Eligibility of Chile to Export Poultry and Poultry Products to the United States, 61793-61796 [E7-21511]
Download as PDF
Federal Register / Vol. 72, No. 211 / Thursday, November 1, 2007 / Rules and Regulations
Dated: October 15, 2007.
Michael Chertoff,
Secretary.
[FR Doc. E7–21506 Filed 10–31–07; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. FSIS–2007–0024]
RIN 0583–AD25
Eligibility of Chile to Export Poultry
and Poultry Products to the United
States
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
SUMMARY: The Food Safety and
Inspection Service (FSIS) is adding
Chile to the list of countries eligible to
export poultry and poultry products to
the United States. Reviews by FSIS of
Chile’s laws, regulations, and inspection
implementation show that its poultry
inspection system requirements are
equivalent to the relevant provisions of
the Poultry Products Inspection Act
(PPIA) and its implementing
regulations.
With this final rule, poultry and
poultry products processed in certified
Chilean establishments may be exported
to the United States. All such products
will be subject to reinspection at United
States ports-of-entry by FSIS inspectors.
DATES: Effective Dates: December 3,
2007.
Ms.
Sally White, Director, International
Equivalence Staff, Office of
International Affairs; (202) 720–6400.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
The Food Safety and Inspection
Service (FSIS) is amending its poultry
products inspection regulations to add
Chile to the list of countries eligible to
export poultry and poultry products to
the United States (9 CFR 381.196).
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Statutory Basis for Proposed Action
Section 17 of the PPIA (21 U.S.C. 466)
prohibits importation into the United
States of slaughtered poultry, or parts or
products thereof, of any kind unless
they are healthful, wholesome, fit for
human food, not adulterated, and
contain no dye, chemical, preservative,
or ingredient that renders them
unhealthful, unwholesome, adulterated,
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or unfit for human food. Under the PPIA
and the regulations that implement it,
poultry products imported into the
United States must be produced under
standards for safety, wholesomeness,
and labeling accuracy that are
equivalent to those of the United States.
Section 381.196 of Title 9 of the CFR
sets out the procedures by which foreign
countries wanting to export poultry and
poultry products to the United States
may become eligible to do so.
Section 381.196(a) provides that a
foreign country’s poultry inspection
system must include standards
equivalent to those of the United States,
and that the legal authority for the
inspection system and its implementing
regulations must also be equivalent to
those of the United States. Specifically,
a country’s regulations must impose
requirements equivalent to those of the
United States with respect to: (1) Antemortem 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; and (6) official controls
over condemned product.
The foreign country’s inspection
system must ensure that establishments
preparing poultry or poultry products
for export to the United States, and their
products, comply with requirements
equivalent to those of the PPIA and the
regulations promulgated by FSIS under
the authority of that statute. The foreign
country certifies the appropriate
establishments as having met the
required standards. The country must
satisfy FSIS that the certifications it
issues are reliable before FSIS will grant
approval to the country to export
poultry or poultry products to the
United States (9 CFR 381.196). To assess
the reliability of the foreign country’s
certifications, FSIS evaluates the
country’s inspection system and
performs ongoing reviews of that
system. To ensure that products
imported into the United States are safe,
wholesome, and properly labeled and
packaged, FSIS randomly re-inspects
and samples those products before they
enter the United States.
In addition to meeting the
certification requirements, a foreign
country’s inspection system must be
evaluated by FSIS before eligibility to
export poultry or poultry products to
the United States can be granted. This
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61793
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
effect its 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. These five
risk areas, which are the focus of the
evaluation, are 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
https://www.fsis.usda.gov/
regulations_&_policies/
equivalence_process/index.asp.
The PPIA and the regulations that
implement it require that foreign
countries be listed as eligible in the
Code of Federal Regulations. FSIS must
do rulemaking to list a country as
eligible. Countries found eligible to
export poultry or poultry products into
the United States are listed in the
poultry inspection regulations at 9 CFR
381.196(b). Once listed, it is the
responsibility of the eligible country to
certify that establishments meet the
requirements to export poultry or
poultry products to the United States,
and to ensure that products from these
establishments are safe, wholesome, and
not misbranded.
Evaluation of the Chilean Inspection
System for Poultry and Poultry
Products
In response to a request from Chile for
approval to export poultry and poultry
products to the United States, FSIS
conducted a review of Chile’s poultry
slaughter inspection system to
determine whether it is equivalent to
the U.S. poultry inspection system.
