[Federal Register: September 16, 2009 (Volume 74, Number 178)]
[Proposed Rules]
[Page 47647-47669]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se09-21]
[[Page 47647]]
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Part II
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 321, 332, and 381
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Products; Proposed Rule
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 321, 332, and 381
[Docket No. FSIS-2008-0039]
RIN 0583-AD37
Cooperative Inspection Programs: Interstate Shipment of Meat and
Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing
regulations to implement a new voluntary cooperative program under
which State-inspected establishments with 25 or fewer employees will be
eligible to ship meat and poultry products in interstate commerce. In
participating States, State-inspected establishments selected to take
part in this program will be required to comply with all Federal
standards under the Federal Meat Inspection Act (FMIA) and the Poultry
Products Inspection Act (PPIA), as well as with all State standards.
These establishments will receive inspection services from State
inspection personnel that have been trained in the enforcement of the
FMIA and PPIA. Meat and poultry products produced under the program
that have been inspected and passed by designated State personnel will
bear an official Federal mark of inspection and will be permitted to be
distributed in interstate commerce. FSIS will provide oversight and
enforcement of the program.
FSIS is proposing these regulations in response to the Food,
Conservation, and Energy Act, enacted on June 18, 2008. Section 11015
of the law amended the FMIA and PPIA to provide for these cooperative
programs.
DATES: Submit comments on or before November 16, 2009.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by either of the following
methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov and
follow the online instructions at that site for submitting comments.
Mail, including floppy disks or CD-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 2-2127 George Washington
Carver Center, 5601 Sunnyside Avenue, Beltsville, MD 20705.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2008-0039. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to: 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:
I. Background
A. Federal-State Cooperative Inspection Programs
FSIS has been delegated the authority to carry out the functions of
the Secretary of Agriculture as provided in the Federal Meat Inspection
Act (FMIA) (21 U.S.C. 601, et seq.) and the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451, et seq.). These statutes mandate that FSIS
protect the public by ensuring that meat and poultry products are safe,
wholesome, unadulterated, and properly labeled and packaged.
The FMIA and the PPIA (``the Acts'') provide for FSIS to cooperate
with State agencies in developing and administering their own meat or
poultry inspection programs (21 U.S.C. 661 and 454). The FMIA and the
PPIA restrict each cooperative State meat or poultry products
inspection program to the inspection and regulation of products that
are produced and sold within the State (21 U.S.C. 661(a)(1) and
454(a)(1)). Under section 661 of the FMIA and section 454 of the PPIA,
cooperative State inspection programs are required to operate in a
manner and with authorities ``at least equal to'' the provisions set
out in the Acts (21 U.S.C. 661(a)(1) and 454(a)(1)).
The Acts provide for FSIS to contribute up to 50 percent of the
cost of the cooperative State inspection programs, as long as the State
programs are effectively enforcing requirements that are ``at least
equal to'' the Federal program (21 U.S.C. 661(a)(3) and 454(a)(3)).
States that have enacted a mandatory State meat or poultry inspection
law must apply to FSIS to enter into a cooperative State inspection
program agreement with the Agency.
If a State is unable or unwilling to continue to operate a
cooperative State inspection program on an ``at least equal to'' basis,
FSIS designates the State as not having an ``at least equal to''
program by publishing this designation in the Federal Register. After
the expiration of thirty days of such publication, the State
establishments are subject to Federal inspection (21 U.S.C. 661(c)(1)
and 454(c)(1)).
The Talmadge-Aiken Act authorizes the Secretary of Agriculture to
enter into cooperative arrangements with State departments of
agriculture and other State agencies to assist the Secretary in the
enforcement of relevant Federal laws and regulations to the extent and
in the manner appropriate to the public interest (7 U.S.C. 450).
Pursuant to the Talmadge-Aiken Act, FSIS enters into a separate
agreement with a State agency for the State program to conduct meat,
poultry, or egg products inspection or other regulatory activities on
behalf of FSIS. FSIS provides 50 percent funding to the State programs
for these services.
B. The Food, Conservation, and Energy Act of 2008
On June 18, 2008, Congress enacted The Food, Conservation, and
Energy Act of 2008 (also referred to as ``the 2008 Farm Bill'') (Pub.
L. 110-246, 112 Stat. 1651). Section 11015 of Title XI of the 2008 Farm
bill amended the FMIA to add a new title V--``Inspections by Federal
and State Agencies,'' which contains a new section 501, ``Interstate
Shipment of Meat Inspected by Federal and State Agencies for Certain
Small Establishments (122 Stat. 2124; codified at 21 U.S.C. 683).
Section 11015 also amended the PPIA to add a new section 31,
``Interstate Shipment of Poultry Inspected by Federal and State
Agencies for Certain Small Establishments'' (122 Stat. 2127; codified
at 21 U.S.C. 472). These new sections supplement the existing
cooperative State meat and poultry inspection programs by establishing
a new cooperative program under which certain State-inspected
establishments would be permitted to ship meat and poultry products in
interstate commerce.
The new law provides that the Secretary of Agriculture, ``in
coordination with the appropriate State agency of the State in which
the establishment is located,'' may select State-inspected
establishments with 25 or fewer employees to ship meat and poultry
products interstate (Sec. 501(b) and Sec. 31(b)). Inspection services
for these establishments must be provided by State inspection personnel
that have
[[Page 47649]]
``undergone all necessary inspection training and certification to
assist the Secretary with the administration and enforcement of [the
FMIA or PPIA]'' (Sec. 501(a)(2) and Sec. 31(a)(2)). Meat and poultry
products inspected and passed by these State inspection personnel would
bear a ``Federal mark, stamp, tag, or label of inspection'' (Sec.
501(b)(1) and Sec. 31(b)(1)). The law provides for the Secretary to
``designate an employee of the Federal government'' to ``provide
oversight and enforcement'' of the program (Sec. 501(d)(1) and Sec.
31(d)(1)).
The law is to take effect ``on the date on which the Secretary * *
* promulgates final regulations to carry out [section 11015]'' (Sec.
501(j)(1) and Sec. 31(i)(1)). The law requires that the Secretary
promulgate final regulations ``not later than 18 months after the date
of enactment'' (Sec. 501(j)(2) and Sec. 31(i)(2)).
FSIS is issuing this proposed rule to implement section 11015 of
the 2008 Farm Bill. Following is a summary of the provisions of section
11015 that are addressed in this proposed rule.
Selected establishments. The law applies to certain establishments
that are already operating under a cooperative State meat or poultry
inspection program. The law defines an ``eligible establishment'' as
``an establishment that is in compliance with * * * the State
inspection program of the State in which the establishment is located''
and the Acts, including the rules and regulations issued under the Acts
(Sec. 501(a)(3) and Sec. 31(a)(3)). A ``selected establishment'' is
defined as ``an establishment that is authorized by the Secretary, in
coordination with * * * the appropriate State agency of the State in
which the establishment is located * * * to ship [meat or poultry]
items in interstate commerce'' (Sec. 501(a)(5) and Sec. 31(a)(5)).
The law prohibits the Secretary from selecting an establishment for
interstate shipment that ``on average, employs more than 25 employees
(including supervisory and nonsupervisory employees), as defined by the
Secretary'' (Sec. 501(b)(2)(A) and Sec. 31(b)(2)(A)). The law also
prohibits the selection of establishments that currently ship
interstate, as well as certain former and future Federal establishments
(Sec. 501(b)(2)(B), Sec. 501(b)(2)(C), Sec. 31(b)(2)(B), and Sec.
31(b)(2)(C)).
Transition to a Federal establishment. The law permits the
Secretary to select establishments with ``more than 25 employees but
less than 35 employees'' to participate in the program (Sec.
501(b)(3)(B)(i) and Sec. 31(b)(3)(B)(i)). However, if selected, these
establishments must transition to Federal establishments ``beginning on
the date that is 3 years after the effective date'' if they
consistently employ, on average, more than 25 employees (Sec.
501(b)(3)(B)(ii) and Sec. 31(b)(3)(B)(ii)). The law authorizes the
Secretary to develop a procedure to transition certain selected
establishments to a Federal establishment (Sec. 501(b)(3)(A) and Sec.
31(b)(3)(A)). The law also requires that ``[a]ny selected establishment
that the Secretary determines to be in violation of any requirement of
the Act, be transitioned to a Federal establishment'' (Sec. 501(h) and
Sec. 31(g)).
Federal-State coordination. Under the law, the Secretary is
authorized to designate a Federal employee as ``State coordinator'' for
each State to ``provide oversight and enforcement'' of the interstate
shipment program and to ``oversee the training and inspection
activities'' of the State personnel providing inspection services to
selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)). The law
provides that if the State coordinator determines that a selected
establishment under the State coordinator's jurisdiction is in
violation of the Acts, the State coordinator must ``immediately notify
the Secretary of the violation'' and ``deselect the selected
establishment or suspend inspection at the selected establishment''
(Sec. 501(d)(3)(C) and Sec. 31(d)(3(C)).
This proposed rule refers to the ``State coordinator'' established
in section 11015 of the 2008 Farm Bill as the FSIS ``selected
establishment coordinator'' to maintain consistency with the other
terminology in this proposed rule and to make clear that the ``State
coordinator'' is a Federal employee. The term ``State coordinator'' is
often used to refer to a State employee under the Talmadge-Aiken
program, so FSIS has tentatively decided not to use this term in these
proposed regulations.
Federal reimbursement of State costs. The law requires that the
Secretary ``reimburse a State for costs related to the inspection of
selected establishments * * * in an amount of not less than 60 percent
of eligible State costs'' (Sec. 501(c) and Sec. 31(c)).
Inspection training division. The law amended the FMIA to provide
that not later than 180 days after the effective date of section 11015
of the 2008 Farm Bill, the Secretary shall establish in FSIS an
inspection training division to provide outreach, education, and
training to, and provide grants to appropriate State agencies to
provide outreach, technical assistance, education, and training to
small and very small establishments (as defined by the Secretary) (Sec.
501(f)). FSIS implemented this provision by establishing an Office of
Outreach, Education and Training. A substantive part of the program's
function is to provide training, education, and outreach services to
small and very small plants.
Transition grants. The law permits the Secretary to provide grants
to States to assist them in helping establishments operating under a
cooperative State meat or poultry inspection program transition to
selected establishments (Sec. 501(g) and Sec. 31(f)).
II. The Proposed Rule
A. General
FSIS is proposing to amend 9 CFR part 321 of the Federal meat
inspection regulations and 9 CFR part 381, subpart R, of the poultry
products inspection regulations to add new sections that describe the
cooperative interstate shipment program established in section 11015 of
the 2008 Farm Bill. FSIS is also proposing to add a new 9 CFR part 332
to the Federal meat inspection regulations and a new 9 CFR part 381,
subpart Z, to the poultry products inspection regulations that
prescribe the conditions under which States and establishments
operating under a State-inspection program will be permitted to
participate in a cooperative interstate shipment program.
When FSIS completes the rulemaking process and issues a final rule,
the Federal meat and poultry products regulations will provide for
three separate cooperative State meat and poultry products inspection
programs: (1) Cooperative State meat or poultry products inspection
programs under the FMIA and PPIA; (2) cooperative agreements for State
programs to conduct meat or poultry products inspection or other
regulatory activities on behalf of the Agency under the Talmadge-Aiken
Act; and (3) cooperative programs for the interstate shipment of State-
inspected meat and poultry products under the FMIA and PPIA as amended
by section 11015 of the 2008 Farm Bill.
The proposed regulations to implement section 11015 are described
in detail below.
B. Description of Cooperative Programs--9 CFR Part 321 and 9 CFR Part
381, Subpart R
9 CFR part 321 of the Federal meat inspection regulations and 9 CFR
part 381, subpart R, of the poultry products inspection regulations
describe
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cooperative meat and poultry products inspection programs authorized
under the FMIA, PPIA, and the Talmadge-Aiken Act. These regulations
reference the legal authority for each cooperative inspection program
and provide a general description of each program. FSIS is proposing to
amend part 321 and part 381, subpart R, to add a new Sec. 321.3 and a
new Sec. 381.187 to describe the cooperative interstate shipment
program established under section 11015 of the 2008 Farm Bill.
The amendments to the FMIA in section 501 of section 11015 of the
2008 Farm Bill have been codified at 21 U.S.C. 683, and the amendments
to the PPIA in section 31 have been codified at 21 U.S.C. 472 (122
Stat. 2124, 2127). Therefore, proposed Sec. 321.3(a) provides that
under 21 U.S.C. 683(b), FSIS is authorized to coordinate with States
that have cooperative State meat inspection programs to select certain
establishments operating under these programs to ship carcasses, parts
of carcasses, meat, and meat food products in interstate commerce.
Similarly, proposed Sec. 381.187(a) provides that under 21 U.S.C.
472(b), FSIS is authorized to coordinate with States that have
cooperative State poultry products inspection programs to select
certain establishments operating under these programs to ship poultry
products in interstate commerce. Proposed Sec. Sec. 321.3(a) and
381.187(a) both explain that this type of cooperative program is called
a ``cooperative interstate shipment program.''
Proposed Sec. Sec. 321.3(b) and 381.187(b) contain a general
description of the cooperative interstate shipment program and make
clear that the Federal contribution for inspection services provided by
States that have entered into such a program will be at least 60
percent of eligible State costs. Under the FMIA and PPIA, FSIS is
required to contribute up to 50 percent of the cost of a cooperative
State meat or poultry products inspection program (21 U.S.C. 661(a)(3)
and 454(a)(3)). Thus, States that participate in the new cooperative
interstate shipment program will receive additional reimbursement for
costs related to inspection of selected establishments in the State.
As required under the statute, the Federal contribution for
inspection services provided by States that enter into a cooperative
interstate shipment program under this proposal will be at least 60
percent of eligible State costs. When the program is implemented, FSIS
does not intend to reimburse States for more than 60 percent of their
eligible costs unless Congress directs it, and provides the money for
it, to do so.
To be reimbursed under this proposed rule, States will be expected
to submit their budgets for their cooperative interstate shipment
programs to FSIS for approval prior to receiving Federal funds. States
will also be expected to submit a separate justification for any costs
related to the cooperative interstate shipment program that were not
included in their initial budget request. FSIS will also need to
approve a State's request for additional funds before the Agency will
reimburse the State for not less than 60% of the cost. FSIS has
tentatively decided that, for purposes of this proposed rule, eligible
State costs will be those costs that a State has justified and FSIS has
approved as necessary for the State to provide inspection services to
selected establishments in the State. The Agency requests comments on
whether the final rule resulting from this proposal should codify this
definition or any other requirements related to State reimbursement for
eligible costs related to inspection of selected establishments.
