Compliance With and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations; Draft Guidance for Industry; Availability, 7751-7753 [2017-01128]
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules
this chapter, the exchange determines
that a person has violated exchange
rules relating to decorum or attire, or
timely submission of accurate records
required for clearing or verifying each
day’s transactions or other similar
activities; or
(4) The person against whom the
action is taken has consented to the
penalty to be imposed and to the timing
of its effectiveness.
(b) Notice of early effective date. If the
exchange determines in accordance
with paragraph (a)(1) of this section that
a disciplinary action will become
effective prior to the expiration of
fifteen days after written notice thereof,
it must notify the person disciplined in
writing, either personally or by email to
the person’s last known email address,
stating the reasons for the
determination. The exchange must also
immediately notify the Commission by
email to secretary@cftc.gov. Where
notice is delivered by email, the time
within which the person so notified
may file a petition for stay pursuant to
§ 9.24(a)(2) will be increased by one
day.
■ 12. Revise § 9.13 to read as follows:
§ 9.13
Publication of notice.
Whenever an exchange suspends,
expels or otherwise disciplines, or
denies any person access to the
exchange, it must make public its
findings by disclosing at least the
information contained in the notice
required by § 9.11(b). An exchange must
make such findings public as soon as
the disciplinary action or access denial
action becomes effective in accordance
with the provisions of § 9.12 by posting
a notice on its Web site to which its
members and the public regularly have
access. Such notice must be maintained
and readily available on the exchange’s
Web site.
■ 13. In § 9.24, revise paragraph (a)(2) to
read as follows:
mstockstill on DSK3G9T082PROD with PROPOSALS
§ 9.24
Petition for stay pending review.
(a) * * *
(2) Within ten days after a notice of
summary action has been delivered in
accordance with § 9.12(b) to a person
who is the subject of a summary action
permitted by part 37, appendix B, Core
Principle 2, paragraph (a)(14) or part 38,
appendix B, Core Principle 13,
paragraph (a)(7) (emergency disciplinary
actions) of this chapter, that person may
petition the Commission to stay the
effectiveness of the summary action
pending completion of the exchange
proceeding.
*
*
*
*
*
■ 14. Revise § 9.31 to read as follows:
VerDate Sep<11>2014
18:58 Jan 19, 2017
Jkt 241001
§ 9.31 Commission review of disciplinary
or access denial action on its own motion.
7751
Appendix to Amendments to Parts 3
and 9 of the Commodity Futures
(a) Request for additional information. Trading Commission’s Rules—
Commission Voting Summary
Where a person disciplined or denied
On this matter, Chairman Massad and
access has not appealed the exchange
Commissioners Bowen and Giancarlo
decision to the Commission, upon
voted in the affirmative. No
review of the notice specified in § 9.11,
Commissioner voted in the negative.
the Division of Market Oversight or the
[FR Doc. 2017–01232 Filed 1–19–17; 8:45 am]
Division of Swap Dealer and
Intermediary Oversight may request that BILLING CODE 6351–01–P
the exchange file with the Division the
record of the exchange proceeding, or
designated portions of the record, a brief DEPARTMENT OF HEALTH AND
statement of the evidence and testimony HUMAN SERVICES
adduced to support the exchange’s
Food and Drug Administration
findings that a rule or rules of the
exchange were violated and such
21 CFR Parts 11, 16, and 112
recordings, transcripts and other
[Docket No. FDA–2017–D–0175]
documents applicable to the particular
exchange proceeding as the Division
Compliance With and
may specify. The exchange must
Recommendations for Implementation
promptly advise the person who is the
of the Standards for the Growing,
subject of the disciplinary or access
Harvesting, Packing, and Holding of
denial action of the Division’s request.
Produce for Human Consumption for
Within thirty days after service of the
Sprout Operations; Draft Guidance for
Division’s request, the exchange must
Industry; Availability
file the information requested with the
Division in the manner requested by the AGENCY: Food and Drug Administration,
Division and, upon request, deliver that HHS.