First, FSIS compared Chile’s poultry
inspection laws and regulations with
U.S. requirements. The Agency
concluded that the requirements
contained in Chile’s poultry slaughter
inspection laws and regulations are
equivalent to the PPIA and to the
regulations that FSIS has adopted under
the PPIA to effect that statute.
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FSIS then conducted an on-site
review of Chile’s poultry slaughter
inspection system in operation from
August 9 through 18, 2005. The FSIS
review team concluded that, as
implemented, Chile’s poultry slaughter
standards and procedures are equivalent
to those of the United States. As a result,
FSIS published a proposed rule (FSIS–
2006–0030) in the Federal Register of
February 26, 2007 (72 FR 8293–8296),
that would add Chile to the list of
countries eligible to export poultry and
poultry products to the United States.
One comment to the proposed rule
noted a deficiency that FSIS had found
in its 2005 onsite audit of Chile’s
inspection system—that Chile was not
conducting species verification testing
as required—and questioned how, given
that deficiency, FSIS could find Chile’s
system equivalent. On May 10, 2007,
FSIS replied to this question through a
Federal Register document (FSIS–2007–
0016) providing SUPPLEMENTARY
INFORMATION and re-opening the
comment period for the proposed rule
(72 FR 26567) so that the public could
comment on the new information made
available, with comments to be received
by May 25, 2007. In this Federal
Register document, FSIS noted that
Chile had immediately committed to
remedying the deficiency and had
documented the steps that it had taken
to implement species verification
testing. FSIS evaluated the
documentation provided by Chile and
became confident that Chile has
sufficient controls in place to ensure
that species verification testing is being
performed. FSIS documentation of the
materials submitted by Chile to satisfy
the species verification requirement for
poultry can be found online as an
addendum to the 2005 FSIS audit report
on Chile’s poultry inspection system at
https://www.fsis.usda.gov/
regulations_&_policies/
Foreign_Audit_Reports/index.asp.
Comments on the Proposal
The Agency received a total of 13
comments on the proposed rule. All
comments received were in response to
the proposed rule published February
26, 2007. FSIS did not receive any
additional comments to the May 10,
2007, Federal Register document that
re-opened the comment period on the
proposal.
All comments supported the proposal
except one that questioned whether
FSIS import reinspection would be
adequate to prevent public health
threats from entering the United States
from Chile.
With this final rule in effect, any
poultry and poultry products exported
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to the United States from Chile will be
subject to reinspection by FSIS at the
ports-of-entry for transportation damage,
labeling, proper certification, general
condition, and accurate count. FSIS will
also conduct other types of inspection,
including examination of products for
defects and sampling and laboratory
analysis of products for chemical
residues or for microbiological
contamination. Products that pass
reinspection will be stamped with the
official U.S. 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 reexported, destroyed, or converted to
animal food. Thus, FSIS import
reinspection is more than adequate to
prevent products that present a public
health threat from entering the U.S.
Furthermore, the FSIS process to
determine the equivalence of a country’s
meat or poultry inspection system is
independent from any animal health
status determination that may be made
for the same country by USDA’s Animal
and Plant Health Inspection Service
(APHIS). The APHIS declaration
regarding animal health or disease
status, however, also determines
whether a country can export product to
the U.S., as well as the types of products
that would be eligible. Even though a
foreign country is listed in FSIS
regulations as eligible to export poultry
and poultry products to the U.S., those
poultry products must also comply with
all other U.S. requirements before entry.
Before a shipment of poultry or poultry
products may be presented for
reinspection at the port-of entry by
FSIS, it must have first met the
requirements of both U.S. Customs and
Border Protection and APHIS.
APHIS is responsible for keeping
foreign animal diseases out of the
United States. Under Title 9, Part 94 of
the Code of Federal Regulations (9 CFR
Part 94), APHIS sets forth restrictions on
the importation of any fresh, frozen, and
chilled meat and meat products, poultry
and poultry products, and edible
products from countries in which
certain animal diseases exist. APHIS can
independently restrict an eligibility
listing through a ‘‘regionalization’’
process (9 CFR Part 92—Importation of
Animals and Animal Products:
Procedures for Requesting Recognition
of Regions). Those products that APHIS
has restricted from entering the United
States because of animal disease
conditions in the country of origin will
be refused entry before reaching an FSIS
import inspection facility.
