[Federal Register Volume 74, Number 63 (Friday, April 3, 2009)]
[Rules and Regulations]
[Pages 15215-15218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7507]



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Rules and Regulations
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Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Rules 
and Regulations

[[Page 15215]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 166

[Docket No. APHIS-2008-0120]
RIN 0579-AC91


Swine Health Protection; Feeding of Processed Product to Swine

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the swine health protection regulations to 
clarify the applicability of the regulations regarding the treatment of 
garbage that consists of industrially processed materials. This interim 
rule makes clear that such materials are subject to the same treatment 
requirements as other regulated garbage, except for materials that meet 
the definition of processed product that we are adding to the 
regulations. This action is necessary to ensure that garbage fed to 
swine has been treated to inactivate disease organisms that pose a risk 
to the U.S. swine industry.

DATES: This interim rule is effective April 3, 2009. We will consider 
all comments that we receive on or before June 2, 2009.

ADDRESSES: You may submit comments by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0120 to submit or view comments and 
to view supporting and related materials available electronically.
    <bullet> Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0120, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0120.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Dave Pyburn, Senior Staff 
Veterinarian, Swine Health Programs, VS, APHIS, Room 891, 210 Walnut 
Street, Des Moines, IA 50309; (515) 284-4122.

SUPPLEMENTARY INFORMATION:

Background

    The Swine Health Protection Act (7 U.S.C. 3801 et seq., referred to 
below as the Act) is intended to protect the commerce of the United 
States and the health and welfare of the people of the United States by 
ensuring that food waste fed to swine does not contain active disease 
organisms that pose a risk to U.S. swine. The regulations in 9 CFR part 
166 regarding swine health protection (referred to below as the 
regulations) were promulgated in accordance with the Act. The 
regulations contain provisions that regulate food waste containing any 
meat products fed to swine. Compliance with the regulations ensures 
that all food waste fed to swine is properly treated to kill disease 
organisms. Raw or undercooked meat may transmit numerous infectious or 
communicable diseases to swine, including exotic viral diseases such as 
foot-and-mouth disease, African swine fever, classical swine fever, and 
swine vesicular disease. In accordance with the regulations, food waste 
containing meat may be fed to swine only if it has been treated to kill 
disease organisms.
    In part 166 of the regulations, such food waste is referred to as 
``garbage.'' In Sec.  166.1, garbage is defined as ``[a]ll waste 
material derived in whole or in part from the meat of any animal 
(including fish and poultry) or other animal material, and other refuse 
of any character whatsoever that has been associated with any such 
material, resulting from the handling, preparation, cooking or 
consumption of food, except that such term shall not include waste from 
ordinary household operations which is fed directly to swine on the 
same premises where such household is located.''
    Under Sec.  166.2 of the regulations, with some exceptions 
discussed below, garbage may not be fed to swine unless it is first 
treated in accordance with the requirements of part 166 at a facility 
operated by a person holding a valid license for the treatment of 
garbage. The regulations in Sec.  166.7 require that garbage be heated 
throughout at boiling (212 [deg]F or 100 [deg]C at sea level) for 30 
minutes before being fed to swine. Requirements regarding the licensing 
of facilities that treat garbage for feeding to swine are contained in 
Sec.  166.10.
    The requirement that the material be heated throughout at boiling 
takes into account a margin of safety to ensure that disease organisms 
of concern are inactivated. Although the scientific literature 
recognizes that heating meat throughout at 167 [deg]F (75 [deg]C) for 
30 minutes is sufficient to inactivate the disease organisms,\1\ in 
many cases it is difficult on a practical level to determine precisely 
when every piece of meat in the garbage being treated has been heated 
to 167 [deg]F throughout. Larger pieces of meat may take longer than 
smaller pieces to reach that temperature throughout. By requiring that 
garbage be heated at boiling throughout for 30 minutes, the regulations 
have provided a documentable and easily visible way to ensure that meat 
has been heated to a temperature sufficient to inactivate disease 
organisms of concern.
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    \1\ McKercher P.D., J.H.Graves, J.J. Callis, and F. Carmichael. 
(1974). Swine vesicular disease: virus survival in pork products. 
Proceedings of the Annual Meeting of the U.S. Animal Health 
Association; (78):213a-213g.
    Edwards, S. (2000). Survival and inactivation of classical swine 
fever virus. Vet Microbiol. Apr 13; 73(2-3):175-81.
    Scott Williams Consulting Pty Ltd. (2003), Persistence of 
Disease Agents in Carcasses and Animal Products. Report for Animal 
Health Australia, December.
    World Organization for Animal Health (OIE). (2008).