ACTION: Notification of availability.
information to the person who is the
subject of the disciplinary or access
SUMMARY: The Food and Drug
denial action. Delivery to the person
Administration (FDA or we) is
who is the subject of the disciplinary or
announcing the availability of a draft
access denial action must be in the
guidance for industry entitled
manner prescribed by § 9.11(c). A
‘‘Compliance with and
person subject to the disciplinary action Recommendations for Implementation
or access denial action requesting a
of the Standards for the Growing,
copy of the information furnished to the Harvesting, Packing, and Holding of
Division must, if the exchange rules so
Produce for Human Consumption for
provide, agree to pay the exchange
Sprout Operations.’’ The draft guidance,
reasonable fees for printing the copy.
when finalized, will help sprout
operations subject to FDA’s final rule
(b) Review on motion of the
entitled ‘‘Standards for the Growing,
Commission. The Commission may
Harvesting, Packing, and Holding of
institute review of an exchange
Produce for Human Consumption’’ (the
disciplinary or access denial action on
Produce Safety Rule), and primarily
its own motion. Other than in
focuses on assisting such operations in
extraordinary circumstances, such
review will be initiated within 180 days complying with the sprout-specific
after the NFA has received the notice of requirements in Subpart M (Sprouts) of
the Produce Safety Rule. The draft
exchange action provided for in § 9.11.
guidance also includes limited
If the Commission should institute
discussion on certain other applicable
review on its own motion, it will issue
requirements of the Produce Safety
an order permitting the person who is
Rule. This draft guidance may also be
the subject of the disciplinary or access
useful to sprout operations that are not
denial action an opportunity to file an
subject to the Produce Safety Rule that
appropriate submission, and the
voluntarily choose to follow the
exchange an opportunity to file a reply
standards established by the rule.
thereto.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
Issued in Washington, DC, on January 13,
10.115(g)(5)), to ensure that the Agency
2017, by the Commission.
considers your comment on this draft
Christopher J. Kirkpatrick,
guidance before it begins work on the
Secretary of the Commission.
final version of the guidance, submit
Note: The following appendix will not
either electronic or written comments
appear in the Code of Federal Regulations.
on the draft guidance by July 24, 2017.
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7752
ADDRESSES:
Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules
You may submit comments
as follows:
mstockstill on DSK3G9T082PROD with PROPOSALS
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): 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–
2017–D–0175 for ‘‘Compliance with and
Recommendations for Implementation
of the Standards for the Growing,
Harvesting, Packing, and Holding of
Produce for Human Consumption for
Sprout Operations.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the 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
VerDate Sep<11>2014
18:58 Jan 19, 2017
Jkt 241001
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.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the 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: https://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 https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Produce Safety, Center for
Food Safety and Applied Nutrition
(HFS–317), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1600.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Samir Assar, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740–3835, 240–
402–1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
‘‘Compliance with and
Recommendations for Implementation
of the Standards for the Growing,
Harvesting, Packing, and Holding of
Produce for Human Consumption for
Sprout Operations.’’ We are issuing the
draft guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent our current
thinking 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 alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
The draft guidance for industry is
intended to explain our current thinking
on how to comply with the
requirements for the safe growing,
harvesting, packing and holding of
produce under 21 CFR part 112,
focusing on subparts impacting sprout
operations covered by Subpart M.
Topics discussed in the draft guidance
include:
• General Sprout Production;
• Buildings, Tools, and Equipment;
• Cleaning and Sanitizing;
• Agricultural Water in Sprouting
Operations;
• Seeds for Sprouting;
• Sampling and Testing of Spent
Sprout Irrigation Water or Sprouts;
• Environmental Monitoring; and
• Recordkeeping.
FDA welcomes comments on any
aspect of this draft guidance. We are
particularly interested in receiving
information about the types of seed or
bean treatments that have been used by
sprout operations and/or seed suppliers,
as well as their feasibility of use, cost,
impact on germination; scientific
information related to the effectiveness
in reducing or eliminating
microorganisms of public health
significance; and any variability in
treatment effectiveness based on seed
type.