FSIS and APHIS work closely together
to ensure that all poultry and poultry
products imported into the United
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States comply with the regulatory
requirements of both agencies. In 1985,
FSIS and APHIS signed a memorandum
of understanding (MOU) in which both
agencies agreed to cooperate in meeting
their respective needs relative to
information exchange of disease
surveillance, diagnostic testing,
investigations, trace backs, and animal
and public health emergencies to
achieve their related objectives of
reducing the spread of animal diseases,
and of providing a wholesome and
economical food supply. The MOU is
updated periodically to ensure that it
addresses areas of importance to both
agencies. In accord with this MOU, FSIS
and APHIS established procedures for
communication between the two
agencies regarding the inspection,
handling, and disposition of imported
meat and poultry products. APHIS and
FSIS communicate regularly to ensure
that products APHIS has restricted from
entering the United States because of
animal disease concerns are not
imported into the United States.
FSIS notes that APHIS has found no
current evidence of animal disease of
consequence in Chile. For all these
reasons, FSIS believes that sufficient
controls are in place to ensure that
poultry and poultry products processed
in Chile will not pose a risk in the U.S.
As a country eligible to export poultry
and poultry products to the United
States, the government of Chile must
certify to FSIS those establishments that
wish to export such products to the
United States and that operate in
accordance with these requirements.
FSIS will retain the right to verify that
the establishments certified by Chile’s
government are meeting the U.S.
requirements and will verify that Chile’s
inspection system meets U.S.
requirements through annual audits.
Therefore, based on its review of the
Chilean system and its consideration of
the comments on the proposal, FSIS
concludes that Chile’s poultry
inspection system is equivalent to that
of the U.S., and therefore, Chilean
poultry establishments that have been
certified by the Chilean government are
eligible to begin exporting product to
the U.S.
Executive Order 12866 and Regulatory
Flexibility Act
This final rule has been reviewed
under Executive Order 12866 by the
Office of Management and Budget
(OMB) and has been determined to be
not significant for purposes of E.O.
12866. This rulemaking will add Chile
to the list of countries eligible to export
poultry and poultry products to the
United States.
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Economic Impact Analysis
This rule was designated as nonsignificant. It is expected that
approximately five establishments in
Chile will be exporting poultry and
poultry products to the U.S. Chile
expects to export raw young chicken
breast (deboned) products, starting in
2007 with 5,000 Metric Tons (MT) and
reaching an estimated 12,000 MT in
2010. These estimates are based on
Chile’s actual and future production
capacity and its decision to maintain an
increasing presence in the export
market. For comparison, FSIS estimated,
based on data from the USDA
Agricultural Marketing Service (AMS)
and the National Agricultural Statistics
Service (NASS), that in 2005 the U.S.
produced about 1,444,000 MT of raw
young chicken breast (deboned)
products. Chile’s estimated initial
exports to the U.S. in 2007 should
represent about three-tenths of one
percent (5,000 MT/1,444,000 MT) of the
U.S. domestic production of raw young
chicken breast (deboned) products, in
2005. Further, if Chile’s exports to the
U.S. reach, in 2010, the estimate of
12,000 MT of raw young chicken breast
(deboned) products, these imports will
represent about eight-tenths of one
percent (12,000 MT/1,444,000 MT) of
the U.S. domestic production of raw
young chicken breast (deboned)
products in 2005.
Expected benefits from this type of
final rule will accrue primarily to
consumers in the form of lower prices.
The small volume of trade stimulated by
this final rule, however, will likely have
little effect on supply and prices.
Consumers, apart from any change in
prices, would benefit in principle from
increased choices at competitive price
points in the marketplace.
The costs of this rule will accrue
primarily to U.S. producers in the form
of greater competition from Chile.
Again, it must be noted that the volume
of trade stimulated by this rule will be
very small, likely having little
discernible effect on supply and prices.
General benefits will include
increased trade with Chile and the
availability to U.S. consumers of a
greater quantity of poultry and poultry
products. Both nations will benefit from
an expansion of trade in poultry and
poultry products as part of a wide range
of commodities.
Constraints on the expansion of trade
in poultry and poultry products
between the United States and Chile are
expected to occur mainly in the form of
restrictions imposed under U.S. animal
health laws. APHIS has agreed to supply
FSIS with evaluations and updates of
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the animal disease status of regions in
Chile where establishments likely to
export poultry and poultry product to
the United States are located.
The additional poultry and poultry
product shipments are likely to have
only a slight effect on the Agency’s
assignment of import inspection
resources at points of entry on the East
and West coasts. It is unlikely, on the
basis of current information, that any
additional import inspection personnel
would need to be hired.
Estimates of benefits and costs of
increased trade in poultry and poultry
products with Chile are based on data
supplied by the FSIS Office of
International Affairs and Office of Field
Operations; Foreign Agricultural Service
(FAS) databases and trade reports;
Economic Research Service (ERS)
databases, reports, and analyses;
Agricultural Marketing Service (AMS)
databases, reports, and analyses;
National Agricultural Statistics Service
(NASS) databases, reports, and analyses;
and Census Bureau databases and
reports. Standard economic analytical
techniques were used in estimating
effects of this rulemaking.
