
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Rules and Regulations]
[Pages 57784-57796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 
129, 179, 211, and 507

[Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-
2011-N-0143]
RIN 0910-AG10, 0910-AG35, 0910-AG36, 0910-AG64


The Food and Drug Administration Food Safety Modernization Act; 
Extension and Clarification of Compliance Dates for Certain Provisions 
of Four Implementing Rules

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension and clarification of compliance dates for 
certain provisions.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
dates for compliance with certain provisions in four final rules. We 
are extending the compliance dates to address concerns about the 
practicality of compliance with certain provisions, consider changes to 
the regulatory text, and better align compliance dates across the 
rules. In addition, we are clarifying certain compliance dates in the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption rule.

DATES: This final rule is effective August 24, 2016. See sections 
III.C, IV.A.2, IV.B, and V through VIII for the extended compliance 
dates.

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

SUPPLEMENTARY INFORMATION:

I. Background: The Four Related Rules Implementing the FDA Food Safety 
Modernization Act

    This extension and clarification of compliance dates concerns 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). The 
four final rules are entitled ``Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' 
(published in the Federal Register of September 17, 2015, 80 FR 55908) 
(http://www.fda.gov/fsma); ``Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Food for 
Animals'' (published in the Federal Register of September 17, 2015, 80 
FR 51670) (http://www.fda.gov/fsma); ``Foreign Supplier Verification 
Programs for Importers of Food for Humans and Animals'' (published in 
the Federal Register of November 27, 2015, 80 FR 74226) (http://www.fda.gov/fsma); and ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption'' (published in 
the Federal Register of November 27, 2015, 80 FR 74354) (http://www.fda.gov/fsma).
    In part 117 (21 CFR part 117), we have established our regulation 
entitled ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food'' (80 FR 55908, September 
17, 2015). Among other things, the rulemaking to establish part 117 
amended our current good manufacturing practice (CGMP) regulation for 
manufacturing, packing, or holding human food to modernize it and 
establish it in new part 117, subparts A, B, and F. Part 117 also 
includes new requirements for domestic and foreign facilities that are 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) in subparts A, C, D, E, F, 
and G to establish and implement hazard analysis and risk-based 
preventive controls for human food (the human food preventive controls 
requirements). In the preamble of the final rule establishing part 117, 
we stated that the rule is effective November 16, 2015, and provided 
for compliance dates of 1 to 3 years from the date of publication in 
most cases (see table 53 in the preamble of the final rule establishing 
part 117, 80 FR 55908 at 56128). In the rulemaking to establish part 
117, we also amended the ``farm'' definition in our regulations 
implementing section 415 of the FD&C Act (the section 415 registration 
regulation; 21 CFR part 1, subpart H) to clarify the scope of the 
exemption from registration requirements provided for ``farms'' and, in 
so doing, to clarify which human food establishments are subject to the 
human food preventive controls requirements, and which human food 
establishments are exempt from those requirements because they are 
``farms.''
    In part 507 (21 CFR part 507), we have established our regulation 
entitled ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Food for Animals'' (80 FR 56170, 
September 17, 2015). Among other things, the rulemaking to establish 
part 507 established new requirements for CGMPs in subparts A, B, and F 
(CGMP requirements) and also established requirements for hazard 
analysis and risk-based preventive controls for food for animals in 
subparts A, C, D, E, and F (the animal food preventive controls 
requirements). The part 507 requirements apply to domestic and foreign 
facilities that are required to register under the section 415 
registration regulation and, thus, the ``farm'' definition that we 
amended as part of the rulemaking to establish part 117 also clarifies 
which animal food establishments are subject to the part 507 
requirements, and which animal food establishments are exempt from 
those requirements because they are ``farms.'' In the preamble of the 
final rule establishing part 507, we stated that the rule is effective 
November 16, 2015 (80 FR 56170). We provided for compliance dates of 1 
to 3 years from the date of publication in most cases for compliance 
with the CGMP requirements, with an additional year beyond that for 
compliance with the animal food preventive controls

[[Page 57785]]

requirements (see table 32 in the preamble of the final rule 
establishing part 507, 80 FR 56170 at 56329).
    In part 1, subpart L (21 CFR part 1, subpart L), we have 
established our regulation entitled ``Foreign Supplier Verification 
Programs for Importers of Food for Humans and Animals'' (the FSVP 
regulation; 80 FR 74226, November 27, 2015). The FSVP regulation 
requires importers to establish foreign supplier verification programs 
to verify that their foreign suppliers are using processes and 
procedures that provide the same level of public health protection as 
those required under the provisions on hazard analysis and risk-based 
preventive controls and standards for produce safety in the FD&C Act, 
that the imported food is not adulterated, and that food is not 
misbranded with respect to food allergen labeling. In the preamble of 
the final rule establishing the FSVP regulation, we stated that the 
rule is effective January 26, 2016, and provided for varying compliance 
dates based in part on the size of the foreign supplier, the nature of 
the importer, and whether the foreign supplier is subject to certain 
other FSMA regulations (80 FR 74226 at 74332 to 74333, as corrected in 
a technical amendment (81 FR 25326, April 28, 2016)).
    In part 112 (21 CFR part 112), we have established our regulation 
entitled ``Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption'' (the produce safety regulation; 80 
FR 74354, November 27, 2015). Among other things, the rulemaking to 
establish the produce safety regulation set forth in a new part 112 
procedures, processes, and practices that minimize the risk of serious 
adverse health consequences or death, including those reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable biological hazards into or onto produce and to provide 
reasonable assurances that the produce is not adulterated on account of 
such hazards. The produce safety regulation applies to certain produce 
farms, and does not apply to activities of facilities that are subject 
to part 117 (as established in part 117). In the preamble of the final 
rule establishing the produce safety regulation, we stated that the 
produce safety regulation is effective January 26, 2016, and provided 
for compliance dates of 1 to 6 years from the effective date depending 
on the commodity and the provision(s) (see table 30 in the preamble of 
the final rule establishing the produce safety regulation, 80 FR 74354 
at 74527, as corrected in a technical amendment at 81 FR 26466, May 3, 
2016). (Some of the compliance dates identified in the technical 
amendment fall on weekends (i.e., January 26, 2019, is a Saturday and 
January 26, 2020, is a Sunday) and should therefore be read as 
referring to the next business day (i.e., January 28, 2019, and January 
27, 2020, respectively). We use the latter dates throughout this 
document.)

II. Summary of Compliance Date Extensions in This Rule

    We are extending the dates for compliance with certain provisions 
in four final rules to address concerns about the practicality of 
compliance with certain provisions, consider changes to the regulatory 
text, and better align compliance dates across the rules. First, we are 
extending the compliance dates for certain related provisions 
concerning customer assurances when controls are applied downstream in 
the distribution chain in all four rules. Second, we are extending the 
compliance dates for part 117 and part 507 for facilities solely 
engaged in packing and/or holding activities conducted on raw 
agricultural commodities (RACs) that are produce and/or nut hulls and 
shells and for certain facilities that would qualify as secondary 
activities farms except for the ownership of the facility. Third, we 
are extending the compliance dates for part 117 for certain facilities 
that color RACs. Fourth, we are extending the compliance dates for part 
507 for facilities solely engaged in the ginning of cotton. Fifth, we 
are extending the compliance dates for the FSVP regulation for 
importation of food contact substances. Sixth, we are extending the 
date for certain facilities producing Grade ``A'' milk and milk 
products covered by the National Conference on Interstate Milk 
Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply 
with the CGMP requirements of part 117.
    Finally, we are clarifying how we interpret the compliance dates 
for certain provisions related to agricultural water testing in the 
produce safety regulation.