Proposed Sec. Sec. 321.3(c) and 381.187(c) identify 9 CFR part 332
and 9 CFR part 381, subpart Z, as the regulations that prescribe
conditions under which States and establishments may participate in the
cooperative interstate shipment program. Proposed Sec. Sec. 321.3(d)
and 381.187(d) provide that the Administrator will terminate an
agreement for a cooperative interstate shipment program with a State if
the Administrator determines that the State is not conducting
inspection at selected establishments in a manner that complies with
the Acts and their implementing regulations.
C. Requirements for a Cooperative Interstate Shipment Program--9 CFR
Part 332 and 9 CFR 381 Subpart Z
1. General
FSIS is proposing to amend title 9, Chapter III, Subchapter A of
the Code of Federal Regulations (CFR) to add a new part 332 titled
``Selected Establishments; Cooperative Program for Interstate Shipment
of Carcasses, Parts of Carcasses, Meat, and Meat Food Products,'' and
to add to part 381 a new subpart Z titled ``Selected Establishments;
Cooperative Program for Interstate Shipment of Poultry Products.'' The
regulations in the proposed new part 332 and the proposed new subpart Z
prescribe the requirements for a cooperative interstate shipment
program.
2. Definitions and Purpose
Proposed Sec. Sec. 332.1 and 381.511 define the terms
``cooperative interstate shipment program,'' ``cooperative State meat
inspection program,'' ``cooperative State poultry products inspection
program,'' ``selected establishment,'' and ``designated personnel.''
Terms used in the proposed regulations that are defined in 9 CFR 301.2
and 9 CFR 381.1 retain their same meaning.
Under proposed Sec. Sec. 332.1 and 381.511, ``cooperative
interstate shipment program,'' ``cooperative State meat inspection
program,'' and ``cooperative poultry products inspection program'' are
defined by providing a cross-reference to the description of these
cooperative programs in 9 CFR part 321 and 9 CFR part 381 subpart R,
described above. Under this proposal, ``selected establishment'' is
defined as ``an establishment operating under a State cooperative [meat
or poultry products] inspection program that has been selected by the
Administrator, in coordination with the State where the establishment
is located, to participate in a cooperative interstate shipment
program.''
FSIS is proposing to define ``designated personnel'' as ``State
inspection personnel that have been trained in the enforcement of the
Acts and any additional State program requirements in order to provide
inspection services to selected establishments.''
In addition to proposing new definitions, proposed Sec. Sec. 332.1
and 381.511 make clear that the term ``interstate commerce,'' as used
in the proposed regulations has the same meaning as ``commerce'' under
9 CFR 301.2 and 381.1. The regulations in 9 CFR 301.2 and 381.1 define
``commerce'' as ``[c]ommerce between any State, any Territory, or the
District of Columbia, and any place outside thereof * * *.'' Thus,
under this proposal, State-inspected establishments that are selected
to participate in a cooperative interstate shipment program will be
permitted to distribute and sell meat or poultry products across State
lines and to export these products to foreign countries.
Proposed Sec. Sec. 332.2 and 381.512 state that the purpose of
part 332 and part 381, subpart Z, is to prescribe the conditions under
which States that administer cooperative State meat or poultry products
inspection programs and establishments that operate under such programs
may participate in a cooperative interstate shipment program.
3. Requirements for Establishments
The proposed regulations in Sec. Sec. 332.3 and 381.513 prescribe
conditions that establishments operating under a
[[Page 47651]]
cooperative State meat or poultry products inspection program must
comply with in order to apply to participate in a cooperative
interstate shipment program. Proposed Sec. Sec. 332.3 and 381.513 also
describe establishments that are ineligible to be selected for such a
program.
Number of employees. Under proposed Sec. Sec. 332.3(a)(1) and
381.513(a)(1), an establishment operating under a cooperative State
meat or poultry products inspection program may apply to participate in
a cooperative interstate shipment program if the establishment employs,
on average, no more than 25 employees. Standards for determining the
average number of employees for purposes of this proposal are described
in proposed Sec. Sec. 332.3(b) and 381.513(b) below.
Under proposed Sec. Sec. 332.3(a)(2) and 381.513(a)(2),
establishments that employed more than 25 but fewer than 35 employees
as of June 18, 2008, are also permitted to apply for a cooperative
interstate shipment program. However, Sec. Sec. 332.3(a)(2) and
381.513(a)(2) provide, reflecting the amended FMIA and PPIA, that if
selected, these establishments must employ, on average, 25 or fewer
employees as of the date three years from the date that the final rule
resulting from this proposal becomes effective. If they do not,
proposed Sec. Sec. 332.3(a)(2) and 381.513(a)(2) require that they be
deselected from the program and transition to become official
establishments.
Standards for determining number of employees. Proposed Sec. Sec.
332.3(b) and 381.513(b) establish standards for determining whether an
establishment employs, on average, 25 or fewer employees for purposes
of this proposed rule. FSIS developed these proposed standards to carry
out Congress' intent that ``[t]he term `average' should be interpreted
to provide some flexibility to these selected establishments that
require seasonal employees for certain parts of the year, as long as
the increase in employees are [sic] manageable by the establishment and
the increase * * * does not undermine food safety standards'' (S. Rep.
No. 220, 110th Cong., 1st Sess., at 211 (2007)).
For the most part, the proposed standards in Sec. Sec. 332.3(b)
and 381.513(b) reflect applicable methods used by the Small Business
Administration (SBA) to calculate the number of employees of a business
concern where the size standard is number of employees (13 CFR 121.105
and 121.106). In addition, as explained below, FSIS is also proposing
to limit the total number of employees at any given time to 35
individuals. Under this proposal, the standards developed by FSIS will
apply to the employees of an individual establishment. The proposed
standards are as follows:
All individuals, both supervisory and non-supervisory,
employed by the establishment on a full-time, part-time, or temporary
basis are to be counted when calculating the total number of employees;
All individuals employed from a temporary employee agency,
professional employee organization, or leasing concern are to be
counted;
The average number of employees is calculated for each of
the pay periods for the preceding calendar year;
Part-time and temporary employees are to be counted the
same as full-time employees;
If an establishment has not been in business for 12
months, the average number of employees is calculated for the pay
periods in which the establishment has been in business;
Volunteers who receive no compensation are not considered
employees; and
The total number of employees can never exceed 35
individuals at any given time, regardless of the average number of
employees.
As noted above, the standard that limits the total number of
employees on any given day to 35 individuals is not derived from SBA's
methods for calculating the number of employees. FSIS is proposing to
limit the number of individuals employed by a selected establishment at
any given time to carry out Congress' intent that any increase in the
number of employees be ``manageable by the selected establishment'' and
that the increase ``does not undermine food safety standards.'' FSIS is
proposing that this number never exceed 35 because section 11015 of the
2008 Farm Bill permits the Agency to select certain establishments that
employ as many as 35 employees to participate in a cooperative
interstate shipment program (Sec. 501(b)(3)(i) and Sec. 31(b)(3)(i)).
Therefore, FSIS believes that a temporary increase in the number of
employees of up to 35 individuals is likely to be considered
``manageable'' under the law, provided that the average number of
employees remains at 25 or fewer.
FSIS requests comments on the proposed standards for determining an
establishment's average number of employees. The Agency specifically
requests comment on whether part-time and temporary employees should be
counted the same as full-time employees.
Ineligible establishments. Proposed Sec. Sec. 332.3(c) and
381.513(c) describe establishments that are ineligible to participate
in a cooperative interstate shipment program. For the most part, these
establishments reflect the ``prohibited establishments'' described in
section 11015 of the 2008 Farm Bill (Sec. 501(b)(2) and 31(b)(2)).
These establishments include:
Establishments that employ more than 25 employees on
average, with a limited exception for establishments that had between
25 and 35 employees as of June 18, 2008 and that have 25 or fewer
employees as of the date three years from the date that the final rule
resulting from this rule becomes effective;
Establishments operating under a cooperative inspection
program under the Talmadge-Aiken Act;
Official establishments;
Establishments that were official establishments as of
June 18, 2008, but that were reorganized on a later date by the person
that controlled the establishment as of June 18, 2008;
State-inspected establishments that employed more than 35
employees as of June 18, 2008, but that were later reorganized by the
person that controlled the establishment as of June 18, 2008;
Establishments that are transitioning to become official
establishments;
Establishments that are in violation of the FMIA or PPIA;
and
Establishments located in a State without a cooperative
meat or poultry products inspection program.
In addition, the proposed regulations also include among the
establishments ineligible to participate in a cooperative interstate
shipment programs, establishments located in a State whose agreement
for an interstate shipment program was terminated by the Administrator.
Proposed Sec. Sec. 332.3(d) and 381.513(d) provide that an
eligible establishment may apply for selection into a cooperative
interstate shipment program through the State where the establishment
is located. FSIS is proposing that establishments apply for selection
into a cooperative interstate shipment program through the State
because the State will be responsible for providing inspection services
to the establishment if the establishment is selected for the program.
Thus, establishment participation in the cooperative interstate
shipment program will depend on whether the State is able, and willing,
to provide the necessary inspection services to the establishment.
However, if a State enters into an agreement with FSIS for a
cooperative interstate shipment
[[Page 47652]]
program, FSIS, in coordination with the State, will make the final
determination on whether to select an establishment to participate in
the program.
4. State Request for a Cooperative Interstate Shipment Program
Under this proposed rule, a State that does not have a cooperative
interstate shipment program, but that is interested in establishing
one, may submit a request for such a program to FSIS. Proposed
Sec. Sec. 332.4 and 381.514 prescribe the procedures for States to
request an agreement for a cooperative interstate shipment program.
Under this proposal, a State will submit the request through the FSIS
District Office that covers the State. Proposed Sec. Sec. 332.4(a) and
381.514(a) make clear that State participation in a cooperative
interstate shipment program is limited to States that have cooperative
State meat or poultry products inspection programs.
Required information. Proposed Sec. Sec. 332.4(b) and 381.514(b)
describe the information that States will need to include in their
requests for an agreement for a cooperative interstate shipment
program. Because a cooperative interstate shipment program requires
participation from both States and establishments, the State's request
for an agreement for a cooperative interstate shipment program must
identify establishments in the State that have requested to be selected
and that the State recommends for initial selection into the program
(proposed Sec. Sec. 332.4(b)(1) and 381.514(b)(1)). If FSIS and the
State enter into an agreement for a cooperative interstate shipment
program under this proposal, these establishments will be the first to
be considered for the program. Other establishments operating under the
State's meat or poultry products inspection program may apply to become
selected establishments after the cooperative interstate shipment
program has been implemented within the State.
A State's request for a cooperative interstate shipment program
must also include documentation to demonstrate that the State is able
to provide necessary inspection services to selected establishments in
the State and conduct any related activities that would be required
under a cooperative interstate shipment program (proposed Sec. Sec.
332.4(b)(2) and 381.514(b)(2)). Under this proposal, this documentation
would be similar to the documentation that States provide when they
request an agreement for a cooperative State meat or poultry products
inspection program. However, instead of demonstrating that the State's
inspection program is ``at least equal to'' the Federal inspection
program, the statute requires that the State demonstrate that
inspection services provided to selected establishments will be ``the
same as'' the inspection services provided under the Federal program.
Thus, to qualify for a cooperative interstate shipment program
under this proposal, States will need to demonstrate, among other
things, that they have the authority under State law to provide the
same inspection services to selected establishments in the State as the
inspection services that FSIS provides to official Federal
establishments. States will also need to demonstrate that they have
staffing sufficient to conduct the same inspection activities in
selected establishments that FSIS conducts in official Federal
establishments, and that designated personnel have been properly
trained in Federal inspection methodology. FSIS currently offers
training courses in Federal inspection methodology to State inspection
personnel. Under this proposal, States that are interested in
participating in a cooperative interstate shipment program will be
responsible for making arrangements for their inspection personnel to
attend these courses. FSIS will also expect States to demonstrate that
they can provide the necessary equipment for State personnel to provide
the same inspection services to selected establishments that FSIS
provides to official Federal establishments, including computers and
supplies for collecting product samples.
Because the statute requires compliance with all Federal standards,
meat and poultry products produced in selected establishments will be
subject to the same regulatory sampling programs as those established
in the Federal inspection program. Thus, to be eligible to participate
in a cooperative interstate shipment program, States will need to
demonstrate that State personnel will collect the same number and type
of regulatory product samples from selected establishments as are
collected under FSIS's inspection sampling program.
In addition, the State will need to demonstrate that the laboratory
services that it intends to use to analyze product samples from
selected establishments are capable of conducting the same chemical,
microbiological, physical, and pathology testing as are required under
the Federal meat and poultry products inspection programs. FSIS's
Office of Public Health Science will provide audit assistance to the
State to verify that the methodologies used by a State's laboratory
services to analyze samples from selected establishments are capable of
producing the same results as the methodologies used by FSIS
laboratories. FSIS will not enter into an agreement for a cooperative
interstate shipment program with a State that does not meet the
conditions described above.
Additional conditions. Proposed Sec. Sec. 332.4(b)(3) and
381.514(b)(3) prescribe additional conditions that States applying for
a cooperative interstate shipment program must agree to in order to
qualify for the program. These proposed regulations provide that when a
State submits a request to establish a cooperative interstate shipment
program, the State must agree that, if it enters into an agreement with
FSIS for such a program, that the State will:
Provide FSIS with access to the results of all laboratory
analyses conducted on product samples from selected establishments in
the State;
Notify the selected establishment coordinator (SEC) for
the State of the results of any laboratory analyses that indicate that
a product prepared or processed in a selected establishment may be
adulterated or may otherwise present a food safety concern; and
If necessary, cooperate with FSIS to transition selected
establishments in the State that have been deselected from a
cooperative interstate shipment program to become official
establishments. FSIS will not enter into an agreement for a cooperative
interstate shipment program if a State does not agree to these terms.
Qualified States. Under this proposal, after a State submits a
request for a cooperative interstate shipment program, the FSIS
Administrator will review the request and determine whether the State
qualifies for such a program. If, based on the information submitted in
the request the Administrator determines that a State is eligible to
enter into a cooperative agreement for an interstate shipment program,
the Administrator and the State will sign a cooperative agreement that
sets forth the terms and conditions under which each party will
cooperate to provide inspection services to selected establishments in
the State (proposed Sec. Sec. 331.4(c) and 381.514(c)). After the
Administrator and a State have signed an agreement for a cooperative
interstate shipment program, the Administrator will: (1) Appoint an
FSIS employee as the selected establishment coordinator (SEC) for the
State and (2) coordinate with the State to select the establishments
that will participate in the program (proposed Sec. Sec. 332.4(d) and
381.514(d)).