The major source of uncertainty in
estimating the effects of this final rule
is in forecasting the number of
establishments likely to be certified by
Chile to export poultry and poultry
products to the United States. Other,
less important, sources of uncertainty
include imprecision in the economic
data consulted, e.g. estimates of demand
and supply elasticities and probable
errors in multi-year forecasts of prices
for the poultry and poultry product
commodities that would be regulated
under the final rule.
Effect on Small Entities
This final 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 final rule will add Chile to
the list of countries eligible to export
poultry and poultry products to the
United States. The volume of trade
stimulated by this rule will be very
small and will have minimal effect on
poultry and poultry products supplies
and prices.
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this final 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
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61795
(3) Administrative proceedings will
not be required before parties may file
suit in court challenging this rule.
Paperwork Requirements
No new paperwork requirements are
associated with this final rule. Foreign
countries wanting to export poultry and
poultry products to the United States
are required to provide information to
FSIS certifying that their inspection
systems effect standards equivalent to
those of the United States, and that the
legal authority for the systems and their
implementing regulations are equivalent
to those of the United States. FSIS
collects this information one time only.
FSIS gave Chile questionnaires asking
for detailed information about the
country’s inspection practices and
procedures to assist that country in
organizing its materials. This
information collection was approved
under OMB number 0583–0094. The
final rule contains no other paperwork
requirements.
E-Government Act Compliance
The Food Safety and Inspection
Service is committed to complying with
the E-Government Act, to promote the
use of the Internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
ensure that the public and in particular
minorities, women, and persons with
disabilities, are aware of this proposed
rule, FSIS will announce it online
through the FSIS Web page located at
https://www.fsis.usda.gov/
regulations_&_policies/
2007_Interim_&_Final_Rules_Index/
index.asp.
The Regulations.gov Web site is the
central online rulemaking portal of the
United States Government. It is 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
https://www.regulations.gov/.
FSIS will also make copies of this
Federal Register publication available
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Federal Register / Vol. 72, No. 211 / Thursday, November 1, 2007 / Rules and Regulations
through the FSIS Constituent Update,
which is used to provide information
regarding FSIS policies, procedures,
regulations, Federal Register notices,
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 is
also available on the FSIS Web page.
Through Listserv and the Web page,
FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail
subscription service that provides an
automatic and customized notification
when popular pages are updated,
including Federal Register publications
and related documents. This service is
available at https://www.fsis.usda.gov/
news_and_events/email_subscription/
and allows FSIS customers to sign up
for subscription options across eight
categories. Options range from recalls to
export information to regulations,
directives and notices. Customers can
add or delete subscriptions themselves
and have the option to password protect
their accounts.
List of Subjects in 9 CFR Part 381
Imported Products.
For the reasons set out in the
preamble, FSIS is amending 9 CFR part
381 as follows:
I
PART 381—POULTRY PRODUCTS
INSPECTION REGULATIONS
1. The authority citation for part 381
continues to read as follows:
I
Authority: 7 U.S.C. 138f, 450; 21 U.S.C.
451–470; 7 CFR 2.7, 2.18, 2.53.
§ 381.196(b)
[Amended]
2. Section 381.196(b) is amended by
adding Chile in alphabetical order to the
list of countries in paragraph (b).
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I
Done at Washington, DC, on October 29,
2007.
Alfred V. Alamanza,
Administrator.
[FR Doc. E7–21511 Filed 10–31–07; 8:45 am]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2007–0076; Directorate
Identifier 2007–NM–241–AD; Amendment
39–15246; AD 2007–22–10]
RIN 2120–AA64
Airworthiness Directives; Airbus Model
A330–200, A330–300, A340–200, A340–
300, A340–500, and A340–600 Series
Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule; request for
comments.
AGENCY:
SUMMARY: We are superseding an
existing airworthiness directive (AD) for
the products listed above. This AD
results from mandatory continuing
airworthiness information (MCAI)
originated by an aviation authority of
another country to identify and correct
an unsafe condition on an aviation
product. The MCAI describes the unsafe
condition as:
During MLG (main landing gear)
lubrication, a crack was found visually in the
MLG rib 6 aft bearing forward lug on one
A330 in service aircraft. * * * This condition,
if not detected and corrected, could affect the
structural integrity of the MLG attachment.
