable methods used by the
Small Business Administration (SBA) to
calculate the number of employees of a
business concern where the size
standard is number of employees (13
CFR 121.105 and 121.106). In addition,
as explained below, FSIS is also
proposing to limit the total number of
employees at any given time to 35
individuals. Under this proposal, the
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standards developed by FSIS will apply
to the employees of an individual
establishment. The proposed standards
are as follows:
• 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;
• All individuals employed from a
temporary employee agency,
professional employee organization, or
leasing concern are to be counted;
• The average number of employees
is calculated for each of the pay periods
for the preceding calendar year;
• Part-time and temporary employees
are to be counted the same as full-time
employees;
• If an establishment has not been in
business for 12 months, the average
number of employees is calculated for
the pay periods in which the
establishment has been in business;
• Volunteers who receive no
compensation are not considered
employees; and
• The total number of employees can
never exceed 35 individuals at any
given time, regardless of the average
number of employees.
As noted above, the standard that
limits the total number of employees on
any given day to 35 individuals is not
derived from SBA’s methods for
calculating the number of employees.
FSIS is proposing to limit the number of
individuals employed by a selected
establishment at any given time to carry
out Congress’ intent that any increase in
the number of employees be
‘‘manageable by the selected
establishment’’ and that the increase
‘‘does not undermine food safety
standards.’’ FSIS is proposing that this
number never exceed 35 because section
11015 of the 2008 Farm Bill permits the
Agency to select certain establishments
that employ as many as 35 employees to
participate in a cooperative interstate
shipment program (Sec. 501(b)(3)(i) and
Sec. 31(b)(3)(i)). Therefore, FSIS
believes that a temporary increase in the
number of employees of up to 35
individuals is likely to be considered
‘‘manageable’’ under the law, provided
that the average number of employees
remains at 25 or fewer.
FSIS requests comments on the
proposed standards for determining an
establishment’s average number of
employees. The Agency specifically
requests comment on whether part-time
and temporary employees should be
counted the same as full-time
employees.
Ineligible establishments. Proposed
§§ 332.3(c) and 381.513(c) describe
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establishments that are ineligible to
participate in a cooperative interstate
shipment program. For the most part,
these establishments reflect the
‘‘prohibited establishments’’ described
in section 11015 of the 2008 Farm Bill
(Sec. 501(b)(2) and 31(b)(2)). These
establishments include:
• Establishments that employ more
than 25 employees on average, with a
limited exception for establishments
that had between 25 and 35 employees
as of June 18, 2008 and that have 25 or
fewer employees as of the date three
years from the date that the final rule
resulting from this rule becomes
effective;
• Establishments operating under a
cooperative inspection program under
the Talmadge-Aiken Act;
• Official establishments;
• Establishments that were official
establishments as of June 18, 2008, but
that were reorganized on a later date by
the person that controlled the
establishment as of June 18, 2008;
• State-inspected establishments that
employed more than 35 employees as of
June 18, 2008, but that were later
reorganized by the person that
controlled the establishment as of June
18, 2008;
• Establishments that are
transitioning to become official
establishments;
• Establishments that are in violation
of the FMIA or PPIA; and
• Establishments located in a State
without a cooperative meat or poultry
products inspection program.
In addition, the proposed regulations
also include among the establishments
ineligible to participate in a cooperative
interstate shipment programs,
establishments located in a State whose
agreement for an interstate shipment
program was terminated by the
Administrator.
Proposed §§ 332.3(d) and 381.513(d)
provide that an eligible establishment
may apply for selection into a
cooperative interstate shipment program
through the State where the
establishment is located. FSIS is
proposing that establishments apply for
selection into a cooperative interstate
shipment program through the State
because the State will be responsible for
providing inspection services to the
establishment if the establishment is
selected for the program. Thus,
establishment participation in the
cooperative interstate shipment program
will depend on whether the State is
able, and willing, to provide the
necessary inspection services to the
establishment. However, if a State enters
into an agreement with FSIS for a
cooperative interstate shipment
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program, FSIS, in coordination with the
State, will make the final determination
on whether to select an establishment to
participate in the program.
4. State Request for a Cooperative
Interstate Shipment Program
Under this proposed rule, a State that
does not have a cooperative interstate
shipment program, but that is interested
in establishing one, may submit a
request for such a program to FSIS.
Proposed §§ 332.4 and 381.514
prescribe the procedures for States to
request an agreement for a cooperative
interstate shipment program. Under this
proposal, a State will submit the request
through the FSIS District Office that
covers the State. Proposed §§ 332.4(a)
and 381.514(a) make clear that State
participation in a cooperative interstate
shipment program is limited to States
that have cooperative State meat or
poultry products inspection programs.
Required information. Proposed
§§ 332.4(b) and 381.514(b) describe the
information that States will need to
include in their requests for an
agreement for a cooperative interstate
shipment program. Because a
cooperative interstate shipment program
requires participation from both States
and establishments, the State’s request
for an agreement for a cooperative
interstate shipment program must
identify establishments in the State that
have requested to be selected and that
the State recommends for initial
selection into the program (proposed
§§ 332.4(b)(1) and 381.514(b)(1)). If FSIS
and the State enter into an agreement for
a cooperative interstate shipment
program under this proposal, these
establishments will be the first to be
considered for the program. Other
establishments operating under the
State’s meat or poultry products
inspection program may apply to
become selected establishments after the
cooperative interstate shipment program
has been implemented within the State.
A State’s request for a cooperative
interstate shipment program must also
include documentation to demonstrate
that the State is able to provide
necessary inspection services to selected
establishments in the State and conduct
any related activities that would be
required under a cooperative interstate
shipment program (proposed
§§ 332.4(b)(2) and 381.514(b)(2)). Under
this proposal, this documentation
would be similar to the documentation
that States provide when they request
an agreement for a cooperative State
meat or poultry products inspection
program. However, instead of
demonstrating that the State’s
inspection program is ‘‘at least equal to’’
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the Federal inspection program, the
statute requires that the State
demonstrate that inspection services
provided to selected establishments will
be ‘‘the same as’’ the inspection services
provided under the Federal program.
Thus, to qualify for a cooperative
interstate shipment program under this
proposal, States will need to
demonstrate, among other things, that
they have the authority under State law
to provide the same inspection services
to selected establishments in the State
as the inspection services that FSIS
provides to official Federal
establishments. States will also need to
demonstrate that they have staffing
sufficient to conduct the same
inspection activities in selected
establishments that FSIS conducts in
official Federal establishments, and that
designated personnel have been
properly trained in Federal inspection
methodology. FSIS currently offers
training courses in Federal inspection
methodology to State inspection
personnel. Under this proposal, 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
will also expect States to demonstrate
that they can provide the necessary
equipment for State personnel to
provide the same inspection services to
selected establishments that FSIS
provides to official Federal
establishments, including computers
and supplies for collecting product
samples.
Because the statute requires
compliance with all Federal standards,
meat and poultry products produced in
selected establishments will be subject
to the same regulatory sampling
programs as those established in the
Federal inspection program. Thus, to be
eligible to participate in a cooperative
interstate shipment program, States will
need to demonstrate that State
personnel will collect the same number
and type of regulatory product samples
from selected establishments as are
collected under FSIS’s inspection
sampling program.
In addition, the State will need to
demonstrate that the laboratory services
that it intends to use to analyze product
samples from selected establishments
are capable of conducting the same
chemical, microbiological, physical, and
pathology testing as are required under
the Federal meat and poultry products
inspection programs. FSIS’s Office of
Public Health Science will provide
audit assistance to the State to verify
that the methodologies used by a State’s
laboratory services to analyze samples
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from selected establishments are
capable of producing the same results as
the methodologies used by FSIS
laboratories. FSIS will not enter into an
agreement for a cooperative interstate
shipment program with a State that does
not meet the conditions described
above.
Additional conditions. Proposed
§§ 332.4(b)(3) and 381.514(b)(3)
prescribe additional conditions that
States applying for a cooperative
interstate shipment program must agree
to in order to qualify for the program.
These proposed regulations provide that
when a State submits a request to
establish a cooperative interstate
shipment program, the State must agree
that, if it enters into an agreement with
FSIS for such a program, that the State
will:
• Provide FSIS with access to the
results of all laboratory analyses
conducted on product samples from
selected establishments in the State;
• Notify the selected establishment
coordinator (SEC) for the State of the
results of any laboratory analyses that
indicate that a product prepared or
processed in a selected establishment
may be adulterated or may otherwise
present a food safety concern; and
• 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. FSIS
will not enter into an agreement for a
cooperative interstate shipment program
if a State does not agree to these terms.
Qualified States. Under this proposal,
after a State submits a request for a
cooperative interstate shipment
program, the FSIS Administrator will
review the request and determine
whether the State qualifies for such a
program. If, based on the information
submitted in the request the
Administrator determines that a State is
eligible to enter into a cooperative
agreement for an interstate shipment
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 in the State
(proposed §§ 331.4(c) and 381.514(c)).
After the Administrator and a State have
signed an agreement for a cooperative
interstate shipment program, the
Administrator will: (1) Appoint an FSIS
employee as the selected establishment
coordinator (SEC) for the State and (2)
coordinate with the State to select the
establishments that will participate in
the program (proposed §§ 332.4(d) and
381.514(d)).
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Summary of actions needed to
establish a cooperative interstate
shipment program under the proposed
regulations.
The proposed regulations discussed
above describe conditions that both
establishments and States must meet to
participate in a cooperative interstate
shipment program. If FSIS adopts these
proposed regulations in a final rule, the
steps for establishing a new cooperative
interstate shipment program will be the
following.
• An establishment that is eligible for
the interstate shipment program, and
that is interested in participating in the
program, will apply for the program
through the State agency that
administers the State meat and poultry
products inspection program under
which the establishment operates. States
will develop their own application
procedures.
• The State will then evaluate the
establishment’s application to
determine whether the State will
recommend the establishment for
selection into the cooperative interstate
shipment program.
• If the State determines that an
establishment qualifies for selection into
the program, and the State is able, and
willing, to provide the necessary
inspection services to the establishment,
the State will recommend the
establishment for selection into the
program. The State will need to submit
its recommendation through the FSIS
District Office whose jurisdiction
includes the State.
• If the State has not entered into an
agreement with FSIS for a cooperative
interstate shipment program, but is
qualified to participate in such a
program, it will need to submit a request
for a cooperative agreement for the
program to the FSIS District Office that
covers the State.
• In its request for a cooperative
interstate shipment program, a State
will need to: (1) Identify those
establishments that have submitted a
request for, and that the States
recommends for, initial selection into
the program and (2) demonstrate that it
is able to provide the necessary
inspection services to these
establishments if they are selected for
the program. The State will also need to
agree to comply with certain conditions
associated with FSIS oversight and
enforcement of the program.
• After a State submits a request for
a cooperative interstate shipment
program, the FSIS Administrator will
evaluate the request and determine
whether the State qualifies for the
program.
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• If the Administrator determines that
the State qualifies for the cooperative
interstate shipment 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 in the State.
• The Administrator will then
appoint an SEC for the State, and the
Administrator, in coordination with the
State, will begin selecting
establishments for participation in the
program.
5. Selection of Establishments
As discussed above, under this
proposal, State-inspected
establishments that are interested in
participating in a cooperative interstate
shipment program will apply for
selection into the program through the
State agency that administers the State’s
meat or poultry products inspection
program. When, and if, an establishment
applies to participate in a cooperative
interstate shipment program, the State
will evaluate the establishment to
determine whether it qualifies to
become a selected establishment.
Proposed §§ 332.5(a) and 381.515(a)
provide that a State-inspected
establishment will qualify for selection
into a cooperative interstate shipment
program if the establishment:
• Has submitted a request to the State
to be selected for the program;
• Has the appropriate number of
employees;
• Is not ineligible for a cooperative
interstate shipment;
• Is in compliance with all
requirements under the State inspection
program; and
• Is in compliance with the all
Federal meat or poultry products
inspection requirements.
Establishments that do not meet all of
these criteria will not qualify, and will
not be selected, for the program. To
participate in a cooperative interstate
shipment program, an establishment
that qualifies for such a program must
be selected by the Administrator, in
coordination with the State where the
establishment is located (proposed
§§ 332.5(b) and 381.515(b)).
Thus, under this proposal, 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
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47653
State. The FSIS Administrator, in
coordination with the State, will decide
whether to select the establishment for
the program. When deciding whether to
select and establishment for the
program, the Administrator will
consider whether the establishment
meets the criteria needed to qualify 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.