[[Page 47653]]
Summary of actions needed to establish a cooperative interstate
shipment program under the proposed regulations.
The proposed regulations discussed above describe conditions that
both establishments and States must meet to participate in a
cooperative interstate shipment program. If FSIS adopts these proposed
regulations in a final rule, the steps for establishing a new
cooperative interstate shipment program will be the following.
An establishment that is eligible for the interstate
shipment program, and that is interested in participating in the
program, will apply for the program through the State agency that
administers the State meat and poultry products inspection program
under which the establishment operates. States will develop their own
application procedures.
The State will then evaluate the establishment's
application to determine whether the State will recommend the
establishment for selection into the cooperative interstate shipment
program.
If the State determines that an establishment qualifies
for selection into the program, and the State is able, and willing, to
provide the necessary inspection services to the establishment, the
State will recommend the establishment for selection into the program.
The State will need to submit its recommendation through the FSIS
District Office whose jurisdiction includes the State.
If the State has not entered into an agreement with FSIS
for a cooperative interstate shipment program, but is qualified to
participate in such a program, it will need to submit a request for a
cooperative agreement for the program to the FSIS District Office that
covers the State.
In its request for a cooperative interstate shipment
program, a State will need to: (1) Identify those establishments that
have submitted a request for, and that the States recommends for,
initial selection into the program and (2) demonstrate that it is able
to provide the necessary inspection services to these establishments if
they are selected for the program. The State will also need to agree to
comply with certain conditions associated with FSIS oversight and
enforcement of the program.
After a State submits a request for a cooperative
interstate shipment program, the FSIS Administrator will evaluate the
request and determine whether the State qualifies for the program.
If the Administrator determines that the State qualifies
for the cooperative interstate shipment program, the Administrator and
the State will sign a cooperative agreement that sets forth the terms
and conditions under which each party will cooperate to provide
inspection services to selected establishments in the State.
The Administrator will then appoint an SEC for the State,
and the Administrator, in coordination with the State, will begin
selecting establishments for participation in the program.
5. Selection of Establishments
As discussed above, under this proposal, State-inspected
establishments that are interested in participating in a cooperative
interstate shipment program will apply for selection into the program
through the State agency that administers the State's meat or poultry
products inspection program. When, and if, an establishment applies to
participate in a cooperative interstate shipment program, the State
will evaluate the establishment to determine whether it qualifies to
become a selected establishment. Proposed Sec. Sec. 332.5(a) and
381.515(a) provide that a State-inspected establishment will qualify
for selection into a cooperative interstate shipment program if the
establishment:
Has submitted a request to the State to be selected for
the program;
Has the appropriate number of employees;
Is not ineligible for a cooperative interstate shipment;
Is in compliance with all requirements under the State
inspection program; and
Is in compliance with the all Federal meat or poultry
products inspection requirements.
Establishments that do not meet all of these criteria will not
qualify, and will not be selected, for the program. To participate in a
cooperative interstate shipment program, an establishment that
qualifies for such a program must be selected by the Administrator, in
coordination with the State where the establishment is located
(proposed Sec. Sec. 332.5(b) and 381.515(b)).
Thus, under this proposal, if a State determines that an
establishment operating under the State's meat or poultry products
inspection program qualifies for selection into a cooperative
interstate shipment program, and the State is able, and willing, to
provide the necessary inspection services to the establishment, the
State is to submit its evaluation of the establishment through the FSIS
District Office that covers the State. The FSIS Administrator, in
coordination with the State, will decide whether to select the
establishment for the program. When deciding whether to select and
establishment for the program, the Administrator will consider whether
the establishment meets the criteria needed to qualify for the program
and whether the Agency has the resources that it needs to provide the
required oversight of the establishment if it is selected for the
program.
As stated above, to qualify to participate in a cooperative
interstate shipment program, an establishment must be in compliance
with all Federal inspection requirements under the FMIA, PPIA, and
their implementing regulations in title 9, chapter III, of the CFR.
Thus, as part of the selection process, the SEC, in coordination with
the State, will verify that each establishment that has applied to
participate in a cooperative interstate shipment program: (1) Meets the
Federal regulatory performance standards established in 9 CFR 416.1
through 416.6; (2) has submitted all labeling material to the State for
approval, and that the materials meet all Federal requirements in 9 CFR
parts 316, 317, and 319 and Part 381, subparts M, N, and P; (3) has
obtained the same water source and sewage system approval that FSIS
requires for official establishments; (4) has developed Sanitation
Standard Operating Procedures (Sanitation SOPs) that comply with 9 CFR
416.11-416.17; and (5) has conducted a hazard analysis and developed a
validated Hazard Analysis and Critical Control Points (HACCP) plan that
complies with 9 CFR part 417.
These criteria reflect the standards that meat and poultry products
establishments are required to meet to obtain a Federal grant of
inspection under 9 CFR part 304 and 9 CFR part 381. Establishments that
do not meet all of these requirements are not in compliance with all
Federal standards and thus will not be selected for the program.
If an establishment qualifies for, and is selected to participate
in, a cooperative interstate shipment program under this proposed rule,
proposed Sec. Sec. 332.5(c) and 381.515(c) provide that the State is
to assign the establishment an official number that reflects the fact
that the establishment is a participant in the cooperative interstate
shipment program. These proposed regulations provide that the State is
to advise the SEC of the number assigned to each selected establishment
in the State. Proposed Sec. Sec. 332.5(c) and 381.515(c) go on to
state that the official numbers
[[Page 47654]]
assigned to selected establishments need to contain the suffix ``SE''
to identify the establishments as selected establishments. FSIS is
proposing this requirement to ensure that establishments participating
in the cooperative interstate shipment program can be identified by
reference to their establishment number. It will also ensure that meat
and poultry products prepared in selected establishments are identified
as articles produced under a cooperative interstate shipment program.
Proposed Sec. Sec. 332.5(c) and 381.515(c) also provide that the
selected establishment numbers must include, as a suffix, the
abbreviation for the State in which the establishment is located. In
addition, proposed Sec. 381.515(c) provides that the suffix of the
number for a selected poultry products establishments needs to contain
the letter ``P'' to identify the establishment as one that processes
poultry products. Thus, under this proposal, an official number for a
selected establishment in Texas that prepares meat products would
contain the suffix ``SETX,'' while an official number for an
establishment in North Dakota that process poultry products would
contain the suffix ``SEPND.''
As discussed below, articles that have been inspected and passed in
a selected establishment will bear an official USDA mark, stamp, tag,
or label of inspection.
Finally, proposed Sec. Sec. 332.5(d) and 381.515(d) provide that
failure of a State to comply with Sec. Sec. 332.5(c) and 381.515(c)
will disqualify that State from participation in a cooperative
interstate shipment program. Full compliance by a State with these
provisions is essential if the program is to succeed.
6. Inspection at Selected Establishments, Official Mark, and Interstate
Shipment
Proposed Sec. Sec. 332.6(a) and 381.516(a) provide that a
cooperative interstate shipment program will commence when the
Administrator, in coordination with a State that has entered into an
agreement for a cooperative meat or poultry products inspection
program, have selected establishments in the State to participate in
the program.
Proposed Sec. Sec. 332.6(b) and 381.516(b) provide that inspection
services for selected establishments participating in a cooperative
interstate shipment program must be provided by designated personnel,
who will be under the direct supervision of a State employee. As
discussed below, the FSIS SEC will oversee the inspection activities of
the designated personnel.
Proposed Sec. Sec. 332.6(c) and 381.516(c) provide that articles
prepared or processed in a selected establishment that have been
inspected and passed by designated personnel must bear an official USDA
mark, stamp, tag, or label of inspection as specified in 9 CFR 312.2 or
9 CFR 381.96. 9 CFR 312.2 and 9 CFR 381.96 are the regulations that
prescribe the appropriate wording and form for use of the official
Federal inspection legend on meat or poultry products. In addition, the
establishment number contained in the Federal mark, stamp, tag, or
label of inspection must comply with all the conditions proposed in
Sec. Sec. 332.5(c) or 381.515(c).
Under proposed Sec. Sec. 332.6(d) and 381.516(d) meat or poultry
products prepared in selected establishments may be shipped in
interstate commerce if they have been inspected and by selected State
personnel and bear the Federal mark of inspection.
7. Federal Oversight of Cooperative Interstate Shipment Programs
Section 11015 of the 2008 Farm Bill requires that the Secretary
designate an employee of the Federal government as a ``State
coordinator'' for each State that has a cooperative State meat or
poultry products inspection program (Sec. 501(d) and Sec. 31(d)). The
State coordinator is required to ``provide oversight and enforcement''
of the program and ``to oversee the training and inspection
activities'' of State personnel designated to provide inspection
services to selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)).
As noted above, when, and if, a State qualifies to participate in a
cooperative interstate shipment program, proposed Sec. Sec.
332.4(c)(1) and 381.514(c)(1) provide that the Administrator will
appoint an FSIS employee as the FSIS SEC for the State. The SEC is the
``State coordinator'' prescribed by the statute.
FSIS has tentatively decided that the SEC will be an employee of
the FSIS Office of Field Operations (OFO) and will be assigned to an
FSIS District Office. The SEC will likely be under the direct
supervision of an FSIS District Manager. The number of States in an
FSIS district assigned to an SEC will likely depend on several factors,
including, but not limited to: (1) The number of States and selected
establishments, if any, that participate in the cooperative interstate
shipment program; (2) the location of each selected establishment; (3)
the number of State inspection personnel providing inspection services
to selected establishments in a State; (4) the complexity of the
operations conducted at each selected establishment; and (5) the
schedule of operations for each selected establishment. The number of
States assigned to an SEC would also need to be based on consideration
of the most effective allocation of available Agency resources.
SEC initial responsibilities. One of the SEC's initial
responsibilities will be, in conjunction with the District Office, to
coordinate with the State to select establishments to participate in
the program. The SEC will coordinate with the State to verify that all
State personnel selected to provide inspection services to these
establishments have successfully completed the same training in the
fundamentals of meat and poultry inspection, covering the Sanitation
Performance Standards, Sanitation Standard Operating Procedures (SOPs),
HACCP, and enforcement procedures, that is required for FSIS inspection
personnel. The SEC will also coordinate with the State to verify that
designated personnel have successfully completed the appropriate
customized food safety training required for FSIS inspection personnel
based on the types of products being produced at the establishments
where designated personnel are assigned.
SEC's oversight responsibilities. Proposed Sec. Sec. 332.7 and
381.517 prescribe how the FSIS SEC is to provide Federal oversight of
the cooperative interstate shipment program.
Proposed Sec. Sec. 332.7(a) and 381.517(a) provide that the SEC is
to visit each selected establishment in the State on a regular basis to
verify that these establishments are operating in a manner that is
consistent with the Acts and the implementing regulations in title 9,
chapter III, of the CFR. The SEC's frequency of visits and oversight
activities for each selected establishment will need to reflect the
type of operations conducted by a selected establishment, as well as
the establishment's production processes. FSIS requests comments on how
frequently the SEC should visit each establishment under his or her
jurisdiction. Proposed Sec. Sec. 332.7(a) and 381.517(a) also provide
that if necessary, the SEC, in consultation with the District Manager
that covers the State, may designate qualified FSIS personnel to visit
a selected establishment on behalf of the SEC.
Under proposed Sec. Sec. 332.7(b) and 381.517(b), the SEC, in
coordination with the State, will verify that selected establishments
in the State are receiving the necessary inspection services from
[[Page 47655]]
designated personnel, and that these establishments are eligible, and
remain eligible, to participate in the cooperative interstate shipment
program. These proposed regulations provide that the SEC's verification
activities may include:
Verifying that each selected establishment in the State
employs, and continues to employ, 25 or fewer employees on average,
unless the establishment is transitioning to become an official
establishment;
Verifying that the designated personnel are providing
inspection services to selected establishments in an manner that
complies with the Acts and implementing regulations;
Verifying that the State staffing levels for each selected
establishment are appropriate to carry out the required inspection
activities; and
Assessing each selected establishment's compliance with
the Acts and implementing regulations under title 9, chapter III, of
the CFR.
To verify that designated personnel are providing inspection
services in compliance with the Acts, the SEC for the establishment, in
coordination with the State, will verify that the designated personnel
are correctly applying Federal inspection methodology, making decisions
based upon the correct application of this methodology, accurately
documenting their findings, and, when authorized to do so, implementing
enforcement actions in accordance with the FSIS Rules of Practice in 9
CFR part 500.
To assess each selected establishment's compliance with Federal
food safety standards, the SEC will observe the condition of the
establishment, observe establishment employees performing their duties,
review the establishment's records, and submit product samples for
analysis to determine that product produced by the establishment meets
Federal food safety standards.
The SEC will have discretion to increase the frequency of visits to
a selected establishment if the SEC, in consultation with the District
Manager for the State where the selected establishment is located,
determines that such action is necessary to ensure that the
establishment is operating in a manner consistent with the Acts. The
SEC will also be authorized to conduct a comprehensive food safety
assessment (FSA) for a selected establishment, or to request that an
FSIS Enforcement, Investigation, and Analysis Officer (EIAO) conduct an
FSA, if the SEC, in consultation with the District Manager, determines
that such action would help determine whether the establishment is
operating in compliance with the Acts. A comprehensive food safety
assessment is an assessment that considers all the food safety aspects
that relate to an establishment and all the products the plant
produces.
If the SEC determines that designated personnel are not providing
inspection services to selected establishments in a manner that
complies with the Acts, proposed Sec. Sec. 332.7(c) and 381.517(c)
provide that FSIS will provide an opportunity consistent with these
regulations for the State to develop and implement a corrective action
plan to address inspection deficiencies identified by the SEC. These
proposed regulations also provide that if the State fails to develop a
corrective action plan, or if the SEC determines that the State's
corrective action plan is inadequate, the Administrator will terminate
the cooperative agreement with the State.
As discussed above, selected establishments in a State whose
agreement for a cooperative interstate shipment program has been
terminated by the Administrator are among the establishments that are
ineligible to participate in the program. As such, these establishments
will be deselected from the program and transitioned to become Federal
establishments as described below.
Quarterly reports. As required under section 11015 of the 2008 Farm
Bill (Sec. 501(d)(3)(b) and Sec. 31(d)(3)(b)), the SEC is to prepare a
report on a quarterly basis that describes the status of each selected
establishment under the SEC's jurisdiction (proposed Sec. Sec.