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[[Page 15216]]

    Although the general requirement is that garbage be heated at 
boiling for 30 minutes before being fed to swine, the regulations do 
contain certain exceptions. There are some materials that meet the 
definition of garbage that APHIS has determined can be safely fed to 
swine without being heated at boiling for 30 minutes. These materials, 
which are listed in Sec.  166.2, are the following: Rendered products, 
bakery waste, candy waste, eggs, domestic dairy products (including 
milk), fish from the Atlantic Ocean within 200 miles of the continental 
United States or Canada, and fish from inland waters of the United 
States or Canada that do not flow into the Pacific Ocean.\2\ In 
addition to exempting the listed materials from the heating 
requirements in Sec.  166.7, the regulations provide that it is not 
necessary that the materials be treated by a person licensed to do so 
under the requirements of Sec.  166.10.
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    \2\ The rationale for exempting rendered products from the 
garbage regulations was addressed in rulemaking that culminated in a 
final rule published in the Federal Register on May 18, 1983 (48 FR 
22288-22290, Docket No. 83-024). The other products listed were 
addressed in rulemaking that culminated in a final rule published in 
the Federal Register on April 12, 1984 (48 FR 14495-14497, Docket 
No. 83-115).
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    In this interim rule, we are adding another type of material to the 
list in Sec.  166.2 of materials that are exempted from the treatment 
and licensing requirements of Sec. Sec.  166.7 and 166.10. We refer to 
the type of material we are adding to the list of exempted materials as 
``processed products'' and define processed product in Sec.  166.1. In 
defining processed product, we are reinforcing that materials that are 
similar to processed product, but that do not meet the full definition 
of processed product, are subject to the treatment requirements of part 
166. In the following paragraphs, we discuss our definition of 
processed product and our rationale for exempting it from the 
requirements of Sec. Sec.  166.7 and 166.10.
    The swine health protection regulations that were implemented in 
1983 were designed to address the materials and method of treatment 
that were commonly used at that time to treat garbage for feeding to 
swine--i.e., the cooking over an open flame of food waste from 
restaurants, grocery stores, and other food establishments. Subsequent 
to establishment of the regulations, however, certain swine producers 
began to use materials from other than the traditional sources of 
garbage as feed for swine.
    It has become increasingly common for producers to feed to swine 
products that have undergone industrial processing, such as pet foods 
or pre-cooked foods that are used for canning for human consumption. In 
some cases, such products have been heated to at least 167 [deg]F for 
at least 30 minutes as part of the processing procedure; in other 
cases, the products have not been so heated. Failure to heat such 
products to the minimum heat necessary for the minimum period of time 
necessary to inactivate disease organisms of concern could expose swine 
to which the products are fed to the risk of infection by the 
organisms.
    However, because commercially produced food products that contain 
meat and that have undergone industrial processing often differ in 
appearance, production process, and source from materials traditionally 
viewed as ``garbage,'' we have found that some swine producers are not 
aware they are feeding to swine material that meets the definition of 
garbage and thus must be heated throughout according to the regulations 
in part 166. Therefore, we consider it necessary in this interim rule 
to specifically address the way in which industrially processed 
foodstuffs intended for feeding to swine are regulated.
    If such industrially processed products contain meat, they meet the 
definition of garbage in Sec.  166.1 and, in general, must be heated 
throughout at boiling or an equivalent temperature for 30 minutes to be 
eligible for feeding to swine. However, in some cases, the procedures 
used to process such materials are controlled and monitored in such a 
way that it is possible for the processors of the material to 
demonstrate that the materials have been heated throughout to at least 
167 [deg]F for at least 30 minutes, making the additional ``margin of 
safety'' of heating the material at boiling unnecessary. In such cases, 
we consider it warranted to exempt those materials from the requirement 
in Sec.  166.7 that the garbage be heated at boiling for 30 minutes 
before being fed to swine. Therefore, in this interim rule, we are 
amending the regulations to include an exemption in Sec.  166.2 for 
such materials, which we define in this interim rule as processed 
product.
    We are adding to Sec.  166.1 the following definition of processed 
product: ``Material derived in whole or in part from the meat of any 
animal (including fish and poultry) or other animal material, and other 
refuse of any character whatsoever that has been associated with any 
such material, that has undergone an industrial manufacturing procedure 
to prevent spoilage or add shelf stability, and that has, at a minimum, 
been cooked to a temperature of 167 [deg]F (75 [deg]C) for at least 30 
minutes or has been subjected to an industrial process demonstrated to 
provide an equivalent level of inactivation of disease organisms, as 
approved by the Administrator.'' Although heating is the standard 
method of inactivating the disease organisms addressed by the swine 
health regulations, we recognize that other industrial manufacturing 
procedures might exist, or might come to exist, that can be 
demonstrated to be equally effective in reducing disease risk, and we 
allow for that possibility in our definition of processed product.
    We note that Sec.  166.10(a) provides that types of garbage listed 
in Sec.  166.2 as being exempt from the treatment requirements in Sec.  
166.7--which, under this interim rule, includes processed products--are 
also exempted from the requirement that the garbage be treated by a 
person licensed to treat garbage under Sec.  166.10.

