[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Rules and Regulations]
[Pages 46104-46107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 110

[Docket No. FDA-2011-N-0920]


Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
removing instruction 13 from the Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food 
(Preventive Controls for Human Food) regulation. Instruction 13 directs 
the Federal Register to remove and reserve as of September 17, 2018, 
the Current Good Manufacturing Practice in Manufacturing, Packing, or 
Holding Human Food (Human Food CGMP) regulation. Removal of instruction 
13 is necessary because the compliance dates for certain facilities 
subject to the modernized current good manufacturing practice 
requirements in the Preventive Controls for Human Food regulation have 
been extended. Retaining the Human Food CGMP regulation will maintain 
the status quo while these facilities prepare for compliance with the 
new CGMP requirements and will avoid an unintended gap in public health 
protection.

DATES: Effective September 12, 2018, FDA withdraws amendatory 
instruction 13 on page 56144 of the final rule published at 80 FR 55908 
at 56144 on September 17, 2015. Submit either electronic or written 
comments by October 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 12, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2011-N-0920 for ``Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Human Food.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your

[[Page 46105]]

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.

FOR FURTHER INFORMATION 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.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background and Discussion
II. Legal Authority
III. Analysis of Environmental Impact
IV. Paperwork Reduction Act of 1995

I. Background and Discussion

    In the Federal Register of September 17, 2015, FDA published the 
final rule, ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food'' (80 FR 55908; the 
``rule establishing part 117''). Among other things, in the final rule 
establishing part 117 (21 CFR part 117), we modernized and placed in 
part 117, subpart B the longstanding current good manufacturing 
practice requirements (CGMPs) codified in part 110 (21 CFR part 110). 
We staggered the compliance dates for part 117 based on business size. 
We also instructed the Federal Register to remove and reserve part 110 
effective September 17, 2018, the latest of the staggered compliance 
dates, which we treated as a conforming amendment (see instruction 
number 13 at 80 FR 55908 at 56144).
    Subsequently, in a final rule published in the Federal Register of 
August 24, 2016 (81 FR 57784; the ``compliance date final rule''), 
among other things, we extended by up to 16 months the part 117 
compliance dates for certain facilities, to address concerns about the 
practicality of compliance, consider changes to the regulatory text, 
and better align compliance dates across various rules. The compliance 
date final rule extended the part 117 compliance dates for the 
following establishments, as set out in table 1:

  Table 1--Facilities That Received Extended Part 117 Compliance Dates
------------------------------------------------------------------------
                                                        Compliance date
                                    Compliance date    with extension as
                                  announced in final     announced in
                                   rule establishing    compliance date
                                       part 117           final rule
------------------------------------------------------------------------
Facility solely engaged in
 packing and/or holding
 activities on produce RACs,
 that is:
    <bullet> a very small         September 17, 2018  January 27, 2020.
     business.
    <bullet> a small business...  September 18, 2017  January 28, 2019.
    <bullet> not a small or very  September 19, 2016  January 26, 2018.
     small business.
Facility that would qualify as a
 secondary activities farm
 except for ownership of the
 facility, that is:
    <bullet> a very small         September 17, 2018  January 27, 2020.
     business.
    <bullet> a small business...  September 18, 2017  January 28, 2019.
    <bullet> not a small or very  September 19, 2016  January 26, 2018.
     small business.
Facilities that would qualify as
 a farm if it did not color
 RACs, that is:
    a very small business.......  September 17, 2018  January 27, 2020.
    a small business............  September 18, 2017  January 28, 2019.
    not a small or very small     September 19, 2016  January 26, 2018.
     business.
------------------------------------------------------------------------

