[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Proposed Rules]
[Pages 70714-70724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28751]
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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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Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 /
Proposed Rules
[[Page 70714]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 304, 327, 381, and 590
[Docket No. FSIS-2009-0022]
RIN 0583-AD39
Electronic Import Inspection Application and Certification of
Imported Products and Foreign Establishments; Amendments To Facilitate
the Public Health Information System (PHIS) and Other Changes To Import
Inspection Regulations
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
amend the meat, poultry, and egg products import regulations to provide
for the Agency's Public Health Information System (PHIS) Import
Component. The PHIS Import Component, launched on May 29, 2012,
provides an electronic alternative to the paper-based import inspection
application and imported product foreign inspection and foreign
establishment certificate processes. In addition, the Agency is
proposing to delete the discontinued ``streamlined'' import inspection
procedures for Canadian product and to require Sanitation Standard
Operating Procedures (SOPs) at official import inspection
establishments. In addition to the proposed regulatory amendments
outlined above, FSIS is announcing its intention to discontinue its
practice of conducting imported product reinspection based on a foreign
government's guarantee to replace a lost or incorrect foreign
inspection certificate and is clarifying its policy of addressing
imported product that is not presented for reinspection.
DATES: Submit comments on or before January 28, 2013.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by one of the following
methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Patriots
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A,
Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to Patriots
Plaza 3, 355 E. Street SW., Room 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2009-0022. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 8-
164A, Washington, DC 20250-3700 between 8:30 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Ms. Mary Stanley, Director,
International Policy Division, Office of Policy and Program
Development, FSIS, U.S. Department of Agriculture, 1400 Independence
Avenue SW., Room 2125, Washington, DC 20250-3700, Phone: (202)720-0287.
SUPPLEMENTARY INFORMATION:
Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 620) and the
Poultry Products Inspection Act (PPIA) (21 U.S.C. 466) prohibit the
importation of meat and poultry products into the United States if such
products are adulterated or misbranded and unless they comply with all
the inspection and other requirements of the Acts and regulations as
are applied to domestic products. The Egg Products Inspection Act
(EPIA) (21 U.S.C. 1046) prohibits the importation of egg products
unless they were processed under an approved continuous inspection
system of the government of the foreign country of origin and comply
with the other pertinent requirements of the Act and regulations as are
applied to domestic products.
Foreign Establishment Certificate
The meat and poultry products import regulations require that an
official of the foreign inspection system determine and certify, on an
annual basis, only those foreign establishments that are eligible to
have their products imported into the United States (9 CFR 327.2 (a)(3)
and 381.196(a)(3)). The certificate prescribes a narrative statement
format for certifying that the establishments fully comply with all of
the requirements applied to official establishments in the United
States and otherwise meet the requirements of 9 CFR 327.2(a) and
381.196(a). The certificate must list the name, address, and control
number (the establishment number assigned by the foreign inspection
agency) of each establishment and include the foreign official's title,
signature, and date.
The egg products import regulations require that egg products
imported into the United States must be from foreign countries that
comply with the EPIA and the applicable regulations (9 CFR 590.910).
When FSIS determines that a foreign country is eligible to import egg
products into the United States, the foreign country is listed in 9 CFR
590.910(b).
Imported Product Foreign Inspection Certificates
The meat, poultry, and egg products import regulations require a
foreign inspection certificate for every shipment of product imported
into the United States (9 CFR 327.4, 381.197, and 590.915). The
regulations provide for four foreign product inspection certificates--a
fresh meat and meat byproducts certificate, a meat food product
certificate, a poultry product certificate, and an egg products
certificate.
The regulations also prescribe a narrative statement and format,
certifying that the product was derived from livestock and poultry that
received ante-mortem and post-mortem veterinary inspections at the time
of slaughter in establishments certified for importation of their
products into the
[[Page 70715]]
United States, is not adulterated, and is in compliance with
requirements equivalent to domestic requirements. The egg products
inspection certificate must certify that the product was produced under
the approved regulations, requirements, and continuous government
inspection of the exporting country.
In addition, the regulations require specific information about the
product, including the kind of product, the consignor and consignee
(for meat and poultry product certificates), the importer and exporter
(for egg product certificates), the weight, the identification marks on
the product, the establishment number, the number of containers, and
the shipping marks. The certificates must also include the date of
certification and the name, title, and signature of the foreign
official authorized to issue inspection certificates. Each foreign meat
inspection certificate must be both in English and the language of the
foreign country and bear the official seal of the national government
agency responsible for the inspection of the product. The meat and
poultry products foreign inspection certificate is required to be in
the form illustrated in 9 CFR 327.4(a) and (b) and 381.197(b).
Import Inspection Application
The FSIS meat, poultry, and egg products import regulations require
importers to apply for the inspection of imported product (9 CFR 327.5,
381.198, and 590.920).
Prior to the PHIS Import Component implementation, applicants
submitting paper-based applications completed FSIS Form 9540-1,
``Import Inspection Application and Report,'' for meat and poultry
products and, for egg products, FSIS Form 5200-8, ``Import Request Egg
Products.'' The import inspection application forms were submitted to
FSIS import inspection program personnel.
Prior Notification of Imported Product
The meat, poultry, and egg products import regulations require that
the importer apply for the inspection of imported product as long as
possible in advance of the anticipated arrival of each consignment (9
CFR 327.5(b), 381.198(a), and 590.920). Prior to the PHIS Import
Component implementation, meat and poultry products applications (FSIS
Form 9540-1) were submitted to import inspection personnel when the
product was presented for reinspection at an official import inspection
establishment. For egg products, applicants submitted the import
inspection application (FSIS Form 5200-8) to FSIS electronically by
facsimile or email prior to the product entering the country.
Streamlined Inspection Procedures for Canadian Products
The meat and poultry product import regulations require that
products be reinspected before they are allowed entry into the United
States (9 CFR 327.6 and 381.199). The regulations require that every
lot of imported product be given a visual inspection for appearance and
condition, proper certification, and labeling compliance (9 CFR
327.6(a)(2) and 381.199(a)(2)). Reinspection levels and procedures are
computer generated based on established sampling plans, or established
sampling plans and established product and plant history (9 CFR
327.6(a)(3) and 381.199(a)(3)).