As stated above, to qualify to
participate in a cooperative interstate
shipment program, an establishment
must be in compliance with all Federal
inspection requirements under the
FMIA, PPIA, and their implementing
regulations in title 9, chapter III, of the
CFR. Thus, as part of the selection
process, the SEC, in coordination with
the State, will verify that each
establishment that has applied to
participate in a cooperative interstate
shipment program: (1) Meets the Federal
regulatory performance standards
established in 9 CFR 416.1 through
416.6; (2) has submitted all labeling
material to the State for approval, and
that the materials meet all Federal
requirements in 9 CFR parts 316, 317,
and 319 and Part 381, subparts M, N,
and P; (3) has obtained the same water
source and sewage system approval that
FSIS requires for official establishments;
(4) has developed Sanitation Standard
Operating Procedures (Sanitation SOPs)
that comply with 9 CFR 416.11–416.17;
and (5) has conducted a hazard analysis
and developed a validated Hazard
Analysis and Critical Control Points
(HACCP) plan that complies with 9 CFR
part 417.
These criteria reflect the standards
that meat and poultry products
establishments are required to meet to
obtain a Federal grant of inspection
under 9 CFR part 304 and 9 CFR part
381. Establishments that do not meet all
of these requirements are not in
compliance with all Federal standards
and thus will not be selected for the
program.
If an establishment qualifies for, and
is selected to participate in, a
cooperative interstate shipment program
under this proposed rule, proposed
§§ 332.5(c) and 381.515(c) provide that
the State is to assign the establishment
an official number that reflects the fact
that the establishment is a participant in
the cooperative interstate shipment
program. These proposed regulations
provide that the State is to advise the
SEC of the number assigned to each
selected establishment in the State.
Proposed §§ 332.5(c) and 381.515(c) go
on to state that the official numbers
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assigned to selected establishments
need to contain the suffix ‘‘SE’’ to
identify the establishments as selected
establishments. FSIS is proposing this
requirement to ensure that
establishments participating in the
cooperative interstate shipment program
can be identified by reference to their
establishment number. It will also
ensure that meat and poultry products
prepared in selected establishments are
identified as articles produced under a
cooperative interstate shipment
program.
Proposed §§ 332.5(c) and 381.515(c)
also provide that the selected
establishment numbers must include, as
a suffix, the abbreviation for the State in
which the establishment is located. In
addition, proposed § 381.515(c)
provides that the suffix of the number
for a selected poultry products
establishments needs to contain the
letter ‘‘P’’ to identify the establishment
as one that processes poultry products.
Thus, under this proposal, an official
number for a selected establishment in
Texas that prepares meat products
would contain the suffix ‘‘SETX,’’ while
an official number for an establishment
in North Dakota that process poultry
products would contain the suffix
‘‘SEPND.’’
As discussed below, articles that have
been inspected and passed in a selected
establishment will bear an official
USDA mark, stamp, tag, or label of
inspection.
Finally, proposed §§ 332.5(d) and
381.515(d) provide that failure of a State
to comply with §§ 332.5(c) and
381.515(c) will disqualify that State
from participation in a cooperative
interstate shipment program. Full
compliance by a State with these
provisions is essential if the program is
to succeed.
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6. Inspection at Selected
Establishments, Official Mark, and
Interstate Shipment
Proposed §§ 332.6(a) and 381.516(a)
provide that a cooperative interstate
shipment program will commence when
the Administrator, in coordination with
a State that has entered into an
agreement for a cooperative meat or
poultry products inspection program,
have selected establishments in the
State to participate in the program.
Proposed §§ 332.6(b) and 381.516(b)
provide that 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. As discussed below, the FSIS
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SEC will oversee the inspection
activities of the designated personnel.
Proposed §§ 332.6(c) and 381.516(c)
provide that articles prepared or
processed in a selected establishment
that have been inspected and passed by
designated personnel must bear an
official USDA mark, stamp, tag, or label
of inspection as specified in 9 CFR
312.2 or 9 CFR 381.96. 9 CFR 312.2 and
9 CFR 381.96 are the regulations that
prescribe the appropriate wording and
form for use of the official Federal
inspection legend on meat or poultry
products. In addition, the establishment
number contained in the Federal mark,
stamp, tag, or label of inspection must
comply with all the conditions
proposed in §§ 332.5(c) or 381.515(c).
Under proposed §§ 332.6(d) and
381.516(d) meat or poultry products
prepared in selected establishments may
be shipped in interstate commerce if
they have been inspected and by
selected State personnel and bear the
Federal mark of inspection.
7. Federal Oversight of Cooperative
Interstate Shipment Programs
Section 11015 of the 2008 Farm Bill
requires that the Secretary designate an
employee of the Federal government as
a ‘‘State coordinator’’ for each State that
has a cooperative State meat or poultry
products inspection program (Sec.
501(d) and Sec. 31(d)). The State
coordinator is required to ‘‘provide
oversight and enforcement’’ of the
program and ‘‘to oversee the training
and inspection activities’’ of State
personnel designated to provide
inspection services to selected
establishments (Sec. 501(d)(1) and Sec.
31(d)(1)). As noted above, when, and if,
a State qualifies to participate in a
cooperative interstate shipment
program, proposed §§ 332.4(c)(1) and
381.514(c)(1) provide that the
Administrator will appoint an FSIS
employee as the FSIS SEC for the State.
The SEC is the ‘‘State coordinator’’
prescribed by the statute.
FSIS has tentatively decided that the
SEC will be an employee of the FSIS
Office of Field Operations (OFO) and
will be assigned to an FSIS District
Office. The SEC will likely be under the
direct supervision of an FSIS District
Manager. 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
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Sfmt 4702
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. 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.
SEC initial responsibilities. One of the
SEC’s initial responsibilities will be, in
conjunction with the District Office, to
coordinate with the State to select
establishments to participate in the
program. The SEC will coordinate with
the State to verify that all State
personnel selected to provide inspection
services to these establishments have
successfully completed the same
training in the fundamentals of meat
and poultry inspection, covering the
Sanitation Performance Standards,
Sanitation Standard Operating
Procedures (SOPs), HACCP, and
enforcement procedures, that is required
for FSIS inspection personnel. The SEC
will also coordinate with the State to
verify that designated personnel have
successfully completed the appropriate
customized food safety training required
for FSIS inspection personnel based on
the types of products being produced at
the establishments where designated
personnel are assigned.
SEC’s oversight responsibilities.
Proposed §§ 332.7 and 381.517
prescribe how the FSIS SEC is to
provide Federal oversight of the
cooperative interstate shipment
program.
Proposed §§ 332.7(a) and 381.517(a)
provide that the 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 in
title 9, chapter III, of the CFR. 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.
FSIS requests comments on how
frequently the SEC should visit each
establishment under his or her
jurisdiction. Proposed §§ 332.7(a) and
381.517(a) also provide that if
necessary, the SEC, in consultation with
the District Manager that covers the
State, may designate qualified FSIS
personnel to visit a selected
establishment on behalf of the SEC.
Under proposed §§ 332.7(b) and
381.517(b), the SEC, in coordination
with the State, will verify that selected
establishments in the State are receiving
the necessary inspection services from
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designated personnel, and that these
establishments are eligible, and remain
eligible, to participate in the cooperative
interstate shipment program. These
proposed regulations provide that the
SEC’s verification activities may
include:
• Verifying that each selected
establishment in the State employs, and
continues to employ, 25 or fewer
employees on average, unless the
establishment is transitioning to become
an official establishment;
• Verifying that the designated
personnel are providing inspection
services to selected establishments in an
manner that complies with the Acts and
implementing regulations;
• Verifying that the State staffing
levels for each selected establishment
are appropriate to carry out the required
inspection activities; and
• Assessing each selected
establishment’s compliance with the
Acts and implementing regulations
under title 9, chapter III, of the CFR.
To verify that designated personnel
are providing inspection services in
compliance with the Acts, 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.
To assess each selected
establishment’s compliance with
Federal food safety standards, the SEC
will observe the condition of the
establishment, observe establishment
employees performing their duties,
review the establishment’s records, and
submit product samples for analysis to
determine that product produced by the
establishment meets Federal food safety
standards.
The SEC will have discretion to
increase the frequency of visits to a
selected establishment if the SEC, in
consultation with the District Manager
for the State where the selected
establishment is located, determines
that such action is necessary to ensure
that the establishment is operating in a
manner consistent with the Acts. The
SEC will also be authorized to conduct
a comprehensive food safety assessment
(FSA) for a selected establishment, 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
determine whether the establishment is
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operating in compliance with the Acts.
A comprehensive food safety
assessment is an assessment that
considers all the food safety aspects that
relate to an establishment and all the
products the plant produces.
If the SEC determines that designated
personnel are not providing inspection
services to selected establishments in a
manner that complies with the Acts,
proposed §§ 332.7(c) and 381.517(c)
provide that FSIS will provide an
opportunity consistent with these
regulations for the State to develop and
implement a corrective action plan to
address inspection deficiencies
identified by the SEC. These proposed
regulations also provide that if the State
fails to develop a corrective action plan,
or if the SEC determines that the State’s
corrective action plan is inadequate, the
Administrator will terminate the
cooperative agreement with the State.
As discussed above, selected
establishments in a State whose
agreement for a cooperative interstate
shipment program has been terminated
by the Administrator are among the
establishments that are ineligible to
participate in the program. As such,
these establishments will be deselected
from the program and transitioned to
become Federal establishments as
described below.
Quarterly reports. As required under
section 11015 of the 2008 Farm Bill
(Sec. 501(d)(3)(b) and Sec. 31(d)(3)(b)),
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 §§ 332.8(a)
and 381.518(a)).
The SEC’s quarterly report will
include the SEC’s assessment of the
performance of the designated
personnel in conducting inspection
activities (proposed §§ 332.8(b)(1) and
381.518(b)(1)). The quarterly report will
also 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 §§ 332.8(b)(1)
and 381.518(b)(1)). The SEC will submit
the report to the Administrator through
the District Manager for the State in
which the selected establishments
identified in the report are located
(proposed §§ 332.8(c) and 381.518(c)).
Enforcement. Section 11015 of the
2008 Farm Bill provides 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
Secretary (the FSIS Administrator by
delegation) of the violation and (2)
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47655
‘‘deselect’’ the establishment or suspend
inspection at the establishment (Sec.
501(d)(3)(C) and Sec. 31(d)(3)(C)). In
adopting this language, Congress
intended that the SEC ‘‘* * * shall be
provided all the tools necessary under
the Secretary to prevent or control any
food safety issue that would harm
human health’’ (S. Rep. No. 220, 110th
Cong., 1st Sess., at 211 (2007)).
Because many of the SEC’s
verification and enforcement activities
require that the SEC have access to a
selected establishment’s records,
proposed §§ 332.9(a) and 381.519(a)
provide that to facilitate oversight and
enforcement of the cooperative
interstate shipment program, selected
establishments must, upon request, give
SECs or other FSIS officials access to all
establishment records required under
the FMIA, PPIA, and the implementing
regulations in title 9, chapter III, of the
CFR. These proposed regulations go on
to state that FSIS will move to deselect
an establishment that does not comply
with this requirement.
Under proposed §§ 332.9(b) and
381.519(b), the SEC is authorized to
initiate any appropriate enforcement
action provided for in the FSIS rules of
practice 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.
Such actions include, among others,
regulatory control actions, withholding
actions, and suspensions. The proposed
regulations provide that selected
establishments participating in a
cooperative interstate shipment program
are subject to the notification and
appeal procedures set out in part 500
(proposed §§ 332.9(b) and 381.519(b)).
Proposed §§ 332.9(c) and 381.519(c)
provide that if inspection at a selected
establishment is suspended for any of
the reasons specified in 9 CFR 500.3 or
9 CFR 500.4, FSIS 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. The
decision to deselect a selected
establishment under a suspension will
be made on a case-by-case basis
(proposed §§ 332.9(d) and 381.519(d)).
In making this decision, the
Administrator, 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,
which will be documented in noncompliance reports prepared by the
designated personnel and the SEC’s
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quarterly reports; and (3) the corrective
actions proposed by the establishment
(proposed §§ 332.9(d) and 381.519(d))
The Administrator will have the
discretion to allow a selected
establishment that has been suspended
to remain in the program if the
establishment implements corrective
actions to address any non-compliance.
The Administrator will consider the
criteria described above in determining
whether to provide an opportunity for
corrective actions. Establishments that
are given an opportunity to take
corrective actions but that are unable to
effectively implement these actions will
be deselected.
FSIS will also consider the State’s
recommendation as to whether a
selected establishment in the State
should be deselected. However, the final
decision to deselect an establishment for
violations of the FMIA or PPIA will be
made by FSIS. As discussed below,
consistent with the law, this proposed
rule requires that deselected
establishments be transitioned to
become official establishments.