III. Extension of Compliance Dates for ``Customer Provisions'' in Part 
117 and Related Rules

A. Background

    In a supplemental notice of proposed rulemaking for part 117 (79 FR 
58524, September 29, 2014), we proposed several exceptions to the 
requirement for a manufacturer/processor to establish and implement a 
supply-chain program. Under one proposed exception, a receiving 
facility would not have been required to have a supply-chain program if 
it relied on its customer to control the hazard and annually obtained 
from its customer written assurance that the customer had established 
and was following procedures (identified in the written assurance) that 
would significantly minimize or prevent the hazard (see the discussion 
in the preamble of the final rule at 80 FR 55908 at 56036; see the 
proposed regulatory text at 79 FR 58524 at 58565).
    After considering comments, we replaced this proposed provision 
with several provisions (Sec. Sec.  117.136(a)(2) through (4) and 
117.137) (referred to collectively as ``customer provisions'') that 
apply when a manufacturer/processor identifies a hazard requiring a 
preventive control (``identified hazard''), does not control the 
identified hazard, and relies on an entity in its distribution chain to 
address the hazard (80 FR 55908 at 56037 to 56039). (In these 
provisions, ``customer'' means a commercial customer, not a consumer.) 
A manufacturer/processor that complies with the customer provisions is 
not required to implement a preventive control for the identified 
hazard. The combination of three requirements in the customer 
provisions is intended to provide assurance that the food will be 
processed to control the identified hazard before it reaches consumers:
     Documentation provided by the manufacturer/processor to 
its direct customer that the food is ``not processed to control 
[identified hazard]'' (the disclosure statement provisions; Sec.  
117.136(a)(2)(i), (3)(i), and (4)(i));
     Written assurance provided by the customer to the 
manufacturer/processor that the customer is manufacturing, processing, 
or preparing the food in accordance with applicable food safety 
requirements (the written assurance provisions; Sec.  
117.136(a)(2)(ii), (3)(ii), and (4)(ii)); and
     Provisions relating to accountability for written 
assurances (the accountability provision; Sec.  117.137).
    We established similar requirements in three other FSMA rules 
(``related rules''): Part 507 (Sec. Sec.  507.36 (a)(2) through (4) and 
507.37); the FSVP regulation (Sec. Sec.  1.507(a)(2) through (4), and 
1.507(c)); and the produce safety regulation (Sec.  112.2(b)(2) through 
(4), and (6)).

B. Written Assurances From Customers

    On March 23, 2016, FDA met with the Grocery Manufacturers 
Association (GMA) at their request to listen to concerns regarding the 
customer

[[Page 57786]]

provisions in the part 117 rule (Ref. 1). GMA provided examples of 
product distribution chains that would require vastly more written 
assurances and consequently resources to comply with the requirement 
than anticipated by FDA. For example, a manufacturing facility may sell 
such foods to a distributor, who may sell numerous items requiring 
assurances to multiple restaurants, cafeterias, delicatessens, and 
other distributors. GMA estimated that this could result in hundreds or 
even thousands of written assurances needed by a single distributor. A 
similar concern exists for the related rules.
    After considering the information presented by GMA, FDA believes 
that the requirement for written assurance in the customer provisions 
of part 117 significantly exceeds the current practices of even the 
largest facilities; compliance by those facilities by September 19, 
2016, may not be feasible; and it is appropriate to extend the 
compliance dates for 2 years for the written assurance requirements for 
part 117 and the related rules while FDA considers the best approach to 
address feasibility concerns.
    We believe it continues to be appropriate to provide for an entity 
earlier in the distribution chain to disclose that a hazard has not 
been controlled and rely on a subsequent entity to control a hazard in 
human or animal food. For example, it would not make sense to require a 
facility that chops nuts to have a preventive control for Salmonella if 
the nuts are going to be used by customers in baked goods in accordance 
with a process validated to adequately control the hazard. In addition, 
it would not make sense to require a facility that manufactures a 
rendered meat ingredient for pet food to have a preventive control for 
Salmonella when the final pet food will go through an extrusion process 
at a customer's facility to control Salmonella. A manufacturer/
processor under part 117 or part 507 that relies on a customer to 
control a hazard will continue to be required to comply with the 
disclosure statement provisions and disclose that the food has not been 
processed to control the hazard on the compliance date originally 
specified (we note that FDA will soon be making available for public 
comment draft guidance on the disclosure statement provisions). 
Subsequent entities in the distribution chain will continue to be 
subject to applicable requirements related to food adulteration in 
Federal and/or state and local laws and regulations, e.g., part 117, 
part 507, and the Retail Food Code.

C. Extension of Compliance Dates

    Table 1 provides a summary of the revised compliance dates.

Table 1--Extension of Compliance Dates for the Written Assurances in the
            Customer Provisions in Part 117 and Related Rules
------------------------------------------------------------------------
                                      Previously
                                       announced        Compliance date
                                    compliance date     with extension
------------------------------------------------------------------------
       Human Food--Sec.   117.136(a)(2)(ii), (3)(ii), and (4)(ii)
------------------------------------------------------------------------
Small Business (a business        September 18, 2017  September 18,
 (including any subsidiaries and                       2019.
 affiliates) employing fewer
 than 500 full-time equivalent
 employees).
Business that is neither small    September 19, 2016  September 19,
 or very small (a business                             2018.
 (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)).
------------------------------------------------------------------------
       Animal Food--Sec.   507.36(a)(2)(ii), (3)(ii), and (4)(ii)
------------------------------------------------------------------------
Small Business (a business        September 17, 2018  September 17,
 (including any subsidiaries and                       2020.
 affiliates) employing fewer
 than 500 full-time equivalent
 employees).
Business that is neither small    September 18, 2017  September 18,
 or very small ((a business                            2019.
 (including any subsidiaries and
 affiliates) averaging less than
 $2,500,000, adjusted for
 inflation, per year, during the
 3-year period preceding the
 applicable calendar year in
 sales of animal food plus the
 market value of animal food
 manufactured, processed, packed
 or held without sale (e.g.,
 held for a fee or supplied to a
 farm without sale)).
------------------------------------------------------------------------
           FSVP--Sec.   1.507(a)(2)(ii), (3)(ii), and (4)(ii))
------------------------------------------------------------------------
Latest date of:
18 months after the publication   May 30, 2017......  May 28, 2019.
 of the final rule.
Importers of food from foreign    6 months after      30 months after
 supplier subject to preventive    supplier is         previously
 controls regulation for human     required to         announced
 food, the preventive controls     comply with the     compliance date
 or CGMP requirements in part      relevant            for the relevant
 507, or the produce safety        regulations.        regulations.
 regulation:
------------------------------------------------------------------------
                   Produce Safety--Sec.   112.2(b)(3)
------------------------------------------------------------------------
Very small businesses relying on  January 28, 2019..  January 26, 2021.
 the exemption in Sec.
 112.2(b) for sprouts that would
 otherwise be subject to subpart
 M (those with more than $25,000
 but no more than $250,000 in
 average annual produce sales
 during the previous three year
 period).
Small businesses relying on the   January 26, 2018..  January 27, 2020.
 exemption in Sec.   112.2(b)
 for sprouts that would
 otherwise be subject to subpart
 M (those with more than
 $250,000 but no more than
 $500,000 in average annual
 produce sales during the
 previous three year period).
All other businesses relying on   January 26, 2017..  January 28, 2019.
 the exemption in Sec.
 112.2(b) for sprouts that would
 otherwise be subject to subpart
 M.

