[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Proposed Rules]
[Pages 70714-70724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28751]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / 
Proposed Rules  

[[Page 70714]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 304, 327, 381, and 590

[Docket No. FSIS-2009-0022]
RIN 0583-AD39


Electronic Import Inspection Application and Certification of 
Imported Products and Foreign Establishments; Amendments To Facilitate 
the Public Health Information System (PHIS) and Other Changes To Import 
Inspection Regulations

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the meat, poultry, and egg products import regulations to provide 
for the Agency's Public Health Information System (PHIS) Import 
Component. The PHIS Import Component, launched on May 29, 2012, 
provides an electronic alternative to the paper-based import inspection 
application and imported product foreign inspection and foreign 
establishment certificate processes. In addition, the Agency is 
proposing to delete the discontinued ``streamlined'' import inspection 
procedures for Canadian product and to require Sanitation Standard 
Operating Procedures (SOPs) at official import inspection 
establishments. In addition to the proposed regulatory amendments 
outlined above, FSIS is announcing its intention to discontinue its 
practice of conducting imported product reinspection based on a foreign 
government's guarantee to replace a lost or incorrect foreign 
inspection certificate and is clarifying its policy of addressing 
imported product that is not presented for reinspection.

DATES: Submit comments on or before January 28, 2013.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to Patriots 
Plaza 3, 355 E. Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2009-0022. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 8-
164A, Washington, DC 20250-3700 between 8:30 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Ms. Mary Stanley, Director, 
International Policy Division, Office of Policy and Program 
Development, FSIS, U.S. Department of Agriculture, 1400 Independence 
Avenue SW., Room 2125, Washington, DC 20250-3700, Phone: (202)720-0287.

SUPPLEMENTARY INFORMATION:

Background

    The Federal Meat Inspection Act (FMIA) (21 U.S.C. 620) and the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 466) prohibit the 
importation of meat and poultry products into the United States if such 
products are adulterated or misbranded and unless they comply with all 
the inspection and other requirements of the Acts and regulations as 
are applied to domestic products. The Egg Products Inspection Act 
(EPIA) (21 U.S.C. 1046) prohibits the importation of egg products 
unless they were processed under an approved continuous inspection 
system of the government of the foreign country of origin and comply 
with the other pertinent requirements of the Act and regulations as are 
applied to domestic products.

Foreign Establishment Certificate

    The meat and poultry products import regulations require that an 
official of the foreign inspection system determine and certify, on an 
annual basis, only those foreign establishments that are eligible to 
have their products imported into the United States (9 CFR 327.2 (a)(3) 
and 381.196(a)(3)). The certificate prescribes a narrative statement 
format for certifying that the establishments fully comply with all of 
the requirements applied to official establishments in the United 
States and otherwise meet the requirements of 9 CFR 327.2(a) and 
381.196(a). The certificate must list the name, address, and control 
number (the establishment number assigned by the foreign inspection 
agency) of each establishment and include the foreign official's title, 
signature, and date.
    The egg products import regulations require that egg products 
imported into the United States must be from foreign countries that 
comply with the EPIA and the applicable regulations (9 CFR 590.910). 
When FSIS determines that a foreign country is eligible to import egg 
products into the United States, the foreign country is listed in 9 CFR 
590.910(b).

Imported Product Foreign Inspection Certificates

    The meat, poultry, and egg products import regulations require a 
foreign inspection certificate for every shipment of product imported 
into the United States (9 CFR 327.4, 381.197, and 590.915). The 
regulations provide for four foreign product inspection certificates--a 
fresh meat and meat byproducts certificate, a meat food product 
certificate, a poultry product certificate, and an egg products 
certificate.
    The regulations also prescribe a narrative statement and format, 
certifying that the product was derived from livestock and poultry that 
received ante-mortem and post-mortem veterinary inspections at the time 
of slaughter in establishments certified for importation of their 
products into the

[[Page 70715]]

United States, is not adulterated, and is in compliance with 
requirements equivalent to domestic requirements. The egg products 
inspection certificate must certify that the product was produced under 
the approved regulations, requirements, and continuous government 
inspection of the exporting country.
    In addition, the regulations require specific information about the 
product, including the kind of product, the consignor and consignee 
(for meat and poultry product certificates), the importer and exporter 
(for egg product certificates), the weight, the identification marks on 
the product, the establishment number, the number of containers, and 
the shipping marks. The certificates must also include the date of 
certification and the name, title, and signature of the foreign 
official authorized to issue inspection certificates. Each foreign meat 
inspection certificate must be both in English and the language of the 
foreign country and bear the official seal of the national government 
agency responsible for the inspection of the product. The meat and 
poultry products foreign inspection certificate is required to be in 
the form illustrated in 9 CFR 327.4(a) and (b) and 381.197(b).

Import Inspection Application

    The FSIS meat, poultry, and egg products import regulations require 
importers to apply for the inspection of imported product (9 CFR 327.5, 
381.198, and 590.920).
    Prior to the PHIS Import Component implementation, applicants 
submitting paper-based applications completed FSIS Form 9540-1, 
``Import Inspection Application and Report,'' for meat and poultry 
products and, for egg products, FSIS Form 5200-8, ``Import Request Egg 
Products.'' The import inspection application forms were submitted to 
FSIS import inspection program personnel.

Prior Notification of Imported Product

    The meat, poultry, and egg products import regulations require that 
the importer apply for the inspection of imported product as long as 
possible in advance of the anticipated arrival of each consignment (9 
CFR 327.5(b), 381.198(a), and 590.920). Prior to the PHIS Import 
Component implementation, meat and poultry products applications (FSIS 
Form 9540-1) were submitted to import inspection personnel when the 
product was presented for reinspection at an official import inspection 
establishment. For egg products, applicants submitted the import 
inspection application (FSIS Form 5200-8) to FSIS electronically by 
facsimile or email prior to the product entering the country.

