Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products, 47648-47669 [E9-21952]

Download as PDF 47648 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 321, 332, and 381 [Docket No. FSIS–2008–0039] RIN 0583–AD37 Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products mstockstill on DSKH9S0YB1PROD with PROPOSALS2 AGENCY: Food Safety and Inspection Service, USDA. ACTION: Proposed rule. SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing regulations to implement a new voluntary cooperative program under which State-inspected establishments with 25 or fewer employees will be eligible to ship meat and poultry products in interstate commerce. In participating States, State-inspected establishments selected to take part in this program will be required to comply with all Federal standards under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), as well as with all State standards. These establishments will receive inspection services from State inspection personnel that have been trained in the enforcement of the FMIA and PPIA. Meat and poultry products produced under the program that have been inspected and passed by designated State personnel will bear an official Federal mark of inspection and will be permitted to be distributed in interstate commerce. FSIS will provide oversight and enforcement of the program. FSIS is proposing these regulations in response to the Food, Conservation, and Energy Act, enacted on June 18, 2008. Section 11015 of the law amended the FMIA and PPIA to provide for these cooperative programs. DATES: Submit comments on or before November 16, 2009. ADDRESSES: FSIS invites interested persons to submit comments on this proposed rule. Comments may be submitted by either of the following methods: Federal eRulemaking Portal: Go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Mail, including floppy disks or CD– ROM’s, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 2–2127 George Washington Carver Center, 5601 VerDate Nov<24>2008 19:41 Sep 15, 2009 Jkt 217001 Sunnyside Avenue, Beltsville, MD 20705. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2008–0039. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to: https:// www.regulations.gov. Docket: For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Philip Derfler, Assistant Administrator, Office of Policy and Program Development, Room 350–E, Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington, DC 20250; Telephone (202) 720–2709, Fax (202) 720–2025. SUPPLEMENTARY INFORMATION: I. Background A. Federal-State Cooperative Inspection Programs FSIS has been delegated the authority to carry out the functions of the Secretary of Agriculture as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.). These statutes mandate that FSIS protect the public by ensuring that meat and poultry products are safe, wholesome, unadulterated, and properly labeled and packaged. The FMIA and the PPIA (‘‘the Acts’’) provide for FSIS to cooperate with State agencies in developing and administering their own meat or poultry inspection programs (21 U.S.C. 661 and 454). The FMIA and the PPIA restrict each cooperative State meat or poultry products inspection program to the inspection and regulation of products that are produced and sold within the State (21 U.S.C. 661(a)(1) and 454(a)(1)). Under section 661 of the FMIA and section 454 of the PPIA, cooperative State inspection programs are required to operate in a manner and with authorities ‘‘at least equal to’’ the provisions set out in the Acts (21 U.S.C. 661(a)(1) and 454(a)(1)). The Acts provide for FSIS to contribute up to 50 percent of the cost of the cooperative State inspection programs, as long as the State programs are effectively enforcing requirements that are ‘‘at least equal to’’ the Federal program (21 U.S.C. 661(a)(3) and 454(a)(3)). States that have enacted a mandatory State meat or poultry inspection law must apply to FSIS to PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 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 E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules ‘‘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)). VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 However, if selected, these establishments must transition to Federal establishments ‘‘beginning on the date that is 3 years after the effective date’’ if they consistently employ, on average, more than 25 employees (Sec. 501(b)(3)(B)(ii) and Sec. 31(b)(3)(B)(ii)). The law authorizes the Secretary to develop a procedure to transition certain selected establishments to a Federal establishment (Sec. 501(b)(3)(A) and Sec. 31(b)(3)(A)). The law also requires that ‘‘[a]ny selected establishment that the Secretary determines to be in violation of any requirement of the Act, be transitioned to a Federal establishment’’ (Sec. 501(h) and Sec. 31(g)). Federal-State coordination. Under the law, the Secretary is authorized to designate a Federal employee as ‘‘State coordinator’’ for each State to ‘‘provide oversight and enforcement’’ of the interstate shipment program and to ‘‘oversee the training and inspection activities’’ of the State personnel providing inspection services to selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)). The law provides that if the State coordinator determines that a selected establishment under the State coordinator’s jurisdiction is in violation of the Acts, the State coordinator must ‘‘immediately notify the Secretary of the violation’’ and ‘‘deselect the selected establishment or suspend inspection at the selected establishment’’ (Sec. 501(d)(3)(C) and Sec. 31(d)(3(C)). This proposed rule refers to the ‘‘State coordinator’’ established in section 11015 of the 2008 Farm Bill as the FSIS ‘‘selected establishment coordinator’’ to maintain consistency with the other terminology in this proposed rule and to make clear that the ‘‘State coordinator’’ is a Federal employee. The term ‘‘State coordinator’’ is often used to refer to a State employee under the TalmadgeAiken program, so FSIS has tentatively decided not to use this term in these proposed regulations. Federal reimbursement of State costs. The law requires that the Secretary ‘‘reimburse a State for costs related to the inspection of selected establishments * * * in an amount of not less than 60 percent of eligible State costs’’ (Sec. 501(c) and Sec. 31(c)). Inspection training division. The law amended the FMIA to provide that not later than 180 days after the effective date of section 11015 of the 2008 Farm Bill, the Secretary shall establish in FSIS an inspection training division to provide outreach, education, and training to, and provide grants to appropriate State agencies to provide outreach, technical assistance, PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 47649 education, and training to small and very small establishments (as defined by the Secretary) (Sec. 501(f)). FSIS implemented this provision by establishing an Office of Outreach, Education and Training. A substantive part of the program’s function is to provide training, education, and outreach services to small and very small plants. Transition grants. The law permits the Secretary to provide grants to States to assist them in helping establishments operating under a cooperative State meat or poultry inspection program transition to selected establishments (Sec. 501(g) and Sec. 31(f)). II. The Proposed Rule A. General FSIS is proposing to amend 9 CFR part 321 of the Federal meat inspection regulations and 9 CFR part 381, subpart R, of the poultry products inspection regulations to add new sections that describe the cooperative interstate shipment program established in section 11015 of the 2008 Farm Bill. FSIS is also proposing to add a new 9 CFR part 332 to the Federal meat inspection regulations and a new 9 CFR part 381, subpart Z, to the poultry products inspection regulations that prescribe the conditions under which States and establishments operating under a Stateinspection program will be permitted to participate in a cooperative interstate shipment program. When FSIS completes the rulemaking process and issues a final rule, the Federal meat and poultry products regulations will provide for three separate cooperative State meat and poultry products inspection programs: (1) Cooperative State meat or poultry products inspection programs under the FMIA and PPIA; (2) cooperative agreements for State programs to conduct meat or poultry products inspection or other regulatory activities on behalf of the Agency under the Talmadge-Aiken Act; and (3) cooperative programs for the interstate shipment of State-inspected meat and poultry products under the FMIA and PPIA as amended by section 11015 of the 2008 Farm Bill. The proposed regulations to implement section 11015 are described in detail below. B. Description of Cooperative Programs—9 CFR Part 321 and 9 CFR Part 381, Subpart R 9 CFR part 321 of the Federal meat inspection regulations and 9 CFR part 381, subpart R, of the poultry products inspection regulations describe E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 47650 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules cooperative meat and poultry products inspection programs authorized under the FMIA, PPIA, and the TalmadgeAiken Act. These regulations reference the legal authority for each cooperative inspection program and provide a general description of each program. FSIS is proposing to amend part 321 and part 381, subpart R, to add a new § 321.3 and a new § 381.187 to describe the cooperative interstate shipment program established under section 11015 of the 2008 Farm Bill. The amendments to the FMIA in section 501 of section 11015 of the 2008 Farm Bill have been codified at 21 U.S.C. 683, and the amendments to the PPIA in section 31 have been codified at 21 U.S.C. 472 (122 Stat. 2124, 2127). Therefore, proposed § 321.3(a) provides that under 21 U.S.C. 683(b), FSIS is authorized to coordinate with States that have cooperative State meat inspection programs to select certain establishments operating under these programs to ship carcasses, parts of carcasses, meat, and meat food products in interstate commerce. Similarly, proposed § 381.187(a) provides that under 21 U.S.C. 472(b), FSIS is authorized to coordinate with States that have cooperative State poultry products inspection programs to select certain establishments operating under these programs to ship poultry products in interstate commerce. Proposed §§ 321.3(a) and 381.187(a) both explain that this type of cooperative program is called a ‘‘cooperative interstate shipment program.’’ Proposed §§ 321.3(b) and 381.187(b) contain a general description of the cooperative interstate shipment program and make clear that the Federal contribution for inspection services provided by States that have entered into such a program will be at least 60 percent of eligible State costs. Under the FMIA and PPIA, FSIS is required to contribute up to 50 percent of the cost of a cooperative State meat or poultry products inspection program (21 U.S.C. 661(a)(3) and 454(a)(3)). Thus, States that participate in the new cooperative interstate shipment program will receive additional reimbursement for costs related to inspection of selected establishments in the State. As required under the statute, the Federal contribution for inspection services provided by States that enter into a cooperative interstate shipment program under this proposal will be at least 60 percent of eligible State costs. When the program is implemented, FSIS does not intend to reimburse States for more than 60 percent of their eligible costs unless Congress directs it, and provides the money for it, to do so. VerDate Nov<24>2008 19:41 Sep 15, 2009 Jkt 217001 To be reimbursed under this proposed rule, States will be expected to submit their budgets for their cooperative interstate shipment programs to FSIS for approval prior to receiving Federal funds. States will also be expected to submit a separate justification for any costs related to the cooperative interstate shipment program that were not included in their initial budget request. FSIS will also need to approve a State’s request for additional funds before the Agency will reimburse the State for not less than 60% of the cost. FSIS has tentatively decided that, for purposes of this proposed rule, eligible State costs will be those costs that a State has justified and FSIS has approved as necessary for the State to provide inspection services to selected establishments in the State. The Agency requests comments on whether the final rule resulting from this proposal should codify this definition or any other requirements related to State reimbursement for eligible costs related to inspection of selected establishments. Proposed §§ 321.3(c) and 381.187(c) identify 9 CFR part 332 and 9 CFR part 381, subpart Z, as the regulations that prescribe conditions under which States and establishments may participate in the cooperative interstate shipment program. Proposed §§ 321.3(d) and 381.187(d) provide that the Administrator will terminate an agreement for a cooperative interstate shipment program with a State if the Administrator determines that the State is not conducting inspection at selected establishments in a manner that complies with the Acts and their implementing regulations. C. Requirements for a Cooperative Interstate Shipment Program—9 CFR Part 332 and 9 CFR 381 Subpart Z 1. General FSIS is proposing to amend title 9, Chapter III, Subchapter A of the Code of Federal Regulations (CFR) to add a new part 332 titled ‘‘Selected Establishments; Cooperative Program for Interstate Shipment of Carcasses, Parts of Carcasses, Meat, and Meat Food Products,’’ and to add to part 381 a new subpart Z titled ‘‘Selected Establishments; Cooperative Program for Interstate Shipment of Poultry Products.’’ The regulations in the proposed new part 332 and the proposed new subpart Z prescribe the requirements for a cooperative interstate shipment program. 2. Definitions and Purpose Proposed §§ 332.1 and 381.511 define the terms ‘‘cooperative interstate PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 shipment program,’’ ‘‘cooperative State meat inspection program,’’ ‘‘cooperative State poultry products inspection program,’’ ‘‘selected establishment,’’ and ‘‘designated personnel.’’ Terms used in the proposed regulations that are defined in 9 CFR 301.2 and 9 CFR 381.1 retain their same meaning. Under proposed §§ 332.1 and 381.511, ‘‘cooperative interstate shipment program,’’ ‘‘cooperative State meat inspection program,’’ and ‘‘cooperative poultry products inspection program’’ are defined by providing a crossreference to the description of these cooperative programs in 9 CFR part 321 and 9 CFR part 381 subpart R, described above. Under this proposal, ‘‘selected establishment’’ is defined as ‘‘an establishment operating under a State cooperative [meat or poultry products] inspection program that has been selected by the Administrator, in coordination with the State where the establishment is located, to participate in a cooperative interstate shipment program.’’ FSIS is proposing to define ‘‘designated personnel’’ as ‘‘State inspection personnel that have been trained in the enforcement of the Acts and any additional State program requirements in order to provide inspection services to selected establishments.’’ In addition to proposing new definitions, proposed §§ 332.1 and 381.511 make clear that the term ‘‘interstate commerce,’’ as used in the proposed regulations has the same meaning as ‘‘commerce’’ under 9 CFR 301.2 and 381.1. The regulations in 9 CFR 301.2 and 381.1 define ‘‘commerce’’ as ‘‘[c]ommerce between any State, any Territory, or the District of Columbia, and any place outside thereof * * *.’’ Thus, under this proposal, State-inspected establishments that are selected to participate in a cooperative interstate shipment program will be permitted to distribute and sell meat or poultry products across State lines and to export these products to foreign countries. Proposed §§ 332.2 and 381.512 state that the purpose of part 332 and part 381, subpart Z, is to prescribe the conditions under which States that administer cooperative State meat or poultry products inspection programs and establishments that operate under such programs may participate in a cooperative interstate shipment program. 3. Requirements for Establishments The proposed regulations in §§ 332.3 and 381.513 prescribe conditions that establishments operating under a E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules cooperative State meat or poultry products inspection program must comply with in order to apply to participate in a cooperative interstate shipment program. Proposed §§ 332.3 and 381.513 also describe establishments that are ineligible to be selected for such a program. Number of employees. Under proposed §§ 332.3(a)(1) and 381.513(a)(1), an establishment operating under a cooperative State meat or poultry products inspection program may apply to participate in a cooperative interstate shipment program if the establishment employs, on average, no more than 25 employees. Standards for determining the average number of employees for purposes of this proposal are described in proposed §§ 332.3(b) and 381.513(b) below. Under proposed §§ 332.3(a)(2) and 381.513(a)(2), establishments that employed more than 25 but fewer than 35 employees as of June 18, 2008, are also permitted to apply for a cooperative interstate shipment program. However, §§ 332.3(a)(2) and 381.513(a)(2) provide, reflecting the amended FMIA and PPIA, that if selected, these establishments must employ, on average, 25 or fewer employees as of the date three years from the date that the final rule resulting from this proposal becomes effective. If they do not, proposed §§ 332.3(a)(2) and 381.513(a)(2) require that they be deselected from the program and transition to become official establishments. Standards for determining number of employees. Proposed §§ 332.3(b) and 381.513(b) establish standards for determining whether an establishment employs, on average, 25 or fewer employees for purposes of this proposed rule. FSIS developed these proposed standards to carry out Congress’ intent that ‘‘[t]he term ‘average’ should be interpreted to provide some flexibility to these selected establishments that require seasonal employees for certain parts of the year, as long as the increase in employees are [sic] manageable by the establishment and the increase * * * does not undermine food safety standards’’ (S. Rep. No. 220, 110th Cong., 1st Sess., at 211 (2007)). For the most part, the proposed standards in §§ 332.3(b) and 381.513(b) reflect applicable methods used by the Small Business Administration (SBA) to calculate the number of employees of a business concern where the size standard is number of employees (13 CFR 121.105 and 121.106). In addition, as explained below, FSIS is also proposing to limit the total number of employees at any given time to 35 individuals. Under this proposal, the VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 standards developed by FSIS will apply to the employees of an individual establishment. The proposed standards are as follows: • All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis are to be counted when calculating the total number of employees; • All individuals employed from a temporary employee agency, professional employee organization, or leasing concern are to be counted; • The average number of employees is calculated for each of the pay periods for the preceding calendar year; • Part-time and temporary employees are to be counted the same as full-time employees; • If an establishment has not been in business for 12 months, the average number of employees is calculated for the pay periods in which the establishment has been in business; • Volunteers who receive no compensation are not considered employees; and • The total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees. As noted above, the standard that limits the total number of employees on any given day to 35 individuals is not derived from SBA’s methods for calculating the number of employees. FSIS is proposing to limit the number of individuals employed by a selected establishment at any given time to carry out Congress’ intent that any increase in the number of employees be ‘‘manageable by the selected establishment’’ and that the increase ‘‘does not undermine food safety standards.’’ FSIS is proposing that this number never exceed 35 because section 11015 of the 2008 Farm Bill permits the Agency to select certain establishments that employ as many as 35 employees to participate in a cooperative interstate shipment program (Sec. 501(b)(3)(i) and Sec. 31(b)(3)(i)). Therefore, FSIS believes that a temporary increase in the number of employees of up to 35 individuals is likely to be considered ‘‘manageable’’ under the law, provided that the average number of employees remains at 25 or fewer. FSIS requests comments on the proposed standards for determining an establishment’s average number of employees. The Agency specifically requests comment on whether part-time and temporary employees should be counted the same as full-time employees. Ineligible establishments. Proposed §§ 332.3(c) and 381.513(c) describe PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 47651 establishments that are ineligible to participate in a cooperative interstate shipment program. For the most part, these establishments reflect the ‘‘prohibited establishments’’ described in section 11015 of the 2008 Farm Bill (Sec. 501(b)(2) and 31(b)(2)). These establishments include: • Establishments that employ more than 25 employees on average, with a limited exception for establishments that had between 25 and 35 employees as of June 18, 2008 and that have 25 or fewer employees as of the date three years from the date that the final rule resulting from this rule becomes effective; • Establishments operating under a cooperative inspection program under the Talmadge-Aiken Act; • Official establishments; • Establishments that were official establishments as of June 18, 2008, but that were reorganized on a later date by the person that controlled the establishment as of June 18, 2008; • State-inspected establishments that employed more than 35 employees as of June 18, 2008, but that were later reorganized by the person that controlled the establishment as of June 18, 2008; • Establishments that are transitioning to become official establishments; • Establishments that are in violation of the FMIA or PPIA; and • Establishments located in a State without a cooperative meat or poultry products inspection program. In addition, the proposed regulations also include among the establishments ineligible to participate in a cooperative interstate shipment programs, establishments located in a State whose agreement for an interstate shipment program was terminated by the Administrator. Proposed §§ 332.3(d) and 381.513(d) provide that an eligible establishment may apply for selection into a cooperative interstate shipment program through the State where the establishment is located. FSIS is proposing that establishments apply for selection into a cooperative interstate shipment program through the State because the State will be responsible for providing inspection services to the establishment if the establishment is selected for the program. Thus, establishment participation in the cooperative interstate shipment program will depend on whether the State is able, and willing, to provide the necessary inspection services to the establishment. However, if a State enters into an agreement with FSIS for a cooperative interstate shipment E:\FR\FM\16SEP2.SGM 16SEP2 47652 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules mstockstill on DSKH9S0YB1PROD with PROPOSALS2 program, FSIS, in coordination with the State, will make the final determination on whether to select an establishment to participate in the program. 