332.8(a) and 381.518(a)).
The SEC's quarterly report will include the SEC's assessment of the
performance of the designated personnel in conducting inspection
activities (proposed Sec. Sec. 332.8(b)(1) and 381.518(b)(1)). The
quarterly report will also identify the selected establishments that
the SEC has verified are in compliance with all Federal requirements,
those that have been deselected, and those that are transitioning to
become Federal establishments (proposed Sec. Sec. 332.8(b)(1) and
381.518(b)(1)). The SEC will submit the report to the Administrator
through the District Manager for the State in which the selected
establishments identified in the report are located (proposed
Sec. Sec. 332.8(c) and 381.518(c)).
Enforcement. Section 11015 of the 2008 Farm Bill provides that if
the SEC determines that any selected establishment is in violation of
any requirement of the Acts, the SEC is required to: (1) Immediately
notify the Secretary (the FSIS Administrator by delegation) of the
violation and (2) ``deselect'' the establishment or suspend inspection
at the establishment (Sec. 501(d)(3)(C) and Sec. 31(d)(3)(C)). In
adopting this language, Congress intended that the SEC ``* * * shall be
provided all the tools necessary under the Secretary to prevent or
control any food safety issue that would harm human health'' (S. Rep.
No. 220, 110th Cong., 1st Sess., at 211 (2007)).
Because many of the SEC's verification and enforcement activities
require that the SEC have access to a selected establishment's records,
proposed Sec. Sec. 332.9(a) and 381.519(a) provide that to facilitate
oversight and enforcement of the cooperative interstate shipment
program, selected establishments must, upon request, give SECs or other
FSIS officials access to all establishment records required under the
FMIA, PPIA, and the implementing regulations in title 9, chapter III,
of the CFR. These proposed regulations go on to state that FSIS will
move to deselect an establishment that does not comply with this
requirement.
Under proposed Sec. Sec. 332.9(b) and 381.519(b), the SEC is
authorized to initiate any appropriate enforcement action provided for
in the FSIS rules of practice in 9 CFR part 500 if he or she determines
that a selected establishment under his or her jurisdiction is
operating in a manner that is inconsistent with the Acts or their
implementing regulations. Such actions include, among others,
regulatory control actions, withholding actions, and suspensions. The
proposed regulations provide that selected establishments participating
in a cooperative interstate shipment program are subject to the
notification and appeal procedures set out in part 500 (proposed
Sec. Sec. 332.9(b) and 381.519(b)).
Proposed Sec. Sec. 332.9(c) and 381.519(c) provide that if
inspection at a selected establishment is suspended for any of the
reasons specified in 9 CFR 500.3 or 9 CFR 500.4, FSIS will provide an
opportunity for the establishment to implement corrective actions and
remain in the cooperative interstate shipment program, or the Agency
will move to deselect the establishment. The decision to deselect a
selected establishment under a suspension will be made on a case-by-
case basis (proposed Sec. Sec. 332.9(d) and 381.519(d)). In making
this decision, the Administrator, in consultation with the State where
the selected establishment is located, will consider, among other
factors: (1) The non-compliance that led to the suspension; (2) the
selected establishment's compliance history, which will be documented
in non-compliance reports prepared by the designated personnel and the
SEC's
[[Page 47656]]
quarterly reports; and (3) the corrective actions proposed by the
establishment (proposed Sec. Sec. 332.9(d) and 381.519(d))
The Administrator will have the discretion to allow a selected
establishment that has been suspended to remain in the program if the
establishment implements corrective actions to address any non-
compliance. The Administrator will consider the criteria described
above in determining whether to provide an opportunity for corrective
actions. Establishments that are given an opportunity to take
corrective actions but that are unable to effectively implement these
actions will be deselected.
FSIS will also consider the State's recommendation as to whether a
selected establishment in the State should be deselected. However, the
final decision to deselect an establishment for violations of the FMIA
or PPIA will be made by FSIS. As discussed below, consistent with the
law, this proposed rule requires that deselected establishments be
transitioned to become official establishments.
8. Deselection
There may be circumstances in which an establishment that initially
qualifies to be selected to participate in a cooperative interstate
shipment program later acquires characteristics that would cause it to
become ineligible for the program. For example, an establishment may
hire additional employees after it has been selected, or, as discussed
above, FSIS may determine that a selected establishment is in violation
of the Acts. Therefore, proposed Sec. Sec. 332.10(a) and 381.520(a)
provide that the Administrator will deselect an establishment that
becomes ineligible to participate in a cooperative interstate shipment
program. Proposed Sec. Sec. 332.10(b) and 381.520(b) provide that an
establishment that has been deselected from a cooperative interstate
shipment program must be transitioned to become an official
establishment.
FSIS is proposing to require that deselected establishments be
transitioned to become official Federal establishments as provided for
in the law. Section 11015 of the 2008 Farm Bill allows the Agency to
establish a procedure to transition selected establishments that
employ, on average, more than 25 employees to become Federal
establishments, and it requires that selected establishments that the
Administrator determines to be in violation of any provision of the
Acts, be transitioned to Federal establishments in accordance with the
procedure developed for establishments that employ more than 25
employees (Sec. 501(b)(3), 501(h), 31(b)(3) and 31(g)).
Thus, as required by the law, under this proposal, establishments
that become ineligible to participate in the cooperative interstate
shipment program because they violated Federal food safety standards
will not permitted to avoid implementing appropriate corrective actions
by withdrawing from the cooperative interstate shipment program and
reverting back to the State inspection program. In addition, requiring
that deselected establishments transition to become official Federal
establishments will help to ensure that the resources that FSIS and the
States provide to establish and maintain a cooperative interstate
shipment program are used most effectively to provide inspection
services to establishments that are committed to maintaining Federal
food safety standards.
9. Transition Procedures for Deselected Establishments
As discussed above, under the law, FSIS is authorized to develop a
procedure to transition selected establishments to become official
establishments if they employ more than 25 employees on average, or if
the Agency determines that they are in violation of any provision of
the Acts (Sec 501(b), Sec. 501(h), Sec. 31(b) and Sec. 31(g)). At a
minimum, a procedure to transition a selected establishment to an
official establishment would include: (1) Adding the establishment to
an FSIS circuit within the FSIS District that covers the State where
the establishment is located; (2) replacing the establishment's State
establishment number with a Federal establishment number, and (3)
replacing the designated personnel with FSIS inspection personnel.
Other actions needed to successfully transition a selected
establishment to become an official establishment are likely to depend
on the reason the establishment was deselected. For example, an
establishment that was deselected from a cooperative interstate
shipment program for violating provisions of the Acts would likely need
to develop a corrective action plan as part of its process to
transition to an official establishment, while an establishment that
was deselected for hiring additional employees would not.
Therefore, instead of prescribing a specific procedure to
transition selected establishments to official establishments, proposed
Sec. Sec. 332.11 and 381.521 provide that if a selected establishment
is deselected, FSIS will coordinate with the State where the
establishment is located to develop and implement a plan to transition
the establishment to become an official establishment. The SEC with
jurisdiction over the deselected establishment will likely be charged
with coordinating with the State and the FSIS District Office to
develop and implement the transition plan.
10. Technical Assistance Division and Transition Grants
Section 11015 of the 2008 Farm Bill amended the FMIA to require
that FSIS establish a ``technical assistance division'' to coordinate
the initiatives of other USDA agencies to provide ``outreach,
education, and training to certain small and very small
establishments'' and to provide ``grants to States to provide outreach,
technical assistance, education, and training to certain small and very
small establishments'' (Sec. 501(f)). As noted earlier in this
document, FSIS fulfilled this requirement by establishing the Office of
Outreach Employee Education and Training (OOEET).
OOEET is responsible for directing outreach, education, and
training programs for FSIS to ensure public health and food safety
through both inspection and enforcement activities. OOEET is also
responsible for coordinating with other USDA agencies, such as the
Rural Development Mission Area and the Cooperative State Research,
Education, and Extension Service.
The OOEET State Outreach and Technical Assistance Division promotes
State programs and activities to achieve national food safety, food
security, and other consumer protection goals by planning, organizing,
coordinating, and supporting FSIS cooperative activities with State
agencies with responsibility for State meat, poultry and egg product
public health assurance inspection programs. It also provides technical
expertise, information, and advice to small and very small plant owners
and operators on the interpretation, application, implementation and
enforcement of the statutes and regulations that FSIS implements.
Transition grants. In addition to requiring that FSIS establish a
``technical assistance division'' to coordinate the initiatives of
other USDA agencies to provide grants to States, section 11015 of the
2008 Farm Bill authorizes FSIS to provide ``transition grants'' to
States to assist the States in helping State-inspected establishments
transition to selected establishments (Sec. 501(g) and Sec. 31(f)). The
Agency has tentatively decided to use this authority, subject to the
availability of funds, to grant funds to States that
[[Page 47657]]
participate in a cooperative interstate shipment program to reimburse
selected establishments in the State for their costs to train one
individual in HACCP and associated training in Sanitation SOP
requirements.
The regulations that prescribe conditions for receiving Federal
inspection, which represent the conditions that selected establishments
must meet to be in compliance with Federal standards, require that an
establishment develop written Sanitation SOPs as required by 9 CFR part
416, and that it have conducted a hazard analysis and developed and
validated a HACCP plan as required in 9 CFR 417.2 and 417.4 (9 CFR
304.3 and 381.22). Under 9 CFR 417.7 of the HACCP regulations, the
individual that develops the HACCP plan for an establishment must have
successfully completed a course of instruction in the application of
the seven HACCP principles to meat or poultry product processing,
including a segment on the development of a HACCP plan for a specific
product and on record review.
State-inspected establishments that apply to participate in a
cooperative interstate shipment program will be required to have an
individual trained in HACCP in order to transition to a selected
establishment. Therefore, for purposes of this proposed rule, FSIS has
tentatively concluded that it is appropriate to provide funds to a
State for the purpose of reimbursing selected establishments for the
cost of this training. Accordingly, proposed Sec. Sec. 332.12(a) and
381.522(a) provide that these ``transition grants'' are funds that a
State participating in a cooperative interstate shipment program must
use to reimburse selected establishments in the State for the cost to
train one individual in the HACCP principles applicable to meat or
poultry processing as required under 9 CFR 417.7 and associated
training in the development of Sanitation SOPs required under 9 CFR
part 416.
Proposed Sec. Sec. 332.12(b) and 381.522(b) make clear that States
must use transition grants only for this described purpose. Once a
selected establishment receives such funding from the State, the State
may not use additional transition grant funds to reimburse that
establishment's training costs in the future.
Under this proposal, establishments that train an individual in
HACCP or Sanitation SOP requirements as part of their transition to
become selected establishments may request reimbursement for these
training costs through the State agency that administers the State's
cooperative interstate shipment program. These selected establishments
will need to submit a training certificate or other documentation to
demonstrate that an individual completed the appropriate training. The
State would then submit the documentation to FSIS, and request a
``transition grant'' to reimburse the establishment for its training
costs.
Executive Order 12866 and Regulatory Flexibility Act:
This proposed rule has been reviewed under Executive Order 12866.
It has been determined to be significant, but not economically
significant for purposes of E.O. 12866 and, therefore, has been
reviewed by the Office of Management and Budget (OMB).
Currently, 27 States administer cooperative State meat or poultry
inspection programs. These States have approximately 1,873
establishments that would be eligible to apply for selection into the
new cooperative interstate shipment program. However, because
participation in the new program will be voluntary, FSIS will not know
how many States and establishments will apply to participate until
final implementing regulations become effective and establishments are
selected for the program. Information obtained through the Agency's
outreach activities indicates that, as of July 2008, about 170
establishments in sixteen States have approached the State Meat and
Poultry programs to indicate that they are interested in the new
program. These sixteen States have in total 1,133 establishments that
could potentially be eligible for the new program.
Expected Benefits of the Proposed Action: State-inspected
establishments selected to participate in the new cooperative
interstate shipment program will be permitted to ship and sell their
meat and poultry products in interstate and foreign commerce. Thus, the
proposed action would benefit these establishments by opening new
markets for their products.
The proposed action would also benefit consumers by generating more
product choices, as more products can be shipped to new markets. In
addition, the Federal inspection legend and official State
establishment inspection number may facilitate traceback of these
products if such products are ever the subject of an investigation or
recall.
States that participate in the program would benefit because FSIS
would reimburse them for at least 60% of their costs related to
inspection of selected establishments in the State. FSIS provides up to
50% of the costs of existing cooperative State inspection programs. The
Agency has tentatively concluded that most States will benefit from the
10% increase in reimbursement for the cooperative interstate shipment
program because, as explained below, for many States, the costs to
administer the new program are not expected to exceed the costs to
administer the State meat and poultry inspection programs.
Expected Costs of the Proposed Action:
Costs to the participating establishments. To be eligible to
participate in the cooperative interstate shipment program, a State-
inspected establishment must be in compliance with: (1) The State-
inspection program of the State in which the establishment is located
and (2) the FMIA or PPIA, and their implementing regulations. Before
State-inspected establishments can be selected to participate in a
cooperative interstate shipment program, they will need to apply for
selection into the program and demonstrate that they comply with both
State and Federal requirements.
Thus, an establishment that chooses to apply for selection into the
program will incur one-time start-up costs associated with filing an
application, training employees, meeting regulatory performance
standards, obtaining label approval, and implementing a food safety
system that complies with all Federal requirements (e.g., Sanitation
SOP and HACCP requirements).
In addition, to qualify for a cooperative interstate shipment
program, some State-inspection establishments may need to invest in
structural modifications to their facilities in order to comply with
Federal standards. Based on information obtained through FSIS' outreach
activities with the States, the Agency estimates that the cost for
State-inspected establishments to fully comply with Federal standards,
as required by the law, will range from $1,500 to $50,000. According to
most State Directors, the cost to very small establishments that do not
need to make structural modifications to their facilities is likely to
be in the range of $5,000 to $10,000. On the other hand, if the
establishments need to make structural modifications or perform new
construction then the range would be about $15,000 to $30,000.\1\
However, because this is a voluntary program, establishments that
choose to incur the costs associated with participating in the program
will most likely do so because they anticipate that such
[[Page 47658]]
participation will provide an overall net benefit for them. The Agency
welcomes comments on these estimates.
---------------------------------------------------------------------------
\1\ Note that under this proposed rule, establishments selected
for the program will be eligible to be reimbursed the cost to train
one employee in HACCP and Sanitation SOPs.