Streamlined Inspection Procedures for Canadian Products

    The meat and poultry product import regulations require that 
products be reinspected before they are allowed entry into the United 
States (9 CFR 327.6 and 381.199). The regulations require that every 
lot of imported product be given a visual inspection for appearance and 
condition, proper certification, and labeling compliance (9 CFR 
327.6(a)(2) and 381.199(a)(2)). Reinspection levels and procedures are 
computer generated based on established sampling plans, or established 
sampling plans and established product and plant history (9 CFR 
327.6(a)(3) and 381.199(a)(3)).
    For participating Canadian establishments, the meat and poultry 
import regulations provide ``streamlined'' inspection procedures on a 
voluntary basis (9 CFR 327.5 (d) and 381.199(b)). Under these 
streamlined procedures, Canadian officials contact FSIS import offices 
directly for reinspection assignments. If the shipment is not 
designated for reinspection, it can proceed to the consignee for 
further distribution. If the shipment is designated for reinspection, 
Canadian officials select the samples according to USDA sampling tables 
and identify and place the samples in the vehicle for easy removal and 
reinspection by an FSIS import inspector. These streamlined procedures 
were provided in January 1989 to further the goal of the 1988 U.S.-
Canada Free Trade Agreement to reduce trade restrictions between the 
United States and Canada.

Sanitation Standard Operating Procedures (SOPs) Requirements for 
Official Import Inspection Establishments

    FSIS meat import regulations require that all imported products be 
inspected only at an official establishment or at an official import 
inspection establishment (9 CFR 327.6(b)). Owners or operators of 
establishments where imported product is inspected must furnish 
adequate sanitary facilities and equipment for examining the product 
and, as a condition for approval, must comply with the provisions of 
the sanitation regulations, 9 CFR 416.1 through 416.6 (9 CFR 327.6(e)). 
However, 9 CFR 327.6(e) does not require that official import 
inspection establishments comply with the Sanitation SOP requirements 
provided in 9 CFR 416.11 through 416.17.
    FSIS poultry and egg products import regulations do not require 
product inspection only at an official establishment or official import 
inspection establishment. However, in practice, imported poultry and 
egg products are inspected only at official establishments or official 
import inspection establishments.

PHIS Import Component

    FSIS launched the PHIS Import Component on May 29, 2012. The PHIS 
Import Component replaced the Agency's Automated Import Inspection 
System (AIIS) and integrated and automated its paper-based business 
processes into one comprehensive and automated data-driven import 
inspection system. The PHIS enables U.S. importers to file for FSIS 
inspection in advance of arrival of shipments destined to the United 
States. The PHIS also enables the receipt of electronic foreign health 
certificate information that provides a secure and timely advance 
notice of a foreign shipment certified by a foreign government.
    Information on implementation of the PHIS Import Component is 
provided on the FSIS Web site at http://www.fsis.usda.gov/regulations_&_policies/PHIS_Import_Component/index.asp. FSIS is also 
coordinating with foreign countries to enable the electronic submission 
of the foreign establishment and foreign inspection certifications. Any 
updated information will be posted on the Agency's PHIS Import 
Component Web site.

PHIS and the Automated Commercial Environment (ACE) Interface

    FSIS has actively participated in the development of the 
International Trade Data System (ITDS), a government-wide project to 
build an electronic ``single-window'' for collecting and sharing trade 
data for reporting imports and exports among federal agencies. The goal 
of the ITDS is to eliminate the redundant reporting of data, replacing 
multiple filings, many of which are on paper, with a single electronic 
filing. The U.S. Customs and Border Protection (CBP) has developed the 
Automated Commercial Environment (ACE), a U.S. commercial trade 
processing system that automates border processing of products. The ACE 
system connects the trade community and participating government 
agencies by providing a single, centralized, online access point. When 
applicants file entries with the CBP through ACE, relevant data is 
electronically distributed to appropriate government agencies.

[[Page 70716]]

    The PHIS interfaces with the ACE, permitting the direct electronic 
transfer of imported meat, poultry, and egg products data directly into 
the PHIS Import Component. FSIS considers any electronic data 
transferred from ACE into the PHIS Import Component as certified by the 
applicant. In addition, FSIS considers any electronic records, digital 
images, data, or information from a foreign government for foreign 
inspection and foreign establishment certification to be equivalent to 
paper records and certified by the foreign government.
    When developing, procuring, maintaining, or using electronic and 
information technology (EIT), federal agencies are required by Section 
508(a)(1)(a) of the Rehabilitation Act of 1973 (29 U.S.C. 794d) to 
ensure that EIT is accessible to people with disabilities, including 
employees and members of the public. The PHIS Import Component meets 
these requirements.

Proposed Amendments

Foreign Establishment Certification

    As discussed above, FSIS meat and poultry import inspection 
regulations require an official of the foreign government to determine 
and certify the foreign establishments that are eligible to export 
their products into the United States. The regulations require a 
prescriptive narrative statement certifying that the establishments 
fully meet the requirement of 9 CFR 327.2(a)(2)(i) and (ii) and 
381.196(a)(2)(i) and (ii). The establishment certificate must also 
include: the date; the foreign country; the foreign establishment's 
name, address, and control number (the foreign establishment's number 
assigned by the foreign country); and the foreign official's title and 
signature.
    FSIS is proposing to amend 9 CFR 327.2(a)(3) and 381.196(a)(3) to 
provide concise regulatory language, delete the prescriptive narrative 
statement on the certificate, and require (in addition to information 
listed above): the type of operations conducted at the foreign 
establishment (e.g., slaughter, processing, storage, exporting 
warehouse), and the establishment's eligibility status (i.e., identify 
establishments that have been added or delisted and subsequently 
relisted since the last annual certification). In addition, for 
slaughter and processing establishments, the Agency is proposing to 
require the species and type of products produced and the process 
category. This information is necessary to ensure that FSIS has 
complete information on the types of products produced and the types of 
operations conducted in each foreign establishment.
    Because the foreign establishment certification regulations are 
currently paper-based, FSIS is proposing to provide for the electronic 
transmittal of foreign establishment certifications to FSIS from 
foreign governments. FSIS will continue to require that foreign 
establishment certifications be renewed on an annual basis and that, 
consistent with current procedures, paper certificates, if used, be 
submitted to FSIS Headquarters.
    As discussed above, the egg products import regulations provide for 
foreign country (not establishment) certification to export to the 
United States. FSIS is not proposing foreign establishment eligibility 
requirements for imported egg products at this time. The Agency will 
propose foreign establishment certification in a separate proposed 
rule, currently under development.