8. Deselection
There may be circumstances in which
an establishment that initially qualifies
to be selected to participate in a
cooperative interstate shipment program
later acquires characteristics that would
cause it to become ineligible for the
program. For example, an establishment
may hire additional employees after it
has been selected, or, as discussed
above, FSIS may determine that a
selected establishment is in violation of
the Acts. Therefore, proposed
§§ 332.10(a) and 381.520(a) provide that
the Administrator will deselect an
establishment that becomes ineligible to
participate in a cooperative interstate
shipment program. Proposed
§§ 332.10(b) and 381.520(b) provide that
an establishment that has been
deselected from a cooperative interstate
shipment program must be transitioned
to become an official establishment.
FSIS is proposing to require that
deselected establishments be
transitioned to become official Federal
establishments as provided for in the
law. Section 11015 of the 2008 Farm
Bill allows the Agency to establish a
procedure to transition selected
establishments that employ, on average,
more than 25 employees to become
Federal establishments, and it requires
that selected establishments that the
Administrator determines to be in
violation of any provision of the Acts,
be transitioned to Federal
establishments in accordance with the
procedure developed for establishments
that employ more than 25 employees
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(Sec. 501(b)(3), 501(h), 31(b)(3) and
31(g)).
Thus, as required by the law, under
this proposal, establishments that
become ineligible to participate in the
cooperative interstate shipment program
because they violated Federal food
safety standards will not permitted to
avoid implementing appropriate
corrective actions by withdrawing from
the cooperative interstate shipment
program and reverting back to the State
inspection program. In addition,
requiring that deselected establishments
transition to become official Federal
establishments will help to ensure that
the resources that FSIS and the States
provide to establish and maintain a
cooperative interstate shipment program
are used most effectively to provide
inspection services to establishments
that are committed to maintaining
Federal food safety standards.
9. Transition Procedures for Deselected
Establishments
As discussed above, under the law,
FSIS is authorized to develop a
procedure to transition selected
establishments to become official
establishments if they employ more
than 25 employees on average, or if the
Agency determines that they are in
violation of any provision of the Acts
(Sec 501(b), Sec. 501(h), Sec. 31(b) and
Sec. 31(g)). At a minimum, a procedure
to transition a selected establishment to
an official establishment would include:
(1) Adding the establishment to an FSIS
circuit within the FSIS District that
covers the State where the
establishment is located; (2) replacing
the establishment’s State establishment
number with a Federal establishment
number, and (3) replacing the
designated personnel with FSIS
inspection personnel. Other actions
needed to successfully transition a
selected establishment to become an
official establishment are likely to
depend on the reason the establishment
was deselected. For example, an
establishment that was deselected from
a cooperative interstate shipment
program for violating provisions of the
Acts would likely need to develop a
corrective action plan as part of its
process to transition to an official
establishment, while an establishment
that was deselected for hiring additional
employees would not.
Therefore, instead of prescribing a
specific procedure to transition selected
establishments to official
establishments, proposed §§ 332.11 and
381.521 provide that if a selected
establishment is deselected, FSIS will
coordinate with the State where the
establishment is located to develop and
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implement a plan to transition the
establishment to become an official
establishment. The SEC with
jurisdiction over the deselected
establishment will likely be charged
with coordinating with the State and the
FSIS District Office to develop and
implement the transition plan.
10. Technical Assistance Division and
Transition Grants
Section 11015 of the 2008 Farm Bill
amended the FMIA to require that FSIS
establish a ‘‘technical assistance
division’’ to coordinate the initiatives of
other USDA agencies 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’’ (Sec. 501(f)). As noted
earlier in this document, FSIS 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.
OOEET is also responsible for
coordinating with other USDA agencies,
such as the Rural Development Mission
Area and the Cooperative State
Research, Education, and Extension
Service.
The OOEET State Outreach and
Technical Assistance Division promotes
State programs and activities to achieve
national food safety, food security, and
other consumer protection goals by
planning, organizing, coordinating, and
supporting FSIS cooperative activities
with State agencies with responsibility
for State meat, poultry and egg product
public health assurance inspection
programs. It also provides technical
expertise, information, and advice to
small and very small plant owners and
operators on the interpretation,
application, implementation and
enforcement of the statutes and
regulations that FSIS implements.
Transition grants. In addition to
requiring that FSIS establish a
‘‘technical assistance division’’ to
coordinate the initiatives of other USDA
agencies to provide grants to States,
section 11015 of the 2008 Farm Bill
authorizes FSIS to provide ‘‘transition
grants’’ to States to assist the States in
helping State-inspected establishments
transition to selected establishments
(Sec. 501(g) and Sec. 31(f)). The Agency
has tentatively decided to use this
authority, subject to the availability of
funds, to grant funds to States that
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participate in a cooperative interstate
shipment program to reimburse selected
establishments in the State for their
costs to train one individual in HACCP
and associated training in Sanitation
SOP requirements.
The regulations that prescribe
conditions for receiving Federal
inspection, which represent the
conditions that selected establishments
must meet to be in compliance with
Federal standards, require that an
establishment develop written
Sanitation SOPs as required by 9 CFR
part 416, and that it have conducted a
hazard analysis and developed and
validated a HACCP plan as required in
9 CFR 417.2 and 417.4 (9 CFR 304.3 and
381.22). Under 9 CFR 417.7 of the
HACCP regulations, the individual that
develops the HACCP plan for an
establishment must have successfully
completed a course of instruction in the
application of the seven HACCP
principles to meat or poultry product
processing, including a segment on the
development of a HACCP plan for a
specific product and on record review.
State-inspected establishments that
apply to participate in a cooperative
interstate shipment program will be
required to have an individual trained
in HACCP in order to transition to a
selected establishment. Therefore, for
purposes of this proposed rule, FSIS has
tentatively concluded that it is
appropriate to provide funds to a State
for the purpose of reimbursing selected
establishments for the cost of this
training. Accordingly, proposed
§§ 332.12(a) and 381.522(a) provide that
these ‘‘transition grants’’ are 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 the HACCP principles applicable to
meat or poultry processing as required
under 9 CFR 417.7 and associated
training in the development of
Sanitation SOPs required under 9 CFR
part 416.
Proposed §§ 332.12(b) and 381.522(b)
make clear that States must use
transition grants only for this described
purpose. Once a selected establishment
receives such funding from the State,
the State may not use additional
transition grant funds to reimburse that
establishment’s training costs in the
future.
Under this proposal, establishments
that train an individual in HACCP or
Sanitation SOP requirements as part of
their transition to become selected
establishments may request
reimbursement for these training costs
through the State agency that
administers the State’s cooperative
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interstate shipment program. These
selected establishments will need to
submit a training certificate or other
documentation to demonstrate that an
individual completed the appropriate
training. The State would then submit
the documentation to FSIS, and request
a ‘‘transition grant’’ to reimburse the
establishment for its training costs.
Executive Order 12866 and
Regulatory Flexibility Act:
This proposed rule has been reviewed
under Executive Order 12866. It has
been determined to be significant, but
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 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 will be
voluntary, FSIS will not know how
many States and establishments will
apply to participate until final
implementing regulations become
effective and establishments are selected
for the program. Information obtained
through the Agency’s outreach activities
indicates that, as of July 2008, about 170
establishments in sixteen States have
approached the State Meat and Poultry
programs to indicate that they are
interested in the new program. These
sixteen States have in total 1,133
establishments that could potentially be
eligible for the new program.
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, the
proposed action would benefit these
establishments by opening new markets
for their products.
The proposed action would also
benefit consumers by generating more
product choices, as more products can
be shipped to new markets. In addition,
the Federal inspection legend and
official State establishment inspection
number may facilitate traceback of these
products if such products are ever the
subject of an investigation or recall.
States that participate in the program
would benefit because FSIS would
reimburse them for at least 60% of their
costs related to inspection of selected
establishments in the State. FSIS
provides up to 50% of the costs of
existing cooperative State inspection
programs. The Agency has tentatively
concluded that most States will benefit
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47657
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 exceed the costs to
administer the State meat and poultry
inspection programs.
Expected Costs of the Proposed
Action:
Costs to the participating
establishments. To be eligible to
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, the Agency
estimates 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. 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. On the other hand, if
the establishments need to make
structural modifications or perform new
construction then the range would be
about $15,000 to $30,000.1 However,
because this 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
1 Note that under this proposed 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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participation will provide an overall net
benefit for them. The Agency welcomes
comments on these estimates.
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 is aware that
the cooperative State meat and poultry
products inspection programs are not
identical to Federal inspection, as they
must be under the cooperative interstate
shipment program. So FSIS anticipates
that State inspection procedures will
need to be changed somewhat to comply
with the requirements of the cooperative
interstate shipment program. However,
since the State programs are required to
be 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 that
would change the burden of the
inspection regimen on the
establishments.
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.
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.2
Thus, State costs to train State
personnel are likely to be minimal
because many State personnel have
received training in Federal inspection
2 Based on Agency’s most recent (FY 2008) review
of the 27 States’ self-assessment reports (including
the State Laboratory Activity Tables) by the Federal
State Audit Branch, Internal Control and Audit
Division of the Office of Program Evaluation,
Enforcement, and Review.
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methodology as part of the State MPI
program.
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. The
Agency requests comments on potential
State costs associated with the
processing and evaluation of these
applications.
FSIS anticipates that State inspection
procedures will need to be changed
somewhat to comply with the
requirements of the proposed
cooperative interstate shipment
program. However, since the State
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. FSIS requests
input from State Program officials that
might be useful to refine this estimate.
Expected FSIS Budgetary Effects:
The new Federal-State cooperative
inspection program option which
section 11015 of the 2008 Farm Bill
requires the Secretary to create and
which we propose to implement via this
regulatory action is expected to have
budgetary effects on FSIS to support
about 16 full-time equivalent new staff.
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. FSIS staff have worked with
the 27 directors of the Federal-State
meat and poultry inspection program to
gauge the level of interest at the State
and establishment level. Their input has
been incorporated into the assumptions
here.
Baseline:
Federal-State cooperative inspection
programs operated in 27 States and
1,873 establishments in FY 2008, the
baseline year for this analysis. Actual
Federal spending for the Federal-State
cooperative inspection programs was
$63,959,709 for FY 2008 as reported in
the FY 2010 President’s Budget, which
also projected $64,703,000 for FY 2009
and $65,654,000 for FY 2010. By statute,
the States may be reimbursed for up to
50 percent of the cost of their State
cooperative inspection programs.
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Federal reimbursements to State
programs reported in the FY 2010
budget, included in the above figures,
are $49,061,068 for FY 2008,
$50,332,000 for FY 2009, and
$50,332,000 for FY 2010. In fact, actual
total State spending for the FederalState cooperative inspection programs
for FY 2008 was $104 million with $49
million of that reimbursed by FSIS, as
noted above.
FSIS extends these figures into years
2010 through 2014, see table below, the
5-year analysis period for this rule, by
assuming that, had the cooperative
interstate shipment program option not
been enacted, State cooperative
programs operations would continue
through the period on a generally stable
basis. The Agency assumes that the
same 27 States would continue to
participate and the program would
inspect about the same number of
establishments as were inspected in FY
2008, i.e., 1,873. This appears
reasonable because, among the 27 States
in the program the number of
establishments has been relatively
stable. Since the number of
establishments and States is assumed to
remain unchanged, and no significant
changes in program requirements are
expected, baseline program costs are
assumed to change only with the cost of
inflation.
Turning to FSIS administrative costs,
we note that FSIS staffing has been
stable in the 28 to 33 person range for
the past decade, and is expected to
remain at 29 for the foreseeable future.
Consistent with State level activities,
since the number of States is expected
to remain the same with no particular
change in the number of establishments,
and since no significant changes in
program requirements are expected,
FSIS administrative costs are expected
to change consistent with the cost of
inflation, i.e., the Agency anticipates no
significant increase or decrease in FSIS
administrative activity during the five
years in the baseline scenario (i.e., the
baseline assumes no cooperative
interstate shipment program). FSIS
spending to administer Federal-State
cooperative inspection programs,
excluding the reimbursement costs, was
$14,898,641 for FY 2008 as reported in
the FY 2010 budget, and is projected at
$14,371,000 for FY 2009 and
$15,322,000 for FY 2010. For the years
out to 2014, these costs would change
with inflation and are shown in the
following table.
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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
29
29
29
29
29
FSIS Staff Years ....................................................
2010
(Budget)
State Level Costs, Fiscal Year
2011
2012
2013
2014
....................