[[Page 57787]]

 
Very small businesses relying on  January 27, 2020..  January 26, 2022.
 the exemption in Sec.
 112.2(b) for all other produce
 that would otherwise be covered
 (those with more than $25,000
 but no more than $250,000 in
 average annual produce sales
 during the previous three year
 period).
Small businesses relying on the   January 28, 2019..  January 26, 2021.
 exemption in Sec.   112.2(b)
 for all other produce that
 would otherwise be covered
 (those with more than $250,000
 but no more than $500,000 in
 average annual produce sales
 during the previous three year
 period).
All other businesses relying on   January 26, 2018..  January 27, 2020.
 the exemption in Sec.
 112.2(b) for all other produce
 that would otherwise be covered.
------------------------------------------------------------------------

    We are extending the compliance date by 2 years for the written 
assurance requirement in the customer provisions in part 117. With the 
extension, facilities that are small businesses must comply with Sec.  
117.136(a)(2)(ii), (3)(ii), and (4)(ii) by September 18, 2019, and 
other facilities subject to the requirements must comply with those 
provisions by September 19, 2018. As a result of the extension, the 
compliance date for certain associated requirements that are contingent 
on the specified delayed provisions are also delayed (i.e., the 
recordkeeping requirements in Sec. Sec.  117.136(b)(2) through (4) and 
117.335 and the requirements in Sec.  117.137 for a facility that 
provides a written assurance under Sec.  117.136(a)(2), (3), or (4)). 
We are not extending the compliance date for qualified facilities 
(including very small businesses) as defined in Sec.  117.3 because 
they are not subject to the requirements in Sec.  117.136(a)(2)(ii), 
(3)(ii), and (4)(ii).
    We are also extending the compliance date by 2 years for the 
written assurance requirement in the customer provisions in part 507. 
With the extension, facilities that are small businesses must comply 
with Sec.  507.36(a)(2)(ii), (3)(ii), and (4)(ii) by September 17, 
2020, and other facilities subject to the requirements must comply with 
those provisions by September 18, 2019. As a result of the extension, 
the compliance dates for certain associated requirements that are 
contingent on the specified delayed provisions are also delayed (i.e., 
the recordkeeping requirements in Sec. Sec.  507.36(b)(2) through (4) 
and 507.215 and the requirements in Sec.  507.37 for a facility that 
provides a written assurance under Sec.  507.36(a)(2), (3), or (4)). We 
are not extending the compliance date for qualified facilities 
(including very small businesses) as defined in Sec.  507.3 because 
they are not subject to the requirements in Sec.  507.36(a)(2)(ii), 
(3)(ii), and (4)(ii).
    In addition, we are extending the compliance date under the FSVP 
regulation for complying with the written assurance requirements in 
Sec.  1.507(a)(2)(ii), (3)(ii), and (4)(ii) by 2 years beyond the dates 
established in the final rule (as corrected in the technical 
amendment). In the preamble of the final rule, as corrected by the 
technical amendment, we stated that importers would need to comply with 
the FSVP regulation by the latest of the following:
     18 months after the publication of the final rule;
     For importers of food from a foreign supplier that is 
subject to part 117, the CGMP requirements or the preventive controls 
requirements for animal food in part 507, or the produce safety 
regulation, 6 months after the supplier was required to comply with the 
relevant regulations; or
     For an importer subject to the supply-chain program 
provisions of the human or animal food preventive controls regulations, 
the date the importer, as a receiving facility, was required to comply 
with the supply-chain program provisions of the relevant regulation.
    As a result of this extension, the earliest that an importer would 
be required to comply with the written assurance requirements in the 
customer provisions in Sec.  1.507 would be May 28, 2019. When an 
importer's compliance date is determined by when the foreign supplier 
must comply with the preventive controls regulation for human food, the 
preventive controls or CGMP requirements in part 507, or the produce 
safety regulation (i.e., when the importer must comply with FSVP 6 
months after the foreign supplier is required to come into compliance), 
the importer's compliance date for the written assurance requirements 
in Sec.  1.507 will be 2 years and 6 months after the previously-
announced compliance dates for the relevant regulations. That is, the 
other changes we are making to compliance dates for the human and 
animal food preventive controls and produce safety regulations will not 
impact when an FSVP importer must comply with the written assurance 
requirements in the customer provisions in Sec.  1.507. For example, 
although this rule extends the compliance dates for part 117 and part 
507 for facilities solely engaged in packing and/or holding activities 
conducted on RACs that are produce that would qualify as secondary 
activities farms except for the ownership of the facility, an importer 
whose foreign supplier is such a facility will be required to comply 
with the assurance requirements in Sec.  1.507 2 years and 6 months 
after the foreign supplier would have been required to comply with part 
117 or part 507 under the final rules published on September 17, 2015 
(80 FR 55908; 80 FR 56170). The importer's compliance date for the 
assurance requirements in Sec.  1.507 is not 2 years and 6 months after 
the newly-established part 117 and part 507 compliance dates announced 
in this rule. As a result of the extension, the compliance dates for 
certain associated requirements that are contingent on the specified 
delayed provisions are also delayed (i.e., the requirements in Sec.  
1.507(c) for a customer or subsequent entity that provides a written 
assurance under Sec.  1.507(a)(2), (3), or (4)).
    Finally, we are extending by 2 years the compliance dates for the 
written assurance requirements in the customer provisions of the 
produce safety regulation in Sec.  112.2(b)(3). With the extension, 
sprout operations wishing to rely on the exemption in Sec.  112.2(b) 
with respect to sprouts that would otherwise be subject to subpart M of 
part 112 must comply with the written assurances provisions in Sec.  
112.2(b)(3) by January 26, 2021 (very small businesses); January 27, 
2020 (small businesses); and January 28, 2019 (all other businesses). 
With the extension, operations wishing

[[Page 57788]]

to rely on the exemption in Sec.  112.2(b) with respect to other types 
of produce that would otherwise be covered must comply with the written 
assurances provisions in Sec.  112.2(b)(3) by January 26, 2022 (very 
small businesses); January 26, 2021 (small businesses), and January 27, 
2020 (all other businesses). As a result of the extension, the 
compliance dates for certain associated requirements that are 
contingent on the specified delayed provisions are also delayed (i.e., 
Sec.  112.2(b)(4) and (6)).