FDA has developed a risk assessment
model to evaluate the public health
impact of seed treatment and testing of
spent irrigation water in a sprout
production system and anticipates
making it available in the near future,
following peer review.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
E:\FR\FM\23JAP1.SGM
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to publish notice in the
Federal Register soliciting public
comment on each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, we will
publish a 60-day notice on the proposed
collection of information in a future
issue of the Federal Register.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
reference to temporary regulation at 81
FR 89022, December 9, 2016, are still
being accepted and must be received by
March 9, 2017.
Send submissions to
CC:PA:LPD:PR (REG–133353–16), Room
5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand delivered Monday through
Friday between the hours of 8 a.m. and
4 p.m. to CC:PA:LPD:PR (REG–133353–
16), Courier’s desk, Internal Revenue
Service, 1111 Constitution Avenue NW.,
Washington, DC 20224, or sent
electronically, via the Federal
eRulemaking Portal at
www.regulations.gov (IRS REG–133353–
16).
ADDRESSES:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
Background
Need for Correction
DEPARTMENT OF THE TREASURY
[REG–133353–16]
As published, the notice of proposed
rulemaking by cross-reference to
temporary regulation (REG–133353–16)
contains errors that are misleading and
are in need of clarification.
RIN 1545–BN63
Correction to Publication
Disclosures of Return Information
Reflected on Returns to Officers and
Employees of the Department of
Commerce for Certain Statistical
Purposes and Related Activities;
Correction
Accordingly, the notice of proposed
rulemaking by cross-reference to
temporary regulation, that is the subject
of FR Doc. 2016–29490, is corrected as
follows:
1. On page 89022, in the preamble,
second column, second line from the
top of column, the language
‘‘CC:PA:LPD:PR (REG–133533–16),
Room’’ is corrected to read
‘‘CC:PA:LPD:PR (REG–133353–16),
Room’’.
2. On page 89022, in the preamble,
second column, eighth line from the top
of column, the language ‘‘4 p.m. to
CC:PA:LPD:PR (REG–133533–’’ is
corrected to read ‘‘4 p.m. to
CC:PA:LPD:PR (REG–133353–’’.
3. On page 89022, in the preamble,
second column, sixth line from the
bottom of ADDRESSES caption, the
language ‘‘Service, 1111 Constitutional
Avenue’’ is corrected to read ‘‘Service,
1111 Constitution Avenue’’.
Internal Revenue Service
26 CFR Part 1
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulation; correction.
AGENCY:
This document contains
corrections to a notice of proposed
rulemaking by cross-reference to
temporary regulation (REG–133353–16)
that was published in the Federal
Register on Friday, December 9, 2016.
The proposed regulations authorize the
disclosure of specified return
information to the Census Bureau
(Bureau) for purposes of structuring the
censuses and national economic
accounts and conducting related
statistical activities authorized by title
13.
mstockstill on DSK3G9T082PROD with PROPOSALS
SUMMARY:
Written or electronic comments
and request for public hearing for the
notice of proposed rulemaking by cross-
DATES:
VerDate Sep<11>2014
18:58 Jan 19, 2017
Jkt 241001
§ 301.6103(j)(1)–1
[Corrected]
4. On page 89023, first column, third
line of paragraph (e), the language
‘‘(b)(3)(v), (b)(3)(xxv), (b)(3)(xxv)
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through’’ is corrected to read ‘‘(b)(3)(v),
(b)(3)(xxv) through’’.
Martin V. Franks,
Branch Chief, Publications and Regulations
Branch, Legal Processing Division, Associate
Chief Counsel (Procedure and
Administrative).
[FR Doc. 2017–00946 Filed 1–19–17; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Parts 24 and 27
[Docket No. TTB–2016–0014; Notice No.
168; Re: T.D. TTB–147]
RIN 1513–AC31
The notice of proposed rulemaking by
cross-reference to temporary regulation
that is the subject of this document is
under section 6103(j)(1)(A) of the
Internal Revenue Code.
[FR Doc. 2017–01128 Filed 1–19–17; 8:45 am]
7753
Implementation of Statutory
Amendments Requiring the
Modification of the Definition of Hard
Cider
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Notice of proposed rulemaking;
cross-reference to temporary rule.
