[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Proposed Rules]
[Pages 58421-58422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 117 and 507

[Docket No. FDA-2016-D-2373]


Classification of Activities as Harvesting, Packing, Holding, or 
Manufacturing/Processing for Farms and Facilities; Draft Guidance for 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 or we) is announcing the 
availability of a draft guidance for industry entitled ``Classification 
of Activities as Harvesting, Packing, Holding, or Manufacturing/
Processing for Farms and Facilities; Draft Guidance for Industry.'' The 
draft guidance, when finalized, will help food establishments determine 
whether the activities that they perform are within the ``farm'' 
definition established in our regulation for Registration of Food 
Facilities. Determining whether the activities a food establishment 
performs are within the ``farm'' definition plays a key role in 
determining whether its business is exempt from our regulations for 
Registration of Food Facilities, and from certain requirements in our 
regulations for ``Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food'' and ``Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Food for Animals.''

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10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
February 21, 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 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-2373 for ``Classification of Activities as Harvesting, 
Packing, Holding, or Manufacturing/Processing for Farms and Facilities; 
Draft 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

[[Page 58422]]

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 
the Office of Food Safety, Center for Food Safety and Applied Nutrition 
(HFS-300), Food and Drug Administration, 5001 Campus Dr., 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: 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: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Classification of Activities as Harvesting, Packing, 
Holding, or Manufacturing/Processing for Farms and Facilities.'' We are 
issuing the draft guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the current thinking of the FDA on this topic. It does not 
establish any rights for 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.
    Section 103(c) of the FDA Food Safety Modernization Act (FSMA) 
directed us to conduct rulemaking to clarify the on-farm activities 
that would, in part, determine when an establishment is required to 
register with us as a ``facility,'' or is not required to register with 
us because the establishment is a ``farm.'' To do so, we conducted 
rulemaking to revise and add farm-related definitions to our existing 
regulation for Registration of Food Facilities in the same rulemaking 
documents that we issued to establish our regulation entitled ``Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food'' in part 117 (21 CFR part 117). (See the final 
rule at 80 FR 55908, September 17, 2015). For the purposes of the draft 
guidance, we call that rulemaking ``the farm definition rulemaking.'' 
The farm definition rulemaking revised the ``farm'' definition to 
provide for two types of farms: (1) Primary production farms and (2) 
secondary activities farms. The farm definition rulemaking also revised 
three definitions associated with the ``farm'' definition (i.e., the 
definitions of ``packing,'' ``holding,'' and ``manufacturing/
processing'') and added more examples of activities in each of these 
definitions. The farm definition rulemaking also established a new 
definition associated with the ``farm'' definition (i.e., the 
definition of ``harvesting'') and included examples of harvesting 
activities in the definition. During the farm definition rulemaking, 
several comments asked us to classify specific on-farm activities as 
harvesting, packing, holding, or manufacturing/processing so that an 
operation that conducts these activities on a farm can determine 
whether conducting that specific activity is within, or outside, the 
``farm'' definition. Some comments asked us to make a table of 
activities prominently available on our Internet site for easy access 
whenever the public seeks out information regarding regulations to 
which these activities apply. (See 80 FR 55908 at 55920.) To address 
these comments, we announced our intent to issue a draft guidance with 
our current thinking on the classification of activities as 
``harvesting,'' ``packing,'' ``holding,'' or ``manufacturing/
processing'' (80 FR 55908 at 55921). The draft guidance that we are 
making available implements that stated intent.
    The draft guidance provides examples of activities classified as 
``harvesting,'' ``packing,'' ``holding,'' or ``manufacturing/
processing,'' as well as activities classified in more than one way. We 
note that the list of examples of activities classified as ``holding'' 
in the draft guidance does not include ``repacking and blast freezing . 
. . when product is not exposed to the environment,'' despite our 
statement in the farm definition rulemaking that such activities would 
be considered practical necessities for distribution and therefore 
``holding.'' See 80 FR 55908 at 55934 (Comment/Response 44). We made 
similar statements in a related rulemaking to establish our regulation 
entitled ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Food for Animals'' in part 507 (21 
CFR part 507) (80 FR 56170, September 17, 2015). See 80 FR 56170 at 
56192 (Comment/Response 39). Our prior statements were incorrect and we 
hereby withdraw them. Neither ``repacking'' nor ``blast freezing'' 
should be considered a ``holding'' activity. We have thought more about 
what should be considered a ``practical necessity'' and are explaining 
our thinking more in the draft guidance.

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 1, subpart H have been 
approved under OMB control number 0910-0502. The collections of 
information in 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 121 
have been approved under OMB control number 0910-0812.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153033.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: August 19, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20301 Filed 8-24-16; 8:45 am]
 BILLING CODE 4164-01-P