Failure of the forward lug could result
in collapse of the MLG upon landing.
This AD requires actions that are
intended to address the unsafe
condition described in the MCAI.
DATES: This AD becomes effective
November 16, 2007.
The Director of the Federal Register
approved the incorporation by reference
of certain publications listed in the AD
as of November 16, 2007.
The Director of the Federal Register
approved the incorporation by reference
of certain other publications listed in
the AD as of February 15, 2007 (72 FR
4416, January 31, 2007).
We must receive comments on this
AD by December 3, 2007.
ADDRESSES: You may send comments by
any of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: (202) 493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
• Hand Delivery: U.S. Department of
Transportation, Docket Operations, M–
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30, West Building Ground Floor, Room
W12–40, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://
www.regulations.gov; or in person at the
Docket Operations office between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains this AD, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Operations office (telephone
(800) 647–5527) is in the ADDRESSES
section. Comments will be available in
the AD docket shortly after receipt.
FOR FURTHER INFORMATION CONTACT: Tim
Backman, Aerospace Engineer,
International Branch, ANM–116,
Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton,
Washington 98057–3356; telephone
(425) 227–2797; fax (425) 227–1149.
SUPPLEMENTARY INFORMATION:
Discussion
On January 23, 2007, we issued AD
2007–03–04, Amendment 39–14915 (72
FR 4416, January 31, 2007). That AD
required actions intended to address an
unsafe condition on the products listed
above.
Since we issued AD 2007–03–04, it
has been determined that the previous
modification/repair (interference fit
bushings) cannot be considered as
terminating action to the inspection
because of the unknown root cause of
the cracking.
The European Aviation Safety Agency
(EASA), which is the Technical Agent
for the Member States of the European
Community, has issued Emergency
Airworthiness Directive 2007–0247 R1E, dated September 7, 2007, corrected
October 4, 2007 (referred to after this as
‘‘the MCAI’’), to correct an unsafe
condition for the specified products.
The MCAI states:
During MLG (main landing gear)
lubrication, a crack was found visually in the
MLG rib 6 aft bearing forward lug on one
A330 in service aircraft. The crack had
extended through the entire thickness of the
forward lug at approximately the 4 o’clock
position (when looking forward). Despite
intensive investigation so far, Airbus has not
been able to determine the root cause of this
single event. This condition, if not detected
and corrected, could affect the structural
integrity of the MLG attachment.
Emergency Airworthiness Directive (EAD)
2006–0364–E [which corresponds to FAA AD
2007–03–04] was issued to require repetitive
detailed visual inspections of the LH (left
hand) and RH (right hand) wing MLG rib 6
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Agencies
[Federal Register Volume 72, Number 211 (Thursday, November 1, 2007)]
[Rules and Regulations]
[Pages 61793-61796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21511]
=======================================================================
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. FSIS-2007-0024]
RIN 0583-AD25
Eligibility of Chile to Export Poultry and Poultry Products to
the United States
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is adding Chile
to the list of countries eligible to export poultry and poultry
products to the United States. Reviews by FSIS of Chile's laws,
regulations, and inspection implementation show that its poultry
inspection system requirements are equivalent to the relevant
provisions of the Poultry Products Inspection Act (PPIA) and its
implementing regulations.
With this final rule, poultry and poultry products processed in
certified Chilean establishments may be exported to the United States.
All such products will be subject to reinspection at United States
ports-of-entry by FSIS inspectors.
DATES: Effective Dates: December 3, 2007.
FOR FURTHER INFORMATION CONTACT: Ms. Sally White, Director,
International Equivalence Staff, Office of International Affairs; (202)
720-6400.
SUPPLEMENTARY INFORMATION:
Background
The Food Safety and Inspection Service (FSIS) is amending its
poultry products inspection regulations to add Chile to the list of
countries eligible to export poultry and poultry products to the United
States (9 CFR 381.196).
Statutory Basis for Proposed Action
Section 17 of the PPIA (21 U.S.C. 466) prohibits importation into
the United States of slaughtered poultry, or parts or products thereof,
of any kind unless they are healthful, wholesome, fit for human food,
not adulterated, and contain no dye, chemical, preservative, or
ingredient that renders them unhealthful, unwholesome, adulterated, or
unfit for human food. Under the PPIA and the regulations that implement
it, poultry products imported into the United States must be produced
under standards for safety, wholesomeness, and labeling accuracy that
are equivalent to those of the United States. Section 381.196 of Title
9 of the CFR sets out the procedures by which foreign countries wanting
to export poultry and poultry products to the United States may become
eligible to do so.