4. State Request for a Cooperative Interstate Shipment Program Under this proposed rule, a State that does not have a cooperative interstate shipment program, but that is interested in establishing one, may submit a request for such a program to FSIS. Proposed §§ 332.4 and 381.514 prescribe the procedures for States to request an agreement for a cooperative interstate shipment program. Under this proposal, a State will submit the request through the FSIS District Office that covers the State. Proposed §§ 332.4(a) and 381.514(a) make clear that State participation in a cooperative interstate shipment program is limited to States that have cooperative State meat or poultry products inspection programs. Required information. Proposed §§ 332.4(b) and 381.514(b) describe the information that States will need to include in their requests for an agreement for a cooperative interstate shipment program. Because a cooperative interstate shipment program requires participation from both States and establishments, the State’s request for an agreement for a cooperative interstate shipment program must identify establishments in the State that have requested to be selected and that the State recommends for initial selection into the program (proposed §§ 332.4(b)(1) and 381.514(b)(1)). If FSIS and the State enter into an agreement for a cooperative interstate shipment program under this proposal, these establishments will be the first to be considered for the program. Other establishments operating under the State’s meat or poultry products inspection program may apply to become selected establishments after the cooperative interstate shipment program has been implemented within the State. A State’s request for a cooperative interstate shipment program must also include documentation to demonstrate that the State is able to provide necessary inspection services to selected establishments in the State and conduct any related activities that would be required under a cooperative interstate shipment program (proposed §§ 332.4(b)(2) and 381.514(b)(2)). Under this proposal, this documentation would be similar to the documentation that States provide when they request an agreement for a cooperative State meat or poultry products inspection program. However, instead of demonstrating that the State’s inspection program is ‘‘at least equal to’’ VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 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 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 from selected establishments are capable of producing the same results as the methodologies used by FSIS laboratories. FSIS will not enter into an agreement for a cooperative interstate shipment program with a State that does not meet the conditions described above. Additional conditions. Proposed §§ 332.4(b)(3) and 381.514(b)(3) prescribe additional conditions that States applying for a cooperative interstate shipment program must agree to in order to qualify for the program. These proposed regulations provide that when a State submits a request to establish a cooperative interstate shipment program, the State must agree that, if it enters into an agreement with FSIS for such a program, that the State will: • Provide FSIS with access to the results of all laboratory analyses conducted on product samples from selected establishments in the State; • Notify the selected establishment coordinator (SEC) for the State of the results of any laboratory analyses that indicate that a product prepared or processed in a selected establishment may be adulterated or may otherwise present a food safety concern; and • If necessary, cooperate with FSIS to transition selected establishments in the State that have been deselected from a cooperative interstate shipment program to become official establishments. FSIS will not enter into an agreement for a cooperative interstate shipment program if a State does not agree to these terms. Qualified States. Under this proposal, after a State submits a request for a cooperative interstate shipment program, the FSIS Administrator will review the request and determine whether the State qualifies for such a program. If, based on the information submitted in the request the Administrator determines that a State is eligible to enter into a cooperative agreement for an interstate shipment program, the Administrator and the State will sign a cooperative agreement that sets forth the terms and conditions under which each party will cooperate to provide inspection services to selected establishments in the State (proposed §§ 331.4(c) and 381.514(c)). After the Administrator and a State have signed an agreement for a cooperative interstate shipment program, the Administrator will: (1) Appoint an FSIS employee as the selected establishment coordinator (SEC) for the State and (2) coordinate with the State to select the establishments that will participate in the program (proposed §§ 332.4(d) and 381.514(d)). E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules 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. VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 • If the Administrator determines that the State qualifies for the cooperative interstate shipment program, the Administrator and the State will sign a cooperative agreement that sets forth the terms and conditions under which each party will cooperate to provide inspection services to selected establishments in the State. • The Administrator will then appoint an SEC for the State, and the Administrator, in coordination with the State, will begin selecting establishments for participation in the program. 5. Selection of Establishments As discussed above, under this proposal, State-inspected establishments that are interested in participating in a cooperative interstate shipment program will apply for selection into the program through the State agency that administers the State’s meat or poultry products inspection program. When, and if, an establishment applies to participate in a cooperative interstate shipment program, the State will evaluate the establishment to determine whether it qualifies to become a selected establishment. Proposed §§ 332.5(a) and 381.515(a) provide that a State-inspected establishment will qualify for selection into a cooperative interstate shipment program if the establishment: • Has submitted a request to the State to be selected for the program; • Has the appropriate number of employees; • Is not ineligible for a cooperative interstate shipment; • Is in compliance with all requirements under the State inspection program; and • Is in compliance with the all Federal meat or poultry products inspection requirements. Establishments that do not meet all of these criteria will not qualify, and will not be selected, for the program. To participate in a cooperative interstate shipment program, an establishment that qualifies for such a program must be selected by the Administrator, in coordination with the State where the establishment is located (proposed §§ 332.5(b) and 381.515(b)). Thus, under this proposal, if a State determines that an establishment operating under the State’s meat or poultry products inspection program qualifies for selection into a cooperative interstate shipment program, and the State is able, and willing, to provide the necessary inspection services to the establishment, the State is to submit its evaluation of the establishment through the FSIS District Office that covers the PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 47653 State. The FSIS Administrator, in coordination with the State, will decide whether to select the establishment for the program. When deciding whether to select and establishment for the program, the Administrator will consider whether the establishment meets the criteria needed to qualify for the program and whether the Agency has the resources that it needs to provide the required oversight of the establishment if it is selected for the program. As stated above, to qualify to participate in a cooperative interstate shipment program, an establishment must be in compliance with all Federal inspection requirements under the FMIA, PPIA, and their implementing regulations in title 9, chapter III, of the CFR. Thus, as part of the selection process, the SEC, in coordination with the State, will verify that each establishment that has applied to participate in a cooperative interstate shipment program: (1) Meets the Federal regulatory performance standards established in 9 CFR 416.1 through 416.6; (2) has submitted all labeling material to the State for approval, and that the materials meet all Federal requirements in 9 CFR parts 316, 317, and 319 and Part 381, subparts M, N, and P; (3) has obtained the same water source and sewage system approval that FSIS requires for official establishments; (4) has developed Sanitation Standard Operating Procedures (Sanitation SOPs) that comply with 9 CFR 416.11–416.17; and (5) has conducted a hazard analysis and developed a validated Hazard Analysis and Critical Control Points (HACCP) plan that complies with 9 CFR part 417. These criteria reflect the standards that meat and poultry products establishments are required to meet to obtain a Federal grant of inspection under 9 CFR part 304 and 9 CFR part 381. Establishments that do not meet all of these requirements are not in compliance with all Federal standards and thus will not be selected for the program. If an establishment qualifies for, and is selected to participate in, a cooperative interstate shipment program under this proposed rule, proposed §§ 332.5(c) and 381.515(c) provide that the State is to assign the establishment an official number that reflects the fact that the establishment is a participant in the cooperative interstate shipment program. These proposed regulations provide that the State is to advise the SEC of the number assigned to each selected establishment in the State. Proposed §§ 332.5(c) and 381.515(c) go on to state that the official numbers E:\FR\FM\16SEP2.SGM 16SEP2 47654 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules assigned to selected establishments need to contain the suffix ‘‘SE’’ to identify the establishments as selected establishments. FSIS is proposing this requirement to ensure that establishments participating in the cooperative interstate shipment program can be identified by reference to their establishment number. It will also ensure that meat and poultry products prepared in selected establishments are identified as articles produced under a cooperative interstate shipment program. Proposed §§ 332.5(c) and 381.515(c) also provide that the selected establishment numbers must include, as a suffix, the abbreviation for the State in which the establishment is located. In addition, proposed § 381.515(c) provides that the suffix of the number for a selected poultry products establishments needs to contain the letter ‘‘P’’ to identify the establishment as one that processes poultry products. Thus, under this proposal, an official number for a selected establishment in Texas that prepares meat products would contain the suffix ‘‘SETX,’’ while an official number for an establishment in North Dakota that process poultry products would contain the suffix ‘‘SEPND.’’ As discussed below, articles that have been inspected and passed in a selected establishment will bear an official USDA mark, stamp, tag, or label of inspection. Finally, proposed §§ 332.5(d) and 381.515(d) provide that failure of a State to comply with §§ 332.5(c) and 381.515(c) will disqualify that State from participation in a cooperative interstate shipment program. Full compliance by a State with these provisions is essential if the program is to succeed. mstockstill on DSKH9S0YB1PROD with PROPOSALS2 6. Inspection at Selected Establishments, Official Mark, and Interstate Shipment Proposed §§ 332.6(a) and 381.516(a) provide that a cooperative interstate shipment program will commence when the Administrator, in coordination with a State that has entered into an agreement for a cooperative meat or poultry products inspection program, have selected establishments in the State to participate in the program. Proposed §§ 332.6(b) and 381.516(b) provide that inspection services for selected establishments participating in a cooperative interstate shipment program must be provided by designated personnel, who will be under the direct supervision of a State employee. As discussed below, the FSIS VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 SEC will oversee the inspection activities of the designated personnel. Proposed §§ 332.6(c) and 381.516(c) provide that articles prepared or processed in a selected establishment that have been inspected and passed by designated personnel must bear an official USDA mark, stamp, tag, or label of inspection as specified in 9 CFR 312.2 or 9 CFR 381.96. 9 CFR 312.2 and 9 CFR 381.96 are the regulations that prescribe the appropriate wording and form for use of the official Federal inspection legend on meat or poultry products. In addition, the establishment number contained in the Federal mark, stamp, tag, or label of inspection must comply with all the conditions proposed in §§ 332.5(c) or 381.515(c). Under proposed §§ 332.6(d) and 381.516(d) meat or poultry products prepared in selected establishments may be shipped in interstate commerce if they have been inspected and by selected State personnel and bear the Federal mark of inspection. 7. Federal Oversight of Cooperative Interstate Shipment Programs Section 11015 of the 2008 Farm Bill requires that the Secretary designate an employee of the Federal government as a ‘‘State coordinator’’ for each State that has a cooperative State meat or poultry products inspection program (Sec. 501(d) and Sec. 31(d)). The State coordinator is required to ‘‘provide oversight and enforcement’’ of the program and ‘‘to oversee the training and inspection activities’’ of State personnel designated to provide inspection services to selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)). As noted above, when, and if, a State qualifies to participate in a cooperative interstate shipment program, proposed §§ 332.4(c)(1) and 381.514(c)(1) provide that the Administrator will appoint an FSIS employee as the FSIS SEC for the State. The SEC is the ‘‘State coordinator’’ prescribed by the statute. FSIS has tentatively decided that the SEC will be an employee of the FSIS Office of Field Operations (OFO) and will be assigned to an FSIS District Office. The SEC will likely be under the direct supervision of an FSIS District Manager. The number of States in an FSIS district assigned to an SEC will likely depend on several factors, including, but not limited to: (1) The number of States and selected establishments, if any, that participate in the cooperative interstate shipment program; (2) the location of each selected establishment; (3) the number of State inspection personnel providing inspection services to selected PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 establishments in a State; (4) the complexity of the operations conducted at each selected establishment; and (5) the schedule of operations for each selected establishment. The number of States assigned to an SEC would also need to be based on consideration of the most effective allocation of available Agency resources. SEC initial responsibilities. One of the SEC’s initial responsibilities will be, in conjunction with the District Office, to coordinate with the State to select establishments to participate in the program. The SEC will coordinate with the State to verify that all State personnel selected to provide inspection services to these establishments have successfully completed the same training in the fundamentals of meat and poultry inspection, covering the Sanitation Performance Standards, Sanitation Standard Operating Procedures (SOPs), HACCP, and enforcement procedures, that is required for FSIS inspection personnel. The SEC will also coordinate with the State to verify that designated personnel have successfully completed the appropriate customized food safety training required for FSIS inspection personnel based on the types of products being produced at the establishments where designated personnel are assigned. SEC’s oversight responsibilities. Proposed §§ 332.7 and 381.517 prescribe how the FSIS SEC is to provide Federal oversight of the cooperative interstate shipment program. Proposed §§ 332.7(a) and 381.517(a) provide that the SEC is to visit each selected establishment in the State on a regular basis to verify that these establishments are operating in a manner that is consistent with the Acts and the implementing regulations in title 9, chapter III, of the CFR. The SEC’s frequency of visits and oversight activities for each selected establishment will need to reflect the type of operations conducted by a selected establishment, as well as the establishment’s production processes. FSIS requests comments on how frequently the SEC should visit each establishment under his or her jurisdiction. Proposed §§ 332.7(a) and 381.517(a) also provide that if necessary, the SEC, in consultation with the District Manager that covers the State, may designate qualified FSIS personnel to visit a selected establishment on behalf of the SEC. Under proposed §§ 332.7(b) and 381.517(b), the SEC, in coordination with the State, will verify that selected establishments in the State are receiving the necessary inspection services from E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules 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 VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 operating in compliance with the Acts. A comprehensive food safety assessment is an assessment that considers all the food safety aspects that relate to an establishment and all the products the plant produces. If the SEC determines that designated personnel are not providing inspection services to selected establishments in a manner that complies with the Acts, proposed §§ 332.7(c) and 381.517(c) provide that FSIS will provide an opportunity consistent with these regulations for the State to develop and implement a corrective action plan to address inspection deficiencies identified by the SEC. These proposed regulations also provide that if the State fails to develop a corrective action plan, or if the SEC determines that the State’s corrective action plan is inadequate, the Administrator will terminate the cooperative agreement with the State. As discussed above, selected establishments in a State whose agreement for a cooperative interstate shipment program has been terminated by the Administrator are among the establishments that are ineligible to participate in the program. As such, these establishments will be deselected from the program and transitioned to become Federal establishments as described below. Quarterly reports. As required under section 11015 of the 2008 Farm Bill (Sec. 501(d)(3)(b) and Sec. 31(d)(3)(b)), the SEC is to prepare a report on a quarterly basis that describes the status of each selected establishment under the SEC’s jurisdiction (proposed §§ 332.8(a) and 381.518(a)). The SEC’s quarterly report will include the SEC’s assessment of the performance of the designated personnel in conducting inspection activities (proposed §§ 332.8(b)(1) and 381.518(b)(1)). The quarterly report will also identify the selected establishments that the SEC has verified are in compliance with all Federal requirements, those that have been deselected, and those that are transitioning to become Federal establishments (proposed §§ 332.8(b)(1) and 381.518(b)(1)). The SEC will submit the report to the Administrator through the District Manager for the State in which the selected establishments identified in the report are located (proposed §§ 332.8(c) and 381.518(c)). Enforcement. Section 11015 of the 2008 Farm Bill provides that if the SEC determines that any selected establishment is in violation of any requirement of the Acts, the SEC is required to: (1) Immediately notify the Secretary (the FSIS Administrator by delegation) of the violation and (2) PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 47655 ‘‘deselect’’ the establishment or suspend inspection at the establishment (Sec. 501(d)(3)(C) and Sec. 31(d)(3)(C)). In adopting this language, Congress intended that the SEC ‘‘* * * shall be provided all the tools necessary under the Secretary to prevent or control any food safety issue that would harm human health’’ (S. Rep. No. 220, 110th Cong., 1st Sess., at 211 (2007)). Because many of the SEC’s verification and enforcement activities require that the SEC have access to a selected establishment’s records, proposed §§ 332.9(a) and 381.519(a) provide that to facilitate oversight and enforcement of the cooperative interstate shipment program, selected establishments must, upon request, give SECs or other FSIS officials access to all establishment records required under the FMIA, PPIA, and the implementing regulations in title 9, chapter III, of the CFR. These proposed regulations go on to state that FSIS will move to deselect an establishment that does not comply with this requirement. Under proposed §§ 332.9(b) and 381.519(b), the SEC is authorized to initiate any appropriate enforcement action provided for in the FSIS rules of practice in 9 CFR part 500 if he or she determines that a selected establishment under his or her jurisdiction is operating in a manner that is inconsistent with the Acts or their implementing regulations. Such actions include, among others, regulatory control actions, withholding actions, and suspensions. The proposed regulations provide that selected establishments participating in a cooperative interstate shipment program are subject to the notification and appeal procedures set out in part 500 (proposed §§ 332.9(b) and 381.519(b)). Proposed §§ 332.9(c) and 381.519(c) provide that if inspection at a selected establishment is suspended for any of the reasons specified in 9 CFR 500.3 or 9 CFR 500.4, FSIS will provide an opportunity for the establishment to implement corrective actions and remain in the cooperative interstate shipment program, or the Agency will move to deselect the establishment. The decision to deselect a selected establishment under a suspension will be made on a case-by-case basis (proposed §§ 332.9(d) and 381.519(d)). In making this decision, the Administrator, in consultation with the State where the selected establishment is located, will consider, among other factors: (1) The non-compliance that led to the suspension; (2) the selected establishment’s compliance history, which will be documented in noncompliance reports prepared by the designated personnel and the SEC’s E:\FR\FM\16SEP2.SGM 16SEP2 47656 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules mstockstill on DSKH9S0YB1PROD with PROPOSALS2 quarterly reports; and (3) the corrective actions proposed by the establishment (proposed §§ 332.9(d) and 381.519(d)) The Administrator will have the discretion to allow a selected establishment that has been suspended to remain in the program if the establishment implements corrective actions to address any non-compliance. The Administrator will consider the criteria described above in determining whether to provide an opportunity for corrective actions. Establishments that are given an opportunity to take corrective actions but that are unable to effectively implement these actions will be deselected. FSIS will also consider the State’s recommendation as to whether a selected establishment in the State should be deselected. However, the final decision to deselect an establishment for violations of the FMIA or PPIA will be made by FSIS. As discussed below, consistent with the law, this proposed rule requires that deselected establishments be transitioned to become official establishments. 8. Deselection There may be circumstances in which an establishment that initially qualifies to be selected to participate in a cooperative interstate shipment program later acquires characteristics that would cause it to become ineligible for the program. For example, an establishment may hire additional employees after it has been selected, or, as discussed above, FSIS may determine that a selected establishment is in violation of the Acts. Therefore, proposed §§ 332.10(a) and 381.520(a) provide that the Administrator will deselect an establishment that becomes ineligible to participate in a cooperative interstate shipment program. Proposed §§ 332.10(b) and 381.520(b) provide that an establishment that has been deselected from a cooperative interstate shipment program must be transitioned to become an official establishment. FSIS is proposing to require that deselected establishments be transitioned to become official Federal establishments as provided for in the law. Section 11015 of the 2008 Farm Bill allows the Agency to establish a procedure to transition selected establishments that employ, on average, more than 25 employees to become Federal establishments, and it requires that selected establishments that the Administrator determines to be in violation of any provision of the Acts, be transitioned to Federal establishments in accordance with the procedure developed for establishments that employ more than 25 employees VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 (Sec. 501(b)(3), 501(h), 31(b)(3) and 31(g)). Thus, as required by the law, under this proposal, establishments that become ineligible to participate in the cooperative interstate shipment program because they violated Federal food safety standards will not permitted to avoid implementing appropriate corrective actions by withdrawing from the cooperative interstate shipment program and reverting back to the State inspection program. In addition, requiring that deselected establishments transition to become official Federal establishments will help to ensure that the resources that FSIS and the States provide to establish and maintain a cooperative interstate shipment program are used most effectively to provide inspection services to establishments that are committed to maintaining Federal food safety standards. 