Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments, 14361-14368 [2010-6629]
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14361
Proposed Rules
Federal Register
Vol. 75, No. 57
Thursday, March 25, 2010
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 417 and 418
[FDMS Docket Number FSIS–2008–0025]
RIN 0583–AD34
Notification, Documentation, and
Recordkeeping Requirements for
Inspected Establishments
AGENCY: Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
The Food Safety and
Inspection Service (FSIS) is proposing
to implement provisions of the Food,
Conservation, and Energy Act of 2008
by adopting regulations that require
official establishments to promptly
notify the appropriate District Office
that an adulterated or misbranded meat
or poultry product has entered
commerce; require official
establishments to prepare and maintain
current procedures for the recall of meat
and poultry products produced and
shipped by the establishment; and
require official establishments to
document each reassessment of the
establishment’s process control plans,
that is, its Hazard Analysis and Critical
Control Point plans.
DATES: Comments due on or before May
24, 2010.
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: This
Web site provides the ability to type
short comments directly into the
comment field on this Web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the online instructions at that site for
submitting comments.
• Mail, including CD–ROMs, and
hand- or courier-delivered items: Send
to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, Room 2–2127
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SUMMARY:
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George Washington Carver Center, 5601
Sunnyside Avenue, Beltsville, MD
20705.
Instructions: All items submitted by
mail or via Regulations.gov must
include the Agency name and docket
number FSIS–2008–0025. 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:
Background
FSIS administers the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601–
695), the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451–470), and the
regulations that implement these Acts.
Under these statutes and rules, the
Agency is responsible for ensuring that
the nation’s commercial supply of meat
and poultry is safe, not adulterated,
wholesome, and properly marked,
labeled, and packaged.
On June 18, 2008, section 11017 of the
Food, Conservation, and Energy Act of
2008, Public Law 110–246, 122 Stat
1651, 448–49, otherwise known as the
2008 Farm Bill, amended the FMIA and
the PPIA by adding new sections 12 and
13 to the FMIA (21 U.S.C. 612 and 613)
and amending section 10 of the PPIA
(21 U.S.C. 459). Section 12 of the
amended FMIA and section 10(b) of the
amended PPIA require establishments
subject to inspection under the Acts that
believe, or have reason to believe, that
an adulterated or misbranded meat,
meat food, poultry, or poultry product
received by or originating from the
establishment has entered into
commerce, to promptly notify the
Secretary of Agriculture of that belief.
They also require these establishments
to inform the Secretary of the type,
amount, origin, and destination of the
adulterated or misbranded product.
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Section 13 of the amended FMIA and
section 10(c) of the amended PPIA also
require establishments subject to
inspection under these statutes to:
(1) Prepare and maintain current
procedures for the recall of all meat,
meat food, poultry, and poultry
products produced and shipped by the
establishment; (2) document each
reassessment of the establishment’s
process control plans, i.e., its Hazard
Analysis and Critical Control Point
(HACCP) plans; and (3) make the recall
procedures and written records of the
establishment’s HACCP plan
reassessments available for official
review and copying.
FSIS is proposing regulations to
implement these new statutory
provisions. Establishments subject to
inspection under the Acts are official
meat 1 and poultry products 2
establishments.
I. Notification Requirement
The FMIA and PPIA, and their
implementing regulations, prohibit the
sale, transport, offer for sale or
transportation, or receipt for
transportation in commerce of any meat,
meat food, poultry, or poultry products
(hereinafter referred to as meat or
poultry products) that are capable of use
as human food and are adulterated or
misbranded at the time of such sale,
transportation, offer for sale or
transportation, or receipt for
transportation by any person,3 firm,4 or
corporation.5 The FMIA also prohibits
the importation of adulterated or
misbranded 6 meat and meat food
products, while the PPIA prohibits the
importation of adulterated 7 poultry or
poultry products. Imported meat and
poultry products must also ‘‘* * *
1 9 CFR 301.2. Official establishment means any
slaughtering, cutting, boning, meat canning, curing,
smoking, salting, packing, rendering, or similar
establishment at which inspection is maintained
under the regulations in this subchapter.
2 9 CFR 381.1. Official establishment means any
establishment as determined by the Administrator
at which inspection of the slaughter of poultry, or
the processing of poultry products, is maintained
pursuant to the regulations.
3 21 U.S.C. 453(j). A person is ‘‘any individual,
partnership, corporation, association, or other
business unit.’’
4 21 U.S.C. 601(b). A firm is ‘‘any partnership,
association, or other unincorporated business
organization.’’
5 21 U.S.C. 610(c)(1) and 9 CFR 320.7, and 21
U.S.C. 458(a)(2) and 9 CFR 381.181.
6 21 U.S.C. 620(a)
7 21 U.S.C. 466(a)
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comply with the rules and regulations
made by the Secretary of Agriculture to
assure that they comply with the
standards provided for in * * *’’ the
Act, including the misbranding
provision found in 21 U.S.C. 458(a)(2).
While the Federal meat and poultry
products inspection regulations have
provisions that address the receipt of
adulterated or misbranded products by
an official establishment or consignee
under specific circumstances,8 they do
not explicitly require establishments
subject to inspection under the FMIA or
PPIA to notify FSIS 9 when an
adulterated or misbranded product
received by or originating from the
establishment has entered commerce.
Therefore, in accordance with section
11017 of the 2008 Farm Bill and the
newly enacted sections 12 of the FMIA
and 10(b) of the PPIA, FSIS is proposing
to require that official establishments
promptly notify the appropriate District
Office that an adulterated or misbranded
product received by or originating from
the establishment has entered
commerce, if the establishment believes
or has reason to believe that this has
happened. FSIS is also proposing to
require that the establishment inform
the District Office of the type, amount,
origin, and destination of the
adulterated or misbranded product.10
If this proposed rule becomes final,
the required information concerning the
type of product will need to include the
product name, any code or lot numbers
on the individual packages or cases, and
the type and size of the packages.
Information concerning the origin and
destination of the product will need to
include the official establishment
numbers and addresses of both the
producing establishment and the
receiving establishment, or, if the
product is not going, or is not only
going, to an official establishment, the
names and addresses of any facilities to
which the product has been shipped.
8 See, e.g., 9 CFR 318.1(j), ‘‘If any slaughtered
poultry or poultry products or other articles are
received at an official establishment and are
suspected of being adulterated or misbranded under
the Poultry Products Inspection Act or the Federal
Food, Drug, and Cosmetic Act, or applicable State
law, the appropriate governmental authority will be
notified.’’ See also 9 CFR 320.7 and 381.181, which
require the consignee of any product that bears an
official inspection legend that refuses to accept the
delivery of the product on the grounds that it may
be adulterated or misbranded to notify the Inspector
in Charge of the kind, quantity, source, and present
location of the product and the respects in which
it is alleged to be adulterated or misbranded.
9 The functions of the Secretary of Agriculture
contained in the FMIA and the PPIA are delegated
to the Under Secretary for Food Safety in 7 CFR
2.18. These functions, in turn, are delegated to the
Administrator, Food Safety and Inspection Service
in 7 CFR 2.53.
10 Proposed 9 CFR 418.2.
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The new notification provisions of the
FMIA and PPIA do not provide an
explicit timeframe within which
notification must be given. However, the
purpose of notification is to ensure that
potentially adulterated or misbranded
product is removed from commerce as
quickly as possible. Thus, FSIS is
proposing to require that official
establishments notify the appropriate
District Office as quickly as possible,
but within 48 hours of learning or
determining that an adulterated or
misbranded product received by or
originating from the establishment has
entered commerce. FSIS requests
comment on whether 48 hours is an
appropriate time in which to expect
official establishments that have
shipped or received, or have reason to
believe that they have shipped or
received, adulterated or misbranded
product, to notify the appropriate
District Office of that situation.
II. Documentation and Recordkeeping
A. Recall Procedures
The FMIA and PPIA require Federal
inspection 11 and provide for Federal
regulation of meat and poultry products
prepared for distribution in commerce
for use as human food.12 Before
enactment of the 2008 Farm Bill, there
was no requirement that official
establishments prepare and maintain
written procedures for the recall of meat
and poultry products produced and
shipped by them, although FSIS
strongly recommended that
establishments do so. Such a plan
involves preparing and maintaining
detailed, written recall plans or
procedures that specify how the firm
will decide whether to conduct a
product recall, and how the
establishment will effect the recall
should it decide that one is necessary.13
Under newly enacted section 13 of the
FMIA and section 10(c) of the PPIA, the
preparation and maintenance of written,
up-to-date recall procedures are
mandatory. Therefore, FSIS is proposing
to require that official meat and poultry
establishments prepare and maintain
written procedures for the recall of meat
or poultry products produced or
shipped by an establishment for use
should it become necessary for the
establishment to remove such products
from commerce. FSIS is proposing to
require that these written procedures
specify how the official establishment
11 21
U.S.C. 603(a), 604, 606, and 455.
U.S.C. 602 and 451.
13 See Attachment 1 to FSIS Directive 8080.1,
Revision 5, Product Guidelines for Firms, which
discusses the elements that should be addressed by
a recall plan.
12 21
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will decide whether to conduct a
product recall, and how the
establishment will effect the recall.
Consistent with the 2008 Farm Bill, the
proposed rule requires that these
procedures be available for official
review and copying.
Under the proposed rule, recall
procedures will not have to be included
in an establishment’s HACCP plan or
used as a prerequisite program, as long
as each official establishment has
procedures that meet the requirements
of 9 CFR 418.2. These could, however,
be incorporated into HACCP plans or
prerequisite programs as corrective
actions to be followed to address
deviations that resulted in the shipment
of adulterated or misbranded product in
commerce. 9 CFR 417.3 requires that
HACCP plans identify corrective actions
to be followed in response to a deviation
from a critical limit.