For participating Canadian establishments, the meat and poultry
import regulations provide ``streamlined'' inspection procedures on a
voluntary basis (9 CFR 327.5 (d) and 381.199(b)). Under these
streamlined procedures, Canadian officials contact FSIS import offices
directly for reinspection assignments. If the shipment is not
designated for reinspection, it can proceed to the consignee for
further distribution. If the shipment is designated for reinspection,
Canadian officials select the samples according to USDA sampling tables
and identify and place the samples in the vehicle for easy removal and
reinspection by an FSIS import inspector. These streamlined procedures
were provided in January 1989 to further the goal of the 1988 U.S.-
Canada Free Trade Agreement to reduce trade restrictions between the
United States and Canada.
Sanitation Standard Operating Procedures (SOPs) Requirements for
Official Import Inspection Establishments
FSIS meat import regulations require that all imported products be
inspected only at an official establishment or at an official import
inspection establishment (9 CFR 327.6(b)). Owners or operators of
establishments where imported product is inspected must furnish
adequate sanitary facilities and equipment for examining the product
and, as a condition for approval, must comply with the provisions of
the sanitation regulations, 9 CFR 416.1 through 416.6 (9 CFR 327.6(e)).
However, 9 CFR 327.6(e) does not require that official import
inspection establishments comply with the Sanitation SOP requirements
provided in 9 CFR 416.11 through 416.17.
FSIS poultry and egg products import regulations do not require
product inspection only at an official establishment or official import
inspection establishment. However, in practice, imported poultry and
egg products are inspected only at official establishments or official
import inspection establishments.
PHIS Import Component
FSIS launched the PHIS Import Component on May 29, 2012. The PHIS
Import Component replaced the Agency's Automated Import Inspection
System (AIIS) and integrated and automated its paper-based business
processes into one comprehensive and automated data-driven import
inspection system. The PHIS enables U.S. importers to file for FSIS
inspection in advance of arrival of shipments destined to the United
States. The PHIS also enables the receipt of electronic foreign health
certificate information that provides a secure and timely advance
notice of a foreign shipment certified by a foreign government.
Information on implementation of the PHIS Import Component is
provided on the FSIS Web site at http://www.fsis.usda.gov/regulations_&_policies/PHIS_Import_Component/index.asp. FSIS is also
coordinating with foreign countries to enable the electronic submission
of the foreign establishment and foreign inspection certifications. Any
updated information will be posted on the Agency's PHIS Import
Component Web site.
PHIS and the Automated Commercial Environment (ACE) Interface
FSIS has actively participated in the development of the
International Trade Data System (ITDS), a government-wide project to
build an electronic ``single-window'' for collecting and sharing trade
data for reporting imports and exports among federal agencies. The goal
of the ITDS is to eliminate the redundant reporting of data, replacing
multiple filings, many of which are on paper, with a single electronic
filing. The U.S. Customs and Border Protection (CBP) has developed the
Automated Commercial Environment (ACE), a U.S. commercial trade
processing system that automates border processing of products. The ACE
system connects the trade community and participating government
agencies by providing a single, centralized, online access point. When
applicants file entries with the CBP through ACE, relevant data is
electronically distributed to appropriate government agencies.
[[Page 70716]]
The PHIS interfaces with the ACE, permitting the direct electronic
transfer of imported meat, poultry, and egg products data directly into
the PHIS Import Component. FSIS considers any electronic data
transferred from ACE into the PHIS Import Component as certified by the
applicant. In addition, FSIS considers any electronic records, digital
images, data, or information from a foreign government for foreign
inspection and foreign establishment certification to be equivalent to
paper records and certified by the foreign government.
When developing, procuring, maintaining, or using electronic and
information technology (EIT), federal agencies are required by Section
508(a)(1)(a) of the Rehabilitation Act of 1973 (29 U.S.C. 794d) to
ensure that EIT is accessible to people with disabilities, including
employees and members of the public. The PHIS Import Component meets
these requirements.
Proposed Amendments
Foreign Establishment Certification
As discussed above, FSIS meat and poultry import inspection
regulations require an official of the foreign government to determine
and certify the foreign establishments that are eligible to export
their products into the United States. The regulations require a
prescriptive narrative statement certifying that the establishments
fully meet the requirement of 9 CFR 327.2(a)(2)(i) and (ii) and
381.196(a)(2)(i) and (ii). The establishment certificate must also
include: the date; the foreign country; the foreign establishment's
name, address, and control number (the foreign establishment's number
assigned by the foreign country); and the foreign official's title and
signature.
FSIS is proposing to amend 9 CFR 327.2(a)(3) and 381.196(a)(3) to
provide concise regulatory language, delete the prescriptive narrative
statement on the certificate, and require (in addition to information
listed above): the type of operations conducted at the foreign
establishment (e.g., slaughter, processing, storage, exporting
warehouse), and the establishment's eligibility status (i.e., identify
establishments that have been added or delisted and subsequently
relisted since the last annual certification). In addition, for
slaughter and processing establishments, the Agency is proposing to
require the species and type of products produced and the process
category. This information is necessary to ensure that FSIS has
complete information on the types of products produced and the types of
operations conducted in each foreign establishment.
Because the foreign establishment certification regulations are
currently paper-based, FSIS is proposing to provide for the electronic
transmittal of foreign establishment certifications to FSIS from
foreign governments. FSIS will continue to require that foreign
establishment certifications be renewed on an annual basis and that,
consistent with current procedures, paper certificates, if used, be
submitted to FSIS Headquarters.
As discussed above, the egg products import regulations provide for
foreign country (not establishment) certification to export to the
United States. FSIS is not proposing foreign establishment eligibility
requirements for imported egg products at this time. The Agency will
propose foreign establishment certification in a separate proposed
rule, currently under development.
Imported Product Foreign Inspection Certificates
As discussed above, the foreign product inspection certificate
regulations provide four types of certificates--a fresh meat and meat
byproducts certificate, a meat food product certificate, a poultry
product certificate, and an egg products certificate. The meat and
poultry certificates contain a form with a prescriptive narrative
statement certifying that the products listed on the certificate are in
compliance with equivalent U.S requirements in the Acts and
regulations. The imported egg products foreign inspection certificate
regulation specifies the required information.
