80 FR 70747 - Availability of FSIS Compliance Guidelines for Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration Through Labeling
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service Federal Register Volume 80, Issue 220 (November 16, 2015)
Food Safety and Inspection Service
Federal Register Volume 80, Issue 220 (November 16, 2015)
| Page Range | 70747-70749 | |
| FR Document | 2015-28935 |
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)] [Notices] [Pages 70747-70749] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28935] ======================================================================== 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. ======================================================================== 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. ----------------------------------------------------------------------- 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
![70747
Notices Federal Register
Vol. 80, No. 220
Monday, November 16, 2015
This section of the FEDERAL REGISTER Background references. In response to the comments
contains documents other than rules or
On April 21, 2014, FSIS published a discussed below, FSIS updated the
proposed rules that are applicable to the guidelines by:
public. Notices of hearings and investigations, Federal Register notice (79 FR 22083)
committee meetings, agency decisions and announcing the availability of and • Clarifying, on pages 2 and 4, that the
rulings, delegations of authority, filing of opportunity to comment on Agency focus of the document is on FSIS-
petitions and applications and agency guidance on allergens and other regulated establishments, state-regulated
statements of organization and functions are ingredients of public health concern. establishments, and operations where
examples of documents appearing in this FSIS explained that in recent years all or part of the premises meet the
section. (2008-2012), there had been a sustained ‘‘food processing plant’’ definition, as
increase in the number of recalls of defined in the Food and Drug
FSIS-regulated product that contained Administration’s (FDA) ‘‘2013 Food
DEPARTMENT OF AGRICULTURE undeclared allergens, and that these Code’’;
recalls were preventable as many had • clarifying, in Section 1.2, page 5,
Food Safety and Inspection Service
been the result of ingredient changes, that sulfur-based preservatives (sulfites),
[Docket Number FSIS–2013–0029] product changes, products in the wrong lactose, FD&C Yellow 5 (Tartrazine),
package, or products with misprinted gluten, and monosodium glutamate
RIN 0583–AD39 labels. The Agency also explained that (MSG) are ingredients of concern that
the consumption of meat and poultry may result in adverse reactions in
Availability of FSIS Compliance products containing ingredients of
Guidelines for Allergens and certain susceptible individuals, yet they
public health concern, such as are not considered allergens;
Ingredients of Public Health Concern: undeclared allergens, may result in
Identification, Prevention and Control, • revising the ‘‘What is a letter of
adverse health outcomes for certain
and Declaration Through Labeling guarantee (LOG)?’’ box on page 8, and
individuals.
The Agency explained that it was adding a paragraph on page 9 to clarify
AGENCY: Food Safety and Inspection and describe a LOG, the difference
Service, USDA. issuing the guidelines to provide meat
and poultry establishments with between a LOG and a Certificate of
ACTION: Notice of availability. Analysis (COA), and the communication
recommendations on how to identify
hazards with respect to allergens and and coordination between an
SUMMARY: The Food Safety and
other ingredients of public health establishment and its suppliers that
Inspection Service (FSIS) is announcing
concern when conducting their hazard FSIS recommends when an
the availability of an updated version of
analysis, how to prevent and control establishment relies on LOGs;
the Agency’s compliance guidelines for
controlling hazards posed by allergens these hazards through HACCP plans, • adding ‘‘Allergenic Ingredients and
and other ingredients of public health Sanitation SOPs, or other prerequisite Foods,’’ a listing of allergenic
concern. The guidelines provide programs, and how to properly declare ingredients and foods that may contain
recommendations for identifying allergens in product. The guidelines allergenic ingredients, as a resource
hazards when conducting a hazard also provided information on proper (Appendix 6);
analysis and for preventing and procedures for processing, handling, • adding ‘‘Tips for Avoiding Your
controlling hazards through a hazard storing, and labeling a product with an Allergen,’’ published by Food Allergy
analysis and critical control point allergenic ingredient or ingredient of Research and Education (FARE) to the
(HACCP) plan or Sanitation standard public health concern. ‘‘References and Resources’’ section
operating procedures (SOPs) or other In addition, the Agency explained (Appendix 7); and
prerequisite programs with respect to that the guidelines represent the best
practice recommendations of FSIS, • adding FSIS Directive 8080.1,
these substances. ‘‘Recall of Meat and Poultry Products,’’
ADDRESSES: A downloadable version of
based on scientific and practical
considerations, and that the to the ’’References and Resources’’
the revised compliance guide is section (Appendix 7).
available to view and print at [http:// recommendations are not requirements.
