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Rules and Regulations Federal Register Vol. 66, No. 88

Monday, May 7, 2001

This section of the FEDERAL REGISTER April 26, 2001. Interested parties may 2001, grants of voluntary inspection for contains regulatory documents having general comment on this interim final rule. ratites and squabs will no longer be applicability and legal effect, most of which DATES: This interim final rule will be valid. Fees for ratite and squab are keyed to and codified in the Code of effective April 26, 2001. Comments inspection services will no longer be Federal Regulations, which is published under charged, except for overtime and 50 titles pursuant to 44 U.S.C. 1510. must be received on this interim final rule by July 2, 2001. holiday inspection services. The Code of Federal Regulations is sold by ADDRESSES: Submit one original and Applications for mandatory inspection the Superintendent of Documents. Prices of two copies of written comments within must be submitted on an FSIS new books are listed in the first FEDERAL the scope of the rulemaking to FSIS application form available from any REGISTER issue of each week. Docket Clerk, Docket #01–045IF, U.S. FSIS District Office or from FSIS Department of Agriculture, Food Safety Headquarters, Washington, DC 20250. and Inspection Service, Room 102, FSIS will give notice in writing to each DEPARTMENT OF AGRICULTURE Cotton Annex, 300 12th Street, SW., applicant granted (or denied) inspection. Food Safety and Inspection Service Washington, DC 20250–3700. All comments submitted in response to this Under the regulations that implement the PPIA, before being granted Federal 9 CFR Parts 362 and 381 proposal will be available for public inspection in the Docket Clerk’s Office inspection, an establishment must have [Docket No. 01–045IF] between 8:30 a.m. and 4:30 p.m., written Sanitation Standard Operating Monday through Friday. Procedures (SOPs) (§ 381.22(a)) and a RIN 0583–AC84 FOR FURTHER INFORMATION CONTACT: For Hazard Analysis and Critical Control information about the interim final rule, Point (HACCP) plan that the Mandatory Inspection of Ratites and contact Dr. Arshad Hussain, Director, establishment has validated (§ 381.22 (b) Squabs Inspection and Enforcement Standards and (c)). Establishments can receive Development Staff, Office of Policy, conditional grants of inspection for a Editorial Note: Federal Register rule Program Development, and Evaluation, period of not more than 90 days while document 01–10679 originally appeared in FSIS, U.S. Department of Agriculture, they validate their HACCP plans the issue of Tuesday, May 1, 2001 at 66 FR Room 202, Cotton Annex, 300 12th (§ 381.22(b)). 21631–21639. Due to several errors (repeated Street, SW, Washington, DC 20250– Import Inspection text and missing text on page 21635) the 3700, (202) 720–3219. document is being reprinted in its entirety. SUPPLEMENTARY INFORMATION: This interim final rule will be AGENCY: Food Safety and Inspection effective on April 26, 2001. Within 18 Service, USDA. Background months of that date, imported ratite or ACTION: Interim final rule. On October 28, 2000, the President squab products will have to originate in signed the Appropriations Act, which countries that are eligible to export SUMMARY: The Food Safety and provides that 180 days after the date of to the United States and will Inspection Service (FSIS) is amending its enactment, U.S. establishments that have to be processed in establishments the Poultry Products Inspection slaughter or process ratites (such as certified by the government of the Regulations (Part 381) and the ostriches, , and rheas) or squabs for foreign country as eligible to export to Voluntary Poultry Inspection distribution into commerce as human the United States. Currently, these Regulations (Part 362) to include ratites food will be subject to the requirements countries include Canada, France, Great and squabs under the mandatory of the PPIA (21 U.S.C. 451, et seq.), Britain, and Israel. Hong Kong and poultry products inspection regulations. rather than the voluntary poultry Mexico have not yet been approved by The Agency is responding to the FY inspection program under section 203 of the United States to slaughter poultry; 2001 Agriculture, Rural Development, the AMA (7 U.S.C. 1622). This provision therefore, they are only eligible to Food and Drug Administration and of the Appropriation Act is effective on export to the United States processed Related Agencies Appropriations Act April 26, 2001. poultry products that originate from (the Appropriations Act), signed by the Ratites are members of a superorder Canada, France, Great Britain, Israel, or President on October 28, 2000, which (Ratitae) of flightless birds that have the United States (§ 381.196). provides that 180 days after the date of small or rudimentary wings and flat All countries exporting or wanting to its enactment, U.S. establishments breastplates, e.g., ostriches, emus, and export ratite and squabs products to the slaughtering or processing ratites or rheas. Squabs are young pigeons that United States, regardless of their current squabs for distribution into commerce have not yet flown. eligibility status regarding and as human food will be subject to the Ratites are currently inspected under poultry product exports to the United requirements of the Poultry Products the Voluntary Poultry Inspection States, may do so for the next 18 months Inspection Act (PPIA), rather than the Regulations as an experimental subject to the following. Countries voluntary poultry inspection program program. Operators who wish to already eligible to export poultry to the under section 203 of the Agricultural continue to slaughter or process ratites United States will be able to export Marketing Act of 1946 (AMA). The or squabs after April 26, 2001, for ratites and squabs as soon as they certify provision of the Appropriations Act transport or sale in commerce must to FSIS those establishments eligible to specifying that ratites and squabs come apply to FSIS for a grant of inspection export to the United States. These under the Agency’s mandatory for mandatory inspection service countries are Canada, Israel, Great inspection requirements is effective on (§§ 381.6 and 381.16). As of April 26, Britain, and France. Animal health