To clarify and simplify the foreign inspection certificate
requirement, FSIS is proposing to require the same information for
meat, poultry, and egg products and delete the prescriptive narrative
and format requirements for meat and poultry foreign inspection
certificates. The meat and poultry products foreign inspection
certificate's narrative statement reiterates the requirements in 9 CFR
327.2 and 381.196 with respect to ante-mortem and post-mortem
inspection, establishment certification, sanitary handling of product,
and requirements equivalent to those in Acts and relevant regulations,
and therefore, is unnecessary. The prescriptive formatting requirements
(i.e., certificate title, headings, lines) for meat and poultry foreign
inspection certificates are also unnecessary.
The Agency is also proposing to delete the requirement that the
meat foreign inspection certificates bear the official seal of the
government agency responsible for the inspection of the product and be
in the language of the foreign country of origin (9 CFR 327.4(c) and
(d)). The certificates must in English so they can be read by U.S.
import inspectors, and the seal has no purpose. In addition, the Agency
is proposing to delete the requirement that the meat and poultry
inspection certificate identify the foreign city. The foreign
establishment number provides sufficient information to identify the
foreign city.
The egg products foreign inspection certificate requires the name
and address of the importer and the exporter, but not the name and
address of the consignee and the consignor. The meat and poultry
products foreign inspection certificate requires the consignor and
consignee addresses, but not the importer and exporter addresses. The
``exporter'' is the party in the foreign country that sold the product.
The ``importer'' is the party in the United States to whom the overseas
shipper sold the imported product. The ``consignee'' is the party that
holds the product for sale or for delivery. The ``consignor'' is the
party that delivers the product to the consignee. The Agency is
proposing to amend its regulations to require the identity and address
of the consignee, consignor, exporter, and importer and is proposing
that this information be provided for meat, poultry, and egg product
inspection certificates. The Agency is also proposing to delete the
product ``destination'' requirement since it will be replaced with the
``consignee address.'' This information provides additional contact
information concerning who owns or is responsible for the product,
where the product is coming from, and its destination.
In addition to the current required information, the Agency is
proposing to require: the source country and foreign establishment
number for the source material when the source materials originate from
a country other than the exporting country; and the product's
description, including the process category, the product category, and
the product group.
The product's source information is needed to verify that the
source materials are from countries and establishments eligible to
export products to the United States, and that the product itself is
eligible to be imported into the United States. The product description
information, including the process category, the product category, and
the product group provides further information about the
[[Page 70717]]
product and assists in accurately assigning product reinspections and
laboratory testing. FSIS also collects this information in PHIS for
domestic plants. Examples of process categories include: raw product
(non-intact)--ground; raw product (intact)--not ground; thermally
processed (commercially sterile); not heat treated (shelf stable); heat
treated (shelf stable); fully cooked (not shelf stable); and heat
treated but not fully cooked (not shelf stable). Within these process
categories are the product categories, e.g., raw ground, comminuted, or
otherwise non-intact (species); raw intact (species); not ready-to-eat
otherwise processed (species); ready-to-eat dried meat; and ready-to-
eat fully cooked (species). Within the product categories are the
product groups, e.g., ground beef, hamburger, carcass, primals,
sausage, ham, soups. FSIS will issue guidelines to assist foreign
governments in completing the process category, product category, and
product group portion of the foreign inspection certificate.
Because the foreign inspection certification regulations are
currently paper-based, FSIS is proposing to amend the foreign product
inspection certificate regulations to provide for the electronic
transmittal of foreign inspection certifications. For electronic
foreign inspection certifications, foreign governments will transmit
data, which will serve as the certification that the product meets the
FSIS regulatory requirements.
In addition, FSIS is proposing that the Administrator may
specifically request any additional information necessary to determine
whether the product is eligible to be imported into the United States.
Such information may include, when appropriate, production date
information. Production date information will be requested when
restrictions have been placed on the country, the foreign
establishment, or its products, to determine whether the product was
produced in the foreign establishment during an eligible or ineligible
timeframe. Import inspection personnel will notify the importer or the
foreign official when additional information is required.
Import Inspection Application
The Agency has revised FSIS Form 9540-1, Import Inspection
Application, to include egg products and additional information the
Agency needs to accurately assign reinspection tasks and sampling of
the product. FSIS will ensure that copies of this revised application
are available to applicants in paper format.
FSIS is proposing to amend the imported product inspection
application regulations (9 CFR 327.5, 381.198, and 590.920) to require
that applicants submit FSIS Form 9540-1, Import Inspection Application,
to import inspection personnel for the inspection of any product
offered for entry into the United States. The Agency is also proposing
to provide the option of submitting the application electronically or
in paper.
As discussed above, the PHIS Import Component interfaces with the
ACE, permitting the direct electronic transfer of relevant data from
imported meat, poultry, and egg products entries submitted through ACE
into the PHIS. Applicants that are filing at ports that are not under
CBP control (e.g., American Samoa, Guam) can continue to submit paper
import inspection applications to FSIS inspection personnel at an
official import inspection establishment.
Prior Notification of Imported Product
As discussed above, FSIS requires importers to provide advance
notice, as long in advance as possible, before the anticipated arrival
of each consignment (9 CFR 327.5, 381.198, and 590.920). FSIS will
continue to require advance notification but is proposing to revise the
regulations to make clear that applicants must submit electronic or
paper import inspection applications to FSIS in advance of the
shipment's arrival but no later than when the entry is filed with CBP.
Paper applications must be submitted to the official import
establishment where the reinspection is to be performed.
Streamlined Inspection Procedures for Canadian Products
As discussed above, the meat and poultry import regulations provide
streamlined inspection procedures for products imported from Canada (9
CFR 327.5 and 381.198). The Canadian streamlined procedures became
effective January 1989.
In response to a congressional request, the General Accounting
Office (now known as the Government Accountability Office, or GAO)
reviewed, among other things, how the streamlined inspection procedures
differed from past procedures, and how the procedures affected the
imported product rejection rate between 1988 and 1989. The GAO issued
its findings in July 1990.\1\
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\1\ ``Food Safety--Issues USDA Should Address Before Ending
Canadian Meat Inspections,'' United States General Accounting Office
Report to Congressional Requestors AO/RCED-90-176, July 1990.