IV. Extension of Certain Compliance Dates for Both Part 117 and Part 
507

A. Facilities Solely Engaged in Packing and/or Holding Activities 
Conducted on Produce RACs and/or Nut Hulls and Shells

    Some facilities that are subject to part 117 are solely engaged in 
packing and/or holding RACs that are produce (``produce RACs''). These 
activities are similar to packing and holding activities commonly 
conducted on produce RACs by farms subject to the produce safety 
regulation. Examples of such facilities are produce packinghouses, 
warehouses that hold produce RACs, and facilities that hull, shell, 
pack and/or hold nuts (nuts are produce RACs and hulling and shelling 
may be considered ``packing'' when done for safe or effective packing). 
(We note that FDA will soon be making available for public comment a 
draft guidance on classification of activities as harvesting, packing, 
holding, or manufacturing/processing for farms and facilities). During 
the rulemaking to establish part 117, we received comments asking us to 
revise the regulatory text to ensure that similar activities would be 
treated similarly under either the produce safety regulation or part 
117. (See Comment 25, 80 FR 55908 at 55927 to 55928.)
    We received comments that expressed concern about how the 
requirements in part 117 for environmental monitoring and product 
testing would apply to off-farm facilities that pack or hold produce 
RACs. (See Comment 524, 80 FR 55908 at 56062.) In responding to those 
comments, we stated that we were considering developing a separate 
guidance on packing and holding operations for produce RACs in light of 
the questions we have received regarding similarities and differences 
for off-farm packing and holding compared to on-farm packing and 
holding. In a letter to us dated April 19, 2016, the United Fresh 
Produce Association and 21 other organizations (UFPA et al.) noted that 
such guidance has not been issued, and the September 19, 2016, 
compliance date for part 117 is approaching (Ref. 2).
1. Similarities of Packing and Holding Activities Conducted on Produce 
RACs
    In the preamble of the final rule establishing part 117, we 
described several changes to the regulatory text in response to 
comments asking us to consider revisions to ensure that similar 
activities would be treated the same way under either the produce 
safety regulation or part 117. (See Response 25, 80 FR 55908 at 55928 
to 5929.) For example, we revised the ``farm'' definition to provide 
for two types of farms: (1) A primary production farm and (2) a 
secondary activities farm (see Sec. Sec.  1.227 and 117.3). With the 
added definition of ``secondary activities farm,'' some packinghouses 
that are managed by a business entity (such as a cooperative) that is 
different from the business entity growing crops (such as individual 
farms) can be within the ``farm'' definition and, thus, not be subject 
to the human food preventive controls requirements. We also established 
a new provision to allow off-farm establishments that package, pack, 
and hold produce RACs to comply with the CGMPs in part 117 by complying 
with the relevant requirements for packing and holding in the final 
produce safety regulation (see Sec.  117.8).
    In responding to these comments, we noted that the revised ``farm'' 
definition did not, as requested, provide for all off-farm operations 
such as certain packinghouses and hulling/shelling operations to be 
subject to the produce safety regulation rather than part 117. We 
explained that the statutory framework does not provide for entities 
such as packinghouses and hulling/shelling operations that do not have 
a sufficient connection to a farm to be subject to the requirements of 
the produce safety regulation. However, we stated that we continued to 
believe that an off-farm packinghouse that is subject to the human food 
preventive controls requirements in part 117 will be able to draw from 
the provisions of the produce safety regulation in developing its food 
safety plan and establishing preventive control management components 
that are appropriate in light of the nature of the preventive controls 
and their role in the facility's food safety system. For example, we 
stated our expectation that the food safety plan for an off-farm 
packinghouse would focus on a few key preventive controls, including 
some that would have counterparts in the produce safety regulation, 
such as maintaining and monitoring the temperature of water used during 
packing (which would have counterparts under Sec.  112.48(c) in the 
produce safety regulation). We also expected that an off-farm 
packinghouse would establish sanitation controls to address the 
cleanliness of food-contact surfaces (including food-contact surfaces 
of utensils and equipment) and the prevention of cross-contamination 
from insanitary objects and from personnel to food, food-packaging 
material, and other food-contact surfaces. On-farm packinghouses would 
be subject to similar, but not identical, requirements (see, e.g., 
Sec. Sec.  112.111(b) and 112.123(d)(1) for cleanliness of food-contact 
surfaces, and Sec. Sec.  112.113 and 112.132 for protection against 
contamination).
    We agree that certain activities conducted on produce RACs are 
similar regardless of where they happen. Therefore, facilities for 
which the packing and/or holding of produce RACs is subject to the 
human food preventive controls requirements may nonetheless still be 
able to draw from the provisions of the produce safety regulation in 
developing their food safety plans and establishing preventive control 
management components that are appropriate in light of the nature of 
the preventive controls and their role in the facility's food safety 
system. We acknowledge that we have not yet issued guidance with 
specific recommendations for how packinghouses subject to the human 
food preventive controls requirements could comply with those 
requirements.
2. Extension of Compliance Dates for Facilities Solely Engaged in 
Packing and/or Holding Produce RACs and/or Nut Hulls and Shells
    Table 2 provides a summary of the revised compliance dates.

[[Page 57789]]



  Table 2--Extension of Compliance Dates for Both Part 117 and Part 507
for Facilities Solely Engaged in Packing and/or Holding Produce RACs and/
                         or Nut Hulls and Shells
------------------------------------------------------------------------
                                      Previously
                                       announced        Compliance date
                                    compliance date     with extension
------------------------------------------------------------------------
     Human Food--Facilities solely engaged in packing and/or holding
                  activities on produce RACs (part 117)
------------------------------------------------------------------------
Very Small Businesses (a          September 17, 2018  January 27, 2020.
 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)).
Small Businesses (a business      September 18, 2017  January 28, 2019.
 (including any subsidiaries and
 affiliates) employing fewer
 than 500 full-time equivalent
 employees).
Other Businesses................  September 19, 2016  January 26, 2018.
------------------------------------------------------------------------
    Animal Food--Facilities solely engaged in packing and/or holding
 activities on produce RACs and/or nut hulls and shells that are used as
                         animal food (part 507)
------------------------------------------------------------------------
Very Small Businesses (a          September 17, 2018  January 27, 2020
 business (including any           (CGMPs).            (CGMPs)
 subsidiaries and affiliates)     September 17, 2019  January 26, 2021
 averaging less than $2,500,000,   (preventive         (preventive
 adjusted for inflation, per       controls).          controls).
 year, during the 3-year period
 preceding the applicable
 calendar year in sales of
 animal food plus the market
 value of animal food
 manufactured, processed, packed
 or held without sale (e.g.,
 held for a fee or supplied to a
 farm without sale)).
Small Businesses (a business      September 18, 2017  January 28, 2019
 (including any subsidiaries and   (CGMPs).            (CGMPs)
 affiliates) employing fewer      September 17, 2018  January 27, 2020
 than 500 full-time equivalent     (preventive         (preventive
 employees).                       controls).          controls).
Other Businesses................  September 19, 2016  January 26, 2018
                                   (CGMPs).            (CGMPs).
                                  September 18, 2017  January 28, 2019
                                   (preventive         (preventive
                                   controls).          controls).
------------------------------------------------------------------------

    We published the final rule establishing part 117 more than 2 
months before we published the final rule establishing the produce 
safety regulation and, thus, the compliance dates for the produce 
safety regulation had not yet been established. To provide facilities 
that are solely engaged in packing and/or holding activities on produce 
RACs the same time to understand the applicable provisions of the 
produce safety regulation as farms that conduct similar packing and 
holding activities, and to enable such facilities to develop a food 
safety plan that builds on the requirements of the produce safety 
regulation, where applicable, we are extending the date for facilities 
that are solely engaged in packing and/or holding activities on produce 
RACs to comply with part 117 by approximately 16 months to make the 
compliance dates the same as for businesses in the same size categories 
in the produce safety regulation. For example, the new compliance date 
for a facility that is a small business under part 117 is the 
compliance date for a small business under the produce safety 
regulation, regardless of whether the facility subject to part 117 
would be considered a small business under the produce safety 
regulation. (Note that the produce safety regulation has different 
compliance dates associated with sprouts but for the purposes of this 
extension we are not establishing different dates for sprouts.) This 
will match the other extended compliance dates that relate to the 
``farm'' definition or the produce safety regulation in this document.
    With the extension, eligible facilities that are very small 
businesses must comply with part 117 by January 27, 2020; eligible 
facilities that are small businesses must comply by January 28, 2019, 
and all other eligible facilities must comply by January 26, 2018. We 
are extending compliance dates for very small businesses because, 
although they are not required to comply with subparts C and G (e.g., 
they are not required to have food safety plans), one of their options 
for compliance includes identifying the potential hazards associated 
with the food being produced, implementing preventive controls to 
address the hazards, and monitoring the performance of the preventive 
controls to ensure that such controls are effective (21 CFR 
117.201(a)(2)(i)).
    To maintain the intended alignment between part 117 and part 507, 
we also are making a parallel extension to the dates for facilities 
that are solely engaged in packing and/or holding activities on produce 
RACs that are used as animal food to comply with part 507 requirements. 
While there may be limited facilities that pack and hold produce RACs 
exclusively for animal food, the by-products, such as culls, from 
packing and holding of produce RACs for human food are often used as 
animal food. The rulemaking to establish part 507 included a provision 
for certain human food by-products used as animal food (Sec.  507.12). 
To qualify for Sec.  507.12, the human food facility whose packing or 
holding of produce results in by-products for use as animal food must 
be in compliance with the part 117 CGMPs or in compliance with the 
applicable requirements for packing and holding in part 112. The 
extension of compliance dates allows for facilities that are providing 
by-products for use as animal food time to implement the applicable 
part 117 or part 112 requirements. The parallel 16 month compliance 
date extension for part 507 is staggered to allow time for such 
operations to first comply with the part 507 CGMP requirements, 
including the related requirement in Sec.  507.12. With the extension, 
eligible facilities that are very small businesses must comply with the 
CGMP requirements of part 507 by January 27, 2020, and with the 
preventive controls requirements of part 507 by January 26, 2021; 
eligible facilities that are small businesses must comply with the CGMP 
requirements of part 507 by January 28, 2019, and with the preventive 
controls requirements of