FSIS said that by following the In addition, in Section 2.1, FSIS
www.fsis.usda.gov/wps/wcm/connect/ edited the text to emphasize the purpose
f9cbb0e9-6b4d-4132-ae27- guidelines, establishments would be
likely to ensure that product labels of a hazard analysis and a hazard
53e0b52e840e/Allergens- identification. Under Section 2.3, FSIS
Ingredients.pdf?MOD=AJPERES]. No declare all ingredients, as required in
the regulations, and that the product edited the third paragraph to delete that
hard copies of the compliance an establishment include storage in its
guidelines have been published. would not contain undeclared allergens
or other undeclared ingredients. FSIS HACCP system because that guidance is
FOR FURTHER INFORMATION CONTACT: For recommended that establishments included in the first paragraph of this
further information contact Daniel consider incorporating the guidelines in section. Also, in Section 2.3, FSIS added
Engeljohn, Assistant Administrator,
tkelley on DSK3SPTVN1PROD with NOTICES
their HACCP plan or Sanitation SOPs or the recommendation that an
Office of Policy and Program other prerequisite programs. establishment conduct simulations with
Development, FSIS, U.S. Department of Updated Guidelines: inaccurate product labels to test system,
Agriculture, 1400 Independence Avenue FSIS has updated the guidelines to checklists, and procedures as a step to
SW., Washington, DC 20250–3700, (202) include numbered appendices for prevent mislabeling during packing,
205–0495. diagrams, checklists, and supplemental labeling, and storage of the final
SUPPLEMENTARY INFORMATION: information to simplify locating these product.
VerDate Sep<11>2014 19:47 Nov 13, 2015 Jkt 238001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1](https://thefederalregister.org/doc/80_FR_70967/page/1.svg)
![Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices 70749
Guarantee. As mentioned above, separation would be an unwarranted broader, more diverse audience. In
establishments are required to be aware expense that would not effectively addition, FSIS offers an email
of the ingredients they are using in the correct the cause of allergen recalls. subscription service which provides
production of their products and to Response: Properly labeling and automatic and customized access to
determine whether they have packaging products is essential and selected food safety news and
considered and employed the necessary required by FSIS regulations and information. This service is available at:
in-plant controls to prevent cross- authorizing statues. As an additional http://www.fsis.usda.gov/subscribe.
contact and assure accurate label preventive measure, as stated in the Options range from recalls to export
declarations. LOGs are a means to guidance, establishments should
information, regulations, directives, and
prevent the possible inclusion in the consider whether the identification and
notices. Customers can add or delete
product of an allergen that is not separation of products would effectively
prevent employees from selecting the subscriptions themselves, and have the
declared on the product label. If a LOG
is only a general statement, the wrong ingredient during formulation, option to password protect their
establishment should consider initiating the wrong label, or the wrong product. accounts.
a dialogue with its suppliers to ensure Comment: Two trade organizations USDA Non-Discrimination Statement
the establishment understands commented that the compliance
ingredient information or to recommend guideline establishes regulatory No agency, officer, or employee of the
that more specific information be requirements. They recommended that USDA shall, on the grounds of race,
included in LOGs. However, these are the document more clearly state that the color, national origin, religion, sex,
guidelines, and FSIS is not establishing practices in the compliance guidelines gender identity, sexual orientation,
any new requirements. are neither regulatory requirements nor disability, age, marital status, family/
Comment: Two trade organizations the only way to control and prevent parental status, income derived from a
commented that if the Agency is undeclared allergens in the production public assistance program, or political
suggesting that testing is the only way process. beliefs, exclude from participation in,
to meet the guidelines, the guidelines Response: The compliance guidelines
deny the benefits of, or subject to
are regulatory requirements that should are intended to inform industry about
effective and innovative methods to discrimination any person in the United
follow proper rulemaking procedures.
