[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3447-3449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01296]



[[Page 3447]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 112, 117, and 507

[Docket No. FDA-2017-D-0397]


Considerations for Determining Whether a Measure Provides the 
Same Level of Public Health Protection as the Corresponding Requirement 
in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 
or 507; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Considerations for Determining Whether a Measure Provides the Same 
Level of Public Health Protection as the Corresponding Requirement in 
21 CFR 112 or the Preventive Controls Requirements in Part 117 or 
507.'' The draft guidance describes FDA's current thinking on the 
concept of ``same level of public health protection'' (SLPHP), and 
FDA's expectations for how an SLPHP evaluation should be conducted and 
an SLPHP determination should be reached. The draft guidance identifies 
certain points to consider that a competent authority, a farm, a 
facility, an importer, or other relevant entity should take into 
consideration when evaluating whether a measure that is different from 
that required under (part 112) 21 CFR part 112 or the preventive 
controls requirements in (part 117 or part 507) 21 CFR part 117 or 507 
meets the SLPHP threshold under the foreign supplier verification 
program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112.

DATES: Submit either electronic or written comments on the draft 
guidance by May 25, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2017-D-0397 for ``Considerations for Determining Whether a Measure 
Provides the Same Level of Public Health Protection as the 
Corresponding Requirement in 21 CFR 112 or the Preventive Controls 
Requirements in Part 117 or 507.'' 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 draft guidance to 
the Center for Food Safety and Applied Nutrition (HFS-300), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send one 
self-addressed adhesive label 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: Ritu Nalubola, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20993, 301-796-3252.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Considerations for Determining Whether a Measure Provides 
the Same Level of Public Health Protection as the Corresponding 
Requirement in 21 CFR 112 or the Preventive Controls Requirements in 
Part 117 or 507.'' 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 establish any rights for

[[Page 3448]]

any person and is not binding on FDA or the public. You can use an 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.
    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.

                    Table 1--The Four Foundational FSMA Rules Relevant to the Draft Guidance
----------------------------------------------------------------------------------------------------------------
  Title and abbreviations for the          Regulatory
      purpose of this document            codification                           Publication
----------------------------------------------------------------------------------------------------------------
Current Good Manufacturing           21 CFR part 117.......  80 FR 55908, September 17, 2015.
 Practice, Hazard Analysis, and
 Risk-Based Preventive Controls for
 Human Food (PC for Human Food
 regulation).
Current Good Manufacturing           21 CFR part 507.......  80 FR 56170, September 17, 2015.
 Practice, Hazard Analysis, and
 Risk-Based Preventive Controls for
 Food for Animals (PC for Animal
 Food regulation).
Standards for the Growing,           21 CFR part 112.......  80 FR 74354, November 27, 2015.
 Harvesting, Packing, and Holding
 of Produce for Human Consumption
 (Produce Safety regulation).
Foreign Supplier Verification        21 CFR part 1, subpart  80 FR 74226, November 27, 2015.
 Programs for Importers of Food for   L.
 Humans and Animals (FSVP
 regulation).
----------------------------------------------------------------------------------------------------------------

    The FSVP regulation requires, in relevant part, that importers 
develop, maintain, and follow an FSVP that provides adequate assurances 
that the foreign supplier of a food is using processes and procedures 
that provide the SLPHP as those required under part 112 or the 
preventive controls requirements in part 117 or part 507, respectively, 
if any is applicable. As incorporated in 21 CFR 1.502(a), this means 
that importers may import food consistent with the FSVP regulation even 
if their foreign supplier uses a process or procedure that varies in 
some way from the processes and procedures required under the 
applicable requirements in these regulations, provided that the 
importer follows an FSVP that provides adequate assurance that the 
processes or procedures that the supplier uses provide the SLPHP as 
those required under the relevant FDA requirement. Similarly, a 
provision in the FSVP requirements for dietary supplements, in 21 CFR 
1.511(c), also requires that foreign supplier verification activities 
performed under that section must provide adequate assurances that a 
supplier is producing the dietary supplement in accordance with 
processes and procedures that provide the same level of public health 
protection as those required under 21 CFR part 111 (the dietary 
supplement current good manufacturing practice regulations). In 
addition, the Produce Safety regulation includes certain provisions 
whereby farms may use measures different from those required under part 
112, provided all relevant requirements are met, including that those 
measures must provide the SLPHP as the corresponding FDA-established 
requirement (Sec. Sec.  112.12, 112.49, and 112.171-182 (Subpart P--
Variances)).
    The draft guidance describes FDA's current thinking on 
considerations relevant to SLPHP determinations, specifically in 
relation to the FSVP, PC for Human Food, PC for Animal Food, and 
Produce Safety regulations. The draft guidance identifies certain 
points to consider that a competent authority, a farm, a facility, an 
importer, or other relevant entity should take into consideration when 
evaluating whether a measure that is different from that required under 
part 112 or the preventive controls requirements in part 117 or 507 
meets the SLPHP threshold under the FSVP or Produce Safety regulations. 
In addition, FDA expects to apply these same points in our own 
evaluations of whether a measure that is different from that required 
under the applicable provisions of these regulations provides the same 
level of public health protection as the corresponding requirement.
    These points are intended to provide a general framework for 
evaluating the adequacy of a measure to provide the necessary level of 
public health protection that FDA determined is appropriate by 
establishing the corresponding requirement. We rely on an overarching 
principle that an SLPHP determination should be supported by sound 
scientific evidence that is analyzed by competent individuals, taking 
into account any unique measure-specific considerations. There are 
different scenarios under which an SLPHP evaluation may be conducted, 
and we recognize that an evaluation of a measure's level of public 
health protection compared to the corresponding FDA requirement can 
vary widely, including with respect to the scope of evaluation and the 
entity that conducts the evaluation. Although the points to consider 
can be flexibly used, as appropriate and applicable, considering the 
specific circumstances applicable to the measure and the context for 
its evaluation, we expect using these points will help achieve 
consistency in the application of the concept of SLPHP across different 
circumstances and by different entities. As we implement the FSMA 
rules, FDA will also consider what, if any, training may be necessary 
for our personnel to better understand and apply these points, and help 
ensure consistency in our evaluations for SLPHP determinations.

II. The 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 part 117 have been approved under OMB 
control number 0910-0751. The collections of information in part 507 
have been approved under OMB control number 0910-0789. The collections 
of information in part 112 have been approved under OMB control number 
0910-0816. The collections of information in 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 https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.


[[Page 3449]]


    Dated: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01296 Filed 1-24-18; 8:45 am]
 BILLING CODE 4164-01-P


