[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Rules and Regulations]
[Pages 56220-56235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22206]


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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: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending 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 the 
foreign inspection and foreign establishment certificate processes. The 
Agency is also removing from the regulations the discontinued 
``streamlined'' import inspection procedures for Canadian product and 
is requiring Sanitation Standard Operating Procedures (SOPs) at 
official import inspection establishments.
    In addition to the regulatory amendments outlined above, FSIS is 
discontinuing 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: Effective Date: November 18, 2014.
    Compliance Date: Revised Import Inspection Application (FSIS Form 
9540-1): March 18, 2015.

FOR FURTHER INFORMATION CONTACT: Ms. Mary Stanley, Director, 
International Relations and Strategic Planning Staff, Office of Policy 
and Program Development, FSIS, U.S. Department of Agriculture, 1400 
Independence Avenue SW., Room 2925, Washington, DC 20250-3700, Phone: 
(202) 720-0287.

SUPPLEMENTARY INFORMATION: 

Executive Summary

    On November 27, 2012, FSIS issued a proposed rule to amend the 
meat, poultry, and egg products import regulations to provide for the 
import component of the Agency's Public Health Information System 
(PHIS). The PHIS is an electronic data analytic system, launched to 
collect, consolidate, and analyze data in order to improve public 
health.
    In addition to providing for the PHIS Import Component, FSIS 
proposed to amend the regulations to delete overly prescriptive 
formatting and narrative requirements for foreign establishments and 
inspection certificates and to make the certificate requirements the 
same for imported meat, poultry, and egg products. The Agency also 
proposed to require additional information on these certificates so it 
would have complete foreign establishment and product information to 
determine eligibility and reinspection.
    The proposed rule also amended the regulations to require that 
official import inspection establishments comply with Sanitation 
Standard Operating Procedures (SOPs) to prevent the direct 
contamination or adulteration of products. The proposal also deleted 
certain streamlined inspection procedures for products imported from 
Canada. The streamlined procedures were implemented 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. 
However, FSIS suspended the use of these procedures in 1992.
    In addition to the proposed regulatory amendments, FSIS announced 
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 within 30 
days and clarified its policy of addressing imported product that is 
not presented for reinspection.
    This rule finalizes all of the proposed amendments, with the 
following modifications and clarifications:
     The final rule changes the proposed foreign establishment 
certification regulations (9 CFR 327.2(a)(3) and 381.196(a)(3)) to 
provide that when a foreign government certifies a foreign

[[Page 56221]]

establishment for which the preceding year's certificate information 
has not changed, the certificate or certification only needs to list 
the date, the foreign country, the foreign establishment's name, and 
the foreign official's title and signature (for paper certificates 
only). Also, the final rule will not require the foreign official's 
title for electronic foreign establishment certifications because this 
information is required in an electronic certification agreement and 
Memorandum of Understanding (MOU) between FSIS and the foreign country.
     The final rule revises the foreign inspection certificate 
regulations (9 CFR 327.4, 381.197, and 590.5915) to require that 
foreign governments provide the names and addresses of the ``importer 
or consignee'' and the ``exporter or consignor.'' The Agency is also 
clarifying that ``the process category'' is an example of the type of 
product produced, not additional required information. This final rule 
also amends the proposal to require the seal of the foreign government 
on paper foreign inspection certificates. In addition, the final rule 
will not require the foreign official's name and title for electronic 
foreign inspection certifications because, as discussed above for 
foreign establishment certifications, this information is required in 
an electronic certification agreement and MOU between FSIS and the 
foreign country.
    The benefits of the final rule include reduced data-entry time for 
import inspectors, streamlined existing import documentation 
requirements, and increased effectiveness of import inspection 
regulations. An additional potential benefit is that the rule provides 
the option to file mandatory import application data electronically. 
Compared to the old paper-based application, FSIS estimates that it 
will take 6 additional minutes to complete the new paper-based 
application and an additional minute to submit an electronic 
application. Monetizing this time, FSIS estimates the industry wide 
cost to complete the new application is about $77,000 per year. The 
Agency expects few or no costs to arise from the Sanitation SOPs or the 
removal of regulatory provisions for the streamlined import inspection 
system for Canadian products.

Background

    On November 27, 2012, FSIS published the proposed rule, 
``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'' (77 FR 70714). In it, the Agency proposed to 
amend the meat, poultry, and egg products import regulations to provide 
for the PHIS Import Component, an electronic alternative to the paper-
based import inspection application and imported product foreign 
inspection and foreign establishment certificate processes.
    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 the 
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.

PHIS Import Component

    On May 29, 2012, FSIS launched the PHIS Import Component, which 
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 Import Component enables United States importers to file for FSIS 
inspection in advance of arrival of shipments destined to the United 
States.

PHIS and the Automated Commercial Environment (ACE) Interface

    FSIS has actively participated in the development of the 
International Trade Data System (ITDS), an electronic information 
exchange capability, or ``single-window,'' through which businesses 
will transmit data required by participating agencies for the 
importation or exportation of cargo. The goal of the ITDS is to 
eliminate redundant data reporting and replace multiple filings, many 
of which are on paper. As part of the ITDS initiative, the U.S. Customs 
and Border Protection (CBP) developed the Automated Commercial 
Environment (ACE), a United States commercial trade processing system 
that automates border processing of shipments of amenable products. The 
ACE system provides a single, centralized, online access point that 
connects the trade community and partner government agencies. The ACE 
system interfaces with the PHIS Import Component and electronically 
transfers CBP entry data on meat, poultry, and egg products to FSIS but 
does not yet provide all of the required FSIS information.
    Since the implementation of the PHIS Import Component, the Agency 
has collaborated with CBP to develop the capability to collect and 
transfer, through the ACE/PHIS Import Component interface, all of the 
FSIS required information through a Partner Government Agency (PGA) 
Message Set, which will eliminate the need to submit a paper 
application for import inspection. In March 2013, the Agency published 
a Federal Register Notice, ``Electronic Filing of Import Inspection 
Applications for Meat, Poultry, and Egg Products: Availability of Draft 
Compliance Guide and PGA Message Set Pilot Program,'' announcing the 
availability of a compliance guide on the PGA Message Set and a pilot 
program intended to test the transfer of FSIS data from the ACE/PGA 
Message Set to the PHIS Import Component (http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2012-0037.pdf). The compliance guide, which FSIS 
developed in conjunction with CBP, provides specific guidance to 
industry to take advantage of the ``single window'' initiative. FSIS 
began piloting the PGA Message Set with two brokers in April 2014.
    On December 13, 2013, CBP published a Federal Register Notice, 
``National Customs Automation Program (NCAP) Test Concerning the 
Submission of Certain Data Required by the Environmental Protection 
Agency and the Food Safety and Inspection Service Using the Partner 
Government Agency Message Set Through the Automated Commercial 
Environment (ACE),'' which announced the testing of electronic filings 
of import data using the Automated Commercial Environment (ACE) Partner 
Government Agency (PGA) Message Set and the Automated Broker Interface 
(ABI) to transmit the data (78 FR 75931). On February 19, 2014, 
President Obama signed an Executive Order that mandates the completion 
of the ITDS by December 2016 (http://www.whitehouse.gov/the-press-office/2014/02/19/executive-order-streamlining-exportimport-process-america-s-businesses).
    FSIS considers any electronic data transferred from ACE into the 
PHIS Import Component as certified by the applicant. FSIS also 
considers any electronic records, digital images, data, or information 
from a foreign

[[Page 56222]]

government for foreign inspection and foreign establishment 
certification to be equivalent to paper records and certified by the 
foreign government.