FSIS requests comment on when, after
the effective date of this rule, assuming
it becomes final, written recall
procedures must be completed in
accordance with proposed § 418.3. FSIS
is also seeking comment as to within
what time from new establishments
must prepare written recall procedures.
B. Process Control Plans
HACCP is a science-based process
control system for food safety that
promotes systematic prevention of
biological, chemical, and physical
hazards. HACCP plans are
establishment-developed process
control plans designed to identify and
prevent hazards before they occur and
to correct problems if they are detected.
FSIS requires every official
establishment to develop and
implement a written HACCP plan
covering each product produced by that
establishment whenever a hazard
analysis reveals one or more food safety
hazards that are reasonably likely to
occur in the production process.14
Official establishments must reassess
the adequacy of their HACCP plans at
least annually and whenever any
changes occur that could affect the
hazard analysis or alter the HACCP
plan.15 9 CFR 417.4(a)(3) contains
examples of changes that could affect
the hazard analysis or alter the HACCP
plan.
FSIS has, on occasion, notified the
public when changes have occurred that
could affect the hazard analysis or alter
the HACCP plans for particular
products. For example, FSIS notified the
public of the availability of new
scientific data indicating that
14 9
15 9
CFR 417.2(b)(1).
CFR 417.4(a)(3).
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Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Proposed Rules
Escherichia coli (E. coli) O157:H7 was
more prevalent than was previously
thought (67 FR 62326, Oct. 7, 2002) and
notified the public of E. coli O157:H7
outbreaks associated with the
consumption of mechanically
tenderized beef (70 FR 30331, May 26,
2005).
Under FSIS’s regulations, the
reassessment required by 9 CFR
417.4(a)(3) does not have to be
documented. The 2008 Farm Bill
changes this situation. It requires that
official establishments document each
reassessment of their process control
plans. Therefore, this rule proposes to
require that official establishments make
a written record when they perform
reassessment as required by 9 CFR
417.4(a)(3) or for any other reason. The
Agency is proposing to require that
establishments document the reasons
for any changes that they made to their
HACCP plans based on the
reassessment, or, if they did not make
any changes, that they document the
reasons that they did not. If, however,
an establishment performs its annual
reassessment and determines that no
changes are needed to its HACCP plan,
it may briefly state this fact in lieu of
more extensive documentation.
Consistent with the statute, official
establishments must make all
documentation of the reassessment
available for official review and
copying.16
Documenting reassessments is
important for a number of reasons. It
will facilitate verification that
establishments are actually reassessing
their HACCP plans. Without a record,
this has proven difficult to do. It will
also help FSIS personnel to identify
whether there are emerging hazards that
the establishment has decided not to
address. Finally, a record of
reassessments will help an
establishment to track the situation in
its operation over time.
If this proposed rule becomes final,
official establishments will be able to
maintain these records on computers (9
CFR 417.5(d)), and establishments will
be required to retain the records for up
to two years, as prescribed in 9 CFR
417.5(e).
If this proposed rule becomes final,
foreign countries that export meat and
poultry products to the United States
will be expected to establish
requirements equivalent to those that
FSIS is proposing in this rulemaking, or
to establish why their system remains
equivalent if they fail to do so.
16 See
§ 417.5(f).
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Executive Order 12866 and Regulatory
Flexibility Act
This rule was reviewed by the Office
of Management and Budget (OMB)
under Executive Order 12866 and was
determined to be significant.
I. Background
The Food, Conservation, and Energy
Act of 2008 (Pub. L. 110–246, Sec.
11017), known as the 2008 Farm Bill,
amended the Federal Meat Inspection
Act (FMIA) and the Poultry Products
Inspection Act (PPIA) to require
establishments subject to inspection
under these Acts to promptly notify the
Secretary of Agriculture that an
adulterated or misbranded product
received by or originating from the
establishment has entered into
commerce, if the establishment believes
or has reason to believe that this has
happened. Section 11017 also requires
establishments subject to inspection
under the FMIA and PPIA to: (1)
Prepare and maintain procedures for the
recall of all products produced and
shipped by the establishment; (2)
document each reassessment of the
process control plans of the
establishment (i.e., HACCP plans); and
(3) upon request, make the procedures
and reassessed control plans available
for inspectors appointed by the
Secretary to review and copy.
II. What Is Being Proposed
This proposed action will amend 9
CFR 417.4 (a)(3) to require that every
establishment make a written record of
each reassessment of the adequacy of its
process control plan, i.e., HACCP plan,
or to document the reasons for not
making a change to the HACCP plan
based on the reassessment (except for
annual reassessments of the HACCP
plan, for which, if no change is found
necessary, only the fact that the
reassessment occurred need be
documented). It will also establish a
new 9 CFR Part 418, Recalls, under
which official establishments will have
to promptly notify FSIS that an
adulterated or misbranded product
received by or originating from the
establishment has entered into
commerce, if the establishment believes
or has reason to believe that this has
happened, and prepare and maintain
current procedures for the recall of
products produced and shipped by the
establishment if there is a reason to
believe that its product are adulterated
or misbranded.
III. Need for the Proposed Rule
• FSIS believes that prompt
notification that adulterated or
misbranded product has entered
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14363
commerce is an important prerequisite
for effective action to prevent such
product from causing harm.
• Having established procedures will
help establishments to conduct effective
and efficient recalls, should it be
necessary for them to do so.
• Moreover, records of reassessments
will help establishment and Agency
personnel to assess the adequacy and
appropriateness of what has been done.
IV. Baseline
FSIS expects that this proposed rule
will affect about 6,300 official
establishments that slaughter or process
meat, meat food, poultry, and poultry
products, based on FSIS’s Performance
Based Inspection System (PBIS) of 2008.
Based on HACCP classification, about
400 are large establishments, 3,044 are
small, and 2,856 are very small (Table
3).
V. Expected Costs
Under the current regulations, the
development and maintenance of recall
procedures and the written
documentation of HACCP reassessments
are voluntary. This proposed rule will
make them mandatory. Costs occur
because about 6,300 official
establishments will need to develop
recall procedures, maintain written
documentation of HACCP
reassessments, and make the records
accessible to the Agency’s review. The
Agency used in this analysis the best
available data, based on discussions
with FSIS experts. FSIS solicits costs
data from other sources to be sure that
the Agency is using the best available
data. The methodology of the labor cost
estimates is as follows:
(1) Developing Recall Procedures =
Number of establishments 17 ×
hours 18 × wage rate 19
(2) Documenting HACCP Reassessment
= Number of establishments × hours
× response rate 20 × wage rate
(3) Records Backup and Storage =
Number of establishments × hours ×
response rate × wage rate
Since estimates of all of the above
factors are provided by experts in the
related fields, not collected directly
from related establishments, FSIS
invites comments and inputs from
industries likely to improve the cost
17 The number of establishments is the number of
Federally-inspected processing and slaughter
establishments.
18 Hours are labor hours likely spent on the
required provisions.
19 The wage rate is estimated according to the
current labor market and the nature of work,
including all non-salary benefits to workers.
20 Response rate is the projected frequencies of an
action within a year.
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estimation. In particular, FSIS welcomes
comments on the total cost and the
annual cost estimation related to the
notification, documentation, and
recordkeeping provisions affected by
this proposed rule.
The cost of notifying FSIS, with a few
phone calls, facsimiles, and e-mails
about questionable products in
commerce is negligible. FSIS certifies
that there will be no impact on the
Agency’s operational costs resulting
from this proposed rule, because the
Agency will not need to add any staff
or incur any non-labor expenditure if
the proposed rule is adopted.
In addition to the labor cost, FSIS
estimates that the extra material cost
would be about 1 percent of the labor
cost of the development of the recall
procedures and the documenting of
each reassessment or the documenting
that no changes to the HACCP plan were
found necessary based on the
reassessment. For the cost estimation of
records backup and storage, the ratio of
labor cost versus material cost was
estimated to be 2:1, or 2 thirds labor cost
versus 1 third material cost. These costs
are significantly mitigated by the fact
that FSIS has guidance materials on
preparing recall plans available. See
footnote 16, above. The material cost
would mostly be paper, ink, and
electronic storage media. The estimated
total average costs of about $5 million
for labor and $76 thousand for materials
are shown in Table 1.
Considering the facts that: (1) Some
unknown number of establishments
already have plans which could likely
be adequate with little or no change, (2)
establishments in the meat and poultry
industries have differing levels of
expertise in writing HACCP plans, (3)
the Agency makes model recall plans
available to the industry, and (4)
establishments have a range of different
processes for producing meat and
poultry products, FSIS believes that the
estimated cost of developing recall
procedures tends to be overstated by
using the maximum number of
establishments. However, given the
uncertainty of incurred labor cost in
different regions and with various
experience levels, FSIS assumes a 20%
range, or plus and minus 10%, of the
estimated average-compliance cost. The
estimated cost summary is shown in
Table 2.
FSIS expects that in the first year of
the proposed rule, one-time costs for
developing recall procedures would cost
the industry of approximately 6,300
establishments $4.5 million, in an
estimated range of $4.0 and $4.9
million, 10% lower and upper bound,
respectively. Furthermore, the proposed
rule would have first year and recurring
costs of approximately $0.5 million for
documenting periodical reassessments
of HACCP plans, and $0.1 million for
records backup and storage, although
these costs may well be overstated.