address the problem of undeclared States under any program or activity
The commenters stated that examples of
cleaning controls and procedures of allergens and ingredients of public conducted by the USDA.
sanitation verification should be health concern. The document does not How To File a Complaint of
provided in the guidelines. They also establish any new requirements that Discrimination
recommended that testing ingredients industry must follow, but rather it is
should only be done in cooperation and intended to assist establishments in To file a complaint of discrimination,
knowledge of the supplier to ensure that meeting the existing FSIS labeling and complete the USDA Program
related product is properly held. HACCP regulations. Discrimination Complaint Form, which
Response: Because some FSIS- The compliance guidelines provide may be accessed online at http://
regulated establishments conduct recommendations, not requirements, to www.ocio.usda.gov/sites/default/files/
testing for allergens in their products, establishments for identifying hazards docs/2012/Complain_combined_6_8_
page 12 of the guidelines includes when conducting a hazard analysis and 12.pdf, or write a letter signed by you
information about the test kits and the for preventing and controlling hazards or your authorized representative.
use of reference laboratories. As stated with respect to allergens and other
in the guidelines, allergen testing may ingredients of public health concern Send your completed complaint form
be considered to verify and document through the implementation of HACCP or letter to USDA by mail, fax, or email:
sanitation effectiveness. As also noted plans, sanitation SOPs, or other Mail
in the guidelines, testing is not the only prerequisite programs. The guidelines
way to demonstrate that allergens are were edited to clarify that the document U.S. Department of Agriculture,
not presented on a production line, on consists of recommendations, not Director, Office of Adjudication, 1400
equipment, or in product, Section 2.2 requirements. Independence Avenue SW.,
specifically addresses sanitation. Washington, DC 20250–9410.
Therefore, testing is not required, and Additional Public Notification
the guidelines do not represent Public awareness of all segments of Fax
regulatory requirements. rulemaking and policy development is
When establishments conduct important. Consequently, FSIS will (202) 690–7442
allergen testing of ingredients, FSIS announce this Federal Register Email
encourages communication with the publication on-line through the FSIS
supplier. Also, FSIS recommends that Web page located at: http:// program.intake@usda.gov
establishments hold or control product www.fsis.usda.gov/federal-register. Persons with disabilities who require
tested for allergens until they receive FSIS also will make copies of this alternative means for communication
results, although doing so is not publication available through the FSIS (Braille, large print, audiotape, etc.),
required. Establishments should design Constituent Update, which is used to
should contact USDA’s TARGET Center
their food safety system within their provide information regarding FSIS
at (202) 720–2600 (voice and TDD).
available resources to take all necessary policies, procedures, regulations,
tkelley on DSK3SPTVN1PROD with NOTICES
and practical steps to ensure that only Federal Register notices, FSIS public Done, at Washington, DC, on: November 9,
safe product enters commerce. meetings, and other types of information 2015.
Comment: Two trade organizations that could affect or would be of interest Alfred V. Almanza,
commented that proper labeling and to our constituents and stakeholders. Acting Administrator.
packaging of products constitutes The Update is available on the FSIS [FR Doc. 2015–28935 Filed 11–13–15; 8:45 am]
product separation. They stated that Web page. Through the Web page, FSIS
BILLING CODE 3410–DM–P
recommending unrealistic definitions of is able to provide information to a much
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Document Created: 2015-12-14 14:13:16
Document Modified: 2015-12-14 14:13:16
| 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 | Notice of availability. | |
| 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. | |
| FR Citation | 80 FR 70747 | |
| RIN Number | 0583-AD39 |
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