[Federal Register: August 13, 2004 (Volume 69, Number 156)]
[Proposed Rules]
[Page 50086-50088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au04-14]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 50086]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 327
[Docket No. 01-029P]
RIN 0583-AC91
Addition of San Marino to the List of Countries Eligible To
Export Meat and Meat Products to the United States
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
add San Marino to the list of countries eligible to export meat and
meat products to the United States. Reviews of San Marino's laws,
regulations, and other written materials show that its meat processing
system meets requirements equivalent to all provisions in the Federal
Meat Inspection Act (FMIA) and its implementing regulations.
Although a foreign country may be listed as eligible to export meat
and meat products, products from that country must also comply with all
other U.S. requirements, including those of the U.S. Customs Service
and the restrictions under Title 9, part 94 of the Animal and Plant
Health Inspection Service (APHIS) regulations that relate to the
importation of meat and meat products from foreign countries into the
United States. FSIS and APHIS work closely together to ensure that meat
and meat products imported into the United States comply with the
regulatory requirements of both agencies.
Establishments that would be certified under this proposed
regulation would only be exporting pork products to the United States.
Pork products from San Marino may be imported into the United States
only if these products are from swine slaughtered in certified
slaughter establishments located in other countries eligible to export
meat to the United States and are processed in certified establishments
in San Marino. All meat products exported from San Marino to the United
States would be subject to reinspection at the U.S. ports-of-entry by
FSIS inspectors as required by law.
DATES: Comments must be received on or before October 12, 2004.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by any of the following
methods:
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, 300 12th Street, SW.,
Room 102 Cotton Annex, Washington, DC 20250.
Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions at that site for
submitting comments.
All submissions received must include the Agency name and docket
number 01-029P.
All comments submitted in response to this proposal, as well as
research and background information used by FSIS in developing this
document, will be available for public inspection in the FSIS Docket
Room at the address listed above between 8:30 a.m. and 4:30 p.m.,
Monday through Friday. The comments also will be posted on the Agency's
Web site at http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
FOR FURTHER INFORMATION CONTACT: Ms. Sally White, Director,
International Equivalence Staff, Office of International Affairs; (202)
720-6400.
SUPPLEMENTARY INFORMATION:
Background
FSIS is proposing to amend the Federal meat inspection regulations
to add San Marino to the list of countries eligible to export meat and
meat products to the United States.
Section 20 of the FMIA (21 U.S.C. 620) prohibits the importation
into the United States of carcasses, parts of carcasses, meat or meat
food products of cattle, sheep, swine, goats, horses, mules, or other
equines which are capable of use as human food that are adulterated or
misbranded. The FMIA also requires that livestock from which imported
meat products are produced be slaughtered and handled in connection
with slaughter in accordance with the Humane Slaughter Act (7 U.S.C.
1901-1906). Imported meat products must be in compliance with part 327
of title 9, Code of Federal Regulations (9 CFR part 327) to ensure that
they meet the standards provided in the FMIA. 9 CFR 327.2 establishes
the procedures by which foreign countries wanting to export meat and
meat products to the United States may become eligible to do so.
Section 327.2(a) requires authorities in a foreign country's meat
inspection system to certify that (1) the system provides standards
equivalent to those of the United States and (2) the legal authority
for the system and its implementing regulations are equivalent to those
of the United States. Specifically, a country's regulations must impose
requirements equivalent to those of the United States in the following
areas: (1) Ante-mortem and post-mortem inspection; (2) official
controls by the national government over plant construction,
facilities, and equipment; (3) direct and continuous supervision of
slaughter activities, where applicable, and product preparation by
official inspection personnel; (4) separation of establishments
certified to export from those not certified; (5) maintenance of a
single standard of inspection and sanitation throughout certified
establishments; (6) official controls over condemned product; and (7)
requirements of a Hazard Analysis and Critical Control Point (HACCP)
system within certified establishments.
Section 327.2 also requires a meat inspection system maintained by
a foreign country, with respect to establishments preparing products in
that country for export to the United States, to ensure that those
establishments and their meat products comply with requirements
equivalent to the provisions of the FMIA and the meat product
inspection regulations. Foreign country authorities must be able to
ensure that all certifications required under part 327 of the meat
product inspection regulations (Imported Products) can be relied upon
before USDA-FSIS will grant approval to export meat products to the
United States.
