82 FR 10562 - Preventing Undeclared Allergens: A Strategic Approach To Reducing Recalls

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 82, Issue 29 (February 14, 2017)

Page Range		10562-10563
FR Document		2017-02939

The Food Safety and Inspection Service (FSIS), with participation from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), international partners, and academic institutions, is hosting a public meeting to discuss the prevention of undeclared allergens in FSIS-regulated product. Specifically, the meeting will address the continued occurrence of product recalls due to undeclared allergens and best practices for preventing the presence of undeclared allergens in FSIS-regulated products. Topics will focus on FSIS policy and enforcement regarding undeclared allergens, labeling compliance, best practices for prevention, and emerging issues. Industry and interested individuals, organizations, and other stakeholders are invited to participate in the meeting and comment on these topics.

Federal Register, Volume 82 Issue 29 (Tuesday, February 14, 2017)

[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Notices]
[Pages 10562-10563]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-02939]


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Notices
                                                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.

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Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / 
Notices

[[Page 10562]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2017-0005]


Preventing Undeclared Allergens: A Strategic Approach To Reducing 
Recalls

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notification of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS), with 
participation from the Food and Drug Administration (FDA), the Centers 
for Disease Control and Prevention (CDC), international partners, and 
academic institutions, is hosting a public meeting to discuss the 
prevention of undeclared allergens in FSIS-regulated product. 
Specifically, the meeting will address the continued occurrence of 
product recalls due to undeclared allergens and best practices for 
preventing the presence of undeclared allergens in FSIS-regulated 
products. Topics will focus on FSIS policy and enforcement regarding 
undeclared allergens, labeling compliance, best practices for 
prevention, and emerging issues. Industry and interested individuals, 
organizations, and other stakeholders are invited to participate in the 
meeting and comment on these topics.

DATES: The public meeting will be held on Thursday, March 16, 2017, 
8:00 a.m. to 5:30 p.m. EST.

ADDRESSES: The meeting will be held at the Jefferson Auditorium in the 
South Building, U.S. Department of Agriculture (USDA), 14th & 
Independence Avenue SW., Washington, DC 20250. The South Building is a 
Federal facility, and attendees should plan adequate time to pass 
through the security screening systems. Attendance is free. Non-USDA 
employees must enter through the Wing 3 entrance on Independence 
Avenue. Attendees must be pre-registered for the meeting (and check-in 
onsite the day of the meeting) and show a valid photo ID to enter the 
building. See the pre-registration instructions under ``Registration 
and Meeting Materials.'' Only registered attendees will be permitted to 
enter the building.

FOR FURTHER INFORMATION CONTACT: Evelyn Arce, Outreach and Partnership 
Analyst, Office of Outreach, Employee Education and Training, FSIS, 
1400 Independence Ave. SW., Mail Stop 3778, Washington, DC 20250; 
Telephone: (202) 418-8903; Fax: (202) 690-6519; Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    More than 170 foods have been reported to cause allergic reactions. 
However, eight of the most common allergenic foods, usually referred to 
as the ``Big 8,'' account for 90 percent of all food allergic reactions 
and are the sources from which many other allergenic ingredients are 
derived. The Big 8 food allergens are wheat, crustacean shellfish 
(e.g., shrimp, crab, lobster), eggs, fish, peanuts, milk, tree nuts 
(e.g., almonds, pecans, walnuts), and soybeans.
    Food allergies are increasing in reported prevalence and present a 
significant public health problem that affects both adults and 
children. Food allergens may be ingredients in meat, poultry, and egg 
products and thus the presence of undeclared allergens in these 
products may result in adverse health outcomes for certain individuals. 
FSIS-regulated establishments are required to declare all ingredients, 
including allergens, on the product label (9 CFR 317.2(f)(1), 
381.118(a)(1), and 590.411(c)(1)). If FSIS finds that product under its 
jurisdiction in commerce contains undeclared allergens, FSIS will 
request that the establishment recall the product.
    Since 2008, FSIS has seen a notable increase in the number of 
recalls due to undeclared allergens in FSIS-regulated products. Under 
the Federal Meat Inspection Act, the Poultry Products Inspection Act, 
and the Egg Products Inspection Act, meat, poultry, and egg products 
that contain an allergen 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), 601(m)(1), and 1033(a)(1)). Furthermore, the meat, 
poultry, and egg products also are misbranded because the labeling is 
false and misleading (21 U.S.C. 453(h)(1), 601(n)(1) and 1033(l)). The 
presence of undeclared allergens in product is often preventable, as it 
results from incorrect labeling or packaging of products, due to 
unexpected product and ingredient changes, cross-contamination of 
product during processing, and other types of procedural and human 
error.
    To address the presence of undeclared allergens in product and the 
increasing number of recalls involving undeclared allergens, FSIS, with 
speakers from FDA, CDC, international partners and academic 
institutions, is hosting a public meeting to highlight the problem of 
undeclared allergens in food, food allergy trends, and best practices 
for preventing undeclared allergen-related recalls.
    In addition to holding this public meeting, FSIS has developed a 
compliance guideline to assist establishments in addressing the hazards 
posed by allergens in their products, available at: https://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES. FSIS updates this guidance as 
necessary as new information becomes available.

II. Registration and Meeting Materials

    There is no fee to register for the public meeting, but pre-
registration is mandatory for participants attending in-person. On-site 
registration will not be permitted. Early registration is recommended 
as space is limited. All attendees must register online by emailing 
[email protected] by March 9, 2017.
    FSIS will finalize an agenda on or before the meeting dates and 
post it on the FSIS Web page at http://www.fsis.usda.gov/meetings.

III. Public Comments and Participation in Meetings

Public Comments: Oral Comments

    Stakeholders will have an opportunity to provide oral comments 
during the public meeting. Due to the anticipated high level of 
interest in the opportunity to make public comments and the

[[Page 10563]]

limited time available to do so, FSIS will do its best to accommodate 
all persons who wish to express an opinion. FSIS encourages persons and 
groups who have similar interests to consolidate their information for 
presentation by a single representative.

Public Comments: Written Comments

    Any stakeholders wishing to submit written comments before or after 
the meeting can do so on or before April 17, 2017, using any of the 
following methods: Electronically--go to http://www.regulations.gov and 
follow the online instructions for submitting comments; Mail, including 
CD-ROMS--send to Docket Clerk, USDA, FSIS Docket Room, 1400 
Independence Avenue SW., Patriots Plaza III, Mailstop 3782, Room 8-
163A, Washington, DC 20250-3700; Hand- or courier-delivered items--
deliver to the Docket Clerk, USDA, FSIS Docket Room at Patriots Plaza 
III, 355 E Street SW., Room 8-164, Washington, DC 20250, between 8:30 
a.m. and 4:30 p.m., Monday through Friday.
    All items submitted by mail or electronic mail must include the 
Agency name and docket number: FSIS-2017-0005. Written 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. For access to background 
documents or written comments received, go to the FSIS Docket Room at 
Patriots Plaza III, 355 E Street SW., Room 8-164, Washington, DC 20250, 
between 8:30 a.m. and 4:30 p.m., Monday through Friday.
    Question-and-Answer Periods: Time has been allotted for audience 
questions after most presentations delivered during the meeting. 
Participants will have the opportunity to ask questions via a 
microphone in the auditorium.

IV. Transcripts

    The transcript of the proceedings from the public meeting will 
become part of the administrative record. As soon as the meeting 
transcripts are available they will be accessible on the FSIS Web site 
at http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings. The 
transcripts may also be viewed at the FSIS Docket Room at the address 
listed above.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of 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 much broader, more 
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. 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 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).

    Done at Washington, DC, on: February 9, 2017.
Alfred V. Almanza,
Administrator.
[FR Doc. 2017-02939 Filed 2-13-17; 8:45 am]
BILLING CODE 3410-DM-P

10562

Notices Federal Register
Vol. 82, No. 29

Tuesday, February 14, 2017

This section of the FEDERAL REGISTER Attendees must be pre-registered for the bear or contain a poisonous or
contains documents other than rules or meeting (and check-in onsite the day of deleterious substance (21 U.S.C.
proposed rules that are applicable to the the meeting) and show a valid photo ID 453(g)(1), 601(m)(1), and 1033(a)(1)).
public. Notices of hearings and investigations, to enter the building. See the pre- Furthermore, the meat, poultry, and egg
committee meetings, agency decisions and registration instructions under products also are misbranded because
rulings, delegations of authority, filing of
‘‘Registration and Meeting Materials.’’ the labeling is false and misleading (21
petitions and applications and agency
statements of organization and functions are Only registered attendees will be U.S.C. 453(h)(1), 601(n)(1) and 1033(l)).
examples of documents appearing in this permitted to enter the building. The presence of undeclared allergens in
section. FOR FURTHER INFORMATION CONTACT: product is often preventable, as it
Evelyn Arce, Outreach and Partnership results from incorrect labeling or
Analyst, Office of Outreach, Employee packaging of products, due to
DEPARTMENT OF AGRICULTURE Education and Training, FSIS, 1400 unexpected product and ingredient
Independence Ave. SW., Mail Stop changes, cross-contamination of product
Food Safety and Inspection Service 3778, Washington, DC 20250; during processing, and other types of
[Docket No. FSIS–2017–0005] Telephone: (202) 418–8903; Fax: (202) procedural and human error.
690–6519; Email: Evelyn.Arce@ To address the presence of undeclared
Preventing Undeclared Allergens: A fsis.usda.gov. allergens in product and the increasing
Strategic Approach To Reducing SUPPLEMENTARY INFORMATION:
number of recalls involving undeclared
Recalls allergens, FSIS, with speakers from
I. Background FDA, CDC, international partners and
AGENCY: Food Safety and Inspection academic institutions, is hosting a
More than 170 foods have been
Service, USDA. public meeting to highlight the problem
reported to cause allergic reactions.
ACTION: Notification of public meeting. However, eight of the most common of undeclared allergens in food, food
allergenic foods, usually referred to as allergy trends, and best practices for
SUMMARY: The Food Safety and preventing undeclared allergen-related
Inspection Service (FSIS), with the ‘‘Big 8,’’ account for 90 percent of
all food allergic reactions and are the recalls.
participation from the Food and Drug In addition to holding this public
Administration (FDA), the Centers for sources from which many other
allergenic ingredients are derived. The meeting, FSIS has developed a
Disease Control and Prevention (CDC), compliance guideline to assist
international partners, and academic Big 8 food allergens are wheat,
crustacean shellfish (e.g., shrimp, crab, establishments in addressing the
institutions, is hosting a public meeting hazards posed by allergens in their
to discuss the prevention of undeclared lobster), eggs, fish, peanuts, milk, tree
nuts (e.g., almonds, pecans, walnuts), products, available at: https://
allergens in FSIS-regulated product. www.fsis.usda.gov/wps/wcm/connect/
Specifically, the meeting will address and soybeans.
Food allergies are increasing in f9cbb0e9-6b4d-4132-ae27-
the continued occurrence of product 53e0b52e840e/Allergens-
reported prevalence and present a
recalls due to undeclared allergens and Ingredients.pdf?MOD=AJPERES. FSIS
significant public health problem that
best practices for preventing the updates this guidance as necessary as
affects both adults and children. Food
presence of undeclared allergens in new information becomes available.
allergens may be ingredients in meat,
FSIS-regulated products. Topics will
poultry, and egg products and thus the II. Registration and Meeting Materials
focus on FSIS policy and enforcement
presence of undeclared allergens in
regarding undeclared allergens, labeling There is no fee to register for the
these products may result in adverse
compliance, best practices for public meeting, but pre-registration is
health outcomes for certain individuals.
prevention, and emerging issues. mandatory for participants attending in-
FSIS-regulated establishments are
Industry and interested individuals, person. On-site registration will not be
required to declare all ingredients,
organizations, and other stakeholders permitted. Early registration is
including allergens, on the product label
are invited to participate in the meeting recommended as space is limited. All
(9 CFR 317.2(f)(1), 381.118(a)(1), and
and comment on these topics. attendees must register online by
590.411(c)(1)). If FSIS finds that product
DATES: The public meeting will be held under its jurisdiction in commerce emailing AllergenPublicMeeting@
on Thursday, March 16, 2017, 8:00 a.m. contains undeclared allergens, FSIS will fsis.usda.gov by March 9, 2017.
to 5:30 p.m. EST. request that the establishment recall the FSIS will finalize an agenda on or
ADDRESSES: The meeting will be held at product. before the meeting dates and post it on
the Jefferson Auditorium in the South Since 2008, FSIS has seen a notable the FSIS Web page at http://
Building, U.S. Department of increase in the number of recalls due to www.fsis.usda.gov/meetings.
Agriculture (USDA), 14th & undeclared allergens in FSIS-regulated III. Public Comments and Participation
Independence Avenue SW., products. Under the Federal Meat
sradovich on DSK3GMQ082PROD with NOTICES

in Meetings
Washington, DC 20250. The South Inspection Act, the Poultry Products
Building is a Federal facility, and Inspection Act, and the Egg Products Public Comments: Oral Comments
attendees should plan adequate time to Inspection Act, meat, poultry, and egg Stakeholders will have an opportunity
pass through the security screening products that contain an allergen not to provide oral comments during the
systems. Attendance is free. Non-USDA declared on the product label are public meeting. Due to the anticipated
employees must enter through the Wing adulterated because, to individuals who high level of interest in the opportunity
3 entrance on Independence Avenue. are allergic to the allergen, the products to make public comments and the

VerDate Sep<11>2014 16:48 Feb 13, 2017 Jkt 241001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1

Document Created: 2017-02-13 23:40:23
Document Modified: 2017-02-13 23:40:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notification of public meeting.
Dates		The public meeting will be held on Thursday, March 16, 2017, 8:00 a.m. to 5:30 p.m. EST.
Contact		Evelyn Arce, Outreach and Partnership Analyst, Office of Outreach, Employee Education and Training, FSIS, 1400 Independence Ave. SW., Mail Stop 3778, Washington, DC 20250; Telephone: (202) 418-8903; Fax: (202) 690-6519; Email: [email protected]
FR Citation		82 FR 10562

82 FR 10562 - Preventing Undeclared Allergens: A Strategic Approach To Reducing Recalls

DEPARTMENT OF AGRICULTUREFood Safety and Inspection Service

Federal Register Volume 82, Issue 29 (February 14, 2017)

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service