Thus, the total cost for the first year is
$5.0 ($4.4 + $0.5 +$0.1) million, in an
estimated range of $4.6 and $5.6
million, 10% lower and upper bound,
respectively. The average cost adjusted
with a 3% inflation rate of following
years would be $0.7 ($0.5 + $0.2)
million, in an estimated range of $0.6
and $0.8 million, 10% lower and upper
bound, respectively (Table 2).
The present value of total estimated
costs with a 3% discount rate for 10
years would be $4.3 million, in an
estimated range of $3.9 and $4.8
million, 10% lower and upper bound,
respectively. The present value of
estimated costs with a 7% discount rate
for 10 years would be $3.6 million, in
an estimated range of $3.2 and $3.9
million, 10% lower and upper bound,
respectively. The above present values
of estimated costs were calculated in
year 2003 dollars, with 7% and 3%
discount rates, in accordance with OMB
Circular A–4 requirements (Table 2).
Table 3 shows the drilled-down costs
in establishment size, of which $0.3
million is attributed to large, $2.5
million to small, and $2.3 million to
very small establishments. The cost per
official establishment is between $700
and $900, 10% lower and upper bound,
respectively.
Table 4 gives the estimated annual
and total cost by establishment size
classes for the first five years. Table 4,
column 4, shows all cost categories of
the first year (assumed to be 2010) and
comes from Table 3 column 3,
distributed by the counts of
establishment size classes. The costs of
following year, in Table 4, columns 5–
8, are based on annual recurring costs
(Table 2), compounded at the 3%
inflation rate for the following four
years. FSIS expects that the first five
years of the proposed rule, if adopted,
would cost the industry of
approximately 6,300 establishments
$7.9 million, in an estimated range of
$7.1 and $8.7 million, 10% lower and
upper bound, respectively. The present
value of a 2009 dollar at 7% is $5.6
million, in the range of $5.1 million to
$6.2 million, minus and plus 10%,
respectively. The present value of a
2009 dollar at 3% is $6.8 million, in the
range of $6.1 million to $7.5 million,
minus and plus 10%, respectively. Total
costs of the first five years for small/very
small and large establishments as a
central estimate are $7.4 million and
$0.5 million, respectively; the average
recurring cost after the first year for
small/very small and large
establishments will be $0.7 million and
$0.04 million, respectively.
TABLE 1—FIRST YEAR COST BREAK-DOWN, IN DOLLARS, FOR 6,300 ESTABLISHMENTS
Response
rate
Required
man
hours
Wage
rate
Factor for
paper, ink
& media
cost
Material
(paper, ink &
media) cost
(×$1,000)
Total cost
(×$1,000)
(1)
Cost component
(2)
(3)
(4)
(5)=(4)×(6)
(6)=(1)×(2)×(3)×(4)×6.3
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Recall-Procedures development (one-time) ......
Documenting Reassessment .............................
Records backup and storage .............................
1
5
1
20
0.25
0.25
35
60
35
1.01
1.01
1.5
44
5
28
4,454
477
83
Total ............................................................
................
................
................
................
77
5,014
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TABLE 2—ESTIMATED FIRST YEAR TOTAL COST AND AVERAGE COST OF FOLLOWING YEAR
Low-range
estimate
(¥10%)
Total cost
(×$ million)
(A) Recall-Procedures development (one-time) ..........................................................................
(B) Documenting Reassessment .................................................................................................
(C ) Records backup and storage ...............................................................................................
(D) First Year Cost (Total) (D=A+B+C)* ......................................................................................
Average Cost of Following Years (for next 10 years) .................................................................
Present Value (2003) at 3% ........................................................................................................
Present Value (2003) at 7% ........................................................................................................
4.4
0.5
0.1
5.0
0.7
4.3
3.6
High-range
estimate
(+10%)
4.0
0.4
0.1
4.6
0.6
3.9
3.2
4.9
0.5
0.1
5.6
0.8
4.8
3.9
* Note: Summation is subject to rounding error.
TABLE 3—NUMBER OF ESTABLISHMENTS, AND TOTAL AND AVERAGE COST IN SIZE (× $1,000)
Number of
establishments
Recall
procedures
development
(one-time)
Documenting
HACCP
reassessment
Very Small ....................................
Small ............................................
Subtotal ........................................
Large ............................................
2,856
3,044
5,900
400
2,030
2,164
4,194
260
218
232
449
28
38
40
78
5
2,285
2,436
4,721
293
0.8
0.8
0.8
0.8
0.7
0.7
0.7
0.7
0.9
0.9
0.9
0.9
Total .............................................
6,300
4,454
477
83
5,014
0.8
0.7
0.9
HACCP class
Records
backup
and
storage
Total cost
Cost per
establishment
Low
estimates
(¥10%)
High
estimates
(+10%)
TABLE 4—ESTIMATED ANNUAL AND 5-YEAR TOTAL COST BY ESTABLISHMENT SIZE CLASSES (×$1,000), ASSUMING
INFLATION RATE = 3%
Number
of Establishments
Small .............................
2,856
3,044
2nd Year
(2011)
3rd Year
(2012)
4th Year
(2013)
5th Year
(2014)
Recall-Procedures development & updating .............
Documenting HACCP Reassessment .......................
Records backup and storage ....................................
2,030
218
38
278
30
5
286
31
5
295
32
5
304
33
6
3,193
342
59
2,285
313
322
332
342
3,594
Recall-Procedures development & updating .............
Documenting HACCP Reassessment .......................
Records backup and storage ....................................
2,164
232
40
296
32
5
305
33
6
314
34
6
324
35
6
3,403
365
63
Subtotal ..............................................................
Very Small .....................
1st Year
(2010)
Subtotal ..............................................................
HACCP Class
2,436
333
343
354
364
3,831
Activities
5-Year
Total
Small & Very Small .......
5,900
Subtotal .....................................................................
4,721
646
666
686
706
7,425
Large .............................
400
Recall-Procedures development & updating .............
Documenting HACCP Reassessment .......................
Records backup and storage ....................................
260
28
5
36
4
1
37
4
1
38
4
1
39
4
1
409
44
8
Subtotal ..............................................................
293
40
41
43
44
461
Total All .........................
6,300
Recall-Procedures development & updating .............
Documenting HACCP Reassessment .......................
Records backup and storage ....................................
4,454
477
83
610
65
11
628
67
12
647
69
12
666
71
12
7,005
751
130
Total ...................................................................
5,014
686
707
728
750
7,886
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VI. Expected Benefits
Expected benefits will likely result
from this proposed rule, which is
intended to improve the effectiveness of
the nation’s food safety system for meat
and poultry products. These benefits
will not be monetized in this section
because quantified data on benefits
attributable to this proposed rule are not
available to FSIS. FSIS solicits data that
would permit the monetization of the
expected benefits. However, without
VerDate Nov<24>2008
16:39 Mar 24, 2010
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discussing monetized benefits, FSIS
would expect to gain the following
benefits related to:
HACCP Reassessment and
Documentation of Reassessments
While HACCP reassessment is already
required by 9 CFR 417, requiring
establishments to document in writing
each reassessment of their HACCP plans
or the reasons for not making changes to
the HACCP plan based on the
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reassessment will allow establishment
supervisory and audit personnel, as well
as FSIS personnel, to verify that
establishments are, in fact, reassessing
those plans at least annually, as
required by § 417.4(a)(3), and that they
are appropriately assessing their
findings when they do (although FSIS is
proposing not to require an explanation
if no change is made to the HACCP plan
on the basis of the annual reassessment).
Requiring these written reassessments to
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Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Proposed Rules
be made available to inspection program
personnel ensures that the records are
prepared and available.
Notification Requirement
In addition, this proposed rule will
likely be a preventive measure that will
result in FSIS being alerted to potential
meat and poultry recall situations
earlier than otherwise is the case today.
If this proposed rule is adopted,
establishments will be required to notify
the local FSIS District Office within 48
hours of learning or determining that an
adulterated or misbranded product
received by or originating from the
establishment has entered commerce, if
the establishment believes or has reason
to believe that this has happened. This
notification, in turn, will allow FSIS to
begin coordinating more rapidly
preliminary inquiries to determine
whether a recall is necessary.
Improve Recall Effectiveness With
Documented Procedures
FSIS expects that this proposed rule
will likely assist meat and poultry
establishments during recalls. By
requiring these establishments to
prepare and maintain recall procedures
for all products they produce, FSIS
expects that establishments that do not
currently have such plans will likely be
able to act more effectively to remove
adulterated or misbranded products
from commerce. This added efficiency
and effectiveness should help
establishments to move quickly to
disseminate information about the need
to return the product to it and thus
maximize the amount of product it will
be able to recover. Table 5 gives a
summary of the benefits discussed
above.
TABLE 5—SUMMARY OF BENEFITS
Benefit related to:
Required actions:
Expected benefits:
Document Reassessment .................................
• Establishments are to document all reassessments of HACCP plans.
• Establishments are to make the documentation of the HACCP plans available to inspection program personnel.
• FSIS is to verify that establishments are, in
fact, reassessing their HACCP plans at
least annually.
• Establishments are to notify the local FSIS
District Office within 48 hours of learning or
determining that an adulterated or misbranded product received by or originating
from the official establishment has entered
commerce.
• Establishments are to prepare and maintain
recall procedures for all products they
produce.
• Improved HACCP systems for establishments.
Disposition Reporting System (ADRS,
2008) 22 database, and volume estimates
of the USDA Economic Research Service
(ERS, 2009),23 these 5,900 small entities
process about 12 percent or about 8
billion pounds of the U.S. meat and
poultry food supply per annum.