Proposed and Final Regulatory Amendments

Foreign Establishment Certificate

    As discussed in the proposed rule (77 FR 70714), the meat and 
poultry products import regulations require that an official of the 
foreign inspection system determine and certify, on an annual basis, 
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 proposed rule also explained that the annual foreign establishment 
certificate regulations prescribe a narrative format that requires the 
foreign establishment's 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 for its egg 
products to be imported into the United States, the country is listed 
in 9 CFR 590.910(b). As discussed in the proposed rule (77 FR 70716), 
because the egg products import regulations do not require foreign 
establishment certification, FSIS did not propose eligibility 
requirements for foreign egg product plants. The Agency intends to 
propose foreign egg product plant certification requirements in a 
separate rulemaking.
    FSIS proposed (77 FR 70716) to amend the meat and poultry foreign 
establishment certificate regulations to provide concise regulatory 
language, delete the prescriptive narrative certificate statement, 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 proposed to require the species and type of 
products produced and the process category. FSIS also proposed to 
provide for the electronic transmittal of foreign establishment 
certifications to FSIS from foreign governments, in lieu of paper-based 
foreign establishment certifications.
    This rule finalizes the proposed amendments to the foreign 
establishment certification regulations (9 CFR 327.2(a)(3) and 
381.196(a)(3)), with minor modifications. FSIS proposed that slaughter 
and processing establishments must address the species and type of 
products produced at the establishment and the process category. In 
this final rule, in response to comments, the Agency is clarifying that 
``the process category'' is an example of the type of product produced, 
not additional information. Therefore, the last sentence of the 
regulatory text in proposed 9 CFR 327.2(a)(3) and 381.196(a)(3) is 
changed in this final rule to provide that slaughter and processing 
establishment certifications must address the species and type of 
products produced at the establishment (e.g., the process category).
    FSIS also proposed to require the foreign official's title on 
foreign establishment certificates and electronic certifications. 
However, because foreign countries that utilize electronic 
certification (eCert) identify the foreign official's title in an 
Interconnection Security Agreement (ISA) and a Memorandum of 
Understanding (MOU) with FSIS, the Agency reconsidered requiring this 
information for electronic certifications. In this final rule, for 
foreign governments that utilize eCert to transmit foreign 
establishment certifications, the foreign official's title will not be 
required information.
    In addition, since actively exporting foreign establishment 
information is stored in the PHIS Import Component's foreign 
establishment profile, the Agency reconsidered requiring all of the 
information on a yearly basis. To minimize the burden to foreign 
countries, FSIS determined that, for foreign establishments that have 
no changes to the previous year's certification information, foreign 
governments only have to provide the date, the foreign country, the 
foreign establishment name, and, for paper certificates, the foreign 
official's title and signature. The Agency is amending 9 CFR 
327.2(a)(3) and 381.196(a)(3) to add subparagraph (i) to list the 
requirements for a new establishment, or any establishment for which 
information from last year's information has changed, and subparagraph 
(ii) to list the establishment certification requirements for 
establishments listed the preceding year that have no changes to the 
required information.

Imported Product Foreign Inspection Certificates

    As discussed in the proposed rule (77 FR 70714), the meat, poultry, 
and egg products import regulations require a foreign inspection 
certificate for every shipment of product that is offered for import 
into the United States (9 CFR 327.4, 381.197, and 590.915). Depending 
on the type of product to be imported, the regulations provide four 
different 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 meat and poultry foreign inspection certificate regulations 
prescribe a narrative statement and format, certifying that the product 
was derived from livestock or poultry that received ante-mortem and 
post-mortem veterinary inspection at the time of slaughter in 
establishments certified to export their products to the United States, 
is not adulterated, and is in compliance with requirements equivalent 
to the U.S. domestic requirements. The regulations also require 
specific information about the product. Meat and poultry products 
foreign inspection certificates are required to be in the form 
illustrated in 9 CFR 327.4(a) and (b) and 381.197(b), the 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 (9 CFR 327.4(c) 
and (d)).
    The egg products foreign inspection certification regulations (9 
CFR 590.915) contain a list of required information and require 
certification that the product was produced under the approved 
regulations, requirements, and continuous inspection of the government 
of the exporting country.
    FSIS proposed to amend the meat, poultry, and egg product foreign 
inspection certification regulations to clarify and simplify the 
foreign inspection certificate requirements; to require the same 
information for meat, poultry, and egg product certificates; and to 
delete the prescriptive narrative and format requirements for the meat 
and poultry foreign inspection certificates (77 FR 70716). The Agency 
proposed to delete the requirement that the meat certificate 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. 
In addition, the Agency proposed to delete the requirement that the

[[Page 56223]]

certificate identify the city where the establishment is located, 
because the foreign establishment number provides sufficient 
information to identify that city. The Agency also proposed to require 
the identity and address of the consignee, consignor, exporter, and 
importer and to delete the product ``destination'' requirement because 
it would be replaced with the ``consignee address.'' In addition, the 
Agency proposed to amend the foreign inspection certification 
regulations to provide for the electronic transmittal of foreign 
inspection certifications.
    The proposed meat, poultry, and egg products foreign inspection 
certification regulations (9 CFR 327.4, 381.197, and 590.915) require: 
The date, name, and title of the official authorized to issue 
inspection certificates for products that are offered for import into 
the United States; the foreign country of export and the producing 
foreign establishment number; 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; 
the product's description, including the process category, the product 
category, and the product group; the name and address of the consignor; 
the name and address of the exporter; the name and address of the 
consignee; the name and address of the importer; the number of units 
(pieces or containers) and the shipping or identification mark on the 
units; the net weight of each lot; and any additional information the 
Administrator requests to determine whether the product is eligible to 
be imported into the United States.
    This rule finalizes the proposed amendments to the foreign 
inspection certificate regulations with minor modifications. In 
response to comment, FSIS reconsidered requiring the names and 
addresses of the consignor, exporter, consignee, and importer, as this 
information is redundant and may not be consistent with international 
data standards. Therefore, the Agency is modifying 9 CFR 327.4(e), 
381.197(e), and 590.915(e) to require the names and addresses of the 
``importer or consignee'' and the ``exporter or consignor.'' In 
addition, in proposing to delete the seal requirements for paper 
foreign inspection certificates, FSIS anticipated that paper 
certificates would be replaced by secure electronic government-to-
government transmission of foreign inspection certification data. 
However, until a foreign government has the capability to 
electronically transmit foreign inspection certification data, the 
Agency will continue to require that paper foreign inspection 
certificates bear the official seal of the foreign government agency 
responsible for the inspection of the product, to ensure the 
authenticity of the certificate. Therefore, the regulations will 
continue to require that paper foreign inspection certificates bear the 
official seal of the foreign government (9 CFR 327.4(d), 381.197(d), 
and 590.915(d)).
    In addition, FSIS proposed to require the foreign official's name 
and title on the electronic foreign inspection certification. However, 
as discussed above for foreign establishment certification, foreign 
countries that utilize eCert identify the foreign official's name and 
title in an ISA and MOU. Therefore, in this final rule, for foreign 
governments utilizing eCert to transmit foreign inspection 
certification, the foreign official's name and title will not be 
required information.

Import Inspection Application

    As discussed in the proposed rule (77 FR 70715), 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). Before the PHIS Import Component implementation, applicants 
submitted FSIS Form 9540-1, ``Import Inspection Application and 
Report,'' for meat and poultry products and FSIS Form 5200-8, ``Import 
Request Egg Products'' for egg products, to FSIS import inspection 
program personnel.
    FSIS proposed to amend the imported product inspection application 
regulations (9 CFR 327.5, 381.198, and 590.920) to require applicants 
to 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 (77 FR 70717). The Agency revised the 
application to include egg products and additional information the 
Agency needs to accurately assign reinspection tasks and sampling of 
the product. In addition, the Agency proposed to provide the option of 
submitting the application electronically or in paper.
    As discussed above, the PHIS Import Component interfaces with CBP's 
ACE system and receives a limited amount of data needed to complete the 
inspection application. FSIS inspection program personnel enter the 
additional required data into the PHIS Import Component by using 
information from the paper Import Inspection Application. The PGA 
Message Set will electronically collect and transfer all FSIS-specific 
data fields from ACE to PHIS. For applicants that electronically file 
entries with CBP, including the PGA Message Set, this entry will 
replace the paper inspection application. Applicants that do not file 
the PGA Message Set data or that do not electronically file entries 
with CBP can continue to submit paper applications to FSIS inspection 
personnel at an official import inspection establishment. Paper 
applications must be provided to FSIS at the time the entry is filed, 
in advance of the presentation of the shipment at the official import 
inspection establishment.
    When the revised Import Inspection Application (FSIS Form 9540-1) 
receives final approval from OMB, FSIS will post the form on its Web 
site. FSIS will provide applicants with six months from the date of 
this final rule to transition from the current to the revised form.

Prior Notification of Imported Product

    As discussed in the proposed rule (77 FR 70717), the meat, poultry, 
and egg products import regulations require that the importer apply for 
the inspection of imported product as far as possible in advance of the 
anticipated arrival of each consignment (9 CFR 327.5(b), 381.198(a), 
and 590.920).
    FSIS proposed 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 (proposed 9 CFR 327.5(b), 
381.198(b), and 590.920(b)).
    This rule finalizes the proposed amendments.

Streamlined Inspection Procedures for Canadian Products

    As discussed in the proposed rule (77 FR 70715), for participating 
Canadian establishments, the meat and poultry import regulations 
provide ``streamlined'' inspection procedures on a voluntary basis (9 
CFR 327.5(d) and 381.198(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. The 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. However, because of issues

[[Page 56224]]

raised in a 1990 General Accounting Office (now known as the Government 
Accountability Office, or GAO) report about the streamlined procedures, 
in 1992, the Agency suspended using the streamlined inspection 
procedures for Canadian product (77 FR 70717).
    FSIS proposed (77 FR 70717) to delete the discontinued streamlined 
procedures provided in 9 CFR 327.5(d) and 381.198(b). The Agency also 
proposed to amend 9 CFR 327.1 and 381.195, to revise paragraph 
designations and 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.''
    This rule finalizes the proposed amendments.

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

    As discussed in the proposed rule (77 FR 70715), 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 proposed (77 FR 70718) to amend 9 CFR 327.6(e) to require that 
an official import inspection establishment must, in order to receive a 
grant of inspection, meet the Sanitation SOP requirements in 9 CFR 
416.11 through 416.17.
    In addition, the Agency proposed to amend the poultry products 
regulations (9 CFR 381.199) to parallel the meat import regulations to 
require that all poultry products offered for import be inspected only 
at an official establishment or at an official import inspection 
establishment approved by the Administrator. The Agency also proposed 
to amend the requirements for the conditions of approval (9 CFR 
327.6(b), (c), (d), (f), (g), and (h)).
    The Agency also proposed to amend 9 CFR 381.1, ``Definitions'' to 
include the definition of ``Official Import Inspection Establishment,'' 
to parallel the definition in 9 CFR 301.2. and 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).
    For imported egg products, importers are advised of the point where 
inspection will be made (9 CFR 590.925(a)). The Agency did not propose 
amendments to the egg products regulations but will be proposing 
amendments to the imported egg products regulations in a separate 
rulemaking.
    This rule finalizes the proposed amendments. As discussed in the 
proposal (77 FR 70718), official import inspection establishments 
operating under a grant of inspection must develop and implement 
written Sanitation SOP within 60 days of the publication of this final 
rule.

Other Proposed Amendment

    As discussed in the proposed rule (77 FR 70718), FSIS proposed 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.''
    This rule finalizes the proposed amendment.

Discontinued Import Practice and Enforcement Notification

    In the proposed rule, in addition to the proposed regulatory 
amendments outlined above, FSIS announced that it would end two of its 
imported meat, poultry, and egg products reinspection practices (77 FR 
70718). These practices will end on the effective date of this rule.

30-Day Guarantee Foreign Inspection Certificate Replacement

    As discussed in the proposed rule, when official foreign inspection 
certificates are lost in transit or contain errors, FSIS will 
discontinue its practice of reinspecting imported product based on the 
foreign government's guarantee to replace lost or incorrect foreign 
inspection certificates (77 FR 70718). If certificates 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 
File (PDF) by email ([email protected]) or by an expedited 
mail service. FSIS will only reinspect imported product upon receipt of 
the replacement foreign inspection certificate.

Failure To Present (FTP) Imported Product for Reinspection

    Imported meat, poultry and egg products are considered ``in-
commerce'' when they are off-loaded at a location other than the 
official import inspection establishment or the official establishment 
designated on the import inspection application.
    As discussed in the proposed rule, imported product that has 
bypassed FSIS import reinspection and entered commerce constitutes a 
``failure to present'' (FTP) and violates the Acts (77 FR 70718). In 
response to comments requesting that the Agency provide clarification 
concerning activities that trigger FTP determinations and the 
disposition of FTP products in general, the Agency is providing further 
clarification on its FTP product enforcement policies. As discussed in 
the proposed rule, when a product has been identified as a FTP, FSIS 
will request, through CBP, a redelivery of the shipment and appropriate 
penalties. Any imported product that has not been presented for 
reinspection at the official FSIS establishment identified on the 
Import Inspection Application is considered a FTP.
    If FTP product has been removed from the original cartons or 
further processed, FSIS will initiate a regulatory control action on 
all applicable FTP product, including any further processed product 
that contains the FTP product for appropriate disposition (i.e., 
destruction).

Comments and Responses

    FSIS received 14 comments in response to the proposed rule. The 
comments were from domestic and foreign trade associations, private 
citizens, foreign government agencies, and a consumer advocacy 
organization.

General Support

    Most comments supported the proposal to provide an electronic 
method of processing import inspection applications and foreign 
inspection certificates. The comments stated that the PHIS Import 
Component offered the promise of increased efficiency and better use of 
resources, and that it expedited the processing of imported products. A 
commenter stated that the proposed amendments would harmonize 
requirements across meat, poultry and egg products and removed 
unnecessary prescriptive narratives and

[[Page 56225]]

formatting for foreign inspection and establishment certificates. A 
commenter also supported the Sanitation Standard Operating Procedures 
(Sanitation SOPs) requirements at official import inspection 
establishments because it would harmonize food safety requirements 
between official establishments and official import inspection 
establishments.

PHIS Import Component System Operation and Required Information

    Comment: Because the PHIS Import Component launched in May 2012, 
before the publication of the proposed rule, some commenters familiar 
with the system expressed concern about its efficiency. In the event of 
system breakdowns, importers requested the Agency's commitment to work 
with the industry to ensure that shipments are cleared. Several 
domestic trade associations stated that delays involving the PHIS 
Import Component will lead to added overtime inspection charges for 
refused entries, data entry, and system downtime that will negatively 
affect the industry. One trade association asked if FSIS would redefine 
overtime based on PHIS.
    Response: The PHIS Import Component is a significant new 
information technology (IT) application and its implementation was a 
major initiative. As with any new system, there was an initial period 
of transition and adjustment for inspection personnel and industry. 
When the Agency launched the PHIS Import Component, it cancelled the 
long-standing Import Manual of Procedures and issued FSIS Import PHIS 
Directives to provide inspection personnel with instructions on their 
duties (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives/phis_directives). In January 2013, PHIS Directive 
9500.1, ``Contingency Plan for Import Reinspection When the Public 
Health Information System (PHIS) is Unavailable,'' was updated to 
provide guidance on obtaining reinspection assignments when the system 
is not accessible (http://www.fsis.usda.gov/wps/wcm/connect/dbdd4bb4-2601-44b3-a855-282253304988/PHIS_9500.1.pdf?MOD=AJPERES). The 
Agency is committed to resolving PHIS Import Component operational 
issues and ACE/PHIS Import Component data transfer problems. Because 
brokers can submit entries well in advance the shipment's presentation 
for import reinspection, there should be no problem in completing the 
FSIS reinspection in a timely fashion. The Agency has no plans to 
redefine overtime as it relates to the PHIS Import Component.
    Comment: Foreign governments and a trade association asked that 
FSIS consult with foreign authorities to determine how long they will 
need to make the changes to comply with the foreign establishment 
certification and foreign inspection certification requirements in the 
final rule. Foreign governments stated that they needed sufficient time 
to change their IT operating systems to collect the newly required data 
and to be able to submit data electronically to FSIS.
    Several commenters asked if FSIS would work with industry, foreign 
countries, and brokers in submitting the new data requirements on the 
foreign establishment and foreign inspection certifications, and the 
Import Inspection Application before enforcement actions would be taken 
based on incomplete information.
    Response: Many of the amendments in this final rule have been 
implemented voluntarily. In March 2012, before implementing the Import 
PHIS Component, FSIS sent letters to the competent authorities of all 
eligible foreign countries, notifying them of the changes in foreign 
establishment and the foreign inspection certification requirements 
(http://www.fsis.usda.gov/wps/wcm/connect/d5f3ad49-133c-4a21-b0d9-5975c9e3e838/PHIS_Letter_to_Foreign_Countries_03202012.pdf?MOD=AJPERES&;CACHEID=d2e89cb3-0581-45b5-8190-
489bd4d7d36e). In April 2012, FSIS sent letters to importers providing 
them with information on changes in certification requirements, product 
categorization, and import reinspection presentation and sampling at 
official import inspection establishments (http://www.fsis.usda.gov/wps/wcm/connect/165e4c94-5fcf-4aab-abc7-1bec486b8f33/PHIS_Letter_to_Importers_04182012.pdf?MOD=AJPERES&;CACHEID=e2ca0872-608b-43c0-be2e-79002cbb65e9).
    In addition, FSIS conducted several outreach sessions with industry 
and foreign governments to provide information on the PHIS Import 
Component, including the information requirements.
    Because of the letters, the outreach sessions, the implementation 
of the PHIS Import Component in May 2012, and the publication of the 
November 2012 proposed rule, some foreign governments have already made 
the changes needed to provide the foreign establishment and foreign 
inspection certifications. This final rule will be effective 60 days 
from the date of publication, and FSIS does not foresee any additional 
impact on foreign governments. However, FSIS will conduct 
teleconference calls or hold meetings to address requests for 
clarification or further information specific to individual foreign 
country's needs.
    As discussed above, the Agency is providing applicants with six 
months, from the date of this final rule, to transition from the 
current to the revised Import Inspection Application. In addition, the 
Agency is conducting a pilot program, which started in April 2014, that 
tests the electronic transfer of all FSIS-specific data elements 
included in the PGA Message Set to the PHIS Import Component.

Foreign Establishment Certification

    Comment: Several commenters asked for general guidelines to assist 
foreign governments with completing foreign establishment certification 
requirements. Commenters specifically requested that the Agency explain 
the new ``type of products produced'' and ``process category'' 
information. A foreign government asked that FSIS confirm that the 
``process category'' will be the same as that used for the Electronic 
Certification (eCert) exchange.
    Response: Some of the foreign establishment certification 
information is not new, e.g., the date; the foreign establishment name, 
address, and number; and the foreign official's title and signature. 
Some of the information that is new, such as the foreign country, the 
type of operations conducted at the establishment (e.g., slaughter, 
processing, storage, or export certification), and the establishment's 
eligibility status (e.g., new, listed as eligible the previous year, 
delisted, relisted (if previously delisted)), does not need 
explanation. For slaughter and processing establishments, FSIS proposed 
requiring the species, the type of product produced, and the process 
category. The March 2012 letters to foreign countries discussed above 
included an ``FSIS Product Categorization'' appendix document that 
identified the nine (9) process categories in 9 CFR 417.2(b).
    In this final rule, the Agency is amending the regulatory text to 
clarify that the ``process category'' is an example of the type of 
product produced. The ``process category'' is the same information that 
would be provided through eCert, the electronic government-to-
government exchange that is currently utilized by two foreign 
countries.
    Comment: Two foreign countries asked if the ``eligibility status'' 
was

[[Page 56226]]

necessary because they provide FSIS with establishment notifications 
throughout the year. One foreign country stated that the new 
establishment information is already supplied in various forms to FSIS; 
specifically, the FSIS Self Reporting Tool (SRT) captures the types of 
products produced and the process category at each foreign 
establishment. One trade organization asked whether FSIS will require a 
foreign government that exports or wishes to begin exporting product to 
the U.S. to complete the SRT, and whether FSIS will add that 
requirement to the regulations. The commenter also asked how FSIS will 
verify the data from the annual certification and other systems, such 
as the SRT.
    Response: The ``eligibility status'' information is necessary to 
ensure the appropriate and efficient reinspection, enforcement, and 
audit planning activities, and any changes in eligibility status need 
to be updated as necessary and reported annually. The FSIS SRT collects 
and catalogs information submitted by foreign countries during the 
initial and on-going equivalence process. FSIS will not include the SRT 
in the regulations. FSIS requests that countries complete the SRT to 
collect and evaluate the information countries are required to submit 
to FSIS to be eligible to import product to the U.S. (9 CFR 327.2, 
381.196, and 590.910). On January 25, 2013, FSIS published a Federal 
Register Notice, ``Ongoing Equivalence Verifications of Foreign Food 
Regulatory Systems,'' that describes the methodology the Agency is 
using to conduct ongoing verification of foreign country's regulatory 
food safety systems and includes a discussion of the SRT (http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2012-0049.pdf). FSIS is evaluating 
comments on that notice and is considering necessary changes to its 
equivalence verification procedures. FSIS will respond to comments and 
clarify issues commenters raised on the January 25, 2013, notice in an 
upcoming Federal Register notice. The Agency will verify annual 
establishment certification data during foreign audit activities.
    Comment: One trade association asked how FSIS will handle 
establishment certification data errors, given that errors may cause 
trade delays.
    Response: If there are foreign establishment certification data 
errors, e.g., the product is from a foreign establishment that is not 
listed in the PHIS Import Component, FSIS will contact the competent 
authority in the foreign country to resolve the issue.
    Comment: One foreign country asked whether FSIS intended to request 
separate lists of eligible foreign establishments based on species and 
products.
    Response: FSIS has no intention to request separate lists of 
eligible foreign establishments based on species and products. It 
intends to maintain an accurate list of eligible foreign 
establishments, which will include the name and establishment number, 
the eligible species, the type of operations (e.g., slaughter, 
processing, or storage), and the types of products produced, based on 
the process categories. This information will be maintained in the PHIS 
foreign country profile and published on the FSIS Web site.

Foreign Inspection Certificate

    Comment: Domestic trade associations stated that many countries 
will use different foreign inspection certificate formats, causing 
import inspectors to question shipment certification and delaying 
reinspection. The commenters asked whether FSIS will issue a compliance 
guide for foreign governments to follow so that reinspections are not 
delayed because import inspectors question certificates. One trade 
organization recommended that FSIS establish a standard for acceptable 
foreign inspection certificates.
    Response: FSIS requires specific foreign inspection certificate 
information (9 CFR 327.4, 381.197, and 590.915); however, there are no 
formatting requirements. As instructed in FSIS Directive 9900.1, 
``Imported Product Shipment Presentation,'' inspection program 
personnel with questions about information in a foreign inspection 
certificate, or about the certificate's validity are to contact their 
supervisor. If a significant number of foreign inspection certificates 
are noncompliant with these regulations, FSIS may issue compliance 
guidelines to assist foreign countries.
    Foreign countries can use the Codex Alimentarius generic model 
official certificate as a guideline for organizing the required data 
elements on an official certificate. The certificate guideline can be 
found on the Codex Alimentarius Web site at: http://www.codexalimentarius.org/standards/list-of-standards/.
    Comment: Trade associations asked whether FSIS will issue 
guidelines to assist foreign governments in completing the process 
category, product category, and product group portion of the foreign 
inspection certificate.
    Response: FSIS provided guidance on the process categories, product 
categories, and product groups in letters sent to foreign countries and 
industry before the PHIS Import component was implemented. This 
information is currently available on the FSIS Web site http://www.fsis.usda.gov/wps/wcm/connect/d5f3ad49-133c-4a21-b0d9-5975c9e3e838/PHIS_Letter_to_Foreign_Countries_03202012.pdf?MOD=AJPERES&;CACHEID=d2e89cb3-0581-45b5-8190-
489bd4d7d36e. In addition, the Agency is developing compliance 
guidelines to further assist in providing the required information. The 
industry guidance will be posted on the Agency's Web site, and the 
foreign government guidance will be sent to the competent authority of 
the foreign government.
    Comment: Commenters questioned how FSIS will handle any delays 
caused by data entry errors on foreign inspection certificates. A 
commenter asked how FSIS will certify shipments when the electronic 
foreign certificate is unavailable through the PHIS Import Component 
and asked whether FSIS inspection personnel would clear shipments if 
they were presenting with a digital image, photocopy, or fax copy of 
the foreign inspection certificate. The commenter also asked how FSIS 
would handle replacement certificates.
    Response: If there are data entry errors on the foreign inspection 
certificate, the shipment will either be refused entry or will be held 
by FSIS until the replacement certificate has been issued by the 
competent authority in the foreign country. FSIS Directive 9900.1, 
``Imported Product Shipment Presentation,'' instructs FSIS inspection 
personnel to ``fail'' the Certification Type-of-Inspection (TOI) in 
PHIS and ask the applicant if they intend to rectify the issue (e.g., 
through replacement certificates) or allow the shipment to remain 
refused entry. The directive also instructs inspection personnel on how 
to proceed according to the applicant's response (e.g., replacement 
certification or refused-entry disposition).
    Foreign governments that electronically transmit their foreign 
inspection certificates generally do so well in advance of the 
shipment's arrival at the United States port-of-entry so any unexpected 
disruption in transmission of the data into PHIS should have minimal 
impact with timely reinspection of the shipments at port-of-entry.
    When a shipment from a country that does not certify electronically 
is presented to FSIS, the Agency will need an original paper 
certificate to clear the

[[Page 56227]]

shipment. For countries that do not have electronic certification, FSIS 
will accept replacement certificates in an alternative format, such as 
through email (e.g., digital image) from the foreign government to 
FSIS.
    Comment: One trade association asked whether the original foreign 
inspection certificates will be needed when countries provide the 
certificates electronically.
    Response: FSIS will no longer require a paper copy of the foreign 
inspection certificate when the competent authority in the foreign 
country certifies the shipment data electronically.
    Comment: Commenters asked why FSIS was requiring importer, 
exporter, consignee, and consignor information on the foreign 
inspection certificate when this information may be redundant, is not 
useful for enforcement action, and is not consistent with United 
Nations Centre for Trade Facilitation and Electronic Commerce 
(UNCEFACT) international Electronic Certification (eCert) data 
standards and message structure, which requires only the name and 
contact details of the ``importer or consignee'' and ``exporter or 
consignor.'' One foreign country asked whether the new foreign 
inspection certificate requirements affect the current eCert data 
exchange.
    Response: Although other parties are involved, the United States 
importer of record is required to control and present shipments to FSIS 
for reinspection. Therefore, FSIS requires importer information. FSIS 
requires exporter information because the exporter is the party 
responsible for sending the consignment (or shipment). However, FSIS 
acknowledges that proposing to require the importer, exporter, 
consignee, and consignor information is redundant and not consistent 
with international standards. Therefore, the Agency is amending the 
final rule to require information of the ``importer or consignee'' and 
``exporter or consignor.''
    The new data requirements may impact the current electronic data 
exchange as a result of having to map the new data elements between 
systems, though this issue has been addressed with the two countries 
that currently provide electronic certification data to the PHIS Import 
Component.
    Comment: A consumer advocacy organization stated that FSIS should 
continue to require the product destination address if that address 
differs from the consignee's business address. The commenter also 
stated that FSIS should continue to require the foreign government's 
seal on foreign inspection certificates, as it serves to authenticate 
the government document.
    Response: Because of the way shipments are manifested, there may be 
several consignees for one entry. Requiring an ``importer or 
consignee'' address, rather than the product destination address, 
provides sufficient information without compromising product control or 
information necessary for enforcement. In proposing to delete the seal 
requirements, FSIS anticipated that, as the electronic capabilities of 
the United States and its trading partners evolved, official seals 
would be replaced by secure data transmissions subject to security 
agreements between governments. However, in this final rule, until a 
foreign government has the capability to electronically transmit 
foreign inspection certification data, the Agency will continue to 
require that paper foreign inspection certificates bear the official 
seal of the foreign government agency responsible for the inspection of 
the product, to ensure the authenticity of the certificate.
    Comment: One foreign government agency stated that, although the 
eCert data exchange with FSIS has been in place for months, the Agency 
has not conducted preliminary paperwork checks on certificates in the 
time available before presentation of product.
    Response: Although FSIS has access to the data elements certified 
electronically in advance of the shipment arrival, most discrepancies 
with the certificates cannot be detected until the product is presented 
for reinspection. FSIS will consider performing preliminary 
verification on certificate information, recognizing that the final 
check will occur when the entry is filed and the shipment presented.

Import Inspection Application

    Comment: Commenters asked whether the revised FSIS Form 9540-1, 
``Import Inspection Application,'' would be available before or after 
the regulations are finalized so that exporters could begin creating 
application templates and adjusting to the new information 
requirements. A domestic trade association stated that FSIS should be 
more transparent in the development of the application. Several 
commenters also asked whether the Agency is moving forward with 
implementing the Partnering Government Agency (PGA) Message Set data 
collected through the U.S. Customs and Border Protection's (CBP) 
Automated Commercial Environment (ACE) system. The commenter stated 
that the use of the PGA Message Set data would reduce inspector data 
entry, thereby minimizing delays obtaining reinspection assignments.
    Response: Before the PHIS Import Component was implemented in May 
2012, FSIS notified foreign countries, importers, customs brokers, and 
official import inspection establishments of the new information in the 
revised Import Inspection Application (FSIS Form 9540-1) and provided a 
draft of the revised form. In addition, FSIS consulted with several 
major customs brokers when revising the application.
    As discussed above, the Agency has finalized the draft revised 
Import Inspection Application (FSIS Form 9540-1). As discussed in the 
Paperwork Reduction Act section below, FSIS has submitted the form to 
OMB for final approval. When the form receives final OMB approval, the 
Agency will post the form on its Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules. The Agency is providing six months from the date of the 
publication of this final rule for applicants who continue to file 
paper applications to transition to the revised form and for applicants 
to update any templates they use to collect application information. In 
addition, the Agency began piloting the PGA message set with two 
brokers in April 2014.
    Comment: One commenter asked whether FSIS would be updating FSIS 
directives and notices to give inspection program personnel guidance on 
the new data elements for the Import Inspection Application.
    Response: All FSIS Import Directives (9000 Series) were revised 
before the implementation of the PHIS Import Component and are 
available on the FSIS Web site (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives/phis_directives). In 
addition, inspection program personnel have been entering inspection 
application information into the PHIS Import Component since its 
implementation in May 2012. The Agency is updating the Import 
Directives to reflect the Agency's reorganization but does not believe 
it needs to provide further instruction on the new data elements to its 
inspection program personnel.
    Comment: Commenters questioned the timeframes for completing the 
revised paper-based Import Inspection Application (an additional 6 
minutes when compared to the old version) and for filing the 
application electronically rather than submitting a paper-based 
application (an additional 1 minute). The commenters stated that it 
would take much longer and asked for the justification of the 
timeframes and the

[[Page 56228]]

economic analysis based on the additional timeframes.
    Response: As discussed in the Benefits and Costs section of the 
proposed rule (77 FR 70718), specifically Footnote 2, the Agency 
provided the time frames. Staff members conducted data entry simulation 
(i.e., entered data using the different formats) to estimate the 
additional time necessary to complete the revised paper-based Import 
Inspection Application and to electronically enter information into the 
ACE. The estimated additional time, the estimated number of Import 
Inspection Applications, and wage data from the Bureau of Labor 
Statistics provided the basis for the cost estimates to complete the 
paper-based application and electronically file the application.
    Comment: One comment asked whether FSIS would increase staffing to 
enter data from the Import Inspection Application into the PHIS Import 
Component. One comment stated that the increase in the amount of data 
entry results in inspection assignment delays. Another comment asked 
whether FSIS will accept paper applications when the PHIS Import 
Component is unavailable, and what procedures are in place to 
distinguish between inspection applications filed electronically or by 
paper.
    Response: FSIS does not intend to increase staffing for Import 
Inspection Application data entry. As FSIS inspection personnel have 
become more familiar with the PHIS Import Component, data entry time 
has decreased. Since implementation of the component, system 
enhancements have allowed more efficient data entry. When the PGA 
Message Set is implemented, the additional data elements needed to 
complete the Import Inspection Application will be transferred from ACE 
to the PHIS Import Component, eliminating the need for manual data 
entry by FSIS inspection personnel. When the PHIS Import Component is 
unavailable, FSIS Directive 9500.1, ``Contingency Plan for Import 
Reinspections When the Public Health Information System (PHIS) is 
Unavailable,'' instructs inspection personnel to verify the eligibility 
of the shipment and appropriate ``types of inspection'' according to 
the defined rates of inspection under the contingency plan. When the 
system becomes available, inspection personnel retrieve and complete 
the application in PHIS and proceed with requesting the assignments and 
entering the results of the inspection tasks that were performed. The 
PHIS Import Component tracks behind the user interface the method by 
which the application was received, i.e., whether it was entered 
manually or received from ACE.
    Comment: One commenter wanted to know what action FSIS would take 
if a shipment arrives for reinspection before the paper import 
inspection application arrives.
    Response: This final rule requires that Import Inspection 
Applications be submitted to FSIS in advance of the shipment's arrival 
at the official import inspection establishment, but no later than when 
the entry is filed with CBP (9 CFR 327.5(b), 381.198(b), and 
590.920(b)). Inspection program personnel will first check the PHIS 
Import Component to confirm that the shipment made entry with CBP. For 
minor or inadvertent prior notice violations, FSIS will consider 
utilizing outreach (e.g., education and communication) with the IOR, 
and proceed with the reinspection if the entry is confirmed and a copy 
of the Import Inspection Application, along with the original foreign 
inspection certificate is submitted. However, if the violation reflects 
a history of repeated conduct of a similar nature by an IOR who has 
been notified of such violations, the shipment may be refused entry. It 
should be noted that applicants filing entry with the PGA Message Set 
will meet this prior notice requirement.
    Comment: Comments from domestic trade associations stated that some 
data elements are the same for the import inspection application and 
the foreign inspection certificate, however the information may differ 
between the application and the certificate, e.g., a corporate address 
listed on the certificate, a company address on the application. The 
commenters asked which information, if different, would take 
precedence. One trade association asked how differences in data 
elements would be handled, e.g., a foreign country uses one Harmonized 
Tariff Schedule (HTS) code and a broker uses another.
    Response: The Import Inspection Application is completed by an 
applicant, usually an importer or customs broker. Therefore, if there 
is any discrepancy in importer or consignee information between the 
Import Inspection Application and the Foreign Inspection Certificate, 
FSIS would rely on the information provided on the Import Inspection 
Application. For importers and brokers participating in the PGA Message 
Set, FSIS would rely on any importer or consignee information 
electronically transferred from ACE to the PHIS Import Component. For 
any product-based information, the foreign inspection certificate 
information, which is certified by an official of the foreign 
government, would take precedence over information provided on the 
Import Inspection Application. The HTS Code used by customs brokers 
must accurately represent the imported product. The HTS Code is filed 
with CBP when the entry is made, and transferred by CBP's ACE system 
into the PHIS Import Component. Therefore, the HTS code filed with CBP 
is the code that will take precedence.
    Comment: Trade associations asked FSIS to clarify what HTS code 
will be required on the Import Inspection Application, since multiple 
HTS codes could be used for a specific product. The commenters also 
requested that FSIS clarify how new HTS codes will be made available to 
brokers.
    Response: Customs brokers, when filing for entry with CBP, identify 
the HTS code for the entry, and those HTS codes are transferred from 
ACE to the PHIS Import Component. FSIS requires all the applicable HTS 
codes associated with the Import Inspection Application to be listed on 
the form (9 CFR 327.5, 381.198, and 590.920). For applicants that will 
utilize the PGA Message Set, ACE will prompt the filer to provide 
additional FSIS data elements (PG Records) for HTS codes that FSIS has 
identified as amenable product. CBP manages changes to the Harmonized 
Tariff Schedule.
    Comment: One commenter asked that FSIS define the ``production 
codes'' information required on the Import Inspection Application.
    Response: The revised Import Inspection Application (FSIS Form 
9540-1), requests the ``production date(s),'' the date that the product 
was produced. If ``production codes'' are used on the product, they 
need to be translated into dates on the inspection certificate. 
However, the dates are only necessary if the foreign establishment has 
been delisted or relisted (9 CFR 327.2, 381.196).
    Comments: One trade association asked how FSIS will process 
informal entries, because they may not use CBP's ACE system.
    Response: Applicants (importers or consignees) are required to 
submit an Import Inspection Application to FSIS to apply for the 
reinspection of any amenable product offered for entry (9 CFR 327.5, 
381.199, and 590.920). When an informal entry is made, i.e., an entry 
that does not utilize CBP's ACE system, CBP inputs the data into its 
electronic systems. FSIS receives the electronic data for informal 
entries via the Interconnectivity Web Services (IWS).

[[Page 56229]]

Prior Notification of Imported Product

    Comment: One domestic trade association stated that FSIS should 
issue clear and consistent prior notification guidance and enforcement 
instructions to inspection program personnel. Other domestic trade 
associations stated that FSIS should clarify whether its import 
policies are aligned with CBP's, and whether there will be allowances 
for legitimate, mitigating circumstances, e.g., when ACE is not 
operational. In addition, these commenters asked that the Agency 
explain the consequences of failing to provide notification.
    Response: When this final rule becomes effective, the applicant 
will be required to submit an Import Inspection Application in advance 
of the shipment's arrival, but no later than when the entry is filed 
with CBP (9 CFR 327.5, 381.198, 590.920). FSIS is committed to working 
through any ACE-to-PHIS Import Component data transfer problems to 
avoid any delays in completing reinspection. As discussed above, FSIS 
will take necessary enforcement actions if an importer repeatedly fails 
to provide prior notice to FSIS, should the need arise.
    Comment: One trade association stated that airline shipments 
utilize manifests or air bills for entry into the United States, which 
often do not translate into ACE system entries. The commenter stated 
that FSIS should provide guidance to inspection program personnel on 
how to handle airline shipments.
    Response: Air shipments are accompanied by manifests or air bills 
that report cargo to CBP; however, air shipment entries are processed 
the same way as other modes of transportation. Meat, poultry, and egg 
products shipments are identified by FSIS-specific HTS codes, the CBP 
entry data transfers from ACE to the PHIS Import Component, and 
inspection program personnel proceed with their reinspection 
activities.

Canadian Streamlined Inspection Procedures

    Comment: Commenters stated that, since the United States and Canada 
currently have the U.S.-Canada Regulatory Cooperation Council (RCC) and 
the Beyond-the-Border (BtB) initiatives underway, the Agency should 
reconsider deleting the Canadian Streamlined Inspection procedures. One 
commenter asked FSIS to retain the streamlined procedures because 
reintroducing the streamlined procedures through future rulemaking may 
be more challenging than leaving the existing regulations in place. One 
comment stated that the streamlined procedures should not be deleted 
but amended to provide future flexibility for other countries. One 
comment stated that deleting the streamlined inspection procedures was 
a good housekeeping measure, and that the Agency should proceed with 
caution in moving forward too hastily with any pilot programs.
    Response: As discussed in the preamble of the proposed rule (77 FR 
70717), the Canadian Streamlined Inspection Procedures were codified in 
1989 to further the goal of the 1988 U.S.-Canada Free Trade Agreement 
to reduce trade restrictions between the United States and Canada. 
However, because of concerns raised in a Government Accountability 
Office (GAO) report, FSIS suspended use of these inspection procedures 
in 1992.
    The 2011 RCC and BtB initiatives were launched to explore more 
effective approaches to regulation that enhance the economic 
competitiveness and well-being of the United States and Canada, while 
maintaining high standards of public health and safety, and 
environmental protection. To further these initiatives, in July 2012, 
FSIS announced that it would conduct a BtB Action Plan pre-clearance 
initiative pilot program that would consider alternative methods for 
reviewing import documents before the shipments arrival at the United 
States border and alternative methods for releasing shipments destined 
for further processing at FSIS establishments. To date, the BtB pilot 
program has not begun. The Agency will evaluate the BtB pilot program 
when it is complete and will seek public input before taking any action 
or effecting any changes more broadly. Current FSIS regulations require 
reinspection of all imported shipments but are flexible enough to 
allow, in appropriate circumstances, these activities to occur in 
official establishments, egg product plants, or official import 
inspection establishments. To this extent, the regulations are 
consistent with the objective of the BtB pilot project. Consequently, 
FSIS is finalizing the proposed deletion of the Canadian Streamlined 
Inspection Procedures.

Sanitation Standard Operating Procedures (Sanitation SOPs)

    Comment: Commenters questioned whether FSIS would withdraw or 
withhold inspection from official import establishments that fail to 
develop and implement Sanitation SOPs within the 60 days after 
publication of the final rule.
    Response: FSIS does not anticipate that official import inspection 
establishments will delay or fail to develop Sanitation SOPs within 60 
days after the publication of this final rule (the effective date) 
because, in practice, these establishments maintain these procedures 
during the reinspection of imported product. FSIS clearly explained in 
the proposed rule's preamble (77 FR 70717) and regulatory text (9 CFR 
304.3 and 381.22) that official import inspection establishments would 
be required to develop and implement Sanitation SOPs. If an official 
import inspection establishment does not develop and implement 
Sanitation SOPs by the effective date of this final rule, the Agency 
may withhold inspection, under its Rules of Practice (9 CFR 
500.3(a)(3)), until the official import inspection establishment meets 
the requirements of 9 CFR 304.3 and 381.22.
    Comment: One foreign government asserted that reinspecting products 
at official import inspection establishments may preclude the 
opportunity for a more flexible future approach to import inspection, 
e.g., inspecting products while they are still at the port. The 
commenter stated that reinspection at port facilities would be less 
costly and less trade-restrictive, and that this is the predominant 
international practice.
    Response: Conducting reinspection at official import inspection 
establishments does not preclude FSIS from considering alternative 
approaches to reinspecting imported product. FSIS requires reinspection 
of all products offered for entry (9 CFR 327.6(a), 381.199(a), and 
590.925(a)), and it is the Agency's policy to perform import 
reinspection activities at official import inspection establishments in 
close proximity to a port-of-entry, thus minimizing costs to importers.

Foreign Inspection Certificate Replacement

    Comment: Domestic trade associations stated that replacement 
certificates are not overly burdensome to the industry, as long as the 
foreign country's competent authority is able to quickly transmit the 
replacement certification through the PHIS Import Component. One 
commenter stated that the Agency should provide options for expedited 
reinspections for importers that do not use the PHIS Import Component, 
or when the PHIS Import Component is unavailable. A comment from a 
foreign government requested that FSIS clarify what constitutes a 
``short time frame'' for lost foreign inspection certificates or 
certificates that contain mistakes.

[[Page 56230]]

    Response: As FSIS explained in the preamble to the proposed rule, 
replacement foreign inspection certificates can easily be replaced by 
emailing a PDF of the certificate to [email protected] or 
sending the certificate by expedited mail service (77 FR 70718). 
Foreign countries that use eCert can resend foreign inspection 
certification electronically. FSIS inspection program personnel will 
proceed with import reinspection activities only when they receive 
either the paper replacement certificate, or the electronic 
certification. Foreign countries are required to ensure that foreign 
inspection certificates accompany product (9 CFR 327.4, 381.197, and 
590.915). Therefore, it is not appropriate for FSIS to designate a 
specific timeframe to foreign countries for replacing the certificate.

Failure To Present (FTP)

    Comment: Several domestic trade associations requested that FSIS 
define ``in-commerce,'' for purposes of imported product that has 
bypassed reinspection and entered commerce. These commenters also 
requested clarification on whether transporting and storing imported 
product at a U.S. warehouse prior to reinspection would be considered a 
FTP.
    Response: The importer is required to present all imported meat, 
poultry, and egg products for reinspection upon entry into the United 
States (9 CFR 327.6, 381.199, and 590.925). Once imported product 
leaves the official import inspection establishment, it is considered 
``in-commerce,'' unless it is moved to another location under the 
control of the official import inspection establishment (e.g., under 
company seal).
    If the FTP product shipment is delivered to the end user in the 
United States, the imported product, or any product produced from the 
ineligible product, may be subject to FSIS recall or destruction. FSIS 
does not permit storing of imported meat, poultry, and egg products in 
a warehouse or other facility prior to reinspection, unless the 
warehouse or facility has the same physical address as the official 
import inspection establishment and it is physically connected to the 
official import establishment.
    Comment: A domestic trade association requested that FSIS alert 
import companies to potential FTP product problems as soon as they are 
discovered.
    Response: FSIS inspection program personnel are instructed in FSIS 
Directive 9900.1 http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/PHIS_9900.1.pdf to notify the applicant electronically through 
the PHIS Import Component when a shipment has not arrived at the 
official import inspection establishment by the Estimated Date of 
Arrival (EDA) recorded on the import inspection application.
    Comment: Domestic trade associations requested clarification on 
whether storing a product shipment at an official import inspection 
establishment pending reinspection is an FTP. These commenters also 
asked FSIS to clarify if imported product in a truck driven past an 
official import inspection establishment after hours of operations to a 
rest stop 10 miles away for the weekend would be considered an FTP.
    Response: FSIS does not consider a product shipment stored at an 
official import inspection establishment pending reinspection to be an 
FTP. Establishment managers notify FSIS import inspection personnel of 
the shipment's arrival so that the status of the shipment can be 
changed to ``On Premises'' in the PHIS Import Component. If a truck is 
driven past an official import inspection establishment to a rest stop, 
the product shipment would not be considered FTP if it arrives at the 
official import inspection establishment by the EDA, provided the 
shipment is intact and has not been off-loaded.
    Comment: Trade associations asked if FTP product guidelines will be 
available to importers, brokers, and I-houses for correlation.
    Response: FSIS is currently developing compliance guidelines that 
will include FTP product guidance for the importers, customs brokers, 
and official import inspection establishments, and will post the 
guidelines on the FSIS Web site as soon as they are available.

Other Comments

Preclearance Sampling

    Comment: A foreign government commented that FSIS should collect 
the samples before the product is shipped to the United States so that 
the consignment could remain at the foreign establishment pending the 
results of the testing.
    Response: FSIS's port-of-entry sampling is designed to monitor the 
performance and effectiveness of the foreign inspection system, and the 
Agency will continue to sample imported shipments before their entry 
into U.S. commerce. The foreign country has the opportunity to collect 
samples under its own sampling programs.

Stamping of Product

    Comment: One foreign government requested that FSIS explain the 
justification for manually stamping every carton of product in a 
consignment.
    Response: As required in 9 CFR 327.10(b) and 381.204(a), the 
outside containers of all products offered for entry from any foreign 
country (excluding Canada) that are accompanied with a foreign 
inspection certificate, are found not to be adulterated or misbranded, 
and are otherwise eligible for entry into the United States, shall be 
marked with the official inspection legend prescribed in 9 CFR 327.26 
and 381.204(b). The stamping of imported product was not addressed in 
the proposed rule and is outside the scope of this final rule.

FSIS Jurisdiction in Facilities

    Comment: Two trade associations asked FSIS to define where, within 
an official import inspection establishment, inspection program 
personnel would have jurisdiction.
    Response: As provided in 9 CFR 304.2(a), when FSIS gives notice to 
the applicant granted inspection, the notice includes the limits of the 
establishment's premises, including official import inspection 
establishments, to which the grant pertains. In addition, the owner or 
operators of the official import inspection establishment must provide 
adequate facilities and equipment for examination of the imported 
product presented to FSIS personnel (9 CFR 327.6(e)). FSIS inspection 
personnel have authority to enter any areas of the premises in order to 
monitor and verify compliance with these conditions.

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,

[[Page 56231]]

the rule has not been reviewed by the Office of Management and Budget.

Benefits and Costs of the Final Rule

    The changes made by this final 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 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 final rule streamlines 
existing import documentation requirements by making the foreign 
inspection certificate consistent among meat, poultry, and egg 
products. In addition, the final 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 will require the source 
country and establishment number when the source materials originate 
from a country other than the exporting country. The additional 
information will help FSIS 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 final rule may have a cost impact on the 
industry. However, the Agency believes the impacts of the final rule 
will be very small, if any. The possible impacts include:
    (1) The electronic foreign inspection and foreign establishment 
certificates and the electronic import inspection application. Under 
this final rule, the industry will have the option of filing Import 
Inspection Applications electronically, and foreign governments will 
have the option of submitting electronic inspection and foreign 
establishment certifications and data. As this is a voluntary option, 
FSIS assumes industry will chose to file electronically only if the 
benefits to them surpass their costs.
    (2) Additional information entry. This final rule 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, i.e., paper or 
electronic.
    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.\1\ Updated Agency data show that there 
are, on average, a total of 108,140 applications per year that will be 
filed electronically using the ACE, and that 2,300 applications per 
year will be completed manually.\2\ Therefore, the total additional 
time for electronically filing the application will be 1,802 hours 
(108,140 * 1/60 = 1,802) and the additional time for completing the new 
paper-based application will be 232 hours (2,317 * 6/60 = 232). 
Monetizing these hours by $38 per hour,\3\ the estimated cost to 
complete the new application would be about $77,000 ($38 * (232 + 
1,802)) per year.
---------------------------------------------------------------------------

    \1\ Time estimates from the International Policy Division 
(currently the International Relations and Strategic Planning Staff 
(IRSPS)), Office of Policy and Program Development, FSIS, USDA.
    \2\ Number of applications from the Automated Import Inspection 
System (AIIS) and the Public Health Information System, FSIS, USDA.
    \3\ Bureau of Labor Statistics ``Occupational Employment & 
Wages'' Database, May 2012. Animal Production Managers, all other 
$48.51 @ 47.6% time; General and Operations Managers $37.22 @26.2% 
time; Food scientists and technologists $18.45 @ 26.2% time = $38.00 
Managerial Median hourly wage.
---------------------------------------------------------------------------

    (3) Sanitation Standard Operating Procedures (SOPs) as a condition 
of approval for official import inspection establishments. The final 
rule clarifies that official import inspection establishments must have 
developed written Sanitation SOPs before being granted approval. 
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, requiring Sanitation SOPs will have little cost 
impact (including recordkeeping cost impact) on the industry.
    (4) The final rule removes 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 certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will 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 will continue to accept paper applications. Similarly, the other 
changes in the final rule will not result in significant costs to 
industry and, therefore, will not have a significant impact on a 
substantial number of small entities.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this final 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 final 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(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection 
requirement associated with this final rule has been submitted for 
approval to the Office of Management and Budget (OMB). This information 
collection request is at OMB awaiting approval. FSIS will collect no 
information associated with this rule until the information collection 
is approved by OMB.

[[Page 56232]]

    Copies of this information collection assessment can be obtained 
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and 
Inspection Service, USDA, 1400 Independence Avenue SW., Room 6077, 
South Building, Washington, DC 20250-3700; (202) 690-6510.

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/wps/portal/fsis/programs-and-services/email-subscription-service.
    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 Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write 
a letter signed by you or your authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 
1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax: (202) 690-7442
Email: [email protected]

    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

List of Subjects

9 CFR Part 304

    Meat inspection.

9 CFR Part 327

    Imports.

9 CFR Part 381

    Poultry and poultry products.

9 CFR Part 590

    Eggs and egg products.

    For the reasons discussed in the preamble, FSIS is amending 9 CFR 
Chapter III as follows:

PART 304--APPLICATION FOR INSPECTION; GRANT OF INSPECTION

0
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.


0
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 Procedures, as required 
by part 416 of this chapter, and written recall procedures as required 
by part 418 of this chapter.
* * * * *

PART 327--IMPORTED PRODUCTS

0
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.


0
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.
* * * * *

0
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.
    (i) For a new establishment, or any establishment for which 
information from last year's electronic certification

[[Page 56233]]

or paper certificate has changed, the certification or certificate must 
contain: The date; the foreign country; the foreign establishment's 
name, address, and foreign establishment number; the foreign official's 
title and signature (for paper certificates only); the type of 
operations 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 products produced at the establishment (e.g., the process 
category).
    (ii) If the establishment information provided on the preceding 
year's electronic foreign establishment certification or paper 
certificate, as required in paragraph (a)(3)(i) of this section, has 
not changed, the certification or certificate must contain: The date, 
the foreign country, the foreign establishment's name, and the foreign 
official's title and signature (for paper certificates only).
* * * * *

0
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; bear the 
official seal of the foreign government responsible for the inspection 
of the product, and the name, title, and signature of the official 
authorized to issue inspection certificates for products imported to 
the United States.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date;
    (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 importer or consignee;
    (6) The name and address of the exporter or consignor;
    (7) The number of units (pieces or containers) and the shipping or 
identification mark on the units;
    (8) The net weight of each lot; and
    (9) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the 
United States.
0
7. Revise Sec.  327.5 to read as follows:


Sec.  327.5  Import inspection application.

    (a) Applicants must submit an 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 form.
    (b) Import inspection applications for each consignment must be 
submitted (electronically or on 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.

0
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 inspection 
by a Program import inspector for appearance and condition, and checked 
for certification and label compliance.
    (3) The electronic inspection system shall be consulted for 
reinspection instructions. The electronic inspection system will assign 
reinspection levels and procedures based on established sampling plans 
and established product and plant history.
    (4) When the inspector deems it necessary, the inspector may sample 
and inspect lots not designated by the electronic inspection system.
* * * * *
    (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

0
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.


0
10. In Sec.  381.1, in paragraph (b), add a definition for Official 
import inspection 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 
definition where inspections are authorized to be conducted as 
prescribed in Sec.  381.199.
* * * * *

0
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 
establishment or an official import inspection establishment, must have 
developed written Sanitation Standard Operating Procedures, as required 
by part 416 of this chapter, and written recall procedures as required 
by part 418 of this chapter.
* * * * *

0
12. In Sec.  381.195, revise paragraph (a) to read as follows:

[[Page 56234]]

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.
* * * * *

0
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 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.
    (i) For a new establishment or any establishment for which 
information from last year's electronic certification or paper 
certificate has changed, the certification or 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 certificates 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 products produced 
at the establishment (e.g., the process category).
    (ii) If the establishment information provided on the preceding 
year's electronic foreign establishment certification or paper 
certificate, as required in paragraph (a)(3)(i) of this section, has 
not changed, the certification or certificate must contain: The date, 
the foreign country, the foreign establishment's name, the foreign 
official's title and signature (for paper certificates only).
* * * * *

0
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 
official seal of the foreign government responsible for the inspection 
of the product, and the name, title, and signature of the official 
authorized to issue inspection certificates for products imported to 
the United States.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date;
    (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 importer or consignee;
    (6) The name and address of the exporter or consignor;
    (7) The number of units (pieces or containers) and the shipping or 
identification mark on the units;
    (8) The net weight of each lot; and
    (9) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the 
United States.

0
15. Revise Sec.  381.198 to read as follows:


Sec.  381.198  Import inspection application.

    (a) Applicants must submit an 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 form.
    (b) Import inspection applications for each consignment must be 
submitted (electronically or on 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.

0
16. In Sec.  381.199, revise paragraph (a) and add paragraph (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 reinspected 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 electronic inspection system shall be consulted for 
reinspection instructions. The electronic inspection system will assign 
reinspection levels and procedures based on established sampling plans 
and established product and plant history.
    (4) When the inspector deems it necessary, the inspector may sample

[[Page 56235]]

and inspect lots not designated by the electronic inspection system.
* * * * *
    (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 Meat, Poultry and Egg Product Inspection 
Directory, 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 this part.
    (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)

0
17. The authority citation for part 590 continues to read as follows:

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


0
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 
official seal of the foreign government responsible for the inspection 
of the product, and the name, title, and signature of the official 
authorized to issue the inspection certificates for products imported 
into the United States.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date;
    (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 importer or consignee;
    (6) The name and address of the exporter or consignor;
    (7) The number of units (pieces or containers) and the shipping or 
identification mark on the units;
    (8) The net weight of each lot; and
    (9) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the 
United States.

0
19. Revise Sec.  590.920 to read as follows:


Sec.  590.920  Import inspection application.

    (a) Applicants must submit an 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 form.
    (b) Import inspection applications for each consignment must be 
submitted (electronically or on 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 September 11, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-22206 Filed 9-18-14; 8:45 am]
BILLING CODE 3410-DM-P