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In response to how the streamlined procedures differed from past
procedures, the GAO reported that under the new procedures, Canadian
shipments were no longer unloaded at a border inspection facility and
given the routine visual inspection for general condition and labeling
compliance. Canadian government inspectors called FSIS field offices to
determine whether a shipment would be subject to comprehensive
inspection. Shipments not assigned inspection could proceed directly to
their delivery point. If the shipment was selected for a random
comprehensive inspection, a Canadian inspector would select the sample,
following FSIS instructions, and place it in an accessible location in
the back of the truck, eliminating the need for unloading the entire
vehicle. After passing through U.S. Customs, the shipment went to an
import inspection facility where the selected samples were examined by
an FSIS inspector. The GAO expressed concern that FSIS had no control
procedure to ensure that samples were pulled in accordance with FSIS
instructions. The FSIS inspectors union expressed concern about this
procedure because it reduced the control its members had over the
inspection process.
In response to how the streamlined procedures affected the
rejection rates, GAO reported that the rates were higher in 1989 (the
year the streamlined procedures were in effect) than in 1988. However,
neither FSIS nor GAO could determine the cause and significance of the
increased rejection rate. Because of issues raised in the GAO report,
in 1992, the Agency suspended using the streamlined inspection
procedures for Canadian product.
FSIS is proposing to delete the discontinued streamlined procedures
provided in 9 CFR 327.5(d) and 381.198(b). The Agency is also proposing
to amend 9 CFR 327.1 and 381.195, to revise paragraph designations and
to remove specific references to ``for product from eligible countries
other than Canada'' (9 CFR 327.1(a)(2) and 381.195(a)(2)) and delete
paragraphs 9 CFR 327.1(a)(3) and 381.195(a)(3), that provide specific
definitions for ``product from Canada.''
Sanitation Standard Operating Procedures (SOPs) Requirements for
Official Import Inspection Establishments
As discussed above, 9 CFR 327.6(e) requires that official import
inspection establishments, as a condition of approval, meet the
sanitation requirements in 9 CFR 416.1 through 416.6. However, the
requirements do
[[Page 70718]]
not include the Sanitation SOPs in 9 CFR 416.11 through 416.17.
Sanitation SOPs are written procedures official establishments are
required to develop, implement, and maintain to prevent the direct
contamination or adulteration of meat or poultry products.
FSIS is proposing to amend 9 CFR 327.6 (e) to require that an
official import inspection establishment must, in order to receive
grant of inspection, meet the Sanitation SOPs requirements in 9 CFR
416.11 through 416.17. If this proposed amendment is finalized,
official import inspection establishments operating under a grant of
inspection must develop and implement written Sanitation SOPs within 60
days after of the publication of the final rule.
In addition, the Agency is proposing to amend the poultry products
regulations (9 CFR 381.199) to parallel the meat import regulations
requiring that all imported poultry products be inspected only at an
official establishment or at an official import inspection
establishment approved by the Administrator and the requirements for
the conditions of approval (9 CFR 327.6(b), (c), (d), (f), (g), and
(h)). Imported poultry products are currently reinspected at an
official establishment or import inspection establishment, and this
amendment is intended to clarify this requirement.
The Agency is also amending 9 CFR 381.1, ``Definitions'' to include
the definition of ``Official Import Inspection Establishment,'' to
parallel the definition in 9 CFR 301.2.
In addition, FSIS is proposing to amend the ``Conditions for
receiving inspection'' regulations (9 CFR 304.3(a) and 381.22(a)) to
clarify that before being granted federal inspection, establishments
and official import inspection establishments, must develop written
sanitation Standard Operating Procedures(9 CFR 416.12 through 416.7).
Imported egg products are also inspected at official establishments
or official import establishments. FSIS is not proposing amendments to
the egg products import regulations at this time. The Sanitation SOP
requirements for egg products are included in a separate proposed rule,
currently under development.
Other Proposed Amendments
FSIS is proposing to amend the poultry products import regulations
(9 CFR 381.195(a)(2)(ii)) to replace the meat import regulation
citation (9 CFR 327.6) with the correct poultry products regulation
citation (9 CFR 381.204), ``Marking of poultry products offered for
entry; official import inspection marks and devices.''
Discontinued Import Practice and Enforcement Notification
In addition to the proposed regulatory amendments outlined above,
FSIS is announcing that it will end two practices involving imported
meat, poultry, and egg products, as discussed below. FSIS is providing
60 days for comment on the changes to these practices.
30-Day Guarantee Foreign Inspection Certificate Replacement
As discussed above, meat, poultry and egg products imported into
the United States must be accompanied by foreign inspection
certificates (9 CFR 327.4, 381.197, and 590.915). Currently, when an
official foreign inspection certificate is lost in transit or contains
errors (e.g., wrong product name, species, or quantity of contents,
missing foreign official signature), FSIS allows importers (applicants)
to request that the foreign country replace the certificate. The
foreign country can guarantee the replacement of the certificate within
30 days of the importer's (applicant's) request. When FSIS receives the
foreign government's guarantee to replace the certificate, the Agency
proceeds with reinspection and permits accepted imported product to
enter U.S. commerce.
FSIS is announcing its intention to discontinue the practice of
reinspecting imported product based on the foreign government's
guarantee to replace the lost or incorrect foreign inspection
certificate. If certifications are lost or contain mistakes, they can
easily be replaced within a short timeframe. A replacement certificate
can be sent to FSIS in a Portable Document Format (PDF) by email
(importinspection@fsis.usda.gov) or by an expedited mail service, or it
can be transmitted electronically through the PHIS. When the regulatory
amendments in this proposal are finalized, FSIS will end its practice
of reinspecting imported product based on the foreign government's
guarantee to replace the foreign inspection certificate. FSIS will only
reinspect imported product upon receipt of the foreign inspection
certificate.
Failure To Present (FTP) Imported Product for Reinspection
Imported product destined for FSIS import reinspection may
sometimes bypass reinspection and enter commerce, where it may be
further processed into other products or be offered for sale to the
consumer. This bypassing of FSIS reinspection constitutes a ``failure
to present'' (FTP) and violates the Acts.
Through the PHIS Import Component, FSIS is able to more effectively
and efficiently monitor the movement of imported product. Therefore,
when a shipment has been identified as FTP, FSIS will request, through
the CBP, a re-delivery and appropriate penalties. If FSIS finds FTP
product in distribution channels, the Agency will control the product
(e.g., retain or detain the product) or request a recall of the
product. If FSIS finds FTP product in an official establishment that is
being used in further processed product, FSIS will condemn the FTP
product and any further processed product that contains the FTP
product. The FTP product that is contained intact in the original
cartons from the foreign country can return to an official import
inspection establishment, where the FSIS import inspection personnel
will stamp the product as ``refused entry.''