Further, FSIS estimated that the average
processing volume per establishment of
5,900 small entities was about 1.4
million pounds (8,000,000,000/5,900)
per annum. Thus, the average cost for
the first year of this proposed rule to
small entities will be less than one tenth
of one cent (i.e., $0.0006 = $800/
1,400,000) of meat and poultry food
products per pound. This is a relatively
insignificant cost to the small entities
because most of their meat and poultry
food products are valued at more than
$1.00 per pound. The average cost for
the following years, based on annual
recurring costs, decreases to less than
one hundredth of one cent per pound.
Notification Requirement ...................................
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Improve Recall Effectiveness ............................
VII. Flexibility Analysis
The FSIS Administrator has certified
that this proposed rule will not have a
significant impact on a substantial
number of small entities, as defined by
the Regulatory Flexibility Act (5 U.S.C.
601).
These small entities are about 5,900
federally-inspected establishments. The
average cost to small and very small
businesses will be in the range of $700
to $900, 10% lower and upper bound,
respectively (Table 3). FSIS invites
small (with more employees than 10 but
less than 500) and very small (with
fewer than 10 employees)
establishments to comment on the cost
estimation of documentation and
reassessment required under the
proposed rule.
Based on data recorded in the PBIS
(2007) 21 volume database, and slaughter
volume recorded in the FSIS Animal
21 USDA, FSIS Performance Based Inspection
System Volume Database 2007.
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16:39 Mar 24, 2010
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22 USDA, FSIS Animal Disposition Reporting
System Database 2008.
23 USDA, Economic Research Service, Food
Availability (Per Capita) Data System—Per capita
food availability data compiled reflect the amount
of food available for human consumption in the
United States. March 2009, https://
www.ers.usda.gov/Data/FoodConsumption.
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• FSIS will be alerted to potential meat or
poultry recall situations earlier than otherwise is the case today.
• FSIS will be able to begin coordinating
more rapidly preliminary inquiries to determine whether a recall is necessary.
• Establishments will likely be able to act
more effectively to remove adulterated or
misbranded products from commerce.
• Establishments may be able to move more
quickly to disseminate information about the
need to return the product to it.
• Establishments may be able to maximize
the amount of product they will be able to
recover.
VIII. Alternatives
The option of no rulemaking is
unavailable. FSIS was directed to
conduct this rulemaking by Congress.
Executive Order 12988
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. When this final rule is adopted:
(1) All State and local laws and
regulations that are inconsistent with
this rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) administrative proceedings
will not be required before parties may
file suit in court challenging this rule.
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Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Proposed Rules
Paperwork Requirements
In accordance with section 3507(j) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection and recordkeeping
requirements included in this proposed
rule have been submitted for approval to
OMB.
Title: Notification, and Recall
Procedure and HACCP Reassessment
Documentation Requirements.
Type of Collection: New.
Abstract: Under this proposed rule,
FSIS is requiring three information
collection activities. First, FSIS is
proposing to require that official
establishments notify the appropriate
District Office that an adulterated or
misbranded product received by or
originating from the establishment has
entered commerce, if the establishment
believes or has reason to believe that
this has happened. FSIS is proposing
that this notification occur as quickly as
possible, but within 48 hours of the
establishment learning or determining
that an adulterated or misbranded
product received by or originating from
it has entered commerce. Second, FSIS
is also proposing that establishments
prepare and maintain current, written
procedures for the recall of meat and
poultry products produced and shipped
by the establishment for use should it
become necessary for the establishment
to remove product from commerce.
These written recall procedures will
have to specify how the establishment
will decide whether to conduct a
product recall and how the
establishment will effect the recall,
should it decide that one is necessary.
Finally, FSIS is proposing that
establishments document each
reassessment of the establishment’s
HACCP plans. The Agency is proposing
to require that establishments document
the reasons for any changes that they
make to their HACCP plans based on the
reassessment, or if they did not make
any changes, that they document the
reasons that they did not (although FSIS
is proposing not to require an
explanation if no change is made to the
HACCP plan on the basis of the annual
reassessment). The recall procedures
and reassessment documentation will
have to be made available for official
review and copying.
Estimate of Burden of Average Hours
per Response: 1.159.
Respondents: Official meat and
poultry products establishments.
Estimated Number of Respondents:
6,300.
Estimated Number of Responses:
40,960.
Estimated Number of Responses per
Respondent: 6.5.
VerDate Nov<24>2008
16:39 Mar 24, 2010
Jkt 220001
Estimated Total Annual Burden on
Respondents: 47,475.
Copies of this information collection
assessment can be obtained from John
O’Connell, Paperwork Reduction Act
Coordinator, Food Safety and Inspection
Service, USDA, Room 6081, South
Agriculture Building, 1400
Independence Avenue, SW.,
Washington, DC 20250.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of FSIS’s functions, including whether
the information will have practical
utility; (b) the accuracy of FSIS’s
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.
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
E–Government Act Compliance
The Food Safety and Inspection
Service is committed to complying with
the E-Government Act, to promote the
use of the Internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
ensure that minorities, women, and
persons with disabilities are aware of
this notice, FSIS will announce it online
through the FSIS Web page located at
https://www.fsis.usda.gov/regulations/
2010_Proposed Rules_Index/. 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
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14367
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 that 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.
List of Subjects in 9 CFR Parts 417 and
418
Hazard Analysis and Critical Control
Point (HACCP) Systems, Meat
inspection, Poultry and poultry
products inspection, Reporting and
recordkeeping requirements, Recalls.
For the reasons discussed in the
preamble, FSIS is proposing to amend 9
CFR Chapter III, as follows:
1. The authority citation for part 417
continues to read as follows:
Authority: 7 U.S.C. 450; 21 U.S.C. 451–
470, 601–695; 7 U.S.C. 1901–1906; 7 CFR
2.18, 2.53.
2. In § 417.4, paragraph (a)(3) is
redesignated as paragraph (a)(3)(i), and
a new paragraph (a)(3)(ii) is added to
read as follows:
§ 417.4 Validation, Verification,
Reassessment.
*
*
*
*
*
(a) * * *
(3) Reassessment of the HACCP plan.
(i) * * *
(ii) Each establishment shall make a
record of each reassessment required by
paragraph (a)(3)(i) of this section and
shall document the reasons for any
changes to the HACCP plan based on
the reassessment, or the reasons for not
changing the HACCP plan based on the
reassessment; for annual reassessments,
if the establishment determines that no
changes are needed to its HACCP plan,
it may briefly document this
determination.
*
*
*
*
*
3. A new part 418 is added to read as
follows:
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Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Proposed Rules
PART 418—RECALLS
DEPARTMENT OF ENERGY
Sec.
418.1 [Reserved]
418.2 Notification.
418.3 Preparation and maintenance of
current, written recall procedures.
418.4 Records.
10 CFR Part 431
[Docket No. EERE–2008–BT–STD–0006]
RIN 1904–AB47
Energy Conservation Standards for
Residential Central Air Conditioners
and Heat Pumps: Public Meeting and
Availability of the Preliminary
Technical Support Document
Authority: 7 U.S.C. 450; 21 U.S.C. 451–
470, 601–695; 7 CFR 2.18, 2.53.
§ 418.1
[Reserved]
§ 418.2
Notification.
Each official establishment shall
promptly notify the local FSIS District
Office (see 9 CFR 300.3(c)) within 48
hours of learning or determining that an
adulterated or misbranded meat, meat
food, poultry, or poultry product
received by or originating from the
official establishment has entered
commerce, if the official establishment
believes or has reason to believe that
this has happened. The official
establishment shall inform the District
Office of the type, amount, origin, and
destination of the adulterated or
misbranded product.
§ 418.3 Preparation and maintenance of
current, written recall procedures.
Each official establishment shall
prepare and maintain written
procedures for the recall of any meat,
meat food, poultry, and poultry product
produced and shipped by the official
establishment for use should it become
necessary for the official establishment
to remove product from commerce.
These written procedures shall specify
how the official establishment will
decide whether to conduct a product
recall, and how the establishment will
effect the recall, should it decide that
one is necessary.
§ 418.4
Records.
All records, including records
documenting procedures required by
this part, shall be available for official
review and copying.
Done in Washington, DC, on March 19,
2010.
Alfred V. Almanza,
Administrator.
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[FR Doc. 2010–6629 Filed 3–24–10; 8:45 am]
BILLING CODE 3410–DM–P
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16:39 Mar 24, 2010
Jkt 220001
AGENCY: Office of Energy Efficiency and
Renewable Energy, Department of
Energy.
ACTION: Notice of public meeting and
availability of preliminary technical
support document.
SUMMARY: The U.S. Department of
Energy (DOE) will hold a public meeting
to discuss and receive comments on the
product classes that DOE plans to
analyze for purposes of establishing
energy conservation standards for
residential central air conditioners and
heat pumps; the analytical framework,
models, and tools that DOE is using to
evaluate amended standards for these
products; the results of preliminary
analyses performed by DOE for these
products; and potential energy
conservation standard levels derived
from these analyses that DOE could
consider for these products. DOE also
encourages written comments on these
subjects. DOE has prepared a
preliminary technical support document
(TSD), which is available at:
https://www1.eere.energy.gov/
buildings/appliance_standards/
residential/central_ac_hp.html.
DATES: DOE will hold a public meeting
on Wednesday, May 5, 2010, from 9
a.m. to 5 p.m. in Washington, DC. Any
person requesting to speak at the public
meeting should submit such request,
along with an electronic copy of the
statement to be given at the public
meeting, before 4 p.m., Wednesday,
April 21, 2010. Written comments are
welcome, especially following the
public meeting, and should be
submitted by May 10, 2010.