[[Page 57790]]

part 507 by January 27, 2020, and all other eligible facilities must 
comply with the CGMP requirements of part 507 by January 26, 2018, and 
with the preventive controls requirements of part 507 by January 28, 
2019.
    In addition, nut hulls and shells are used for animal food and 
result from some activities performed by those facilities that are 
receiving an extension to comply with part 117. Therefore, we are 
extending the compliance dates for animal food preventive controls 
requirements for facilities solely engaged in packing and/or holding 
activities conducted on nut hulls and shells. Facilities that are 
solely engaged in hulling, shelling, drying, packing, and/or holding of 
nuts and hulls are exempt from the part 507 CGMP requirements (Sec.  
507.5(h)(2)) and will continue to remain exempt. With the extension, 
eligible facilities that are very small businesses must comply with 
animal food preventive controls requirements by January 26, 2021; 
eligible facilities that are small businesses must comply by January 
27, 2020, and all other eligible facilities must comply by January 28, 
2019.
    The extended compliance dates do not apply to facilities that 
manufacture/process produce RACs or nut hulls and shells in addition to 
packing and/or holding produce RACs or nut hulls and shells, because 
such facilities must come into compliance with part 117 and part 507 
with respect to their manufacturing/processing as well as their packing 
and holding. Examples of facilities to which the extended compliance 
dates apply are packinghouses that solely pack and/or hold produce 
RACs; and facilities that solely hull, shell, pack, and/or hold nuts 
(nuts are produce RACs and hulling and shelling may be considered 
``packing'' when done for safe or effective packing). Examples of 
manufacturing/processing facilities to which the extended compliance 
dates do not apply are a ``fresh-cut'' processing facility, such as a 
facility that produces bagged salad mixes or packages of sliced fruit, 
and a facility that grinds nut shells to make an animal food 
ingredient.

B. Certain Facilities That Would Qualify as Secondary Activities Farms 
Except for the Ownership of the Facility

    Table 3 provides a summary of the revised compliance dates.

Table 3--Extension of Compliance Dates for Certain Facilities That Would
    Qualify as Secondary Activities Farms Except for Ownership of the
                                Facility
------------------------------------------------------------------------
                                      Previously
                                       announced        Compliance date
                                    compliance date     with extension
------------------------------------------------------------------------
 Human Food--Facilities that would qualify as secondary activities farms
             except for ownership of the facility (part 117)
------------------------------------------------------------------------
Very Small Businesses (a          September 17, 2018  January 27, 2020.
 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)).
Small Businesses (a business      September 18, 2017  January 28, 2019.
 (including any subsidiaries and
 affiliates) employing fewer
 than 500 full-time equivalent
 employees).
Other Businesses................  September 19, 2016  January 26, 2018.
------------------------------------------------------------------------
Animal Food--Facilities that would qualify as secondary activities farms
             except for ownership of the facility (part 507)
------------------------------------------------------------------------
Very Small Businesses (a          September 17, 2018  January 27, 2020
 business (including any           (CGMPs).            (CGMPs).
 subsidiaries and affiliates)     September 17, 2019  January 26, 2021
 averaging less than $2,500,000,   (preventive         (preventive
 adjusted for inflation, per       controls).          controls).
 year, during the 3-year period
 preceding the applicable
 calendar year in sales of
 animal food plus the market
 value of animal food
 manufactured, processed, packed
 or held without sale (e.g.,
 held for a fee or supplied to a
 farm without sale)).
Small Businesses (a business      September 18, 2017  January 28, 2019
 (including any subsidiaries and   (CGMPs).            (CGMPs).
 affiliates) employing fewer      September 17, 2018  January 27, 2020
 than 500 full-time equivalent     (preventive         (preventive
 employees).                       controls).          controls).
Other Businesses................  September 19, 2016  January 26, 2018
                                   (CGMPs).            (CGMPs).
                                  September 18, 2017  January 28, 2019
                                   (preventive         (preventive
                                   controls).          controls).
------------------------------------------------------------------------

    The rulemaking to establish part 117 created a ``secondary 
activities farm'' definition within the ``farm'' definition to cover 
certain operations that are not located on a primary production farm 
but are sufficiently related to a primary production farm so that it is 
appropriate to consider the operations to be farms (Sec.  1.227). A 
secondary activities farm is devoted to harvesting (such as hulling or 
shelling), packing, and/or holding of RACs (such as produce, grains, 
and eggs). Further, a majority interest in a secondary activities farm 
must be majority-owned (singly or jointly) by the primary production 
farm(s) that grows, harvests, and/or raises the majority of the RACs 
harvested packed, and/or held by the secondary activities farm (Sec.  
1.227).
    We have received questions via our Technical Assistance Network 
regarding whether certain operations qualify as secondary activities 
farms under part 117 and part 507. These questions describe a variety 
of business structures that may satisfy our intention to require a 
close relationship regarding ownership of the primary and secondary 
activities farms but the business structures do not meet the ownership 
requirement as codified in the ``farm'' definition. For example, some 
operations that might otherwise qualify as secondary activities farms 
own the primary production farm, rather than being owned by the primary 
production farm as currently required. Other operations that might 
otherwise qualify as a secondary activities farm are operations that 
are not owned by (and do not own) the primary production farm but are 
majority owned by the same entity as the primary production farm. For 
example, Farm A is a primary

[[Page 57791]]

production farm. Facility B is a produce packinghouse that packs only 
produce from Farm A. Farm A and Facility B are both part of Corporation 
C. Despite the close relationship, Facility B is not a secondary 
activities farm under the current definition because Farm A does not 
own a majority interest in Facility B.
    We are extending the compliance dates for certain operations that 
would be secondary activities farms except that they do not meet the 
ownership criterion in the definition. The extension is applicable only 
to an operation satisfying all of the following requirements: (1) The 
operation is not located on a primary production farm; (2) the 
operation is devoted to harvesting, packing, and/or holding of RACs 
(including operations that hull, shell, and/or dry nuts without 
additional manufacturing); and (3) the operation is under common 
ownership with the primary production farm(s) that grows, harvests, 
and/or raises the majority of the RACs harvested, packed, and/or held 
by the operation. Examples of common ownership include an operation 
that is owned by (or that owns) one or more primary production farms 
(e.g., a packinghouse owned by a cooperative of individual farms) and 
an operation under common ownership with a primary production farm, 
such as operations that are managed within the same business structure 
as the primary production farm (e.g., the farm and packinghouse are 
separate operations owned by parents and their children, respectively, 
and both operations are part of the same business jointly owned by the 
parents and children). Other limitations on secondary activities farms 
remain. For example, feed mills manufacturing animal food for contract 
farms would not qualify because, among other reasons, those feed mills 
are conducting manufacturing/processing outside the farm definition.
    We are extending the compliance dates for part 117 for operations 
satisfying all of the requirements by approximately 16 months to match 
the compliance dates for businesses in the same size categories in the 
produce safety regulation (note that the produce safety regulation has 
different compliance dates associated with sprouts but for purposes of 
this extension we are not establishing different dates for sprouts). 
This will match the other extended compliance dates that relate to the 
``farm'' definition or the produce safety regulation in this document. 
With the extension, eligible facilities that are very small businesses 
must comply with part 117 by January 27, 2020; eligible facilities that 
are small businesses must comply by January 28, 2019, and all other 
eligible facilities must comply by January 26, 2018.
    The parallel 16 month compliance date extension for part 507 is 
staggered to allow time for operations satisfying all of the 
requirements to first comply with the CGMP requirements. With the 
extension, eligible facilities that are very small businesses must 
comply with the CGMP requirements of part 507 by January 27, 2020, and 
with the preventive controls requirements of part 507 by January 26, 
2021; eligible facilities that are small businesses must comply with 
the CGMP requirements of part 507 by January 28, 2019, and with the 
preventive controls requirements of part 507 by January 27, 2020, and 
all other eligible facilities must comply by with the CGMP requirements 
of part 507 by January 26, 2018, and with the preventive controls 
requirements of part 507 by January 28, 2019.