---------------------------------------------------------------------------
Looking at the potential for the establishments to experience new
(incremental) burden or expenses due to State inspection under the
proposed cooperative interstate shipment program, FSIS believes that
there will be essentially no change. FSIS is aware that the cooperative
State meat and poultry products inspection programs are not identical
to Federal inspection, as they must be under the cooperative interstate
shipment program. So FSIS anticipates that State inspection procedures
will need to be changed somewhat to comply with the requirements of the
cooperative interstate shipment program. However, since the State
programs are required to be equal to the Federal inspection programs
now, FSIS anticipates that changes will largely be procedural, and
there will not be any particular increase or decrease in overall State
effort that would change the burden of the inspection regimen on the
establishments.
Costs to the participating States. States that choose to
participate in the program will be required to pay 40 percent of the
eligible costs related to inspection of establishments in the State
that are selected for the program. Under the current cooperative
program, the States are paying 50 percent of the eligible inspection
costs. Although the inspection costs under the new program may be
different from the costs under the existing program, the States' share
of 40 percent or less is unlikely to be higher than its current share.
States that choose to participate in the interstate shipment
program may need to make certain modifications to their State
inspection programs to provide inspection services to selected
establishments in a manner that is the same as the Federal inspection
program. However, most States that have implemented State meat and
poultry products inspection (MPI) programs have incorporated the
Federal requirements into their programs.\2\ Thus, State costs to train
State personnel are likely to be minimal because many State personnel
have received training in Federal inspection methodology as part of the
State MPI program.
---------------------------------------------------------------------------
\2\ Based on Agency's most recent (FY 2008) review of the 27
States' self-assessment reports (including the State Laboratory
Activity Tables) by the Federal State Audit Branch, Internal Control
and Audit Division of the Office of Program Evaluation, Enforcement,
and Review.
---------------------------------------------------------------------------
States may incur some costs associated with the processing and
evaluation of applications submitted by establishments requesting to be
selected for the cooperative interstate shipment program. However,
because the States will develop their own application procedures, FSIS
is unable to estimate these costs with any certainty. The Agency
requests comments on potential State costs associated with the
processing and evaluation of these applications.
FSIS anticipates that State inspection procedures will need to be
changed somewhat to comply with the requirements of the proposed
cooperative interstate shipment program. However, since the State
programs are required to be at least equal to the Federal inspection
programs now, FSIS anticipates that changes will largely be procedural,
and there will not be any particular increase or decrease in overall
State effort or cost. FSIS has no basis on which to assume anything
else. FSIS requests input from State Program officials that might be
useful to refine this estimate.
Expected FSIS Budgetary Effects:
The new Federal-State cooperative inspection program option which
section 11015 of the 2008 Farm Bill requires the Secretary to create
and which we propose to implement via this regulatory action is
expected to have budgetary effects on FSIS to support about 16 full-
time equivalent new staff. This section discusses the baseline costs
and activities, i.e., what is happening now before the cooperative
interstate shipment program option is available, and then lays out the
incremental effects on FSIS. FSIS staff have worked with the 27
directors of the Federal-State meat and poultry inspection program to
gauge the level of interest at the State and establishment level. Their
input has been incorporated into the assumptions here.
Baseline:
Federal-State cooperative inspection programs operated in 27 States
and 1,873 establishments in FY 2008, the baseline year for this
analysis. Actual Federal spending for the Federal-State cooperative
inspection programs was $63,959,709 for FY 2008 as reported in the FY
2010 President's Budget, which also projected $64,703,000 for FY 2009
and $65,654,000 for FY 2010. By statute, the States may be reimbursed
for up to 50 percent of the cost of their State cooperative inspection
programs. Federal reimbursements to State programs reported in the FY
2010 budget, included in the above figures, are $49,061,068 for FY
2008, $50,332,000 for FY 2009, and $50,332,000 for FY 2010. In fact,
actual total State spending for the Federal-State cooperative
inspection programs for FY 2008 was $104 million with $49 million of
that reimbursed by FSIS, as noted above.
FSIS extends these figures into years 2010 through 2014, see table
below, the 5-year analysis period for this rule, by assuming that, had
the cooperative interstate shipment program option not been enacted,
State cooperative programs operations would continue through the period
on a generally stable basis. The Agency assumes that the same 27 States
would continue to participate and the program would inspect about the
same number of establishments as were inspected in FY 2008, i.e.,
1,873. This appears reasonable because, among the 27 States in the
program the number of establishments has been relatively stable. Since
the number of establishments and States is assumed to remain unchanged,
and no significant changes in program requirements are expected,
baseline program costs are assumed to change only with the cost of
inflation.
Turning to FSIS administrative costs, we note that FSIS staffing
has been stable in the 28 to 33 person range for the past decade, and
is expected to remain at 29 for the foreseeable future. Consistent with
State level activities, since the number of States is expected to
remain the same with no particular change in the number of
establishments, and since no significant changes in program
requirements are expected, FSIS administrative costs are expected to
change consistent with the cost of inflation, i.e., the Agency
anticipates no significant increase or decrease in FSIS administrative
activity during the five years in the baseline scenario (i.e., the
baseline assumes no cooperative interstate shipment program). FSIS
spending to administer Federal-State cooperative inspection programs,
excluding the reimbursement costs, was $14,898,641 for FY 2008 as
reported in the FY 2010 budget, and is projected at $14,371,000 for FY
2009 and $15,322,000 for FY 2010. For the years out to 2014, these
costs would change with inflation and are shown in the following table.
[[Page 47659]]
Table 1--Baseline: Cost Federal-State Coop Program With No Change
----------------------------------------------------------------------------------------------------------------
2010 Total 5-
FSIS Level Costs, Fiscal Year (Budget) 2011 2012 2013 2014 year
----------------------------------------------------------------------------------------------------------------
FSIS costs................... $15.3 $15.9 $16.5 $17.1 $17.8 $82.5
Reimburs. to States.......... 50.3 52.1 54.1 56.2 58.4 271.1
----------------------------------------------------------------------------------
Total.................... 65.7 68.0 70.5 73.3 76.1 353.6
----------------------------------------------------------------------------------------------------------------
FSIS Staff Years............. 29 29 29 29 29 ...........
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
State Level Costs, Fiscal 2010 Total 5-
Year (Budget) 2011 2012 2013 2014 year
----------------------------------------------------------------------------------------------------------------
Federal reimbursement........ $50.3 $52.1 $54.1 $56.2 $58.4 $271.1
State program spending....... 50.3 52.1 54.1 56.2 58.4 271.1
----------------------------------------------------------------------------------
Total MPI program........ 100.7 104.2 108.1 112.4 116.7 542.1
----------------------------------------------------------------------------------------------------------------
Number of plants............. 1,873 1,873 1,873 1,873 1,873 ...........
----------------------------------------------------------------------------------------------------------------
Economic Assumptions From OMB for the 2010 Budget
----------------------------------------------------------------------------------------------------------------
State & Local Exp, %......... 3.1 3.5 3.8 3.9 3.9 ...........
FSIS civilian pay, %......... 5.1 4.1 4.1 4.1 4.1 ...........
Non-Pay Expenditure, %....... 0.8 1.2 1.4 1.6 1.6 ...........
----------------------------------------------------------------------------------------------------------------
Interstate Scenario:
To evaluate this scenario, we must estimate the number of
establishments and States that will seek to participate and be selected
for the new cooperative interstate shipment program. Then we will
discuss the likely incremental changes in activity that could
reasonably suggest any changes in cost or burden for FSIS, the States,
or establishments.
Here is how we determined the number of establishments that are
likely to participate in the proposed cooperative interstate shipment
program. The first cut is to look at all establishments and determine
the number with fewer than 25 employees. The statute limits
participation to these smaller establishments. Of the total 1,873
plants in the current Federal-State cooperative inspection program
there are 1,811 that meet the size criterion for eligibility for the
cooperative interstate shipment program. However, as noted earlier,
sixteen States have expressed an interest in the new cooperative
interstate shipment program, and these States have a total of 1,133
establishments that could potentially be eligible for the new program.
The eleven States that have not indicated an interest in the
cooperative interstate shipment program include all nine States that
have establishments operating under the Talmadge-Aiken (TA) program.
The TA States account for the remaining 678 eligible establishments.
Because participation in the cooperative interstate shipment
program is voluntary, the Agency cannot estimate with certainty the
number of eligible establishments that will choose to participate.
Therefore, for illustration purposes, and to obtain a reasonable range
of possible budget impacts, given the uncertainty, the Agency estimated
the costs for three scenarios: 200, 400 and 600 establishments. A five-
year cost estimate was completed covering the FY 2010 through FY 2014.
We further assume that the participating establishments will be evenly
distributed among the participating States and, just as the baseline
assumes, we anticipate no particular change in the numbers of
establishments in the overall program over the 5 years and no change in
the cooperative interstate shipment program establishments.
At this time, we turn to the change in Federal costs for the
program caused by the new statutory reimbursement level. For the
cooperative interstate shipment program the law requires that FSIS
reimburse State for costs related to the inspection of selected
establishments in an amount not less than 60 percent of eligible State
costs, as opposed to current law which allows reimbursement of up to 50
percent of costs for the regular, and continuing, Federal-State
cooperative inspection program. This analysis projects the effects of
the different reimbursement rate on FSIS fiscal requirements assuming
no change in State level activity over the baseline. FSIS assumes that
States will not change their level of activity associated with selected
establishments in the cooperative interstate shipment program as
discussed above. FSIS determined that Agency reimbursements to States
would increase by about $2.2 million in a fully operational cooperative
interstate shipment program in FY 2011 (not all plants will be in the
cooperative interstate shipment program for all of FY 2010).
In all years, the amount of increase in this component of Federal
reimbursement would offset State spending by the same amount. (FY 2011
is used because it is the first, fully operational year, explained
further below.) To calculate this figure, FSIS estimated average per
establishment spending for the Federal-State Cooperative Inspection
Program by States for the 1,873 establishments in the baseline
scenario. For FY 2011, the average per establishment is $55,626,
including State and Federal reimbursement. Reviewing the budget for FY
2008 and 2009, we see that average Federal reimbursement is currently
running about 50 percent of total State costs. The reimbursement ratio
is expected to remain stable for the 5-year period both for inspecting
establishments in the baseline scenario, and for inspecting
establishments that stay with the existing program, while 400
establishments seek and are selected to operate with the cooperative
interstate shipment program. Reimbursement will increase to 60 percent
for inspection services to the 400 establishments that move into the
[[Page 47660]]
cooperative interstate shipment program option. So, for example, FY
2011 State reimbursement for inspection of the average Interstate
establishment would change from the average $27,813 it would receive
for an establishment continuing in the regular Federal-State
cooperative inspection programs, to $33,376 per establishment for
inspection of an Interstate plant, an increase of $5,563 per plant,
which yields $2.2 million for the 400 establishments. This and
analogous figures are reflected in the tables below in the ``Total
grants to States'' line for the 200, 400 and 600 establishment
scenarios.
Under section 11015 of the Farm Bill, in addition to the increased
reimbursement rates that will increase the grants to States for
inspection of establishments participating in the cooperative
interstate shipment program, FSIS is required to oversee the State
inspectors doing the inspections for the cooperative interstate
shipment program more intensively than the Agency typically does for
the current, and the continuing MPI program. FSIS also expects to incur
new costs for outreach and training. This will result in increased
demand for FSIS staff and resources. In summary, this includes state
coordinators, Deputy District Managers (DDM), outreach and training
staff, and lab analysts to certify State laboratories, transition
grants to hone establishment staff skills with HACCP and SOPs and
associated operating expenses and travel expenses.
The statute requires FSIS to appoint a Federal employee to be a
State Coordinator. As explained earlier in this document, the State
Coordinator prescribed by the statute is referred to as the ``selected
establishment coordinator'' (SEC) in this proposed rule. The SEC is
required by statute to visit selected establishments with a frequency
that is appropriate to ensure that such establishments are operating in
a manner that is consistent with the FMIA and PPIA, including
regulations and policies there under and to: (1) Provide oversight and
enforcement of the program, and (2) to oversee the training and
inspection activities of State-personnel designated to provide
inspection services to the selected establishments. SECs will further
provide quarterly reports on each selected establishment under his or
her jurisdiction to document their level of compliance with the
requirements of the Acts.
We estimate that a total of 13 full time equivalent FSIS employees
will be able to perform the SEC functions for the 16 States expected to
participate in the cooperative interstate shipment program. We
anticipate that about one-quarter of the total establishments will
enter the cooperative interstate shipment program each quarter during
FY 2010, reaching the full complement toward the end of that year. So,
for example, in the 400 establishment scenario, 100 establishments will
initiate inspection under a cooperative interstate shipment program
sometime in the first quarter, another 100 in the second quarter,
another in the third quarter, and the final group of 100 in the fourth
quarter. It is expected that early in 2010 SEC time will initially
focus on outreach and start-up activities (including establishment
selection) and shift over until it is more completely the oversight
activities stipulated in the Acts. While there may be one SEC per State
from the beginning, we believe that contiguous States and
establishments that are in relative close proximity could make it
appropriate to have less than 16 full time equivalent SECs. Note that
if 400 establishments convert into the cooperative interstate shipment
program in FY 2010 and continue in the following years, each SEC will
be responsible for 31 establishments in a geographically-limited area.
This is approximately equal to the number of Federal establishments
over which frontline FSIS supervisors have oversight responsibilities.
In the start-up period, in FY 2009 and FY 2010, the first year of
the cooperative interstate shipment program, in addition to SEC
outreach efforts, FSIS expects to incur costs for outreach and
training, and administration from OOEET for the small and very small
establishments that are considering the cooperative interstate shipment
program, that decide to apply for the program, and for those who are
selected to participate in the program. OOEET will conduct face-to-face
workshops in every State to provide information to establishment owners
and operators about the requirements of the new cooperative interstate
shipment program. These workshops will not only educate the interested
owners and operators about the requirements, they will also help them
meet the requirements. This allocation will cover the cost of
developing, printing, and shipping the workshop materials, as well as
the cost of traveling Agency personnel to conduct the workshops, and
the cost of meeting space. The cost is reflected in the tables below in
the ``Training/Outreach'' line. The reason these costs do not change in
the various scenarios--200, 400 or 600 establishments--is because the
information will be provided in a classroom. Costs are expected to be
largely the same whether attendance is high or low. Also note that
these costs drop sharply for each subsequent year as the cooperative
interstate shipment program specific effort changes to operating
training for establishments selected to participate in the program.
