[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Pages 67382-67383]
From the Federal Register Online via the Government Publishing Office FR Doc No: 2015-27846]

                                                Federal Register

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.


Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / 

[[Page 67382]]


Food Safety and Inspection Service

[Docket No. FSIS-2015-0029]

Export Verification Program: Microbiological Testing of Ready-To-
Eat Products Destined for Canada

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the establishment of an FSIS and Agricultural Marketing Service (AMS) 
Export Verification (EV) Program. The program is designed to verify 
establishments' control of closed-faced sandwiches destined for Canada. 
Among other things, Canada is requiring that closed-faced sandwiches be 
produced under a Hazard Analysis and Critical Control Point (HACCP) 
plan. Under the program, the sandwiches will be produced in 
establishments that are under FSIS' voluntary reimbursable inspection 
service and that are operating under conditions that are as consistent 
as practical with those under which other post-lethality exposed meat 
and poultry products are produced under 9 CFR part 430. Closed-faced 
sandwiches are under jurisdiction of the Food and Drug Administration 
(FDA), but FDA does not require that the sandwiches be produced under a 
HACCP plan. It also does not verify that the requirements of 9 CFR part 
430 are met. Consequently, FSIS and AMS are establishing this voluntary 
program. Once the program is implemented, only establishments 
participating in this program will be able to export closed-faced 
sandwiches to Canada.

DATES: Submit comments on or before http://www.ams.usda.gov/services/imports-exports/rte-canada. The program will be implemented February 1, 

ADDRESSES: FSIS invites interested persons to submit comments on the 
issues described below. Comments may be submitted by one of the 
following methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. Go to http://www.regulations.gov/. Follow the on-line instructions at that site for 
submitting comments.
    Mail, CD-ROMs: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 355 
E Street SW., Mailstop 3782, Room 8-163B, Washington, DC 20250-3700.
    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 
355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2015-0029. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or to comments received, 
go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 
164-A, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250; Telephone: (202) 205-0495, or by Fax: (202) 720-2025.
    Establishments seeking to participate in this program should 
contact FSIS by phone at (202) 720-0082, or by email at 


    In February 2013, the Canadian Food Inspection Agency (CFIA) 
audited the United States' food safety system for meat and poultry 
products intended for export to Canada.\1\ CFIA's final audit report 
found that HACCP plans and Listeria monocytogenes (Lm) controls for 
ready-to-eat (RTE) meat products were not required when establishments 
prepared the products under FSIS's voluntary reimbursable inspection 
service. CFIA notified FSIS that CFIA requires that these products be 
produced according to HACCP plans and Lm controls consistent with 9 CFR 
part 430.

    \1\ Final Report Of An Audit Conducted In The United States 
February 5th, through February 22nd, 2013 Evaluating The Food Safety 
Systems Governing The Production Of Meat And Poultry Products 
Intended For Export To Canada, available at: http://www.inspection.gc.ca/food/meat-and-poultry-products/imports/audits-of-meat-inspection-programs/final-report-of-an-audit-us-/eng/1404919271012/1404921262798?chap=8#s5c8.

    Meat and poultry products prepared in official establishments are 
subject to mandatory inspection by FSIS under the Federal Meat 
Inspection Act (21 U.S.C. 601, et seq.) and the Poultry Products 
Inspection Act (21 U.S.C. 451, et seq.). FSIS considers RTE meat and 
poultry products to be adulterated if they test positive or come into 
direct contact with a food-contact surface that tests positive for Lm, 
Salmonella, or other pathogens. FSIS uses microbiological testing in 
its mandatory inspection programs to verify that establishments have 
adequate food safety systems, including measures to control Lm (9 CFR 
part 430).
    However, not all RTE products containing meat or poultry fall under 
FSIS's regulatory jurisdiction. Closed-faced sandwiches are not 
considered traditional products of the meat or poultry industries, and 
therefore they fall under the regulatory jurisdiction of FDA.
    Establishments producing these RTE products may receive FSIS 
reimbursable voluntary inspection, but this inspection does not include 
microbiological testing for pathogen control or verification of HACCP 
plans or sanitation standard operating procedures (Sanitation SOP). 
FSIS conducts this reimbursable voluntary inspection to certify 
products for export under the Agricultural Marketing Act of 1946 (7 
U.S.C. 1621, et seq.). The inspection is intended to meet the importing 
country's requirements for U.S.-produced meat and poultry products (9 
CFR 350.3(b); 9 CFR 381.104-.107). Canada's requirements identified in 
the FSIS Export Library do not require Lm testing, HACCP, or Sanitation 
SOPs for RTE products. The FSIS Export Library is available at: http://

[[Page 67383]]


AMS Testing Program

    AMS and FSIS have developed a collaborative testing program to 
verify pathogen control for closed-face sandwiches produced under FSIS 
voluntary inspection and intended for export to Canada. This program, 
which AMS will administer, may eventually include other RTE products. 
The program will include two types of testing, routine and intensified, 
to ensure that participating establishments are controlling Lm and 
    For routine testing, AMS will randomly select dates once per year 
when product samples will be collected. FSIS will collect the product 
samples and pack them for shipment to the USDA National Science 
Laboratories in Gastonia, North Carolina. FSIS will collect six samples 
regardless of plant size, production volume, or process design. If an 
establishment produces both post-lethality-exposed and non-post-
lethality-exposed products, six product samples will be taken from the 
former and two from the latter. AMS will analyze the samples for Lm and 
Salmonella and will require that establishments hold or maintain 
control of the product until acceptable results become available. If 
the product is positive, the establishment will have to properly 
dispose of the affected product in accordance with FDA regulations.
    At least once per year, AMS also will select dates for intensified 
testing at a participating establishment. AMS will also conduct this 
testing if it finds a positive Lm or Salmonella result or in response 
to continuing sanitation non-compliances at the establishment. The 
samples will vary in number depending on whether product is being 
tested for Lm or Salmonella but will always include environmental, 
product, and food-contact-surface samples. AMS will collect the 
    For both types of testing, the establishment will pay all costs for 
sample collection, shipping, shipping materials, and analysis. See 
http://www.ams.usda.gov/services/import-exports/rte-canada for a full 
description of the program, including sample collection and laboratory 
testing methods.

HACCP Verification

    In order for the establishments to meet Canada's requirements for 
import of closed-face sandwiches, FSIS will offer voluntary inspection 
services and will verify that the establishments are producing these 
products under HACCP and Sanitation SOPs. Therefore, to ship this 
product to Canada, establishments will need to comply with the 
requirements in 9 CFR part 417 and 9 CFR 416.11-.17.
    By participating in the EV program and receiving voluntary 
inspection from FSIS (including verification of HACCP plans and 
Sanitation SOPs), establishments that produce closed-face sandwiches 
and that meet all FSIS and AMS EV program requirements will be able to 
meet Canada's stated import requirements for closed-faced sandwiches. 
To receive these services, establishments should contact FSIS at (202) 
720-0082, or by email at importexport@fsis.usda.gov.
    Comments are invited on: (a) The timetable for implementation of 
this program, including readiness to participate in the program's 
pathogen testing and HACCP verification, and business and trade 
interests affected by compliance or non-compliance with the program; 
(b) how the proposed programs can be implemented operationally to avoid 
disruption of trade or business activities; and (c) any other 
operational issues that commenters need clarified. FSIS will clarify 
any issues or make adjustments to the implementation date of the 
program in a Constituent Update.

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: program.intake@usda.gov.
    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).

Additional Public Notification

    Public awareness of all aspects of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
    FSIS also will make this 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 our constituents and stakeholders. The Update 
is available on the FSIS Web page. Through the Web page, FSIS is able 
to provide information to a broad and diverse audience. In addition, 
FSIS offers an email 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/subscribe. 
Subscription options range from recalls to export information, 
regulations, directives, and notices. Customers can add or delete 
subscriptions themselves, and have the option to password protect their 

    Done at Washington, DC, on October 28, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-27846 Filed 10-30-15; 8:45 am]