Imported Product Foreign Inspection Certificates

    As discussed above, the foreign product inspection certificate 
regulations provide four types of certificates--a fresh meat and meat 
byproducts certificate, a meat food product certificate, a poultry 
product certificate, and an egg products certificate. The meat and 
poultry certificates contain a form with a prescriptive narrative 
statement certifying that the products listed on the certificate are in 
compliance with equivalent U.S requirements in the Acts and 
regulations. The imported egg products foreign inspection certificate 
regulation specifies the required information.
    To clarify and simplify the foreign inspection certificate 
requirement, FSIS is proposing to require the same information for 
meat, poultry, and egg products and delete the prescriptive narrative 
and format requirements for meat and poultry foreign inspection 
certificates. The meat and poultry products foreign inspection 
certificate's narrative statement reiterates the requirements in 9 CFR 
327.2 and 381.196 with respect to ante-mortem and post-mortem 
inspection, establishment certification, sanitary handling of product, 
and requirements equivalent to those in Acts and relevant regulations, 
and therefore, is unnecessary. The prescriptive formatting requirements 
(i.e., certificate title, headings, lines) for meat and poultry foreign 
inspection certificates are also unnecessary.
    The Agency is also proposing to delete the requirement that the 
meat foreign inspection certificates bear the official seal of the 
government agency responsible for the inspection of the product and be 
in the language of the foreign country of origin (9 CFR 327.4(c) and 
(d)). The certificates must in English so they can be read by U.S. 
import inspectors, and the seal has no purpose. In addition, the Agency 
is proposing to delete the requirement that the meat and poultry 
inspection certificate identify the foreign city. The foreign 
establishment number provides sufficient information to identify the 
foreign city.
    The egg products foreign inspection certificate requires the name 
and address of the importer and the exporter, but not the name and 
address of the consignee and the consignor. The meat and poultry 
products foreign inspection certificate requires the consignor and 
consignee addresses, but not the importer and exporter addresses. The 
``exporter'' is the party in the foreign country that sold the product. 
The ``importer'' is the party in the United States to whom the overseas 
shipper sold the imported product. The ``consignee'' is the party that 
holds the product for sale or for delivery. The ``consignor'' is the 
party that delivers the product to the consignee. The Agency is 
proposing to amend its regulations to require the identity and address 
of the consignee, consignor, exporter, and importer and is proposing 
that this information be provided for meat, poultry, and egg product 
inspection certificates. The Agency is also proposing to delete the 
product ``destination'' requirement since it will be replaced with the 
``consignee address.'' This information provides additional contact 
information concerning who owns or is responsible for the product, 
where the product is coming from, and its destination.
    In addition to the current required information, the Agency is 
proposing to require: the source country and foreign establishment 
number for the source material when the source materials originate from 
a country other than the exporting country; and the product's 
description, including the process category, the product category, and 
the product group.
    The product's source information is needed to verify that the 
source materials are from countries and establishments eligible to 
export products to the United States, and that the product itself is 
eligible to be imported into the United States. The product description 
information, including the process category, the product category, and 
the product group provides further information about the

[[Page 70717]]

product and assists in accurately assigning product reinspections and 
laboratory testing. FSIS also collects this information in PHIS for 
domestic plants. Examples of process categories include: raw product 
(non-intact)--ground; raw product (intact)--not ground; thermally 
processed (commercially sterile); not heat treated (shelf stable); heat 
treated (shelf stable); fully cooked (not shelf stable); and heat 
treated but not fully cooked (not shelf stable). Within these process 
categories are the product categories, e.g., raw ground, comminuted, or 
otherwise non-intact (species); raw intact (species); not ready-to-eat 
otherwise processed (species); ready-to-eat dried meat; and ready-to-
eat fully cooked (species). Within the product categories are the 
product groups, e.g., ground beef, hamburger, carcass, primals, 
sausage, ham, soups. FSIS will issue guidelines to assist foreign 
governments in completing the process category, product category, and 
product group portion of the foreign inspection certificate.
    Because the foreign inspection certification regulations are 
currently paper-based, FSIS is proposing to amend the foreign product 
inspection certificate regulations to provide for the electronic 
transmittal of foreign inspection certifications. For electronic 
foreign inspection certifications, foreign governments will transmit 
data, which will serve as the certification that the product meets the 
FSIS regulatory requirements.
    In addition, FSIS is proposing that the Administrator may 
specifically request any additional information necessary to determine 
whether the product is eligible to be imported into the United States. 
Such information may include, when appropriate, production date 
information. Production date information will be requested when 
restrictions have been placed on the country, the foreign 
establishment, or its products, to determine whether the product was 
produced in the foreign establishment during an eligible or ineligible 
timeframe. Import inspection personnel will notify the importer or the 
foreign official when additional information is required.

Import Inspection Application

    The Agency has revised FSIS Form 9540-1, Import Inspection 
Application, to include egg products and additional information the 
Agency needs to accurately assign reinspection tasks and sampling of 
the product. FSIS will ensure that copies of this revised application 
are available to applicants in paper format.
    FSIS is proposing to amend the imported product inspection 
application regulations (9 CFR 327.5, 381.198, and 590.920) to require 
that applicants submit FSIS Form 9540-1, Import Inspection Application, 
to import inspection personnel for the inspection of any product 
offered for entry into the United States. The Agency is also proposing 
to provide the option of submitting the application electronically or 
in paper.
    As discussed above, the PHIS Import Component interfaces with the 
ACE, permitting the direct electronic transfer of relevant data from 
imported meat, poultry, and egg products entries submitted through ACE 
into the PHIS. Applicants that are filing at ports that are not under 
CBP control (e.g., American Samoa, Guam) can continue to submit paper 
import inspection applications to FSIS inspection personnel at an 
official import inspection establishment.