In the start-up period, transition grant authority under 9 CFR
332.12 and 9 CFR 381.522 will be used to provide States funds to
reimburse selected establishments in the State for their costs to train
one individual in HACCP and associated training in Sanitation SOP
requirements. The Agency estimates that the cost of training each
establishment specialist will average about $5,000, including staff
time and travel necessary for the training. Since this is a new expense
necessary to implement the cooperative interstate shipment program and
since statute authorizes it without State matching funds, these costs
will be entirely new costs for FSIS that are part of ``Total grants to
States'' in FY 2010 in Table 2 below. Thus, the cost to FSIS will total
about $1 million, $2 million and $3 million for the 200, 400 and 600
establishment scenarios respectively. This training will only be needed
in the start-up period and, accordingly, appears only in FY 2010 in
Table 2.
SECs are likely to be supervised by Deputy District Managers (DDMs)
at the equivalent of about 1 DDM per 300 establishments. This is
similar to the ratio of DDM effort used to manage frontline FSIS
supervisors in the Federal programs. For the three establishment
levels, this would mean 1 DDM for 200 establishments and 2 DDMs for 400
or 600 establishments. This is reflected in the ``DDM'' line of the
tables below.
FSIS estimates that two laboratory staff will be needed to complete
periodic audits of the State inspection program laboratory systems and
otherwise coordinate with the laboratories to ensure the sampling and
testing programs are equivalent to the Federal program. It is
anticipated that the two lab staff will be needed regardless of whether
200, 400 or 600 establishments eventually participate since the same
number of State labs will need to be reviewed regardless of the volume
of work they do under the cooperative interstate shipment program. This
is reflected in the ``Lab staff'' line of the tables below.
Travel costs are included on the ``Travel--SC & lab staff'' line in
the tables below. The SECs will need to travel a fair amount to
complete their duties and the lab staff will need to travel some.
Travel for SECs and lab
[[Page 47661]]
staff starts in FY 2010 and will run higher for the first year, after
which time the start-up effort will diminish. Since we are assuming the
selected establishments are evenly distributed in the participating
States, we anticipate that the number of participating establishments
would only have slight impact on the cost of travel for each SEC. We
project about $6,150 for training and travel for each SEC in the first
and $630 for subsequent years.
For the lab staff we based our trips to the State program
laboratories on one audit of each laboratory to make an initial
assessment, so that would be one trip to the labs for each of the 27
eligible States. Because most of the labs typically have a chemistry
residue program and a microbiology program, two lab-auditors will go on
each trip--one chemist and one microbiologist. These labs would also
need a follow-up the next year and then we would make a judgment as to
whether there needed to be annual visits after that. The audit will be
based on the program that FSIS developed several years ago, which is
similar to the program that the Agency uses to assess the Pasteurized
Egg Product Recognized Laboratory program. We based the number of
audits on the figures that we had regarding the number of states that
will participate, 16. Each trip ran about $1,500 for each auditor.
Finally, there are the normal operating expenses associated with
field operations including office space, communications costs,
information technology costs (such as laptop computers), other
equipment, office supplies, etc. FSIS estimates $3,500 per new staff
for laptop, LincPass, Black Berries, etc. These costs are generally
stable over time, although they inflate and, of course, are a little
higher in the start-up year. These costs are found in the ``Equipment
and admin'' line of the tables below.
Table 2, below, summarizes the incremental costs to FSIS to operate
the new cooperative interstate shipment program in the three scenarios
200, 400 and 600 establishments, with the 400 establishment level
assumed to be the likely level.
Table 2--Cooperative Interstate Shipment Program Cost Estimates--Three Scenarios
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interstate Program--Summary of Incremental Cost Estimates ($ Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year 2009 2010 2011 2012 2013 2014 5-Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs if 200 establishments............................. $1.93 $5.55 $4.07 $4.22 $4.40 $4.58 $22.83
Costs if 400 establishments............................. 1.93 7.11 5.34 5.55 5.77 6.00 29.77
Costs if 600 establishments............................. 1.93 8.79 6.53 6.79 7.06 7.33 36.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interstate Program with 200 Establishments ($ Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year 2009 2010 2011 2012 2013 2014 5-Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of establishments *.............................. ........... 200 200 200 200 200 ...........
Total grants to States **............................... ........... $1.54 $1.11 $1.15 $1.20 $1.25 ...........
Total salaries & benefits............................... ........... 2.20 2.17 2.25 2.35 2.45 ...........
DDM..................................................... ........... 0.15 0.16 0.16 0.17 0.18 ...........
State coordinator (SC).................................. ........... 1.69 1.76 1.83 1.91 1.98 ...........
Lab staff............................................... ........... 0.24 0.25 0.26 0.27 0.29 ...........
Operating expenses...................................... ........... 1.81 0.79 0.82 0.85 0.89 ...........
Travel-SC & lab staff................................... ........... 0.16 0.09 0.09 0.10 0.10 ...........
Training/Outreach....................................... 1.43 1.25 0.35 0.36 0.38 0.39 ...........
Equipment and admin..................................... 0.50 0.40 0.35 0.36 0.38 0.39 ...........
-----------------------------------------------------------------------------------------------
Total............................................... 1.93 5.55 4.07 4.22 4.40 4.58 22.83
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interstate Program with 400 Establishments ($ Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year 2009 2010 2011 2012 2013 2014 5-Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of establishments *.............................. ........... 400 400 400 400 400 ...........
Total grants to States **............................... ........... $3.07 $2.23 $2.31 $2.40 $2.49 ...........
Total salaries & benefits............................... ........... 2.23 2.32 2.42 2.52 2.62 ...........
DDM..................................................... ........... 0.30 0.31 0.33 0.34 0.35 ...........
State coordinator (SC).................................. ........... 1.69 1.76 1.83 1.91 1.98 ...........
Lab staff............................................... ........... 0.24 0.25 0.26 0.27 0.29 ...........
Operating expenses...................................... ........... 1.81 0.79 0.82 0.85 0.89 ...........
Travel-SC & lab staff................................... ........... 0.16 0.09 0.09 0.10 0.10 ...........
Training/Outreach....................................... 1.43 1.25 0.35 0.36 0.38 0.39 ...........
Equipment and admin..................................... 0.50 0.40 0.35 0.36 0.38 0.39 ...........
-----------------------------------------------------------------------------------------------
Total............................................... 1.93 7.11 5.34 5.55 5.77 6.00 29.77
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interstate Program with 600 Establishments ($ Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year 2009 2010 2011 2012 2013 2014 5-Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of establishments *.............................. ........... 600 600 600 600 600 ...........
Total grants to States **............................... ........... $4.67 $3.34 $3.46 $3.60 $3.74 ...........
Total salaries & benefits............................... ........... 2.23 2.32 2.42 2.52 2.62 ...........
DDM..................................................... ........... 0.30 0.31 0.33 0.34 0.35 ...........
State coordinator (SC).................................. ........... 1.69 1.76 1.83 1.91 1.98 ...........
Lab staff............................................... ........... 0.24 0.25 0.26 0.27 0.29 ...........
Operating expenses...................................... ........... 1.89 0.87 0.90 0.94 0.97 ...........
[[Page 47662]]
Travel-SC & lab staff................................... ........... 0.24 0.17 0.18 0.18 0.19 ...........
Training/Outreach....................................... 1.43 1.25 0.35 0.36 0.38 0.39 ...........
Equipment and admin..................................... 0.50 0.40 0.35 0.36 0.38 0.39 ...........
-----------------------------------------------------------------------------------------------
Total............................................... 1.93 8.79 6.53 6.79 7.06 7.33 36.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Economic Assumptions from OMB for the 2010 Budget
--------------------------------------------------------------------------------------------------------------------------------------------------------
State & Local Exp, %.................................... ........... 3.1 3.5 3.8 3.9 3.9 ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
FSIS Civilian pay, %.................................... ........... 5.1 4.1 4.1 4.1 4.1 ...........
Non-Pay Expenditure, %.................................. ........... 0.8 1.2 1.4 1.6 1.6 ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Grant Incremental Increase in FSIS Reimbursement to the State
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per Establishment....................................... ........... $5,374 $5,563 $5,774 $5,999 $6,233 ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Note that in FY 2010 about one quarter of establishments are expected to enroll each quarter. In subsequent fiscal years, all establishments will be
in the program for the full year.
** Note ``Total grants to States'' includes funding for Transition Grants in 2010 for States to use to help plants train one person in HACCP and SOPs
per Sec. 332.12 and Sec. 381.522.
Effect on Small Entities
This proposed action will primarily affect very small and certain
small establishments that operate under cooperative State meat or
poultry inspection programs. Under section 11015, State-inspected
establishments that employ on average 25 or fewer employees would be
permitted to be selected to participate in a cooperative interstate
shipment program. The law also permits the Secretary to select State-
inspected establishments that employ, on average, more than 25 but less
than 35 employees to participate in the program. However, to remain in
the program, these establishments must employ, on average, 25 or fewer
employees three years after the regulations implementing the new
cooperative interstate shipment program become effective. FSIS provides
for the selection of State-inspected establishments that employ, on
average, more than 25 but fewer than 35 employees in the proposed
implementing regulations. Thus, this proposed rule will benefit these
very small and small State-inspected establishments by allowing them to
ship meat and poultry products in interstate and foreign commerce,
thereby opening new markets for their products.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that
minorities, women, and persons with disabilities are aware of this
proposed rule, FSIS will announce it online through the FSIS Web page
located at http://www.fsis.usda.gov/Regulations_&_Policies/2009_
Proposed _Rules_Index/index.asp. FSIS will also make copies of this
Federal Register publication available through the FSIS Constituent
Update, which is used to provide information regarding FSIS policies,
procedures, regulations, Federal Register notices, FSIS public
meetings, and other types of information that could affect or would be
of interest to constituents and stakeholders. The Update is
communicated via Listserv, a free electronic mail subscription service
for industry, trade groups, consumer interest groups, health
professionals, and other individuals who have asked to be included. The
Update is also available on the FSIS Web page. Through the Listserv and
Web page, FSIS is able to provide information to a much broader and
more diverse audience. In addition, FSIS offers an e-mail subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at http://
www.fsis.usda.gov/news_&_events/email_subscription/. Options range
from recalls to export information to regulations, directives and
notices. Customers can add or delete subscriptions themselves, and have
the option to password protect their accounts.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995, the information collection or recordkeeping requirements
included in this proposed rule have been submitted for approval to the
Office of Management and Budget (OMB).
Title: ``Cooperative Inspection Programs: Interstate Shipment of
Meat and Poultry Products''
Type of collection: New.
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act. Under this proposed rule, FSIS is requiring certain
information collection and recordkeeping activities.
FSIS is proposing that States that are interested in participating
in the cooperative interstate shipment program submit a request for an
agreement to establish such a program through the appropriate FSIS
District Office. In their requests, States must: (1) Identify
establishments in the State that the State recommends for initial
selection into the program; (2) include documentation to demonstrate
that the State is able to provide necessary inspections services to
selected establishments in the State and conduct any related activities
that would be required under a cooperative interstate shipment program;
and (3) agree to comply with certain conditions to assist with
enforcement of the program. FSIS is also proposing that States that
have entered into an agreement with FSIS for a cooperative interstate
shipment program submit, through the FSIS District Office, an
evaluation of each State-inspected establishment that has applied, and
that the State recommends be selected, for the cooperative interstate
shipment program.
Under this proposal, State inspected establishments selected to
participate in the cooperative interstate shipment program will be
required to develop and maintain the same records that are required
under the Acts and their implementing regulations. Selected
[[Page 47663]]
establishment will also be required to give the FSIS selected
establishment coordinator (SEC) access to all establishment records
required under the Acts and implementing regulations. Most States that
have cooperative State meat or poultry products inspection programs
have incorporated the Federal standards into their programs. Thus, most
establishments selected to participate in the interstate shipment
program are currently required to maintain records that comply with
Federal standards. However, establishments located in States that have
implemented recordkeeping requirements that are ``at least equal to''
but not identical to Federal requirements will need to modify their
recordkeeping procedures to comply with Federal standards. All selected
establishments will be required to give the FSIS SEC access to their
records upon request.
Estimate of Burden: FSIS estimates that 16 of the 27 States that
currently have agreements for cooperative State meat or poultry
products inspection programs will prepare and submit a request to FSIS
to establish a cooperative interstate shipment program. The Agency also
estimates that approximately 400 establishments will apply for the
program. Thus, FSIS estimates that each of the 16 States mentioned
above will need to prepare and submit, on average, 25 evaluations for
the State-inspected establishments that have applied for, and that the
State recommends, for selection into the program, for an estimated
total of 400 evaluations.
FSIS estimates that it will take approximately 40 hours for each
State to prepare and submit a request to establish a cooperative
interstate shipment program, for a total burden of 640 hours. The
Agency estimates that it will take each State approximately 24 hours to
prepare an evaluation of a State-inspected establishment's
qualifications to be selected for a cooperative interstate shipment
program, for a total burden of 9,600 hours.
FSIS estimates that if all of the 400 establishments that apply are
selected for the program, approximately 100 of these establishments
will need to modify their recordkeeping procedures to come into
compliance with Federal standards. The extent to which these
establishments will need to modify their recordkeeping procedures will
depend on requirements under the State inspection program. Because
recordkeeping requirements under the State inspection program must be
``at least equal to'' the Federal requirements, these modifications
should be minor. FSIS estimates that it will take approximately 16
hours for each establishment that is currently maintaining records
under State standards to review and revise its recordkeeping
procedures, and about 5 minutes for each establishment to file these
records, for a total burden of approximately 1,608.3 hours.
All of the estimated 400 establishments that participate in the
program will be required to give the SEC access to all records required
under the Federal Acts. FSIS estimates that it will take each
establishment approximately 15 minute to assist the SEC to locate the
necessary records for review on the initial visit, for a total burden
of 100 hours. FSIS estimates that these establishments will need to
spend and approximately 5 minute to assist the SEC locate records for
review for each subsequent visit. If the SEC visits each selected
establishment at least one a month, the total burden per establishment
per year will be 1 hour, for a total estimated annual burden of 400
hours.
Respondents: State agencies that administer cooperative State meat
and poultry products inspection programs and State-inspected
establishments selected to participate in a cooperative interstate
shipment program.
Estimated number of respondents: 416 (16 States and 400 State-
inspected establishments).
Estimated number of responses per respondent: One request to
establish a cooperative interstate shipment program per State and 25
evaluations of State-inspected establishments per State, on average.