In addition to meeting the certification requirements, a foreign
country's inspection system must be evaluated by FSIS before
eligibility to
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export meat products can be granted. This evaluation consists of two
processes: a document review and an on-site review. The document review
is an evaluation of the laws, regulations, and other written materials
used by the country to operate its meat inspection program. To help the
country in organizing its material, FSIS gives the country
questionnaires asking for detailed information about the country's
inspection practices and procedures in five risk areas, which are the
focus of the evaluation. These five risk areas comprise sanitation,
animal disease, slaughter/processing, residues, and enforcement. FSIS
evaluates the information to verify that the critical points in the
five risk areas are addressed satisfactorily with respect to standards,
activities, resources, and enforcement. If the document review is
satisfactory, an on-site review is scheduled using a multi-disciplinary
team to evaluate all aspects of the country's inspection program,
including laboratories and individual establishments within the
country.
The process of determining equivalence is described fully on the
FSIS Web site at http://www.fsis.usda.gov/OPPDE/IPS/EQ/EQProcess.htm.
Besides relying on its initial determination of a country's
eligibility, coupled with ongoing reviews to ensure that products
shipped to the United States are safe, wholesome and properly labeled
and packaged, FSIS randomly samples imported meat and poultry products
for reinspection as they enter the United States.
Evaluation of the San Marino Inspection System
In response to a request from San Marino in 1997 for approval to
export meat and meat products to the United States, FSIS conducted a
thorough review of the San Marino meat inspection system to determine
if it was equivalent to the U.S. meat inspection system. First, FSIS
compared San Marino's meat inspection laws and regulations with U.S.
requirements. The study concluded that the requirements contained in
San Marino's meat inspection laws and regulations are equivalent to
those mandated by the FMIA and implementing regulations. FSIS then
conducted an on-site review of the San Marino meat inspection system in
operation. The FSIS review team concluded that San Marino's
implementation of meat processing standards and procedures was
equivalent to those of the United States.
All meat products exported to the United States from San Marino
will be subject to reinspection at the ports-of-entry for
transportation damage, labeling, proper certification, general
condition and accurate count. Other types of inspection will also be
conducted, including examining product for defects and performing
laboratory analyses to detect chemical residues or microbial
contamination.
Products that pass reinspection will be stamped with the official
mark of inspection and allowed to enter U.S. commerce. If they do not
meet U.S. requirements, they will be ``Refused Entry'' and must be re-
exported, destroyed or allowed entry for the purpose of converting to
animal food.
Accordingly, FSIS is proposing to amend Sec. 327 of the Federal
meat inspection regulations to add San Marino as a country from which
meat and meat products may be eligible for import into the United
States. As a country eligible to export meat products to the United
States, the government of San Marino would certify to FSIS those
establishments wishing to export such products to the U.S. and
operating according to U.S. requirements. FSIS would retain the right
to verify that establishments certified by the San Marino government
are meeting the U.S. requirements. This would be done through annual
on-site reviews of the establishments while they are in operation.
Although a foreign country may be listed as eligible to export meat
and meat products, products from that country must also comply with all
other U.S. requirements, including those of the U.S. Customs Service
and the restrictions under Title 9, part 94 of the Animal and Plant
Health Inspection Service (APHIS) regulations that relate to the
importation of meat and meat products from foreign countries into the
United States. The Agency notes that APHIS has classified San Marino as
having a substantial risk associated with Bovine Spongiform
Encephalopathy (BSE). Although pork is the specific product proposed
for import into the United States from San Marino, FSIS considered BSE
risk in its evaluation process. APHIS is responsible for keeping
foreign animal diseases out of the United States. APHIS sets forth
restrictions on the importation of any fresh, frozen, and chilled meat,
meat products, and edible products from countries in which certain
animal diseases exist. Those products that APHIS has restricted from
entering the United States will be refused entry.
FSIS and APHIS work closely together and communicate regularly to
ensure that meat and meat products imported into the United States
comply with the regulatory requirements of both agencies.
The full report on San Marino can be found on the FSIS Web site at
http://www.fsis.usda.gov/OPPDE/Far/index.htm.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
It has been determined to be not significant for purposes of E.O. 12866
and therefore, has not been reviewed by the Office of Management and
Budget (OMB).
There is only one establishment in San Marino that has applied to
export meat products to the United States. This establishment would
export non-shelf stable cooked meat products. U.S. imports from this
establishment are expected to total approximately 500,000 pounds per
year.