Prior Notification of Imported Product

    As discussed above, FSIS requires importers to provide advance 
notice, as long in advance as possible, before the anticipated arrival 
of each consignment (9 CFR 327.5, 381.198, and 590.920). FSIS will 
continue to require advance notification but is proposing to revise the 
regulations to make clear that applicants must submit electronic or 
paper import inspection applications to FSIS in advance of the 
shipment's arrival but no later than when the entry is filed with CBP. 
Paper applications must be submitted to the official import 
establishment where the reinspection is to be performed.

Streamlined Inspection Procedures for Canadian Products

    As discussed above, the meat and poultry import regulations provide 
streamlined inspection procedures for products imported from Canada (9 
CFR 327.5 and 381.198). The Canadian streamlined procedures became 
effective January 1989.
    In response to a congressional request, the General Accounting 
Office (now known as the Government Accountability Office, or GAO) 
reviewed, among other things, how the streamlined inspection procedures 
differed from past procedures, and how the procedures affected the 
imported product rejection rate between 1988 and 1989. The GAO issued 
its findings in July 1990.\1\
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    \1\ ``Food Safety--Issues USDA Should Address Before Ending 
Canadian Meat Inspections,'' United States General Accounting Office 
Report to Congressional Requestors AO/RCED-90-176, July 1990.
---------------------------------------------------------------------------

    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 
([email protected]) or by an expedited mail service, or it 
can be transmitted electronically through the PHIS. When the regulatory 
amendments in this proposal are finalized, FSIS will end its practice 
of reinspecting imported product based on the foreign government's 
guarantee to replace the foreign inspection certificate. FSIS will only 
reinspect imported product upon receipt of the foreign inspection 
certificate.

Failure To Present (FTP) Imported Product for Reinspection

    Imported product destined for FSIS import reinspection may 
sometimes bypass reinspection and enter commerce, where it may be 
further processed into other products or be offered for sale to the 
consumer. This bypassing of FSIS reinspection constitutes a ``failure 
to present'' (FTP) and violates the Acts.
    Through the PHIS Import Component, FSIS is able to more effectively 
and efficiently monitor the movement of imported product. Therefore, 
when a shipment has been identified as FTP, FSIS will request, through 
the CBP, a re-delivery and appropriate penalties. If FSIS finds FTP 
product in distribution channels, the Agency will control the product 
(e.g., retain or detain the product) or request a recall of the 
product. If FSIS finds FTP product in an official establishment that is 
being used in further processed product, FSIS will condemn the FTP 
product and any further processed product that contains the FTP 
product. The FTP product that is contained intact in the original 
cartons from the foreign country can return to an official import 
inspection establishment, where the FSIS import inspection personnel 
will stamp the product as ``refused entry.''

Executive Order 12866 and Executive Order 13563

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has not been designated a ``significant 
regulatory action'' under section 3(f) of Executive Order 12866. 
Accordingly, the rule has not been reviewed by the Office of Management 
and Budget.

Benefits and Costs of the Proposed Rule

    The changes under this proposed rule are necessary to provide for 
the Agency's PHIS Import Component. The PHIS Import Component 
facilitates trade with foreign countries by providing the electronic 
exchange of import data and documentation. The PHIS Import Component 
interfaces with the ACE to provide the automatic transfer of all 
import-related data among FSIS and other government agencies that 
regulate trade, such as the CBP. This transfer of data creates new 
safety standards and strengthens existing ones.
    The PHIS Import Component enables FSIS import inspection personnel 
to verify import shipments using electronic data. The Agency estimates 
that electronic imported product

[[Page 70719]]

information reduces the data-entry time for import inspectors by 50 to 
60 percent. This does not mean that the Agency is going to reduce the 
number of import inspectors based on enhanced PHIS-related 
efficiencies. This proposed rule streamlines existing import 
documentation requirements by making the foreign inspection certificate 
consistent among meat, poultry, and egg products. In addition, the 
proposed rule updates the required information on applications and 
certificates to fortify the effectiveness of import inspection 
regulations. For example, for the import inspection application (FSIS 
Form 9540-1), the Agency is proposing to require the source country and 
establishment number when the source materials originate from a country 
other than the exporting country and the product's production dates. 
The additional information would help verify that source products are 
from countries and establishments eligible to export products to the 
United States, and that the product itself is eligible for importation. 
The additional information will also assist inspection and enforcement 
personnel in tracing, retrieving, and controlling product in the event 
of a recall.
    Several changes under this proposed rule may have a cost impact on 
the industry. Should this proposed rule become final, the Agency 
believes the impacts will be very small, if any. The impacts would be 
as follows:
    (1) The electronic foreign inspection and foreign establishment 
certificates and the electronic import inspection application. Under 
this proposed rule, the industry would have the option of filing import 
inspection applications electronically, and foreign governments would 
have the option of submitting electronic inspection and foreign 
establishment certifications and data. Since the electronic option is 
voluntary, applicants and the foreign countries would choose to file 
electronically only if it is beneficial to do so.
    (2) Additional information entry. This proposed rule, if finalized, 
requires additional information for the import inspection application, 
which will increase the amount of time to fill out the application. The 
time needed to provide the additional information will depend on (1) 
the number of lots, and (2) how the information is entered.
    Some of the information required on the new import inspection 
application is data that are required by other government agencies, 
such as CBP, and are entered by the applicant into the ACE system. The 
ACE electronically transmits data elements into PHIS, eliminating the 
need for entering all of the data requested on the electronic form.
    For applicants that submit a paper-based import inspection 
application, FSIS estimates that it will take 6 more minutes to 
complete the new application, based on a comparison between the old and 
the new paper-based application. FSIS also estimates that 
electronically filing the import inspection application will take, on 
average, an additional minute per application in comparison with the 
old paper-based application.\2\ Agency data show that there are, on 
average, a total of 44,480 applications per year that will be filed 
electronically using the ACE, and that 2,317 applications per year will 
be completed manually.\3\ Therefore, the total additional time for 
electronically filing the application will be 741 hours (44,480 * 1/60 
= 741) and the additional time for completing the new paper-based 
application will be 232 hours (2,317 * 6/60 = 232). Monetizing these 
hours by $37 per hour,\4\ the estimated cost to complete the new 
application would be about $36,000 ($37 * (232 + 741)) per year.
---------------------------------------------------------------------------