ADDRESSES: The public meeting held at
the U.S. Department of Energy, Forrestal
Building, Room GE–086, 1000
Independence Avenue, SW.,
Washington, DC 20585–0121. Please
note that foreign nationals participating
in the public meeting are subject to
advance security screening procedures.
If a foreign national wishes to
participate in the public meeting, please
inform DOE of this fact as soon as
possible by contacting Ms. Brenda
Edwards at (202) 586–2945 so that the
necessary procedures can be completed.
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Interested persons may submit
comments, identified by docket number
EERE–2008–BT–STD–0006, by any of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov Follow the
instructions for submitting comments.
• E-mail:
Brenda.Edwards@ee.doe.gov Include
EERE–2008–BT–STD–0006 in the
subject line of the message.
• Postal Mail: Ms. Brenda Edwards,
U.S. Department of Energy, Building
Technologies Program, Mailstop EE–2J,
Public Meeting for Residential Central
Air Conditioners and Heat Pumps,
EERE–2008–BT–STD–0006, 1000
Independence Avenue, SW.,
Washington, DC 20585–0121.
Telephone (202) 586–2945. Please
submit one signed paper original.
• Hand Delivery/Courier: Ms. Brenda
Edwards, U.S. Department of Energy,
Building Technologies Program, Sixth
Floor, 950 L’Enfant Plaza, SW.,
Washington, DC 20024. Telephone (202)
586–2945. Please submit one signed
paper original.
Instructions: All submissions must
include the agency name and docket
number.
Docket: For access to the docket to
read background documents or a copy of
the transcript of the public meeting or
comments received, go to the U.S.
Department of Energy, Sixth Floor, 950
L’Enfant Plaza, SW., Washington, DC
20024, (202) 586–2945, between 9 a.m.
and 4 p.m., Monday through Friday,
except Federal holidays. Please call Ms.
Brenda Edwards at (202) 586–2945 for
additional information regarding
visiting the Resource Room.
FOR FURTHER INFORMATION CONTACT:
Direct requests for additional
information to Mr. Wes Anderson, U.S.
Department of Energy, Office of Energy
Efficiency and Renewable Energy,
Building Technologies, EE–2J, 1000
Independence Avenue, SW.,
Washington, DC 20585–0121, (202) 586–
7335. E-mail:
Wes.Anderson@ee.doe.gov. In the Office
of General Counsel, contact Ms.
Elizabeth Kohl, U.S. Department of
Energy, Office of General Counsel, GC–
71, 1000 Independence Avenue, SW.,
Washington, DC 20585, (202) 586–7796.
E-mail: Elizabeth.Kohl@hq.doe.gov.
SUPPLEMENTARY INFORMATION:
A. Statutory Authority
Part A of Title III of the Energy Policy
and Conservation Act (42 U.S.C. 6291 et
seq.) (EPCA) established the Energy
Conservation Program for Consumer
Products Other than Automobiles.
Amendments expanded Title III of
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]]>Agencies
[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Proposed Rules]
[Pages 14361-14368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6629]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 /
Proposed Rules
[[Page 14361]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 417 and 418
[FDMS Docket Number FSIS-2008-0025]
RIN 0583-AD34
Notification, Documentation, and Recordkeeping Requirements for
Inspected Establishments
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
implement provisions of the Food, Conservation, and Energy Act of 2008
by adopting regulations that require official establishments to
promptly notify the appropriate District Office that an adulterated or
misbranded meat or poultry product has entered commerce; require
official establishments to prepare and maintain current procedures for
the recall of meat and poultry products produced and shipped by the
establishment; and require official establishments to document each
reassessment of the establishment's process control plans, that is, its
Hazard Analysis and Critical Control Point plans.
DATES: Comments due on or before May 24, 2010.
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: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including CD-ROMs, and hand- or courier-delivered
items: Send to Docket Clerk, U.S. Department of Agriculture (USDA),
FSIS, Room 2-2127 George Washington Carver Center, 5601 Sunnyside
Avenue, Beltsville, MD 20705.
Instructions: All items submitted by mail or via Regulations.gov
must include the Agency name and docket number FSIS-2008-0025. 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:
Background
FSIS administers the Federal Meat Inspection Act (FMIA) (21 U.S.C.
601-695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-
470), and the regulations that implement these Acts. Under these
statutes and rules, the Agency is responsible for ensuring that the
nation's commercial supply of meat and poultry is safe, not
adulterated, wholesome, and properly marked, labeled, and packaged.
On June 18, 2008, section 11017 of the Food, Conservation, and
Energy Act of 2008, Public Law 110-246, 122 Stat 1651, 448-49,
otherwise known as the 2008 Farm Bill, amended the FMIA and the PPIA by
adding new sections 12 and 13 to the FMIA (21 U.S.C. 612 and 613) and
amending section 10 of the PPIA (21 U.S.C. 459). Section 12 of the
amended FMIA and section 10(b) of the amended PPIA require
establishments subject to inspection under the Acts that believe, or
have reason to believe, that an adulterated or misbranded meat, meat
food, poultry, or poultry product received by or originating from the
establishment has entered into commerce, to promptly notify the
Secretary of Agriculture of that belief. They also require these
establishments to inform the Secretary of the type, amount, origin, and
destination of the adulterated or misbranded product.
Section 13 of the amended FMIA and section 10(c) of the amended
PPIA also require establishments subject to inspection under these
statutes to: (1) Prepare and maintain current procedures for the recall
of all meat, meat food, poultry, and poultry products produced and
shipped by the establishment; (2) document each reassessment of the
establishment's process control plans, i.e., its Hazard Analysis and
Critical Control Point (HACCP) plans; and (3) make the recall
procedures and written records of the establishment's HACCP plan
reassessments available for official review and copying.
FSIS is proposing regulations to implement these new statutory
provisions. Establishments subject to inspection under the Acts are
official meat \1\ and poultry products \2\ establishments.
---------------------------------------------------------------------------
\1\ 9 CFR 301.2. Official establishment means any slaughtering,
cutting, boning, meat canning, curing, smoking, salting, packing,
rendering, or similar establishment at which inspection is
maintained under the regulations in this subchapter.
\2\ 9 CFR 381.1. Official establishment means any establishment
as determined by the Administrator at which inspection of the
slaughter of poultry, or the processing of poultry products, is
maintained pursuant to the regulations.
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I. Notification Requirement
The FMIA and PPIA, and their implementing regulations, prohibit the
sale, transport, offer for sale or transportation, or receipt for
transportation in commerce of any meat, meat food, poultry, or poultry
products (hereinafter referred to as meat or poultry products) that are
capable of use as human food and are adulterated or misbranded at the
time of such sale, transportation, offer for sale or transportation, or
receipt for transportation by any person,\3\ firm,\4\ or
corporation.\5\ The FMIA also prohibits the importation of adulterated
or misbranded \6\ meat and meat food products, while the PPIA prohibits
the importation of adulterated \7\ poultry or poultry products.
Imported meat and poultry products must also ``* * *
[[Page 14362]]
comply with the rules and regulations made by the Secretary of
Agriculture to assure that they comply with the standards provided for
in * * *'' the Act, including the misbranding provision found in 21
U.S.C. 458(a)(2).
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\3\ 21 U.S.C. 453(j). A person is ``any individual, partnership,
corporation, association, or other business unit.''
\4\ 21 U.S.C. 601(b). A firm is ``any partnership, association,
or other unincorporated business organization.''
\5\ 21 U.S.C. 610(c)(1) and 9 CFR 320.7, and 21 U.S.C. 458(a)(2)
and 9 CFR 381.181.
\6\ 21 U.S.C. 620(a)
\7\ 21 U.S.C. 466(a)
---------------------------------------------------------------------------
While the Federal meat and poultry products inspection regulations
have provisions that address the receipt of adulterated or misbranded
products by an official establishment or consignee under specific
circumstances,\8\ they do not explicitly require establishments subject
to inspection under the FMIA or PPIA to notify FSIS \9\ when an
adulterated or misbranded product received by or originating from the
establishment has entered commerce. Therefore, in accordance with
section 11017 of the 2008 Farm Bill and the newly enacted sections 12
of the FMIA and 10(b) of the PPIA, FSIS is proposing to require that
official establishments promptly notify the appropriate District Office
that an adulterated or misbranded product received by or originating
from the establishment has entered commerce, if the establishment
believes or has reason to believe that this has happened. FSIS is also
proposing to require that the establishment inform the District Office
of the type, amount, origin, and destination of the adulterated or
misbranded product.\10\
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\8\ See, e.g., 9 CFR 318.1(j), ``If any slaughtered poultry or
poultry products or other articles are received at an official
establishment and are suspected of being adulterated or misbranded
under the Poultry Products Inspection Act or the Federal Food, Drug,
and Cosmetic Act, or applicable State law, the appropriate
governmental authority will be notified.'' See also 9 CFR 320.7 and
381.181, which require the consignee of any product that bears an
official inspection legend that refuses to accept the delivery of
the product on the grounds that it may be adulterated or misbranded
to notify the Inspector in Charge of the kind, quantity, source, and
present location of the product and the respects in which it is
alleged to be adulterated or misbranded.
\9\ The functions of the Secretary of Agriculture contained in
the FMIA and the PPIA are delegated to the Under Secretary for Food
Safety in 7 CFR 2.18. These functions, in turn, are delegated to the
Administrator, Food Safety and Inspection Service in 7 CFR 2.53.
\10\ Proposed 9 CFR 418.2.