    A small business is a business (including any subsidiaries and 
affiliates) employing fewer than 500 full-time equivalent employees. A 
very small business is a business (including any subsidiaries and 
affiliates) averaging less than $1 million, adjusted for inflation, per 
year, during the 3-year period preceding the applicable calendar year 
in sales of human food plus the market value of human food 
manufactured, processed, packed or held without sale (e.g., held for a 
fee). (See Sec.  117.3.)
    After issuing the compliance date final rule, FDA announced that as 
a matter of enforcement policy it did not intend to enforce certain 
part 117 requirements for certain facilities, including some of the 
facilities in table 1 whose compliance dates had been extended by the 
compliance date final rule. See the January 2018 guidance entitled 
``Policy Regarding Certain Entities Subject to the Current Good 
Manufacturing Practice and Preventive Controls, Produce Safety, and/or 
Foreign Supplier Verification Programs'' (https://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm590661.pdf). The present 
rulemaking does not change the policies contained in this guidance.
    As mentioned above, in the final rule establishing part 117 we 
instructed the Federal Register to remove and reserve part 110, 
effective September 17, 2018, which at the time was the latest of the 
staggered compliance dates. The goal was to have firms subject to the 
Human Food CGMP regulation until the Preventive Controls for Human Food 
regulation took its place, leaving no gap in public health protection. 
However, in the compliance date final rule we extended the compliance 
dates for part 117 by up to 16 months but failed to

[[Page 46106]]