    \2\ Time estimate from International Policy Division, Office of 
Policy and Program Development, FSIS, USDA.
    \3\ Number of applications from International Policy Division, 
Office of Policy and Program Development, FSIS, USDA.
    \4\ Bureau of Labor Statistics ``Occupational Employment & 
Wages'' Database, May 2010. Animal Production Managers, all other 
$51.54 @ 47.6% time; General and Operations Managers $33.08 @ 26.2% 
time; Food scientists and technologists $14.49 @ 26.2% time = $37.00 
Managerial Median hourly wage.
---------------------------------------------------------------------------

    (3) Sanitation Standard Operating Procedures (SOPs) as a condition 
of approval for official import inspection establishments. The proposed 
rule will clarify that official import inspection establishments must 
have developed written Sanitation SOPs before being granted approval. 
If this proposed amendment is finalized, official import inspection 
establishments will be given 60 days after the publication of the final 
rule to develop and implement written Sanitation SOPs. Since, in 
practice, many official import inspection establishments maintain 
sanitation SOPs during the reinspection of imported products, the 
proposed amendment requiring sanitation SOPs will have little cost 
impact (including recordkeeping cost impact) on the industry.
    The proposed rule will remove the regulatory provisions for the 
streamlined import inspection system for Canadian product. Since the 
procedures have been obsolete since 1992, removing the regulatory 
provisions will have no significant economic impact.

Regulatory Flexibility Analysis

    The FSIS Administrator has made a preliminary determination that, 
for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602) 
this proposed rule would not have a significant impact on a substantial 
number of small entities, as defined by the Regulatory Flexibility Act. 
If small entities are unable to meet the requirements necessary to use 
the electronic import system, FSIS would continue to accept paper 
applications. Similarly, the other changes proposed in the rule would 
not result in significant costs to industry and, therefore, would not 
have a significant impact on a substantial number of small entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this proposed rule: (1) All State and local 
laws and regulations that are inconsistent with this rule will be 
preempted; (2) no retroactive effect will be given to this rule; and 
(3) no retroactive proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

Paperwork Reduction Act

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection 
requirement included in this proposed rule concerning the Import 
Inspection Application (FSIS Form 9540-1) was submitted to OMB for 
approval as part of the Public Health Information System (PHIS) 
information collection request. At that time, FSIS anticipated the 
changes to the Import Inspection Application that it is now proposing 
and described them in the PHIS information collection request to OMB, 
which approved the information collection and assigned it OMB control 
number 0583-0153.
    In addition, FSIS has submitted an information collection to OMB 
for the new information collection associated with the proposed rule.
    Title: Electronic Import Inspection
    Type of Collection: New

[[Page 70720]]

    Abstract: Under this proposed rule, FSIS is proposing to require 
foreign governments to submit additional information when submitting 
both the foreign establishment certificate and the foreign inspection 
certificate to FSIS in order for foreign establishments to be permitted 
to import product to the United States. The current information 
collection associated with these two certificates is approved under OMB 
control number 0583-0094.
    FSIS is also proposing to require official import inspection 
establishments to develop, implement, and maintain written Sanitation 
Standard Operating Procedures (SSOPs), as provided in 9 CFR 416.11 
through 416.17.\5\
---------------------------------------------------------------------------

    \5\ The ``Benefits and costs of the proposed rule'' section 
(above) did not include Sanitation Standard Operating Procedures 
(Sanitation SOPs) costs. While not currently required, in practice, 
Import Inspection Establishments maintain Sanitation SOPs; 
therefore, the proposed rule would not be adding any further costs 
to import inspection establishments. However, incorporating the 
Sanitation SOPs into FSIS's regulations requires OMB approval of the 
associated information collection burden. The cost analysis also did 
not address the expanded questions addressed to foreign governments 
because the costs would be experienced by foreign entities.
---------------------------------------------------------------------------

    Estimate of Burden: FSIS estimates that it will take 27.8 hours per 
foreign government (foreign establishment and foreign inspection 
certificates) and 157.6 hours per official import inspection 
establishment (SSOP requirements).
    Respondents: Foreign governments (foreign establishment and foreign 
inspection certificates) and official import inspection establishments 
(SSOP requirements).
    Estimated Number of Respondents: 30 foreign governments and 120 
official import inspection establishments.
    Estimated Number of Responses per Respondent: 556 responses per 
foreign government and 523 responses per official import inspection 
establishments annually.
    Estimated Total Annual Burden on Respondents: 834 hours for foreign 
governments and 18,920 hours for official import inspection 
establishments for a total of 19,754 hours.
    Copies of this information collection assessment can be obtained 
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety 
and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083, 
South Building, Washington, DC 20250-3700.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Comments may be sent to both John O'Connell, Paperwork Reduction 
Act Coordinator, at the address provided above, and the Desk Officer 
for Agriculture, Office of Information and Regulatory Affairs, Office 
of Management and Budget, Washington, DC 20253. To be most effective, 
comments should be sent to OMB within 60 days of the publication date 
of this proposed rule.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

