82 FR 7751 - 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the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 13 (January 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 13 (January 23, 2017)
| Page Range | 7751-7753 | |
| FR Document | 2017-01128 |
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)] [Proposed Rules] [Pages 7751-7753] From the Federal Register Online [www.thefederalregister.org] [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the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce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 The draft guidance, when finalized, will help sprout operations subject to FDA's final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for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 The draft guidance also includes limited discussion on certain other applicable requirements of the Produce Safety Rule. This draft guidance may also be useful to sprout operations that are not subject to the Produce Safety Rule that voluntarily choose to follow the standards established by the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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 24, 2017.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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-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 http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts 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 http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: 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
![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules 7751
this chapter, the exchange determines § 9.31 Commission review of disciplinary Appendix to Amendments to Parts 3
that a person has violated exchange or access denial action on its own motion. and 9 of the Commodity Futures
rules relating to decorum or attire, or (a) Request for additional information. Trading Commission’s Rules—
timely submission of accurate records Where a person disciplined or denied Commission Voting Summary
required for clearing or verifying each access has not appealed the exchange On this matter, Chairman Massad and
day’s transactions or other similar Commissioners Bowen and Giancarlo
decision to the Commission, upon
activities; or voted in the affirmative. No
review of the notice specified in § 9.11,
(4) The person against whom the Commissioner voted in the negative.
the Division of Market Oversight or the
action is taken has consented to the
Division of Swap Dealer and [FR Doc. 2017–01232 Filed 1–19–17; 8:45 am]
penalty to be imposed and to the timing
of its effectiveness. Intermediary Oversight may request that BILLING CODE 6351–01–P
(b) Notice of early effective date. If the the exchange file with the Division the
exchange determines in accordance record of the exchange proceeding, or
with paragraph (a)(1) of this section that designated portions of the record, a brief DEPARTMENT OF HEALTH AND
a disciplinary action will become statement of the evidence and testimony HUMAN SERVICES
effective prior to the expiration of adduced to support the exchange’s
findings that a rule or rules of the Food and Drug Administration
fifteen days after written notice thereof,
it must notify the person disciplined in exchange were violated and such
recordings, transcripts and other 21 CFR Parts 11, 16, and 112
writing, either personally or by email to
the person’s last known email address, documents applicable to the particular [Docket No. FDA–2017–D–0175]
stating the reasons for the exchange proceeding as the Division
determination. The exchange must also may specify. The exchange must Compliance With and
immediately notify the Commission by promptly advise the person who is the Recommendations for Implementation
email to secretary@cftc.gov. Where subject of the disciplinary or access of the Standards for the Growing,
notice is delivered by email, the time denial action of the Division’s request. Harvesting, Packing, and Holding of
within which the person so notified Produce for Human Consumption for
Within thirty days after service of the
may file a petition for stay pursuant to Sprout Operations; Draft Guidance for
Division’s request, the exchange must
§ 9.24(a)(2) will be increased by one Industry; Availability
file the information requested with the
day. Division in the manner requested by the AGENCY: Food and Drug Administration,
■ 12. Revise § 9.13 to read as follows: Division and, upon request, deliver that HHS.
§ 9.13 Publication of notice. information to the person who is the ACTION: Notification of availability.
