[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Proposed Rules]
[Pages 75349-75351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 112, 117, and 507

[Docket No. FDA-2016-D-2841]


Describing a Hazard That Needs Control in Documents Accompanying 
the Food, as Required by Four Rules Implementing the FDA Food Safety 
Modernization Act: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Describing a Hazard That Needs Control in Documents Accompanying the 
Food, as Required by Four Rules Implementing the FDA Food Safety 
Modernization Act: Guidance for Industry.'' This draft guidance 
explains our current thinking on disclosure statements made by an 
entity, in documents accompanying food, that certain hazards have not 
been controlled by that entity as required by certain provisions in 
four final rules. This document describes our current thinking on how 
to describe the hazard under each of the four rules and which documents 
we consider to be ``documents of the trade'' for the purpose of 
disclosure statements.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
May 1, 2017. Submit either electronic or written comments on the 
proposed collection of information by May 1, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a

[[Page 75350]]

third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-2841 for ``Describing a Hazard That Needs Control in 
Documents Accompanying the Food, as Required by Four Rules Implementing 
the FDA Food Safety Modernization Act: Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug 
Administration (HFS-300), 5001 Campus Drive, College Park, MD 20740. 
Send two self-addressed adhesive labels to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:  With regard to this draft guidance: 
For questions regarding this draft guidance as it relates to our 
regulation entitled ``Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Human Food,'' contact 
Jenny Scott, Center for Food Safety and Applied Nutrition, (HFS-300), 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-2166.
    For questions regarding this draft guidance as it relates to our 
regulation entitled ``Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Food for Animals,'' 
contact Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6246.
    For questions regarding this draft guidance as it relates to our 
regulation entitled ``Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption,'' contact Samir Assar, 
Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-401-1636.
    For questions regarding this draft guidance as it relates to our 
regulation entitled ``Foreign Supplier Verification Programs (FSVP) for 
Importers of Food for Humans and Animals,'' contact Rebecca Buckner, 
Office of Food and Veterinary Medicine, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Describing a Hazard That Needs Control in Documents 
Accompanying the Food, as Required by Four Rules Implementing the FDA 
Food Safety Modernization Act: Guidance for Industry.'' We are issuing 
the draft guidance consistent with FDA's good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the current thinking of FDA on this topic. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. You can use an alternate approach if it satisfies 
the requirements of the applicable statutes and regulations.
    The draft guidance relates to four of the seven foundational rules 
that we have established in Title 21 of the Code of Federal Regulations 
(21 CFR) as part of our implementation of the FDA Food Safety 
Modernization Act (FSMA) (Pub. L. 111-353). Table 1 lists these four 
rules. Each of these rules includes ``customer provisions'' as 
specified in table 1.

                    Table 1--The Four Foundational FSMA Rules Relevant to the Draft Guidance
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   Title and abbreviations for the
       purpose of this document        Regulatory codification  ``Customer provisions''        Publication
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Current Good Manufacturing Practice,   21 CFR part 117........  21 CFR 117.136(a)(2),    80 FR 55908, September
 Hazard Analysis, and Risk-Based                                 (3), and (4).            17, 2015.
 Preventive Controls for Human Food
 (part 117).

[[Page 75351]]

 
Current Good Manufacturing Practice,   21 CFR part 507........  21 CFR 507.36(a)(2),     80 FR 56170, September
 Hazard Analysis, and Risk-Based                                 (3), and (4).            17, 2015.
 Preventive Controls for Food for
 Animals (part 507).
Standards for the Growing,             21 CFR part 112........  21 CFR 112.2(b)........  80 FR 74354, November
 Harvesting, Packing, and Holding of                                                      27, 2015.
 Produce for Human Consumption
 (produce safety regulation).
Foreign Supplier Verification          21 CFR part 1, subpart   21 CFR 1.507(a)(2)(i),   80 FR 74226, November
 Programs (FSVP) for Importers of       L.                       (a)(3)(i), and           27, 2015.
 Food for Humans and Animals (FSVP                               (a)(4)(i).
 regulation).
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    The ``customer provisions'' of part 117 and part 507 each include a 
requirement for a ``disclosure statement'' in which a manufacturer/
processor must disclose, in documents accompanying the food, in 
accordance with the practice of the trade, that the food is ``not 
processed to control [identified hazard]'' in certain circumstances. 
Likewise, the ``customer provisions'' of the FSVP regulation include a 
requirement for a ``disclosure statement'' in which an importer must 
disclose, in documents accompanying the food, in accordance with the 
practice of the trade, that the food is ``not processed to control 
[identified hazard]'' in certain circumstances. The ``customer 
provisions'' of the produce safety regulation relate to an exemption 
from that regulation that includes a requirement for a ``disclosure 
statement'' in which a farm must disclose, in documents accompanying 
the food, in accordance with the practice of the trade, that the food 
is ``not processed to adequately reduce the presence of microorganisms 
of public health significance.''
    The draft guidance responds to industry questions regarding these 
requirements for a disclosure statement. On March 23, 2016, FDA met 
with a food trade association at their request to listen to concerns 
regarding the customer provisions of part 117 (Ref. 1), including 
concerns regarding the disclosure statement in part 117. At the 
meeting, the trade association expressed concern about providing a 
disclosure statement when multiple hazards may be present, including 
chemical hazards (such as mycotoxins) and physical hazards (such as 
stones in raw agricultural commodities), as well as for multiple 
biological hazards (such as microbial pathogens). The trade association 
also asked us to allow a variety of types of documents that accompany 
the food to have the disclosure statement (e.g., contractual 
agreements, Web sites referenced on labels and in contracts, labels, 
letters of guarantee, shipment-specific certificates of analysis, 
shipping documents, specifications, and terms and conditions).
    The trade association focused its discussion on the requirements of 
part 117, but noted that it had parallel concerns for the analogous 
provisions of part 507 and the FSVP regulation (Ref. 1). Although the 
trade association did not express concern with the disclosure statement 
in the produce safety regulation, we believe it will be helpful to 
businesses subject to the produce safety regulation, to include our 
current thinking on the disclosure statement in all four rules that 
have requirements for a disclosure statement, not just the three rules 
mentioned by the trade association.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 117 have been approved under 
OMB control number 0910-0751. The collections of information in 21 CFR 
part 507 have been approved under OMB control number 0910-0789. The 
collections of information in 21 CFR part 112 have been approved under 
OMB control number 0910-0816. The collections of information in 21 CFR 
part 1, subpart L have been approved under OMB control number 0910-
0752.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references are on display in the Division of Dockets 
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are 
available for viewing by interested persons between 9 a.m. and 4 p.m., 
Monday through Friday; they are also available electronically at http://www.regulations.gov.

1. Grocery Manufacturers Association, ``21 CFR 117.136. Industry 
Impacts from Disclosure and Written Assurance Requirements,'' 2016.

    Dated: October 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26245 Filed 10-28-16; 8:45 am]
BILLING CODE 4164-01-P