[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70747-70749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28935]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / 
Notices  

[[Page 70747]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket Number FSIS-2013-0029]
RIN 0583-AD39


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.

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SUMMARY:  The Food Safety and Inspection Service (FSIS) is announcing 
the availability of an updated version of the Agency's compliance 
guidelines for controlling hazards posed by allergens and other 
ingredients of public health concern. The guidelines provide 
recommendations for identifying hazards when conducting a hazard 
analysis and for preventing and controlling hazards through a hazard 
analysis and critical control point (HACCP) plan or Sanitation standard 
operating procedures (SOPs) or other prerequisite programs with respect 
to these substances.

ADDRESSES:  A downloadable version of the revised compliance guide is 
available to view and print at [http://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES]. No hard copies of the compliance 
guidelines have been published.

FOR FURTHER INFORMATION CONTACT:  For further information contact 
Daniel Engeljohn, Assistant Administrator, Office of Policy and Program 
Development, FSIS, U.S. Department of Agriculture, 1400 Independence 
Avenue SW., Washington, DC 20250-3700, (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On April 21, 2014, FSIS published a Federal Register notice (79 FR 
22083) announcing the availability of and opportunity to comment on 
Agency guidance on allergens and other ingredients of public health 
concern. FSIS explained that in recent years (2008-2012), there had 
been a sustained increase in the number of recalls of FSIS-regulated 
product that contained undeclared allergens, and that these recalls 
were preventable as many had been the result of ingredient changes, 
product changes, products in the wrong package, or products with 
misprinted labels. The Agency also explained that the consumption of 
meat and poultry products containing ingredients of public health 
concern, such as undeclared allergens, may result in adverse health 
outcomes for certain individuals.
    The Agency explained that it was issuing the 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, how to prevent 
and control these hazards through HACCP plans, Sanitation SOPs, or 
other prerequisite programs, and how to properly declare allergens in 
product. The guidelines also provided information on proper procedures 
for processing, handling, storing, and labeling a product with an 
allergenic ingredient or ingredient of public health concern.
    In addition, the Agency explained that the guidelines represent the 
best practice recommendations of FSIS, based on scientific and 
practical considerations, and that the recommendations are not 
requirements. FSIS said that by following the guidelines, 
establishments would be likely to ensure that product labels declare 
all ingredients, as required in the regulations, and that the product 
would not contain undeclared allergens or other undeclared ingredients. 
FSIS recommended that establishments consider incorporating the 
guidelines in their HACCP plan or Sanitation SOPs or other prerequisite 
programs.
    Updated Guidelines:
    FSIS has updated the guidelines to include numbered appendices for 
diagrams, checklists, and supplemental information to simplify locating 
these references. In response to the comments discussed below, FSIS 
updated the guidelines by:
     Clarifying, on pages 2 and 4, that the focus of the 
document is on FSIS-regulated establishments, state-regulated 
establishments, and operations where all or part of the premises meet 
the ``food processing plant'' definition, as defined in the Food and 
Drug Administration's (FDA) ``2013 Food Code'';
     clarifying, in Section 1.2, page 5, that sulfur-based 
preservatives (sulfites), lactose, FD&C Yellow 5 (Tartrazine), gluten, 
and monosodium glutamate (MSG) are ingredients of concern that may 
result in adverse reactions in certain susceptible individuals, yet 
they are not considered allergens;
     revising the ``What is a letter of guarantee (LOG)?'' box 
on page 8, and adding a paragraph on page 9 to clarify and describe a 
LOG, the difference between a LOG and a Certificate of Analysis (COA), 
and the communication and coordination between an establishment and its 
suppliers that FSIS recommends when an establishment relies on LOGs;
     adding ``Allergenic Ingredients and Foods,'' a listing of 
allergenic ingredients and foods that may contain allergenic 
ingredients, as a resource (Appendix 6);
     adding ``Tips for Avoiding Your Allergen,'' published by 
Food Allergy Research and Education (FARE) to the ``References and 
Resources'' section (Appendix 7); and
     adding FSIS Directive 8080.1, ``Recall of Meat and Poultry 
Products,'' to the ''References and Resources'' section (Appendix 7).
    In addition, in Section 2.1, FSIS edited the text to emphasize the 
purpose of a hazard analysis and a hazard identification. Under Section 
2.3, FSIS edited the third paragraph to delete that an establishment 
include storage in its HACCP system because that guidance is included 
in the first paragraph of this section. Also, in Section 2.3, FSIS 
added the recommendation that an establishment conduct simulations with 
inaccurate product labels to test system, checklists, and procedures as 
a step to prevent mislabeling during packing, labeling, and storage of 
the final product.