---------------------------------------------------------------------------
If this proposed rule becomes final, the required information
concerning the type of product will need to include the product name,
any code or lot numbers on the individual packages or cases, and the
type and size of the packages. Information concerning the origin and
destination of the product will need to include the official
establishment numbers and addresses of both the producing establishment
and the receiving establishment, or, if the product is not going, or is
not only going, to an official establishment, the names and addresses
of any facilities to which the product has been shipped.
The new notification provisions of the FMIA and PPIA do not provide
an explicit timeframe within which notification must be given. However,
the purpose of notification is to ensure that potentially adulterated
or misbranded product is removed from commerce as quickly as possible.
Thus, FSIS is proposing to require that official establishments notify
the appropriate District Office as quickly as possible, but within 48
hours of learning or determining that an adulterated or misbranded
product received by or originating from the establishment has entered
commerce. FSIS requests comment on whether 48 hours is an appropriate
time in which to expect official establishments that have shipped or
received, or have reason to believe that they have shipped or received,
adulterated or misbranded product, to notify the appropriate District
Office of that situation.
II. Documentation and Recordkeeping
A. Recall Procedures
The FMIA and PPIA require Federal inspection \11\ and provide for
Federal regulation of meat and poultry products prepared for
distribution in commerce for use as human food.\12\ Before enactment of
the 2008 Farm Bill, there was no requirement that official
establishments prepare and maintain written procedures for the recall
of meat and poultry products produced and shipped by them, although
FSIS strongly recommended that establishments do so. Such a plan
involves preparing and maintaining detailed, written recall plans or
procedures that specify how the firm will decide whether to conduct a
product recall, and how the establishment will effect the recall should
it decide that one is necessary.\13\
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\11\ 21 U.S.C. 603(a), 604, 606, and 455.
\12\ 21 U.S.C. 602 and 451.
\13\ See Attachment 1 to FSIS Directive 8080.1, Revision 5,
Product Guidelines for Firms, which discusses the elements that
should be addressed by a recall plan.
---------------------------------------------------------------------------
Under newly enacted section 13 of the FMIA and section 10(c) of the
PPIA, the preparation and maintenance of written, up-to-date recall
procedures are mandatory. Therefore, FSIS is proposing to require that
official meat and poultry establishments prepare and maintain written
procedures for the recall of meat or poultry products produced or
shipped by an establishment for use should it become necessary for the
establishment to remove such products from commerce. FSIS is proposing
to require that these written procedures specify how the official
establishment will decide whether to conduct a product recall, and how
the establishment will effect the recall. Consistent with the 2008 Farm
Bill, the proposed rule requires that these procedures be available for
official review and copying.
Under the proposed rule, recall procedures will not have to be
included in an establishment's HACCP plan or used as a prerequisite
program, as long as each official establishment has procedures that
meet the requirements of 9 CFR 418.2. These could, however, be
incorporated into HACCP plans or prerequisite programs as corrective
actions to be followed to address deviations that resulted in the
shipment of adulterated or misbranded product in commerce. 9 CFR 417.3
requires that HACCP plans identify corrective actions to be followed in
response to a deviation from a critical limit.
FSIS requests comment on when, after the effective date of this
rule, assuming it becomes final, written recall procedures must be
completed in accordance with proposed Sec. 418.3. FSIS is also seeking
comment as to within what time from new establishments must prepare
written recall procedures.
B. Process Control Plans
HACCP is a science-based process control system for food safety
that promotes systematic prevention of biological, chemical, and
physical hazards. HACCP plans are establishment-developed process
control plans designed to identify and prevent hazards before they
occur and to correct problems if they are detected.
FSIS requires every official establishment to develop and implement
a written HACCP plan covering each product produced by that
establishment whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur in the production
process.\14\ Official establishments must reassess the adequacy of
their HACCP plans at least annually and whenever any changes occur that
could affect the hazard analysis or alter the HACCP plan.\15\ 9 CFR
417.4(a)(3) contains examples of changes that could affect the hazard
analysis or alter the HACCP plan.
---------------------------------------------------------------------------
\14\ 9 CFR 417.2(b)(1).
\15\ 9 CFR 417.4(a)(3).
---------------------------------------------------------------------------
FSIS has, on occasion, notified the public when changes have
occurred that could affect the hazard analysis or alter the HACCP plans
for particular products. For example, FSIS notified the public of the
availability of new scientific data indicating that
[[Page 14363]]
Escherichia coli (E. coli) O157:H7 was more prevalent than was
previously thought (67 FR 62326, Oct. 7, 2002) and notified the public
of E. coli O157:H7 outbreaks associated with the consumption of
mechanically tenderized beef (70 FR 30331, May 26, 2005).
Under FSIS's regulations, the reassessment required by 9 CFR
417.4(a)(3) does not have to be documented. The 2008 Farm Bill changes
this situation. It requires that official establishments document each
reassessment of their process control plans. Therefore, this rule
proposes to require that official establishments make a written record
when they perform reassessment as required by 9 CFR 417.4(a)(3) or for
any other reason. The Agency is proposing to require that
establishments document the reasons for any changes that they made to
their HACCP plans based on the reassessment, or, if they did not make
any changes, that they document the reasons that they did not. If,
however, an establishment performs its annual reassessment and
determines that no changes are needed to its HACCP plan, it may briefly
state this fact in lieu of more extensive documentation. Consistent
with the statute, official establishments must make all documentation
of the reassessment available for official review and copying.\16\
---------------------------------------------------------------------------
\16\ See Sec. 417.5(f).
---------------------------------------------------------------------------
Documenting reassessments is important for a number of reasons. It
will facilitate verification that establishments are actually
reassessing their HACCP plans. Without a record, this has proven
difficult to do. It will also help FSIS personnel to identify whether
there are emerging hazards that the establishment has decided not to
address. Finally, a record of reassessments will help an establishment
to track the situation in its operation over time.
If this proposed rule becomes final, official establishments will
be able to maintain these records on computers (9 CFR 417.5(d)), and
establishments will be required to retain the records for up to two
years, as prescribed in 9 CFR 417.5(e).
If this proposed rule becomes final, foreign countries that export
meat and poultry products to the United States will be expected to
establish requirements equivalent to those that FSIS is proposing in
this rulemaking, or to establish why their system remains equivalent if
they fail to do so.
Executive Order 12866 and Regulatory Flexibility Act
This rule was reviewed by the Office of Management and Budget (OMB)
under Executive Order 12866 and was determined to be significant.
I. Background
The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246,
Sec. 11017), known as the 2008 Farm Bill, amended the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to
require establishments subject to inspection under these Acts to
promptly notify the Secretary of Agriculture that an adulterated or
misbranded product received by or originating from the establishment
has entered into commerce, if the establishment believes or has reason
to believe that this has happened. Section 11017 also requires
establishments subject to inspection under the FMIA and PPIA to: (1)
Prepare and maintain procedures for the recall of all products produced
and shipped by the establishment; (2) document each reassessment of the
process control plans of the establishment (i.e., HACCP plans); and (3)
upon request, make the procedures and reassessed control plans
available for inspectors appointed by the Secretary to review and copy.
II. What Is Being Proposed
This proposed action will amend 9 CFR 417.4 (a)(3) to require that
every establishment make a written record of each reassessment of the
adequacy of its process control plan, i.e., HACCP plan, or to document
the reasons for not making a change to the HACCP plan based on the
reassessment (except for annual reassessments of the HACCP plan, for
which, if no change is found necessary, only the fact that the
reassessment occurred need be documented). It will also establish a new
9 CFR Part 418, Recalls, under which official establishments will have
to promptly notify FSIS that an adulterated or misbranded product
received by or originating from the establishment has entered into
commerce, if the establishment believes or has reason to believe that
this has happened, and prepare and maintain current procedures for the
recall of products produced and shipped by the establishment if there
is a reason to believe that its product are adulterated or misbranded.
III. Need for the Proposed Rule
FSIS believes that prompt notification that adulterated or
misbranded product has entered commerce is an important prerequisite
for effective action to prevent such product from causing harm.
Having established procedures will help establishments to
conduct effective and efficient recalls, should it be necessary for
them to do so.
Moreover, records of reassessments will help establishment
and Agency personnel to assess the adequacy and appropriateness of what
has been done.
IV. Baseline
FSIS expects that this proposed rule will affect about 6,300
official establishments that slaughter or process meat, meat food,
poultry, and poultry products, based on FSIS's Performance Based
Inspection System (PBIS) of 2008. Based on HACCP classification, about
400 are large establishments, 3,044 are small, and 2,856 are very small
(Table 3).
V. Expected Costs
Under the current regulations, the development and maintenance of
recall procedures and the written documentation of HACCP reassessments
are voluntary. This proposed rule will make them mandatory. Costs occur
because about 6,300 official establishments will need to develop recall
procedures, maintain written documentation of HACCP reassessments, and
make the records accessible to the Agency's review. The Agency used in
this analysis the best available data, based on discussions with FSIS
experts. FSIS solicits costs data from other sources to be sure that
the Agency is using the best available data. The methodology of the
labor cost estimates is as follows:
(1) Developing Recall Procedures = Number of establishments \17\ x
hours \18\ x wage rate \19\
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\17\ The number of establishments is the number of Federally-
inspected processing and slaughter establishments.
\18\ Hours are labor hours likely spent on the required
provisions.
\19\ The wage rate is estimated according to the current labor
market and the nature of work, including all non-salary benefits to
workers.
---------------------------------------------------------------------------
(2) Documenting HACCP Reassessment = Number of establishments x hours x
response rate \20\ x wage rate
---------------------------------------------------------------------------
\20\ Response rate is the projected frequencies of an action
within a year.