Executive Order 12866 and Executive Order 13563
Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action'' under section 3(f) of Executive Order 12866.
Accordingly, the rule has not been reviewed by the Office of Management
and Budget.
Benefits and Costs of the Proposed Rule
The changes under this proposed rule are necessary to provide for
the Agency's PHIS Import Component. The PHIS Import Component
facilitates trade with foreign countries by providing the electronic
exchange of import data and documentation. The PHIS Import Component
interfaces with the ACE to provide the automatic transfer of all
import-related data among FSIS and other government agencies that
regulate trade, such as the CBP. This transfer of data creates new
safety standards and strengthens existing ones.
The PHIS Import Component enables FSIS import inspection personnel
to verify import shipments using electronic data. The Agency estimates
that electronic imported product
[[Page 70719]]
information reduces the data-entry time for import inspectors by 50 to
60 percent. This does not mean that the Agency is going to reduce the
number of import inspectors based on enhanced PHIS-related
efficiencies. This proposed rule streamlines existing import
documentation requirements by making the foreign inspection certificate
consistent among meat, poultry, and egg products. In addition, the
proposed rule updates the required information on applications and
certificates to fortify the effectiveness of import inspection
regulations. For example, for the import inspection application (FSIS
Form 9540-1), the Agency is proposing to require the source country and
establishment number when the source materials originate from a country
other than the exporting country and the product's production dates.
The additional information would help verify that source products are
from countries and establishments eligible to export products to the
United States, and that the product itself is eligible for importation.
The additional information will also assist inspection and enforcement
personnel in tracing, retrieving, and controlling product in the event
of a recall.
Several changes under this proposed rule may have a cost impact on
the industry. Should this proposed rule become final, the Agency
believes the impacts will be very small, if any. The impacts would be
as follows:
(1) The electronic foreign inspection and foreign establishment
certificates and the electronic import inspection application. Under
this proposed rule, the industry would have the option of filing import
inspection applications electronically, and foreign governments would
have the option of submitting electronic inspection and foreign
establishment certifications and data. Since the electronic option is
voluntary, applicants and the foreign countries would choose to file
electronically only if it is beneficial to do so.
(2) Additional information entry. This proposed rule, if finalized,
requires additional information for the import inspection application,
which will increase the amount of time to fill out the application. The
time needed to provide the additional information will depend on (1)
the number of lots, and (2) how the information is entered.
Some of the information required on the new import inspection
application is data that are required by other government agencies,
such as CBP, and are entered by the applicant into the ACE system. The
ACE electronically transmits data elements into PHIS, eliminating the
need for entering all of the data requested on the electronic form.
For applicants that submit a paper-based import inspection
application, FSIS estimates that it will take 6 more minutes to
complete the new application, based on a comparison between the old and
the new paper-based application. FSIS also estimates that
electronically filing the import inspection application will take, on
average, an additional minute per application in comparison with the
old paper-based application.\2\ Agency data show that there are, on
average, a total of 44,480 applications per year that will be filed
electronically using the ACE, and that 2,317 applications per year will
be completed manually.\3\ Therefore, the total additional time for
electronically filing the application will be 741 hours (44,480 * 1/60
= 741) and the additional time for completing the new paper-based
application will be 232 hours (2,317 * 6/60 = 232). Monetizing these
hours by $37 per hour,\4\ the estimated cost to complete the new
application would be about $36,000 ($37 * (232 + 741)) per year.
---------------------------------------------------------------------------
\2\ Time estimate from International Policy Division, Office of
Policy and Program Development, FSIS, USDA.
\3\ Number of applications from International Policy Division,
Office of Policy and Program Development, FSIS, USDA.
\4\ Bureau of Labor Statistics ``Occupational Employment &
Wages'' Database, May 2010. Animal Production Managers, all other
$51.54 @ 47.6% time; General and Operations Managers $33.08 @ 26.2%
time; Food scientists and technologists $14.49 @ 26.2% time = $37.00
Managerial Median hourly wage.
---------------------------------------------------------------------------
(3) Sanitation Standard Operating Procedures (SOPs) as a condition
of approval for official import inspection establishments. The proposed
rule will clarify that official import inspection establishments must
have developed written Sanitation SOPs before being granted approval.
If this proposed amendment is finalized, official import inspection
establishments will be given 60 days after the publication of the final
rule to develop and implement written Sanitation SOPs. Since, in
practice, many official import inspection establishments maintain
sanitation SOPs during the reinspection of imported products, the
proposed amendment requiring sanitation SOPs will have little cost
impact (including recordkeeping cost impact) on the industry.
The proposed rule will remove the regulatory provisions for the
streamlined import inspection system for Canadian product. Since the
procedures have been obsolete since 1992, removing the regulatory
provisions will have no significant economic impact.
Regulatory Flexibility Analysis
The FSIS Administrator has made a preliminary determination that,
for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602)
this proposed rule would not have a significant impact on a substantial
number of small entities, as defined by the Regulatory Flexibility Act.
If small entities are unable to meet the requirements necessary to use
the electronic import system, FSIS would continue to accept paper
applications. Similarly, the other changes proposed in the rule would
not result in significant costs to industry and, therefore, would not
have a significant impact on a substantial number of small entities.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this proposed rule: (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) no retroactive proceedings will be required before parties may file
suit in court challenging this rule.
Executive Order 13175
This proposed rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on Tribal governments and
will not have significant Tribal implications.
Paperwork Reduction Act
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection
requirement included in this proposed rule concerning the Import
Inspection Application (FSIS Form 9540-1) was submitted to OMB for
approval as part of the Public Health Information System (PHIS)
information collection request. At that time, FSIS anticipated the
changes to the Import Inspection Application that it is now proposing
and described them in the PHIS information collection request to OMB,
which approved the information collection and assigned it OMB control
number 0583-0153.
In addition, FSIS has submitted an information collection to OMB
for the new information collection associated with the proposed rule.