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restrictions continue to apply so there is comments and make a final symptoms at ante mortem will be no change with regard to the eligibility determination of equivalence. The handled differently than other diseased of specific products based on APHIS determination to list a country as poultry. regulations. equivalent, and, therefore, eligible to The Agency is amending § 381.76 to Countries eligible to export meat to export poultry products to the United add Ratite Inspection as the fifth post the United States will be permitted to States, is published as a final rule in the mortem poultry inspection system. This export ratites to the United States Federal Register, along with FSIS’s amendment is necessary because provided the animals are slaughtered in responses to the public comments. At inspection of ratites must be done in a an establishment certified to export to that time, the country’s inspection different manner than inspection of the Unites States and provided the service may certify establishments for other amenable poultry species. Thus, countries submit a request for export of poultry products, including inspection of ratites cannot be done establishing equivalency. Certified ratites and squabs, to the United States. under the existing four inspection establishments are required to meet Summary of Interim Final Rule systems. FSIS HACCP and Pathogen Reduction FSIS is amending § 381.96 to provide requirements. At this point, Australia FSIS is making a number of technical that ratite carcasses and parts that are and New Zealand, which are both changes in its regulations, which it shipped unpacked must bear the official eligible to export meat to the United believes are noncontroversial, to brand. This addition is necessary States, have indicated that they want to provide for the inspection of ratites and because ratites are the only species of export ratites. squabs. The Agency is amending 9 CFR amenable species that are likely to be Countries not eligible to export meat 362.1(d) to remove squab from the shipped unpacked. or poultry to the United States will need definition of ‘‘Poultry’’ in the Voluntary Finally, FSIS is proposing to make to submit a request for equivalency and Poultry Inspection Regulations. FSIS is some editorial changes to § 362.1 to FSIS will need to make an equivalency also amending § 362.1(e) to include correct inaccuracies and to provide for determination according to 9 CFR Part ratites and squabs with , greater clarity. 327. turkeys, ducks, geese, and guineas in the As indicated above, however, each definition of ‘‘Poultry Product.’’ The Regulatory Impact Analysis country desiring to begin or continue Agency is also amending § 381.1(b) to Basis for Regulatory Action exporting such products to the United include ratites and squabs within the Currently, ratites and squabs are States will have to apply for an definition of ‘‘Poultry’’ in the Poultry inspected on a voluntary, fee-for-service equivalence determination of its ratite Products Inspection Regulations. and squab inspection system. Countries’ FSIS is amending § 381.36(b) to basis under section 203 of the AMA. ratite and squab export inspection require a pen for the ante mortem The interim final rule will amend systems must be found to be equivalent inspection of ratites. It is necessary to § 362.1(d) to remove squab from the with the U.S. domestic inspection specify that a pen be available for ratites definition of poultry in the Voluntary system within 18 months of the effective because ante mortem inspection of Poultry Inspection Regulations and will date of the Agency’s new mandatory ratites is done on an individual bird amend § 381.1 to include ratites and ratite and squab inspection basis, rather than a lot basis as is done squabs under the Agency’s mandatory requirements (April 26, 2001). for other amenable poultry. poultry inspection requirements. After the 18 month period has ended, The Agency is amending § 381.66 to Congress mandated, in the FY 2001 all shipments of ratites and squabs from exempt ratites from the chilling Agriculture Appropriation Act, that 180 eligible countries must be accompanied requirements of § 381.66 paragraphs (b), days from the date of enactment (April with the appropriate veterinary health (c), and all of (d), except for (d)(1). 26, 2001) U.S. establishments that certificate (§ 381.197) and must be Ratites are air-chilled rather than water- slaughter or process ratites or squabs presented to FSIS for import chilled, as is the case with most will come under mandatory inspection reinspection prior to entry (§ 381.199). amenable poultry. by FSIS. Countries wanting to export ratites FSIS is amending § 381.67 to include Baseline and squab to the United States should squabs with young chickens under make a written request to export poultry traditional inspection procedures. The Ratites and squabs are considered to FSIS through the United States two types of birds are of similar size and non-amenable species and are currently Embassy located in the country. FSIS weight and thus can be inspected in a inspected by the Agency on a voluntary, 1 will conduct both a document review similar manner. fee-for-service basis. These species are and an on-site audit to determine if the The Agency is amending § 381.70 to also inspected on a mandatory or country operates an equivalent poultry permit an exception to examining and voluntary basis under State programs. inspection system. inspecting ratites on the day of slaughter Ratites are an order of flightless birds During the review, FSIS will work for humane reasons or, for low volume that includes ostriches, emus, rheas, cooperatively with the Animal and establishments, under certain , and kiwis. The most Plant Health Inspection Service, which conditions. This amendment allows the economically important species of approves the entry of poultry products humane handling of ratites to be the ratites are the ostrich and the . according to the disease status of the same as that for . Squabs are young domesticated pigeons exporting country. FSIS is amending § 381.71 to provide that have never flown. Ratite and squab If the country’s export inspection information on how suspect and system is found to be equivalent with condemned ratites are to be handled. 1 The FMIA and PPIA do not mandate the inspection of ratites and squabs. FSIS provides, on the U.S. domestic inspection system, This amendment is necessary because a fee-for-service basis, voluntary inspection services FSIS will publish a proposal in the the treatment of suspect and condemned under the Argicultural Marketing Act of 1946 for Federal Register to list the country as ratites is different than the treatment of these species and others such as reindeer, elk, deer, eligible to export poultry products to the suspect and condemned birds of other antelope, water buffalo, , migratory water fowl, birds, and . The Food and Drug United States. After the public has had amenable species. Administration has primary statutory authority over 60 days to comment on this proposed FSIS is amending § 381.72 to reflect all food animals and birds not covered by the FMIA rule, FSIS will review all of the public the fact that ratites showing disease and the PPIA.

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meat is valued for its flavor and Currently 99 establishments possess a ratites inspected (Table 1). Ostriches nutritional characteristics. grant of inspection. In 1999, there were made up the largest share (69%) of the Since 1992, when FSIS first granted a a total of 48,286 (76%) ratites inspected ratites inspected under the Federal request for voluntary inspection for in Federal establishments and 14,427 program, whereas emus made up the ostriches, approximately 166 (24%) ratites inspected in State largest share (56%) of the ratites establishments have been issued a grant establishments, or a total of 62,713 inspected under State programs. of inspection for ratite operations.