subject of the disciplinary or access
Whenever an exchange suspends, SUMMARY: The Food and Drug
denial action. Delivery to the person
expels or otherwise disciplines, or Administration (FDA or we) is
who is the subject of the disciplinary or
denies any person access to the announcing the availability of a draft
exchange, it must make public its access denial action must be in the
guidance for industry entitled
findings by disclosing at least the manner prescribed by § 9.11(c). A ‘‘Compliance with and
information contained in the notice person subject to the disciplinary action Recommendations for Implementation
required by § 9.11(b). An exchange must or access denial action requesting a of the Standards for the Growing,
make such findings public as soon as copy of the information furnished to the Harvesting, Packing, and Holding of
the disciplinary action or access denial Division must, if the exchange rules so Produce for Human Consumption for
action becomes effective in accordance provide, agree to pay the exchange Sprout Operations.’’ The draft guidance,
with the provisions of § 9.12 by posting reasonable fees for printing the copy. when finalized, will help sprout
a notice on its Web site to which its (b) Review on motion of the operations subject to FDA’s final rule
members and the public regularly have Commission. The Commission may entitled ‘‘Standards for the Growing,
access. Such notice must be maintained institute review of an exchange Harvesting, Packing, and Holding of
and readily available on the exchange’s disciplinary or access denial action on Produce for Human Consumption’’ (the
Web site. its own motion. Other than in Produce Safety Rule), and primarily
■ 13. In § 9.24, revise paragraph (a)(2) to extraordinary circumstances, such focuses on assisting such operations in
read as follows: review will be initiated within 180 days complying with the sprout-specific
§ 9.24 Petition for stay pending review. after the NFA has received the notice of requirements in Subpart M (Sprouts) of
exchange action provided for in § 9.11. the Produce Safety Rule. The draft
(a) * * * guidance also includes limited
(2) Within ten days after a notice of If the Commission should institute
discussion on certain other applicable
summary action has been delivered in review on its own motion, it will issue
requirements of the Produce Safety
accordance with § 9.12(b) to a person an order permitting the person who is Rule. This draft guidance may also be
who is the subject of a summary action the subject of the disciplinary or access useful to sprout operations that are not
permitted by part 37, appendix B, Core denial action an opportunity to file an subject to the Produce Safety Rule that
Principle 2, paragraph (a)(14) or part 38, appropriate submission, and the voluntarily choose to follow the
appendix B, Core Principle 13, exchange an opportunity to file a reply standards established by the rule.
mstockstill on DSK3G9T082PROD with PROPOSALS
paragraph (a)(7) (emergency disciplinary thereto. DATES: Although you can comment on
actions) of this chapter, that person may Issued in Washington, DC, on January 13, any guidance at any time (see 21 CFR
petition the Commission to stay the 2017, by the Commission. 10.115(g)(5)), to ensure that the Agency
effectiveness of the summary action Christopher J. Kirkpatrick, considers your comment on this draft
pending completion of the exchange guidance before it begins work on the
proceeding. Secretary of the Commission.
final version of the guidance, submit
* * * * * Note: The following appendix will not either electronic or written comments
■ 14. Revise § 9.31 to read as follows: appear in the Code of Federal Regulations. on the draft guidance by July 24, 2017.
VerDate Sep<11>2014 18:58 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\FR\FM\23JAP1.SGM 23JAP1](https://thefederalregister.org/doc/82_FR_7764/page/1.svg)
![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules 7753
public submit reports, keep records, or reference to temporary regulation at 81 through’’ is corrected to read ‘‘(b)(3)(v),
provide information to a third party. FR 89022, December 9, 2016, are still (b)(3)(xxv) through’’.
Section 3506(c)(2)(A) of the PRA (44 being accepted and must be received by
Martin V. Franks,
U.S.C. 3506(c)(2)(A)) requires Federal March 9, 2017.
Agencies to publish notice in the Branch Chief, Publications and Regulations
Federal Register soliciting public ADDRESSES: Send submissions to Branch, Legal Processing Division, Associate
CC:PA:LPD:PR (REG–133353–16), Room Chief Counsel (Procedure and
comment on each proposed collection of Administrative).
information before submitting the 5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station, [FR Doc. 2017–00946 Filed 1–19–17; 8:45 am]
collection to OMB for approval. To
comply with this requirement, we will Washington, DC 20044. Submissions BILLING CODE 4830–01–P
publish a 60-day notice on the proposed may be hand delivered Monday through
collection of information in a future Friday between the hours of 8 a.m. and
4 p.m. to CC:PA:LPD:PR (REG–133353– DEPARTMENT OF THE TREASURY
issue of the Federal Register.
16), Courier’s desk, Internal Revenue
III. Electronic Access Alcohol and Tobacco Tax and Trade
Service, 1111 Constitution Avenue NW.,
Bureau
Persons with access to the Internet Washington, DC 20224, or sent
may obtain the draft guidance at either electronically, via the Federal
27 CFR Parts 24 and 27
http://www.fda.gov/FoodGuidances or eRulemaking Portal at
http://www.regulations.gov. Use the www.regulations.gov (IRS REG–133353– [Docket No. TTB–2016–0014; Notice No.
FDA Web site listed in the previous 16). 168; Re: T.D. TTB–147]
sentence to find the most current SUPPLEMENTARY INFORMATION: RIN 1513–AC31
version of the guidance.
