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, 70714-70724 [2012-28751]
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70714
Proposed Rules
Federal Register
Vol. 77, No. 228
Tuesday, November 27, 2012
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.
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
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
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
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SUMMARY:
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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 https://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 https://
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
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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
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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).
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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
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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.
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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 https://
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 ‘‘singlewindow’’ 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.
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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.
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.
Proposed Amendments
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
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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
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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
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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 readyto-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.
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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.
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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
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
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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.
entry; official import inspection marks
and devices.’’
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
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
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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.
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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 redelivery 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
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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
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the data requested on the electronic
form.
For applicants that submit a paperbased 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 paperbased 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 paperbased 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.
(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
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.
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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
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Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Proposed Rules
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
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
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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.
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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 EGovernment 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
https://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
https://www.fsis.usda.gov/
News_&_Events/Email_Subscription/.
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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 § 304.3, revise paragraph (a) to
read as follows:
§ 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
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Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Proposed Rules
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 § 327.1, revise paragraph (a) to
read as follows:
§ 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 § 327.26.
*
*
*
*
*
5. In § 327.2, revise paragraph (a)(3) to
read as follows:
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§ 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
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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 § 327.4 to read as follows:
§ 327.4 Foreign inspection certificate
requirements.
(a) Except as provided in § 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
§ 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;
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70721
(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 § 327.5 to read as follows:
§ 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 §§ 327.16 and
327.17.
8. In § 327.6, revise paragraphs (a) and
(e) to read as follows:
§ 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 §§ 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.
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(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 §§ 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 § 381.1, in paragraph (b), add a
definition for Official establishment in
alphabetical order to read as follows:
§ 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 § 381.199.
*
*
*
*
*
11. In § 381.22, revise paragraph (a) to
read as follows:
§ 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 § 381.195, revise paragraph (a)
to read as follows:
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§ 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.
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(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 § 381.204.
*
*
*
*
*
13. In § 381.196, revise paragraph
(a)(3) to read as follows:
§ 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 § 381.197 to read as
follows:
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Fmt 4702
Sfmt 4702
§ 381.197 Foreign inspection certificate
requirements.
(a) Except as provided in §§ 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
§ 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.
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Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Proposed Rules
15. Revise § 381.198 to read as
follows:
§ 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 §§ 381.207 and
381.209.
16. In § 381.199, revise paragraph (a)
and add paragraphs (e) through (k) to
read as follows:
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§ 381.199 Inspection of poultry products
offered for entry.
(a)(1) Except as provided in § 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
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13:17 Nov 26, 2012
Jkt 229001
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 §§ 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.
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Frm 00010
Fmt 4702
Sfmt 4702
70723
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 § 590.915 to read as
follows:
§ 590.915 Foreign inspection certificate
requirements.
(a) Except as provided in § 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
§ 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;
E:\FR\FM\27NOP1.SGM
27NOP1
70724
Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Proposed Rules
(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 § 590.920 to read as
follows:
§ 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 §§ 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
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. FSIS–2012–0019]
RIN 0583–AD49
Eligibility of the Republic of Korea To
Export Poultry Products to the United
States
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is proposing
to add the Republic of Korea (Korea) to
the list of countries eligible to export
poultry products to the United States.
Reviews by FSIS of Korea’s laws,
regulations, and inspection
implementation show that its poultry
inspection system requirements are
equivalent to the Poultry Products
Inspection Act (PPIA) and its
implementing regulations. Under this
wreier-aviles on DSK5TPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
13:17 Nov 26, 2012
Jkt 229001
proposal, slaughtered poultry or parts or
other products thereof processed in
certified Korean establishments would
be eligible for export to the United
States. All such products would be
subject to re-inspection at United States
ports-of-entry by FSIS inspectors.
DATES: Comments must be received 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 https://www.regulations.gov. Follow
the on-line 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–
2012–0019. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
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 8–164,
Washington, DC 20250–3700 between
8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Dr.
Andreas Keller, Director, International
Equivalence Staff, Office of
International Affairs; telephone (202)
690–5646.
SUPPLEMENTARY INFORMATION:
Background
FSIS is proposing to amend its
poultry products inspection regulations
to add Korea to the list of countries
eligible to export poultry products to the
United States (9 CFR 381.196(b)). Korea
is not currently listed as eligible to
export such products to the United
States.
Statutory Basis for Proposed Action
Section 17 of the PPIA (21 U.S.C. 466)
prohibits importation into the United
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
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 Code
of Federal Regulations (CFR) sets out the
procedures by which foreign countries
may become eligible to export poultry
and poultry products to the United
States.
Section 381.196(a) requires a foreign
country’s poultry inspection system to
include standards equivalent to those of
the United States and to provide legal
authority for the inspection system and
its implementing regulations that is
equivalent to that of the United States.
Specifically, a country’s legal authority
and regulations must impose
requirements equivalent to those of the
United States with respect to: (1) Antemortem and post-mortem inspection by,
or under the direct supervision of, a
veterinarian; (2) official controls by the
national government over establishment
construction, facilities, and equipment;
(3) direct and continuous official
supervision of slaughtering of poultry
and processing of poultry products by
inspectors to ensure that product is not
adulterated or misbranded; (4) complete
separation of establishments certified to
export from those not certified; (5)
maintenance of a single standard of
inspection and sanitation throughout
certified establishments; (6)
requirements for sanitation and for
sanitary handling of product at
establishments certified to export; (7)
official controls over condemned
product; (8) a Hazard Analysis and
Critical Control Point (HACCP) system;
and (9) any other requirements found in
the PPIA and its implementing
regulations (9 CFR 381.196(a)(2)(ii)).
In addition to a foreign country’s legal
authority and regulations, the program
itself must be equivalent to the United
States. Specifically, the program
organized and administered by the
national government must impose
requirements equivalent to those of the
United States with respect to: (1)
Organizational structure and staffing, so
as to ensure uniform enforcement of the
requisite laws and regulations in all
certified establishments; (2) ultimate
control and supervision by the national
government over the official activities of
E:\FR\FM\27NOP1.SGM
27NOP1
]]>Agencies
[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]
========================================================================
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.
========================================================================
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 https://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 https://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