revise the previous instruction to remove part 110. Without the current 
action, the small and very small facilities described in table 1 will 
not be subject to any CGMPs until, respectively, January 28, 2019, and 
January 27, 2020. However, FDA's intent always has been that part 110 
would remain unchanged and in effect until all establishments have 
reached the date when they must be in compliance with part 117. 
Therefore, we are amending the rule establishing part 117 to remove the 
instruction to the Federal Register to remove and reserve part 110. We 
intend to remove part 110 in a separate action after all establishments 
have reached their compliance dates for the part 117 CGMPs.
    When FDA conducts rulemaking, it normally does so using notice-and-
comment procedures established under the Administrative Procedure Act 
(APA) and FDA regulations. These procedures allow the public an 
opportunity to participate in Agency rulemaking by submitting written 
comments on proposed rules. FDA considers these comments as it 
finalizes rules. (5 U.S.C. 553(b) and (c); Sec.  10.40 (21 CFR 10.40.)) 
The APA, however, does not require an agency to use notice-and-comment 
procedures in all rulemaking. For example, the APA provides that 
Agencies shall not use notice-and-comment procedures, and shall proceed 
with a final rule, when the Agency for good cause finds that notice and 
public procedure thereon are impracticable, unnecessary, or contrary to 
public interest, and incorporates the finding and a brief statement of 
reasons therefor in the rules issued. (5 U.S.C. 553(b)(B).) Likewise, 
FDA's regulations provide that the requirements of notice and public 
procedure do not apply when the Commissioner of Food and Drugs 
determines for good cause that they are impracticable, unnecessary, or 
contrary to the public interest, in which case, the notice issuing the 
regulation will state the reasons for the determination, and provide an 
opportunity for comment to determine whether the regulation should 
subsequently be modified or revoked. (Sec.  10.40(e)(1).) Pursuant to 
this regulation, FDA requests comments on the timing for the removal of 
part 110.
    In this instance, for several reasons, FDA finds good cause for 
issuing this final rule without notice and comment.
    Notice and comment are unnecessary because this final rule is a 
minor and technical repair of an obvious oversight in the compliance 
date final rule, maintains the CGMP regulatory status quo for industry, 
affirms FDA's plan for transitioning from part 110 to part 117 as 
outlined in the rule establishing part 117, and is not expected to 
generate public concern. FDA is addressing the gap in CGMP regulatory 
coverage from September 17, 2018, to January 27, 2020, by issuing a 
narrowly tailored amendment to remove instruction 13 from the rule to 
establish part 117. The result of this amendment will be that the part 
110 CGMPs will continue in effect for establishments that have not 
reached their part 117 compliance date. This action will serve to 
correct an obvious oversight made in the compliance date final rule. 
FDA does not anticipate public concern with this action. The Agency 
previously sought public comment on its proposal to remove part 110 in 
coordination with the compliance dates for part 117 and received no 
comments that disagreed. The present continuation and planned eventual 
removal of part 110 is a repeat of what was previously proposed without 
public objection. Furthermore, it is clear from the rule establishing 
part 117 that we intended for facilities to remain subject to part 110 
until their part 117 compliance date (80 FR 55908 at 56127). Thus, we 
do not believe there was ever any reasonable expectation on the part of 
the establishments listed in table 1 that they would not be 
continuously subject to CGMPs. For these various reasons, we have 
determined that notice and comment is unnecessary.
    FDA finds further good cause for issuing this final rule without 
notice and comment because notice and comment are contrary to the 
public interest and impracticable. There could be negative public 
health implications if there were a temporal gap in CGMP coverage; for 
example, there have been outbreaks associated with the types of 
facilities still subject to part 110 (e.g., listeria in cantaloupe). 
Many of the establishments listed in table 1 are not required to comply 
with the replacement CGMPs in part 117 until January 2019 or January 
2020, depending on business size. This means that these establishments 
would have no applicable CGMP requirements for 4 to 16 months. CGMP 
requirements have existed for all human food manufacturers since at 
least 1970 (see 34 FR 6977) and serve as a significant basis for FDA's 
determination of what constitutes an insanitary food production 
environment that may result in food that is injurious to public health 
under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342(a)(4)), among other authorities. It would be contrary to the 
public interest to allow the temporal gap in CGMP coverage.
    To summarize, a gap in CGMP coverage would leave FDA without a 
primary tool to execute its function of ensuring that food 
manufacturing establishments follow basic food safety practices, 
potentially endangering the public health, in order to provide the 
public an opportunity to comment on a non-controversial technical 
matter. For these reasons, we are issuing this amendment to the final 
rule establishing part 117 without prior notice and comment. (5 U.S.C. 
553(b)(3)(B)).
    In addition, we find good cause for this amendment to the rule 
establishing part 117 to become effective on the date of publication. 
The APA allows an effective date less than 30 days after publication as 
provided by the Agency for good cause found and published within the 
rule (5 U.S.C. 553(d)(3)). As provided at 80 FR 55908, September 17, 
2015, the amendment removing part 110 was to take effect on September 
17, 2018. In order to continue part 110 for an interim period, this 
final rule needs to be effective on or before September 16, 2018, and 
therefore it is not possible for this rule to take effect 30 days after 
publication in the Federal Register. As previously described, in order 
to prevent a gap in CGMP coverage for certain establishments, an 
immediate effective date is necessary to remove, before September 17, 
2018, the instruction to remove and reserve part 110. Further, because 
the facilities' responsibility to comply with CGMP requirements remains 
unchanged, this rule places no burden on affected parties for which 
they would need a reasonable time to prepare. Therefore, the 
Commissioner finds good cause under 5 U.S.C. 553(d)(3) and Sec.  
10.40(c)(4)(ii) for this amendment to become effective on the date of 
publication.

II. Legal Authority

    We are issuing this final rule removing instruction number 13 of 
the rule to establish part 117 under the same authority for which the 
rule containing instruction number 13 was originally issued. That 
analysis may be found in section II, ``Legal Authority,'' of the rule 
to establish part 117 (80 FR 55908 at 55917 to 55920).

III. Analysis of Environmental Impact

    FDA has determined that the removal of instruction 13 will not 
change the status quo and, therefore, is not a major Federal action 
significantly affecting the quality of the human environment within the 
meaning of section 102(2)(C) of the National Environmental Policy

[[Page 46107]]

Act (42 U.S.C. 4321 et seq.). Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 110

    Food packaging, Foods.

0
Therefore, in FR Rule Doc. No. 2015-21920, published September 17, 
2015, at 80 FR 55908-56168, amendatory instruction 13 in the third 
column on page 56144 is withdrawn.

    Dated: September 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-19855 Filed 9-11-18; 8:45 am]
 BILLING CODE 4164-01-P