[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8103-8104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1398]


Mitigation Strategies To Protect Food Against Intentional 
Adulteration; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a revised draft guidance for industry 
entitled ``Mitigation Strategies to Protect Food Against Intentional 
Adulteration: Guidance for Industry.'' The revised draft guidance 
supersedes the version of the intentional adulteration draft guidance 
that we announced on June 20, 2018. This draft guidance document, when 
finalized, will help food facilities that manufacture, process, pack, 
or hold food, and that are required to register under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our 
regulation entitled ``Mitigation Strategies to Protect Food Against 
Intentional Adulteration.''

DATES: Submit either electronic or written comments on the draft 
guidance by July 5, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-D-1398 for ``Mitigation Strategies to Protect Food Against 
Intentional Adulteration: Guidance for Industry.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-3712, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
enables FDA to better protect public health by helping to ensure the 
safety and security of the food supply. FSMA enables FDA to focus more 
on preventing food safety problems rather than relying primarily on 
reacting to problems after they occur.
    FSMA added to the FD&C Act several new sections that reference 
intentional adulteration. For example, section 418 of the FD&C Act (21 
U.S.C. 350g) addresses intentional adulteration in the context of 
facilities that manufacture, process, pack, or hold food, and that are 
required to register under section 415 (21 U.S.C. 350d). Section 420 of 
the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the 
context of high-risk foods and exempts farms except for farms that 
produce milk.
    We are announcing the availability of a revised draft guidance for 
industry entitled ``Mitigation Strategies to Protect Food Against 
Intentional Adulteration: Guidance for Industry.'' This revised draft 
guidance supersedes the version of

[[Page 8104]]

the intentional adulteration draft guidance that we announced on June 
20, 2018 (83 FR 28651). This multi-chapter draft guidance for industry 
is intended to help food facilities required to comply develop and 
implement some of the components of a food defense plan, including 
conducting vulnerability assessments, and meet other requirements under 
21 CFR part 121. We are announcing the availability of the following 
chapters:

 Introduction
 Chapter One--The Food Defense Plan
 Chapter Two--Vulnerability Assessment to Identify Significant 
Vulnerabilities and Actionable Process Steps
 Chapter Three--Mitigation Strategies for Actionable Process 
Steps
 Chapter Four--Mitigation Strategies Management Components: 
Food Defense Monitoring
 Chapter Eight--Education, Training, or Experience
 Appendix 1--Food Defense Plan Worksheets
 Appendix 4-- Vulnerability Assessment Examples

    We have indicated new content, mostly located in Chapter Two, 
Chapter Eight, Appendix 1 and Appendix 4, with brackets stating, ``[New 
March 2019] or [Updated March 2019].'' We have also made minor changes 
to previously published sections for clarity and consistency with the 
new content. We intend to announce the availability for public comment 
of the final portion of the draft guidance once it is complete.

II. Significance of Guidance

    This level 1 draft guidance is being issued 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 food 
defense measures against intentional adulteration for the regulation 
``Mitigation Strategies to Protect Food Against Intentional 
Adulteration.'' It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations. This guidance is not subject to Executive Order 12866.

III. 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 507 have been approved under 
OMB control number 0910-0789.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Use the FDA website listed 
in the previous sentence to find the most current version of the 
guidance.

    Dated: February 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04060 Filed 3-5-19; 8:45 am]
 BILLING CODE 4164-01-P