A one-time modification of records for each selected establishment
whose recordkeeping does not comply with all Federal standards. One
initial SEC visit in which each selected establishment will need to
provide the SEC with access to all required records. Each establishment
selected for the program will need to provide the FSIS access to its
records on an ongoing basis.
Estimated Total Annual Burden on Respondents: 12,348.3 hours to
establish and implement the cooperative interstate shipment program in
16 States. Once the program has been implemented, an estimated annual
burden of 400 hours for selected establishments to provide the SEC
access to establishment records on-going basis.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue, SW., Room 3532
South Building, Washington, DC 20250.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS' functions,
including whether the information will have practical utility; (b) the
accuracy of FSIS' estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (c) ways to enhance the quality, utility, and clarity of the
information to be collected; ways to minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques, or other forms of
information technology.
Comments may be sent to both John O'Connell, Paperwork Reduction
Act Coordinator, at the address provided above, and the Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253.
To be most effective, comments should be sent to OMB within 60 days
of the publication date of this proposed rule.
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or record
keeping requirements included in this proposed rule have been submitted
for approval to the Office of Management and Budget (OMB).
Proposed Regulations
List of Subjects
9 CFR Part 321
Grant programs--agriculture, Intergovernmental relations, Meat
inspection.
9 CFR Part 332
Grant programs--agriculture, Intergovernmental relations, Meat
inspection.
9 CFR Part 381
Grant programs--agriculture, Intergovernmental relations, Poultry
and poultry products.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR Chapter III as follows:
PART 321--COOPERATION WITH STATES AND TERRITORIES
1. The authority citation for part 321 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
[[Page 47664]]
2. A new Sec. 321.3 is added to read as follows:
Sec. 321.3 Cooperation of States for the interstate shipment of
carcasses, parts of carcasses, meat, and meat food products.
(a) The Administrator is authorized under 21 U.S.C. 683(b) to
coordinate with States that have meat inspection programs as provided
in Sec. 321.1 of this part to select certain establishments operating
under these programs to participate in a cooperative program to ship
carcasses, parts of carcasses, meat, and meat food products in
interstate commerce. A cooperative program for this purpose is called a
``cooperative interstate shipment program.''
(b) Establishments selected to participate in a cooperative
interstate shipment program described in this section must receive
inspection services from designated State personnel that have been
trained in the enforcement of the Act. If the designated personnel
determine that the carcasses, parts of carcasses, meat, and meat food
products prepared in establishments selected to participate in the
cooperative interstate shipment program comply with all requirements
under the Act, these items will bear an official Federal mark of
inspection and may be shipped in interstate commerce. The Administrator
will assign an FSIS ``selected establishment coordinator,'' who will be
an FSIS employee, to each State that participates in a cooperative
interstate shipment program to provide Federal oversight of the program
and enforcement of the program's requirements. The Federal contribution
for inspection services provided by States that enter into a
cooperative interstate shipment program under this section will be at
least 60 percent of eligible State costs.
(c) Part 332 of this subchapter prescribes conditions under which
States and establishments may participate in the cooperative interstate
shipment program.
(d) The Administrator will terminate a cooperative interstate
shipment agreement with a State if the Administrator determines that
the State is not conducting inspection at selected establishments in a
manner that complies with the Act and the implementing regulations in
this chapter.
3. A new Part 332 is added to read as follows:
PART 332--SELECTED ESTABLISHMENTS; COOPERATIVE PROGRAM FOR
INTERSTATE SHIPMENT OF CARCASSES, PARTS OF CARCASSES, MEAT, AND
MEAT FOOD PRODUCTS
Sec.
332.1 Definitions.
332.2 Purpose.
332.3 Requirements for establishments; ineligible establishments.
332.4 State request for cooperative agreement.
332.5 Establishment selection; official number for selected
establishments.
332.6 Commencement of a cooperative interstate shipment program;
inspection by designated personnel and official mark.
332.7 Federal oversight of a cooperative interstate shipment
program.
332.8 Quarterly reports.
332.9 Enforcement authority.
332.10 Deselection of ineligible establishments.
332.11 Transition to official establishments.
332.12 Transition grants.
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 332.1 Definitions.
The following definitions apply to the regulations in this part:
Cooperative interstate shipment program. A cooperative meat
inspection program described in Sec. 321.3 of this subchapter.
Cooperative State meat inspection program. A cooperative State-
Federal meat inspection program described in Sec. 321.1 of this
subchapter.
Designated personnel. State inspection personnel that have been
trained in the enforcement of the Act and any additional State program
requirements in order to provide inspection services to selected
establishments.
Interstate commerce. ``Interstate commerce'' has the same meaning
as ``commerce'' under Sec. 301.2 of this subchapter.
Selected establishment. An establishment operating under a State
cooperative meat inspection program that has been selected by the
Administrator, in coordination with the State where the establishment
is located, to participate in a cooperative interstate shipment
program.
Sec. 332.2 Purpose.
This part prescribes the conditions under which States that
administer cooperative State meat inspection programs and
establishments that operate under such programs may participate in a
cooperative interstate shipment program.
Sec. 332.3 Requirements for establishments; ineligible
establishments.
(a) An establishment that operates under a cooperative State meat
inspection program may apply to participate in a cooperative interstate
shipment program under this part if:
(1) The establishment employs on average no more than 25 employees
based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer
than 35 employees as of June 18, 2008. If selected to participate in a
cooperative interstate shipment program, an establishment under this
paragraph must employ on average no more than 25 employees as of
[insert date 3 years after effective date of final rule] or it must
transition to become an official establishment as provided in Sec.
332.11 of this part.
(b) An establishment that has 25 or fewer employees based on the
following standards is considered to have 25 or fewer employees on
average for purposes of this part.
(1) All individuals, both supervisory and non-supervisory, employed
by the establishment on a full-time, part-time, or temporary basis are
counted when calculating the total number of employees.
(2) All individuals employed by the establishment from a temporary
employee agency, professional employee organization, or leasing concern
are counted when calculating the total number of employees.
(3) The average number of employees is calculated for each of the
pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-
time employees.
(5) If the establishment has not been in business for 12 months,
the average number of employees is calculated for each of the pay
periods in which the establishment has been in business.
(6) Volunteers who receive no compensation are not considered
employees.
(7) The total number of employees can never exceed 35 individuals
at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a
cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average
(except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as
provided in Sec. 321.2 of this subchapter as of June 18, 2008;
[[Page 47665]]
(3) Official establishments;
(4) Establishments that were official establishments as of June 18,
2008, but that were re-organized on a later date by the person that
controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State meat
inspection that employed more than 35 employees as of June 18, 2008,
that were reorganized on a later date by the person that controlled the
establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under Sec.
332.11 of this part;
(7) Establishments that are in violation of the Act;
(8) Establishments located in States without a cooperative State
meat inspection program; and
(9) Establishments located in a State whose agreement for a
cooperative interstate shipment program was terminated by the
Administrator as provided in Sec. 321.3(d) of this subchapter.
(d) An establishment that meets the conditions in paragraph (a) of
this section and that is not an ineligible establishment under
paragraph (c) of this section may apply for selection into a
cooperative interstate shipment program through the State in which the
establishment is located.
Sec. 332.4 State request for cooperative agreement.
(a) State participation in a cooperative interstate shipment
program under this part is limited to States that have implemented
cooperative State meat inspection programs.
(b) To request an agreement for a cooperative interstate shipment
program under this part, a State must submit a written request to the
Administrator through the FSIS District Office for the FSIS District in
which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be
selected for the program that the State recommends for initial
selection into the program;
(2) Demonstrate that the State is able to provide the necessary
inspection services to selected establishments in the State and conduct
any related activities that would be required under a cooperative
interstate shipment program established under this part; and
(3) Agree that, if the State enters into an agreement with FSIS for
a cooperative interstate shipment program, that the State will:
(i) Provide FSIS with access to the results of all laboratory
analyses conducted on product samples from selected establishments in
the State;
(ii) Notify the selected establishment coordinator for the State of
the results of any laboratory analyses that indicate that a product
prepared in a selected establishment may be adulterated or may
otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected
establishments in the State that have been deselected from a
cooperative interstate shipment program to become official
establishments.
(c) If the Administrator determines that a State that has submitted
a request to participate in a cooperative interstate shipment program
qualifies to enter into a cooperative agreement for such a program, the
Administrator and the State will sign a cooperative agreement that sets
forth the terms and conditions under which each party will cooperate to
provide inspection services to selected establishments located in the
State.
(d) After the Administrator and a State have signed an agreement
for a cooperative interstate shipment program as provided in paragraph
(c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment
coordinator for the State and
(2) Coordinate with the State to select establishments to
participate in the program as provided in Sec. 332.5(b) of this part.
Sec. 332.5 Establishment selection; official number for selected
establishments.
(a) An establishment operating under a cooperative State meat
inspection program will qualify for selection into a cooperative
interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the
program;
(2) Has the appropriate number of employees under Sec. 332.3(a) of
this part;
(3) Is not ineligible to participate in a cooperative interstate
shipment program under Sec. 332.3(c) of this part;
(4) Is in compliance with all requirements under the cooperative
State meat inspection program; and
(5) Is in compliance with all requirements under the Act and the
implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an
establishment that meets the conditions in paragraph (a) of this
section must be selected by the Administrator, in coordination with the
State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative
interstate shipment program as provided in paragraph (b) of this
section, the State is to assign the establishment an official number
that reflects the establishment's participation in the cooperative
interstate shipment program and advise the FSIS selected establishment
coordinator for the State of the official number assigned to each
selected establishment in the State. The official number assigned to
every selected establishment must contain a suffix, e.g., ``SE,'' that
identifies the establishment as a selected establishment and that
identifies the State, e.g., ``SETX,'' for ``selected establishment
Texas.''
(d) Failure of the State to comply with paragraph (c) of this
section will disqualify the State from participation in the cooperative
interstate shipment program.
Sec. 332.6 Commencement of a cooperative interstate shipment program;
inspection by designated personnel and official mark.
(a) A cooperative interstate shipment program will commence when
the Administrator, in coordination with the State, has selected
establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating
in a cooperative interstate shipment program must be provided by
designated personnel, who will be under the direct supervision of a
State employee.
(c) Carcasses, parts of carcasses, meat, and meat food products
prepared in a selected establishment and inspected and passed by
designated State personnel must bear an official Federal mark, stamp,
tag, or label of inspection in the appropriate form prescribed in part
312 of this subchapter that includes the information specified in Sec.
332.5(c) of this part.
(d) Carcasses, parts of carcasses, meat, and meat food products
prepared in a selected establishment that comply with the conditions in
paragraph (c) of this section may be distributed in interstate
commerce.
Sec. 332.7 Federal oversight of a cooperative interstate shipment
program.
(a) The FSIS selected establishment coordinator for a State that
has entered into an agreement for a cooperative interstate shipment
program will visit each selected establishment in the State on a
regular basis to verify that the establishment is operating in a manner
that is consistent with the Act and the implementing regulations in
this chapter. If necessary, the selected establishment coordinator, in
consultation with the District Manager that covers the State, may
designate qualified FSIS personnel to visit a
[[Page 47666]]
selected establishment on behalf of the selected establishment
coordinator.
(b) The selected establishment coordinator, in coordination with
the State, will verify that selected establishments in the State are
receiving the necessary inspection services from designated personnel,
and that these establishments are eligible, and remain eligible, to
participate in a cooperative interstate shipment program.
The selected establishment coordinator's verification activities
may include:
(1) Verifying that each selected establishment employs, and
continues to employ, 25 or fewer employees, on average, as required
under Sec. 332.3(a) of this part, unless the establishment is
transitioning to become an official establishment;
(2) Verifying that the designated personnel are providing
inspection services to selected establishments in a manner that
complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that State staffing levels for each selected
establishments are appropriate to carry out the required inspection
activities; and
(4) Assessing each selected establishment's compliance with the Act
and implementing regulations under this chapter.
(c) If the selected establishment coordinator determines that
designated personnel are providing inspection services to selected
establishments in the State in a manner that is inconsistent with the
Act and the implementing regulations in this chapter, the Administrator
will provide an opportunity for the State to develop and implement a
corrective action plan to address inspection deficiencies identified by
the selected establishment coordinator. If the State fails to develop a
corrective action plan, or the selected establishment coordinator for
the State determines that the corrective action plan is inadequate, the
Administrator will terminate the agreement for the cooperative
interstate shipment program as provided in Sec. 321.3(d) of this
chapter.
Sec. 332.8 Quarterly reports.
(a) The selected establishment coordinator will prepare a report on
a quarterly basis that describes the status of each selected
establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section
will:
(1) Include the selected establishment coordinator's assessment of
the performance of the designated personnel in conducting inspection
activities at selected establishments and
(2) Identify those selected establishments that the selected
establishment coordinator has verified are in compliance with the Act
and implementing regulations in this chapter, those that have been
deselected under Sec. 332.10 of this part, and those that are
transitioning to become official establishments under Sec. 332.11 of
this part.
(c) The selected establishment coordinator is to submit the
quarterly report to the Administrator through the District Manager for
the State where the selected establishments identified in the report
are located.
Sec. 332.9 Enforcement authority.
(a) To facilitate oversight and enforcement of this part, selected
establishments operating under a cooperative interstate shipment
program must, upon request, give the FSIS selected establishment
coordinator or other FSIS officials access to all establishment records
required under the Act and the implementing regulations in this
chapter. The Administrator may deselect any selected establishment that
refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any
appropriate enforcement action provided for in part 500 of this chapter
if they determine that a selected establishment under their
jurisdiction is operating in manner that is inconsistent with the Act
and the implementing regulations in this chapter. Selected
establishments participating in a cooperative interstate shipment
program are subject to the notification and appeal procedures set out
in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any
of the reasons specified in Sec. 500.3 or Sec. 500.4 of this chapter,
FSIS will:
(1) Provide an opportunity for the establishment to implement
corrective actions and remain in the cooperative interstate shipment
program, or
(2) Move to deselect the establishment as provided in Sec. 332.10
of this part.
(d) The decision to deselect a selected establishment under a
suspension will be made on a case-by-case basis. In making this
decision, FSIS, in consultation with the State where the selected
establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
Sec. 332.10 Deselection of ineligible establishments.
(a) The Administrator will deselect a selected establishment that
becomes ineligible to participate in a cooperative interstate shipment
program for any reason listed under Sec. 332.3(c) of this part.
(b) An establishment that has been deselected must transition to
become an official establishment as provided in Sec. 332.11 of this
part.
Sec. 332.11 Transition to official establishment.