AGENCY:
Elsewhere in this issue of the
Federal Register, by means of a
temporary rule, the Alcohol and
Tobacco Tax and Trade Bureau (TTB)
implements changes made to the
definition of ‘‘hard cider’’ in the Internal
Revenue Code of 1986 by the Protecting
Americans from Tax Hikes Act of 2015.
The modified definition broadens the
range of wines eligible for the hard cider
tax rate. TTB is amending its regulations
to reflect the modified definition of hard
cider effective for products removed on
or after January 1, 2017, and to set forth
new labeling requirements to identify
products to which the hard cider tax
rate applies. The new labeling
requirements include both a one-year
transitional rule and a new labeling
requirement that takes effect for
products removed on or after January 1,
2018. The text of the regulations in that
temporary rule published elsewhere in
this issue of the Federal Register serves
as the text of the proposed regulations.
DATES: Comments must be received on
or before March 24, 2017.
ADDRESSES: Please send your comments
on this document to one of the
following addresses:
• Internet: https://
www.regulations.gov (via the online
comment form for this document as
posted within Docket No. TTB–2016–
0014 at ‘‘Regulations.gov,’’ the Federal
e-rulemaking portal);
SUMMARY:
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Agencies
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7751-7753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01128]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11, 16, and 112
[Docket No. FDA-2017-D-0175]
Compliance With and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption for Sprout Operations; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Compliance
with and Recommendations for Implementation of the Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption for Sprout Operations.'' The draft guidance, when
finalized, will help sprout operations subject to FDA's final rule
entitled ``Standards for the Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption'' (the Produce Safety Rule), and
primarily focuses on assisting such operations in complying with the
sprout-specific requirements in Subpart M (Sprouts) of the Produce
Safety Rule. The draft guidance also includes limited discussion on
certain other applicable requirements of the Produce Safety Rule. This
draft guidance may also be useful to sprout operations that are not
subject to the Produce Safety Rule that voluntarily choose to follow
the standards established by the rule.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 24, 2017.
[[Page 7752]]
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): 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-2017-D-0175 for ``Compliance with and Recommendations for
Implementation of the Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption for Sprout Operations.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the 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.'' We will review this copy,
including the claimed confidential information, in our consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
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: https://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 https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Division of Produce Safety, Center for Food Safety and Applied
Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1600. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740-3835, 240-402-1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Compliance with and Recommendations for Implementation of
the Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout Operations.'' We are issuing
the draft guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent our current thinking 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 alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
The draft guidance for industry is intended to explain our current
thinking on how to comply with the requirements for the safe growing,
harvesting, packing and holding of produce under 21 CFR part 112,
focusing on subparts impacting sprout operations covered by Subpart M.
Topics discussed in the draft guidance include:
General Sprout Production;
Buildings, Tools, and Equipment;
Cleaning and Sanitizing;
Agricultural Water in Sprouting Operations;
Seeds for Sprouting;
Sampling and Testing of Spent Sprout Irrigation Water or
Sprouts;
Environmental Monitoring; and
Recordkeeping.
FDA welcomes comments on any aspect of this draft guidance. We are
particularly interested in receiving information about the types of
seed or bean treatments that have been used by sprout operations and/or
seed suppliers, as well as their feasibility of use, cost, impact on
germination; scientific information related to the effectiveness in
reducing or eliminating microorganisms of public health significance;
and any variability in treatment effectiveness based on seed type.
FDA has developed a risk assessment model to evaluate the public
health impact of seed treatment and testing of spent irrigation water
in a sprout production system and anticipates making it available in
the near future, following peer review.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the
[[Page 7753]]
public submit reports, keep records, or provide information to a third
party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to publish notice in the Federal Register
soliciting public comment on each proposed collection of information
before submitting the collection to OMB for approval. To comply with
this requirement, we will publish a 60-day notice on the proposed
collection of information in a future issue of the Federal Register.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01128 Filed 1-19-17; 8:45 am]
BILLING CODE 4164-01-P