Total 5-year
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
....................
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State & Local Exp, % .............................................
FSIS civilian pay, % ...............................................
Non-Pay Expenditure, % .......................................
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.
Here is how we determined the
number of establishments that are likely
to participate in the proposed
cooperative interstate shipment
program. The first cut is to look at all
establishments and determine the
number with fewer than 25 employees.
The statute limits participation to these
smaller establishments. Of the total
1,873 plants in the current Federal-State
cooperative inspection program there
are 1,811 that meet the size criterion for
eligibility for the cooperative interstate
shipment program. However, as noted
earlier, sixteen States have expressed an
interest in the new cooperative
interstate shipment program, and these
States have a total of 1,133
establishments that could potentially be
eligible for the new program. The eleven
States that have not indicated an
interest in the cooperative interstate
shipment program include all nine
States that have establishments
operating under the Talmadge-Aiken
(TA) program. The TA States account
for the remaining 678 eligible
establishments.
Because participation in the
cooperative interstate shipment program
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3.1
5.1
0.8
3.5
4.1
1.2
3.8
4.1
1.4
is voluntary, the Agency cannot
estimate with certainty the number of
eligible establishments that will choose
to participate. Therefore, for illustration
purposes, and to obtain a reasonable
range of possible budget impacts, given
the uncertainty, the Agency estimated
the costs for three scenarios: 200, 400
and 600 establishments. A five-year cost
estimate was completed covering the FY
2010 through FY 2014. We further
assume that the participating
establishments will be evenly
distributed among the participating
States and, just as the baseline assumes,
we anticipate no particular change in
the numbers of establishments in the
overall program over the 5 years and no
change in the cooperative interstate
shipment program establishments.
At this time, we turn to the change in
Federal costs for the program caused by
the new statutory reimbursement level.
For the cooperative interstate shipment
program the law requires that FSIS
reimburse State for costs related to the
inspection of selected establishments in
an amount not less than 60 percent of
eligible State costs, as opposed to
current law which allows
reimbursement of up to 50 percent of
costs for the regular, and continuing,
Federal-State cooperative inspection
program. 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
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3.9
4.1
1.6
3.9
4.1
1.6
....................
....................
....................
establishments in the cooperative
interstate shipment program as
discussed above. FSIS determined that
Agency reimbursements to States would
increase by about $2.2 million in a fully
operational cooperative interstate
shipment program in FY 2011 (not all
plants will be in the cooperative
interstate shipment program for all of
FY 2010).
In all years, the amount of increase in
this component of Federal
reimbursement would offset State
spending by the same amount. (FY 2011
is used because it is the first, fully
operational year, explained further
below.) To calculate this figure, FSIS
estimated average per establishment
spending for the Federal-State
Cooperative Inspection Program by
States for the 1,873 establishments in
the baseline scenario. For FY 2011, the
average per establishment is $55,626,
including State and Federal
reimbursement. Reviewing the budget
for FY 2008 and 2009, we see that
average Federal reimbursement is
currently running about 50 percent of
total State costs. The reimbursement
ratio is expected to remain stable for the
5-year period both for inspecting
establishments in the baseline scenario,
and for inspecting establishments that
stay with the existing program, while
400 establishments seek and are
selected to operate with the cooperative
interstate shipment program.
Reimbursement will increase to 60
percent for inspection services to the
400 establishments that move into the
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cooperative interstate shipment program
option. So, for example, FY 2011 State
reimbursement for inspection of the
average Interstate establishment would
change from the average $27,813 it
would receive for an establishment
continuing in the regular Federal-State
cooperative inspection programs, to
$33,376 per establishment for
inspection of an Interstate plant, an
increase of $5,563 per plant, which
yields $2.2 million for the 400
establishments. This and analogous
figures are reflected in the tables below
in the ‘‘Total grants to States’’ line for
the 200, 400 and 600 establishment
scenarios.
Under section 11015 of the Farm Bill,
in addition to the increased
reimbursement rates that will increase
the grants to States for inspection of
establishments participating in the
cooperative interstate shipment
program, FSIS is required to oversee the
State inspectors doing the inspections
for the cooperative interstate shipment
program more intensively than the
Agency typically does for the current,
and the continuing MPI program. 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
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) to oversee the
training and inspection activities of
State-personnel 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 a total of 13 full time
equivalent FSIS employees will be able
to perform the SEC functions for the 16
States expected to participate in the
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cooperative interstate shipment
program. We anticipate that about onequarter of the total establishments will
enter the cooperative interstate
shipment program each quarter during
FY 2010, reaching the full complement
toward the end of that year. So, for
example, in the 400 establishment
scenario, 100 establishments will
initiate inspection under a cooperative
interstate shipment program sometime
in the first quarter, another 100 in the
second quarter, another in the third
quarter, and the final group of 100 in the
fourth quarter. It is expected that early
in 2010 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. While there may be one SEC per
State from the beginning, we believe
that contiguous States and
establishments that are in relative close
proximity could make it appropriate to
have less than 16 full time equivalent
SECs. Note that if 400 establishments
convert into the cooperative interstate
shipment program in FY 2010 and
continue in the following years, each
SEC will be responsible for 31
establishments in a geographicallylimited area. This is approximately
equal to the number of Federal
establishments over which frontline
FSIS supervisors have oversight
responsibilities.
In the start-up period, in FY 2009 and
FY 2010, the first year of the cooperative
interstate shipment program, 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 in the various
scenarios—200, 400 or 600
establishments—is because the
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Fmt 4701
Sfmt 4702
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.
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 FY 2010 in Table 2
below. Thus, the cost to FSIS will total
about $1 million, $2 million and $3
million for the 200, 400 and 600
establishment scenarios respectively.
This training will only be needed in the
start-up period and, accordingly,
appears only in FY 2010 in Table 2.
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 three establishment
levels, this would mean 1 DDM for 200
establishments and 2 DDMs for 400 or
600 establishments. 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 equivalent to the
Federal program. It is anticipated that
the two lab staff will be needed
regardless of whether 200, 400 or 600
establishments eventually participate
since the same number of State labs will
need to be reviewed regardless of the
volume of work they do under the
cooperative interstate shipment
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
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staff starts in FY 2010 and will run
higher for the first year, after which time
the start-up effort will diminish. Since
we are assuming the selected
establishments are evenly distributed in
the participating States, we anticipate
that the number of participating
establishments would only have slight
impact on the cost of travel for each
SEC. We project about $6,150 for
training and travel for each SEC in the
first and $630 for subsequent years.
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 27 eligible
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. The audit
will be based on the program that FSIS
developed several years ago, which is
similar to the program that the Agency
uses to assess the Pasteurized Egg
Product Recognized Laboratory
program. We based the number of audits
on the figures that we had regarding the
number of states that will participate,
16. Each trip ran about $1,500 for each
auditor.
Finally, there are the normal
operating expenses associated with field
47661
operations including office space,
communications costs, information
technology costs (such as laptop
computers), other equipment, office
supplies, etc. FSIS estimates $3,500 per
new staff for laptop, LincPass, Black
Berries, etc. These costs are generally
stable over time, although they inflate
and, of course, are a little higher in the
start-up year. These costs are found in
the ‘‘Equipment and admin’’ line of the
tables below.
Table 2, below, summarizes the
incremental costs to FSIS to operate the
new cooperative interstate shipment
program in the three scenarios 200, 400
and 600 establishments, with the 400
establishment level assumed to be the
likely level.
TABLE 2—COOPERATIVE INTERSTATE SHIPMENT PROGRAM COST ESTIMATES—THREE SCENARIOS
Interstate Program—Summary of Incremental Cost Estimates ($ Millions)
Fiscal Year
2009
Costs if 200 establishments ...........
Costs if 400 establishments ...........
Costs if 600 establishments ...........
$1.93
1.93
1.93
2010
2011
$5.55
7.11
8.79
$4.07
5.34
6.53
2012
$4.22
5.55
6.79
2013
$4.40
5.77
7.06
2014
$4.58
6.00
7.33
5-Year
$22.83
29.77
36.50
Interstate Program with 200 Establishments ($ Millions)
Fiscal Year
2009
2010
2011
2012
2013
2014
5-Year
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 ....................
....................
....................
....................
....................
....................
....................
....................
....................
1.43
0.50
200
$1.54
2.20
0.15
1.69
0.24
1.81
0.16
1.25
0.40
200
$1.11
2.17
0.16
1.76
0.25
0.79
0.09
0.35
0.35
200
$1.15
2.25
0.16
1.83
0.26
0.82
0.09
0.36
0.36
200
$1.20
2.35
0.17
1.91
0.27
0.85
0.10
0.38
0.38
200
$1.25
2.45
0.18
1.98
0.29
0.89
0.10
0.39
0.39
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
Total ........................................
1.93
5.55
4.07
4.22
4.40
4.58
22.83
Interstate Program with 400 Establishments ($ Millions)
Fiscal Year
2009
2010
2011
2012
2013
2014
5-Year
....................
....................
....................
....................
....................
....................
....................
....................
1.43
0.50
400
$3.07
2.23
0.30
1.69
0.24
1.81
0.16
1.25
0.40
400
$2.23
2.32
0.31
1.76
0.25
0.79
0.09
0.35
0.35
400
$2.31
2.42
0.33
1.83
0.26
0.82
0.09
0.36
0.36
400
$2.40
2.52
0.34
1.91
0.27
0.85
0.10
0.38
0.38
400
$2.49
2.62
0.35
1.98
0.29
0.89
0.10
0.39
0.39
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
Total ........................................
mstockstill on DSKH9S0YB1PROD with PROPOSALS2
Number of establishments * ...........
Total grants to States ** .................
Total salaries & benefits ................
DDM ...............................................
State coordinator (SC) ...................
Lab staff .........................................
Operating expenses .......................
Travel-SC & lab staff .....................
Training/Outreach ..........................
Equipment and admin ....................
1.93
7.11
5.34
5.55
5.77
6.00
29.77
Interstate Program with 600 Establishments ($ Millions)
Fiscal Year
Number of establishments * ...........
Total grants to States ** .................
Total salaries & benefits ................
DDM ...............................................
State coordinator (SC) ...................
Lab staff .........................................
Operating expenses .......................
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19:41 Sep 15, 2009
2009
....................
....................
....................
....................
....................
....................
....................
Jkt 217001
PO 00000
2010
2011
600
$4.67
2.23
0.30
1.69
0.24
1.89
Frm 00015
Fmt 4701
600
$3.34
2.32
0.31
1.76
0.25
0.87
Sfmt 4702
2012
600
$3.46
2.42
0.33
1.83
0.26
0.90
E:\FR\FM\16SEP2.SGM
2013
600
$3.60
2.52
0.34
1.91
0.27
0.94
16SEP2
2014
600
$3.74
2.62
0.35
1.98
0.29
0.97
5-Year
....................
....................
....................
....................
....................
....................
....................
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules
TABLE 2—COOPERATIVE INTERSTATE SHIPMENT PROGRAM COST ESTIMATES—THREE SCENARIOS—Continued
Travel-SC & lab staff .....................
Training/Outreach ..........................
Equipment and admin ....................
....................
1.43
0.50
0.24
1.25
0.40
0.17
0.35
0.35
0.18
0.36
0.36
0.18
0.38
0.38
0.19
0.39
0.39
....................
....................
....................
Total ........................................
1.93
8.79
6.53
6.79
7.06
7.33
36.50
Economic Assumptions from OMB for the 2010 Budget
State & Local Exp, % .....................
....................
3.1
3.5
3.8
3.9
3.9
....................
FSIS Civilian pay, % ......................
Non-Pay Expenditure, % ...............
....................
....................
5.1
0.8
4.1
1.2
4.1
1.4
4.1
1.6
4.1
1.6
....................
....................
State Grant Incremental Increase in FSIS Reimbursement to the State
Per Establishment ..........................
....................
$5,374
$5,563
$5,774
$5,999
$6,233
....................
mstockstill on DSKH9S0YB1PROD with PROPOSALS2
* Note that in FY 2010 about one quarter of establishments are expected to enroll each quarter. In subsequent fiscal years, all establishments
will be in the program for the full year.
** Note ‘‘Total grants to States’’ includes funding for Transition Grants in 2010 for States to use to help plants train one person in HACCP and
SOPs per § 332.12 and § 381.522.
Effect on Small Entities
This proposed action will primarily
affect very small and certain small
establishments that operate under
cooperative State meat or poultry
inspection programs. Under section
11015, State-inspected 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 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 State-inspected
establishments that employ, on average,
more than 25 but fewer than 35
employees in the proposed
implementing regulations. Thus, this
proposed rule will benefit these very
small and small State-inspected
establishments by allowing them to ship
meat and poultry products in interstate
and foreign commerce, thereby opening
new markets for their products.