TABLE 1.—RATITES AND SQUAB INSPECTION VOLUME AND ESTABLISHMENTS, FY 1999

Federal State establishments establishments Species Total Number % of Number % of inspected inspected total inspected total

Ratites Ostrich ...... 33,521 86 5,254 14 38,775 Emu ...... 14,745 64 8,068 36 22,813 Other ...... 20 2 1,105 98 1,125

Ratites Total ...... 48,286 76 14,427 24 62,713 Squabs ...... 175,496 14 1,122,131 86 1,297,627

Totals ...... 223,782 16 1,136,558 84 1,360,240

Ests. Number Number

Squabs ...... 2 2 Ratites ...... 99 95

In 1999, states with a large share of Emus confusion in the industry because it ratites inspected under the Federal A mature emu reaches a height of 5 would be difficult to apply some of the program were California, Georgia, to 6 feet tall, weighing 90 to 120 current poultry regulations to ratites and Illinois, Louisiana, Oklahoma, and pounds. In 1999, 22,813 emus were squabs, e.g., chilling and certain Texas. Alabama, California, Mississippi, inspected under Federal and State handling requirements. North Carolina, Ohio, and Texas programs (Table 1). There are a number The Agency’s second option was to inspected a large share of ratites under of valuable products derived from emus make the changes required by statute State programs. There were almost an in addition to their meat. and other changes as noted above. FSIS equal number of establishments There is also significant uncertainty selected this option because it will involved in slaughter of ratites under about the annual production of emus. provide a more orderly transition from the Federal (99) and State (95) Some source indicate that there may be voluntary inspection to mandatory inspection programs. as many as 500,000 birds on 5,000 to inspection of ratites and squabs than the 6,000 farms in the U.S., with the first option at little or no additional Ostriches majority of them in Texas, Oklahoma, cost. and elsewhere in the Southwest. Ostrich is the largest bird in the Benefits world, standing about seven to eight feet Squabs There are three primary benefits that tall and weighing 300–400 pounds Squabs are young domesticated may result from extending mandatory when fully grown. Industry pigeons that have never flown. Squabs inspection services to ratites and representatives indicate that there were usually weigh 1 pound or less at the squabs: industry growth, public health, about 600 ostrich growers 1998, down time of slaughter (about 4 weeks old). In and industry cost savings. from 1000 growers in 1996. There is 1999, California and Oregon were the Having the inspection mark on the significant uncertainty about the annual only two states that inspected squabs ratite and squab products could lead to production of ostriches and other ratites under the Federal voluntary inspection greater consumer confidence and at this time. The Agency requests program. In that year, 175,496 squabs acceptability of the products. Demand reliable information on the annual were inspected (Table 1). During that could be expected to increase as a number of ratites and squab produced same period 1,122,131 squabs were result. Establishments that are able to and the number of producers. inspected under the inspection capitalize on the change in consumer programs of California and South preference may realize increased sales Ostriches are slaughtered at an Carolina. of these products. To the extent that average age of 12 months. The average inspection promotes growth in the ratite weight at slaughter is 350 pounds. Regulatory Alternatives and squab industry, society could Ostrich meat is sold as , fillets, FSIS considered two options in benefit also from the increased medallions, roasts, and . developing its interim final rule. The employment and earnings of workers in Currently, ostriches are processed in first option the Agency considered was these establishments. Studies are not establishments that are equipped to to only change the definition of poultry available to identify the potential process other species such as in the Poultry Products Inspection growth in the industry that may occur. cattle, sheep, goats, and swine. Regulations to include ratites and The public health benefits of squabs. This approach may have caused inspection are related to the reduction

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in risk associated with consumption of provisions of Pathogen Reduction/ will be the species being slaughtered in all ratite and squab meat that must be Hazard Analysis Critical Control Point the greatest number is very low. inspected using the same procedures (PR/HACCP) final rule. Under the Consequently, very few establishments employed in the meat and poultry provisions of the rule, all slaughter will be required to perform additional E. industries. HACCP systems, Sanitation establishments under mandatory coli testing for process control SOPs, and process control practices inspection are required to have HACCP verification. The costs per establishment have been shown to reduce plans and meet process control for E. coli testing are shown in Table 2. contamination by harmful foodborne requirements. Nearly all establishments The Agency is requesting information pathogens. that slaughter and process ratites and on the number of establishments where A shift to the mandatory inspection squabs because they also slaughter other ratites or squabs are, or would become, system will eliminate the payment of species under mandatory inspection the major species for slaughter. fees for inspection services. This is not have already implemented HACCP, For those establishments slaughtering a benefit from an economic perspective Sanitation SOPs, and other measures and processing ratites and squabs under as the costs of inspection are transferred consistent with the requirements of this voluntary inspection, the transition to elsewhere in the economy. Since FSIS rule. These establishments will still be mandatory inspection will not require will recover these costs through required to make changes to their changes in equipment and processing appropriated funds, the change to a HACCP or sanitation procedures to methods. Ratites are currently being mandatory inspection system results in include ratites and squabs. slaughtered and processed in an income transfer from the public to Establishments that have not included establishments that are equipped to the ratite and squab industry. The total ratites and squabs in their HACCP process cattle, sheep, goats, and swine. cost savings to the industry would be plans 2 would incur minimal costs Squabs are processed using the same about $2 million in 2001, with the associated with HACCP plan equipment and procedures as those possibility of increasing over time with modification. used for young chickens. the expansion of the industry. As poultry is subject to mandatory Federal inspection, ratites and squabs The Agency estimates that 50% of the Industry Costs will be subject to E. coli testing Federal establishments (50 The compliance cost of extending requirements. Establishments that establishments) and 25% of the State mandatory inspection to ratite and slaughter more than one kind of poultry establishments (24 establishments) may squab species will be negligible. All and livestock are required to test the be required to make minor changes in establishments involved in slaughtering kind of species slaughtered in the their HACCP plan to accommodate amenable species, as of January 25, greatest number. The number of mandatory inspection requirements for 2000, must be in compliance with the establishments where ratites and squabs ratites.