V. Extension of Compliances Dates for Certain Facilities That Color 
RACs Under Part 117

    Table 4 provides a summary of the revised compliance dates.

     Table 4--Extension of Compliance Dates in Part 117 for Certain
                       Facilities That Color RACs
------------------------------------------------------------------------
                                      Previously
                                       announced        Compliance date
                                    compliance date     with extension
------------------------------------------------------------------------
          Human Food--Facilities that color RACs under part 117
------------------------------------------------------------------------
Very Small Businesses (a          September 17, 2018  January 27, 2020.
 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)).
Small Businesses (a business      September 18, 2017  January 28, 2019.
 (including any subsidiaries and
 affiliates) employing fewer
 than 500 full-time equivalent
 employees).
Other Businesses................  September 19, 2016  January 26, 2018.
------------------------------------------------------------------------

    The definition of RAC in section 201(r) of the FD&C Act includes 
``fruits that are . . . colored . . . in their unpeeled natural form 
prior to marketing.'' (21 U.S.C. 321(r)). As we noted in the proposed 
rule to establish part 117 (78 FR 3646 at 3678 to 3679, January 16, 
2013), FDA does not consider the activity of coloring a RAC to result 
in the transformation of the RAC into a processed food. However, this 
does not mean that coloring a RAC is not manufacturing/processing. The 
activity classification ``manufacturing/processing'' is broader than 
just activities that transform a RAC into a processed food. It includes 
most food-handling activities because it is satisfied by any degree of 
``making food from one or more ingredients, or synthesizing, preparing, 
treating, modifying or manipulating food'' (Sec.  1.227). In contrast, 
transforming a RAC into a processed food generally requires meeting a 
threshold of altering the general state of the commodity. In the 
proposed rule, coloring was provided as an example of an activity that 
is manufacturing/processing but does not transform a RAC into a 
processed food (78 FR 3646 at 3678 to 3679).
    An establishment that conducts manufacturing/processing activities 
other than those specified as being within the ``farm'' definition 
generally is a facility that is required to register and is subject to 
the human food preventive controls requirements in part 117. The 
``farm'' definition provides for farms to do several manufacturing/
processing activities, including treating RACs to manipulate ripening 
and packaging and labeling RACs. These are all manufacturing/processing 
activities that do not transform a RAC into a processed food. However, 
FDA did not include coloring, another manufacturing/processing activity 
that does not transform a RAC into a processed food, within the 
``farm'' definition. Therefore, currently coloring triggers the

[[Page 57792]]

registration requirement and application of the human food preventive 
controls requirements in part 117 (except where other exemptions 
apply). We are considering whether future rulemaking to modify the 
``farm'' definition is appropriate to address the issue.
    Therefore, we are extending the compliance dates for facilities 
that would qualify as farms if they did not color RACs. We are 
extending the compliance dates for such operations by approximately 16 
months to match the compliance dates for businesses in the same size 
categories in the produce safety regulation. (Note that the produce 
safety regulation has different compliance dates associated with 
sprouts but for purposes of this extension, we are not establishing 
different dates for sprouts.) This will match the other extended 
compliance dates that relate to the ``farm'' definition or the produce 
safety regulation in this document. With the extension, eligible 
facilities that are very small businesses must comply with part 117 by 
January 27, 2020; eligible facilities that are small businesses must 
comply by January 28, 2019, and all other eligible facilities must 
comply by January 26, 2018. We are not extending the compliance dates 
for facilities that engage in additional manufacturing/processing 
activities currently outside of the ``farm'' definition because we 
expect such facilities to come into compliance with part 117 as a 
result of those other activities.

VI. Extension of Compliances Dates for Facilities Solely Engaged in the 
Ginning of Cotton Under Part 507

    Table 5--provides a summary of the revised compliance dates.

 Table 5--Extension of Compliance Dates for Facilities Solely Engaged in
                  the Ginning of Cotton Under Part 507
------------------------------------------------------------------------
                                      Previously
                                       announced        Compliance date
                                    compliance date    for part 507 with
                                     for part 507          extension
------------------------------------------------------------------------
  Animal Food--Facilities solely engaged in the ginning of cotton under
                                part 507
------------------------------------------------------------------------
Very Small Businesses (a          September 17, 2019  January 26, 2021.
 business (including any
 subsidiaries and affiliates)
 averaging less than $2,500,000,
 adjusted for inflation, per
 year, during the 3-year period
 preceding the applicable
 calendar year in sales of
 animal food plus the market
 value of animal food
 manufactured, processed, packed
 or held without sale (e.g.,
 held for a fee or supplied to a
 farm without sale)).
Small Businesses (a business      September 17, 2018  January 27, 2020.
 (including any subsidiaries and
 affiliates) employing fewer
 than 500 full-time equivalent
 employees).
Other Businesses................  September 18, 2017  January 28, 2019.
------------------------------------------------------------------------

    Cotton ginning is considered part of harvesting and thus within the 
``farm'' definition when done on a farm (and when done for safe or 
effective packing, it may also be considered a packing activity on a 
farm). When done off-farm, cotton ginning is either a packing activity 
(if done for safe or effective packing), or a manufacturing/processing 
activity, depending on the circumstances. Ginning cotton does not 
transform a RAC into a processed food but results in component RACs, 
some of which (e.g., cotton seed, lint, gin trash) are used for animal 
food. Therefore, currently off-farm cotton ginning in the production of 
animal food generally triggers the food facility registration 
requirement and application of the animal food preventive controls 
requirements in part 507 (facilities solely engaged in the ginning of 
cotton remain exempt from the CGMP requirements in part 507). Since 
publication of the final rule establishing part 507, we have received 
communications from the cotton industry expressing concern that the 
part 507 rule does not apply to the vast majority of cotton ginners 
that are part of a farm, while it does apply to the minority of cotton 
ginners that do not meet the ``farm'' definition, despite the fact that 
both types of operations perform the same activities (Ref. 3). We are 
considering whether and how FDA should address these concerns.
    Therefore, we are extending the compliance dates for animal food 
preventive controls requirements for facilities subject to part 507 
that solely engage in the ginning of cotton. We are extending the 
compliance dates for such operations by approximately 16 months to 
match the other extension dates that relate to the ``farm'' definition. 
With the extension, eligible facilities that are very small businesses 
must comply with the animal food preventive controls requirements of 
part 507 by January 26, 2021; eligible facilities that are small 
businesses must comply with the animal food preventive controls 
requirements of part 507 by January 27, 2020, and all other eligible 
facilities must comply with the animal food preventive controls 
requirements of part 507 by January 28, 2019. We are not extending the 
compliance dates for facilities that engage in additional animal food 
manufacturing/processing activities of cotton currently outside of the 
``farm'' definition (e.g., crushing cotton seed to make cotton seed 
oil) because we expect such facilities to come into compliance with the 
animal food preventive controls requirements of part 507 as a result of 
those other activities.
    In addition, some cotton ginners may be operations that would be 
secondary activities farms except that they do not meet the ownership 
criterion in the current ``farm'' definition. For further discussion of 
the compliance date extension for these types of operations see section 
IV.B. Certain Facilities That Would Qualify as Secondary Activities 
Farms Except for the Ownership of the Facility.

VII. Extension of Compliance Dates for Importation of Food Contact 
Substances Under the FSVP Regulation

    Table 6 provides a summary of the revised compliance dates.