Executive Order 12988
This proposed 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.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
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ensure that minorities, women, and
persons with disabilities are aware of
this proposed rule, FSIS will announce
it online through the FSIS Web page
located at https://www.fsis.usda.gov/
Regulations_&_Policies/2009_Proposed
_Rules_Index/index.asp. FSIS will also
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 constituents and stakeholders. The
Update is communicated via Listserv, a
free electronic mail subscription service
for industry, trade groups, consumer
interest groups, health professionals,
and other individuals who have asked
to be included. The Update is also
available on the FSIS Web page.
Through the Listserv and Web page,
FSIS is able to provide information to a
much broader and more diverse
audience. In addition, FSIS offers an email 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_and_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 or
recordkeeping requirements included in
this proposed rule have been submitted
for approval to the Office of
Management and Budget (OMB).
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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 proposed rule in
accordance with the Paperwork
Reduction Act. Under this proposed
rule, FSIS is requiring certain
information collection and
recordkeeping activities.
FSIS is proposing that States that are
interested in participating in the
cooperative interstate shipment program
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; (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
program. FSIS is also proposing that
States that have entered into an
agreement with FSIS for a cooperative
interstate shipment program submit,
through the FSIS District Office, an
evaluation of each State-inspected
establishment that has applied, and that
the State recommends be selected, for
the cooperative interstate shipment
program.
Under this proposal, 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
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules
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
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: FSIS estimates
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 estimates that
approximately 400 establishments will
apply for the program. Thus, FSIS
estimates 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
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,
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17:58 Sep 15, 2009
Jkt 217001
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 1,608.3 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 minute 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 minute to assist the
SEC locate records for review for each
subsequent visit. If the SEC visits each
selected establishment at least one 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
will need to provide the FSIS access to
its records on an ongoing basis.
Estimated Total Annual Burden on
Respondents: 12,348.3 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
PO 00000
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Fmt 4701
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47663
Avenue, SW., Room 3532 South
Building, Washington, DC 20250.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of FSIS’ functions, including whether
the information will have practical
utility; (b) the accuracy of FSIS’ estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; ways to minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques, or
other forms of information technology.
Comments may be sent to both John
O’Connell, Paperwork Reduction Act
Coordinator, at the address provided
above, and the Desk Officer for
Agriculture, Office of Information and
Regulatory Affairs, Office of
Management and Budget, Washington,
DC 20253.
To be most effective, comments
should be sent to OMB within 60 days
of the publication date of this proposed
rule.
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or record keeping
requirements included in this proposed
rule have been submitted for approval to
the Office of Management and Budget
(OMB).
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 proposing to amend 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.
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules
2. A new § 321.3 is added to read as
follows:
mstockstill on DSKH9S0YB1PROD with PROPOSALS2
§ 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
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.
(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. A new Part 332 is added to read as
follows:
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17:58 Sep 15, 2009
Jkt 217001
PART 332—SELECTED
ESTABLISHMENTS; COOPERATIVE
PROGRAM FOR INTERSTATE
SHIPMENT OF CARCASSES, PARTS
OF CARCASSES, MEAT, AND MEAT
FOOD PRODUCTS
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.
332.10 Deselection of ineligible
establishments.
332.11 Transition to official establishments.
332.12 Transition grants.
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
§ 332.1
Definitions.
The following definitions apply to the
regulations in this part:
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.
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§ 332.3 Requirements for establishments;
ineligible establishments.
(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 [insert date 3 years
after effective date of final rule] or it
must transition to become an official
establishment as provided in § 332.11 of
this part.
(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 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 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.
(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;
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(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;
(7) Establishments that are in
violation of the Act;
(8) Establishments located in States
without a cooperative State meat
inspection program; and
(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;
(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, that 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;
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(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 § 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
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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
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. If necessary, the selected
establishment coordinator, in
consultation with the District Manager
that covers the State, may designate
qualified FSIS personnel to visit a
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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 § 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 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
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(2) Identify those selected
establishments 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 § 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 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.
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§ 332.10 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 § 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.
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.
§ 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.
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. A new § 381.187 is added to
subpart R to read as follows:
§ 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.’’
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(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.
(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.
5. A new subpart Z is added to part
381 to read as follows:
Subpart Z—Selected Establishments;
Cooperative Program for Interstate
Shipment of Poultry Products
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.
(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 [insert date 3 years
after effective date of final rule] 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
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§ 381.511
Definitions.
The following definitions apply to the
regulations in this part:
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 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
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.
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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 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 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.
(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.
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(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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§ 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
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;
(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, that 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.
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(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:
(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
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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
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.
§ 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. 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;
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules
(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 State staffing
levels for each selected establishment
are appropriate to carry out the required
inspection activities; and
(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.
mstockstill on DSKH9S0YB1PROD with PROPOSALS2
(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
implementing regulations in this
chapter, those that have been deselected
under § 381.520 of this subpart, and
those that are transitioning to become
VerDate Nov<24>2008
17:58 Sep 15, 2009
Jkt 217001
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.
(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;
PO 00000
Frm 00023
Fmt 4701
Sfmt 4702
47669
(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.
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.
§ 381.522
Transition grants.
(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
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.
Done at Washington, DC, on September 7,
2009.
Alfred V. Almanza,
Administrator.
[FR Doc. E9–21952 Filed 9–14–09; 11:15 am]
BILLING CODE 3410–DM–P
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Agencies
[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Proposed Rules]
[Pages 47648-47669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21952]
[[Page 47647]]
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Part II
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 321, 332, and 381
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Products; Proposed Rule
Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 /
Proposed Rules
[[Page 47648]]
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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: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing
regulations to implement 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), as well as with all State standards.
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.
FSIS is proposing these regulations in response to the Food,
Conservation, and Energy Act, enacted on June 18, 2008. Section 11015
of the law amended the FMIA and PPIA to provide for these cooperative
programs.
DATES: Submit comments on or before November 16, 2009.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by either of the following
methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov and
follow the online instructions at that site for submitting comments.
Mail, including floppy disks or CD-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 2-2127 George Washington
Carver Center, 5601 Sunnyside Avenue, Beltsville, MD 20705.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2008-0039. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to: https://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8:30 a.m.
and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Philip Derfler, 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
A. Federal-State Cooperative Inspection Programs
FSIS has been delegated the authority to carry out the functions of
the Secretary of Agriculture as provided in 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.). These statutes mandate that FSIS
protect the public by ensuring that meat and poultry products are safe,
wholesome, unadulterated, and properly labeled and packaged.
The FMIA and the PPIA (``the Acts'') provide for FSIS to cooperate
with State agencies in developing and administering their own meat or
poultry inspection programs (21 U.S.C. 661 and 454). The FMIA and the
PPIA restrict each cooperative State meat or poultry products
inspection program to the inspection and regulation of products that
are produced and sold within the State (21 U.S.C. 661(a)(1) and
454(a)(1)). Under section 661 of the FMIA and section 454 of the PPIA,
cooperative State inspection programs are required to operate in a
manner and with authorities ``at least equal to'' the provisions set
out in the Acts (21 U.S.C. 661(a)(1) and 454(a)(1)).
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) and 454(a)(3)).
States that have enacted a mandatory State meat or poultry inspection
law must apply to FSIS to enter into a cooperative State inspection
program agreement with the Agency.
If a State is unable or unwilling to continue to operate a
cooperative State inspection program on an ``at least equal to'' basis,
FSIS designates the State as not having an ``at least equal to''
program by publishing this designation in the Federal Register. After
the expiration of thirty days of such publication, the State
establishments are subject to Federal inspection (21 U.S.C. 661(c)(1)
and 454(c)(1)).
The Talmadge-Aiken Act authorizes the Secretary of Agriculture to
enter into cooperative arrangements with State departments of
agriculture and other State agencies to assist the Secretary in the
enforcement of relevant Federal laws and regulations to the extent and
in the manner appropriate to the public interest (7 U.S.C. 450).
Pursuant to the Talmadge-Aiken Act, 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. FSIS provides 50 percent funding to the State programs
for these services.
B. The Food, Conservation, and Energy Act of 2008
On June 18, 2008, Congress enacted The Food, Conservation, and
Energy Act of 2008 (also referred to as ``the 2008 Farm Bill'') (Pub.
L. 110-246, 112 Stat. 1651). Section 11015 of Title XI of the 2008 Farm
bill amended the FMIA to add a new title V--``Inspections by Federal
and State Agencies,'' which contains a new section 501, ``Interstate
Shipment of Meat Inspected by Federal and State Agencies for Certain
Small Establishments (122 Stat. 2124; codified at 21 U.S.C. 683).
Section 11015 also amended the PPIA to add a new section 31,
``Interstate Shipment of Poultry Inspected by Federal and State
Agencies for Certain Small Establishments'' (122 Stat. 2127; codified
at 21 U.S.C. 472). These new sections supplement the existing
cooperative State meat and poultry inspection programs by establishing
a new cooperative program under which certain State-inspected
establishments would be permitted to ship meat and poultry products in
interstate commerce.
The new law provides that the Secretary of Agriculture, ``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 interstate (Sec. 501(b) and Sec. 31(b)). Inspection services
for these establishments must be provided by State inspection personnel
that have
[[Page 47649]]
``undergone all necessary inspection training and certification to
assist the Secretary with the administration and enforcement of [the
FMIA or PPIA]'' (Sec. 501(a)(2) and Sec. 31(a)(2)). Meat and poultry
products inspected and passed by these State inspection personnel would
bear a ``Federal mark, stamp, tag, or label of inspection'' (Sec.
501(b)(1) and Sec. 31(b)(1)). The law provides for the Secretary to
``designate an employee of the Federal government'' to ``provide
oversight and enforcement'' of the program (Sec. 501(d)(1) and Sec.
31(d)(1)).
The law is to take effect ``on the date on which the Secretary * *
* promulgates final regulations to carry out [section 11015]'' (Sec.
501(j)(1) and Sec. 31(i)(1)). The law requires that the Secretary
promulgate final regulations ``not later than 18 months after the date
of enactment'' (Sec. 501(j)(2) and Sec. 31(i)(2)).
FSIS is issuing this proposed rule to implement section 11015 of
the 2008 Farm Bill. Following is a summary of the provisions of section
11015 that are addressed in this proposed rule.
Selected establishments. The law applies to certain establishments
that are already operating under a cooperative State meat or poultry
inspection program. The law defines an ``eligible establishment'' as
``an establishment that is in compliance with * * * the State
inspection program of the State in which the establishment is located''
and the Acts, including the rules and regulations issued under the Acts
(Sec. 501(a)(3) and Sec. 31(a)(3)). A ``selected establishment'' is
defined as ``an establishment that is authorized by the Secretary, in
coordination with * * * the appropriate State agency of the State in
which the establishment is located * * * to ship [meat or poultry]
items in interstate commerce'' (Sec. 501(a)(5) and Sec. 31(a)(5)).
The law prohibits the Secretary from selecting an establishment for
interstate shipment that ``on average, employs more than 25 employees
(including supervisory and nonsupervisory employees), as defined by the
Secretary'' (Sec. 501(b)(2)(A) and Sec. 31(b)(2)(A)). The law also
prohibits the selection of establishments that currently ship
interstate, as well as certain former and future Federal establishments
(Sec. 501(b)(2)(B), Sec. 501(b)(2)(C), Sec. 31(b)(2)(B), and Sec.
31(b)(2)(C)).
Transition to a Federal establishment. The law permits the
Secretary to select establishments with ``more than 25 employees but
less than 35 employees'' to participate in the program (Sec.
501(b)(3)(B)(i) and Sec. 31(b)(3)(B)(i)). However, if selected, these
establishments must transition to Federal establishments ``beginning on
the date that is 3 years after the effective date'' if they
consistently employ, on average, more than 25 employees (Sec.
501(b)(3)(B)(ii) and Sec. 31(b)(3)(B)(ii)). The law authorizes the
Secretary to develop a procedure to transition certain selected
establishments to a Federal establishment (Sec. 501(b)(3)(A) and Sec.
31(b)(3)(A)). The law also requires that ``[a]ny selected establishment
that the Secretary determines to be in violation of any requirement of
the Act, be transitioned to a Federal establishment'' (Sec. 501(h) and
Sec. 31(g)).