TABLE 2.—POTENTIAL COSTS FOR MANDATORY FEDERAL INSPECTION

Per est. Industry Costs (dollars) ($thousand)

Start up Cost: HACCP Plan Modification ...... 500 37.0 SSOP Modification ...... 100 7.4 Recurring Cost: E. coli Sampling (26 samples@$20 per sample per establishment) ...... 520 38.5 Recordkeeping ...... 300 22.2

Total ...... 1,420 105.1

The Agency seeks comment or further once ratites are officially defined as studies can also be used to develop information pertaining to its cost figures poultry under PPIA regulations, such performance standards for pathogen for mandatory inspection. use will not be allowed in FSIS reduction. The costs of a Other additional costs that would inspected products. FSIS does not have microbiological baseline testing for apply to all establishments applying for information on the types or amounts of ratites are $110,000 and for squabs, Federal mandatory inspection will be product affected by this change, but is $95,000 (Tables 3 and 4). seeking information. the application cost. This cost will be Chemical Residue Testing negligible, as it is limited to a one-time FSIS Costs cost for filling out an application, about The Agency anticipates the need to Chemical residue studies would help $10. The total compliance cost to the conduct baseline microbiological and the Agency determine the presence of establishments identified above are chemical residue studies. These studies violative chemical and drug residues in estimated to be $105,100. constitute the major costs to the Agency ratites and squabs. Chemical residue FSIS is aware that some State totaling $600,000. testing would be necessary to determine inspected ratite product may contain how these additional species would be sodium nitrite and/or sodium nitrate Microbiological Testing incorporated in the Agency’s annual even though the Food and Drug The microbiological studies would residue testing program. FSIS’ one-time Administration (FDA) regulations do help the Agency determine the costs for chemical residue studies for not authorize such use of these prevalence of harmful bacteria or ratites and squabs are $210,000 and substances for ratite products. However, pathogens in ratites and squabs. These $185,000, respectively (Tables 3 and 4).

2 HACCP plans are not required to cover non- amenable species.

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TABLE 3.—COST TO FSIS OF A MANDATORY RATITE INSPECTION PROGRAM

Inspection Thousands of One-time costs hours dollars

Chemical Residue Study ...... 210.0 Microbiological Baseline ...... 110.0

Total ...... 320.0 Transfer Payment:1 Federally-Inspected Ests ...... 38,524 1,959.0 1 The hourly rate for Federal inspection in FY 2000 is estimated to be $38.44 per hour.

TABLE 4.—FSIS MANDATORY SQUAB INSPECTION PROGRAM COSTS

Inspection Thousands of One-time costs hours dollars

Chemical Residue Study ...... 185.0 Microbiological Baseline ...... 95.0

Total ...... 280.0 Transfer Payment:1 Federally-Inspected Ests ...... 322 16.4 1 The hourly rate for Federal inspection in FY 2000 is estimated to be $38.44 per hour.

Transfer Payments inspection that would be brought under voluntary inspection program, the Under voluntary inspection, inspection. Second, an establishment Agency pays half of the inspection establishments pay for inspection currently under a State inspection program costs, or $277,191 (Table 5). services. The funds for mandatory program that is shipping ratites and Under a mandatory program, states inspection activities are appropriated squabs in interstate commerce would would no longer be able to collect fees from Federal tax revenues. The have to shift to Federal inspection to for inspection services. States may transition from voluntary to mandatory maintain its markets. It is expected that decide to terminate their ratite and inspection changes the source of 25% of the establishments under State squab inspection program. If this occurs, inspection program funding. The voluntary inspection would migrate to FSIS will take over inspection at the Agency estimates that the industry cost the Federal mandatory program. The facilities operating under a State of inspection of ratites and squabs for analysis does not take into account the program and thereby absorb the total 1999 in Federal establishments was potential increase in the demand for costs of inspection at these $1,975,000, of which ratites accounted inspection services. Both species establishments. For those states that do for $1,959,000 and squabs, $16,400, currently account for an extremely small not have a State voluntary program for including overhead (Tables 3 and 4). share of meat and poultry inspection. ratites and squabs, the impact of a When ratite and squab inspection Changes in the required level of Federal mandatory inspection program becomes mandatory, it is possible that inspection program personnel are not will be minimal. The payment of these the volume of ratites and squabs expected to be significant in the near- costs at previously State inspected inspected at Federally inspected term. establishments is an income transfer establishments will increase beyond The estimated total cost of inspection similar to that occurring for Federally what is currently being inspected. First, in State establishments is $554,400 for inspected establishments. there may be significant volumes of 14,427 ratites and 1,122,131 squabs for The total transfer payment to Federal ratites and squabs that are currently FY 1999. Under the current agreement and State establishments is $2,252,000 slaughtered and consumed without the Agency has with state having a (1,975,000 plus 277,000).

TABLE 5.—RATITES AND SQUABS INSPECTION COST AT STATE ESTABLISHMENTS—FY 1999

Total Total cost of Number inspection 1 Species inspected hours inspections required ($thousand)

Ratites ...... 14,427 11,510 442.4 Squabs ...... 1,122,131 2,912 111.9

Total ...... 1,136,558 14,422 554.4 1 FSIS hourly base rate of $38.44 times inspection hours required.