---------------------------------------------------------------------------
(3) Records Backup and Storage = Number of establishments x hours x
response rate x wage rate
Since estimates of all of the above factors are provided by experts
in the related fields, not collected directly from related
establishments, FSIS invites comments and inputs from industries likely
to improve the cost
[[Page 14364]]
estimation. In particular, FSIS welcomes comments on the total cost and
the annual cost estimation related to the notification, documentation,
and recordkeeping provisions affected by this proposed rule.
The cost of notifying FSIS, with a few phone calls, facsimiles, and
e-mails about questionable products in commerce is negligible. FSIS
certifies that there will be no impact on the Agency's operational
costs resulting from this proposed rule, because the Agency will not
need to add any staff or incur any non-labor expenditure if the
proposed rule is adopted.
In addition to the labor cost, FSIS estimates that the extra
material cost would be about 1 percent of the labor cost of the
development of the recall procedures and the documenting of each
reassessment or the documenting that no changes to the HACCP plan were
found necessary based on the reassessment. For the cost estimation of
records backup and storage, the ratio of labor cost versus material
cost was estimated to be 2:1, or 2 thirds labor cost versus 1 third
material cost. These costs are significantly mitigated by the fact that
FSIS has guidance materials on preparing recall plans available. See
footnote 16, above. The material cost would mostly be paper, ink, and
electronic storage media. The estimated total average costs of about $5
million for labor and $76 thousand for materials are shown in Table 1.
Considering the facts that: (1) Some unknown number of
establishments already have plans which could likely be adequate with
little or no change, (2) establishments in the meat and poultry
industries have differing levels of expertise in writing HACCP plans,
(3) the Agency makes model recall plans available to the industry, and
(4) establishments have a range of different processes for producing
meat and poultry products, FSIS believes that the estimated cost of
developing recall procedures tends to be overstated by using the
maximum number of establishments. However, given the uncertainty of
incurred labor cost in different regions and with various experience
levels, FSIS assumes a 20% range, or plus and minus 10%, of the
estimated average-compliance cost. The estimated cost summary is shown
in Table 2.
FSIS expects that in the first year of the proposed rule, one-time
costs for developing recall procedures would cost the industry of
approximately 6,300 establishments $4.5 million, in an estimated range
of $4.0 and $4.9 million, 10% lower and upper bound, respectively.
Furthermore, the proposed rule would have first year and recurring
costs of approximately $0.5 million for documenting periodical
reassessments of HACCP plans, and $0.1 million for records backup and
storage, although these costs may well be overstated. Thus, the total
cost for the first year is $5.0 ($4.4 + $0.5 +$0.1) million, in an
estimated range of $4.6 and $5.6 million, 10% lower and upper bound,
respectively. The average cost adjusted with a 3% inflation rate of
following years would be $0.7 ($0.5 + $0.2) million, in an estimated
range of $0.6 and $0.8 million, 10% lower and upper bound, respectively
(Table 2).
The present value of total estimated costs with a 3% discount rate
for 10 years would be $4.3 million, in an estimated range of $3.9 and
$4.8 million, 10% lower and upper bound, respectively. The present
value of estimated costs with a 7% discount rate for 10 years would be
$3.6 million, in an estimated range of $3.2 and $3.9 million, 10% lower
and upper bound, respectively. The above present values of estimated
costs were calculated in year 2003 dollars, with 7% and 3% discount
rates, in accordance with OMB Circular A-4 requirements (Table 2).
Table 3 shows the drilled-down costs in establishment size, of
which $0.3 million is attributed to large, $2.5 million to small, and
$2.3 million to very small establishments. The cost per official
establishment is between $700 and $900, 10% lower and upper bound,
respectively.
Table 4 gives the estimated annual and total cost by establishment
size classes for the first five years. Table 4, column 4, shows all
cost categories of the first year (assumed to be 2010) and comes from
Table 3 column 3, distributed by the counts of establishment size
classes. The costs of following year, in Table 4, columns 5-8, are
based on annual recurring costs (Table 2), compounded at the 3%
inflation rate for the following four years. FSIS expects that the
first five years of the proposed rule, if adopted, would cost the
industry of approximately 6,300 establishments $7.9 million, in an
estimated range of $7.1 and $8.7 million, 10% lower and upper bound,
respectively. The present value of a 2009 dollar at 7% is $5.6 million,
in the range of $5.1 million to $6.2 million, minus and plus 10%,
respectively. The present value of a 2009 dollar at 3% is $6.8 million,
in the range of $6.1 million to $7.5 million, minus and plus 10%,
respectively. Total costs of the first five years for small/very small
and large establishments as a central estimate are $7.4 million and
$0.5 million, respectively; the average recurring cost after the first
year for small/very small and large establishments will be $0.7 million
and $0.04 million, respectively.
Table 1--First Year Cost Break-Down, in Dollars, for 6,300 Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Factor
for Material
Response Required paper, (paper, ink &
Cost component rate man hours Wage rate ink & media) cost Total cost (x$1,000)
media (x$1,000)
cost
(1) (2) (3) (4) (5)=(4)x(6) (6)=(1)x(2)x(3)x(4)x6.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recall-Procedures development (one-time)........................ 1 20 35 1.01 44 4,454
Documenting Reassessment........................................ 5 0.25 60 1.01 5 477
Records backup and storage...................................... 1 0.25 35 1.5 28 83
---------------------------------------------------------------------------------------
Total....................................................... ......... ......... ......... ......... 77 5,014
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 14365]]
Table 2--Estimated First Year Total Cost and Average Cost of Following Year
----------------------------------------------------------------------------------------------------------------
Low-range High-range
Total cost (x$ estimate (- estimate
million) 10%) (+10%)
----------------------------------------------------------------------------------------------------------------
(A) Recall-Procedures development (one-time).................... 4.4 4.0 4.9
(B) Documenting Reassessment.................................... 0.5 0.4 0.5
(C ) Records backup and storage................................. 0.1 0.1 0.1
(D) First Year Cost (Total) (D=A+B+C)*.......................... 5.0 4.6 5.6
Average Cost of Following Years (for next 10 years)............. 0.7 0.6 0.8
Present Value (2003) at 3%...................................... 4.3 3.9 4.8
Present Value (2003) at 7%...................................... 3.6 3.2 3.9
----------------------------------------------------------------------------------------------------------------
* Note: Summation is subject to rounding error.
Table 3--Number of Establishments, and Total and Average Cost in Size (x $1,000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recall
Number of procedures Documenting Records Cost per Low High
HACCP class establishments development HACCP backup and Total cost establishment estimates estimates
(one-time) reassessment storage (-10%) (+10%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very Small................................... 2,856 2,030 218 38 2,285 0.8 0.7 0.9
Small........................................ 3,044 2,164 232 40 2,436 0.8 0.7 0.9
Subtotal..................................... 5,900 4,194 449 78 4,721 0.8 0.7 0.9
Large........................................ 400 260 28 5 293 0.8 0.7 0.9
----------------------------------------------------------------------------------------------------------
Total........................................ 6,300 4,454 477 83 5,014 0.8 0.7 0.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 4--Estimated Annual and 5-Year Total Cost by Establishment Size Classes (x$1,000), Assuming Inflation Rate = 3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of 1st Year 2nd Year 3rd Year 4th Year 5th Year 5-Year
HACCP Class Establishments Activities (2010) (2011) (2012) (2013) (2014) Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very Small............................... 2,856 Recall-Procedures 2,030 278 286 295 304 3,193
development & updating.
.............. Documenting HACCP 218 30 31 32 33 342
Reassessment.
.............. Records backup and storage. 38 5 5 5 6 59
-----------------------------------------------------------------
.............. Subtotal................ 2,285 313 322 332 342 3,594
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small.................................... 3,044 Recall-Procedures 2,164 296 305 314 324 3,403
development & updating.
.............. Documenting HACCP 232 32 33 34 35 365
Reassessment.
.............. Records backup and storage. 40 5 6 6 6 63
-----------------------------------------------------------------
.............. Subtotal................ 2,436 333 343 354 364 3,831
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small & Very Small....................... 5,900 Subtotal................... 4,721 646 666 686 706 7,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large.................................... 400 Recall-Procedures 260 36 37 38 39 409
development & updating.
.............. Documenting HACCP 28 4 4 4 4 44
Reassessment.
.............. Records backup and storage. 5 1 1 1 1 8
-----------------------------------------------------------------
.............. Subtotal................ 293 40 41 43 44 461
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total All................................ 6,300 Recall-Procedures 4,454 610 628 647 666 7,005
development & updating.
.............. Documenting HACCP 477 65 67 69 71 751
Reassessment.
.............. Records backup and storage. 83 11 12 12 12 130
-----------------------------------------------------------------
.............. Total................... 5,014 686 707 728 750 7,886
--------------------------------------------------------------------------------------------------------------------------------------------------------
VI. Expected Benefits
Expected benefits will likely result from this proposed rule, which
is intended to improve the effectiveness of the nation's food safety
system for meat and poultry products. These benefits will not be
monetized in this section because quantified data on benefits
attributable to this proposed rule are not available to FSIS. FSIS
solicits data that would permit the monetization of the expected
benefits. However, without discussing monetized benefits, FSIS would
expect to gain the following benefits related to:
HACCP Reassessment and Documentation of Reassessments
While HACCP reassessment is already required by 9 CFR 417,
requiring establishments to document in writing each reassessment of
their HACCP plans or the reasons for not making changes to the HACCP
plan based on the reassessment will allow establishment supervisory and
audit personnel, as well as FSIS personnel, to verify that
establishments are, in fact, reassessing those plans at least annually,
as required by Sec. 417.4(a)(3), and that they are appropriately
assessing their findings when they do (although FSIS is proposing not
to require an explanation if no change is made to the HACCP plan on the
basis of the annual reassessment). Requiring these written
reassessments to
[[Page 14366]]
be made available to inspection program personnel ensures that the
records are prepared and available.