Federal-State coordination. Under the law, the Secretary is
authorized to designate a Federal employee as ``State coordinator'' for
each State to ``provide oversight and enforcement'' of the interstate
shipment program and to ``oversee the training and inspection
activities'' of the State personnel providing inspection services to
selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)). The law
provides that if the State coordinator determines that a selected
establishment under the State coordinator's jurisdiction is in
violation of the Acts, the State coordinator must ``immediately notify
the Secretary of the violation'' and ``deselect the selected
establishment or suspend inspection at the selected establishment''
(Sec. 501(d)(3)(C) and Sec. 31(d)(3(C)).
This proposed rule refers to the ``State coordinator'' established
in section 11015 of the 2008 Farm Bill as the FSIS ``selected
establishment coordinator'' to maintain consistency with the other
terminology in this proposed rule and to make clear that the ``State
coordinator'' is a Federal employee. The term ``State coordinator'' is
often used to refer to a State employee under the Talmadge-Aiken
program, so FSIS has tentatively decided not to use this term in these
proposed regulations.
Federal reimbursement of State costs. The law requires that the
Secretary ``reimburse a State for costs related to the inspection of
selected establishments * * * in an amount of not less than 60 percent
of eligible State costs'' (Sec. 501(c) and Sec. 31(c)).
Inspection training division. The law amended the FMIA to provide
that not later than 180 days after the effective date of section 11015
of the 2008 Farm Bill, the Secretary shall establish in FSIS an
inspection training division to provide outreach, education, and
training to, and provide grants to appropriate State agencies to
provide outreach, technical assistance, education, and training to
small and very small establishments (as defined by the Secretary) (Sec.
501(f)). FSIS implemented this provision by establishing an Office of
Outreach, Education and Training. A substantive part of the program's
function is to provide training, education, and outreach services to
small and very small plants.
Transition grants. The law permits the Secretary to provide grants
to States to assist them in helping establishments operating under a
cooperative State meat or poultry inspection program transition to
selected establishments (Sec. 501(g) and Sec. 31(f)).
II. The Proposed Rule
A. General
FSIS is proposing to amend 9 CFR part 321 of the Federal meat
inspection regulations and 9 CFR part 381, subpart R, of the poultry
products inspection regulations to add new sections that describe the
cooperative interstate shipment program established in section 11015 of
the 2008 Farm Bill. FSIS is also proposing to add a new 9 CFR part 332
to the Federal meat inspection regulations and a new 9 CFR part 381,
subpart Z, to the poultry products inspection regulations that
prescribe the conditions under which States and establishments
operating under a State-inspection program will be permitted to
participate in a cooperative interstate shipment program.
When FSIS completes the rulemaking process and issues a final rule,
the Federal meat and poultry products regulations will provide for
three separate cooperative State meat and poultry products inspection
programs: (1) Cooperative State meat or poultry products inspection
programs under the FMIA and PPIA; (2) cooperative agreements for State
programs to conduct meat or poultry products inspection or other
regulatory activities on behalf of the Agency under the Talmadge-Aiken
Act; and (3) cooperative programs for the interstate shipment of State-
inspected meat and poultry products under the FMIA and PPIA as amended
by section 11015 of the 2008 Farm Bill.
The proposed regulations to implement section 11015 are described
in detail below.
B. Description of Cooperative Programs--9 CFR Part 321 and 9 CFR Part
381, Subpart R
9 CFR part 321 of the Federal meat inspection regulations and 9 CFR
part 381, subpart R, of the poultry products inspection regulations
describe
[[Page 47650]]
cooperative meat and poultry products inspection programs authorized
under the FMIA, PPIA, and the Talmadge-Aiken Act. These regulations
reference the legal authority for each cooperative inspection program
and provide a general description of each program. FSIS is proposing to
amend part 321 and part 381, subpart R, to add a new Sec. 321.3 and a
new Sec. 381.187 to describe the cooperative interstate shipment
program established under section 11015 of the 2008 Farm Bill.
The amendments to the FMIA in section 501 of section 11015 of the
2008 Farm Bill have been codified at 21 U.S.C. 683, and the amendments
to the PPIA in section 31 have been codified at 21 U.S.C. 472 (122
Stat. 2124, 2127). Therefore, proposed Sec. 321.3(a) provides that
under 21 U.S.C. 683(b), FSIS is authorized to coordinate with States
that have cooperative State meat inspection programs to select certain
establishments operating under these programs to ship carcasses, parts
of carcasses, meat, and meat food products in interstate commerce.
Similarly, proposed Sec. 381.187(a) provides that under 21 U.S.C.
472(b), FSIS is authorized to coordinate with States that have
cooperative State poultry products inspection programs to select
certain establishments operating under these programs to ship poultry
products in interstate commerce. Proposed Sec. Sec. 321.3(a) and
381.187(a) both explain that this type of cooperative program is called
a ``cooperative interstate shipment program.''
Proposed Sec. Sec. 321.3(b) and 381.187(b) contain a general
description of the cooperative interstate shipment program and make
clear that the Federal contribution for inspection services provided by
States that have entered into such a program will be at least 60
percent of eligible State costs. Under the FMIA and PPIA, FSIS is
required to contribute up to 50 percent of the cost of a cooperative
State meat or poultry products inspection program (21 U.S.C. 661(a)(3)
and 454(a)(3)). Thus, States that participate in the new cooperative
interstate shipment program will receive additional reimbursement for
costs related to inspection of selected establishments in the State.
As required under the statute, the Federal contribution for
inspection services provided by States that enter into a cooperative
interstate shipment program under this proposal will be at least 60
percent of eligible State costs. When the program is implemented, FSIS
does not intend to reimburse States for more than 60 percent of their
eligible costs unless Congress directs it, and provides the money for
it, to do so.
To be reimbursed under this proposed rule, States will be expected
to submit their budgets for their cooperative interstate shipment
programs to FSIS for approval prior to receiving Federal funds. States
will also be expected to submit a separate justification for any costs
related to the cooperative interstate shipment program that were not
included in their initial budget request. FSIS will also need to
approve a State's request for additional funds before the Agency will
reimburse the State for not less than 60% of the cost. FSIS has
tentatively decided that, for purposes of this proposed rule, eligible
State costs will be 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 Agency requests comments on
whether the final rule resulting from this proposal should codify this
definition or any other requirements related to State reimbursement for
eligible costs related to inspection of selected establishments.
Proposed Sec. Sec. 321.3(c) and 381.187(c) identify 9 CFR part 332
and 9 CFR part 381, subpart Z, as the regulations that prescribe
conditions under which States and establishments may participate in the
cooperative interstate shipment program. Proposed Sec. Sec. 321.3(d)
and 381.187(d) provide that the Administrator will terminate an
agreement for a cooperative interstate shipment program with a State if
the Administrator determines that the State is not conducting
inspection at selected establishments in a manner that complies with
the Acts and their implementing regulations.
C. Requirements for a Cooperative Interstate Shipment Program--9 CFR
Part 332 and 9 CFR 381 Subpart Z
1. General
FSIS is proposing to amend title 9, Chapter III, Subchapter A of
the Code of Federal Regulations (CFR) to add a new part 332 titled
``Selected Establishments; Cooperative Program for Interstate Shipment
of Carcasses, Parts of Carcasses, Meat, and Meat Food Products,'' and
to add to part 381 a new subpart Z titled ``Selected Establishments;
Cooperative Program for Interstate Shipment of Poultry Products.'' The
regulations in the proposed new part 332 and the proposed new subpart Z
prescribe the requirements for a cooperative interstate shipment
program.
2. Definitions and Purpose
Proposed Sec. Sec. 332.1 and 381.511 define the terms
``cooperative interstate shipment program,'' ``cooperative State meat
inspection program,'' ``cooperative State poultry products inspection
program,'' ``selected establishment,'' and ``designated personnel.''
Terms used in the proposed regulations that are defined in 9 CFR 301.2
and 9 CFR 381.1 retain their same meaning.
Under proposed Sec. Sec. 332.1 and 381.511, ``cooperative
interstate shipment program,'' ``cooperative State meat inspection
program,'' and ``cooperative poultry products inspection program'' are
defined by providing a cross-reference to the description of these
cooperative programs in 9 CFR part 321 and 9 CFR part 381 subpart R,
described above. Under this proposal, ``selected establishment'' is
defined as ``an establishment operating under a State cooperative [meat
or 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.''
FSIS is proposing to define ``designated personnel'' as ``State
inspection personnel that have been trained in the enforcement of the
Acts and any additional State program requirements in order to provide
inspection services to selected establishments.''
In addition to proposing new definitions, proposed Sec. Sec. 332.1
and 381.511 make clear that the term ``interstate commerce,'' as used
in the proposed regulations has the same meaning as ``commerce'' under
9 CFR 301.2 and 381.1. The regulations in 9 CFR 301.2 and 381.1 define
``commerce'' as ``[c]ommerce between any State, any Territory, or the
District of Columbia, and any place outside thereof * * *.'' Thus,
under this proposal, State-inspected establishments that are selected
to participate in a cooperative interstate shipment program will be
permitted to distribute and sell meat or poultry products across State
lines and to export these products to foreign countries.
Proposed Sec. Sec. 332.2 and 381.512 state that the purpose of
part 332 and part 381, subpart Z, is to prescribe the conditions under
which States that administer cooperative State meat or poultry products
inspection programs and establishments that operate under such programs
may participate in a cooperative interstate shipment program.
3. Requirements for Establishments
The proposed regulations in Sec. Sec. 332.3 and 381.513 prescribe
conditions that establishments operating under a
[[Page 47651]]
cooperative State meat or poultry products inspection program must
comply with in order to apply to participate in a cooperative
interstate shipment program. Proposed Sec. Sec. 332.3 and 381.513 also
describe establishments that are ineligible to be selected for such a
program.
Number of employees. Under proposed Sec. Sec. 332.3(a)(1) and
381.513(a)(1), an establishment operating under a cooperative State
meat or poultry products inspection program may apply to participate in
a cooperative interstate shipment program if the establishment employs,
on average, no more than 25 employees. Standards for determining the
average number of employees for purposes of this proposal are described
in proposed Sec. Sec. 332.3(b) and 381.513(b) below.
Under proposed Sec. Sec. 332.3(a)(2) and 381.513(a)(2),
establishments that employed more than 25 but fewer than 35 employees
as of June 18, 2008, are also permitted to apply for a cooperative
interstate shipment program. However, Sec. Sec. 332.3(a)(2) and
381.513(a)(2) provide, reflecting the amended FMIA and PPIA, that if
selected, these establishments must employ, on average, 25 or fewer
employees as of the date three years from the date that the final rule
resulting from this proposal becomes effective. If they do not,
proposed Sec. Sec. 332.3(a)(2) and 381.513(a)(2) require that they be
deselected from the program and transition to become official
establishments.
Standards for determining number of employees. Proposed Sec. Sec.
332.3(b) and 381.513(b) establish standards for determining whether an
establishment employs, on average, 25 or fewer employees for purposes
of this proposed rule. FSIS developed these proposed standards to carry
out Congress' intent that ``[t]he term `average' should be interpreted
to provide some flexibility to these selected establishments 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 * * * does not undermine food safety standards'' (S. Rep.
No. 220, 110th Cong., 1st Sess., at 211 (2007)).
For the most part, the proposed standards in Sec. Sec. 332.3(b)
and 381.513(b) reflect applicable methods used by the Small Business
Administration (SBA) to calculate the number of employees of a business
concern where the size standard is number of employees (13 CFR 121.105
and 121.106). In addition, as explained below, FSIS is also proposing
to limit the total number of employees at any given time to 35
individuals. Under this proposal, the standards developed by FSIS will
apply to the employees of an individual establishment. The proposed
standards are as follows:
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;
All individuals employed from a temporary employee agency,
professional employee organization, or leasing concern are to be
counted;
The average number of employees is calculated for each of
the pay periods for the preceding calendar year;
Part-time and temporary employees are to be counted the
same as full-time employees;
If an establishment has not been in business for 12
months, the average number of employees is calculated for the pay
periods in which the establishment has been in business;
Volunteers who receive no compensation are not considered
employees; and
The total number of employees can never exceed 35
individuals at any given time, regardless of the average number of
employees.
As noted above, the standard that limits the total number of
employees on any given day to 35 individuals is not derived from SBA's
methods for calculating the number of employees. FSIS is proposing to
limit the number of individuals employed by a selected establishment at
any given time to carry out Congress' intent that any increase in the
number of employees be ``manageable by the selected establishment'' and
that the increase ``does not undermine food safety standards.'' FSIS is
proposing that this number never exceed 35 because section 11015 of the
2008 Farm Bill permits the Agency to select certain establishments that
employ as many as 35 employees to participate in a cooperative
interstate shipment program (Sec. 501(b)(3)(i) and Sec. 31(b)(3)(i)).