Title: Electronic Import Inspection
Type of Collection: New
[[Page 70720]]
Abstract: Under this proposed rule, FSIS is proposing to require
foreign governments to submit additional information when submitting
both the foreign establishment certificate and the foreign inspection
certificate to FSIS in order for foreign establishments to be permitted
to import product to the United States. The current information
collection associated with these two certificates is approved under OMB
control number 0583-0094.
FSIS is also proposing to require official import inspection
establishments to develop, implement, and maintain written Sanitation
Standard Operating Procedures (SSOPs), as provided in 9 CFR 416.11
through 416.17.\5\
---------------------------------------------------------------------------
\5\ The ``Benefits and costs of the proposed rule'' section
(above) did not include Sanitation Standard Operating Procedures
(Sanitation SOPs) costs. While not currently required, in practice,
Import Inspection Establishments maintain Sanitation SOPs;
therefore, the proposed rule would not be adding any further costs
to import inspection establishments. However, incorporating the
Sanitation SOPs into FSIS's regulations requires OMB approval of the
associated information collection burden. The cost analysis also did
not address the expanded questions addressed to foreign governments
because the costs would be experienced by foreign entities.
---------------------------------------------------------------------------
Estimate of Burden: FSIS estimates that it will take 27.8 hours per
foreign government (foreign establishment and foreign inspection
certificates) and 157.6 hours per official import inspection
establishment (SSOP requirements).
Respondents: Foreign governments (foreign establishment and foreign
inspection certificates) and official import inspection establishments
(SSOP requirements).
Estimated Number of Respondents: 30 foreign governments and 120
official import inspection establishments.
Estimated Number of Responses per Respondent: 556 responses per
foreign government and 523 responses per official import inspection
establishments annually.
Estimated Total Annual Burden on Respondents: 834 hours for foreign
governments and 18,920 hours for official import inspection
establishments for a total of 19,754 hours.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083,
South Building, Washington, DC 20250-3700.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to both John O'Connell, Paperwork Reduction
Act Coordinator, at the address provided above, and the Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253. To be most effective,
comments should be sent to OMB within 60 days of the publication date
of this proposed rule.
E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.
Additional Public Notification
FSIS will announce this rule online through the FSIS Web page
located at http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. In addition, FSIS offers an electronic mail subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/.
Options range from recalls to export information to regulations,
directives and notices. Customers can add or delete subscriptions
themselves, and have the option to password protect their accounts.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
List of Subjects
9 CFR Part 304
Application for inspection; Grant of inspection
9 CFR Part 327
Imported products
9 CFR Part 381
Poultry products inspection regulations
9 CFR Part 590
Inspection of eggs and egg products (Egg Products Inspection Act)
For the reasons set discussed in the preamble, FSIS proposes to
amend 9 CFR Chapter III as follows:
PART 304--APPLICATION FOR INSPECTION; GRANT OF INSPECTION
1. The authority citation for Part 304 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. In Sec. 304.3, revise paragraph (a) to read as follows:
Sec. 304.3 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an official
establishment or an official import inspection establishment must have
developed written Sanitation Standard Operating
[[Page 70721]]
Procedures, as required by part 416 of this chapter.
* * * * *
PART 327--IMPORTED PRODUCTS
3. The authority citation for Part 327 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
4. In Sec. 327.1, revise paragraph (a) to read as follows:
Sec. 327.1 Definitions; application of provisions.
(a) When used in this part, the following terms are defined to
mean:
(1) Import (imported). To bring within the territorial limits of
the United States whether that arrival is accomplished by land, air, or
water.
(2) Offer(ed) for entry. The point at which the importer presents
the imported product for reinspection.
(3) Entry (entered). The point at which imported product offered
for entry receives reinspection and is marked with the official mark of
inspection, as required by Sec. 327.26.
* * * * *
5. In Sec. 327.2, revise paragraph (a)(3) to read as follows:
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
(a) * * *
(3) Only those establishments that are determined and certified to
the Agency by a responsible official of the foreign meat inspection
system as fully meeting the requirements of paragraphs (a)(2)(i) and
(ii) of this section are eligible to have their products imported into
the United States. Establishment eligibility is subject to review by
the Agency (including observations of the establishments by Program
representatives at times prearranged with the foreign meat inspection
system officials). Foreign establishment certifications must be renewed
annually. Notwithstanding certification by a foreign official, the
Administrator may terminate the eligibility of any foreign
establishment for the importation of its products into the United
States if it does not comply with the requirements listed in paragraphs
(a)(2)(i) and (ii) of this section, or if current establishment
information cannot be obtained. The Administrator will provide
reasonable notice to the foreign government of the proposed termination
of any foreign establishment, unless a delay in terminating its
eligibility could result in the importation of adulterated or
misbranded product. The electronic foreign establishment certification
or paper certificate must contain: the date; the foreign country; the
foreign establishment's name, address, and foreign establishment
number; the foreign official's title; the foreign official's signature
(for paper certificate only); the type of operation(s) conducted at the
establishment (e.g., slaughter, processing, storage, exporting
warehouse); and the establishment's eligibility status (e.g., new or
relisted (if previously delisted)). Slaughter and processing
establishment certifications must address the species and type of
product(s) produced at the establishment and the process category.
* * * * *
6. Revise Sec. 327.4 to read as follows:
Sec. 327.4 Foreign inspection certificate requirements.
(a) Except as provided in Sec. 327.16, each consignment imported
into the United States must have an electronic foreign inspection
certification or a paper foreign inspection certificate issued by an
official of the foreign government agency responsible for the
inspection and certification of the product.
(b) An official of the foreign government must certify that any
product described on any official certificate was produced in
accordance with the regulatory requirements in Sec. 327.2.
(c) The electronic foreign inspection certification must be in
English, be transmitted directly to FSIS before the product's arrival
at the official import inspection establishment, and be available to
import inspection personnel.
(d) The paper foreign inspection certificate must accompany each
consignment, be submitted to import inspection personnel at the
official import inspection establishment, be in English, and bear the
signature of the official authorized to issue inspection certificates
for products imported to the U.S.