Section 381.196(a) provides that a foreign country's poultry
inspection system must include standards equivalent to those of the
United States, and that the legal authority for the inspection system
and its implementing regulations must also be equivalent to those of
the United States. Specifically, a country's regulations must impose
requirements equivalent to those of the United States with respect to:
(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; and
(6) official controls over condemned product.
The foreign country's inspection system must ensure that
establishments preparing poultry or poultry products for export to the
United States, and their products, comply with requirements equivalent
to those of the PPIA and the regulations promulgated by FSIS under the
authority of that statute. The foreign country certifies the
appropriate establishments as having met the required standards. The
country must satisfy FSIS that the certifications it issues are
reliable before FSIS will grant approval to the country to export
poultry or poultry products to the United States (9 CFR 381.196). To
assess the reliability of the foreign country's certifications, FSIS
evaluates the country's inspection system and performs ongoing reviews
of that system. To ensure that products imported into the United States
are safe, wholesome, and properly labeled and packaged, FSIS randomly
re-inspects and samples those products before they enter the United
States.
In addition to meeting the certification requirements, a foreign
country's inspection system must be evaluated by FSIS before
eligibility to export poultry or poultry products to the United States
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 effect its 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. These five risk areas, which are the focus of the
evaluation, are 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 https://
www.fsis.usda.gov/regulations_&_policies/equivalence_process/
index.asp.
The PPIA and the regulations that implement it require that foreign
countries be listed as eligible in the Code of Federal Regulations.
FSIS must do rulemaking to list a country as eligible. Countries found
eligible to export poultry or poultry products into the United States
are listed in the poultry inspection regulations at 9 CFR 381.196(b).
Once listed, it is the responsibility of the eligible country to
certify that establishments meet the requirements to export poultry or
poultry products to the United States, and to ensure that products from
these establishments are safe, wholesome, and not misbranded.
Evaluation of the Chilean Inspection System for Poultry and Poultry
Products
In response to a request from Chile for approval to export poultry
and poultry products to the United States, FSIS conducted a review of
Chile's poultry slaughter inspection system to determine whether it is
equivalent to the U.S. poultry inspection system. First, FSIS compared
Chile's poultry inspection laws and regulations with U.S. requirements.
The Agency concluded that the requirements contained in Chile's poultry
slaughter inspection laws and regulations are equivalent to the PPIA
and to the regulations that FSIS has adopted under the PPIA to effect
that statute.
[[Page 61794]]
FSIS then conducted an on-site review of Chile's poultry slaughter
inspection system in operation from August 9 through 18, 2005. The FSIS
review team concluded that, as implemented, Chile's poultry slaughter
standards and procedures are equivalent to those of the United States.
As a result, FSIS published a proposed rule (FSIS-2006-0030) in the
Federal Register of February 26, 2007 (72 FR 8293-8296), that would add
Chile to the list of countries eligible to export poultry and poultry
products to the United States.
One comment to the proposed rule noted a deficiency that FSIS had
found in its 2005 onsite audit of Chile's inspection system--that Chile
was not conducting species verification testing as required--and
questioned how, given that deficiency, FSIS could find Chile's system
equivalent. On May 10, 2007, FSIS replied to this question through a
Federal Register document (FSIS-2007-0016) providing SUPPLEMENTARY
INFORMATION and re-opening the comment period for the proposed rule (72
FR 26567) so that the public could comment on the new information made
available, with comments to be received by May 25, 2007. In this
Federal Register document, FSIS noted that Chile had immediately
committed to remedying the deficiency and had documented the steps that
it had taken to implement species verification testing. FSIS evaluated
the documentation provided by Chile and became confident that Chile has
sufficient controls in place to ensure that species verification
testing is being performed. FSIS documentation of the materials
submitted by Chile to satisfy the species verification requirement for
poultry can be found online as an addendum to the 2005 FSIS audit
report on Chile's poultry inspection system at https://
www.fsis.usda.gov/regulations_&_policies/Foreign_Audit_Reports/
index.asp.
Comments on the Proposal
The Agency received a total of 13 comments on the proposed rule.
All comments received were in response to the proposed rule published
February 26, 2007. FSIS did not receive any additional comments to the
May 10, 2007, Federal Register document that re-opened the comment
period on the proposal.
All comments supported the proposal except one that questioned
whether FSIS import reinspection would be adequate to prevent public
health threats from entering the United States from Chile.
With this final rule in effect, any poultry and poultry products
exported to the United States from Chile will be subject to
reinspection by FSIS at the ports-of-entry for transportation damage,
labeling, proper certification, general condition, and accurate count.