Immediate Action

    Immediate action is necessary to ensure that swine producers are 
aware that all garbage other than that specifically exempted from the 
heating and licensing requirements of part 166 must be heated 
throughout at boiling (212 [deg]F or 100 [deg]C at sea level) for 30 
minutes before it is fed to swine. Under these circumstances, the 
Administrator has determined that prior notice and opportunity for 
public comment are contrary to the public interest and that there is 
good cause under 5 U.S.C. 553 for making this action effective less 
than 30 days after publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule.

Executive Order 12866 and Regulatory Flexibility Act

    This interim rule has been reviewed under Executive Order 12866. 
The rule has been determined to be not significant for the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities.
    The regulations require that garbage to be fed to swine be heated 
throughout at 212 [deg]F (100 [deg]C) or above for 30 minutes

[[Page 15217]]

before being fed, and that the garbage be treated at a facility 
operated by a person holding a valid license for the treatment of 
garbage. This interim rule makes clear that food waste consisting of 
industrially processed products (such as, but not limited to, pet foods 
or foods cooked for canning for human consumption) that meet the 
definition of garbage is subject to the same requirements as other 
regulated garbage, except for materials that meet the definition of 
processed product. In this interim rule, we define processed product as 
``material derived in whole or in part from the meat of any animal 
(including fish and poultry) or other animal material, and other refuse 
of any character whatsoever that has been associated with any such 
material, that has undergone an industrial manufacturing procedure to 
prevent spoilage or add shelf stability, and that has, at a minimum, 
been cooked to a temperature of 167 [deg]F (75 [deg]C) for at least 30 
minutes or has been subjected to an industrial process demonstrated to 
provide an equivalent level of inactivation of disease organisms, as 
approved by the Administrator''.
    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) 
requires agencies to evaluate the potential effects of rules on small 
businesses, small organizations, and small governmental jurisdictions. 
Section 605 of the Regulatory Flexibility Act allows an agency to 
certify that a rule will not have a significant economic impact on a 
substantial number of small entities. Following is the factual basis 
for such certification of this rule. As background, we first provide 
national statistics on the U.S. swine and pork industries. We then 
describe the expected effects of the rule on swine producers who 
include food waste as part of feed for swine.

The U.S. Swine and Pork Industries

    The U.S. swine industry plays an important role in the U.S. 
economy. Cash receipts from marketing meat animals were about $14.8 
billion in 2007 (the average between 2003 and 2007 was $13.8 
billion).\3\ Additionally, swine and related product exports generated 
over $2.5 billion in sales that year.\4\ At present, U.S. swine and 
swine product exports proceed without disease-related restrictions. 
Maintaining such favorable export conditions depends in part on 
continued efforts to prevent transmission of foreign diseases to U.S. 
swine.
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    \3\ USDA/ERS, Farm Income Costs: Farm Sector Income Forecast, 
http://www.ers.usda.gov/briefing/farmincome/data/cr_t3.htm.
    \4\ http://www.fas.usda.gov/dlp/circular//2008/livestock_poultry_04-2008.pdf.
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    As shown in table 1, U.S. pork production increased from 7,835,000 
metric tons in 1997 to 9,962,000 metric tons in 2007, an annual growth 
rate of about 1.8 percent. During the same period, consumption 
increased from 7,631,000 metric tons to 8,964,000 metric tons, and U.S. 
exports increased from 473,000 metric tons to 1,424,000 metric tons, by 
far outpacing imports. Net exports increased from 185,000 metric tons 
to 985,000 metric tons.\5\
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    \5\ USDA/FAS, PS&D Online, 1996-2007, http://www.fas.usda.gov/dlp/circular//2008/livestock_poultry_04-2008.pdf.

