[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Proposed Rules]
[Pages 14361-14368]
From the Federal Register Online via the Government Publishing 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.

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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 http://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 http://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.
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    \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)
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    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.
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    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.
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    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.
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    \14\ 9 CFR 417.2(b)(1).
    \15\ 9 CFR 417.4(a)(3).
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    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\
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    \16\ See Sec.  417.5(f).
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    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.
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(2) Documenting HACCP Reassessment = Number of establishments x hours x 
response rate \20\ x wage rate
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    \20\ Response rate is the projected frequencies of an action 
within a year.
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(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
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                                                                                                     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
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[[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)
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                                                                  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
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                  Table 4--Estimated Annual and 5-Year Total Cost by Establishment Size Classes (x$1,000), Assuming Inflation Rate = 3%
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                                              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.
---------------------------------------------------------------------------

    \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, http://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 http://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 http://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