FSIS will also conduct other types of inspection, including examination
of products for defects and sampling and laboratory analysis of
products for chemical residues or for microbiological contamination.
Products that pass reinspection will be stamped with the official U.S.
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 converted to animal food. Thus, FSIS import
reinspection is more than adequate to prevent products that present a
public health threat from entering the U.S.
Furthermore, the FSIS process to determine the equivalence of a
country's meat or poultry inspection system is independent from any
animal health status determination that may be made for the same
country by USDA's Animal and Plant Health Inspection Service (APHIS).
The APHIS declaration regarding animal health or disease status,
however, also determines whether a country can export product to the
U.S., as well as the types of products that would be eligible. Even
though a foreign country is listed in FSIS regulations as eligible to
export poultry and poultry products to the U.S., those poultry products
must also comply with all other U.S. requirements before entry. Before
a shipment of poultry or poultry products may be presented for
reinspection at the port-of entry by FSIS, it must have first met the
requirements of both U.S. Customs and Border Protection and APHIS.
APHIS is responsible for keeping foreign animal diseases out of the
United States. Under Title 9, Part 94 of the Code of Federal
Regulations (9 CFR Part 94), APHIS sets forth restrictions on the
importation of any fresh, frozen, and chilled meat and meat products,
poultry and poultry products, and edible products from countries in
which certain animal diseases exist. APHIS can independently restrict
an eligibility listing through a ``regionalization'' process (9 CFR
Part 92--Importation of Animals and Animal Products: Procedures for
Requesting Recognition of Regions). Those products that APHIS has
restricted from entering the United States because of animal disease
conditions in the country of origin will be refused entry before
reaching an FSIS import inspection facility.
FSIS and APHIS work closely together to ensure that all poultry and
poultry products imported into the United States comply with the
regulatory requirements of both agencies. In 1985, FSIS and APHIS
signed a memorandum of understanding (MOU) in which both agencies
agreed to cooperate in meeting their respective needs relative to
information exchange of disease surveillance, diagnostic testing,
investigations, trace backs, and animal and public health emergencies
to achieve their related objectives of reducing the spread of animal
diseases, and of providing a wholesome and economical food supply. The
MOU is updated periodically to ensure that it addresses areas of
importance to both agencies. In accord with this MOU, FSIS and APHIS
established procedures for communication between the two agencies
regarding the inspection, handling, and disposition of imported meat
and poultry products. APHIS and FSIS communicate regularly to ensure
that products APHIS has restricted from entering the United States
because of animal disease concerns are not imported into the United
States.
FSIS notes that APHIS has found no current evidence of animal
disease of consequence in Chile. For all these reasons, FSIS believes
that sufficient controls are in place to ensure that poultry and
poultry products processed in Chile will not pose a risk in the U.S.
As a country eligible to export poultry and poultry products to the
United States, the government of Chile must certify to FSIS those
establishments that wish to export such products to the United States
and that operate in accordance with these requirements. FSIS will
retain the right to verify that the establishments certified by Chile's
government are meeting the U.S. requirements and will verify that
Chile's inspection system meets U.S. requirements through annual
audits. Therefore, based on its review of the Chilean system and its
consideration of the comments on the proposal, FSIS concludes that
Chile's poultry inspection system is equivalent to that of the U.S.,
and therefore, Chilean poultry establishments that have been certified
by the Chilean government are eligible to begin exporting product to
the U.S.
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been reviewed under Executive Order 12866 by
the Office of Management and Budget (OMB) and has been determined to be
not significant for purposes of E.O. 12866. This rulemaking will add
Chile to the list of countries eligible to export poultry and poultry
products to the United States.
[[Page 61795]]
Economic Impact Analysis
This rule was designated as non-significant. It is expected that
approximately five establishments in Chile will be exporting poultry
and poultry products to the U.S. Chile expects to export raw young
chicken breast (deboned) products, starting in 2007 with 5,000 Metric
Tons (MT) and reaching an estimated 12,000 MT in 2010. These estimates
are based on Chile's actual and future production capacity and its
decision to maintain an increasing presence in the export market. For
comparison, FSIS estimated, based on data from the USDA Agricultural
Marketing Service (AMS) and the National Agricultural Statistics
Service (NASS), that in 2005 the U.S. produced about 1,444,000 MT of
raw young chicken breast (deboned) products. Chile's estimated initial
exports to the U.S. in 2007 should represent about three-tenths of one
percent (5,000 MT/1,444,000 MT) of the U.S. domestic production of raw
young chicken breast (deboned) products, in 2005. Further, if Chile's
exports to the U.S. reach, in 2010, the estimate of 12,000 MT of raw
young chicken breast (deboned) products, these imports will represent
about eight-tenths of one percent (12,000 MT/1,444,000 MT) of the U.S.
domestic production of raw young chicken breast (deboned) products in
2005.