9. Transition Procedures for Deselected Establishments As discussed above, under the law, FSIS is authorized to develop a procedure to transition selected establishments to become official establishments if they employ more than 25 employees on average, or if the Agency determines that they are in violation of any provision of the Acts (Sec 501(b), Sec. 501(h), Sec. 31(b) and Sec. 31(g)). At a minimum, a procedure to transition a selected establishment to an official establishment would include: (1) Adding the establishment to an FSIS circuit within the FSIS District that covers the State where the establishment is located; (2) replacing the establishment’s State establishment number with a Federal establishment number, and (3) replacing the designated personnel with FSIS inspection personnel. Other actions needed to successfully transition a selected establishment to become an official establishment are likely to depend on the reason the establishment was deselected. For example, an establishment that was deselected from a cooperative interstate shipment program for violating provisions of the Acts would likely need to develop a corrective action plan as part of its process to transition to an official establishment, while an establishment that was deselected for hiring additional employees would not. Therefore, instead of prescribing a specific procedure to transition selected establishments to official establishments, proposed §§ 332.11 and 381.521 provide that if a selected establishment is deselected, FSIS will coordinate with the State where the establishment is located to develop and PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 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 E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules participate in a cooperative interstate shipment program to reimburse selected establishments in the State for their costs to train one individual in HACCP and associated training in Sanitation SOP requirements. The regulations that prescribe conditions for receiving Federal inspection, which represent the conditions that selected establishments must meet to be in compliance with Federal standards, require that an establishment develop written Sanitation SOPs as required by 9 CFR part 416, and that it have conducted a hazard analysis and developed and validated a HACCP plan as required in 9 CFR 417.2 and 417.4 (9 CFR 304.3 and 381.22). Under 9 CFR 417.7 of the HACCP regulations, the individual that develops the HACCP plan for an establishment must have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry product processing, including a segment on the development of a HACCP plan for a specific product and on record review. State-inspected establishments that apply to participate in a cooperative interstate shipment program will be required to have an individual trained in HACCP in order to transition to a selected establishment. Therefore, for purposes of this proposed rule, FSIS has tentatively concluded that it is appropriate to provide funds to a State for the purpose of reimbursing selected establishments for the cost of this training. Accordingly, proposed §§ 332.12(a) and 381.522(a) provide that these ‘‘transition grants’’ are funds that a State participating in a cooperative interstate shipment program must use to reimburse selected establishments in the State for the cost to train one individual in the HACCP principles applicable to meat or poultry processing as required under 9 CFR 417.7 and associated training in the development of Sanitation SOPs required under 9 CFR part 416. Proposed §§ 332.12(b) and 381.522(b) make clear that States must use transition grants only for this described purpose. Once a selected establishment receives such funding from the State, the State may not use additional transition grant funds to reimburse that establishment’s training costs in the future. Under this proposal, establishments that train an individual in HACCP or Sanitation SOP requirements as part of their transition to become selected establishments may request reimbursement for these training costs through the State agency that administers the State’s cooperative VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 47657 from the 10% increase in reimbursement for the cooperative interstate shipment program because, as explained below, for many States, the costs to administer the new program are not expected to exceed the costs to administer the State meat and poultry inspection programs. Expected Costs of the Proposed Action: Costs to the participating establishments. To be eligible to participate in the cooperative interstate shipment program, a State-inspected establishment must be in compliance with: (1) The State-inspection program of the State in which the establishment is located and (2) the FMIA or PPIA, and their implementing regulations. Before State-inspected establishments can be selected to participate in a cooperative interstate shipment program, they will need to apply for selection into the program and demonstrate that they comply with both State and Federal requirements. Thus, an establishment that chooses to apply for selection into the program will incur one-time start-up costs associated with filing an application, training employees, meeting regulatory performance standards, obtaining label approval, and implementing a food safety system that complies with all Federal requirements (e.g., Sanitation SOP and HACCP requirements). In addition, to qualify for a cooperative interstate shipment program, some State-inspection establishments may need to invest in structural modifications to their facilities in order to comply with Federal standards. Based on information obtained through FSIS’ outreach activities with the States, the Agency estimates that the cost for Stateinspected establishments to fully comply with Federal standards, as required by the law, will range from $1,500 to $50,000. According to most State Directors, the cost to very small establishments that do not need to make structural modifications to their facilities is likely to be in the range of $5,000 to $10,000. On the other hand, if the establishments need to make structural modifications or perform new construction then the range would be about $15,000 to $30,000.1 However, because this is a voluntary program, establishments that choose to incur the costs associated with participating in the program will most likely do so because they anticipate that such 1 Note that under this proposed rule, establishments selected for the program will be eligible to be reimbursed the cost to train one employee in HACCP and Sanitation SOPs. E:\FR\FM\16SEP2.SGM 16SEP2 47658 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules mstockstill on DSKH9S0YB1PROD with PROPOSALS2 participation will provide an overall net benefit for them. The Agency welcomes comments on these estimates. Looking at the potential for the establishments to experience new (incremental) burden or expenses due to State inspection under the proposed cooperative interstate shipment program, FSIS believes that there will be essentially no change. FSIS is aware that the cooperative State meat and poultry products inspection programs are not identical to Federal inspection, as they must be under the cooperative interstate shipment program. So FSIS anticipates that State inspection procedures will need to be changed somewhat to comply with the requirements of the cooperative interstate shipment program. However, since the State programs are required to be equal to the Federal inspection programs now, FSIS anticipates that changes will largely be procedural, and there will not be any particular increase or decrease in overall State effort that would change the burden of the inspection regimen on the establishments. Costs to the participating States. States that choose to participate in the program will be required to pay 40 percent of the eligible costs related to inspection of establishments in the State that are selected for the program. Under the current cooperative program, the States are paying 50 percent of the eligible inspection costs. Although the inspection costs under the new program may be different from the costs under the existing program, the States’ share of 40 percent or less is unlikely to be higher than its current share. States that choose to participate in the interstate shipment program may need to make certain modifications to their State inspection programs to provide inspection services to selected establishments in a manner that is the same as the Federal inspection program. However, most States that have implemented State meat and poultry products inspection (MPI) programs have incorporated the Federal requirements into their programs.2 Thus, State costs to train State personnel are likely to be minimal because many State personnel have received training in Federal inspection 2 Based on Agency’s most recent (FY 2008) review of the 27 States’ self-assessment reports (including the State Laboratory Activity Tables) by the Federal State Audit Branch, Internal Control and Audit Division of the Office of Program Evaluation, Enforcement, and Review. VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 methodology as part of the State MPI program. States may incur some costs associated with the processing and evaluation of applications submitted by establishments requesting to be selected for the cooperative interstate shipment program. However, because the States will develop their own application procedures, FSIS is unable to estimate these costs with any certainty. The Agency requests comments on potential State costs associated with the processing and evaluation of these applications. FSIS anticipates that State inspection procedures will need to be changed somewhat to comply with the requirements of the proposed cooperative interstate shipment program. However, since the State programs are required to be at least equal to the Federal inspection programs now, FSIS anticipates that changes will largely be procedural, and there will not be any particular increase or decrease in overall State effort or cost. FSIS has no basis on which to assume anything else. FSIS requests input from State Program officials that might be useful to refine this estimate. Expected FSIS Budgetary Effects: The new Federal-State cooperative inspection program option which section 11015 of the 2008 Farm Bill requires the Secretary to create and which we propose to implement via this regulatory action is expected to have budgetary effects on FSIS to support about 16 full-time equivalent new staff. This section discusses the baseline costs and activities, i.e., what is happening now before the cooperative interstate shipment program option is available, and then lays out the incremental effects on FSIS. FSIS staff have worked with the 27 directors of the Federal-State meat and poultry inspection program to gauge the level of interest at the State and establishment level. Their input has been incorporated into the assumptions here. Baseline: Federal-State cooperative inspection programs operated in 27 States and 1,873 establishments in FY 2008, the baseline year for this analysis. Actual Federal spending for the Federal-State cooperative inspection programs was $63,959,709 for FY 2008 as reported in the FY 2010 President’s Budget, which also projected $64,703,000 for FY 2009 and $65,654,000 for FY 2010. By statute, the States may be reimbursed for up to 50 percent of the cost of their State cooperative inspection programs. PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 Federal reimbursements to State programs reported in the FY 2010 budget, included in the above figures, are $49,061,068 for FY 2008, $50,332,000 for FY 2009, and $50,332,000 for FY 2010. In fact, actual total State spending for the FederalState cooperative inspection programs for FY 2008 was $104 million with $49 million of that reimbursed by FSIS, as noted above. FSIS extends these figures into years 2010 through 2014, see table below, the 5-year analysis period for this rule, by assuming that, had the cooperative interstate shipment program option not been enacted, State cooperative programs operations would continue through the period on a generally stable basis. The Agency assumes that the same 27 States would continue to participate and the program would inspect about the same number of establishments as were inspected in FY 2008, i.e., 1,873. This appears reasonable because, among the 27 States in the program the number of establishments has been relatively stable. Since the number of establishments and States is assumed to remain unchanged, and no significant changes in program requirements are expected, baseline program costs are assumed to change only with the cost of inflation. Turning to FSIS administrative costs, we note that FSIS staffing has been stable in the 28 to 33 person range for the past decade, and is expected to remain at 29 for the foreseeable future. Consistent with State level activities, since the number of States is expected to remain the same with no particular change in the number of establishments, and since no significant changes in program requirements are expected, FSIS administrative costs are expected to change consistent with the cost of inflation, i.e., the Agency anticipates no significant increase or decrease in FSIS administrative activity during the five years in the baseline scenario (i.e., the baseline assumes no cooperative interstate shipment program). FSIS spending to administer Federal-State cooperative inspection programs, excluding the reimbursement costs, was $14,898,641 for FY 2008 as reported in the FY 2010 budget, and is projected at $14,371,000 for FY 2009 and $15,322,000 for FY 2010. For the years out to 2014, these costs would change with inflation and are shown in the following table. E:\FR\FM\16SEP2.SGM 16SEP2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules 47659 TABLE 1—BASELINE: COST FEDERAL-STATE COOP PROGRAM WITH NO CHANGE 2010 (Budget) FSIS Level Costs, Fiscal Year 2011 2012 2013 2014 Total 5-year FSIS costs .............................................................. Reimburs. to States ............................................... $15.3 50.3 $15.9 52.1 $16.5 54.1 $17.1 56.2 $17.8 58.4 $82.5 271.1 Total ................................................................ 65.7 68.0 70.5 73.3 76.1 353.6 29 29 29 29 29 FSIS Staff Years .................................................... 2010 (Budget) State Level Costs, Fiscal Year 2011 2012 2013 2014 .................... Total 5-year Federal reimbursement .......................................... State program spending ........................................ $50.3 50.3 $52.1 52.1 $54.1 54.1 $56.2 56.2 $58.4 58.4 $271.1 271.1 Total MPI program .......................................... 100.7 104.2 108.1 112.4 116.7 542.1 Number of plants ................................................... 1,873 1,873 1,873 1,873 1,873 .................... Economic Assumptions From OMB for the 2010 Budget mstockstill on DSKH9S0YB1PROD with PROPOSALS2 State & Local Exp, % ............................................. FSIS civilian pay, % ............................................... Non-Pay Expenditure, % ....................................... Interstate Scenario: To evaluate this scenario, we must estimate the number of establishments and States that will seek to participate and be selected for the new cooperative interstate shipment program. Then we will discuss the likely incremental changes in activity that could reasonably suggest any changes in cost or burden for FSIS, the States, or establishments. Here is how we determined the number of establishments that are likely to participate in the proposed cooperative interstate shipment program. The first cut is to look at all establishments and determine the number with fewer than 25 employees. The statute limits participation to these smaller establishments. Of the total 1,873 plants in the current Federal-State cooperative inspection program there are 1,811 that meet the size criterion for eligibility for the cooperative interstate shipment program. However, as noted earlier, sixteen States have expressed an interest in the new cooperative interstate shipment program, and these States have a total of 1,133 establishments that could potentially be eligible for the new program. The eleven States that have not indicated an interest in the cooperative interstate shipment program include all nine States that have establishments operating under the Talmadge-Aiken (TA) program. The TA States account for the remaining 678 eligible establishments. Because participation in the cooperative interstate shipment program VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 3.1 5.1 0.8 3.5 4.1 1.2 3.8 4.1 1.4 is voluntary, the Agency cannot estimate with certainty the number of eligible establishments that will choose to participate. Therefore, for illustration purposes, and to obtain a reasonable range of possible budget impacts, given the uncertainty, the Agency estimated the costs for three scenarios: 200, 400 and 600 establishments. A five-year cost estimate was completed covering the FY 2010 through FY 2014. We further assume that the participating establishments will be evenly distributed among the participating States and, just as the baseline assumes, we anticipate no particular change in the numbers of establishments in the overall program over the 5 years and no change in the cooperative interstate shipment program establishments. At this time, we turn to the change in Federal costs for the program caused by the new statutory reimbursement level. For the cooperative interstate shipment program the law requires that FSIS reimburse State for costs related to the inspection of selected establishments in an amount not less than 60 percent of eligible State costs, as opposed to current law which allows reimbursement of up to 50 percent of costs for the regular, and continuing, Federal-State cooperative inspection program. This analysis projects the effects of the different reimbursement rate on FSIS fiscal requirements assuming no change in State level activity over the baseline. FSIS assumes that States will not change their level of activity associated with selected PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 3.9 4.1 1.6 3.9 4.1 1.6 .................... .................... .................... establishments in the cooperative interstate shipment program as discussed above. FSIS determined that Agency reimbursements to States would increase by about $2.2 million in a fully operational cooperative interstate shipment program in FY 2011 (not all plants will be in the cooperative interstate shipment program for all of FY 2010). In all years, the amount of increase in this component of Federal reimbursement would offset State spending by the same amount. (FY 2011 is used because it is the first, fully operational year, explained further below.) To calculate this figure, FSIS estimated average per establishment spending for the Federal-State Cooperative Inspection Program by States for the 1,873 establishments in the baseline scenario. For FY 2011, the average per establishment is $55,626, including State and Federal reimbursement. Reviewing the budget for FY 2008 and 2009, we see that average Federal reimbursement is currently running about 50 percent of total State costs. The reimbursement ratio is expected to remain stable for the 5-year period both for inspecting establishments in the baseline scenario, and for inspecting establishments that stay with the existing program, while 400 establishments seek and are selected to operate with the cooperative interstate shipment program. Reimbursement will increase to 60 percent for inspection services to the 400 establishments that move into the E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 47660 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules 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 VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 cooperative interstate shipment program. We anticipate that about onequarter of the total establishments will enter the cooperative interstate shipment program each quarter during FY 2010, reaching the full complement toward the end of that year. So, for example, in the 400 establishment scenario, 100 establishments will initiate inspection under a cooperative interstate shipment program sometime in the first quarter, another 100 in the second quarter, another in the third quarter, and the final group of 100 in the fourth quarter. It is expected that early in 2010 SEC time will initially focus on outreach and start-up activities (including establishment selection) and shift over until it is more completely the oversight activities stipulated in the Acts. While there may be one SEC per State from the beginning, we believe that contiguous States and establishments that are in relative close proximity could make it appropriate to have less than 16 full time equivalent SECs. Note that if 400 establishments convert into the cooperative interstate shipment program in FY 2010 and continue in the following years, each SEC will be responsible for 31 establishments in a geographicallylimited area. This is approximately equal to the number of Federal establishments over which frontline FSIS supervisors have oversight responsibilities. In the start-up period, in FY 2009 and FY 2010, the first year of the cooperative interstate shipment program, in addition to SEC outreach efforts, FSIS expects to incur costs for outreach and training, and administration from OOEET for the small and very small establishments that are considering the cooperative interstate shipment program, that decide to apply for the program, and for those who are selected to participate in the program. OOEET will conduct face-toface workshops in every State to provide information to establishment owners and operators about the requirements of the new cooperative interstate shipment program. These workshops will not only educate the interested owners and operators about the requirements, they will also help them meet the requirements. This allocation will cover the cost of developing, printing, and shipping the workshop materials, as well as the cost of traveling Agency personnel to conduct the workshops, and the cost of meeting space. The cost is reflected in the tables below in the ‘‘Training/Outreach’’ line. The reason these costs do not change in the various scenarios—200, 400 or 600 establishments—is because the PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 information will be provided in a classroom. Costs are expected to be largely the same whether attendance is high or low. Also note that these costs drop sharply for each subsequent year as the cooperative interstate shipment program specific effort changes to operating training for establishments selected to participate in the program. In the start-up period, transition grant authority under 9 CFR 332.12 and 9 CFR 381.522 will be used to provide States funds to reimburse selected establishments in the State for their costs to train one individual in HACCP and associated training in Sanitation SOP requirements. The Agency estimates that the cost of training each establishment specialist will average about $5,000, including staff time and travel necessary for the training. Since this is a new expense necessary to implement the cooperative interstate shipment program and since statute authorizes it without State matching funds, these costs will be entirely new costs for FSIS that are part of ‘‘Total grants to States’’ in FY 2010 in Table 2 below. Thus, the cost to FSIS will total about $1 million, $2 million and $3 million for the 200, 400 and 600 establishment scenarios respectively. This training will only be needed in the start-up period and, accordingly, appears only in FY 2010 in Table 2. SECs are likely to be supervised by Deputy District Managers (DDMs) at the equivalent of about 1 DDM per 300 establishments. This is similar to the ratio of DDM effort used to manage frontline FSIS supervisors in the Federal programs. For the three establishment levels, this would mean 1 DDM for 200 establishments and 2 DDMs for 400 or 600 establishments. This is reflected in the ‘‘DDM’’ line of the tables below. FSIS estimates that two laboratory staff will be needed to complete periodic audits of the State inspection program laboratory systems and otherwise coordinate with the laboratories to ensure the sampling and testing programs are equivalent to the Federal program. It is anticipated that the two lab staff will be needed regardless of whether 200, 400 or 600 establishments eventually participate since the same number of State labs will need to be reviewed regardless of the volume of work they do under the cooperative interstate shipment program. This is reflected in the ‘‘Lab staff’’ line of the tables below. Travel costs are included on the ‘‘Travel—SC & lab staff’’ line in the tables below. The SECs will need to travel a fair amount to complete their duties and the lab staff will need to travel some. Travel for SECs and lab E:\FR\FM\16SEP2.SGM 16SEP2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules staff starts in FY 2010 and will run higher for the first year, after which time the start-up effort will diminish. Since we are assuming the selected establishments are evenly distributed in the participating States, we anticipate that the number of participating establishments would only have slight impact on the cost of travel for each SEC. We project about $6,150 for training and travel for each SEC in the first and $630 for subsequent years. For the lab staff we based our trips to the State program laboratories on one audit of each laboratory to make an initial assessment, so that would be one trip to the labs for each of the 27 eligible States. Because most of the labs typically have a chemistry residue program and a microbiology program, two lab-auditors will go on each trip— one chemist and one microbiologist. These labs would also need a follow-up the next year and then we would make a judgment as to whether there needed to be annual visits after that. The audit will be based on the program that FSIS developed several years ago, which is similar to the program that the Agency uses to assess the Pasteurized Egg Product Recognized Laboratory program. We based the number of audits on the figures that we had regarding the number of states that will participate, 16. Each trip ran about $1,500 for each auditor. Finally, there are the normal operating expenses associated with field 47661 operations including office space, communications costs, information technology costs (such as laptop computers), other equipment, office supplies, etc. FSIS estimates $3,500 per new staff for laptop, LincPass, Black Berries, etc. These costs are generally stable over time, although they inflate and, of course, are a little higher in the start-up year. These costs are found in the ‘‘Equipment and admin’’ line of the tables below. Table 2, below, summarizes the incremental costs to FSIS to operate the new cooperative interstate shipment program in the three scenarios 200, 400 and 600 establishments, with the 400 establishment level assumed to be the likely level. TABLE 2—COOPERATIVE INTERSTATE SHIPMENT PROGRAM COST ESTIMATES—THREE SCENARIOS Interstate Program—Summary of Incremental Cost Estimates ($ Millions) Fiscal Year 2009 Costs if 200 establishments ........... Costs if 400 establishments ........... Costs if 600 establishments ........... $1.93 1.93 1.93 2010 2011 $5.55 7.11 8.79 $4.07 5.34 6.53 2012 $4.22 5.55 6.79 2013 $4.40 5.77 7.06 2014 $4.58 6.00 7.33 5-Year $22.83 29.77 36.50 Interstate Program with 200 Establishments ($ Millions) Fiscal Year 2009 2010 2011 2012 2013 2014 5-Year Number of establishments * ........... Total grants to States ** ................. Total salaries & benefits ................ DDM ............................................... State coordinator (SC) ................... Lab staff ......................................... Operating expenses ....................... Travel-SC & lab staff ..................... Training/Outreach .......................... Equipment and admin .................... .................... .................... .................... .................... .................... .................... .................... .................... 1.43 0.50 200 $1.54 2.20 0.15 1.69 0.24 1.81 0.16 1.25 0.40 200 $1.11 2.17 0.16 1.76 0.25 0.79 0.09 0.35 0.35 200 $1.15 2.25 0.16 1.83 0.26 0.82 0.09 0.36 0.36 200 $1.20 2.35 0.17 1.91 0.27 0.85 0.10 0.38 0.38 200 $1.25 2.45 0.18 1.98 0.29 0.89 0.10 0.39 0.39 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... Total ........................................ 1.93 5.55 4.07 4.22 4.40 4.58 22.83 Interstate Program with 400 Establishments ($ Millions) Fiscal Year 2009 2010 2011 2012 2013 2014 5-Year .................... .................... .................... .................... .................... .................... .................... .................... 1.43 0.50 400 $3.07 2.23 0.30 1.69 0.24 1.81 0.16 1.25 0.40 400 $2.23 2.32 0.31 1.76 0.25 0.79 0.09 0.35 0.35 400 $2.31 2.42 0.33 1.83 0.26 0.82 0.09 0.36 0.36 400 $2.40 2.52 0.34 1.91 0.27 0.85 0.10 0.38 0.38 400 $2.49 2.62 0.35 1.98 0.29 0.89 0.10 0.39 0.39 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... Total ........................................ mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Number of establishments * ........... Total grants to States ** ................. Total salaries & benefits ................ DDM ............................................... State coordinator (SC) ................... Lab staff ......................................... Operating expenses ....................... Travel-SC & lab staff ..................... Training/Outreach .......................... Equipment and admin .................... 1.93 7.11 5.34 5.55 5.77 6.00 29.77 Interstate Program with 600 Establishments ($ Millions) Fiscal Year Number of establishments * ........... Total grants to States ** ................. Total salaries & benefits ................ DDM ............................................... State coordinator (SC) ................... Lab staff ......................................... Operating expenses ....................... VerDate Nov<24>2008 19:41 Sep 15, 2009 2009 .................... .................... .................... .................... .................... .................... .................... Jkt 217001 PO 00000 2010 2011 600 $4.67 2.23 0.30 1.69 0.24 1.89 Frm 00015 Fmt 4701 600 $3.34 2.32 0.31 1.76 0.25 0.87 Sfmt 4702 2012 600 $3.46 2.42 0.33 1.83 0.26 0.90 E:\FR\FM\16SEP2.SGM 2013 600 $3.60 2.52 0.34 1.91 0.27 0.94 16SEP2 2014 600 $3.74 2.62 0.35 1.98 0.29 0.97 5-Year .................... .................... .................... .................... .................... .................... .................... 47662 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules TABLE 2—COOPERATIVE INTERSTATE SHIPMENT PROGRAM COST ESTIMATES—THREE SCENARIOS—Continued Travel-SC & lab staff ..................... Training/Outreach .......................... Equipment and admin .................... .................... 1.43 0.50 0.24 1.25 0.40 0.17 0.35 0.35 0.18 0.36 0.36 0.18 0.38 0.38 0.19 0.39 0.39 .................... .................... .................... Total ........................................ 1.93 8.79 6.53 6.79 7.06 7.33 36.50 Economic Assumptions from OMB for the 2010 Budget State & Local Exp, % ..................... .................... 3.1 3.5 3.8 3.9 3.9 .................... FSIS Civilian pay, % ...................... Non-Pay Expenditure, % ............... .................... .................... 5.1 0.8 4.1 1.2 4.1 1.4 4.1 1.6 4.1 1.6 .................... .................... State Grant Incremental Increase in FSIS Reimbursement to the State Per Establishment .......................... .................... $5,374 $5,563 $5,774 $5,999 $6,233 .................... mstockstill on DSKH9S0YB1PROD with PROPOSALS2 * Note that in FY 2010 about one quarter of establishments are expected to enroll each quarter. In subsequent fiscal years, all establishments will be in the program for the full year. ** Note ‘‘Total grants to States’’ includes funding for Transition Grants in 2010 for States to use to help plants train one person in HACCP and SOPs per § 332.12 and § 381.522. Effect on Small Entities This proposed action will primarily affect very small and certain small establishments that operate under cooperative State meat or poultry inspection programs. Under section 11015, State-inspected establishments that employ on average 25 or fewer employees would be permitted to be selected to participate in a cooperative interstate shipment program. The law also permits the Secretary to select State-inspected establishments that employ, on average, more than 25 but less than 35 employees to participate in the program. However, to remain in the program, these establishments must employ, on average, 25 or fewer employees three years after the regulations implementing the new cooperative interstate shipment program become effective. FSIS provides for the selection of State-inspected establishments that employ, on average, more than 25 but fewer than 35 employees in the proposed implementing regulations. Thus, this proposed rule will benefit these very small and small State-inspected establishments by allowing them to ship meat and poultry products in interstate and foreign commerce, thereby opening new markets for their products. Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to VerDate Nov<24>2008 19:41 Sep 15, 2009 Jkt 217001 ensure that minorities, women, and persons with disabilities are aware of this proposed rule, FSIS will announce it online through the FSIS Web page located at https://www.fsis.usda.gov/ Regulations_&_Policies/2009_Proposed _Rules_Index/index.asp. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at https://www.fsis.usda.gov/ news_and_events/email_subscription/. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995, the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 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 E:\FR\FM\16SEP2.SGM 16SEP2 mstockstill on DSKH9S0YB1PROD with PROPOSALS2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules establishment will also be required to give the FSIS selected establishment coordinator (SEC) access to all establishment records required under the Acts and implementing regulations. Most States that have cooperative State meat or poultry products inspection programs have incorporated the Federal standards into their programs. Thus, most establishments selected to participate in the interstate shipment program are currently required to maintain records that comply with Federal standards. However, establishments located in States that have implemented recordkeeping requirements that are ‘‘at least equal to’’ but not identical to Federal requirements will need to modify their recordkeeping procedures to comply with Federal standards. All selected establishments will be required to give the FSIS SEC access to their records upon request. Estimate of Burden: FSIS estimates that 16 of the 27 States that currently have agreements for cooperative State meat or poultry products inspection programs will prepare and submit a request to FSIS to establish a cooperative interstate shipment program. The Agency also estimates that approximately 400 establishments will apply for the program. Thus, FSIS estimates that each of the 16 States mentioned above will need to prepare and submit, on average, 25 evaluations for the State-inspected establishments that have applied for, and that the State recommends, for selection into the program, for an estimated total of 400 evaluations. FSIS estimates that it will take approximately 40 hours for each State to prepare and submit a request to establish a cooperative interstate shipment program, for a total burden of 640 hours. The Agency estimates that it will take each State approximately 24 hours to prepare an evaluation of a State-inspected establishment’s qualifications to be selected for a cooperative interstate shipment program, for a total burden of 9,600 hours. FSIS estimates that if all of the 400 establishments that apply are selected for the program, approximately 100 of these establishments will need to modify their recordkeeping procedures to come into compliance with Federal standards. The extent to which these establishments will need to modify their recordkeeping procedures will depend on requirements under the State inspection program. Because recordkeeping requirements under the State inspection program must be ‘‘at least equal to’’ the Federal requirements, VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 these modifications should be minor. FSIS estimates that it will take approximately 16 hours for each establishment that is currently maintaining records under State standards to review and revise its recordkeeping procedures, and about 5 minutes for each establishment to file these records, for a total burden of approximately 1,608.3 hours. All of the estimated 400 establishments that participate in the program will be required to give the SEC access to all records required under the Federal Acts. FSIS estimates that it will take each establishment approximately 15 minute to assist the SEC to locate the necessary records for review on the initial visit, for a total burden of 100 hours. FSIS estimates that these establishments will need to spend and approximately 5 minute to assist the SEC locate records for review for each subsequent visit. If the SEC visits each selected establishment at least one a month, the total burden per establishment per year will be 1 hour, for a total estimated annual burden of 400 hours. Respondents: State agencies that administer cooperative State meat and poultry products inspection programs and State-inspected establishments selected to participate in a cooperative interstate shipment program. Estimated number of respondents: 416 (16 States and 400 State-inspected establishments). Estimated number of responses per respondent: One request to establish a cooperative interstate shipment program per State and 25 evaluations of Stateinspected establishments per State, on average. A one-time modification of records for each selected establishment whose recordkeeping does not comply with all Federal standards. One initial SEC visit in which each selected establishment will need to provide the SEC with access to all required records. Each establishment selected for the program will need to provide the FSIS access to its records on an ongoing basis. Estimated Total Annual Burden on Respondents: 12,348.3 hours to establish and implement the cooperative interstate shipment program in 16 States. Once the program has been implemented, an estimated annual burden of 400 hours for selected establishments to provide the SEC access to establishment records on-going basis. Copies of this information collection assessment can be obtained from John O’Connell, Paperwork Reduction Act Coordinator, Food Safety and Inspection Service, USDA, 1400 Independence PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 47663 Avenue, SW., Room 3532 South Building, Washington, DC 20250. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS’ functions, including whether the information will have practical utility; (b) the accuracy of FSIS’ estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both John O’Connell, Paperwork Reduction Act Coordinator, at the address provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253. To be most effective, comments should be sent to OMB within 60 days of the publication date of this proposed rule. In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or record keeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Proposed Regulations List of Subjects 9 CFR Part 321 Grant programs—agriculture, Intergovernmental relations, Meat inspection. 9 CFR Part 332 Grant programs—agriculture, Intergovernmental relations, Meat inspection. 9 CFR Part 381 Grant programs—agriculture, Intergovernmental relations, Poultry and poultry products. For the reasons discussed in the preamble, FSIS is proposing to amend 9 CFR Chapter III as follows: PART 321—COOPERATION WITH STATES AND TERRITORIES 1. The authority citation for part 321 is revised to read as follows: Authority: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. E:\FR\FM\16SEP2.SGM 16SEP2 47664 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules 2. A new § 321.3 is added to read as follows: mstockstill on DSKH9S0YB1PROD with PROPOSALS2 § 321.3 Cooperation of States for the interstate shipment of carcasses, parts of carcasses, meat, and meat food products. (a) The Administrator is authorized under 21 U.S.C. 683(b) to coordinate with States that have meat inspection programs as provided in § 321.1 of this part to select certain establishments operating under these programs to participate in a cooperative program to ship carcasses, parts of carcasses, meat, and meat food products in interstate commerce. A cooperative program for this purpose is called a ‘‘cooperative interstate shipment program.’’ (b) Establishments selected to participate in a cooperative interstate shipment program described in this section must receive inspection services from designated State personnel that have been trained in the enforcement of the Act. If the designated personnel determine that the carcasses, parts of carcasses, meat, and meat food products prepared in establishments selected to participate in the cooperative interstate shipment program comply with all requirements under the Act, these items will bear an official Federal mark of inspection and may be shipped in interstate commerce. The Administrator will assign an FSIS ‘‘selected establishment coordinator,’’ who will be an FSIS employee, to each State that participates in a cooperative interstate shipment program to provide Federal oversight of the program and enforcement of the program’s requirements. The Federal contribution for inspection services provided by States that enter into a cooperative interstate shipment program under this section will be at least 60 percent of eligible State costs. (c) Part 332 of this subchapter prescribes conditions under which States and establishments may participate in the cooperative interstate shipment program. (d) The Administrator will terminate a cooperative interstate shipment agreement with a State if the Administrator determines that the State is not conducting inspection at selected establishments in a manner that complies with the Act and the implementing regulations in this chapter. 3. A new Part 332 is added to read as follows: VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 PART 332—SELECTED ESTABLISHMENTS; COOPERATIVE PROGRAM FOR INTERSTATE SHIPMENT OF CARCASSES, PARTS OF CARCASSES, MEAT, AND MEAT FOOD PRODUCTS Sec. 332.1 Definitions. 332.2 Purpose. 332.3 Requirements for establishments; ineligible establishments. 332.4 State request for cooperative agreement. 332.5 Establishment selection; official number for selected establishments. 332.6 Commencement of a cooperative interstate shipment program; inspection by designated personnel and official mark. 332.7 Federal oversight of a cooperative interstate shipment program. 332.8 Quarterly reports. 332.9 Enforcement authority. 332.10 Deselection of ineligible establishments. 332.11 Transition to official establishments. 332.12 Transition grants. Authority: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. § 332.1 Definitions. The following definitions apply to the regulations in this part: Cooperative interstate shipment program. A cooperative meat inspection program described in § 321.3 of this subchapter. Cooperative State meat inspection program. A cooperative State-Federal meat inspection program described in § 321.1 of this subchapter. Designated personnel. State inspection personnel that have been trained in the enforcement of the Act and any additional State program requirements in order to provide inspection services to selected establishments. Interstate commerce. ‘‘Interstate commerce’’ has the same meaning as ‘‘commerce’’ under § 301.2 of this subchapter. Selected establishment. An establishment operating under a State cooperative meat inspection program that has been selected by the Administrator, in coordination with the State where the establishment is located, to participate in a cooperative interstate shipment program. § 332.2 Purpose. This part prescribes the conditions under which States that administer cooperative State meat inspection programs and establishments that operate under such programs may participate in a cooperative interstate shipment program. PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 § 332.3 Requirements for establishments; ineligible establishments. (a) An establishment that operates under a cooperative State meat inspection program may apply to participate in a cooperative interstate shipment program under this part if: (1) The establishment employs on average no more than 25 employees based on the standards described in paragraph (b) of this section, or (2) The establishment employed more than 25 employees but fewer than 35 employees as of June 18, 2008. If selected to participate in a cooperative interstate shipment program, an establishment under this paragraph must employ on average no more than 25 employees as of [insert date 3 years after effective date of final rule] or it must transition to become an official establishment as provided in § 332.11 of this part. (b) An establishment that has 25 or fewer employees based on the following standards is considered to have 25 or fewer employees on average for purposes of this part. (1) All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis are counted when calculating the total number of employees. (2) All individuals employed by the establishment from a temporary employee agency, professional employee organization, or leasing concern are counted when calculating the total number of employees. (3) The average number of employees is calculated for each of the pay periods for the preceding 12 calendar months. (4) Part-time and temporary employees are counted the same as fulltime employees. (5) If the establishment has not been in business for 12 months, the average number of employees is calculated for each of the pay periods in which the establishment has been in business. (6) Volunteers who receive no compensation are not considered employees. (7) The total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees. (c) The following establishments are ineligible to participate in a cooperative interstate shipment program: (1) Establishments that employ more than 25 employees on average (except as provided under paragraph (a)(2) of this section); (2) Establishments operating under a Federal-State program as provided in § 321.2 of this subchapter as of June 18, 2008; E:\FR\FM\16SEP2.SGM 16SEP2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules (3) Official establishments; (4) Establishments that were official establishments as of June 18, 2008, but that were re-organized on a later date by the person that controlled the establishment as of June 18, 2008; (5) Establishments operating under a cooperative State meat inspection that employed more than 35 employees as of June 18, 2008, that were reorganized on a later date by the person that controlled the establishment as of June 18, 2008; (6) Establishments that are the subject of a transition under § 332.11 of this part; (7) Establishments that are in violation of the Act; (8) Establishments located in States without a cooperative State meat inspection program; and (9) Establishments located in a State whose agreement for a cooperative interstate shipment program was terminated by the Administrator as provided in § 321.3(d) of this subchapter. (d) An establishment that meets the conditions in paragraph (a) of this section and that is not an ineligible establishment under paragraph (c) of this section may apply for selection into a cooperative interstate shipment program through the State in which the establishment is located. mstockstill on DSKH9S0YB1PROD with PROPOSALS2 § 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; VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 (ii) Notify the selected establishment coordinator for the State of the results of any laboratory analyses that indicate that a product prepared in a selected establishment may be adulterated or may otherwise present a food safety concern; and (iii) When necessary, cooperate with FSIS to transition selected establishments in the State that have been deselected from a cooperative interstate shipment program to become official establishments. (c) If the Administrator determines that a State that has submitted a request to participate in a cooperative interstate shipment program qualifies to enter into a cooperative agreement for such a program, the Administrator and the State will sign a cooperative agreement that sets forth the terms and conditions under which each party will cooperate to provide inspection services to selected establishments located in the State. (d) After the Administrator and a State have signed an agreement for a cooperative interstate shipment program as provided in paragraph (c) of this section, the Administrator will: (1) Appoint an FSIS employee as the FSIS selected establishment coordinator for the State and (2) Coordinate with the State to select establishments to participate in the program as provided in § 332.5(b) of this part. § 332.5 Establishment selection; official number for selected establishments. (a) An establishment operating under a cooperative State meat inspection program will qualify for selection into a cooperative interstate shipment program if the establishment: (1) Has submitted a request to the State to be selected for the program; (2) Has the appropriate number of employees under § 332.3(a) of this part; (3) Is not ineligible to participate in a cooperative interstate shipment program under § 332.3(c) of this part; (4) Is in compliance with all requirements under the cooperative State meat inspection program; and (5) Is in compliance with all requirements under the Act and the implementing regulations in this chapter. (b) To participate in a cooperative interstate shipment program, an establishment that meets the conditions in paragraph (a) of this section must be selected by the Administrator, in coordination with the State where the establishment is located. (c) If an establishment is selected to participate in a cooperative interstate shipment program as provided in PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 47665 paragraph (b) of this section, the State is to assign the establishment an official number that reflects the establishment’s participation in the cooperative interstate shipment program and advise the FSIS selected establishment coordinator for the State of the official number assigned to each selected establishment in the State. The official number assigned to every selected establishment must contain a suffix, e.g., ‘‘SE,’’ that identifies the establishment as a selected establishment and that identifies the State, e.g., ‘‘SETX,’’ for ‘‘selected establishment Texas.’’ (d) Failure of the State to comply with paragraph (c) of this section will disqualify the State from participation in the cooperative interstate shipment program. § 332.6 Commencement of a cooperative interstate shipment program; inspection by designated personnel and official mark. (a) A cooperative interstate shipment program will commence when the Administrator, in coordination with the State, has selected establishments in the State to participate in the program. (b) Inspection services for selected establishments participating in a cooperative interstate shipment program must be provided by designated personnel, who will be under the direct supervision of a State employee. (c) Carcasses, parts of carcasses, meat, and meat food products prepared in a selected establishment and inspected and passed by designated State personnel must bear an official Federal mark, stamp, tag, or label of inspection in the appropriate form prescribed in part 312 of this subchapter that includes the information specified in § 332.5(c) of this part. (d) Carcasses, parts of carcasses, meat, and meat food products prepared in a selected establishment that comply with the conditions in paragraph (c) of this section may be distributed in interstate commerce. § 332.7 Federal oversight of a cooperative interstate shipment program. (a) The FSIS selected establishment coordinator for a State that has entered into an agreement for a cooperative interstate shipment program will visit each selected establishment in the State on a regular basis to verify that the establishment is operating in a manner that is consistent with the Act and the implementing regulations in this chapter. If necessary, the selected establishment coordinator, in consultation with the District Manager that covers the State, may designate qualified FSIS personnel to visit a E:\FR\FM\16SEP2.SGM 16SEP2 47666 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules selected establishment on behalf of the selected establishment coordinator. (b) The selected establishment coordinator, in coordination with the State, will verify that selected establishments in the State are receiving the necessary inspection services from designated personnel, and that these establishments are eligible, and remain eligible, to participate in a cooperative interstate shipment program. The selected establishment coordinator’s verification activities may include: (1) Verifying that each selected establishment employs, and continues to employ, 25 or fewer employees, on average, as required under § 332.3(a) of this part, unless the establishment is transitioning to become an official establishment; (2) Verifying that the designated personnel are providing inspection services to selected establishments in a manner that complies with the Act and the implementing regulations in this chapter; (3) Verifying that that State staffing levels for each selected establishments are appropriate to carry out the required inspection activities; and (4) Assessing each selected establishment’s compliance with the Act and implementing regulations under this chapter. (c) If the selected establishment coordinator determines that designated personnel are providing inspection services to selected establishments in the State in a manner that is inconsistent with the Act and the implementing regulations in this chapter, the Administrator will provide an opportunity for the State to develop and implement a corrective action plan to address inspection deficiencies identified by the selected establishment coordinator. If the State fails to develop a corrective action plan, or the selected establishment coordinator for the State determines that the corrective action plan is inadequate, the Administrator will terminate the agreement for the cooperative interstate shipment program as provided in § 321.3(d) of this chapter. mstockstill on DSKH9S0YB1PROD with PROPOSALS2 § 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 VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 (2) Identify those selected establishments that the selected establishment coordinator has verified are in compliance with the Act and implementing regulations in this chapter, those that have been deselected under § 332.10 of this part, and those that are transitioning to become official establishments under § 332.11 of this part. (c) The selected establishment coordinator is to submit the quarterly report to the Administrator through the District Manager for the State where the selected establishments identified in the report are located. § 332.9 Enforcement authority. (a) To facilitate oversight and enforcement of this part, selected establishments operating under a cooperative interstate shipment program must, upon request, give the FSIS selected establishment coordinator or other FSIS officials access to all establishment records required under the Act and the implementing regulations in this chapter. The Administrator may deselect any selected establishment that refuses to comply with this paragraph. (b) Selected establishment coordinators may initiate any appropriate enforcement action provided for in part 500 of this chapter if they determine that a selected establishment under their jurisdiction is operating in manner that is inconsistent with the Act and the implementing regulations in this chapter. Selected establishments participating in a cooperative interstate shipment program are subject to the notification and appeal procedures set out in part 500 of this chapter. (c) If inspection at a selected establishment is suspended for any of the reasons specified in § 500.3 or § 500.4 of this chapter, FSIS will: (1) Provide an opportunity for the establishment to implement corrective actions and remain in the cooperative interstate shipment program, or (2) Move to deselect the establishment as provided in § 332.10 of this part. (d) The decision to deselect a selected establishment under a suspension will be made on a case-by-case basis. In making this decision, FSIS, in consultation with the State where the selected establishment is located, will consider, among other factors: (1) The non-compliance that led to the suspension; (2) The selected establishment’s compliance history; and (3) The corrective actions proposed by the selected establishment. PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 § 332.10 Deselection of ineligible establishments. (a) The Administrator will deselect a selected establishment that becomes ineligible to participate in a cooperative interstate shipment program for any reason listed under § 332.3(c) of this part. (b) An establishment that has been deselected must transition to become an official establishment as provided in § 332.11 of this part. § 332.11 Transition to official establishment. If an establishment is deselected from a cooperative interstate shipment program as provided in § 332.10 of this part, FSIS, in coordination with the State where the establishment is located, will develop and implement a plan to transition the establishment to become an official establishment. § 332.12 Transition grants. (a) Transition grants are funds that a State participating in a cooperative interstate shipment program under this part may apply for to reimburse selected establishments in the State for the cost to train one individual in the seven HACCP principles for meat or poultry processing as required under § 417.7 of this chapter and associated training in the development of sanitation standard operating procedures required under part 416 of this chapter. (b) A State participating in a cooperative interstate shipment program that receives a transition grant must use grant funds to reimburse the training costs of one employee per each selected establishment in the State. Any other use of such funds is prohibited. PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS 4. The authority citation for part 381 continues to read as follows: Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451–470; 7 CFR 2.7, 2.18, 2.53. 5. A new § 381.187 is added to subpart R to read as follows: § 381.187 Cooperation of States for the interstate shipment of poultry products. (a) The Administrator is authorized under 21 U.S.C. 472(b) to coordinate with States that have poultry products inspection programs as provided in § 381.185 of this subpart to select certain establishments operating under these programs to participate in a cooperative program to ship poultry products in interstate commerce. A cooperative program for this purpose is called a ‘‘cooperative interstate shipment program.’’ E:\FR\FM\16SEP2.SGM 16SEP2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules mstockstill on DSKH9S0YB1PROD with PROPOSALS2 (b) Establishments selected to participate in a cooperative interstate shipment program described in this section must receive inspection services from designated State personnel that have been trained in the enforcement of the Act. If the designated personnel determine that the poultry products prepared in establishments selected to participate in the cooperative interstate shipment program comply with all requirements under the Act, these items will bear an official Federal mark of inspection and may be shipped in interstate commerce. The Administrator will assign an FSIS ‘‘selected establishment coordinator,’’ who will be an FSIS employee, to each State that participates in a cooperative interstate shipment program to provide Federal oversight of the program and enforcement of the program’s requirements. The Federal contribution for inspection services provided by States that enter into a cooperative interstate shipment program under this section will be at least 60 percent of eligible State costs. (c) Subpart Z, of this part 381 prescribes conditions under which States and establishments may participate in the cooperative interstate shipment program. (d) The Administrator will terminate a cooperative interstate shipment agreement with a State if the Administrator determines that the State is not conducting inspection at selected establishments in a manner that complies with the Act and the implementing regulations in this chapter. 5. A new subpart Z is added to part 381 to read as follows: Subpart Z—Selected Establishments; Cooperative Program for Interstate Shipment of Poultry Products Subpart Z—Selected Establishments; Cooperative Program for Interstate Shipment of Poultry Products Sec. 381.511 Definitions. 381.512 Purpose. 381.513 Requirements for establishments; ineligible establishments. 381.514 State request for cooperative agreement. 381.515 Establishment selection; official number for selected establishments. 381.516 Commencement of a cooperative interstate shipment program; inspection by designated personnel and official mark. 381.517 Federal oversight of a cooperative interstate shipment program. 381.518 Quarterly reports. 381.519 Enforcement authority. 381.520 Deselection of ineligible establishments. 381.521 Transition to official establishment. 381.522 Transition grants. (a) An establishment that operates under a cooperative State poultry products inspection program may apply to participate in a cooperative interstate shipment program under this subpart if: (1) The establishment employs on average no more than 25 employees based on the standards described in paragraph (b) of this section, or (2) The establishment employed more than 25 employees but fewer than 35 employees as of June 18, 2008. If selected to participate in a cooperative interstate shipment program, an establishment under this paragraph must employ on average no more than 25 employees as of [insert date 3 years after effective date of final rule] or it must transition to become an official establishment as provided in § 381.521 of this subpart. (b) An establishment that has 25 or fewer employees based on the following VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 § 381.511 Definitions. The following definitions apply to the regulations in this part: Cooperative interstate shipment program. A cooperative poultry products inspection program described in § 381.187 of this part. Cooperative State poultry products inspection program. A cooperative State-Federal poultry products inspection program described in § 381.185 of this part. Designated personnel. State inspection personnel that have been trained in the enforcement of Act and any additional State program requirements in order to provide inspection services to selected establishments. Interstate commerce. ‘‘Interstate commerce’’ has the same meaning as ‘‘commerce’’ under § 381.1 of this part. Selected establishment. An establishment operating under a State cooperative poultry products inspection program that has been selected by the Administrator, in coordination with the State where the establishment is located, to participate in a cooperative interstate shipment program. § 381.512 Purpose. This subpart Z prescribes the conditions under which States that administer cooperative State poultry products inspection programs and establishments that operate under such programs may participate in a cooperative interstate shipment program. § 381.513 Requirements for establishments; ineligible establishments. PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 47667 standards is considered to have 25 or fewer employees on average for purposes of this subpart. (1) All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis are counted when calculating the total number of employees. (2) All individuals employed by the establishment from a temporary employee agency, professional employee organization, or leasing concern are counted when calculating the total number of employees. (3) The average number of employees is calculated for each of the pay periods for the preceding 12 calendar months. (4) Part-time and temporary employees are counted the same as fulltime employees. (5) If the establishment has not been in business for 12 months, the average number of employees is calculated for each of the pay periods in which the establishment has been in business. (6) Volunteers who receive no compensation are not considered employees. (7) The total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees. (c) The following establishments are ineligible to participate in a cooperative interstate shipment program: (1) Establishments that employ more than 25 employees on average (except as provided under paragraph (a)(2) of this section); (2) Establishments operating under a Federal-State program as provided in § 381.186 of this part as of June 18, 2008; (3) Official establishments; (4) Establishments that were official establishments as of June 18, 2008, but that were re-organized on a later date by the person that controlled the establishment as of June 18, 2008; (5) Establishments operating under a cooperative State poultry products inspection program that employed more than 35 employees as of June 18, 2008, that were reorganized on a later date by the person that controlled the establishment as of June 18, 2008; (6) Establishments that are the subject of a transition under § 381.521 of this subpart; (7) Establishments that are in violation of the Act; and (8) Establishments located in States without a cooperative State poultry products inspection program. (9) Establishments located in a State whose agreement for a cooperative interstate shipment program was terminated by the Administrator as provided in § 381.187(d) of this part. E:\FR\FM\16SEP2.SGM 16SEP2 47668 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules (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. mstockstill on DSKH9S0YB1PROD with PROPOSALS2 § 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. VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 (d) After the Administrator and a State have signed an agreement for a cooperative interstate shipment program as provided in paragraph (c) of this section, the Administrator will: (1) Appoint an FSIS employee as the FSIS selected establishment coordinator for the State and (2) Coordinate with the State to select establishments to participate in the program as provided in § 381.515(b) of this subpart. § 381.515 Establishment selection; official number for selected establishments. (a) An establishment operating under a cooperative State poultry products inspection program will qualify for selection into a cooperative interstate shipment program if the establishment: (1) Has submitted a request to the State to be selected for the program; (2) Has the appropriate number of employees under § 381.513(a) of this subpart; (3) Is not ineligible to participate in a cooperative interstate shipment program under § 381.513(c) of this subpart; (4) Is in compliance with all requirements under the cooperative State poultry products inspection program; and (5) Is in compliance with all requirements under the Act and the implementing regulations in this chapter. (b) To participate in a cooperative interstate shipment program, an establishment that meets the conditions in paragraph (a) of this section must be selected by the Administrator, in coordination with the State where the establishment is located. (c) If an establishment is selected to participate in a cooperative interstate shipment program as provided in paragraph (b) of this section, the State is to assign the establishment an official number that reflects the establishment’s participation in the cooperative interstate shipment program and advise the FSIS selected establishment coordinator for the State of the official number assigned to each selected establishment in the State. The official numbers assigned to every selected establishment must contain a suffix, e.g., ‘‘SE,’’ that identifies the establishment as a selected establishment; that includes the letter ‘‘P,’’ which identifies the establishment as a poultry establishment; and that identifies the State, e.g., ‘‘SEPND,’’ for ‘‘selected establishment poultry North Dakota.’’ (d) Failure of a State to comply with paragraph (c) of this section will disqualify the State from participation PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 in the cooperative interstate shipment program. § 381.516 Commencement of a cooperative interstate shipment program; inspection by designated personnel and official mark. (a) A cooperative interstate shipment program will commence when the Administrator, in coordination with the State, has selected establishments in the State to participate in the program. (b) Inspection services for selected establishments participating in a cooperative interstate shipment program must be provided by designated personnel, who will be under the direct supervision of a State employee. (c) Poultry products processed in a selected establishment and inspected and passed by designated State personnel must bear an official Federal mark, stamp, tag, or label of inspection in the appropriate form prescribed in subpart M of this part that includes the information specified in § 381.515(c) of this subpart. (d) Poultry products processed in a selected establishment that comply with the conditions in paragraph (c) of this section may be distributed in interstate commerce. § 381.517 Federal oversight of a cooperative interstate shipment program. (a) The FSIS selected establishment coordinator for a State that has entered into an agreement for a cooperative interstate shipment program will visit each selected establishment in the State on a regular basis to verify that the establishment is operating in a manner that is consistent with the Act and the implementing regulations in this chapter. If necessary, the selected establishment coordinator, in consultation with the District Manager that covers the State, may designate qualified FSIS personnel to visit a selected establishment on behalf of the selected establishment coordinator. (b) The selected establishment coordinator, in coordination with the State, will verify that selected establishments in the State are receiving the necessary inspection services from designated personnel, and that these establishments are eligible, and remain eligible, to participate in a cooperative interstate shipment program. The selected establishment coordinator’s verification activities may include: (1) Verifying that each selected establishment employs, and continues to employ, 25 or fewer employees, on average, as required under §§ 381.513(a) of this part, unless the establishment is transitioning to become an official establishment; E:\FR\FM\16SEP2.SGM 16SEP2 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Proposed Rules (2) Verifying that the designated personnel are providing inspection services to selected establishments in a manner that complies with the Act and the implementing regulations in this chapter; (3) Verifying that that State staffing levels for each selected establishment are appropriate to carry out the required inspection activities; and (4) Assessing each selected establishment’s compliance with the Act and implementing regulations in this chapter. (c) If the selected establishment coordinator determines that designated personnel are providing inspection services to selected establishments in the State in a manner that is inconsistent with the Acts and the implementing regulations in this chapter, the Administrator will provide an opportunity for the State to develop and implement a corrective action plan to address inspection deficiencies identified by the selected establishment coordinator. If the State fails to develop a corrective action plan, or the selected establishment coordinator for the State determines that the corrective action plan is inadequate, the Administrator will terminate the agreement for the cooperative interstate shipment program as provided in § 381.187(d) of this part. § 381.518 Quarterly reports. mstockstill on DSKH9S0YB1PROD with PROPOSALS2 (a) The selected establishment coordinator will prepare a report on a quarterly basis that describes the status of each selected establishment under his or her jurisdiction. (b) The quarterly report required in paragraph (a) of this section will: (1) Include the selected establishment coordinator’s assessment of the performance of the designated personnel in conducting inspection activities at selected establishments and (2) Identify those selected establishments that the selected establishment coordinator has verified are in compliance with the Act and implementing regulations in this chapter, those that have been deselected under § 381.520 of this subpart, and those that are transitioning to become VerDate Nov<24>2008 17:58 Sep 15, 2009 Jkt 217001 official establishments under § 381.521 of this subpart. (c) The selected establishment coordinator is to submit the quarterly report to the Administrator through the District Manager for the State where the selected establishments identified in the report are located. § 381.519 Enforcement authority. (a) To facilitate oversight and enforcement of this subpart, selected establishments operating under a cooperative interstate shipment program must, upon request, give the FSIS selected establishment coordinator or other FSIS officials access to all establishment records required under the Act and the implementing regulations in this chapter. The Administrator may deselect any selected establishment that refuses to comply with this paragraph. (b) Selected establishment coordinators may initiate any appropriate enforcement action provided for in part 500 of this chapter if they determine that a selected establishment under their jurisdiction is operating in manner that is inconsistent with the Act and the implementing regulations in this chapter. Selected establishments participating in a cooperative interstate shipment program are subject to the notification and appeal procedures set out in part 500 of this chapter. (c) If inspection at a selected establishment is suspended for any of the reasons specified in § 500.3 or § 500.4 of this chapter, FSIS will: (1) Provide an opportunity for the establishment to implement corrective actions and remain in the cooperative interstate shipment program, or (2) Move to deselect the establishment as provided in § 381.520 of this subpart. (d) The decision to deselect a selected establishment under a suspension will be made on a case-by-case basis. In making this decision, FSIS, in consultation with the State where the selected establishment is located, will consider, among other factors: (1) The non-compliance that led to the suspension; PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 47669 (2) The selected establishment’s compliance history; and (3) The corrective actions proposed by the selected establishment. § 381.520 Deselection of ineligible establishments. (a) The Administrator will deselect a selected establishment that becomes ineligible to participate in a cooperative interstate shipment program for any reason listed under § 381.513(c) of this subpart. (b) An establishment that has been deselected must transition to become an official establishment as provided in § 381.521 of this subpart. § 381.521 Transition to official establishment. If an establishment is deselected from a cooperative interstate shipment program as provided in § 381.520 of this subpart, FSIS, in coordination with the State where the establishment is located, will develop and implement a plan to transition the establishment to become an official establishment. § 381.522 Transition grants. (a) Transition grants are funds that a State participating in a cooperative interstate shipment program under this subpart may apply for to reimburse selected establishments in the State for the cost to train one individual in the seven HACCP principles for meat or poultry processing as required under § 417.7 of this chapter and associated training in the development of sanitation standard operating procedures required under part 416 of this chapter. (b) A State participating in a cooperative interstate shipment program that receives a transition grant must use grant funds to reimburse the training costs of one employee per each selected establishment in the State. Any other use of such funds is prohibited. Done at Washington, DC, on September 7, 2009. Alfred V. Almanza, Administrator. [FR Doc. E9–21952 Filed 9–14–09; 11:15 am] BILLING CODE 3410–DM–P E:\FR\FM\16SEP2.SGM 16SEP2