Consumer Cost these cost savings to consumers through Economic Impact on International lower prices. Trade Assessment In large part, the costs of ratite and squab inspection are transferred from Countries that previously had little producers to taxpayers. As the burden of interest in export certification may paying for inspection service is petition FSIS if additional species come eliminated, establishments may transfer under mandatory inspection. Foreign

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establishments that specialize in exotic of those statements and actions on the The paperwork and recordkeeping species may seek to broaden their States, on the relationship between the requirements in this final rule will be markets by exporting to the United national government and the States, or approved on an emergency basis by States. The Agency may need to on the distribution of power and OMB under control number 0583– evaluate the equivalence of a greater responsibilities among the various 01120. FSIS is seeking comments on the number of foreign food regulatory levels of government. The Federal Meat paperwork and recordkeeping inspection systems. Inspection Act (FMIA) and the Poultry requirements in this interim final rule Products Inspection Act (PPIA) preempt so that the Agency may receive a three- Executive Order 12866 and Regulatory State and local laws in regard to the year approval for these requirements. Flexibility Act manufacture and distribution of meat Abstract: FSIS has reviewed the Because this interim final rule has and poultry products. Therefore, FSIS paperwork and record keeping been determined to be significant, the policy statements and actions impact requirements in this interim final rule in Office of Management and Budget federalism within the context of these accordance with the Paperwork (OMB) has reviewed it under Executive statutory preemptions. Reduction Act. Under this proposed Order 12866. States and local jurisdictions are rule, FSIS is requiring several The Administrator, FSIS, has preempted by the FMIA and PPIA from information collection and record determined that this interim final rule imposing any marking, labeling, keeping activities. FSIS is requiring that would not have a significant economic packaging, or ingredient requirements establishments slaughtering and impact, as defined by the Regulatory on federally inspected meat and poultry processing ratites and squabs apply for Flexibility Act (5 U.S.C. 601), on a products that are in addition to, or Federal Inspection. Also, these substantial number of small entities. different than, those imposed under the establishments will need to develop and Small establishments will not be FMIA and the PPIA. States and local maintain Sanitation SOPs, HACCP adversely affected by this interim final jurisdictions may, however, exercise plans, and perform testing for E. coli. rule. Few establishments slaughter and concurrent jurisdiction over meat and Estimate of Burden: FSIS estimates process ratites or squabs exclusively. poultry products that are within their that the time to apply for inspection They usually slaughter and process both jurisdiction and outside official would be two hours. The time to amenable and non-amenable species. establishments for the purpose of develop a Sanitation SOP will be two For small slaughtering establishments as preventing the distribution of meat and days (16 hours) and five minutes to file. well as large ones, ratites and squabs do poultry products that are misbranded or FSIS estimates that an establishment not comprise all or even most of their adulterated under the FMIA and PPIA, will spend about 5 minutes a day business. Of the 100 establishments that or, in the case of imported articles, that developing an average of eight slaughter or process ratites and squabs, are not at such an establishment, after monitoring records, per Sanitation SOP, only two slaughter over 90% of the their entry into the United States. and two minutes a day filing each squabs consumed in the market. There Specifically, under section 301 of the record. The time to develop a HACCP are no establishments that dominate the FMIA and section 5 of the PPIA, a State plan or process schedule would take an slaughtering of ratites. Small entities may administer State meat and poultry average of two days (16 hours) and five will benefit along with the rest of the inspection programs provided that it has minutes to file. FSIS estimates that an industry with the increased developed and is effectively enforcing establishment will spend about five marketability of their product and the State meat and poultry inspection minutes a day developing an average of cost savings realized because they will requirements at least equal to those eight monitoring records, per HACCP no longer have to pay fees to either FSIS imposed under titles I and IV of the plan or process schedule, and two or the state for voluntary inspection FMIA and sections 1–4, 6–10, and 12– minutes a day filing each record. The service. 22 of the PPIA. These titles contemplate time to record E. coli testing results continuous ongoing programs. When Executive Order 12988 would be five minutes a day. States can no longer effectively enforce Respondents: Meat and poultry This interim final rule has been meat and poultry inspection product establishments and irradiation reviewed under Executive Order 12988, requirements at least equal to Federal facilities. Civil Justice Reform. This interim final requirements, they must be Estimated Number of Respondents: rule: (1) Preempts State and local laws ‘‘designated’’ by the Secretary to receive 105 (100 ratite and 5 squab and regulations that are inconsistent Federal inspection. establishments). with this rule; (2) has no retroactive When FSIS revises its meat and Estimated Number of Responses per effect; and (3) does not require poultry inspection requirements, States Respondent: 8,252. administrative proceedings before that administer their own inspection Estimated Total Annual Burden on parties may file suit in court challenging programs may be impacted, since they Respondents: 54,758 hours. this rule. However, the administrative must continue to enforce requirements Copies of this information collection procedures specified in 9 CFR 306.5, equal to those of FSIS. To minimize any assessment can be obtained from Lee 381.35, and 590.320 through 590.370, additional costs States must incur to Puricelli, Paperwork Specialist, Food respectively, must be exhausted before modify their inspection programs, FSIS Safety and Inspection Service, USDA, any judicial challenge of the application grants the States significant flexibility 112 Annex, 300 12th SW., Washington, of the provisions of this proposed rule, under the ‘‘equal to’’ provisions of the DC 20250. if the challenge involves any decision of FMIA and PPIA. Further, States are Comments are invited on: (a) Whether an FSIS employee relating to inspection eligible to receive up to 50 percent the collection of information is services provided under the PPIA. Federal matching funds to cover the necessary for the proper performance of costs of their inspection programs. the functions of the Agency, including Executive Order 13132 whether the information will have Executive Order 13132, ‘‘Federalism,’’ Paperwork Reduction Act Requirements practical utility; (b) the accuracy of the requires that Agencies assess the Title: Mandatory Inspection of Ratites Agency’s estimate of the burden of the federalism implications of their policy and Squabs. collection of information including the statements and actions, i.e., the effects Type of Collection: New. validity of the methodology and