(e) The electronic foreign inspection certification and paper
foreign inspection certificate must contain:
(1) The date, name, and title of the official authorized to issue
inspection certificates for products imported into the U.S.;
(2) The foreign country of export and the producing foreign
establishment number;
(3) The species used to produce the product and the source country
and foreign establishment number, if the source materials originate
from a country other than the exporting country;
(4) The product's description, including the process category, the
product category, and the product group;
(5) The name and address of the consignor;
(6) The name and address of the exporter;
(7) The name and address of the consignee;
(8) The name and address of the importer;
(9) The number of units (pieces or containers) and the shipping or
identification mark on the units;
(10) The net weight of each lot; and
(11) Any additional information the Administrator requests to
determine whether the product is eligible to be imported into the U.S.
7. Revise Sec. 327.5 to read as follows:
Sec. 327.5 Import inspection application.
(a) Applicants must submit FSIS Form 9540-1, Import Inspection
Application, to apply for the inspection of any product offered for
entry. Applicants may apply for inspection using a paper or electronic
application.
(b) Import inspection applications for each consignment must be
submitted (electronically or paper) to FSIS in advance of the
shipment's arrival at the official import establishment where the
product will be reinspected, but no later than when the entry is filed
with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that
are exempted from inspection by Sec. Sec. 327.16 and 327.17.
8. In Sec. 327.6, revise paragraphs (a) and (e) to read as
follows:
Sec. 327.6 Products for importation; program inspection, time and
place; application for approval of facilities as official import
inspection establishment; refusal or withdrawal of approval; official
numbers.
(a)(1) Except as provided in Sec. Sec. 327.16 and 327.17, all
products offered for entry from any foreign country shall be
reinspected by a Program inspector before they shall be allowed entry
into the United States.
(2) Every lot of product shall routinely be given visual inpsection
by a Program import inpsector for appearance and condition, and checked
for certification and label compliance.
(3) The Public Health Information System (PHIS) shall be consulted
for reinspection instructions. The PHIS will assign reinspection levels
and procedures based on established sampling plans and established
product and plant history.
[[Page 70722]]
(4) When the inpsector deems it necessary, the inpsector may sample
and inspect lots not designated by PHIS.
* * * * *
(e) Owners or operators of official import inspection
establishments must furnish adequate sanitary facilities and equipment
for examination of such product. The requirements of Sec. Sec. 304.2,
307.1, 307.2(b), (d), (f), (h), (k), and (l), and part 416 of this
chapter shall apply as conditions for approval of establishments as
official import inspection establishments to the same extent and in the
same manner as they apply with respect to official establishments.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
9. 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.
10. In Sec. 381.1, in paragraph (b), add a definition for Official
establishment in alphabetical order to read as follows:
Sec. 381.1 Definitions.
* * * * *
(b) * * *
Official import inspection establishment. This term means any
establishment, other than an official establishment as defined in this
paragraph where inspections are authorized to be conducted as
prescribed in Sec. 381.199.
* * * * *
11. In Sec. 381.22, revise paragraph (a) to read as follows:
Sec. 381.22 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an official
establishments or an official import inspection establishment, must
have developed written Sanitation Standard Operating Procedures, as
required by part 416 of this chapter.
* * * * *
12. In Sec. 381.195, revise paragraph (a) to read as follows:
Sec. 381.195 Definitions; requirements for importation into the
United States.
(a) When used in this part, the following terms are defined to
mean:
(1) Import (imported). To bring within the territorial limits of
the United States whether that arrival is accomplished by land, air, or
water.
(2) Offer(ed) for entry. The point at which the importer presents
the imported product for reinspection.
(3) Entry (entered). The point at which imported product offered
for entry receives reinspection and is marked with the official mark of
inspection, as required by Sec. 381.204.
* * * * *
13. In Sec. 381.196, revise paragraph (a)(3) to read as follows:
Sec. 381.196 Eligibility of foreign countries for importation of
poultry products into the United States.
(a) * * *
(3) Only those establishments that are determined and certified to
the Agency by a responsible official of the foreign poultry inspection
system as fully meeting the requirements of paragraphs (a)(2)(i) and
(ii) of this section are eligible to have their products imported into
the United States. Establishment eligibility is subject to review by
the Agency (including observations of the establishments by Program
representatives at times prearranged with the foreign meat inspection
system officials). Foreign establishment certifications must be renewed
annually. Notwithstanding certification by a foreign official, the
Administrator may terminate the eligibility of any foreign
establishment for the importation of its products into the United
States if it does not comply with the requirements listed in paragraphs
(a)(2)(i) and (ii) of this section, or if current establishment
information cannot be obtained. The Administrator will provide
reasonable notice to the foreign government of the proposed termination
of any foreign establishment, unless a delay in terminating its
eligibility could result in the importation of adulterated or
misbranded product. The electronic foreign establishment certification
or paper certificate must contain: the date; the foreign country; the
foreign establishment's name, address, and foreign establishment
number; the foreign official's title; the foreign official's signature
(for paper certificate only); the type of operation(s) conducted at the
establishment (e.g., slaughter, processing, storage, exporting
warehouse); and the establishment's eligibility status (e.g., new or
relisted (if previously delisted)). Slaughter and processing
establishment certifications must address the species and type of
product(s) produced at the establishment and the process category.
* * * * *
14. Revise Sec. 381.197 to read as follows:
Sec. 381.197 Foreign inspection certificate requirements.
(a) Except as provided in Sec. Sec. 381.207 and 381.209, each
consignment imported into the United States must have an electronic
foreign inspection certification or a paper foreign inspection
certificate issued by an official of the foreign government agency
responsible for the inspection and certification of the product.
(b) An official of the foreign government must certify that any
product described on any official certificate was produced in
accordance with the regulatory requirements in Sec. 381.196.
(c) The electronic foreign inspection certification must be in
English, be transmitted directly to FSIS before the product's arrival
at the official import inspection establishment, and be available to
import inspection personnel.
(d) The paper foreign inspection certificate must accompany each
consignment, be submitted to import inspection personnel at the
official import inspection establishment, be in English, and bear the
signature of the official authorized to issue inspection certificates
for products imported to the U.S.
(e) The electronic foreign inspection certification and paper
foreign inspection certificate must contain:
(1) The date, name, and title of the official authorized to issue
inspection certificates for products imported into the U.S.;
(2) The foreign country of export and the producing foreign
establishment number;
(3) The species used to produce the product and the source country
and foreign establishment number, if the source materials originate
from a country other than the exporting country;
(4) The product's description, including the process category, the
product category, and the product group;
(5) The name and address of the consignor;
(6) The name and address of the exporter;
(7) The name and address of the consignee;
(8) The name and address of the importer;
(9) The number of units (pieces or containers) and the shipping or
identification mark on the units;
(10) The net weight of each lot; and
(11) Any additional information the Administrator requests to
determine whether the product is eligible to be imported into the U.S.