Therefore, FSIS believes that a temporary increase in the number of
employees of up to 35 individuals is likely to be considered
``manageable'' under the law, provided that the average number of
employees remains at 25 or fewer.
FSIS requests comments on the proposed standards for determining an
establishment's average number of employees. The Agency specifically
requests comment on whether part-time and temporary employees should be
counted the same as full-time employees.
Ineligible establishments. Proposed Sec. Sec. 332.3(c) and
381.513(c) describe establishments that are ineligible to participate
in a cooperative interstate shipment program. For the most part, these
establishments reflect the ``prohibited establishments'' described in
section 11015 of the 2008 Farm Bill (Sec. 501(b)(2) and 31(b)(2)).
These establishments include:
Establishments that employ more than 25 employees on
average, with a limited exception for establishments that had between
25 and 35 employees as of June 18, 2008 and that have 25 or fewer
employees as of the date three years from the date that the final rule
resulting from this rule becomes effective;
Establishments operating under a cooperative inspection
program under the Talmadge-Aiken Act;
Official establishments;
Establishments that were official establishments as of
June 18, 2008, but that were reorganized on a later date by the person
that controlled the establishment as of June 18, 2008;
State-inspected establishments that employed more than 35
employees as of June 18, 2008, but that were later reorganized by the
person that controlled the establishment as of June 18, 2008;
Establishments that are transitioning to become official
establishments;
Establishments that are in violation of the FMIA or PPIA;
and
Establishments located in a State without a cooperative
meat or poultry products inspection program.
In addition, the proposed regulations also include among the
establishments ineligible to participate in a cooperative interstate
shipment programs, establishments located in a State whose agreement
for an interstate shipment program was terminated by the Administrator.
Proposed Sec. Sec. 332.3(d) and 381.513(d) provide that an
eligible establishment may apply for selection into a cooperative
interstate shipment program through the State where the establishment
is located. FSIS is proposing that establishments apply for selection
into a cooperative interstate shipment program through the State
because the State will be responsible for providing inspection services
to the establishment if the establishment is selected for the program.
Thus, establishment participation in the cooperative interstate
shipment program will depend on whether the State is able, and willing,
to provide the necessary inspection services to the establishment.
However, if a State enters into an agreement with FSIS for a
cooperative interstate shipment
[[Page 47652]]
program, FSIS, in coordination with the State, will make the final
determination on whether to select an establishment to participate in
the program.
4. State Request for a Cooperative Interstate Shipment Program
Under this proposed rule, a State that does not have a cooperative
interstate shipment program, but that is interested in establishing
one, may submit a request for such a program to FSIS. Proposed
Sec. Sec. 332.4 and 381.514 prescribe the procedures for States to
request an agreement for a cooperative interstate shipment program.
Under this proposal, a State will submit the request through the FSIS
District Office that covers the State. Proposed Sec. Sec. 332.4(a) and
381.514(a) make clear that State participation in a cooperative
interstate shipment program is limited to States that have cooperative
State meat or poultry products inspection programs.
Required information. Proposed Sec. Sec. 332.4(b) and 381.514(b)
describe the information that States will need to include in their
requests for an agreement for a cooperative interstate shipment
program. Because a cooperative interstate shipment program requires
participation from both States and establishments, the State's request
for an agreement for a cooperative interstate shipment program must
identify establishments in the State that have requested to be selected
and that the State recommends for initial selection into the program
(proposed Sec. Sec. 332.4(b)(1) and 381.514(b)(1)). If FSIS and the
State enter into an agreement for a cooperative interstate shipment
program under this proposal, these establishments will be the first to
be considered for the program. Other establishments operating under the
State's meat or poultry products inspection program may apply to become
selected establishments after the cooperative interstate shipment
program has been implemented within the State.
A State's request for a cooperative interstate shipment program
must also include documentation to demonstrate that the State is able
to provide necessary inspection services to selected establishments in
the State and conduct any related activities that would be required
under a cooperative interstate shipment program (proposed Sec. Sec.
332.4(b)(2) and 381.514(b)(2)). Under this proposal, this documentation
would be similar to the documentation that States provide when they
request an agreement for a cooperative State meat or poultry products
inspection program. However, instead of demonstrating that the State's
inspection program is ``at least equal to'' the Federal inspection
program, the statute requires that the State demonstrate that
inspection services provided to selected establishments will be ``the
same as'' the inspection services provided under the Federal program.
Thus, to qualify for a cooperative interstate shipment program
under this proposal, States will need to demonstrate, among other
things, that they have the authority under State law to provide the
same inspection services to selected establishments in the State as the
inspection services that FSIS provides to official Federal
establishments. States will also need to demonstrate that they have
staffing sufficient to conduct the same inspection activities in
selected establishments that FSIS conducts in official Federal
establishments, and that designated personnel have been properly
trained in Federal inspection methodology. FSIS currently offers
training courses in Federal inspection methodology to State inspection
personnel. Under this proposal, 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 will also expect States to demonstrate that
they can provide the necessary equipment for State personnel to provide
the same inspection services to selected establishments that FSIS
provides to official Federal establishments, including computers and
supplies for collecting product samples.
Because the statute requires compliance with all Federal standards,
meat and poultry products produced in selected establishments will be
subject to the same regulatory sampling programs as those established
in the Federal inspection program. Thus, to be eligible to participate
in a cooperative interstate shipment program, States will need to
demonstrate that State personnel will collect the same number and type
of regulatory product samples from selected establishments as are
collected under FSIS's inspection sampling program.
In addition, the State will need to demonstrate that the laboratory
services that it intends to use to analyze product samples from
selected establishments are capable of conducting the same chemical,
microbiological, physical, and pathology testing as are required under
the Federal meat and poultry products inspection programs. FSIS's
Office of Public Health Science will provide 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. FSIS will not enter into an agreement for a cooperative
interstate shipment program with a State that does not meet the
conditions described above.
Additional conditions. Proposed Sec. Sec. 332.4(b)(3) and
381.514(b)(3) prescribe additional conditions that States applying for
a cooperative interstate shipment program must agree to in order to
qualify for the program. These proposed regulations provide that when a
State submits a request to establish a cooperative interstate shipment
program, the State must agree that, if it enters into an agreement with
FSIS for such a program, that the State will:
Provide FSIS with access to the results of all laboratory
analyses conducted on product samples from selected establishments in
the State;
Notify the selected establishment coordinator (SEC) for
the State of the results of any laboratory analyses that indicate that
a product prepared or processed in a selected establishment may be
adulterated or may otherwise present a food safety concern; and
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. FSIS will not enter into an agreement for a cooperative
interstate shipment program if a State does not agree to these terms.
Qualified States. Under this proposal, after a State submits a
request for a cooperative interstate shipment program, the FSIS
Administrator will review the request and determine whether the State
qualifies for such a program. If, based on the information submitted in
the request the Administrator determines that a State is eligible to
enter into a cooperative agreement for an interstate shipment 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 in
the State (proposed Sec. Sec. 331.4(c) and 381.514(c)). After the
Administrator and a State have signed an agreement for a cooperative
interstate shipment program, the Administrator will: (1) Appoint an
FSIS employee as the selected establishment coordinator (SEC) for the
State and (2) coordinate with the State to select the establishments
that will participate in the program (proposed Sec. Sec. 332.4(d) and
381.514(d)).
[[Page 47653]]
Summary of actions needed to establish a cooperative interstate
shipment program under the proposed regulations.
The proposed regulations discussed above describe conditions that
both establishments and States must meet to participate in a
cooperative interstate shipment program. If FSIS adopts these proposed
regulations in a final rule, the steps for establishing a new
cooperative interstate shipment program will be the following.
An establishment that is eligible for the interstate
shipment program, and that is interested in participating in the
program, will apply for the program through the State agency that
administers the State meat and poultry products inspection program
under which the establishment operates. States will develop their own
application procedures.
The State will then evaluate the establishment's
application to determine whether the State will recommend the
establishment for selection into the cooperative interstate shipment
program.
If the State determines that an establishment qualifies
for selection into the program, and the State is able, and willing, to
provide the necessary inspection services to the establishment, the
State will recommend the establishment for selection into the program.
The State will need to submit its recommendation through the FSIS
District Office whose jurisdiction includes the State.
If the State has not entered into an agreement with FSIS
for a cooperative interstate shipment program, but is qualified to
participate in such a program, it will need to submit a request for a
cooperative agreement for the program to the FSIS District Office that
covers the State.
In its request for a cooperative interstate shipment
program, a State will need to: (1) Identify those establishments that
have submitted a request for, and that the States recommends for,
initial selection into the program and (2) demonstrate that it is able
to provide the necessary inspection services to these establishments if
they are selected for the program. The State will also need to agree to
comply with certain conditions associated with FSIS oversight and
enforcement of the program.
After a State submits a request for a cooperative
interstate shipment program, the FSIS Administrator will evaluate the
request and determine whether the State qualifies for the program.
If the Administrator determines that the State qualifies
for the cooperative interstate shipment 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 in the State.
The Administrator will then appoint an SEC for the State,
and the Administrator, in coordination with the State, will begin
selecting establishments for participation in the program.
5. Selection of Establishments
As discussed above, under this proposal, State-inspected
establishments that are interested in participating in a cooperative
interstate shipment program will apply for selection into the program
through the State agency that administers the State's meat or poultry
products inspection program. When, and if, an establishment applies to
participate in a cooperative interstate shipment program, the State
will evaluate the establishment to determine whether it qualifies to
become a selected establishment. Proposed Sec. Sec. 332.5(a) and
381.515(a) provide that a State-inspected establishment will qualify
for selection into a cooperative interstate shipment program if the
establishment:
Has submitted a request to the State to be selected for
the program;
Has the appropriate number of employees;
Is not ineligible for a cooperative interstate shipment;
Is in compliance with all requirements under the State
inspection program; and
Is in compliance with the all Federal meat or poultry
products inspection requirements.
Establishments that do not meet all of these criteria will not
qualify, and will not be selected, for the program. To participate in a
cooperative interstate shipment program, an establishment that
qualifies for such a program must be selected by the Administrator, in
coordination with the State where the establishment is located
(proposed Sec. Sec. 332.5(b) and 381.515(b)).
Thus, under this proposal, 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. The FSIS Administrator, in
coordination with the State, will decide whether to select the
establishment for the program. When deciding whether to select and
establishment for the program, the Administrator will consider whether
the establishment meets the criteria needed to qualify 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.
As stated above, to qualify to participate in a cooperative
interstate shipment program, an establishment must be in compliance
with all Federal inspection requirements under the FMIA, PPIA, and
their implementing regulations in title 9, chapter III, of the CFR.
Thus, as part of the selection process, the SEC, in coordination with
the State, will verify that each establishment that has applied to
participate in a cooperative interstate shipment program: (1) Meets the
Federal regulatory performance standards established in 9 CFR 416.1
through 416.6; (2) has submitted all labeling material to the State for
approval, and that the materials meet all Federal requirements in 9 CFR
parts 316, 317, and 319 and Part 381, subparts M, N, and P; (3) has
obtained the same water source and sewage system approval that FSIS
requires for official establishments; (4) has developed Sanitation
Standard Operating Procedures (Sanitation SOPs) that comply with 9 CFR
416.11-416.17; and (5) has conducted a hazard analysis and developed a
validated Hazard Analysis and Critical Control Points (HACCP) plan that
complies with 9 CFR part 417.
These criteria reflect the standards that meat and poultry products
establishments are required to meet to obtain a Federal grant of
inspection under 9 CFR part 304 and 9 CFR part 381. Establishments that
do not meet all of these requirements are not in compliance with all
Federal standards and thus will not be selected for the program.
If an establishment qualifies for, and is selected to participate
in, a cooperative interstate shipment program under this proposed rule,
proposed Sec. Sec. 332.5(c) and 381.515(c) provide that the State is
to assign the establishment an official number that reflects the fact
that the establishment is a participant in the cooperative interstate
shipment program. These proposed regulations provide that the State is
to advise the SEC of the number assigned to each selected establishment
in the State. Proposed Sec. Sec. 332.5(c) and 381.515(c) go on to
state that the official numbers
[[Page 47654]]
assigned to selected establishments need to contain the suffix ``SE''
to identify the establishments as selected establishments. FSIS is
proposing this requirement to ensure that establishments participating
in the cooperative interstate shipment program can be identified by
reference to their establishment number. It will also ensure that meat
and poultry products prepared in selected establishments are identified
as articles produced under a cooperative interstate shipment program.