Additional Public Notification

    FSIS will announce this rule online through the FSIS Web page 
located at http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/.
    Options range from recalls to export information to regulations, 
directives and notices. Customers can add or delete subscriptions 
themselves, and have the option to password protect their accounts.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.)
    Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, audiotape, 
etc.) should contact USDA's Target Center at 202-720-2600 (voice and 
TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

List of Subjects

9 CFR Part 304

    Application for inspection; Grant of inspection

9 CFR Part 327

    Imported products

9 CFR Part 381

    Poultry products inspection regulations

9 CFR Part 590

    Inspection of eggs and egg products (Egg Products Inspection Act)

    For the reasons set discussed in the preamble, FSIS proposes to 
amend 9 CFR Chapter III as follows:

PART 304--APPLICATION FOR INSPECTION; GRANT OF INSPECTION

    1. The authority citation for Part 304 continues to read as 
follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    2. In Sec.  304.3, revise paragraph (a) to read as follows:


Sec.  304.3  Conditions for receiving inspection.

    (a) Before being granted Federal inspection, an official 
establishment or an official import inspection establishment must have 
developed written Sanitation Standard Operating

[[Page 70721]]

Procedures, as required by part 416 of this chapter.
* * * * *

PART 327--IMPORTED PRODUCTS

    3. The authority citation for Part 327 continues to read as 
follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    4. In Sec.  327.1, revise paragraph (a) to read as follows:


Sec.  327.1  Definitions; application of provisions.

    (a) When used in this part, the following terms are defined to 
mean:
    (1) Import (imported). To bring within the territorial limits of 
the United States whether that arrival is accomplished by land, air, or 
water.
    (2) Offer(ed) for entry. The point at which the importer presents 
the imported product for reinspection.
    (3) Entry (entered). The point at which imported product offered 
for entry receives reinspection and is marked with the official mark of 
inspection, as required by Sec.  327.26.
* * * * *
    5. In Sec.  327.2, revise paragraph (a)(3) to read as follows:


Sec.  327.2  Eligibility of foreign countries for importation of 
products into the United States.

    (a) * * *
    (3) Only those establishments that are determined and certified to 
the Agency by a responsible official of the foreign meat inspection 
system as fully meeting the requirements of paragraphs (a)(2)(i) and 
(ii) of this section are eligible to have their products imported into 
the United States. Establishment eligibility is subject to review by 
the Agency (including observations of the establishments by Program 
representatives at times prearranged with the foreign meat inspection 
system officials). Foreign establishment certifications must be renewed 
annually. Notwithstanding certification by a foreign official, the 
Administrator may terminate the eligibility of any foreign 
establishment for the importation of its products into the United 
States if it does not comply with the requirements listed in paragraphs 
(a)(2)(i) and (ii) of this section, or if current establishment 
information cannot be obtained. The Administrator will provide 
reasonable notice to the foreign government of the proposed termination 
of any foreign establishment, unless a delay in terminating its 
eligibility could result in the importation of adulterated or 
misbranded product. The electronic foreign establishment certification 
or paper certificate must contain: the date; the foreign country; the 
foreign establishment's name, address, and foreign establishment 
number; the foreign official's title; the foreign official's signature 
(for paper certificate only); the type of operation(s) conducted at the 
establishment (e.g., slaughter, processing, storage, exporting 
warehouse); and the establishment's eligibility status (e.g., new or 
relisted (if previously delisted)). Slaughter and processing 
establishment certifications must address the species and type of 
product(s) produced at the establishment and the process category.
* * * * *
    6. Revise Sec.  327.4 to read as follows:


Sec.  327.4  Foreign inspection certificate requirements.

    (a) Except as provided in Sec.  327.16, each consignment imported 
into the United States must have an electronic foreign inspection 
certification or a paper foreign inspection certificate issued by an 
official of the foreign government agency responsible for the 
inspection and certification of the product.
    (b) An official of the foreign government must certify that any 
product described on any official certificate was produced in 
accordance with the regulatory requirements in Sec.  327.2.
    (c) The electronic foreign inspection certification must be in 
English, be transmitted directly to FSIS before the product's arrival 
at the official import inspection establishment, and be available to 
import inspection personnel.
    (d) The paper foreign inspection certificate must accompany each 
consignment, be submitted to import inspection personnel at the 
official import inspection establishment, be in English, and bear the 
signature of the official authorized to issue inspection certificates 
for products imported to the U.S.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date, name, and title of the official authorized to issue 
inspection certificates for products imported into the U.S.;
    (2) The foreign country of export and the producing foreign 
establishment number;
    (3) The species used to produce the product and the source country 
and foreign establishment number, if the source materials originate 
from a country other than the exporting country;
    (4) The product's description, including the process category, the 
product category, and the product group;
    (5) The name and address of the consignor;
    (6) The name and address of the exporter;
    (7) The name and address of the consignee;
    (8) The name and address of the importer;
    (9) The number of units (pieces or containers) and the shipping or 
identification mark on the units;
    (10) The net weight of each lot; and
    (11) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the U.S.
    7. Revise Sec.  327.5 to read as follows:


Sec.  327.5  Import inspection application.

    (a) Applicants must submit FSIS Form 9540-1, Import Inspection 
Application, to apply for the inspection of any product offered for 
entry. Applicants may apply for inspection using a paper or electronic 
application.
    (b) Import inspection applications for each consignment must be 
submitted (electronically or paper) to FSIS in advance of the 
shipment's arrival at the official import establishment where the 
product will be reinspected, but no later than when the entry is filed 
with U.S. Customs and Border Protection.
    (c) The provisions of this section do not apply to products that 
are exempted from inspection by Sec. Sec.  327.16 and 327.17.
    8. In Sec.  327.6, revise paragraphs (a) and (e) to read as 
follows:


Sec.  327.6  Products for importation; program inspection, time and 
place; application for approval of facilities as official import 
inspection establishment; refusal or withdrawal of approval; official 
numbers.