[[Page 70723]]
15. Revise Sec. 381.198 to read as follows:
Sec. 381.198 Import inspection application.
(a) Applicants must submit FSIS Form 9540-1, Import Inspection
Application, to apply for the inspection of any product offered for
entry. Applicants may apply for inspection using a paper or electronic
application.
(b) Import inspection applications for each consignment must be
submitted (electronically or paper) to FSIS in advance of the
shipment's arrival at the official import establishment where the
product will be reinspected, but no later than when the entry is filed
with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that
are exempted from inspection by Sec. Sec. 381.207 and 381.209.
16. In Sec. 381.199, revise paragraph (a) and add paragraphs (e)
through (k) to read as follows:
Sec. 381.199 Inspection of poultry products offered for entry.
(a)(1) Except as provided in Sec. 381.209 and paragraph (c) of
this section, all slaughtered poultry and poultry products offered for
entry from any foreign country shall be reinspeced by a Program import
inspector before they shall be allowed entry into the United States.
(2) Every lot of product shall routinely be given visual inspection
for appearance and condition, and checked for certification and label
compliance.
(3) The Public Health Information System (PHIS) shall be consulted
for reinspection instructions. The PHIS will assign reinspection levels
and procedures based on established sampling plans and established
product and plant history.
(4) When the inpsector deems it necessary, the inpsector may sample
and inspect lots not designated by PHIS.
* * * * *
(e) All products, required by this part to be inspected, shall be
inspected only at an official establishment or at an official import
inspection establishment approved by the Administrator as provided in
this section. Such approved official import inspection establishments
will be listed in the Directory of Meat and Poultry Inspection Program
Establishments, Circuits and Officials, published by the Food Safety
and Inspection Service. The listing will categorize the kind or kinds
of product which may be inspected at each official import inspection
establishment, based on the adequacy of the facilities for making such
inspections and handling such products in a sanitary manner.
(f) Owners or operators of establishments, other than official
establishments, who want to have import inspections made at their
establishments, shall apply to the Administrator for approval of their
establishments for such purpose. Application shall be made on a form
furnished by the Program, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC, and shall include all
information called for by that form.
(g) Approval for Federal import inspection shall be in accordance
with subpart D of part 381.
(h) Owners or operators of establishments at which import
inspections of product are to be made shall furnish adequate sanitary
facilities and equipment for examination of such product. The
requirements of Sec. Sec. 381.21 and 381.36, and part 416 of this
chapter shall apply as conditions for approval of establishments as
official import inspection establishments to the same extent and in the
same manner as they apply with respect to official establishments.
(i) The Administrator is authorized to approve any establishment as
an official import inspection establishment provided that an
application has been filed and drawings have been submitted in
accordance with the requirements of paragraphs (c) and (d) of this
section and he determines that such establishment meets the
requirements under paragraph (e) of this section. Any application for
inspection under this section may be denied or refused in accordance
with the rules of practice in part 500 of this chapter.
(j) Approval of an official import inspection establishment may be
withdrawn in accordance with applicable rules of practice if it is
determined that the sanitary conditions are such that the product is
rendered adulterated, that such action is authorized by section 21(b)
of the Federal Water Pollution Control Act, as amended (84 Stat. 91),
or that the requirements of paragraph (e) of this section were not
complied with. Approval may also be withdrawn in accordance with
section 401 of the Act and applicable rules of practice.
(k) A special official number shall be assigned to each official
import inspection establishment. Such number shall be used to identify
all products inspected and passed for entry at the establishment.
PART 590--INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS
INSPECTION ACT)
17. The authority citation for part 590 continues to read as
follows:
Authority: 21 U.S.C. 1031-1056.
18. Revise Sec. 590.915 to read as follows:
Sec. 590.915 Foreign inspection certificate requirements.
(a) Except as provided in Sec. 590.960, each consignment imported
into the United States must have an electronic foreign inspection
certification or a paper foreign inspection certificate issued by an
official of the foreign government agency responsible for the
inspection and certification of the product.
(b) An official of the foreign government agency must certify that
any product described on any official certificate was produced in
accordance with the regulatory requirements Sec. 590.910.
(c) The electronic foreign inspection certification must be in
English, be transmitted directly to FSIS before the product's arrival
at the official import inspection establishment, and be available to
import inspection personnel.
(d) The paper foreign inspection certificate must accompany each
consignment, be submitted to import inspection personnel at the
official import inspection establishment, be in English, and bear the
signature of the official authorized to issue the inspection
certificates for products imported into the U.S.
(e) The electronic foreign inspection certification and paper
foreign inspection certificate must contain:
(1) The date, name, and title of the official authorized to issue
inspection certificates for products imported into the U.S.;
(2) The foreign country of export and the producing foreign
establishment number;
(3) The species used to produce the product and the source country
and foreign establishment number, if the source materials originate
from a country other than the exporting country;
(4) The product's description including the process category, the
product category, and the product group;
(5) The name and address of the consignor;
(6) The name and address of the exporter;
(7) The name and address of the consignee;
[[Page 70724]]
(8) The name and address of the importer;
(9) The number of units (pieces or containers) and the shipping or
identification mark on the units;
(10) The net weight of each lot; and
(11) Any additional information the Administrator requests to
determine whether the product is eligible to be imported into the U.S.
19. Revise Sec. 590.920 to read as follows:
Sec. 590.920 Import inspection application.
(a) Applicants must submit FSIS Form 9450-1, Import Inspection
Application, to apply for the inspection of any product offered for
entry. Applicants may apply for inspection using a paper or electronic
application.
(b) Import inspection applications for each consignment must be
submitted (electronically or paper) to FSIS in advance of the
shipment's arrival at the official import establishment where the
product will be reinspected, but no later than when the entry is filed
with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that
are exempted from inspection by Sec. Sec. 590.960 and 590.965.
Done at Washington, DC, on: October 25, 2012
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-28751 Filed 11-26-12; 8:45 am]
BILLING CODE 3410-DM-P