[[Page 57793]]



 Table 6--Extension of Compliance Dates for Importation of Food Contact
                  Substances Under the FSVP Regulation
------------------------------------------------------------------------
                                      Previously           Earliest
                                  announced earliest    compliance date
                                    compliance date     with extension
------------------------------------------------------------------------
Importation of Food Contact       May 30, 2017......  May 28, 2019.
 Substances under the FSVP
 Regulation.
------------------------------------------------------------------------

    In the preamble of the final rule establishing the FSVP regulation, 
we stated that the definition of ``food'' for purposes of FSVP (Sec.  
1.500) includes food contact substances that are considered ``food'' in 
section 201(f) of the FD&C Act. A food contact substance is any 
substance that is intended for use as a component of materials used in 
manufacturing, packing, packaging, transporting, or holding food if 
such use of the substance is not intended to have any technical effect 
in such food (21 CFR 170.3(e)(3)). The term ``food'' is defined in 
section 201(f)(3) of the FD&C Act to include articles used as 
components of food. Therefore, we concluded that importers must have an 
FSVP for a food contact substance that they import that meets the 
definition of ``food'' in section 201(f) of the FD&C Act (80 FR 74226 
at 74233).
    Since we published the final rule establishing the FSVP regulation, 
our Technical Assistance Network has received inquiries regarding the 
applicability of the FSVP regulation to food contact substances. In 
addition, on June 16, 2016, FDA met with representatives of the food 
packaging manufacturing industry at their request to listen to concerns 
regarding the applicability of the FSVP regulation to the importation 
of food contact substances (Ref. 4). The industry representatives 
stated that the supply chain associated with imported substances used 
to manufacture food contact substances is highly complex and very 
different from other foods subject to the FSVP regulation. The industry 
representatives also asserted that the hazards associated with food 
contact substances are already adequately addressed through the food 
additive petition and food contact substance notification processes 
under section 409 of the FD&C Act (21 U.S.C. 348).
    After considering the information presented by the industry 
representatives, FDA believes that compliance with the requirement to 
conduct verification activities under the FSVP regulation for food 
contact substances by May 30, 2017, might not be feasible. Accordingly, 
we are extending the compliance date for the importation of food 
contact substances by 2 years so that we can consider how best to 
address the feasibility concerns. We note the relatively rare 
occurrence of significant safety concerns associated with the 
manufacture of food contact substances and FDA's extensive premarket 
approval and review processes for these substances under section 409 of 
the FD&C Act provide some assurances regarding safety during this time. 
As a result of this extension, the earliest that an importer would be 
required to comply with FSVP for the importation of food contact 
substances would be May 28, 2019.

VIII. Extension of Compliance Date for the CGMP Requirements of Part 
117 for Facilities Producing Grade ``A'' Milk and Milk Products Covered 
by NCIMS Under the PMO

    In the preamble of the final rule establishing part 117, we 
established a compliance date of September 17, 2018, for ``PMO 
facilities'' (see Response 214, 80 FR 55908 at 55987 to 55988). As we 
discussed in Response 214, we agreed that we should make use of the 
existing system of State regulatory oversight for Grade ``A'' milk and 
milk products provided through the NCIMS and the food safety 
requirements of the PMO. We described our reasons for deciding to 
extend the compliance date for ``PMO-regulated facilities'' to comply 
with the human food preventive controls requirements to September 17, 
2018. Those reasons related to the current provisions of the PMO, the 
work already begun by NCIMS to modify the PMO to include all of the 
human food preventive controls requirements established in part 117, 
and complex implementation issues concerning the interstate movement of 
milk and milk products and imported milk.
    In the Federal Register of November 18, 2015 (80 FR 71934), we 
clarified that the extended compliance date of September 17, 2018, for 
``PMO facilities'' applies only to Grade ``A'' milk and milk products 
covered by NCIMS under the PMO, and not to the manufacturing, 
processing, packing, or holding of other food produced in such 
facilities. In the November 18, 2015, clarification, we did not discuss 
the date for ``PMO facilities'' to be in compliance with the CGMP 
requirements of part 117. During our outreach activities for 
implementation of part 117 we have received questions about when ``PMO 
facilities'' must comply with the modernized CGMP requirements of part 
117 (primarily located in subpart B).
    We have not established compliance dates for the modernized CGMPs 
that are different from the general compliance dates for the preventive 
controls requirements in part 117 with one exception related to ``PMO 
facilities'' (see table 53 in the preamble of the final rule 
establishing part 117, 80 FR 55908 at 56128). Specifically, we provided 
that the extension of the compliance date for ``PMO facilities'' until 
September 17, 2018, applied only to ``subparts C and G'' (the principal 
provisions of the human preventive controls requirements) (see Response 
214, 80 FR 55908 at 55987 to 55988). In this document, we are extending 
the date for compliance with the modernized CGMPs by ``PMO facilities'' 
until September 17, 2018. We will continue to work with the NCIMS to 
modify the PMO to reflect the modernized CGMPs and the preventive 
control requirements. The extension will create a single compliance 
date for the Grade ``A'' milk and milk products covered by the PMO. 
Note that this extension applies only to Grade ``A'' milk and milk 
products covered by NCIMS under the PMO, and not to the manufacturing, 
processing, packing, or holding of other food produced in such 
facilities.

IX. Clarification of Compliance Dates for Certain Agricultural Water 
Testing Provisions in Produce Safety Regulation

    In this final rule, we are also clarifying our intent regarding the 
meaning of the compliance dates with respect to certain testing 
requirements related to agricultural water in the produce safety 
regulation.
    Specifically, in the preamble of the final rule establishing the 
produce safety regulation (at 80 FR 74354 at 74453 to 74454) we 
explained that we excluded Sec.  112.46(b)(1), with respect to 
untreated surface water only, from the 2-year extended compliance 
period provided for the remainder of Sec.  112.46 because, in order to 
comply with the microbial quality criteria in Sec.  112.44(b), farms 
must have developed a microbial water quality profile (MWQP) based on

[[Page 57794]]

the initial survey conducted over a minimum of 2 years and not greater 
than 4 years. We stated that to develop the MWQP prior to the point at 
which they must comply with all of the requirements of subpart E, 
covered farms must begin water sampling and subsequent testing not 
later than 4 years after issuance of the rule for very small farms; not 
later than 3 years after issuance of the rule for small farms; and not 
later than 2 years after issuance of the rule for all other farms. As 
an example we stated that initiating water sampling upon publication of 
the rule would allow covered farms that are not small or very small to 
collect 5 samples per year over the next 4 years, sufficient to make up 
the minimum 20 samples necessary to develop the MWQP required under 
Sec.  112.46(b) at the point at which they must comply with all of the 
requirements of subpart E. We also stated that if these covered farms 
initiated water sampling 2 years after issuance of the rule, the farms 
would need to collect 10 samples per year over the next 2 years to make 
up the minimum 20 samples necessary to develop the MWQP.
    We want to clarify and correct these earlier statements. We note 
that Sec.  112.46(b)(1)(i)(A) allows covered farms discretion as to 
both (1) the number of samples they include in their initial survey, 
provided that the total must be 20 or more samples; and (2) the time 
period over which such samples are taken, provided that the period must 
be at least 2 years and no more than 4 years. For each business size 
category, the compliance date for Sec.  112.46(b)(1) with respect to 
untreated surface water testing is 2 years before the compliance date 
for the Sec.  112.44(b) microbial quality criteria for such water. This 
does not mean that covered farms have only 2 years in which to conduct 
their initial surveys for untreated surface water under Sec.  
112.46(b)(1) if they begin testing on the compliance date for that 
provision. Covered farms have 2 to 4 years in which to fulfill that 
requirement, per Sec.  112.46(b)(1)(i)(A). This means that, for 
example, a farm that is not small or very small must begin sampling and 
testing untreated surface water in accordance with Sec.  
112.46(b)(1)(i)(A), as applicable, no later than January 26, 2018. The 
relevant compliance date for the related microbial quality criteria is 
2 years later, on January 27, 2020. However, the farm has discretion 
under Sec.  112.46(b)(1)(i)(A) as to both (1) the number of samples 
they include in their initial survey, provided that the total must be 
20 or more samples; and (2) the time period over which such samples are 
taken, provided that the period must be at least 2 years and no more 
than 4 years. Therefore, to provide a few examples, all of the 
following possible approaches are acceptable for farms that are not 
small or very small:
     Beginning in 2018, conducting an initial survey consisting 
of taking 10 samples per year over 2 years (10 in 2018 and 10 in 2019) 
for a total of 20 samples; calculating the MWQP for the first time upon 
completing the 20-sample data set (e.g., at the end of 2019, early 
2020); and applying any necessary corrective actions under Sec.  
112.45(b) as soon as practicable and no later than the following year 
(e.g., in 2020-2021).
     Beginning in 2018, conducting an initial survey consisting 
of taking 5 samples per year over 4 years (5 in 2018, 5 in 2019, 5 in 
2020, and 5 in 2021) for a total of 20 samples; calculating the MWQP 
for the first time upon completing the 20-sample data set (e.g., at the 
end of 2021, early 2022); and applying any necessary corrective actions 
under Sec.  112.45(b) as soon as practicable and no later than the 
following year (e.g., in 2022-2023).
     Beginning in 2018, conducting an initial survey consisting 
of taking 10 samples per year over 4 years (10 in 2018, 10 in 2019, 10 
in 2020, and 10 in 2021) for a total of 40 samples; calculating the 
MWQP for the first time upon completing the 40-sample data set (e.g., 
at the end of 2021, early 2022); and applying any necessary corrective 
actions under Sec.  112.45(b) as soon as practicable and no later than 
the following year (e.g., in 2022-2023).
    For small and very small farms, the same approaches are acceptable, 
and the relevant dates are 1 and 2 years later, respectively.

