[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Pages 22083-22084]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2014-08956]



Food Safety and Inspection Service

[Docket No. FSIS-2013-0029]

Availability of FSIS Compliance Guidelines for Allergens and 
Ingredients of Public Health Concern: Identification, Prevention and 
Control, and Declaration Through Labeling

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and opportunity for comment.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of guidance on allergens and other ingredients of 
public health concern that provides recommendations for identifying 
hazards when conducting a hazard analysis and to prevent and control 
hazards through hazard analysis and critical control point (HACCP) 
plans or Sanitation standard operating procedures (SOPs) or other 
prerequisite programs with respect to these substances. The emphasis of 
the guidelines is on meat and poultry products. The guidelines 
represent the best practice recommendations of FSIS, based on 
scientific and practical considerations. By following these guidelines, 
establishments are likely to ensure that product labels declare all 
ingredients, as required in the regulations, and that the product does 
not contain undeclared allergens or other undeclared ingredients.

DATES: The Agency must receive comments by June 20, 2014.

ADDRESSES: A downloadable version of the compliance guide is available 
to view and print at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. No hard copies of the compliance 
guide have been published.
    FSIS invites interested persons to submit comments on this notice. 
Comments may be submitted by either 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, including CD-ROMs: Send to Docket Room Manager, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B, 
Washington, DC 20250-3700.

[[Page 22084]]

    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 
355 E Street SW., Room 8-163B, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2013-0029. 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 
8-164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., 
Monday through Friday.

Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495, or by Fax: (202) 720-2025.

SUPPLEMENTARY INFORMATION: Under the Acts, meat and poultry products 
that contain an allergen that is not declared on the product label are 
adulterated because, to individuals who are allergic to the allergen, 
the products bear or contain a poisonous or deleterious substance (21 
U.S.C. 453(g)(1) and 601(m)(1)).
    Also under the Acts, meat and poultry products are misbranded if 
the labeling on the products is false or misleading in any particular 
(21 U.S.C. 601(n)(1) and 453(h)(1)). To prevent meat and poultry 
products from being misbranded, FSIS regulations require a listing of 
all ingredients on the labels of products (9 CFR 317.2(f)(1) and 
    In recent years (2008-2012), there has been a sustained increase in 
the number of recalls of FSIS-regulated products that contained 
undeclared allergens. These recalls are preventable, as many have been 
due to ingredient changes, product changes, products in the wrong 
package, or products with misprinted labels. The Agency is issuing 
these guidelines to provide meat and poultry establishments with 
recommendations on how to identify hazards with respect to allergens 
and other ingredients of public health concern when conducting their 
hazard analysis, prevent and control these hazards through HACCP plans, 
Sanitation SOPs, or other prerequisite programs, and properly declare 
allergens in product. These guidelines also provide information on 
proper procedures for processing, handling, storing, and labeling a 
product with an allergenic ingredient or ingredient of public health 
concern. Although the guidelines set out recommendations rather than 
requirements, FSIS encourages establishments to follow this guidance. 
The guidelines represent FSIS's thinking, and FSIS will update it as 
necessary to reflect comments received any additional information that 
becomes available.

USDA Nondiscrimination Statement

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

Additional Public Notification

    FSIS will announce this notice online through the FSIS Web page 
located at http://www.fsis.usda.gov/federal-register.
    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 

    Done at Washington, DC on: April 1, 2014.
Alfred V. Almanza,
[FR Doc. 2014-08956 Filed 4-18-14; 8:45 am]