Agencies

[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Proposed Rules]
[Pages 47648-47669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21952]



[[Page 47647]]

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Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Parts 321, 332, and 381



Cooperative Inspection Programs: Interstate Shipment of Meat and 
Poultry Products; Proposed Rule

Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / 
Proposed Rules

[[Page 47648]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 321, 332, and 381

[Docket No. FSIS-2008-0039]
RIN 0583-AD37


Cooperative Inspection Programs: Interstate Shipment of Meat and 
Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing 
regulations to implement a new voluntary cooperative program under 
which State-inspected establishments with 25 or fewer employees will be 
eligible to ship meat and poultry products in interstate commerce. In 
participating States, State-inspected establishments selected to take 
part in this program will be required to comply with all Federal 
standards under the Federal Meat Inspection Act (FMIA) and the Poultry 
Products Inspection Act (PPIA), as well as with all State standards. 
These establishments will receive inspection services from State 
inspection personnel that have been trained in the enforcement of the 
FMIA and PPIA. Meat and poultry products produced under the program 
that have been inspected and passed by designated State personnel will 
bear an official Federal mark of inspection and will be permitted to be 
distributed in interstate commerce. FSIS will provide oversight and 
enforcement of the program.
    FSIS is proposing these regulations in response to the Food, 
Conservation, and Energy Act, enacted on June 18, 2008. Section 11015 
of the law amended the FMIA and PPIA to provide for these cooperative 
programs.

DATES: Submit comments on or before November 16, 2009.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by either of the following 
methods:
    Federal eRulemaking Portal: Go to https://www.regulations.gov and 
follow the online instructions at that site for submitting comments.
    Mail, including floppy disks or CD-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 2-2127 George Washington 
Carver Center, 5601 Sunnyside Avenue, Beltsville, MD 20705.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2008-0039. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to: https://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at the address listed above between 8:30 a.m. 
and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Philip Derfler, Assistant 
Administrator, Office of Policy and Program Development, Room 350-E, 
Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington, 
DC 20250; Telephone (202) 720-2709, Fax (202) 720-2025.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Federal-State Cooperative Inspection Programs

    FSIS has been delegated the authority to carry out the functions of 
the Secretary of Agriculture as provided in the Federal Meat Inspection 
Act (FMIA) (21 U.S.C. 601, et seq.) and the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451, et seq.). These statutes mandate that FSIS 
protect the public by ensuring that meat and poultry products are safe, 
wholesome, unadulterated, and properly labeled and packaged.
    The FMIA and the PPIA (``the Acts'') provide for FSIS to cooperate 
with State agencies in developing and administering their own meat or 
poultry inspection programs (21 U.S.C. 661 and 454). The FMIA and the 
PPIA restrict each cooperative State meat or poultry products 
inspection program to the inspection and regulation of products that 
are produced and sold within the State (21 U.S.C. 661(a)(1) and 
454(a)(1)). Under section 661 of the FMIA and section 454 of the PPIA, 
cooperative State inspection programs are required to operate in a 
manner and with authorities ``at least equal to'' the provisions set 
out in the Acts (21 U.S.C. 661(a)(1) and 454(a)(1)).
    The Acts provide for FSIS to contribute up to 50 percent of the 
cost of the cooperative State inspection programs, as long as the State 
programs are effectively enforcing requirements that are ``at least 
equal to'' the Federal program (21 U.S.C. 661(a)(3) and 454(a)(3)). 
States that have enacted a mandatory State meat or poultry inspection 
law must apply to FSIS to enter into a cooperative State inspection 
program agreement with the Agency.
    If a State is unable or unwilling to continue to operate a 
cooperative State inspection program on an ``at least equal to'' basis, 
FSIS designates the State as not having an ``at least equal to'' 
program by publishing this designation in the Federal Register. After 
the expiration of thirty days of such publication, the State 
establishments are subject to Federal inspection (21 U.S.C. 661(c)(1) 
and 454(c)(1)).
    The Talmadge-Aiken Act authorizes the Secretary of Agriculture to 
enter into cooperative arrangements with State departments of 
agriculture and other State agencies to assist the Secretary in the 
enforcement of relevant Federal laws and regulations to the extent and 
in the manner appropriate to the public interest (7 U.S.C. 450). 
Pursuant to the Talmadge-Aiken Act, FSIS enters into a separate 
agreement with a State agency for the State program to conduct meat, 
poultry, or egg products inspection or other regulatory activities on 
behalf of FSIS. FSIS provides 50 percent funding to the State programs 
for these services.

B. The Food, Conservation, and Energy Act of 2008

    On June 18, 2008, Congress enacted The Food, Conservation, and 
Energy Act of 2008 (also referred to as ``the 2008 Farm Bill'') (Pub. 
L. 110-246, 112 Stat. 1651). Section 11015 of Title XI of the 2008 Farm 
bill amended the FMIA to add a new title V--``Inspections by Federal 
and State Agencies,'' which contains a new section 501, ``Interstate 
Shipment of Meat Inspected by Federal and State Agencies for Certain 
Small Establishments (122 Stat. 2124; codified at 21 U.S.C. 683). 
Section 11015 also amended the PPIA to add a new section 31, 
``Interstate Shipment of Poultry Inspected by Federal and State 
Agencies for Certain Small Establishments'' (122 Stat. 2127; codified 
at 21 U.S.C. 472). These new sections supplement the existing 
cooperative State meat and poultry inspection programs by establishing 
a new cooperative program under which certain State-inspected 
establishments would be permitted to ship meat and poultry products in 
interstate commerce.
    The new law provides that the Secretary of Agriculture, ``in 
coordination with the appropriate State agency of the State in which 
the establishment is located,'' may select State-inspected 
establishments with 25 or fewer employees to ship meat and poultry 
products interstate (Sec. 501(b) and Sec. 31(b)). Inspection services 
for these establishments must be provided by State inspection personnel 
that have

[[Page 47649]]

``undergone all necessary inspection training and certification to 
assist the Secretary with the administration and enforcement of [the 
FMIA or PPIA]'' (Sec. 501(a)(2) and Sec. 31(a)(2)). Meat and poultry 
products inspected and passed by these State inspection personnel would 
bear a ``Federal mark, stamp, tag, or label of inspection'' (Sec. 
501(b)(1) and Sec. 31(b)(1)). The law provides for the Secretary to 
``designate an employee of the Federal government'' to ``provide 
oversight and enforcement'' of the program (Sec. 501(d)(1) and Sec. 
31(d)(1)).
    The law is to take effect ``on the date on which the Secretary * * 
* promulgates final regulations to carry out [section 11015]'' (Sec. 
501(j)(1) and Sec. 31(i)(1)). The law requires that the Secretary 
promulgate final regulations ``not later than 18 months after the date 
of enactment'' (Sec. 501(j)(2) and Sec. 31(i)(2)).
    FSIS is issuing this proposed rule to implement section 11015 of 
the 2008 Farm Bill. Following is a summary of the provisions of section 
11015 that are addressed in this proposed rule.
    Selected establishments. The law applies to certain establishments 
that are already operating under a cooperative State meat or poultry 
inspection program. The law defines an ``eligible establishment'' as 
``an establishment that is in compliance with * * * the State 
inspection program of the State in which the establishment is located'' 
and the Acts, including the rules and regulations issued under the Acts 
(Sec. 501(a)(3) and Sec. 31(a)(3)). A ``selected establishment'' is 
defined as ``an establishment that is authorized by the Secretary, in 
coordination with * * * the appropriate State agency of the State in 
which the establishment is located * * * to ship [meat or poultry] 
items in interstate commerce'' (Sec. 501(a)(5) and Sec. 31(a)(5)).
    The law prohibits the Secretary from selecting an establishment for 
interstate shipment that ``on average, employs more than 25 employees 
(including supervisory and nonsupervisory employees), as defined by the 
Secretary'' (Sec. 501(b)(2)(A) and Sec. 31(b)(2)(A)). The law also 
prohibits the selection of establishments that currently ship 
interstate, as well as certain former and future Federal establishments 
(Sec. 501(b)(2)(B), Sec. 501(b)(2)(C), Sec. 31(b)(2)(B), and Sec. 
31(b)(2)(C)).
    Transition to a Federal establishment. The law permits the 
Secretary to select establishments with ``more than 25 employees but 
less than 35 employees'' to participate in the program (Sec. 
501(b)(3)(B)(i) and Sec. 31(b)(3)(B)(i)). However, if selected, these 
establishments must transition to Federal establishments ``beginning on 
the date that is 3 years after the effective date'' if they 
consistently employ, on average, more than 25 employees (Sec. 
501(b)(3)(B)(ii) and Sec. 31(b)(3)(B)(ii)). The law authorizes the 
Secretary to develop a procedure to transition certain selected 
establishments to a Federal establishment (Sec. 501(b)(3)(A) and Sec. 
31(b)(3)(A)). The law also requires that ``[a]ny selected establishment 
that the Secretary determines to be in violation of any requirement of 
the Act, be transitioned to a Federal establishment'' (Sec. 501(h) and 
Sec. 31(g)).
    Federal-State coordination. Under the law, the Secretary is 
authorized to designate a Federal employee as ``State coordinator'' for 
each State to ``provide oversight and enforcement'' of the interstate 
shipment program and to ``oversee the training and inspection 
activities'' of the State personnel providing inspection services to 
selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)). The law 
provides that if the State coordinator determines that a selected 
establishment under the State coordinator's jurisdiction is in 
violation of the Acts, the State coordinator must ``immediately notify 
the Secretary of the violation'' and ``deselect the selected 
establishment or suspend inspection at the selected establishment'' 
(Sec. 501(d)(3)(C) and Sec. 31(d)(3(C)).
    This proposed rule refers to the ``State coordinator'' established 
in section 11015 of the 2008 Farm Bill as the FSIS ``selected 
establishment coordinator'' to maintain consistency with the other 
terminology in this proposed rule and to make clear that the ``State 
coordinator'' is a Federal employee. The term ``State coordinator'' is 
often used to refer to a State employee under the Talmadge-Aiken 
program, so FSIS has tentatively decided not to use this term in these 
proposed regulations.
    Federal reimbursement of State costs. The law requires that the 
Secretary ``reimburse a State for costs related to the inspection of 
selected establishments * * * in an amount of not less than 60 percent 
of eligible State costs'' (Sec. 501(c) and Sec. 31(c)).
    Inspection training division. The law amended the FMIA to provide 
that not later than 180 days after the effective date of section 11015 
of the 2008 Farm Bill, the Secretary shall establish in FSIS an 
inspection training division to provide outreach, education, and 
training to, and provide grants to appropriate State agencies to 
provide outreach, technical assistance, education, and training to 
small and very small establishments (as defined by the Secretary) (Sec. 
501(f)). FSIS implemented this provision by establishing an Office of 
Outreach, Education and Training. A substantive part of the program's 
function is to provide training, education, and outreach services to 
small and very small plants.
    Transition grants. The law permits the Secretary to provide grants 
to States to assist them in helping establishments operating under a 
cooperative State meat or poultry inspection program transition to 
selected establishments (Sec. 501(g) and Sec. 31(f)).

II. The Proposed Rule

A. General

    FSIS is proposing to amend 9 CFR part 321 of the Federal meat 
inspection regulations and 9 CFR part 381, subpart R, of the poultry 
products inspection regulations to add new sections that describe the 
cooperative interstate shipment program established in section 11015 of 
the 2008 Farm Bill. FSIS is also proposing to add a new 9 CFR part 332 
to the Federal meat inspection regulations and a new 9 CFR part 381, 
subpart Z, to the poultry products inspection regulations that 
prescribe the conditions under which States and establishments 
operating under a State-inspection program will be permitted to 
participate in a cooperative interstate shipment program.
    When FSIS completes the rulemaking process and issues a final rule, 
the Federal meat and poultry products regulations will provide for 
three separate cooperative State meat and poultry products inspection 
programs: (1) Cooperative State meat or poultry products inspection 
programs under the FMIA and PPIA; (2) cooperative agreements for State 
programs to conduct meat or poultry products inspection or other 
regulatory activities on behalf of the Agency under the Talmadge-Aiken 
Act; and (3) cooperative programs for the interstate shipment of State-
inspected meat and poultry products under the FMIA and PPIA as amended 
by section 11015 of the 2008 Farm Bill.
    The proposed regulations to implement section 11015 are described 
in detail below.

B. Description of Cooperative Programs--9 CFR Part 321 and 9 CFR Part 
381, Subpart R

    9 CFR part 321 of the Federal meat inspection regulations and 9 CFR 
part 381, subpart R, of the poultry products inspection regulations 
describe

[[Page 47650]]

cooperative meat and poultry products inspection programs authorized 
under the FMIA, PPIA, and the Talmadge-Aiken Act. These regulations 
reference the legal authority for each cooperative inspection program 
and provide a general description of each program. FSIS is proposing to 
amend part 321 and part 381, subpart R, to add a new Sec.  321.3 and a 
new Sec.  381.187 to describe the cooperative interstate shipment 
program established under section 11015 of the 2008 Farm Bill.
    The amendments to the FMIA in section 501 of section 11015 of the 
2008 Farm Bill have been codified at 21 U.S.C. 683, and the amendments 
to the PPIA in section 31 have been codified at 21 U.S.C. 472 (122 
Stat. 2124, 2127). Therefore, proposed Sec.  321.3(a) provides that 
under 21 U.S.C. 683(b), FSIS is authorized to coordinate with States 
that have cooperative State meat inspection programs to select certain 
establishments operating under these programs to ship carcasses, parts 
of carcasses, meat, and meat food products in interstate commerce. 
Similarly, proposed Sec.  381.187(a) provides that under 21 U.S.C. 
472(b), FSIS is authorized to coordinate with States that have 
cooperative State poultry products inspection programs to select 
certain establishments operating under these programs to ship poultry 
products in interstate commerce. Proposed Sec. Sec.  321.3(a) and 
381.187(a) both explain that this type of cooperative program is called 
a ``cooperative interstate shipment program.''
    Proposed Sec. Sec.  321.3(b) and 381.187(b) contain a general 
description of the cooperative interstate shipment program and make 
clear that the Federal contribution for inspection services provided by 
States that have entered into such a program will be at least 60 
percent of eligible State costs. Under the FMIA and PPIA, FSIS is 
required to contribute up to 50 percent of the cost of a cooperative 
State meat or poultry products inspection program (21 U.S.C. 661(a)(3) 
and 454(a)(3)). Thus, States that participate in the new cooperative 
interstate shipment program will receive additional reimbursement for 
costs related to inspection of selected establishments in the State.
    As required under the statute, the Federal contribution for 
inspection services provided by States that enter into a cooperative 
interstate shipment program under this proposal will be at least 60 
percent of eligible State costs. When the program is implemented, FSIS 
does not intend to reimburse States for more than 60 percent of their 
eligible costs unless Congress directs it, and provides the money for 
it, to do so.
    To be reimbursed under this proposed rule, States will be expected 
to submit their budgets for their cooperative interstate shipment 
programs to FSIS for approval prior to receiving Federal funds. States 
will also be expected to submit a separate justification for any costs 
related to the cooperative interstate shipment program that were not 
included in their initial budget request. FSIS will also need to 
approve a State's request for additional funds before the Agency will 
reimburse the State for not less than 60% of the cost. FSIS has 
tentatively decided that, for purposes of this proposed rule, eligible 
State costs will be those costs that a State has justified and FSIS has 
approved as necessary for the State to provide inspection services to 
selected establishments in the State. The Agency requests comments on 
whether the final rule resulting from this proposal should codify this 
definition or any other requirements related to State reimbursement for 
eligible costs related to inspection of selected establishments.
    Proposed Sec. Sec.  321.3(c) and 381.187(c) identify 9 CFR part 332 
and 9 CFR part 381, subpart Z, as the regulations that prescribe 
conditions under which States and establishments may participate in the 
cooperative interstate shipment program. Proposed Sec. Sec.  321.3(d) 
and 381.187(d) provide that the Administrator will terminate an 
agreement for a cooperative interstate shipment program with a State if 
the Administrator determines that the State is not conducting 
inspection at selected establishments in a manner that complies with 
the Acts and their implementing regulations.