If an establishment is deselected from a cooperative interstate
shipment program as provided in Sec. 332.10 of this part, FSIS, in
coordination with the State where the establishment is located, will
develop and implement a plan to transition the establishment to become
an official establishment.
Sec. 332.12 Transition grants.
(a) Transition grants are funds that a State participating in a
cooperative interstate shipment program under this part may apply for
to reimburse selected establishments in the State for the cost to train
one individual in the seven HACCP principles for meat or poultry
processing as required under Sec. 417.7 of this chapter and associated
training in the development of sanitation standard operating procedures
required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment
program that receives a transition grant must use grant funds to
reimburse the training costs of one employee per each selected
establishment in the State. Any other use of such funds is prohibited.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
4. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
5. A new Sec. 381.187 is added to subpart R to read as follows:
Sec. 381.187 Cooperation of States for the interstate shipment of
poultry products.
(a) The Administrator is authorized under 21 U.S.C. 472(b) to
coordinate with States that have poultry products inspection programs
as provided in Sec. 381.185 of this subpart to select certain
establishments operating under these programs to participate in a
cooperative program to ship poultry products in interstate commerce. A
cooperative program for this purpose is called a ``cooperative
interstate shipment program.''
[[Page 47667]]
(b) Establishments selected to participate in a cooperative
interstate shipment program described in this section must receive
inspection services from designated State personnel that have been
trained in the enforcement of the Act. If the designated personnel
determine that the poultry products prepared in establishments selected
to participate in the cooperative interstate shipment program comply
with all requirements under the Act, these items will bear an official
Federal mark of inspection and may be shipped in interstate commerce.
The Administrator will assign an FSIS ``selected establishment
coordinator,'' who will be an FSIS employee, to each State that
participates in a cooperative interstate shipment program to provide
Federal oversight of the program and enforcement of the program's
requirements. The Federal contribution for inspection services provided
by States that enter into a cooperative interstate shipment program
under this section will be at least 60 percent of eligible State costs.
(c) Subpart Z, of this part 381 prescribes conditions under which
States and establishments may participate in the cooperative interstate
shipment program.
(d) The Administrator will terminate a cooperative interstate
shipment agreement with a State if the Administrator determines that
the State is not conducting inspection at selected establishments in a
manner that complies with the Act and the implementing regulations in
this chapter.
5. A new subpart Z is added to part 381 to read as follows:
Subpart Z--Selected Establishments; Cooperative Program for Interstate
Shipment of Poultry Products
Sec.
381.511 Definitions.
381.512 Purpose.
381.513 Requirements for establishments; ineligible establishments.
381.514 State request for cooperative agreement.
381.515 Establishment selection; official number for selected
establishments.
381.516 Commencement of a cooperative interstate shipment program;
inspection by designated personnel and official mark.
381.517 Federal oversight of a cooperative interstate shipment
program.
381.518 Quarterly reports.
381.519 Enforcement authority.
381.520 Deselection of ineligible establishments.
381.521 Transition to official establishment.
381.522 Transition grants.
Subpart Z--Selected Establishments; Cooperative Program for
Interstate Shipment of Poultry Products
Sec. 381.511 Definitions.
The following definitions apply to the regulations in this part:
Cooperative interstate shipment program. A cooperative poultry
products inspection program described in Sec. 381.187 of this part.
Cooperative State poultry products inspection program. A
cooperative State-Federal poultry products inspection program described
in Sec. 381.185 of this part.
Designated personnel. State inspection personnel that have been
trained in the enforcement of Act and any additional State program
requirements in order to provide inspection services to selected
establishments.
Interstate commerce. ``Interstate commerce'' has the same meaning
as ``commerce'' under Sec. 381.1 of this part.
Selected establishment. An establishment operating under a State
cooperative poultry products inspection program that has been selected
by the Administrator, in coordination with the State where the
establishment is located, to participate in a cooperative interstate
shipment program.
Sec. 381.512 Purpose.
This subpart Z prescribes the conditions under which States that
administer cooperative State poultry products inspection programs and
establishments that operate under such programs may participate in a
cooperative interstate shipment program.
Sec. 381.513 Requirements for establishments; ineligible
establishments.
(a) An establishment that operates under a cooperative State
poultry products inspection program may apply to participate in a
cooperative interstate shipment program under this subpart if:
(1) The establishment employs on average no more than 25 employees
based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer
than 35 employees as of June 18, 2008. If selected to participate in a
cooperative interstate shipment program, an establishment under this
paragraph must employ on average no more than 25 employees as of
[insert date 3 years after effective date of final rule] or it must
transition to become an official establishment as provided in Sec.
381.521 of this subpart.
(b) An establishment that has 25 or fewer employees based on the
following standards is considered to have 25 or fewer employees on
average for purposes of this subpart.
(1) All individuals, both supervisory and non-supervisory, employed
by the establishment on a full-time, part-time, or temporary basis are
counted when calculating the total number of employees.
(2) All individuals employed by the establishment from a temporary
employee agency, professional employee organization, or leasing concern
are counted when calculating the total number of employees.
(3) The average number of employees is calculated for each of the
pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-
time employees.
(5) If the establishment has not been in business for 12 months,
the average number of employees is calculated for each of the pay
periods in which the establishment has been in business.
(6) Volunteers who receive no compensation are not considered
employees.
(7) The total number of employees can never exceed 35 individuals
at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a
cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average
(except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as
provided in Sec. 381.186 of this part as of June 18, 2008;
(3) Official establishments;
(4) Establishments that were official establishments as of June 18,
2008, but that were re-organized on a later date by the person that
controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State poultry
products inspection program that employed more than 35 employees as of
June 18, 2008, that were reorganized on a later date by the person that
controlled the establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under Sec.
381.521 of this subpart;
(7) Establishments that are in violation of the Act; and
(8) Establishments located in States without a cooperative State
poultry products inspection program.
(9) Establishments located in a State whose agreement for a
cooperative interstate shipment program was terminated by the
Administrator as provided in Sec. 381.187(d) of this part.
[[Page 47668]]
(d) An establishment that meets the conditions in paragraph (a) of
this section and that is not an ineligible establishment under
paragraph (c) of this section may apply for selection into a
cooperative interstate shipment program through the State in which the
establishment is located.
Sec. 381.514 State request for cooperative agreement.
(a) State participation in a cooperative interstate shipment
program under this subpart is limited to States that have implemented
cooperative State poultry products inspection programs.
(b) To request an agreement for a cooperative interstate shipment
program under this subpart, a State must submit a written request to
the Administrator through the FSIS District Office for the FSIS
District in which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be
selected for the program that the State recommends for initial
selection into the program;
(2) Demonstrate that the State is able to provide the necessary
inspection services to selected establishments in the State and conduct
any related activities that would be required under a cooperative
interstate shipment program established under this subpart; and
(3) Agree that, if the State enters into an agreement with FSIS for
a cooperative interstate shipment program, that the State will:
(i) Provide FSIS with access to the results of all laboratory
analyses conducted on product samples from selected establishments in
the State;
(ii) Notify the selected establishment coordinator for the State of
the results of any laboratory analyses that indicate that a product
prepared in a selected establishment may be adulterated or may
otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected
establishments in the State that have been deselected from a
cooperative interstate shipment program to become official
establishments.
(c) If the Administrator determines that a State that has submitted
a request to participate in a cooperative interstate shipment program
qualifies to enter into a cooperative agreement for such a program, the
Administrator and the State will sign a cooperative agreement that sets
forth the terms and conditions under which each party will cooperate to
provide inspection services to selected establishments located in the
State.
(d) After the Administrator and a State have signed an agreement
for a cooperative interstate shipment program as provided in paragraph
(c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment
coordinator for the State and
(2) Coordinate with the State to select establishments to
participate in the program as provided in Sec. 381.515(b) of this
subpart.
Sec. 381.515 Establishment selection; official number for selected
establishments.
(a) An establishment operating under a cooperative State poultry
products inspection program will qualify for selection into a
cooperative interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the
program;
(2) Has the appropriate number of employees under Sec. 381.513(a)
of this subpart;
(3) Is not ineligible to participate in a cooperative interstate
shipment program under Sec. 381.513(c) of this subpart;
(4) Is in compliance with all requirements under the cooperative
State poultry products inspection program; and
(5) Is in compliance with all requirements under the Act and the
implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an
establishment that meets the conditions in paragraph (a) of this
section must be selected by the Administrator, in coordination with the
State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative
interstate shipment program as provided in paragraph (b) of this
section, the State is to assign the establishment an official number
that reflects the establishment's participation in the cooperative
interstate shipment program and advise the FSIS selected establishment
coordinator for the State of the official number assigned to each
selected establishment in the State. The official numbers assigned to
every selected establishment must contain a suffix, e.g., ``SE,'' that
identifies the establishment as a selected establishment; that includes
the letter ``P,'' which identifies the establishment as a poultry
establishment; and that identifies the State, e.g., ``SEPND,'' for
``selected establishment poultry North Dakota.''
(d) Failure of a State to comply with paragraph (c) of this section
will disqualify the State from participation in the cooperative
interstate shipment program.
Sec. 381.516 Commencement of a cooperative interstate shipment
program; inspection by designated personnel and official mark.
(a) A cooperative interstate shipment program will commence when
the Administrator, in coordination with the State, has selected
establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating
in a cooperative interstate shipment program must be provided by
designated personnel, who will be under the direct supervision of a
State employee.
(c) Poultry products processed in a selected establishment and
inspected and passed by designated State personnel must bear an
official Federal mark, stamp, tag, or label of inspection in the
appropriate form prescribed in subpart M of this part that includes the
information specified in Sec. 381.515(c) of this subpart.
(d) Poultry products processed in a selected establishment that
comply with the conditions in paragraph (c) of this section may be
distributed in interstate commerce.
Sec. 381.517 Federal oversight of a cooperative interstate shipment
program.
(a) The FSIS selected establishment coordinator for a State that
has entered into an agreement for a cooperative interstate shipment
program will visit each selected establishment in the State on a
regular basis to verify that the establishment is operating in a manner
that is consistent with the Act and the implementing regulations in
this chapter. If necessary, the selected establishment coordinator, in
consultation with the District Manager that covers the State, may
designate qualified FSIS personnel to visit a selected establishment on
behalf of the selected establishment coordinator.
(b) The selected establishment coordinator, in coordination with
the State, will verify that selected establishments in the State are
receiving the necessary inspection services from designated personnel,
and that these establishments are eligible, and remain eligible, to
participate in a cooperative interstate shipment program. The selected
establishment coordinator's verification activities may include:
(1) Verifying that each selected establishment employs, and
continues to employ, 25 or fewer employees, on average, as required
under Sec. Sec. 381.513(a) of this part, unless the establishment is
transitioning to become an official establishment;
[[Page 47669]]
(2) Verifying that the designated personnel are providing
inspection services to selected establishments in a manner that
complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that State staffing levels for each selected
establishment are appropriate to carry out the required inspection
activities; and
(4) Assessing each selected establishment's compliance with the Act
and implementing regulations in this chapter.
(c) If the selected establishment coordinator determines that
designated personnel are providing inspection services to selected
establishments in the State in a manner that is inconsistent with the
Acts and the implementing regulations in this chapter, the
Administrator will provide an opportunity for the State to develop and
implement a corrective action plan to address inspection deficiencies
identified by the selected establishment coordinator. If the State
fails to develop a corrective action plan, or the selected
establishment coordinator for the State determines that the corrective
action plan is inadequate, the Administrator will terminate the
agreement for the cooperative interstate shipment program as provided
in Sec. 381.187(d) of this part.
Sec. 381.518 Quarterly reports.
(a) The selected establishment coordinator will prepare a report on
a quarterly basis that describes the status of each selected
establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section
will:
(1) Include the selected establishment coordinator's assessment of
the performance of the designated personnel in conducting inspection
activities at selected establishments and
(2) Identify those selected establishments that the selected
establishment coordinator has verified are in compliance with the Act
and implementing regulations in this chapter, those that have been
deselected under Sec. 381.520 of this subpart, and those that are
transitioning to become official establishments under Sec. 381.521 of
this subpart.
(c) The selected establishment coordinator is to submit the
quarterly report to the Administrator through the District Manager for
the State where the selected establishments identified in the report
are located.
Sec. 381.519 Enforcement authority.
(a) To facilitate oversight and enforcement of this subpart,
selected establishments operating under a cooperative interstate
shipment program must, upon request, give the FSIS selected
establishment coordinator or other FSIS officials access to all
establishment records required under the Act and the implementing
regulations in this chapter. The Administrator may deselect any
selected establishment that refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any
appropriate enforcement action provided for in part 500 of this chapter
if they determine that a selected establishment under their
jurisdiction is operating in manner that is inconsistent with the Act
and the implementing regulations in this chapter. Selected
establishments participating in a cooperative interstate shipment
program are subject to the notification and appeal procedures set out
in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any
of the reasons specified in Sec. 500.3 or Sec. 500.4 of this chapter,
FSIS will:
(1) Provide an opportunity for the establishment to implement
corrective actions and remain in the cooperative interstate shipment
program, or
(2) Move to deselect the establishment as provided in Sec. 381.520
of this subpart.
(d) The decision to deselect a selected establishment under a
suspension will be made on a case-by-case basis. In making this
decision, FSIS, in consultation with the State where the selected
establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
Sec. 381.520 Deselection of ineligible establishments.
(a) The Administrator will deselect a selected establishment that
becomes ineligible to participate in a cooperative interstate shipment
program for any reason listed under Sec. 381.513(c) of this subpart.
(b) An establishment that has been deselected must transition to
become an official establishment as provided in Sec. 381.521 of this
subpart.
Sec. 381.521 Transition to official establishment.
If an establishment is deselected from a cooperative interstate
shipment program as provided in Sec. 381.520 of this subpart, FSIS, in
coordination with the State where the establishment is located, will
develop and implement a plan to transition the establishment to become
an official establishment.
Sec. 381.522 Transition grants.
(a) Transition grants are funds that a State participating in a
cooperative interstate shipment program under this subpart may apply
for to reimburse selected establishments in the State for the cost to
train one individual in the seven HACCP principles for meat or poultry
processing as required under Sec. 417.7 of this chapter and associated
training in the development of sanitation standard operating procedures
required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment
program that receives a transition grant must use grant funds to
reimburse the training costs of one employee per each selected
establishment in the State. Any other use of such funds is prohibited.
Done at Washington, DC, on September 7, 2009.
Alfred V. Almanza,
Administrator.
[FR Doc. E9-21952 Filed 9-14-09; 11:15 am]
BILLING CODE 3410-DM-P