                                  Table 1--U.S. Pork Production, Consumption, Price, Exports and Imports, 1997-2007 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Production in  Consumption in                    Exports in      Imports in    Net exports in
                          Year                             1,000 metric    1,000 metric      Price per     1,000 metric    1,000 metric    1,000 metric
                                                               tons            tons         metric ton         tons            tons            tons
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1997....................................................           7,835           7,631          $1,562             473             288             185
1998....................................................           8,623           8,305           1,170             558             320             238
1999....................................................           8,758           8,594           1,178             582             375             207
2000....................................................           8,596           8,455           1,413             584             438             146
2001....................................................           8,691           8,389           1,473             707             431             276
2002....................................................           8,929           8,685           1,179             731             486             245
2003....................................................           9,056           8,816           1,298             779             538             241
2004....................................................           9,312           8,817           1,621             989             499             490
2005....................................................           9,392           8,671           1,562           1,207             464             743
2006....................................................           9,559           8,640           1,404           1,359             449             910
2007....................................................           9,962           8,964           1,433           1,424             439             985
5-Year Average (2003-2007)..............................           9,456           8,782           1,464           1,152             478             674
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\1\ Sources: USDA/FAS, PS&D Online, 1997-2007, http://www.fas.usda.gov/dlp/circular//2008/livestock_poultry_04-2008.pdf; prices, reported as $/100
  pounds for yearly pork carcass cut-out values, are converted to dollars per metric ton, and are taken from Red Meat Yearbook (94006), http://usda.mannlib.cornell.edu/usda/ers/94006/wholesaleprices.xls. The 2006 and 2007 per metric ton prices are from USDA/ERS, Livestock, Dairy, and Poultry
  Outlook, Feb. 20, 2007, and Jan.18, 2008. Net exports are calculated as the difference between exports and imports for each year.

Effects of the Interim Rule

    The amount of food waste that meets the definition of garbage under 
Sec.  166.1 represents a very small fraction of total commercial 
feeding of swine in the United States.\6\ According to a study in 2000, 
there were 300,000 market swine fed with about 550,000 tons of food 
waste in 1997.\7\ The number of market swine fed such food waste has 
since declined. At present, there are 2,722 licensed garbage feeders 
producing about 160,000 market swine per year.\8\ Assuming the same 
ratio as in 1997 between the numbers of market swine fed food waste and 
the quantity of such food waste utilized, the amount of food waste fed 
to swine in 2007 is estimated to have been about 293,330 tons. These 
quantities of swine and feed are very small, compared to the total 
number of market swine produced in the United States (0.12 percent) and 
the total tonnage of commercial feed utilized (0.6 
percent).<SUP>9 10</SUP>
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    \6\ Food waste includes plate waste (62.01%), eggs (0.13%), 
unpasteurized dairy (1.06%), fish (1.11%), bakery waste (8.94%), 
slaughter by-products (0.02%), other products of animal origin 
(13.45%), and other waste products of non-animal origin (such as 
candy, brewers waste, etc.). USDA/APHIS/VS, 2001 National Waste 
Feeding Report, June 2003.
    \7\ Felix J. Spinelli and Barbara Corso, ``The Economics of 
Feeding Processed Food Waste to Swine'' in Michael L. Westendorf 
(ed.) Food Waste in Animal Feed, Iowa State University Press, 2000.
    \8\ USDA/APHIS/VS, Swine Health Protection Reports, October 
2008, and personal communication with APHIS, Veterinary Services.
    \9\ USDA/NASS, Meat Animal Production, Disposition, and Income: 
2007 Summary, April 2008 (137,758,900 swine were marketed in 2007).
    \10\ Total tons of swine feed is estimated as follows: 
137,758,900 market swine, multiplied by 716 pounds of feed per 
swine, divided by 2000 pounds per ton, where 716 pounds of feed per 
swine is taken from the National Pork Producer Council, Swine 
Industry Crisis, April 2008 (http://www.wppa.org/Portals/wppa/WebEconomicImpactFinalpdf.pdf), and 137,758,900 market swine is from 
footnote 9. We note that the 716 pounds of feed consumption per 
animal is less than half of the food waste consumption per garbage-
fed animal reported by Spinelli and Corso (2000).