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assumptions used: (c) ways to enhance § 362.2 Types and availability of service. (3) The mark of inspection shall be the quality, utility, and clarity of the Upon application, in accordance with applied only under the immediate information to be collected; and (d) § 362.3, the following types of service supervision of an inspector. ways to minimize the burden of the may be furnished under the regulations (4) This service does not cover further collection of information on those who in this part: cutting and processing of products. are to respond, including through the (a) Inspection service. An inspection These activities must take place at an use of appropriate automated, and certification service for official establishment. electronic, mechanical, or other wholesomeness relating to the slaughter (5) The registration and recordkeeping technological collection techniques or and processing of poultry and the requirements enumerated in Part 381, other forms of information technology. processing of poultry products. All subpart Q, of this chapter shall apply to Comments are requested by July 2, provisions of Part 381 and §§ 416.1 persons requesting voluntary 2001. To be most effective, comments through 416.6 of this chapter shall apply identification service under this should be sent to OMB within 30 days to the slaughter of poultry, and the paragraph (c). of the publication date. preparation, labeling, and certification List of Subjects of the poultry and poultry products PART 381—POULTRY PRODUCTS processed under this poultry inspection INSPECTION REGULATIONS 9 CFR Part 362 service except for the following Poultry and poultry products. provisions: the definitions of ‘‘Act,’’ 3. The authority citation for Part 381 ‘‘animal food manufacturer,’’ continues to read as follows: 9 CFR Part 381 ‘‘Inspection Service,’’ ‘‘inspector,’’ Authority: 7 U.S.C. 138f, 450; 21 USC 451– Poultry and poultry products. ‘‘Inspector in Charge,’’ ‘‘poultry,’’ 470; 7 CFR 2.18, 2.53. ‘‘poultry product,’’ ‘‘poultry food PART 362—VOLUNTARY POULTRY product,’’ ‘‘poultry products broker,’’ 4. Section 381.1 (b) is amended by INSPECTION REGULATIONS ‘‘renderer,’’ and ‘‘U.S. Refused Entry’’ in revising the definition of poultry to read §§ 381.1 (b), 381.3 (a), 381.6, 381.10, as follows: For the reasons stated in the 381.13–381.17, 381.21, 381.29, 381.39– Poultry. ‘‘Poultry’’ means any preamble, FSIS is amending 9 CFR 381.42, 381.175 (a)(2), 381.175 (a)(3), domesticated bird (chickens, turkeys, chapter III as follows: 381.179, 381.185–381.187, 381.192, and ducks, geese, guineas, ratites, or squabs, 1. The authority citation for part 362 381.195–381.225. also termed young flightless pigeons), is revised to read as follows: (b) Export certification service. At the whether live or dead. Authority: 7 U.S.C. 1622; 7 CFR 2.18 (g) request of any person intending to * * * * * and (i) and 2.53. export any slaughtered poultry or 5. Amend § 381.36 by revising the poultry product, inspectors may make 2. Sections 362.1 and 362.2 are first sentence of paragraph (b) to read as certification regarding products for revised to read as follows: follows: human food purposes, to be exported, as § 362.1 Definitions. meeting conditions or standards that are § 381.36 Facilities required. not imposed or are in addition to those The definitions in § 381.1 are (b) Facilities for ante mortem imposed by the regulations in this incorporated in this part except for the inspection. A suspect pen is required for chapter and the laws under which such definitions excluded in § 362.2(a). In adequate ratite inspection. * * * addition to those definitions, the regulations were issued. * * * * * following definitions will be applicable (c) Identification Service. (1) Poultry to the regulations in this part. or other product that is federally 6. Amend § 381.66 by revising the (a) Act. ‘‘Act’’ means the Agricultural inspected and passed at an official headings of paragraphs (b) and (c), and Marketing Act of 1946, as amended (60 establishment, or upon importation, by revising paragraph (d)(1) to read as Stat. 1087, as amended; 7 U.S.C. 1621 et under the Poultry Products Inspection follows: seq.). Act, is officially marked to identify it as § 381.66 Temperatures and chilling and (b) Inspector. ‘‘Inspector’’ means any federally inspected and passed. In order freezing procedures. officer or employee of the Department to facilitate the division of such poultry authorized to perform any duties under or other product into smaller portions or * * * * * the regulations in this part. its combination into larger units and (b) General chilling requirements, (c) Person. ‘‘Person’’ means any still maintain its identify as product except for ratites. *** individual, corporation, company, which has been federally inspected and (c) Ice and water chilling association, firm, partnership, society, passed and so marked, inspectors may requirements, except for ratites. *** or joint stock company, or other supervise the handling and weighing of (d) (1) Moisture absorption and organized business unit. the product and mark such portions and retention limits. units with the official mark of (d) Poultry. ‘‘Poultry’’ means any (1) Poultry washing, chilling, and migratory water fowl or game bird, inspection when they determine that identify has been maintained. draining practices and procedures shall whether dead or alive. be such as will minimize moisture (e) Poultry Product. ‘‘Poultry product’’ (2) At the time service is furnished, absorption and retention at time of means any poultry carcass or part product must be sound, wholesome, and packaging. Ratites must meet the thereof; or any human food product fit for human food. The service will be requirements of this paragraph but are which is made wholly or in part from available only on premises other than exempt from the rest of § 381.66(d). the carcass of any domesticated bird (as those of an official establishment. The defined in § 381.1(b) of this chapter) and sanitation of the place or area where * * * * * is excepted from the inspection service is furnished must comply with 7. Amend § 381.67, by revising the requirements of the Poultry Products provisions of §§ 416.1 through 416.6 of text preceding the table and the heading Inspection Act (21 U.S.C. 451 et seq.). this chapter. of the table, to read as follows:

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§ 381.67 Young and squab (b) Dead-on-arrival ratite carcasses shall be segregated from the other slaughter inspection rate maximums under and ratites condemned on ante mortem poultry and held for separate slaughter, traditional inspection procedure under inspection will be tagged ‘‘U.S. evisceration, and post mortem traditional inspection procedure. Condemned’’ by an establishment inspection. The inspector shall be The maximum number of birds to be employee under FSIS supervision and notified when such segregated lots are inspected by each inspector per minute disposed of by one of the methods presented for post mortem inspection, under the traditional inspection prescribed in § 381.95. and inspection of such birds shall be procedure for the different young (c) All seriously crippled ratites and conducted separately. Such procedure chicken and squab slaughter line non-ambulatory ratites, commonly for the correlation of ante mortem and configurations are specified in the termed ‘‘downers,’’ shall be identified as post mortem findings by the inspector, following table. These maximum rates ‘‘U.S. Suspects.’’ as may be prescribed or approved by the will not be exceeded. The inspector in (d) Ratites exhibiting signs of drug or Administrator, shall be carried out. charge will be responsible for reducing chemical poisoning shall be withheld (b) All ratites showing symptoms of production line rates where in the from slaughter. disease will be segregated, individually inspector’s judgment the prescribed (e) Ratites identified as ‘‘U.S. tagged as ‘‘U.S. Suspects’’ by inspection procedure cannot be Suspects’’ or ‘‘U.S. Condemned’’ may be establishment personnel under FSIS adequately performed within the time set aside for treatment. The ‘‘U.S. supervision with a serially numbered available, either because the birds are Suspect’’ or ‘‘U.S. Condemned’’ metal or plastic leg band or tag bearing not presented by the official identification device will be removed by the term ‘‘U.S. Suspect,’’ and held for establishment in such a manner that the an establishment employee under FSIS further examination by an FSIS carcasses, including both internal and supervision following treatment if the veterinarian. Depending upon the external surfaces and all organs, are bird is found to be free of disease. Such findings of the veterinarian’s readily accessible for inspection, or a bird found to have recovered from the examination, these birds will either be because the health conditions of a condition for which it was treated may passed for regular slaughter, slaughtered particular flock dictate a need for a more be released for slaughter or for purposes as suspects, withheld from slaughter, or extended inspection procedure. The other than slaughter, provided that in condemned on ante mortem. Those standards in 381.170(a) of this part the latter instance permission is first ratites affected with conditions that specify which classes of birds constitute obtained from the local, State, or would be readily detected on post young chickens and squabs. Section Federal sanitary official having mortem inspection need not be 381.76(b) specifies when either the jurisdiction over movement of such individually tagged on ante mortem traditional inspection procedure or the birds. inspection with the ‘‘U.S. Suspect’’ tag modified traditional inspection (f) When it is necessary for humane provided that such ratites are segregated procedure can or must be used. reasons to slaughter an injured ratite at and otherwise handled as ‘‘U.S. Maximum Production Line Rates— night or Sunday or a holiday, and the Suspects.’’ All ratites identified as ‘‘U.S. Chickens and Squabs-Traditional Agency veterinary medical officer Condemned’’ shall be tagged by Inspection Procedures cannot be obtained, the carcass and all establishment personnel, under FSIS * * * * * parts shall be kept for inspection, with supervision, with a serially numbered the head and all viscera except the metal or plastic leg band or tag bearing 8. Amend § 381.70 by designating the text as paragraph (a) and by adding gastrointestinal tract held by the natural the term ‘‘U.S. Condemned.’’ paragraph (b) to read as follows: attachment. If all parts are not so kept 11. Amend § 381.76 by revising the for inspection, the carcass shall be introductory text of paragraph (b) (1) to § 381.70 Ante mortem inspection; when condemned. If on inspection of a carcass read as follows: required; extent. slaughtered in the absence of an * * * * * inspector, any lesion or other evidence § 381.76 Post-mortem inspection, when (b) The examination and inspection of is found indicating that the bird was required; extent; traditional, Streamlined Inspection System (SIS), New Line Speed ratites will be on the day of slaughter, sick or diseased, or affected with any (NELS) Inspection System and the New except: other condition requiring condemnation Turkey Inspection (NTI) System; rate of (1) When it is necessary for humane of the animal on ante mortem inspection. reasons to slaughter an injured animal at inspection, or if there is lacking * * * * * night or on a Sunday or holiday, and the evidence of the condition that rendered (b)(1) There are five systems of post- FSIS veterinary medical officer cannot emergency slaughter necessary, the mortem inspection: Streamlined be obtained; or carcass shall be condemned. Ratites that Inspection System (SIS) and the New (2) In low volume establishments, are sick, dying, or that have been treated when ante mortem inspection cannot be Line Speed (NELS) Inspection System, with a drug or chemical and presented both of which shall be used only for done on the day of slaughter, and the for slaughter before the required birds to be slaughtered have received broilers and cornish game hens; the withdrawal period, are not covered by New Turkey Inspection (NTI) System, ante mortem inspection in the last 24 emergency slaughter provisions. hours, provided the establishment has which shall be used only for turkeys; an identification and control system 10. Revise § 381.72 to read as follows: Traditional Inspection; and Ratite over birds that have received ante Inspection. § 381.72 Segregation of suspects on ante * * * * * mortem inspection. mortem inspection. 9. Amend § 381.71 by designating the 12. Revise § 381.96 to read as follows: text as paragraph (a) and by adding (a) All birds, except ratites, that on paragraphs (b), (c), (d), (e), and (f) to ante mortem inspection do not plainly § 381.96 Wording and form of the official inspection legend. read as follows: show, but are suspected of being affected with, any disease or condition Except as otherwise provided in this § 381.71 Condemnation on ante mortem that under §§ 381.80 to 381.93 of this subpart, the official inspection legend inspection. Part may cause condemnation in whole required to be used with respect to * * * * * or in part on post mortem inspection, inspected and passed poultry products