Proposed Sec. Sec. 332.5(c) and 381.515(c) also provide that the
selected establishment numbers must include, as a suffix, the
abbreviation for the State in which the establishment is located. In
addition, proposed Sec. 381.515(c) provides that the suffix of the
number for a selected poultry products establishments needs to contain
the letter ``P'' to identify the establishment as one that processes
poultry products. Thus, under this proposal, an official number for a
selected establishment in Texas that prepares meat products would
contain the suffix ``SETX,'' while an official number for an
establishment in North Dakota that process poultry products would
contain the suffix ``SEPND.''
As discussed below, articles that have been inspected and passed in
a selected establishment will bear an official USDA mark, stamp, tag,
or label of inspection.
Finally, proposed Sec. Sec. 332.5(d) and 381.515(d) provide that
failure of a State to comply with Sec. Sec. 332.5(c) and 381.515(c)
will disqualify that State from participation in a cooperative
interstate shipment program. Full compliance by a State with these
provisions is essential if the program is to succeed.
6. Inspection at Selected Establishments, Official Mark, and Interstate
Shipment
Proposed Sec. Sec. 332.6(a) and 381.516(a) provide that a
cooperative interstate shipment program will commence when the
Administrator, in coordination with a State that has entered into an
agreement for a cooperative meat or poultry products inspection
program, have selected establishments in the State to participate in
the program.
Proposed Sec. Sec. 332.6(b) and 381.516(b) provide that 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. As
discussed below, the FSIS SEC will oversee the inspection activities of
the designated personnel.
Proposed Sec. Sec. 332.6(c) and 381.516(c) provide that articles
prepared or processed in a selected establishment that have been
inspected and passed by designated personnel must bear an official USDA
mark, stamp, tag, or label of inspection as specified in 9 CFR 312.2 or
9 CFR 381.96. 9 CFR 312.2 and 9 CFR 381.96 are the regulations that
prescribe the appropriate wording and form for use of the official
Federal inspection legend on meat or poultry products. In addition, the
establishment number contained in the Federal mark, stamp, tag, or
label of inspection must comply with all the conditions proposed in
Sec. Sec. 332.5(c) or 381.515(c).
Under proposed Sec. Sec. 332.6(d) and 381.516(d) meat or poultry
products prepared in selected establishments may be shipped in
interstate commerce if they have been inspected and by selected State
personnel and bear the Federal mark of inspection.
7. Federal Oversight of Cooperative Interstate Shipment Programs
Section 11015 of the 2008 Farm Bill requires that the Secretary
designate an employee of the Federal government as a ``State
coordinator'' for each State that has a cooperative State meat or
poultry products inspection program (Sec. 501(d) and Sec. 31(d)). The
State coordinator is required to ``provide oversight and enforcement''
of the program and ``to oversee the training and inspection
activities'' of State personnel designated to provide inspection
services to selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)).
As noted above, when, and if, a State qualifies to participate in a
cooperative interstate shipment program, proposed Sec. Sec.
332.4(c)(1) and 381.514(c)(1) provide that the Administrator will
appoint an FSIS employee as the FSIS SEC for the State. The SEC is the
``State coordinator'' prescribed by the statute.
FSIS has tentatively decided that the SEC will be an employee of
the FSIS Office of Field Operations (OFO) and will be assigned to an
FSIS District Office. The SEC will likely be under the direct
supervision of an FSIS District Manager. 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. 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.
SEC initial responsibilities. One of the SEC's initial
responsibilities will be, in conjunction with the District Office, to
coordinate with the State to select establishments to participate in
the program. The SEC will coordinate with the State to verify that all
State personnel selected to provide inspection services to these
establishments have successfully completed the same training in the
fundamentals of meat and poultry inspection, covering the Sanitation
Performance Standards, Sanitation Standard Operating Procedures (SOPs),
HACCP, and enforcement procedures, that is required for FSIS inspection
personnel. The SEC will also coordinate with the State to verify that
designated personnel have successfully completed the appropriate
customized food safety training required for FSIS inspection personnel
based on the types of products being produced at the establishments
where designated personnel are assigned.
SEC's oversight responsibilities. Proposed Sec. Sec. 332.7 and
381.517 prescribe how the FSIS SEC is to provide Federal oversight of
the cooperative interstate shipment program.
Proposed Sec. Sec. 332.7(a) and 381.517(a) provide that the 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 in title 9,
chapter III, of the CFR. 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. FSIS requests comments on how
frequently the SEC should visit each establishment under his or her
jurisdiction. Proposed Sec. Sec. 332.7(a) and 381.517(a) also provide
that if necessary, the SEC, in consultation with the District Manager
that covers the State, may designate qualified FSIS personnel to visit
a selected establishment on behalf of the SEC.
Under proposed Sec. Sec. 332.7(b) and 381.517(b), the SEC, in
coordination with the State, will verify that selected establishments
in the State are receiving the necessary inspection services from
[[Page 47655]]
designated personnel, and that these establishments are eligible, and
remain eligible, to participate in the cooperative interstate shipment
program. These proposed regulations provide that the SEC's verification
activities may include:
Verifying that each selected establishment in the State
employs, and continues to employ, 25 or fewer employees on average,
unless the establishment is transitioning to become an official
establishment;
Verifying that the designated personnel are providing
inspection services to selected establishments in an manner that
complies with the Acts and implementing regulations;
Verifying that the State staffing levels for each selected
establishment are appropriate to carry out the required inspection
activities; and
Assessing each selected establishment's compliance with
the Acts and implementing regulations under title 9, chapter III, of
the CFR.
To verify that designated personnel are providing inspection
services in compliance with the Acts, 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.
To assess each selected establishment's compliance with Federal
food safety standards, the SEC will observe the condition of the
establishment, observe establishment employees performing their duties,
review the establishment's records, and submit product samples for
analysis to determine that product produced by the establishment meets
Federal food safety standards.
The SEC will have discretion to increase the frequency of visits to
a selected establishment if the SEC, in consultation with the District
Manager for the State where the selected establishment is located,
determines that such action is necessary to ensure that the
establishment is operating in a manner consistent with the Acts. The
SEC will also be authorized to conduct a comprehensive food safety
assessment (FSA) for a selected establishment, 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 determine whether the establishment is
operating in compliance with the Acts. A comprehensive food safety
assessment is an assessment that considers all the food safety aspects
that relate to an establishment and all the products the plant
produces.
If the SEC determines that designated personnel are not providing
inspection services to selected establishments in a manner that
complies with the Acts, proposed Sec. Sec. 332.7(c) and 381.517(c)
provide that FSIS will provide an opportunity consistent with these
regulations for the State to develop and implement a corrective action
plan to address inspection deficiencies identified by the SEC. These
proposed regulations also provide that if the State fails to develop a
corrective action plan, or if the SEC determines that the State's
corrective action plan is inadequate, the Administrator will terminate
the cooperative agreement with the State.
As discussed above, selected establishments in a State whose
agreement for a cooperative interstate shipment program has been
terminated by the Administrator are among the establishments that are
ineligible to participate in the program. As such, these establishments
will be deselected from the program and transitioned to become Federal
establishments as described below.
Quarterly reports. As required under section 11015 of the 2008 Farm
Bill (Sec. 501(d)(3)(b) and Sec. 31(d)(3)(b)), 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 Sec. Sec.
332.8(a) and 381.518(a)).
The SEC's quarterly report will include the SEC's assessment of the
performance of the designated personnel in conducting inspection
activities (proposed Sec. Sec. 332.8(b)(1) and 381.518(b)(1)). The
quarterly report will also 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 Sec. Sec. 332.8(b)(1) and
381.518(b)(1)). The SEC will submit the report to the Administrator
through the District Manager for the State in which the selected
establishments identified in the report are located (proposed
Sec. Sec. 332.8(c) and 381.518(c)).
Enforcement. Section 11015 of the 2008 Farm Bill provides 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 Secretary (the FSIS Administrator by delegation) of the
violation and (2) ``deselect'' the establishment or suspend inspection
at the establishment (Sec. 501(d)(3)(C) and Sec. 31(d)(3)(C)). In
adopting this language, Congress intended that the SEC ``* * * shall be
provided all the tools necessary under the Secretary to prevent or
control any food safety issue that would harm human health'' (S. Rep.
No. 220, 110th Cong., 1st Sess., at 211 (2007)).
Because many of the SEC's verification and enforcement activities
require that the SEC have access to a selected establishment's records,
proposed Sec. Sec. 332.9(a) and 381.519(a) provide that to facilitate
oversight and enforcement of the cooperative interstate shipment
program, selected establishments must, upon request, give SECs or other
FSIS officials access to all establishment records required under the
FMIA, PPIA, and the implementing regulations in title 9, chapter III,
of the CFR. These proposed regulations go on to state that FSIS will
move to deselect an establishment that does not comply with this
requirement.
Under proposed Sec. Sec. 332.9(b) and 381.519(b), the SEC is
authorized to initiate any appropriate enforcement action provided for
in the FSIS rules of practice 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. Such actions include, among others,
regulatory control actions, withholding actions, and suspensions. The
proposed regulations provide that selected establishments participating
in a cooperative interstate shipment program are subject to the
notification and appeal procedures set out in part 500 (proposed
Sec. Sec. 332.9(b) and 381.519(b)).
Proposed Sec. Sec. 332.9(c) and 381.519(c) provide that if
inspection at a selected establishment is suspended for any of the
reasons specified in 9 CFR 500.3 or 9 CFR 500.4, FSIS 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. The decision to deselect a
selected establishment under a suspension will be made on a case-by-
case basis (proposed Sec. Sec. 332.9(d) and 381.519(d)). In making
this decision, the Administrator, 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, which will be documented
in non-compliance reports prepared by the designated personnel and the
SEC's
[[Page 47656]]
quarterly reports; and (3) the corrective actions proposed by the
establishment (proposed Sec. Sec. 332.9(d) and 381.519(d))
The Administrator will have the discretion to allow a selected
establishment that has been suspended to remain in the program if the
establishment implements corrective actions to address any non-
compliance. The Administrator will consider the criteria described
above in determining whether to provide an opportunity for corrective
actions. Establishments that are given an opportunity to take
corrective actions but that are unable to effectively implement these
actions will be deselected.
FSIS will also consider the State's recommendation as to whether a
selected establishment in the State should be deselected. However, the
final decision to deselect an establishment for violations of the FMIA
or PPIA will be made by FSIS. As discussed below, consistent with the
law, this proposed rule requires that deselected establishments be
transitioned to become official establishments.
8. Deselection
There may be circumstances in which an establishment that initially
qualifies to be selected to participate in a cooperative interstate
shipment program later acquires characteristics that would cause it to
become ineligible for the program. For example, an establishment may
hire additional employees after it has been selected, or, as discussed
above, FSIS may determine that a selected establishment is in violation
of the Acts. Therefore, proposed Sec. Sec. 332.10(a) and 381.520(a)
provide that the Administrator will deselect an establishment that
becomes ineligible to participate in a cooperative interstate shipment
program. Proposed Sec. Sec. 332.10(b) and 381.520(b) provide that an
establishment that has been deselected from a cooperative interstate
shipment program must be transitioned to become an official
establishment.
FSIS is proposing to require that deselected establishments be
transitioned to become official Federal establishments as provided for
in the law. Section 11015 of the 2008 Farm Bill allows the Agency to
establish a procedure to transition selected establishments that
employ, on average, more than 25 employees to become Federal
establishments, and it requires that selected establishments that the
Administrator determines to be in violation of any provision of the
Acts, be transitioned to Federal establishments in accordance with the
procedure developed for establishments that employ more than 25
employees (Sec. 501(b)(3), 501(h), 31(b)(3) and 31(g)).
Thus, as required by the law, under this proposal, establishments
that become ineligible to participate in the cooperative interstate
shipment program because they violated Federal food safety standards
will not permitted to avoid implementing appropriate corrective actions
by withdrawing from the cooperative interstate shipment program and
reverting back to the State inspection program. In addition, requiring
that deselected establishments transition to become official Federal
establishments will help to ensure that the resources that FSIS and the
States provide to establish and maintain a cooperative interstate
shipment program are used most effectively to provide inspection
services to establishments that are committed to maintaining Federal
food safety standards.
9. Transition Procedures for Deselected Establishments
As discussed above, under the law, FSIS is authorized to develop a
procedure to transition selected establishments to become official
establishments if they employ more than 25 employees on average, or if
the Agency determines that they are in violation of any provision of
the Acts (Sec 501(b), Sec. 501(h), Sec. 31(b) and Sec. 31(g)). At a
minimum, a procedure to transition a selected establishment to an
official establishment would include: (1) Adding the establishment to
an FSIS circuit within the FSIS District that covers the State where
the