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[[Page 15218]]

    This interim rule provides that, although industrially processed 
products that meet the definition of garbage must, as a general rule, 
be heated at boiling for 30 minutes before being fed to swine, those 
materials that meet the definition of processed product (i.e., that 
have undergone an industrial manufacturing procedure to prevent 
spoilage or add shelf stability, and that have, at a minimum, been 
cooked to a temperature of 167 [deg]F (75 [deg]C) for at least 30 
minutes or have been subjected to an industrial process demonstrated to 
provide an equivalent level of inactivation of disease organisms, as 
approved by the Administrator) are exempt from the requirement for 
boiling. The main heat treatment methods used by garbage feeders are 
direct-fire cookers (mostly for smaller loads) and steam injection 
cookers (larger loads). Spinelli and Corso (2000) assumed an average 
heating cost of $5 per ton in 1997 (or about $6.67 per ton in 2008 
dollars) for food waste heated at 212 [deg]F for 30 minutes.\11\
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    \11\ Felix J. Spinelli and Barbara Corso, ``The Economics of 
Feeding Processed Food Waste to Swine'' in Michael L. Westendorf 
(ed.) Food Waste in Animal Feed, Iowa State University Press, 2000.
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    We do not know what proportion of garbage as defined in part 166 is 
derived in whole or in part from animal material that has undergone 
heating to 167 [deg]F for 30 minutes or has been subjected to an 
industrial process that provides an equivalent level of disease 
mitigation. As an illustrative example of the potential effect of this 
rule on producers who feed to swine those materials that meet the 
definition of processed product, if such materials were to comprise 5 
percent of garbage fed to swine, then the cost to producers who feed 
such materials could be nearly $100,000 less overall than it would be 
if all such processed product were treated by being heated at boiling 
for 30 minutes.\12\
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    \12\ An estimated 293,330 tons of food waste used in 2007, 
multiplied by a heating cost of $6.67 per ton, multiplied by 5 
percent equals $97,826.
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Affected Small Entities

    The Small Business Administration (SBA) has established size 
standards for determining whether firms are considered small under the 
Regulatory Flexibility Act. The majority of U.S. swine producers (NAICS 
112210) are small entities, based on the SBA small-entity standard of 
not more than $750,000 in annual receipts.\13\ In 2007, there were a 
total 2,722 feeders that potentially could be affected by this rule, 
depending upon whether they include processed products in their feed. 
The average income of these entities is estimated to be about $4,290, 
well below the small-entity size standard.\14\
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    \13\ SBA, Small Business Size Standards matched to North 
American Industry Classification System 2002, Effective July, 2006 
(http://www.sba.gov/size/sizetable2002.html).
    \14\ This average income is calculated by multiplying the number 
of market swine fed food waste by their average market value, and 
dividing that product by the number of garbage feeders in 2007: 
160,000*$73/2,722 = $4,290.96.
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Summary

    Producers known to feed garbage to swine numbered 2,722 in 2007 
(about 3 percent of all swine producers), and produced only about 0.12 
percent of the swine marketed that year. Of these producers, the cost 
of feeding garbage to swine will be less for those who use processed 
products as feed. The rule will also provide swine producers who do not 
currently feed garbage to swine the option of feeding to swine 
processed product that is not required to be heated at boiling for 30 
minutes at a licensed facility.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are in conflict 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.

Paperwork Reduction Act

    This interim rule contains no information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 166

    Animal diseases, Hogs, Reporting and recordkeeping requirements.

0
Accordingly, we are amending 9 CFR part 166 as follows:

PART 166--SWINE HEALTH PROTECTION

0
1. The authority citation for part 166 continues to read as follows:

    Authority:  7 U.S.C. 3801-3813; 7 CFR 2.22, 2.80, and 371.4.


0
2. In Sec.  166.1, a definition of processed product is added, in 
alphabetical order, to read as follows:


Sec.  166.1   Definitions in alphabetical order.

* * * * *
    Processed product. Material derived in whole or in part from the 
meat of any animal (including fish and poultry) or other animal 
material, and other refuse of any character whatsoever that has been 
associated with any such material, that has undergone an industrial 
manufacturing procedure to prevent spoilage or add shelf stability, and 
that has, at a minimum, been cooked to a temperature of 167 [deg]F (75 
[deg]C) for at least 30 minutes or has been subjected to an industrial 
process demonstrated to provide an equivalent level of inactivation of 
disease organisms, as approved by the Administrator.
* * * * *


Sec.  166.2   [Amended]

0
3. In Sec.  166.2, paragraph (a) is amended by adding the words 
``Processed products;'' immediately after the words ``any of the 
following:''.

    Done in Washington, DC, this 31st day of March 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-7507 Filed 4-2-09; 8:45 am]
BILLING CODE 3410-34-P