Expected benefits from this type of final rule will accrue
primarily to consumers in the form of lower prices. The small volume of
trade stimulated by this final rule, however, will likely have little
effect on supply and prices. Consumers, apart from any change in
prices, would benefit in principle from increased choices at
competitive price points in the marketplace.
The costs of this rule will accrue primarily to U.S. producers in
the form of greater competition from Chile. Again, it must be noted
that the volume of trade stimulated by this rule will be very small,
likely having little discernible effect on supply and prices.
General benefits will include increased trade with Chile and the
availability to U.S. consumers of a greater quantity of poultry and
poultry products. Both nations will benefit from an expansion of trade
in poultry and poultry products as part of a wide range of commodities.
Constraints on the expansion of trade in poultry and poultry
products between the United States and Chile are expected to occur
mainly in the form of restrictions imposed under U.S. animal health
laws. APHIS has agreed to supply FSIS with evaluations and updates of
the animal disease status of regions in Chile where establishments
likely to export poultry and poultry product to the United States are
located.
The additional poultry and poultry product shipments are likely to
have only a slight effect on the Agency's assignment of import
inspection resources at points of entry on the East and West coasts. It
is unlikely, on the basis of current information, that any additional
import inspection personnel would need to be hired.
Estimates of benefits and costs of increased trade in poultry and
poultry products with Chile are based on data supplied by the FSIS
Office of International Affairs and Office of Field Operations; Foreign
Agricultural Service (FAS) databases and trade reports; Economic
Research Service (ERS) databases, reports, and analyses; Agricultural
Marketing Service (AMS) databases, reports, and analyses; National
Agricultural Statistics Service (NASS) databases, reports, and
analyses; and Census Bureau databases and reports. Standard economic
analytical techniques were used in estimating effects of this
rulemaking.
The major source of uncertainty in estimating the effects of this
final rule is in forecasting the number of establishments likely to be
certified by Chile to export poultry and poultry products to the United
States. Other, less important, sources of uncertainty include
imprecision in the economic data consulted, e.g. estimates of demand
and supply elasticities and probable errors in multi-year forecasts of
prices for the poultry and poultry product commodities that would be
regulated under the final rule.
Effect on Small Entities
This final 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 final rule will add Chile to the list of countries
eligible to export poultry and poultry products to the United States.
The volume of trade stimulated by this rule will be very small and will
have minimal effect on poultry and poultry products supplies and
prices.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this final 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.
Paperwork Requirements
No new paperwork requirements are associated with this final rule.
Foreign countries wanting to export poultry and poultry products to the
United States are required to provide information to FSIS certifying
that their inspection systems effect standards equivalent to those of
the United States, and that the legal authority for the systems and
their implementing regulations are equivalent to those of the United
States. FSIS collects this information one time only. FSIS gave Chile
questionnaires asking for detailed information about the country's
inspection practices and procedures to assist that country in
organizing its materials. This information collection was approved
under OMB number 0583-0094. The final rule contains no other paperwork
requirements.
E-Government Act Compliance
The Food Safety and Inspection Service is committed to complying
with the E-Government Act, to promote the use of the Internet and other
information technologies to provide increased opportunities for citizen
access to Government information and services, and for other purposes.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this proposed rule, FSIS will announce it
online through the FSIS Web page located at https://www.fsis.usda.gov/
regulations_&_policies/2007_Interim_&_Final_Rules_Index/
index.asp.
The Regulations.gov Web site is the central online rulemaking
portal of the United States Government. It is 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 https://www.regulations.gov/.
FSIS will also make copies of this Federal Register publication
available
[[Page 61796]]
through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, 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 is also available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service that
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at https://www.fsis.usda.gov/news_
and_events/email_subscription/ and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their accounts.
List of Subjects in 9 CFR Part 381
Imported Products.
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For the reasons set out in the preamble, FSIS is amending 9 CFR part
381 as follows:
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
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1. The authority citation for part 381 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
Sec. 381.196(b) [Amended]
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2. Section 381.196(b) is amended by adding Chile in alphabetical order
to the list of countries in paragraph (b).
Done at Washington, DC, on October 29, 2007.
Alfred V. Alamanza,
Administrator.
[FR Doc. E7-21511 Filed 10-31-07; 8:45 am]
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