C. Requirements for a Cooperative Interstate Shipment Program--9 CFR 
Part 332 and 9 CFR 381 Subpart Z

1. General
    FSIS is proposing to amend title 9, Chapter III, Subchapter A of 
the Code of Federal Regulations (CFR) to add a new part 332 titled 
``Selected Establishments; Cooperative Program for Interstate Shipment 
of Carcasses, Parts of Carcasses, Meat, and Meat Food Products,'' and 
to add to part 381 a new subpart Z titled ``Selected Establishments; 
Cooperative Program for Interstate Shipment of Poultry Products.'' The 
regulations in the proposed new part 332 and the proposed new subpart Z 
prescribe the requirements for a cooperative interstate shipment 
program.
2. Definitions and Purpose
    Proposed Sec. Sec.  332.1 and 381.511 define the terms 
``cooperative interstate shipment program,'' ``cooperative State meat 
inspection program,'' ``cooperative State poultry products inspection 
program,'' ``selected establishment,'' and ``designated personnel.'' 
Terms used in the proposed regulations that are defined in 9 CFR 301.2 
and 9 CFR 381.1 retain their same meaning.
    Under proposed Sec. Sec.  332.1 and 381.511, ``cooperative 
interstate shipment program,'' ``cooperative State meat inspection 
program,'' and ``cooperative poultry products inspection program'' are 
defined by providing a cross-reference to the description of these 
cooperative programs in 9 CFR part 321 and 9 CFR part 381 subpart R, 
described above. Under this proposal, ``selected establishment'' is 
defined as ``an establishment operating under a State cooperative [meat 
or poultry products] inspection program that has been selected by the 
Administrator, in coordination with the State where the establishment 
is located, to participate in a cooperative interstate shipment 
program.''
    FSIS is proposing to define ``designated personnel'' as ``State 
inspection personnel that have been trained in the enforcement of the 
Acts and any additional State program requirements in order to provide 
inspection services to selected establishments.''
    In addition to proposing new definitions, proposed Sec. Sec.  332.1 
and 381.511 make clear that the term ``interstate commerce,'' as used 
in the proposed regulations has the same meaning as ``commerce'' under 
9 CFR 301.2 and 381.1. The regulations in 9 CFR 301.2 and 381.1 define 
``commerce'' as ``[c]ommerce between any State, any Territory, or the 
District of Columbia, and any place outside thereof * * *.'' Thus, 
under this proposal, State-inspected establishments that are selected 
to participate in a cooperative interstate shipment program will be 
permitted to distribute and sell meat or poultry products across State 
lines and to export these products to foreign countries.
    Proposed Sec. Sec.  332.2 and 381.512 state that the purpose of 
part 332 and part 381, subpart Z, is to prescribe the conditions under 
which States that administer cooperative State meat or poultry products 
inspection programs and establishments that operate under such programs 
may participate in a cooperative interstate shipment program.
3. Requirements for Establishments
    The proposed regulations in Sec. Sec.  332.3 and 381.513 prescribe 
conditions that establishments operating under a

[[Page 47651]]

cooperative State meat or poultry products inspection program must 
comply with in order to apply to participate in a cooperative 
interstate shipment program. Proposed Sec. Sec.  332.3 and 381.513 also 
describe establishments that are ineligible to be selected for such a 
program.
    Number of employees. Under proposed Sec. Sec.  332.3(a)(1) and 
381.513(a)(1), an establishment operating under a cooperative State 
meat or poultry products inspection program may apply to participate in 
a cooperative interstate shipment program if the establishment employs, 
on average, no more than 25 employees. Standards for determining the 
average number of employees for purposes of this proposal are described 
in proposed Sec. Sec.  332.3(b) and 381.513(b) below.
    Under proposed Sec. Sec.  332.3(a)(2) and 381.513(a)(2), 
establishments that employed more than 25 but fewer than 35 employees 
as of June 18, 2008, are also permitted to apply for a cooperative 
interstate shipment program. However, Sec. Sec.  332.3(a)(2) and 
381.513(a)(2) provide, reflecting the amended FMIA and PPIA, that if 
selected, these establishments must employ, on average, 25 or fewer 
employees as of the date three years from the date that the final rule 
resulting from this proposal becomes effective. If they do not, 
proposed Sec. Sec.  332.3(a)(2) and 381.513(a)(2) require that they be 
deselected from the program and transition to become official 
establishments.
    Standards for determining number of employees. Proposed Sec. Sec.  
332.3(b) and 381.513(b) establish standards for determining whether an 
establishment employs, on average, 25 or fewer employees for purposes 
of this proposed rule. FSIS developed these proposed standards to carry 
out Congress' intent that ``[t]he term `average' should be interpreted 
to provide some flexibility to these selected establishments that 
require seasonal employees for certain parts of the year, as long as 
the increase in employees are [sic] manageable by the establishment and 
the increase * * * does not undermine food safety standards'' (S. Rep. 
No. 220, 110th Cong., 1st Sess., at 211 (2007)).
    For the most part, the proposed standards in Sec. Sec.  332.3(b) 
and 381.513(b) reflect applicable methods used by the Small Business 
Administration (SBA) to calculate the number of employees of a business 
concern where the size standard is number of employees (13 CFR 121.105 
and 121.106). In addition, as explained below, FSIS is also proposing 
to limit the total number of employees at any given time to 35 
individuals. Under this proposal, the standards developed by FSIS will 
apply to the employees of an individual establishment. The proposed 
standards are as follows:
     All individuals, both supervisory and non-supervisory, 
employed by the establishment on a full-time, part-time, or temporary 
basis are to be counted when calculating the total number of employees;
     All individuals employed from a temporary employee agency, 
professional employee organization, or leasing concern are to be 
counted;
     The average number of employees is calculated for each of 
the pay periods for the preceding calendar year;
     Part-time and temporary employees are to be counted the 
same as full-time employees;
     If an establishment has not been in business for 12 
months, the average number of employees is calculated for the pay 
periods in which the establishment has been in business;
     Volunteers who receive no compensation are not considered 
employees; and
     The total number of employees can never exceed 35 
individuals at any given time, regardless of the average number of 
employees.
    As noted above, the standard that limits the total number of 
employees on any given day to 35 individuals is not derived from SBA's 
methods for calculating the number of employees. FSIS is proposing to 
limit the number of individuals employed by a selected establishment at 
any given time to carry out Congress' intent that any increase in the 
number of employees be ``manageable by the selected establishment'' and 
that the increase ``does not undermine food safety standards.'' FSIS is 
proposing that this number never exceed 35 because section 11015 of the 
2008 Farm Bill permits the Agency to select certain establishments that 
employ as many as 35 employees to participate in a cooperative 
interstate shipment program (Sec. 501(b)(3)(i) and Sec. 31(b)(3)(i)). 
Therefore, FSIS believes that a temporary increase in the number of 
employees of up to 35 individuals is likely to be considered 
``manageable'' under the law, provided that the average number of 
employees remains at 25 or fewer.
    FSIS requests comments on the proposed standards for determining an 
establishment's average number of employees. The Agency specifically 
requests comment on whether part-time and temporary employees should be 
counted the same as full-time employees.
    Ineligible establishments. Proposed Sec. Sec.  332.3(c) and 
381.513(c) describe establishments that are ineligible to participate 
in a cooperative interstate shipment program. For the most part, these 
establishments reflect the ``prohibited establishments'' described in 
section 11015 of the 2008 Farm Bill (Sec. 501(b)(2) and 31(b)(2)). 
These establishments include:
     Establishments that employ more than 25 employees on 
average, with a limited exception for establishments that had between 
25 and 35 employees as of June 18, 2008 and that have 25 or fewer 
employees as of the date three years from the date that the final rule 
resulting from this rule becomes effective;
     Establishments operating under a cooperative inspection 
program under the Talmadge-Aiken Act;
     Official establishments;
     Establishments that were official establishments as of 
June 18, 2008, but that were reorganized on a later date by the person 
that controlled the establishment as of June 18, 2008;
     State-inspected establishments that employed more than 35 
employees as of June 18, 2008, but that were later reorganized by the 
person that controlled the establishment as of June 18, 2008;
     Establishments that are transitioning to become official 
establishments;
     Establishments that are in violation of the FMIA or PPIA; 
and
     Establishments located in a State without a cooperative 
meat or poultry products inspection program.
    In addition, the proposed regulations also include among the 
establishments ineligible to participate in a cooperative interstate 
shipment programs, establishments located in a State whose agreement 
for an interstate shipment program was terminated by the Administrator.
    Proposed Sec. Sec.  332.3(d) and 381.513(d) provide that an 
eligible establishment may apply for selection into a cooperative 
interstate shipment program through the State where the establishment 
is located. FSIS is proposing that establishments apply for selection 
into a cooperative interstate shipment program through the State 
because the State will be responsible for providing inspection services 
to the establishment if the establishment is selected for the program. 
Thus, establishment participation in the cooperative interstate 
shipment program will depend on whether the State is able, and willing, 
to provide the necessary inspection services to the establishment. 
However, if a State enters into an agreement with FSIS for a 
cooperative interstate shipment

[[Page 47652]]

program, FSIS, in coordination with the State, will make the final 
determination on whether to select an establishment to participate in 
the program.
4. State Request for a Cooperative Interstate Shipment Program
    Under this proposed rule, a State that does not have a cooperative 
interstate shipment program, but that is interested in establishing 
one, may submit a request for such a program to FSIS. Proposed 
Sec. Sec.  332.4 and 381.514 prescribe the procedures for States to 
request an agreement for a cooperative interstate shipment program. 
Under this proposal, a State will submit the request through the FSIS 
District Office that covers the State. Proposed Sec. Sec.  332.4(a) and 
381.514(a) make clear that State participation in a cooperative 
interstate shipment program is limited to States that have cooperative 
State meat or poultry products inspection programs.
    Required information. Proposed Sec. Sec.  332.4(b) and 381.514(b) 
describe the information that States will need to include in their 
requests for an agreement for a cooperative interstate shipment 
program. Because a cooperative interstate shipment program requires 
participation from both States and establishments, the State's request 
for an agreement for a cooperative interstate shipment program must 
identify establishments in the State that have requested to be selected 
and that the State recommends for initial selection into the program 
(proposed Sec. Sec.  332.4(b)(1) and 381.514(b)(1)). If FSIS and the 
State enter into an agreement for a cooperative interstate shipment 
program under this proposal, these establishments will be the first to 
be considered for the program. Other establishments operating under the 
State's meat or poultry products inspection program may apply to become 
selected establishments after the cooperative interstate shipment 
program has been implemented within the State.
    A State's request for a cooperative interstate shipment program 
must also include documentation to demonstrate that the State is able 
to provide necessary inspection services to selected establishments in 
the State and conduct any related activities that would be required 
under a cooperative interstate shipment program (proposed Sec. Sec.  
332.4(b)(2) and 381.514(b)(2)). Under this proposal, this documentation 
would be similar to the documentation that States provide when they 
request an agreement for a cooperative State meat or poultry products 
inspection program. However, instead of demonstrating that the State's 
inspection program is ``at least equal to'' the Federal inspection 
program, the statute requires that the State demonstrate that 
inspection services provided to selected establishments will be ``the 
same as'' the inspection services provided under the Federal program.
    Thus, to qualify for a cooperative interstate shipment program 
under this proposal, States will need to demonstrate, among other 
things, that they have the authority under State law to provide the 
same inspection services to selected establishments in the State as the 
inspection services that FSIS provides to official Federal 
establishments. States will also need to demonstrate that they have 
staffing sufficient to conduct the same inspection activities in 
selected establishments that FSIS conducts in official Federal 
establishments, and that designated personnel have been properly 
trained in Federal inspection methodology. FSIS currently offers 
training courses in Federal inspection methodology to State inspection 
personnel. Under this proposal, States that are interested in 
participating in a cooperative interstate shipment program will be 
responsible for making arrangements for their inspection personnel to 
attend these courses. FSIS will also expect States to demonstrate that 
they can provide the necessary equipment for State personnel to provide 
the same inspection services to selected establishments that FSIS 
provides to official Federal establishments, including computers and 
supplies for collecting product samples.
    Because the statute requires compliance with all Federal standards, 
meat and poultry products produced in selected establishments will be 
subject to the same regulatory sampling programs as those established 
in the Federal inspection program. Thus, to be eligible to participate 
in a cooperative interstate shipment program, States will need to 
demonstrate that State personnel will collect the same number and type 
of regulatory product samples from selected establishments as are 
collected under FSIS's inspection sampling program.
    In addition, the State will need to demonstrate that the laboratory 
services that it intends to use to analyze product samples from 
selected establishments are capable of conducting the same chemical, 
microbiological, physical, and pathology testing as are required under 
the Federal meat and poultry products inspection programs. FSIS's 
Office of Public Health Science will provide audit assistance to the 
State to verify that the methodologies used by a State's laboratory 
services to analyze samples from selected establishments are capable of 
producing the same results as the methodologies used by FSIS 
laboratories. FSIS will not enter into an agreement for a cooperative 
interstate shipment program with a State that does not meet the 
conditions described above.
    Additional conditions. Proposed Sec. Sec.  332.4(b)(3) and 
381.514(b)(3) prescribe additional conditions that States applying for 
a cooperative interstate shipment program must agree to in order to 
qualify for the program. These proposed regulations provide that when a 
State submits a request to establish a cooperative interstate shipment 
program, the State must agree that, if it enters into an agreement with 
FSIS for such a program, that the State will:
     Provide FSIS with access to the results of all laboratory 
analyses conducted on product samples from selected establishments in 
the State;
     Notify the selected establishment coordinator (SEC) for 
the State of the results of any laboratory analyses that indicate that 
a product prepared or processed in a selected establishment may be 
adulterated or may otherwise present a food safety concern; and
     If necessary, cooperate with FSIS to transition selected 
establishments in the State that have been deselected from a 
cooperative interstate shipment program to become official 
establishments. FSIS will not enter into an agreement for a cooperative 
interstate shipment program if a State does not agree to these terms.
    Qualified States. Under this proposal, after a State submits a 
request for a cooperative interstate shipment program, the FSIS 
Administrator will review the request and determine whether the State 
qualifies for such a program. If, based on the information submitted in 
the request the Administrator determines that a State is eligible to 
enter into a cooperative agreement for an interstate shipment program, 
the Administrator and the State will sign a cooperative agreement that 
sets forth the terms and conditions under which each party will 
cooperate to provide inspection services to selected establishments in 
the State (proposed Sec. Sec.  331.4(c) and 381.514(c)). After the 
Administrator and a State have signed an agreement for a cooperative 
interstate shipment program, the Administrator will: (1) Appoint an 
FSIS employee as the selected establishment coordinator (SEC) for the 
State and (2) coordinate with the State to select the establishments 
that will participate in the program (proposed Sec. Sec.  332.4(d) and 
381.514(d)).

[[Page 47653]]

    Summary of actions needed to establish a cooperative interstate 
shipment program under the proposed regulations.
    The proposed regulations discussed above describe conditions that 
both establishments and States must meet to participate in a 
cooperative interstate shipment program. If FSIS adopts these proposed 
regulations in a final rule, the steps for establishing a new 
cooperative interstate shipment program will be the following.
     An establishment that is eligible for the interstate 
shipment program, and that is interested in participating in the 
program, will apply for the program through the State agency that 
administers the State meat and poultry products inspection program 
under which the establishment operates. States will develop their own 
application procedures.
     The State will then evaluate the establishment's 
application to determine whether the State will recommend the 
establishment for selection into the cooperative interstate shipment 
program.
     If the State determines that an establishment qualifies 
for selection into the program, and the State is able, and willing, to 
provide the necessary inspection services to the establishment, the 
State will recommend the establishment for selection into the program. 
The State will need to submit its recommendation through the FSIS 
District Office whose jurisdiction includes the State.
     If the State has not entered into an agreement with FSIS 
for a cooperative interstate shipment program, but is qualified to 
participate in such a program, it will need to submit a request for a 
cooperative agreement for the program to the FSIS District Office that 
covers the State.
     In its request for a cooperative interstate shipment 
program, a State will need to: (1) Identify those establishments that 
have submitted a request for, and that the States recommends for, 
initial selection into the program and (2) demonstrate that it is able 
to provide the necessary inspection services to these establishments if 
they are selected for the program. The State will also need to agree to 
comply with certain conditions associated with FSIS oversight and 
enforcement of the program.
     After a State submits a request for a cooperative 
interstate shipment program, the FSIS Administrator will evaluate the 
request and determine whether the State qualifies for the program.
     If the Administrator determines that the State qualifies 
for the cooperative interstate shipment program, the Administrator and 
the State will sign a cooperative agreement that sets forth the terms 
and conditions under which each party will cooperate to provide 
inspection services to selected establishments in the State.
     The Administrator will then appoint an SEC for the State, 
and the Administrator, in coordination with the State, will begin 
selecting establishments for participation in the program.
5. Selection of Establishments
    As discussed above, under this proposal, State-inspected 
establishments that are interested in participating in a cooperative 
interstate shipment program will apply for selection into the program 
through the State agency that administers the State's meat or poultry 
products inspection program. When, and if, an establishment applies to 
participate in a cooperative interstate shipment program, the State 
will evaluate the establishment to determine whether it qualifies to 
become a selected establishment. Proposed Sec. Sec.  332.5(a) and 
381.515(a) provide that a State-inspected establishment will qualify 
for selection into a cooperative interstate shipment program if the 
establishment:
     Has submitted a request to the State to be selected for 
the program;
     Has the appropriate number of employees;
     Is not ineligible for a cooperative interstate shipment;
     Is in compliance with all requirements under the State 
inspection program; and
     Is in compliance with the all Federal meat or poultry 
products inspection requirements.
    Establishments that do not meet all of these criteria will not 
qualify, and will not be selected, for the program. To participate in a 
cooperative interstate shipment program, an establishment that 
qualifies for such a program must be selected by the Administrator, in 
coordination with the State where the establishment is located 
(proposed Sec. Sec.  332.5(b) and 381.515(b)).
    Thus, under this proposal, if a State determines that an 
establishment operating under the State's meat or poultry products 
inspection program qualifies for selection into a cooperative 
interstate shipment program, and the State is able, and willing, to 
provide the necessary inspection services to the establishment, the 
State is to submit its evaluation of the establishment through the FSIS 
District Office that covers the State. The FSIS Administrator, in 
coordination with the State, will decide whether to select the 
establishment for the program. When deciding whether to select and 
establishment for the program, the Administrator will consider whether 
the establishment meets the criteria needed to qualify for the program 
and whether the Agency has the resources that it needs to provide the 
required oversight of the establishment if it is selected for the 
program.
    As stated above, to qualify to participate in a cooperative 
interstate shipment program, an establishment must be in compliance 
with all Federal inspection requirements under the FMIA, PPIA, and 
their implementing regulations in title 9, chapter III, of the CFR. 
Thus, as part of the selection process, the SEC, in coordination with 
the State, will verify that each establishment that has applied to 
participate in a cooperative interstate shipment program: (1) Meets the 
Federal regulatory performance standards established in 9 CFR 416.1 
through 416.6; (2) has submitted all labeling material to the State for 
approval, and that the materials meet all Federal requirements in 9 CFR 
parts 316, 317, and 319 and Part 381, subparts M, N, and P; (3) has 
obtained the same water source and sewage system approval that FSIS 
requires for official establishments; (4) has developed Sanitation 
Standard Operating Procedures (Sanitation SOPs) that comply with 9 CFR 
416.11-416.17; and (5) has conducted a hazard analysis and developed a 
validated Hazard Analysis and Critical Control Points (HACCP) plan that 
complies with 9 CFR part 417.
    These criteria reflect the standards that meat and poultry products 
establishments are required to meet to obtain a Federal grant of 
inspection under 9 CFR part 304 and 9 CFR part 381. Establishments that 
do not meet all of these requirements are not in compliance with all 
Federal standards and thus will not be selected for the program.
    If an establishment qualifies for, and is selected to participate 
in, a cooperative interstate shipment program under this proposed rule, 
proposed Sec. Sec.  332.5(c) and 381.515(c) provide that the State is 
to assign the establishment an official number that reflects the fact 
that the establishment is a participant in the cooperative interstate 
shipment program. These proposed regulations provide that the State is 
to advise the SEC of the number assigned to each selected establishment 
in the State. Proposed Sec. Sec.  332.5(c) and 381.515(c) go on to 
state that the official numbers