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shall include wording as follows: inflation and a decrease in the projected Paperwork Reduction Act Statement ‘‘Inspected for wholesomeness by U.S. volume of copying by the NRC This final rule does not contain a new Department of Agriculture.’’ This contractor. In addition, the revisions or amended information collection wording shall be contained within a will provide for electronic copying to requirement subject to the Paperwork circle. The form and arrangement of CD–ROM. Reduction Act of 1995 (44 U.S.C. 3501 such wording shall be exactly as EFFECTIVE DATE: The rule is effective et seq.). indicated in the example in Figure 1, June 6, 2001. except that the appropriate official Public Protection Notification establishment number shall be shown, FOR FURTHER INFORMATION CONTACT: If a means used to impose an and if the establishment number Thomas E. Smith, Acting Chief, Public information collection does not display appears elsewhere on the labeling Document Room, Office of the Chief a currently valid OMB control number, material in the manner prescribed in Information Officer, Nuclear Regulatory the NRC may not conduct or sponsor, § 381.123(b), it may be omitted from the Commission, Washington, DC 20555, and a person is not required to respond inspection mark. The administrator may 301–415–7204, or 1–800–397–4209 to, the information collection. approve the use of abbreviations of such (toll-free). Regulatory Analysis inspection mark; and such approved SUPPLEMENTARY INFORMATION: The PDR abbreviations shall have the same force A regulatory analysis has not been retains a copy service to reproduce for and effect as the inspection mark. The prepared for this final rule because the a fee publicly available documents official inspection legend, or the final rule makes only minor conforming whatever their format. Since the NRC’s approved abbreviation thereof, shall be changes to the regulations that reference Agency-wide Document Access and printed on consumer packages and other Section 202 of the Energy Management System (ADAMS) was immediate containers of inspected and Reorganization Act and minor changes implemented in November 2000, passed poultry products, or on labels to to other regulations. making recently released documents be securely affixed to such containers of available in full text online, there has Backfit Analysis such products and may be printed or been a significant reduction in the stenciled thereon, but shall not be The NRC has determined that these volume of document reproduction. The applied by rubber stamping. When amendments do not involve any total volume of copying has fallen from provisions which would impose backfits applied by a stencil, the legend shall not over 3,000,000 pages a year to 1,600,000 as defined in 10 CFR 50.109(a)(1); be less than 4 inches in diameter. An in 2000. Based on first quarter data, the therefore a backfit analysis need not be official brand must be applied to projected level of copying for 2001 will prepared. inspected and passed carcasses and be just under 1,000,000 pages. Since the parts of ratites that are shipped Small Business Regulatory Enforcement copy service contract is at no cost to the unpacked. Fairness Act government, the contractor must Done at Washington, DC, on: April 25, provide all supplies and equipment. In accordance with the Small 2001. The NRC believes that the price increase Business Regulatory Enforcement Thomas J. Billy, is reasonable and in line with the prices Fairness Act of 1996, the NRC has Administrator. charged by other Federal agencies. A determined that this action is not a [FR Doc. 01–10679 Filed 4–26–01; 1:36 pm] market survey showed that the average major rule and has verified this BILLING CODE 3410–DM–P price is 20 cents per page for paper-to- determination with the Office of Editorial Note: Federal Register rule paper copies and 27 cents for Information and Regulatory Affairs of document 01-10679 originally appeared in microfiche-to-paper copies. OMB. the issue of Tuesday, May 1, 2001 at 66 FR The contractor will offer two new List of Subjects in 10 CFR Part 9 21631-21639. Due to several errors (repeated services to the public: copying Criminal penalties, freedom of text and missing text on page 21635) the documents from ADAMS to CD–ROM document is being reprinted in its entirety. information, privacy, reporting and and copying color documents from [FR Doc. R1–10679 Filed 5–4–01; 8:45 am] recordkeeping requirements, the ADAMS to paper. The contractor will be Sunshine Act. BILLING CODE 1505–01–D able to accept orders directly online from ADAMS through the new ADAMS For the reasons set out in the Online Order Module scheduled to be preamble and under the authority of the NUCLEAR REGULATORY released shortly. Atomic Energy Act of 1954, as amended, COMMISSION the Energy Reorganization Act of 1974, Because this amendment concerns an as amended, and 5 U.S.C. 552 and 553, 10 CFR Part 9 agency practice and procedure, the NRC the NRC is adopting the following has determined that notice and amendments to 10 CFR Part 9. [3150–AG78] comment under the Administrative Procedures Act, 5 U.S.C. 553(b) (A) and PART 9—PUBLIC RECORDS Charges for Reproducing Records (B), is unnecessary and that good cause 1. The authority citation for Part 9 AGENCY: exists to dispense with the comment. Nuclear Regulatory continues to read as follows: Commission. Environmental Impact: Categorical Authority: Sec. 161, 68 Stat. 948, as ACTION: Final rule. Exclusion amended (42 U.S.C. 2201); Sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). SUMMARY: The Nuclear Regulatory The NRC has determined that this Commission (NRC) is revising its final rule is the type of action described Subpart A is also issued under 5 U.S.C. 552 regulations to permit its contractor to in categorical exclusion 10 CFR 51.22 and 31 U.S.C. 9701; (Pub. L. 99–570). Subpart increase the charges for copying (c) (1) and (2). Therefore, neither an B is also issued under 5 U.S.C. 552a. Subpart C is also issued under 5 U.S.C. 552b. publicly available documents at the environmental impact statement nor an NRC’s Public Document Room (PDR). environmental assessment has been 2. Section 9.35 is amended by revising The increases are necessary to adjust for prepared for this final rule. paragraph (a)(1) to read as follows:

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