    (a)(1) Except as provided in Sec. Sec.  327.16 and 327.17, all 
products offered for entry from any foreign country shall be 
reinspected by a Program inspector before they shall be allowed entry 
into the United States.
    (2) Every lot of product shall routinely be given visual inpsection 
by a Program import inpsector for appearance and condition, and checked 
for certification and label compliance.
    (3) The Public Health Information System (PHIS) shall be consulted 
for reinspection instructions. The PHIS will assign reinspection levels 
and procedures based on established sampling plans and established 
product and plant history.

[[Page 70722]]

    (4) When the inpsector deems it necessary, the inpsector may sample 
and inspect lots not designated by PHIS.
* * * * *
    (e) Owners or operators of official import inspection 
establishments must furnish adequate sanitary facilities and equipment 
for examination of such product. The requirements of Sec. Sec.  304.2, 
307.1, 307.2(b), (d), (f), (h), (k), and (l), and part 416 of this 
chapter shall apply as conditions for approval of establishments as 
official import inspection establishments to the same extent and in the 
same manner as they apply with respect to official establishments.
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    9. The authority citation for Part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7, 
2.18, 2.53.

    10. In Sec.  381.1, in paragraph (b), add a definition for Official 
establishment in alphabetical order to read as follows:


Sec.  381.1  Definitions.

* * * * *
    (b) * * *
    Official import inspection establishment. This term means any 
establishment, other than an official establishment as defined in this 
paragraph where inspections are authorized to be conducted as 
prescribed in Sec.  381.199.
* * * * *
    11. In Sec.  381.22, revise paragraph (a) to read as follows:


Sec.  381.22  Conditions for receiving inspection.

    (a) Before being granted Federal inspection, an official 
establishments or an official import inspection establishment, must 
have developed written Sanitation Standard Operating Procedures, as 
required by part 416 of this chapter.
* * * * *
    12. In Sec.  381.195, revise paragraph (a) to read as follows:


Sec.  381.195  Definitions; requirements for importation into the 
United States.

    (a) When used in this part, the following terms are defined to 
mean:
    (1) Import (imported). To bring within the territorial limits of 
the United States whether that arrival is accomplished by land, air, or 
water.
    (2) Offer(ed) for entry. The point at which the importer presents 
the imported product for reinspection.
    (3) Entry (entered). The point at which imported product offered 
for entry receives reinspection and is marked with the official mark of 
inspection, as required by Sec.  381.204.
* * * * *
    13. In Sec.  381.196, revise paragraph (a)(3) to read as follows:


Sec.  381.196  Eligibility of foreign countries for importation of 
poultry products into the United States.

    (a) * * *
    (3) Only those establishments that are determined and certified to 
the Agency by a responsible official of the foreign poultry inspection 
system as fully meeting the requirements of paragraphs (a)(2)(i) and 
(ii) of this section are eligible to have their products imported into 
the United States. Establishment eligibility is subject to review by 
the Agency (including observations of the establishments by Program 
representatives at times prearranged with the foreign meat inspection 
system officials). Foreign establishment certifications must be renewed 
annually. Notwithstanding certification by a foreign official, the 
Administrator may terminate the eligibility of any foreign 
establishment for the importation of its products into the United 
States if it does not comply with the requirements listed in paragraphs 
(a)(2)(i) and (ii) of this section, or if current establishment 
information cannot be obtained. The Administrator will provide 
reasonable notice to the foreign government of the proposed termination 
of any foreign establishment, unless a delay in terminating its 
eligibility could result in the importation of adulterated or 
misbranded product. The electronic foreign establishment certification 
or paper certificate must contain: the date; the foreign country; the 
foreign establishment's name, address, and foreign establishment 
number; the foreign official's title; the foreign official's signature 
(for paper certificate only); the type of operation(s) conducted at the 
establishment (e.g., slaughter, processing, storage, exporting 
warehouse); and the establishment's eligibility status (e.g., new or 
relisted (if previously delisted)). Slaughter and processing 
establishment certifications must address the species and type of 
product(s) produced at the establishment and the process category.
* * * * *
    14. Revise Sec.  381.197 to read as follows:


Sec.  381.197  Foreign inspection certificate requirements.

    (a) Except as provided in Sec. Sec.  381.207 and 381.209, each 
consignment imported into the United States must have an electronic 
foreign inspection certification or a paper foreign inspection 
certificate issued by an official of the foreign government agency 
responsible for the inspection and certification of the product.
    (b) An official of the foreign government must certify that any 
product described on any official certificate was produced in 
accordance with the regulatory requirements in Sec.  381.196.
    (c) The electronic foreign inspection certification must be in 
English, be transmitted directly to FSIS before the product's arrival 
at the official import inspection establishment, and be available to 
import inspection personnel.
    (d) The paper foreign inspection certificate must accompany each 
consignment, be submitted to import inspection personnel at the 
official import inspection establishment, be in English, and bear the 
signature of the official authorized to issue inspection certificates 
for products imported to the U.S.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date, name, and title of the official authorized to issue 
inspection certificates for products imported into the U.S.;
    (2) The foreign country of export and the producing foreign 
establishment number;
    (3) The species used to produce the product and the source country 
and foreign establishment number, if the source materials originate 
from a country other than the exporting country;
    (4) The product's description, including the process category, the 
product category, and the product group;
    (5) The name and address of the consignor;
    (6) The name and address of the exporter;
    (7) The name and address of the consignee;
    (8) The name and address of the importer;
    (9) The number of units (pieces or containers) and the shipping or 
identification mark on the units;
    (10) The net weight of each lot; and
    (11) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the U.S.

[[Page 70723]]

    15. Revise Sec.  381.198 to read as follows:


Sec.  381.198  Import inspection application.

    (a) Applicants must submit FSIS Form 9540-1, Import Inspection 
Application, to apply for the inspection of any product offered for 
entry. Applicants may apply for inspection using a paper or electronic 
application.
    (b) Import inspection applications for each consignment must be 
submitted (electronically or paper) to FSIS in advance of the 
shipment's arrival at the official import establishment where the 
product will be reinspected, but no later than when the entry is filed 
with U.S. Customs and Border Protection.
    (c) The provisions of this section do not apply to products that 
are exempted from inspection by Sec. Sec.  381.207 and 381.209.
    16. In Sec.  381.199, revise paragraph (a) and add paragraphs (e) 
through (k) to read as follows:


Sec.  381.199  Inspection of poultry products offered for entry.

    (a)(1) Except as provided in Sec.  381.209 and paragraph (c) of 
this section, all slaughtered poultry and poultry products offered for 
entry from any foreign country shall be reinspeced by a Program import 
inspector before they shall be allowed entry into the United States.
    (2) Every lot of product shall routinely be given visual inspection 
for appearance and condition, and checked for certification and label 
compliance.
    (3) The Public Health Information System (PHIS) shall be consulted 
for reinspection instructions. The PHIS will assign reinspection levels 
and procedures based on established sampling plans and established 
product and plant history.
    (4) When the inpsector deems it necessary, the inpsector may sample 
and inspect lots not designated by PHIS.
* * * * *
    (e) All products, required by this part to be inspected, shall be 
inspected only at an official establishment or at an official import 
inspection establishment approved by the Administrator as provided in 
this section. Such approved official import inspection establishments 
will be listed in the Directory of Meat and Poultry Inspection Program 
Establishments, Circuits and Officials, published by the Food Safety 
and Inspection Service. The listing will categorize the kind or kinds 
of product which may be inspected at each official import inspection 
establishment, based on the adequacy of the facilities for making such 
inspections and handling such products in a sanitary manner.
    (f) Owners or operators of establishments, other than official 
establishments, who want to have import inspections made at their 
establishments, shall apply to the Administrator for approval of their 
establishments for such purpose. Application shall be made on a form 
furnished by the Program, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC, and shall include all 
information called for by that form.
    (g) Approval for Federal import inspection shall be in accordance 
with subpart D of part 381.
    (h) Owners or operators of establishments at which import 
inspections of product are to be made shall furnish adequate sanitary 
facilities and equipment for examination of such product. The 
requirements of Sec. Sec.  381.21 and 381.36, and part 416 of this 
chapter shall apply as conditions for approval of establishments as 
official import inspection establishments to the same extent and in the 
same manner as they apply with respect to official establishments.
    (i) The Administrator is authorized to approve any establishment as 
an official import inspection establishment provided that an 
application has been filed and drawings have been submitted in 
accordance with the requirements of paragraphs (c) and (d) of this 
section and he determines that such establishment meets the 
requirements under paragraph (e) of this section. Any application for 
inspection under this section may be denied or refused in accordance 
with the rules of practice in part 500 of this chapter.
    (j) Approval of an official import inspection establishment may be 
withdrawn in accordance with applicable rules of practice if it is 
determined that the sanitary conditions are such that the product is 
rendered adulterated, that such action is authorized by section 21(b) 
of the Federal Water Pollution Control Act, as amended (84 Stat. 91), 
or that the requirements of paragraph (e) of this section were not 
complied with. Approval may also be withdrawn in accordance with 
section 401 of the Act and applicable rules of practice.
    (k) A special official number shall be assigned to each official 
import inspection establishment. Such number shall be used to identify 
all products inspected and passed for entry at the establishment.

PART 590--INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS 
INSPECTION ACT)

    17. The authority citation for part 590 continues to read as 
follows:

    Authority: 21 U.S.C. 1031-1056.

    18. Revise Sec.  590.915 to read as follows:


Sec.  590.915  Foreign inspection certificate requirements.

    (a) Except as provided in Sec.  590.960, each consignment imported 
into the United States must have an electronic foreign inspection 
certification or a paper foreign inspection certificate issued by an 
official of the foreign government agency responsible for the 
inspection and certification of the product.
    (b) An official of the foreign government agency must certify that 
any product described on any official certificate was produced in 
accordance with the regulatory requirements Sec.  590.910.
    (c) The electronic foreign inspection certification must be in 
English, be transmitted directly to FSIS before the product's arrival 
at the official import inspection establishment, and be available to 
import inspection personnel.
    (d) The paper foreign inspection certificate must accompany each 
consignment, be submitted to import inspection personnel at the 
official import inspection establishment, be in English, and bear the 
signature of the official authorized to issue the inspection 
certificates for products imported into the U.S.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date, name, and title of the official authorized to issue 
inspection certificates for products imported into the U.S.;
    (2) The foreign country of export and the producing foreign 
establishment number;
    (3) The species used to produce the product and the source country 
and foreign establishment number, if the source materials originate 
from a country other than the exporting country;
    (4) The product's description including the process category, the 
product category, and the product group;
    (5) The name and address of the consignor;
    (6) The name and address of the exporter;
    (7) The name and address of the consignee;

[[Page 70724]]

    (8) The name and address of the importer;
    (9) The number of units (pieces or containers) and the shipping or 
identification mark on the units;
    (10) The net weight of each lot; and
    (11) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the U.S.
    19. Revise Sec.  590.920 to read as follows:


Sec.  590.920  Import inspection application.

    (a) Applicants must submit FSIS Form 9450-1, Import Inspection 
Application, to apply for the inspection of any product offered for 
entry. Applicants may apply for inspection using a paper or electronic 
application.
    (b) Import inspection applications for each consignment must be 
submitted (electronically or paper) to FSIS in advance of the 
shipment's arrival at the official import establishment where the 
product will be reinspected, but no later than when the entry is filed 
with U.S. Customs and Border Protection.
    (c) The provisions of this section do not apply to products that 
are exempted from inspection by Sec. Sec.  590.960 and 590.965.

    Done at Washington, DC, on: October 25, 2012
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-28751 Filed 11-26-12; 8:45 am]
BILLING CODE 3410-DM-P