[[Page 70748]]

Comments and Responses

    FSIS received a total of seven comments in response to the April 
2014 Federal Register notice and guidelines. The commenters included 
consumer and trade organizations, individuals, and a professional 
organization. The comments and the Agency's responses are discussed 
below.
    Comment: A professional organization recommended that FSIS modify 
the introductory sections of the document to clarify that the 
compliance guidelines were developed for a processing setting.
    Response: FSIS has modified the introductory sections of the 
guidelines to clarify that the emphasis of the document is on FSIS-
regulated establishments, state-regulated establishments, and 
operations where all or part of the premises meet the food processing 
plant definition as defined in the FDA ``2013 Food Code,'' available 
online at (http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM374510.pdf).
    Comment: An individual commented that Attachment 3 to FSIS Notice 
29-13, ``Allergenic Ingredients and Foods,'' is very useful, especially 
to very small meat and poultry establishments, including those that are 
dual jurisdiction processing establishments, and that it should be 
included in the compliance guidelines.
    Response: The attachment, entitled, ``Allergenic Ingredients and 
Foods,'' is based on ``Tips for Avoiding Your Allergen,'' published by 
Food Allergy Research and Education (FARE). FSIS Notice 29-13 was 
issued in April 2013 and is now expired. FSIS agrees that the 
attachment provides useful information and has included it in the 
guidelines as Appendix 7.
    Comment: A consumer group recommended clarifying that some of the 
ingredients listed under Section 1.2 are not allergens, and that 
monosodium glutamate (MSG) should not be included because research has 
not confirmed that it causes adverse reactions.
    Response: The list of ingredients in Section 1.2 has been modified 
to clarify that sulfur-based preservatives (sulfites), lactose, FD&C 
Yellow 5 (Tartrazine), gluten, and monosodium glutamate (MSG) are 
ingredients that may result in an adverse reaction in certain 
susceptible individuals, yet they are not considered allergens. FSIS is 
concerned about all foods or food ingredients that may cause adverse 
health effects. Therefore, MSG remains an ingredient of public health 
concern.
    Comment: A trade group recommended that, to ensure that industry is 
aware of the recommendations in the compliance guide, FSIS provide 
outreach to the meat and poultry industry.
    Response: FSIS intends to provide outreach to the meat and poultry 
industry on the compliance guidelines by conducting web-based (webinar) 
sessions for industry and announcing he compliance guide 
recommendations on the FSIS Small Plant News Web page at http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/small-plant-news/small-plant-news.
    Comment: One commenter requested that FSIS require the listing of 
all spices by name on product labels. The commenter stated that spice 
allergies are significant health concerns and that food labels need to 
specifically list all spices in the product. The commenter was 
specifically concerned with the labeling of garlic.
    Response: The Federal Meat Inspection Act (FMIA) and the Poultry 
Products Inspection Act (PPIA) require the listing of the common or 
usual name of ingredients on product labels, except that spices and 
flavorings may be designated as ``spices'' and ``flavorings,'' without 
naming each ingredient. Therefore, FSIS does not have the legal 
authority to require the listing of each spice or flavoring. The term 
``spice'' is defined in the FSIS labeling regulations (9 CFR 
317.2(f)(1)(i)(A) and 381.118(c)(1)) to mean any aromatic vegetable 
substance in the whole, broken or ground form, with the exceptions of 
onions, garlic and celery, whose primary function in food is seasoning 
rather than nutritional, and from which no portion of any volatile oil 
or other flavoring principle has been removed. In addition, the terms 
``natural flavor,'' ``natural flavoring,'' ``flavor,'' or ``flavoring'' 
may be used to designate spices as well as powdered garlic, powdered 
onion, or celery powder, specifically. If whole or broken garlic is 
used in the formulation of the product, it would need to be declared in 
the list of ingredients.
    Comment: Two trade organizations commented that throughout the 
guidelines, the focus was on the ``Big Eight'' allergens with little 
discussion of the ingredients of concern that may cause adverse 
reactions in susceptible individuals. The commenters recommended that a 
list of ingredients of public health concern be created in 
collaboration with the National Institute of Allergy and Infectious 
Diseases or similarly informed entity.
    Response: FSIS is concerned about all foods or food ingredients 
that may cause adverse health effects. These include the ``Big Eight'' 
ingredients as well as other ingredients of concern. As discussed 
above, FSIS has modified the list of ingredients in Section 1.2 to 
clarify that sulfur-based preservatives (sulfites), lactose, FD&C 
Yellow 5 (Tartrazine), gluten, and monosodium glutamate (MSG) are 
ingredients of concern that may cause adverse reactions in certain 
susceptible individuals. However, FSIS has not established a list of 
all ingredients to which consumers have reported adverse reactions. 
Establishments are required to be aware of the ingredients they are 
using in the production of their products and to determine whether the 
ingredients may trigger food sensitivities. They need to employ the 
necessary in-plant controls to prevent cross-contact and assure 
accurate label declarations.
    In addition, FSIS Directive 8080.1, ``Recall of Meat and Poultry 
Products,'' lists factors considered by the FSIS Recall Committee when 
evaluating the public health significance of an undeclared ingredient 
in a meat or poultry product. The directive lists the questions and 
other factors that the Agency considers. Although the Directive 
provides instructions to FSIS personnel, the questions that the FSIS 
recall committee considers will be helpful to industry also. Therefore, 
the Directive has been added to the ``References and Resources'' 
section (Appendix 7).
    Comment: A trade organization recommended that the list of 
undeclared allergen recalls include the corrective actions taken to 
ensure that allergens appear on the label.
    Response: FSIS agrees that providing undeclared allergen corrective 
action scenarios could be a useful mechanism to ensure that allergens 
appear on the label. ``Allergen Scenarios and Possible Prevention 
Measures,'' Appendix 5 of the compliance guidelines, is based on 
historical recalls, giving some insight into the possible preventive 
measures that would have prevented the undeclared allergen.
    Comment: Two trade organizations commented that requiring 
establishments to review ingredient lists on a continuous basis, 
especially when an establishment has changed suppliers, or the supplier 
has modified the ingredient formula, would create unjustified increases 
in manufacturing cost. They additionally commented that a review of 
letters of guarantee should not to be confused with certificates of 
analysis.
    Response: FSIS has edited the ``What is a letter of guarantee 
(LOG)'' box on page 8 of the guidelines, as well as the description of 
recommendations on page 9 to clarify what are Letters of