Notification Requirement
In addition, this proposed rule will likely be a preventive measure
that will result in FSIS being alerted to potential meat and poultry
recall situations earlier than otherwise is the case today. If this
proposed rule is adopted, establishments will be required to notify the
local FSIS District Office within 48 hours of learning or determining
that an adulterated or misbranded product received by or originating
from the establishment has entered commerce, if the establishment
believes or has reason to believe that this has happened. This
notification, in turn, will allow FSIS to begin coordinating more
rapidly preliminary inquiries to determine whether a recall is
necessary.
Improve Recall Effectiveness With Documented Procedures
FSIS expects that this proposed rule will likely assist meat and
poultry establishments during recalls. By requiring these
establishments to prepare and maintain recall procedures for all
products they produce, FSIS expects that establishments that do not
currently have such plans will likely be able to act more effectively
to remove adulterated or misbranded products from commerce. This added
efficiency and effectiveness should help establishments to move quickly
to disseminate information about the need to return the product to it
and thus maximize the amount of product it will be able to recover.
Table 5 gives a summary of the benefits discussed above.
Table 5--Summary of Benefits
------------------------------------------------------------------------
Expected benefits:
Benefit related to: Required actions:
------------------------------------------------------------------------
Document Reassessment........... Improved
Establishments HACCP systems for
are to document establishments.
all reassessments
of HACCP plans.
Establishments
are to make the
documentation of
the HACCP plans
available to
inspection
program personnel.
FSIS is
to verify that
establishments
are, in fact,
reassessing their
HACCP plans at
least annually.
Notification Requirement........ FSIS will
Establishments be alerted to
are to notify the potential meat or
local FSIS poultry recall
District Office situations
within 48 hours earlier than
of learning or otherwise is the
determining that case today.
an adulterated or FSIS will
misbranded be able to begin
product received coordinating more
by or originating rapidly
from the official preliminary
establishment has inquiries to
entered commerce. determine whether
a recall is
necessary.
Improve Recall Effectiveness....
Establishments Establishments
are to prepare will likely be
and maintain able to act more
recall procedures effectively to
for all products remove
they produce. adulterated or
misbranded
products from
commerce.
Establishments
may be able to
move more quickly
to disseminate
information about
the need to
return the
product to it.
Establishments
may be able to
maximize the
amount of product
they will be able
to recover.
------------------------------------------------------------------------
VII. Flexibility Analysis
The FSIS Administrator has certified that this proposed rule will
not have a significant impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
These small entities are about 5,900 federally-inspected
establishments. The average cost to small and very small businesses
will be in the range of $700 to $900, 10% lower and upper bound,
respectively (Table 3). FSIS invites small (with more employees than 10
but less than 500) and very small (with fewer than 10 employees)
establishments to comment on the cost estimation of documentation and
reassessment required under the proposed rule.
Based on data recorded in the PBIS (2007) \21\ volume database, and
slaughter volume recorded in the FSIS Animal Disposition Reporting
System (ADRS, 2008) \22\ database, and volume estimates of the USDA
Economic Research Service (ERS, 2009),\23\ these 5,900 small entities
process about 12 percent or about 8 billion pounds of the U.S. meat and
poultry food supply per annum. Further, FSIS estimated that the average
processing volume per establishment of 5,900 small entities was about
1.4 million pounds (8,000,000,000/5,900) per annum. Thus, the average
cost for the first year of this proposed rule to small entities will be
less than one tenth of one cent (i.e., $0.0006 = $800/1,400,000) of
meat and poultry food products per pound. This is a relatively
insignificant cost to the small entities because most of their meat and
poultry food products are valued at more than $1.00 per pound. The
average cost for the following years, based on annual recurring costs,
decreases to less than one hundredth of one cent per pound.
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\21\ USDA, FSIS Performance Based Inspection System Volume
Database 2007.
\22\ USDA, FSIS Animal Disposition Reporting System Database
2008.
\23\ USDA, Economic Research Service, Food Availability (Per
Capita) Data System--Per capita food availability data compiled
reflect the amount of food available for human consumption in the
United States. March 2009, https://www.ers.usda.gov/Data/FoodConsumption.
---------------------------------------------------------------------------
VIII. Alternatives
The option of no rulemaking is unavailable. FSIS was directed to
conduct this rulemaking by Congress.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. When this final rule is adopted: (1) All State and
local laws and regulations that are inconsistent with this rule will be
preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
[[Page 14367]]
Paperwork Requirements
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this proposed rule have been
submitted for approval to OMB.
Title: Notification, and Recall Procedure and HACCP Reassessment
Documentation Requirements.
Type of Collection: New.
Abstract: Under this proposed rule, FSIS is requiring three
information collection activities. First, FSIS is proposing to require
that official establishments notify the appropriate District Office
that an adulterated or misbranded product received by or originating
from the establishment has entered commerce, if the establishment
believes or has reason to believe that this has happened. FSIS is
proposing that this notification occur as quickly as possible, but
within 48 hours of the establishment learning or determining that an
adulterated or misbranded product received by or originating from it
has entered commerce. Second, FSIS is also proposing that
establishments prepare and maintain current, written procedures for the
recall of meat and poultry products produced and shipped by the
establishment for use should it become necessary for the establishment
to remove product from commerce. These written recall procedures will
have to specify how the establishment will decide whether to conduct a
product recall and how the establishment will effect the recall, should
it decide that one is necessary. Finally, FSIS is proposing that
establishments document each reassessment of the establishment's HACCP
plans. The Agency is proposing to require that establishments document
the reasons for any changes that they make to their HACCP plans based
on the reassessment, or if they did not make any changes, that they
document the reasons that they did not (although FSIS is proposing not
to require an explanation if no change is made to the HACCP plan on the
basis of the annual reassessment). The recall procedures and
reassessment documentation will have to be made available for official
review and copying.
Estimate of Burden of Average Hours per Response: 1.159.
Respondents: Official meat and poultry products establishments.
Estimated Number of Respondents: 6,300.
Estimated Number of Responses: 40,960.
Estimated Number of Responses per Respondent: 6.5.
Estimated Total Annual Burden on Respondents: 47,475.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, Room 6081, South Agriculture Building,
1400 Independence Avenue, SW., Washington, DC 20250.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's 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.
All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.
E-Government Act Compliance
The Food Safety and Inspection Service is committed to complying
with the E-Government Act, to promote the use of the Internet and other
information technologies to provide increased opportunities for citizen
access to Government information and services, and for other purposes.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that
minorities, women, and persons with disabilities are aware of this
notice, FSIS will announce it online through the FSIS Web page located
at https://www.fsis.usda.gov/regulations/2010_Proposed Rules--Index/.
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 e-mail subscription service that 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.
List of Subjects in 9 CFR Parts 417 and 418
Hazard Analysis and Critical Control Point (HACCP) Systems, Meat
inspection, Poultry and poultry products inspection, Reporting and
recordkeeping requirements, Recalls.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR Chapter III, as follows:
1. The authority citation for part 417 continues to read as
follows:
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C.
1901-1906; 7 CFR 2.18, 2.53.
2. In Sec. 417.4, paragraph (a)(3) is redesignated as paragraph
(a)(3)(i), and a new paragraph (a)(3)(ii) is added to read as follows:
Sec. 417.4 Validation, Verification, Reassessment.
* * * * *
(a) * * *
(3) Reassessment of the HACCP plan.
(i) * * *
(ii) Each establishment shall make a record of each reassessment
required by paragraph (a)(3)(i) of this section and shall document the
reasons for any changes to the HACCP plan based on the reassessment, or
the reasons for not changing the HACCP plan based on the reassessment;
for annual reassessments, if the establishment determines that no
changes are needed to its HACCP plan, it may briefly document this
determination.
* * * * *
3. A new part 418 is added to read as follows:
[[Page 14368]]
PART 418--RECALLS
Sec.
418.1 [Reserved]
418.2 Notification.
418.3 Preparation and maintenance of current, written recall
procedures.
418.4 Records.
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 CFR 2.18,
2.53.
Sec. 418.1 [Reserved]
Sec. 418.2 Notification.
Each official establishment shall promptly notify the local FSIS
District Office (see 9 CFR 300.3(c)) within 48 hours of learning or
determining that an adulterated or misbranded meat, meat food, poultry,
or poultry product received by or originating from the official
establishment has entered commerce, if the official establishment
believes or has reason to believe that this has happened. The official
establishment shall inform the District Office of the type, amount,
origin, and destination of the adulterated or misbranded product.
Sec. 418.3 Preparation and maintenance of current, written recall
procedures.
Each official establishment shall prepare and maintain written
procedures for the recall of any meat, meat food, poultry, and poultry
product produced and shipped by the official establishment for use
should it become necessary for the official establishment to remove
product from commerce. These written procedures shall specify how the
official establishment will decide whether to conduct a product recall,
and how the establishment will effect the recall, should it decide that
one is necessary.
Sec. 418.4 Records.
All records, including records documenting procedures required by
this part, shall be available for official review and copying.
Done in Washington, DC, on March 19, 2010.
Alfred V. Almanza,
Administrator.
[FR Doc. 2010-6629 Filed 3-24-10; 8:45 am]
BILLING CODE 3410-DM-P