[[Page 47654]]

assigned to selected establishments need to contain the suffix ``SE'' 
to identify the establishments as selected establishments. FSIS is 
proposing this requirement to ensure that establishments participating 
in the cooperative interstate shipment program can be identified by 
reference to their establishment number. It will also ensure that meat 
and poultry products prepared in selected establishments are identified 
as articles produced under a cooperative interstate shipment program.
    Proposed Sec. Sec.  332.5(c) and 381.515(c) also provide that the 
selected establishment numbers must include, as a suffix, the 
abbreviation for the State in which the establishment is located. In 
addition, proposed Sec.  381.515(c) provides that the suffix of the 
number for a selected poultry products establishments needs to contain 
the letter ``P'' to identify the establishment as one that processes 
poultry products. Thus, under this proposal, an official number for a 
selected establishment in Texas that prepares meat products would 
contain the suffix ``SETX,'' while an official number for an 
establishment in North Dakota that process poultry products would 
contain the suffix ``SEPND.''
    As discussed below, articles that have been inspected and passed in 
a selected establishment will bear an official USDA mark, stamp, tag, 
or label of inspection.
    Finally, proposed Sec. Sec.  332.5(d) and 381.515(d) provide that 
failure of a State to comply with Sec. Sec.  332.5(c) and 381.515(c) 
will disqualify that State from participation in a cooperative 
interstate shipment program. Full compliance by a State with these 
provisions is essential if the program is to succeed.
6. Inspection at Selected Establishments, Official Mark, and Interstate 
Shipment
    Proposed Sec. Sec.  332.6(a) and 381.516(a) provide that a 
cooperative interstate shipment program will commence when the 
Administrator, in coordination with a State that has entered into an 
agreement for a cooperative meat or poultry products inspection 
program, have selected establishments in the State to participate in 
the program.
    Proposed Sec. Sec.  332.6(b) and 381.516(b) provide that inspection 
services for selected establishments participating in a cooperative 
interstate shipment program must be provided by designated personnel, 
who will be under the direct supervision of a State employee. As 
discussed below, the FSIS SEC will oversee the inspection activities of 
the designated personnel.
    Proposed Sec. Sec.  332.6(c) and 381.516(c) provide that articles 
prepared or processed in a selected establishment that have been 
inspected and passed by designated personnel must bear an official USDA 
mark, stamp, tag, or label of inspection as specified in 9 CFR 312.2 or 
9 CFR 381.96. 9 CFR 312.2 and 9 CFR 381.96 are the regulations that 
prescribe the appropriate wording and form for use of the official 
Federal inspection legend on meat or poultry products. In addition, the 
establishment number contained in the Federal mark, stamp, tag, or 
label of inspection must comply with all the conditions proposed in 
Sec. Sec.  332.5(c) or 381.515(c).
    Under proposed Sec. Sec.  332.6(d) and 381.516(d) meat or poultry 
products prepared in selected establishments may be shipped in 
interstate commerce if they have been inspected and by selected State 
personnel and bear the Federal mark of inspection.
7. Federal Oversight of Cooperative Interstate Shipment Programs
    Section 11015 of the 2008 Farm Bill requires that the Secretary 
designate an employee of the Federal government as a ``State 
coordinator'' for each State that has a cooperative State meat or 
poultry products inspection program (Sec. 501(d) and Sec. 31(d)). The 
State coordinator is required to ``provide oversight and enforcement'' 
of the program and ``to oversee the training and inspection 
activities'' of State personnel designated to provide inspection 
services to selected establishments (Sec. 501(d)(1) and Sec. 31(d)(1)). 
As noted above, when, and if, a State qualifies to participate in a 
cooperative interstate shipment program, proposed Sec. Sec.  
332.4(c)(1) and 381.514(c)(1) provide that the Administrator will 
appoint an FSIS employee as the FSIS SEC for the State. The SEC is the 
``State coordinator'' prescribed by the statute.
    FSIS has tentatively decided that the SEC will be an employee of 
the FSIS Office of Field Operations (OFO) and will be assigned to an 
FSIS District Office. The SEC will likely be under the direct 
supervision of an FSIS District Manager. The number of States in an 
FSIS district assigned to an SEC will likely depend on several factors, 
including, but not limited to: (1) The number of States and selected 
establishments, if any, that participate in the cooperative interstate 
shipment program; (2) the location of each selected establishment; (3) 
the number of State inspection personnel providing inspection services 
to selected establishments in a State; (4) the complexity of the 
operations conducted at each selected establishment; and (5) the 
schedule of operations for each selected establishment. The number of 
States assigned to an SEC would also need to be based on consideration 
of the most effective allocation of available Agency resources.
    SEC initial responsibilities. One of the SEC's initial 
responsibilities will be, in conjunction with the District Office, to 
coordinate with the State to select establishments to participate in 
the program. The SEC will coordinate with the State to verify that all 
State personnel selected to provide inspection services to these 
establishments have successfully completed the same training in the 
fundamentals of meat and poultry inspection, covering the Sanitation 
Performance Standards, Sanitation Standard Operating Procedures (SOPs), 
HACCP, and enforcement procedures, that is required for FSIS inspection 
personnel. The SEC will also coordinate with the State to verify that 
designated personnel have successfully completed the appropriate 
customized food safety training required for FSIS inspection personnel 
based on the types of products being produced at the establishments 
where designated personnel are assigned.
    SEC's oversight responsibilities. Proposed Sec. Sec.  332.7 and 
381.517 prescribe how the FSIS SEC is to provide Federal oversight of 
the cooperative interstate shipment program.
    Proposed Sec. Sec.  332.7(a) and 381.517(a) provide that the SEC is 
to visit each selected establishment in the State on a regular basis to 
verify that these establishments are operating in a manner that is 
consistent with the Acts and the implementing regulations in title 9, 
chapter III, of the CFR. The SEC's frequency of visits and oversight 
activities for each selected establishment will need to reflect the 
type of operations conducted by a selected establishment, as well as 
the establishment's production processes. FSIS requests comments on how 
frequently the SEC should visit each establishment under his or her 
jurisdiction. Proposed Sec. Sec.  332.7(a) and 381.517(a) also provide 
that if necessary, the SEC, in consultation with the District Manager 
that covers the State, may designate qualified FSIS personnel to visit 
a selected establishment on behalf of the SEC.
    Under proposed Sec. Sec.  332.7(b) and 381.517(b), the SEC, in 
coordination with the State, will verify that selected establishments 
in the State are receiving the necessary inspection services from

[[Page 47655]]

designated personnel, and that these establishments are eligible, and 
remain eligible, to participate in the cooperative interstate shipment 
program. These proposed regulations provide that the SEC's verification 
activities may include:
     Verifying that each selected establishment in the State 
employs, and continues to employ, 25 or fewer employees on average, 
unless the establishment is transitioning to become an official 
establishment;
     Verifying that the designated personnel are providing 
inspection services to selected establishments in an manner that 
complies with the Acts and implementing regulations;
     Verifying that the State staffing levels for each selected 
establishment are appropriate to carry out the required inspection 
activities; and
     Assessing each selected establishment's compliance with 
the Acts and implementing regulations under title 9, chapter III, of 
the CFR.
    To verify that designated personnel are providing inspection 
services in compliance with the Acts, the SEC for the establishment, in 
coordination with the State, will verify that the designated personnel 
are correctly applying Federal inspection methodology, making decisions 
based upon the correct application of this methodology, accurately 
documenting their findings, and, when authorized to do so, implementing 
enforcement actions in accordance with the FSIS Rules of Practice in 9 
CFR part 500.
    To assess each selected establishment's compliance with Federal 
food safety standards, the SEC will observe the condition of the 
establishment, observe establishment employees performing their duties, 
review the establishment's records, and submit product samples for 
analysis to determine that product produced by the establishment meets 
Federal food safety standards.
    The SEC will have discretion to increase the frequency of visits to 
a selected establishment if the SEC, in consultation with the District 
Manager for the State where the selected establishment is located, 
determines that such action is necessary to ensure that the 
establishment is operating in a manner consistent with the Acts. The 
SEC will also be authorized to conduct a comprehensive food safety 
assessment (FSA) for a selected establishment, or to request that an 
FSIS Enforcement, Investigation, and Analysis Officer (EIAO) conduct an 
FSA, if the SEC, in consultation with the District Manager, determines 
that such action would help determine whether the establishment is 
operating in compliance with the Acts. A comprehensive food safety 
assessment is an assessment that considers all the food safety aspects 
that relate to an establishment and all the products the plant 
produces.
    If the SEC determines that designated personnel are not providing 
inspection services to selected establishments in a manner that 
complies with the Acts, proposed Sec. Sec.  332.7(c) and 381.517(c) 
provide that FSIS will provide an opportunity consistent with these 
regulations for the State to develop and implement a corrective action 
plan to address inspection deficiencies identified by the SEC. These 
proposed regulations also provide that if the State fails to develop a 
corrective action plan, or if the SEC determines that the State's 
corrective action plan is inadequate, the Administrator will terminate 
the cooperative agreement with the State.
    As discussed above, selected establishments in a State whose 
agreement for a cooperative interstate shipment program has been 
terminated by the Administrator are among the establishments that are 
ineligible to participate in the program. As such, these establishments 
will be deselected from the program and transitioned to become Federal 
establishments as described below.
    Quarterly reports. As required under section 11015 of the 2008 Farm 
Bill (Sec. 501(d)(3)(b) and Sec. 31(d)(3)(b)), the SEC is to prepare a 
report on a quarterly basis that describes the status of each selected 
establishment under the SEC's jurisdiction (proposed Sec. Sec.  
332.8(a) and 381.518(a)).
    The SEC's quarterly report will include the SEC's assessment of the 
performance of the designated personnel in conducting inspection 
activities (proposed Sec. Sec.  332.8(b)(1) and 381.518(b)(1)). The 
quarterly report will also identify the selected establishments that 
the SEC has verified are in compliance with all Federal requirements, 
those that have been deselected, and those that are transitioning to 
become Federal establishments (proposed Sec. Sec.  332.8(b)(1) and 
381.518(b)(1)). The SEC will submit the report to the Administrator 
through the District Manager for the State in which the selected 
establishments identified in the report are located (proposed 
Sec. Sec.  332.8(c) and 381.518(c)).
    Enforcement. Section 11015 of the 2008 Farm Bill provides that if 
the SEC determines that any selected establishment is in violation of 
any requirement of the Acts, the SEC is required to: (1) Immediately 
notify the Secretary (the FSIS Administrator by delegation) of the 
violation and (2) ``deselect'' the establishment or suspend inspection 
at the establishment (Sec. 501(d)(3)(C) and Sec. 31(d)(3)(C)). In 
adopting this language, Congress intended that the SEC ``* * * shall be 
provided all the tools necessary under the Secretary to prevent or 
control any food safety issue that would harm human health'' (S. Rep. 
No. 220, 110th Cong., 1st Sess., at 211 (2007)).
    Because many of the SEC's verification and enforcement activities 
require that the SEC have access to a selected establishment's records, 
proposed Sec. Sec.  332.9(a) and 381.519(a) provide that to facilitate 
oversight and enforcement of the cooperative interstate shipment 
program, selected establishments must, upon request, give SECs or other 
FSIS officials access to all establishment records required under the 
FMIA, PPIA, and the implementing regulations in title 9, chapter III, 
of the CFR. These proposed regulations go on to state that FSIS will 
move to deselect an establishment that does not comply with this 
requirement.
    Under proposed Sec. Sec.  332.9(b) and 381.519(b), the SEC is 
authorized to initiate any appropriate enforcement action provided for 
in the FSIS rules of practice in 9 CFR part 500 if he or she determines 
that a selected establishment under his or her jurisdiction is 
operating in a manner that is inconsistent with the Acts or their 
implementing regulations. Such actions include, among others, 
regulatory control actions, withholding actions, and suspensions. The 
proposed regulations provide that selected establishments participating 
in a cooperative interstate shipment program are subject to the 
notification and appeal procedures set out in part 500 (proposed 
Sec. Sec.  332.9(b) and 381.519(b)).
    Proposed Sec. Sec.  332.9(c) and 381.519(c) provide that if 
inspection at a selected establishment is suspended for any of the 
reasons specified in 9 CFR 500.3 or 9 CFR 500.4, FSIS will provide an 
opportunity for the establishment to implement corrective actions and 
remain in the cooperative interstate shipment program, or the Agency 
will move to deselect the establishment. The decision to deselect a 
selected establishment under a suspension will be made on a case-by-
case basis (proposed Sec. Sec.  332.9(d) and 381.519(d)). In making 
this decision, the Administrator, in consultation with the State where 
the selected establishment is located, will consider, among other 
factors: (1) The non-compliance that led to the suspension; (2) the 
selected establishment's compliance history, which will be documented 
in non-compliance reports prepared by the designated personnel and the 
SEC's

[[Page 47656]]

quarterly reports; and (3) the corrective actions proposed by the 
establishment (proposed Sec. Sec.  332.9(d) and 381.519(d))
    The Administrator will have the discretion to allow a selected 
establishment that has been suspended to remain in the program if the 
establishment implements corrective actions to address any non-
compliance. The Administrator will consider the criteria described 
above in determining whether to provide an opportunity for corrective 
actions. Establishments that are given an opportunity to take 
corrective actions but that are unable to effectively implement these 
actions will be deselected.
    FSIS will also consider the State's recommendation as to whether a 
selected establishment in the State should be deselected. However, the 
final decision to deselect an establishment for violations of the FMIA 
or PPIA will be made by FSIS. As discussed below, consistent with the 
law, this proposed rule requires that deselected establishments be 
transitioned to become official establishments.
8. Deselection
    There may be circumstances in which an establishment that initially 
qualifies to be selected to participate in a cooperative interstate 
shipment program later acquires characteristics that would cause it to 
become ineligible for the program. For example, an establishment may 
hire additional employees after it has been selected, or, as discussed 
above, FSIS may determine that a selected establishment is in violation 
of the Acts. Therefore, proposed Sec. Sec.  332.10(a) and 381.520(a) 
provide that the Administrator will deselect an establishment that 
becomes ineligible to participate in a cooperative interstate shipment 
program. Proposed Sec. Sec.  332.10(b) and 381.520(b) provide that an 
establishment that has been deselected from a cooperative interstate 
shipment program must be transitioned to become an official 
establishment.
    FSIS is proposing to require that deselected establishments be 
transitioned to become official Federal establishments as provided for 
in the law. Section 11015 of the 2008 Farm Bill allows the Agency to 
establish a procedure to transition selected establishments that 
employ, on average, more than 25 employees to become Federal 
establishments, and it requires that selected establishments that the 
Administrator determines to be in violation of any provision of the 
Acts, be transitioned to Federal establishments in accordance with the 
procedure developed for establishments that employ more than 25 
employees (Sec. 501(b)(3), 501(h), 31(b)(3) and 31(g)).
    Thus, as required by the law, under this proposal, establishments 
that become ineligible to participate in the cooperative interstate 
shipment program because they violated Federal food safety standards 
will not permitted to avoid implementing appropriate corrective actions 
by withdrawing from the cooperative interstate shipment program and 
reverting back to the State inspection program. In addition, requiring 
that deselected establishments transition to become official Federal 
establishments will help to ensure that the resources that FSIS and the 
States provide to establish and maintain a cooperative interstate 
shipment program are used most effectively to provide inspection 
services to establishments that are committed to maintaining Federal 
food safety standards.
9. Transition Procedures for Deselected Establishments
    As discussed above, under the law, FSIS is authorized to develop a 
procedure to transition selected establishments to become official 
establishments if they employ more than 25 employees on average, or if 
the Agency determines that they are in violation of any provision of 
the Acts (Sec 501(b), Sec. 501(h), Sec. 31(b) and Sec. 31(g)). At a 
minimum, a procedure to transition a selected establishment to an 
official establishment would include: (1) Adding the establishment to 
an FSIS circuit within the FSIS District that covers the State where 
the
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