U.S. firms export small amounts of pork and poultry products to San
Marino. Table A reports the most current information, from 1996-2000,
on U.S. exports of poultry and pork products to San Marino. Poultry
exports were highest in 1994, before declining and eventually falling
to zero. Poultry exports reappeared again in 1998, but again at
relatively low levels. Between 1994 and 2000, U.S. firms exported pork
products to San Marino only once, in 1994. Since then, there have been
no further exports of pork products.
Adoption of this proposed rule would continue to open trade between
the U.S. and San Marino. This proposed rule would also increase the
U.S. food supply.
The impact of this proposed rule on U.S. consumers is voluntary in
that consumers will not be required to purchase meat products produced
and processed in San Marino, although they may choose to do so.
Expected benefits from this type of proposed rule would accrue
primarily to consumers in the form of competitive prices due to a
larger market variety of meat products. The volume of trade stimulated
by this proposed rule, however, will likely be so small as to have
little effect on supply and prices. Consumers, apart from any change in
prices, would
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benefit from increased choices in the marketplace.
The costs of this rule will accrue primarily to producers in the
form of greater competition from San Marino. Again, it must be noted
that the volume of trade stimulated by this rule would be very small,
likely having little effect on supply and prices. Nonetheless, it is
possible that U.S. firms that produce products that would compete with
San Marino imports could face short-term difficulty. However, in the
long run, such firms could adjust their product mix in order to compete
effectively.
Table A.--U.S. Exports of Poultry and Pork Products to San Marino 1996-
2000
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Average
Calendar year Quantity Value price per
(tons) ($1,000) ton
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Poultry:
1996............................... 0 $0.00 NA
1997............................... 0 0.00 NA
1998............................... 68 68 $1.00
1999............................... 24 14 0.58
2000............................... 69 55 0.80
Pork:
1996............................... 0 $0.00 NA
1997............................... 0 0.00 NA
1998............................... 0 0.00 NA
1999............................... 0 0.00 NA
2000............................... 0 0.00 NA
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Effect on Small Entities
The Administrator, FSIS, has made an initial determination that
this proposed rule will not have a significant impact on a substantial
number of small entities, as defined by the Regulatory Flexibility Act
(5 U.S.C. 601). This proposed rule would add San Marino to the list of
countries eligible to export meat products into the United States.
Currently, only one San Marino establishment has applied to export
product to the United States. This establishment is planning to export
approximately 500,000 pounds of non-shelf stable cooked meat products
to the United States per year. The volume of trade stimulated by this
rule would be very small, likely having little effect on supply and
prices. Therefore, this proposed rule is not expected to have a
significant impact on small entities that produce these types of
products domestically.
Paperwork Requirements
No new paperwork requirements are associated with this proposed
rule. Foreign countries wanting to export livestock products to the
United States are required to provide information to FSIS certifying
that its inspection system provides standards equivalent to those of
the United States and that the legal authority for the system and its
implementing regulations are equivalent to those of the United States
before they may start exporting such product to the United States. FSIS
collects this information one time only. FSIS gave San Marino
questionnaires asking for detailed information about the country's
inspection practices and procedures to assist the country in organizing
its materials. This information collection was approved under OMB
number 0583-0094. The proposed rule contains no other paperwork
requirements.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. In an effort to ensure that this notice comes
to the attention of the public--including minorities, women, and
persons with disabilities--FSIS will announce it on-line through the
FSIS Web page located at http://www.fsis.usda.gov. The Regulations.gov
Web site is the central online rulemaking portal of the United States
government. It is being offered as a public service to increase
participation in the Federal government's regulatory activities. FSIS
participates in Regulations.gov and will accept comments on documents
published on the site. The site allows visitors to search by keyword or
Department or Agency for rulemakings that allow for public comment.
Each entry provides a quick link to a comment form so that visitors can
type in their comments and submit them to FSIS. The Web site is located
at http://www.regulations.gov.
FSIS also will 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, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
broader and more diverse audience.
List of Subjects in 9 CFR Part 327
Imports, Meat and meat products.
For the reasons set out in the preamble, 9 CFR part 327 would be
amended as follows:
PART 327--IMPORTED PRODUCTS
1. The authority citation for part 327 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 327.2 [Amended]
2. Section 327.2 would be amended by adding ``San Marino'' in
alphabetical order to the list of countries in paragraph (b).
Done in Washington, DC, on August 1, 2004.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 04-18567 Filed 8-12-04; 8:45 am]
BILLING CODE 3410-DM-P