X. Economic Analysis of Impacts

    In the final regulatory impact analysis (FRIA) for part 117, we 
concluded that extension of the compliance dates would be unlikely to 
significantly affect the cost estimates made (Ref. 5). In the FRIA for 
the produce safety regulation, we noted that extended compliance dates 
would result in a decrease in costs as smaller operations would have 
additional time to fully and correctly implement the rule's 
requirements (Ref. 6). We did not quantify the potential impact of 
extended compliance periods on the costs of part 507 or the FSVP 
regulation but expect the impacts would be similar to those of part 117 
or the produce safety regulation.
    We are extending the compliance dates by 2 years for the written 
assurances in the customer provisions in part 117 and part 507, the 
produce safety regulation, and the FSVP regulation. Although none of 
the FRIAs provided a separate cost analysis for the written assurance 
provisions, based on our general conclusions about the costs of 
extending compliance dates and because the affected businesses will not 
be incurring the costs associated with the written assurances during 
the compliance delay period, we believe that a 2-year delay in the 
compliance dates for the written assurances in the customer provisions 
for these rules is unlikely to significantly affect the costs of the 
rules.
    We are extending the compliance dates in part 117 and part 507 for 
facilities that are solely engaged in packing and/or holding activities 
on produce RACs and/or nut hulls and shells. The new compliance dates 
for part 117 are the same as the compliance dates under the produce 
safety regulation for the same size categories: January 27, 2020 (very 
small businesses), January 28, 2019 (small businesses), and January 26, 
2018 (other businesses). The new compliance dates for part 507 are 
staggered to allow for compliance with CGMP requirements first followed 
by the animal food preventive controls requirements 1 year later. The 
part 507 CGMP compliance dates for these facilities are the same as the 
compliance dates under the produce safety regulation for the same size 
categories: January 27, 2020 (very small businesses), January 28, 2019 
(small businesses), and January 26, 2018 (other businesses). The part 
507 animal food preventive controls requirements for the same size 
categories are: January 26, 2021 (very small businesses), January 27, 
2020 (small businesses), and January 28, 2019 (other businesses). 
Although the FRIAs for part 117 and part 507 did not provide a separate 
compliance cost analysis for facilities solely engaged in packing and/
or holding activities on produce RACs and/or nut hulls and shells, 
based on our general conclusions about the costs of extending 
compliance dates and because the affected businesses will not be 
incurring the costs associated with compliance during the delay period, 
we believe that the delay in the compliance dates for these facilities 
is unlikely to significantly affect the costs of the rules.
    We are similarly extending the compliance dates in part 117 and 
part 507 for certain facilities that would qualify as secondary 
activities farms except for the ownership of the facility. Although the 
FRIAs for part 117 and part 507 did not provide a separate compliance 
cost analysis for these facilities, based on our general conclusions 
about the costs of extending

[[Page 57795]]

compliance dates and because the affected businesses will not be 
incurring the costs associated with compliance during the delay period, 
we believe that the delay in the compliance dates for these facilities 
is unlikely to significantly affect the costs of the rules.
    We are similarly extending the compliance dates in part 117 for 
certain facilities that color RACs. Although the FRIA for part 117 did 
not provide a separate compliance cost analysis for these facilities, 
based on our general conclusions about the costs of extending 
compliance dates and because the affected businesses will not be 
incurring the costs associated with compliance during the delay period, 
we believe that the delay in the compliance dates for these facilities 
is unlikely to significantly affect the costs of the rule.
    We are similarly extending the compliance dates in part 507 for 
facilities that are solely engaged in the ginning of cotton. Although 
the FRIA for part 507 did not provide a separate compliance cost 
analysis for these facilities, based on our general conclusions about 
the costs of extending compliance dates and because the affected 
businesses will not be incurring the costs associated with compliance 
during the delay period, we believe that the delay in the compliance 
dates for these facilities is unlikely to significantly affect the cost 
of the rule.
    We are extending the compliance date for the importation of food 
contact substances by 2 years, such that the earliest that an importer 
would be required to comply with the FSVP regulation for the 
importation of food contact substances would be May 28, 2019. Although 
the FRIA for the FSVP regulation did not provide a separate compliance 
cost analysis for importers of food contact substances, based on our 
general conclusions about the costs of extending compliance dates and 
because the affected businesses will not be incurring the costs 
associated with compliance during the delay period, we believe that the 
delay in the compliance dates for these facilities is unlikely to 
significantly affect the cost of the rule.
    We are extending the compliance date for the CGMP Requirements of 
part 117 for facilities producing Grade ``A'' milk and milk products 
covered by NCIMS under the PMO. Although the FRIA for part 117 did not 
provide a separate compliance cost analysis for these facilities to 
comply with subpart B of part 117, based on our general conclusions 
about the costs of extending compliance dates and because the affected 
businesses will not be incurring the costs associated with compliance 
during the delay period, we believe that the delay in the compliance 
dates for these facilities is unlikely to significantly affect the 
costs of the rule.
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
Executive Order 13563 states the importance of quantifying costs and 
benefits, reducing costs and burdens, and harmonizing rules. We believe 
this final rule will not increase compliance costs and will serve an 
important purpose of providing us an opportunity to consider how to 
reduce burdens on the public and maintain or improve coordination among 
the four rules affected. We believe that this final rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this final rule only extends various compliance dates 
for certain provisions and/or certain entities with respect to the four 
rules discussed here, we have determined that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $146 million, using the most current (2015) Implicit 
Price Deflator for the Gross Domestic Product. This final rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

XI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

XII. 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.

XIII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

XIV. Executive Order 13175

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive order and, consequently, a 
tribal summary impact statement is not required.

XV. 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.
2. Letter dated April 19, 2016, from United Fresh Produce 
Association and 21 other organizations to Michael Taylor and Stephen 
Ostroff of FDA.
3. Letter dated May 20, 2016, from Roger A. Isom of the California 
Cotton Ginners Association to Jeanette Murphy of FDA.

[[Page 57796]]

4. Letter dated May 3, 2016, from Society of Plastics Industry, 
Inc., and other organizations to Michael Taylor and Stephen Ostroff 
of FDA.
5. FDA, ``Part 117. FSMA Final Rulemaking for Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: Final Regulatory Impact Analysis, Final 
Regulatory Flexibility Analysis, Final Unfunded Mandates Reform Act 
Analysis, and Final Paperwork Reduction Act Analysis,'' 2015. 
(http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472884.pdf).
6. FDA, ``Final Regulatory Impact Analysis, Final Regulatory 
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for 
the Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption,'' 2015. (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472330.pdf).

    Dated: August 18, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20176 Filed 8-23-16; 8:45 am]
 BILLING CODE 4164-01-P