[[Page 70749]]

Guarantee. As mentioned above, establishments are required to be aware 
of the ingredients they are using in the production of their products 
and to determine whether they have considered and employed the 
necessary in-plant controls to prevent cross-contact and assure 
accurate label declarations. LOGs are a means to prevent the possible 
inclusion in the product of an allergen that is not declared on the 
product label. If a LOG is only a general statement, the establishment 
should consider initiating a dialogue with its suppliers to ensure the 
establishment understands ingredient information or to recommend that 
more specific information be included in LOGs. However, these are 
guidelines, and FSIS is not establishing any new requirements.
    Comment: Two trade organizations commented that if the Agency is 
suggesting that testing is the only way to meet the guidelines, the 
guidelines are regulatory requirements that should follow proper 
rulemaking procedures. The commenters stated that examples of cleaning 
controls and procedures of sanitation verification should be provided 
in the guidelines. They also recommended that testing ingredients 
should only be done in cooperation and knowledge of the supplier to 
ensure that related product is properly held.
    Response: Because some FSIS-regulated establishments conduct 
testing for allergens in their products, page 12 of the guidelines 
includes information about the test kits and the use of reference 
laboratories. As stated in the guidelines, allergen testing may be 
considered to verify and document sanitation effectiveness. As also 
noted in the guidelines, testing is not the only way to demonstrate 
that allergens are not presented on a production line, on equipment, or 
in product, Section 2.2 specifically addresses sanitation. Therefore, 
testing is not required, and the guidelines do not represent regulatory 
requirements.
    When establishments conduct allergen testing of ingredients, FSIS 
encourages communication with the supplier. Also, FSIS recommends that 
establishments hold or control product tested for allergens until they 
receive results, although doing so is not required. Establishments 
should design their food safety system within their available resources 
to take all necessary and practical steps to ensure that only safe 
product enters commerce.
    Comment: Two trade organizations commented that proper labeling and 
packaging of products constitutes product separation. They stated that 
recommending unrealistic definitions of separation would be an 
unwarranted expense that would not effectively correct the cause of 
allergen recalls.
    Response: Properly labeling and packaging products is essential and 
required by FSIS regulations and authorizing statues. As an additional 
preventive measure, as stated in the guidance, establishments should 
consider whether the identification and separation of products would 
effectively prevent employees from selecting the wrong ingredient 
during formulation, the wrong label, or the wrong product.
    Comment: Two trade organizations commented that the compliance 
guideline establishes regulatory requirements. They recommended that 
the document more clearly state that the practices in the compliance 
guidelines are neither regulatory requirements nor the only way to 
control and prevent undeclared allergens in the production process.
    Response: The compliance guidelines are intended to inform industry 
about effective and innovative methods to address the problem of 
undeclared allergens and ingredients of public health concern. The 
document does not establish any new requirements that industry must 
follow, but rather it is intended to assist establishments in meeting 
the existing FSIS labeling and HACCP regulations.
    The compliance guidelines provide recommendations, not 
requirements, to establishments for identifying hazards when conducting 
a hazard analysis and for preventing and controlling hazards with 
respect to allergens and other ingredients of public health concern 
through the implementation of HACCP plans, sanitation SOPs, or other 
prerequisite programs. The guidelines were edited to clarify that the 
document consists of recommendations, not requirements.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line 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: November 9, 2015.
Alfred V. Almanza,
Acting Administrator.
 [FR Doc. 2015-28935 Filed 11-13-15; 8:45 am]
BILLING CODE 3410-DM-P