Background
Dated: January 12, 2017. Implementation of Statutory
Leslie Kux, The notice of proposed rulemaking by Amendments Requiring the
Associate Commissioner for Policy. cross-reference to temporary regulation Modification of the Definition of Hard
[FR Doc. 2017–01128 Filed 1–19–17; 8:45 am] that is the subject of this document is Cider
BILLING CODE 4164–01–P under section 6103(j)(1)(A) of the AGENCY: Alcohol and Tobacco Tax and
Internal Revenue Code. Trade Bureau, Treasury.
Need for Correction ACTION: Notice of proposed rulemaking;
DEPARTMENT OF THE TREASURY cross-reference to temporary rule.
As published, the notice of proposed
Internal Revenue Service rulemaking by cross-reference to SUMMARY: Elsewhere in this issue of the
temporary regulation (REG–133353–16) Federal Register, by means of a
26 CFR Part 1 contains errors that are misleading and temporary rule, the Alcohol and
[REG–133353–16] are in need of clarification. Tobacco Tax and Trade Bureau (TTB)
implements changes made to the
RIN 1545–BN63 Correction to Publication
definition of ‘‘hard cider’’ in the Internal
Accordingly, the notice of proposed Revenue Code of 1986 by the Protecting
Disclosures of Return Information
rulemaking by cross-reference to Americans from Tax Hikes Act of 2015.
Reflected on Returns to Officers and
temporary regulation, that is the subject The modified definition broadens the
Employees of the Department of
of FR Doc. 2016–29490, is corrected as range of wines eligible for the hard cider
Commerce for Certain Statistical
follows: tax rate. TTB is amending its regulations
Purposes and Related Activities;
to reflect the modified definition of hard
Correction 1. On page 89022, in the preamble, cider effective for products removed on
second column, second line from the or after January 1, 2017, and to set forth
AGENCY: Internal Revenue Service (IRS),
top of column, the language new labeling requirements to identify
Treasury.
‘‘CC:PA:LPD:PR (REG–133533–16), products to which the hard cider tax
ACTION: Notice of proposed rulemaking Room’’ is corrected to read
by cross-reference to temporary rate applies. The new labeling
‘‘CC:PA:LPD:PR (REG–133353–16), requirements include both a one-year
regulation; correction. Room’’. transitional rule and a new labeling
SUMMARY: This document contains 2. On page 89022, in the preamble, requirement that takes effect for
corrections to a notice of proposed second column, eighth line from the top products removed on or after January 1,
rulemaking by cross-reference to of column, the language ‘‘4 p.m. to 2018. The text of the regulations in that
temporary regulation (REG–133353–16) CC:PA:LPD:PR (REG–133533–’’ is temporary rule published elsewhere in
that was published in the Federal corrected to read ‘‘4 p.m. to this issue of the Federal Register serves
Register on Friday, December 9, 2016. CC:PA:LPD:PR (REG–133353–’’. as the text of the proposed regulations.
The proposed regulations authorize the 3. On page 89022, in the preamble, DATES: Comments must be received on
disclosure of specified return second column, sixth line from the or before March 24, 2017.
information to the Census Bureau bottom of ADDRESSES caption, the ADDRESSES: Please send your comments
mstockstill on DSK3G9T082PROD with PROPOSALS
(Bureau) for purposes of structuring the language ‘‘Service, 1111 Constitutional on this document to one of the
censuses and national economic Avenue’’ is corrected to read ‘‘Service, following addresses:
accounts and conducting related 1111 Constitution Avenue’’. • Internet: https://
statistical activities authorized by title www.regulations.gov (via the online
13. § 301.6103(j)(1)–1 [Corrected]
comment form for this document as
DATES: Written or electronic comments 4. On page 89023, first column, third posted within Docket No. TTB–2016–
and request for public hearing for the line of paragraph (e), the language 0014 at ‘‘Regulations.gov,’’ the Federal
notice of proposed rulemaking by cross- ‘‘(b)(3)(v), (b)(3)(xxv), (b)(3)(xxv) e-rulemaking portal);
VerDate Sep<11>2014 18:58 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 E:\FR\FM\23JAP1.SGM 23JAP1](https://thefederalregister.org/doc/82_FR_7764/page/3.svg)
Document Created: 2017-01-20 01:30:20
Document Modified: 2017-01-20 01:30:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 7751 | |
| CFR Citation | 21
CFR
11 21 CFR 112 21 CFR 16 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR