81_FR_88136 81 FR 87902 - National Organic Program: Notice of Draft Guidance for Calculating the Percentage of Organic Ingredients in Multi-Ingredient Products

81 FR 87902 - National Organic Program: Notice of Draft Guidance for Calculating the Percentage of Organic Ingredients in Multi-Ingredient Products

DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service

Federal Register Volume 81, Issue 234 (December 6, 2016)

Page Range87902-87903
FR Document2016-29173

The Agricultural Marketing Service (AMS) is announcing the availability of a draft guidance document intended for use by accredited certifying agents and certified handling operations. The draft guidance document is entitled as follows: Calculating Percentage Organic in Multi-Ingredient Products (NOP 5037). This draft guidance document is intended to inform the public of AMS' current thinking on this topic. AMS invites organic producers, handlers, certifying agents, material evaluation programs, consumers and other interested parties to submit comments.

Federal Register, Volume 81 Issue 234 (Tuesday, December 6, 2016)
[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Notices]
[Pages 87902-87903]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29173]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / 
Notices

[[Page 87902]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

[Doc. No. AMS-NOP-16-0085; NOP-16-06]


National Organic Program: Notice of Draft Guidance for 
Calculating the Percentage of Organic Ingredients in Multi-Ingredient 
Products

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice of availability of draft guidance with request for 
comments.

-----------------------------------------------------------------------

SUMMARY: The Agricultural Marketing Service (AMS) is announcing the 
availability of a draft guidance document intended for use by 
accredited certifying agents and certified handling operations. The 
draft guidance document is entitled as follows: Calculating Percentage 
Organic in Multi-Ingredient Products (NOP 5037). This draft guidance 
document is intended to inform the public of AMS' current thinking on 
this topic. AMS invites organic producers, handlers, certifying agents, 
material evaluation programs, consumers and other interested parties to 
submit comments.

DATES: Comments must be submitted on or before February 6, 2017.

ADDRESSES: Submit written requests for hard copies of this draft 
guidance to Paul I. Lewis, Ph.D., Standards Division Director, National 
Organic Program (NOP), USDA-AMS-NOP, 1400 Independence Ave. SW., Room 
2646--So., Ag Stop 0268, Washington, DC 20250-0268. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    You may submit comments on this draft guidance document by any of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Paul I. Lewis, Ph.D., Standards Division Director, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., 
Room 2646--So., Ag Stop 0268, Washington, DC 20250-0268.
    Instructions: Written comments responding to this request should be 
identified with the document number AMS-NOP-XX-XXXX; NOP-16-06. You 
should clearly indicate your position and the reasons supporting your 
position. If you are suggesting changes to the draft guidance document, 
you should include recommended language changes, as appropriate, along 
with any relevant supporting documentation. AMS is specifically 
requesting that stakeholders comment and quantify any impacts that the 
guidance will have on certified operations. AMS is also requesting 
comments from accredited certifying agents on the policy related to the 
calculation of multi-ingredient ingredients. How is the industry 
currently calculating organic products that use organic ingredients 
that contain several ingredients? What are the sound and sensible 
approaches currently being used?
    USDA intends to make available all comments, including names and 
addresses when provided, regardless of submission procedure used, on 
www.regulations.gov and at USDA, AMS, NOP, Room 2646--South building, 
1400 Independence Ave. SW., Washington, DC, from 9 a.m. to noon and 
from 1 to 4 p.m., Monday through Friday (except official Federal 
holidays). Persons wanting to visit the USDA South building to view 
comments from the public to this notice are requested to make an 
appointment by calling (202) 720-3252.

FOR FURTHER INFORMATION CONTACT: Paul I. Lewis, Ph.D., Standards 
Division Director, National Organic Program (NOP), USDA-AMS-NOP, 1400 
Independence Ave. SW., Room 2646--So., Ag Stop 0268, Washington, DC 
20250-0268; Telephone: (202) 720-3252; Fax: (202) 260-9151; Email: 
[email protected]; or visit the NOP Web site at: 
www.ams.usda.gov/nop.

SUPPLEMENTARY INFORMATION: 

I. Background

    The draft guidance document announced through this notice was 
developed to respond to an April 2013 National Organic Standards Board 
(NOSB) request that the National Organic Program (NOP) correct and/or 
clarify the requirements codified at 7 CFR 205.302(a), calculating the 
percentage of organically produced ingredients. Section 205.302(a)(1) 
states the method of calculation as ``[d]ividing the total net weight 
(excluding water and salt) of combined organic ingredients at 
formulation by the total weight (excluding water and salt) of the 
finished product.'' Current interpretation of 205.302(a)(1) is to 
``[d]ivid[e] the total net weight (excluding water and salt) of 
combined organic ingredients at formulation by the total weight 
(excluding water and salt) of all ingredients.'' [Emphasis added.]
    The NOSB recommendation asked the NOP to: (1) Correct the 
regulatory language at Sec.  205.302(a) to clarify that organic 
percentages should be calculated by dividing the total net weight 
(excluding water and salt) of combined organic ingredients at 
formulation by the total net weight (excluding water and salt) of all 
ingredients. The NOSB asked that the NOP clarify that the percentage of 
organic ingredients in a product should be calculated based on the net 
weight of ``all ingredients'' in that product, and not the net weight 
of the ``finished product'' because most products lose weight during 
processing; (2) Clarify how to calculate the organic percentages of a 
multi-ingredient product that contains ingredients that are themselves 
composed of more than one ingredient; (3) Clarify when to exclude salt 
and water from ingredients; (4) Provide guidance on how to calculate 
raw agricultural product and processed single ingredient ingredients; 
and to (5) Develop and publish example self-calculating forms on items 
related to the organic percentage of each ingredient and the exclusion 
of salt and water. This guidance addresses the NOSB recommendation.
    The draft guidance is available from AMS on its Web site at http://www.ams.usda.gov/rules-regulations/organic/draft-guidance. If 
finalized, any final guidance would be available in ``The Program 
Handbook: Guidance and Instructions for Accredited Certifying Agents 
(ACAs) and Certified Operations''. This Handbook provides those who 
own, manage, or certify organic operations with guidance and

[[Page 87903]]

instructions that can assist them in complying with the USDA organic 
regulations. The current edition of the Program Handbook is available 
online at http://www.ams.usda.gov/rules-regulations/organic/handbook.

II. Significance of Guidance

    This draft guidance document is being issued in accordance with the 
Office of Management and Budget (OMB) Bulletin on Agency Good Guidance 
Practices (GGPs) (January 25, 2007, 72 FR 3432-3440).
    The purpose of GGPs is to ensure that program guidance documents 
are developed with adequate public participation, are readily available 
to the public, and are not applied as binding requirements. The draft 
guidance, when finalized, will represent AMS' current thinking on these 
topics. It does not create or confer any rights for, or on, any person 
and does not operate to bind AMS or the public. Guidance documents are 
intended to provide a uniform method for operations to comply that can 
reduce the burden of developing their own methods and simplify audits 
and inspections. Alternative approaches that can demonstrate compliance 
with the Organic Foods Production Act (OFPA), as amended (7 U.S.C. 
6501-6522), and its implementing regulations are also acceptable. AMS 
strongly encourages industry to discuss alternative approaches with the 
NOP before implementing them to avoid unnecessary or wasteful 
expenditures of resources and to ensure the proposed alternative 
approach complies with the Act and its implementing regulations.

III. Electronic Access

    Persons with access to Internet may obtain the draft guidance at 
either AMS' Web site at http://www.ams.usda.gov/nop or http://www.regulations.gov. Requests for hard copies of the draft guidance 
documents can be obtained by submitting a written request to the person 
listed in the ADDRESSES section of this Notice.

    Authority: 7 U.S.C. 6501-6522.

    Dated: November 30, 2016.
Elanor Starmer,
Administrator, Agricultural Marketing Service.
[FR Doc. 2016-29173 Filed 12-5-16; 8:45 am]
BILLING CODE 3410-02-P



                                                  87902

                                                  Notices                                                                                                       Federal Register
                                                                                                                                                                Vol. 81, No. 234

                                                                                                                                                                Tuesday, December 6, 2016



                                                  This section of the FEDERAL REGISTER                    Organic Program, USDA–AMS–NOP,                        (NOSB) request that the National
                                                  contains documents other than rules or                  1400 Independence Ave. SW., Room                      Organic Program (NOP) correct and/or
                                                  proposed rules that are applicable to the               2646—So., Ag Stop 0268, Washington,                   clarify the requirements codified at 7
                                                  public. Notices of hearings and investigations,         DC 20250–0268.                                        CFR 205.302(a), calculating the
                                                  committee meetings, agency decisions and                   Instructions: Written comments                     percentage of organically produced
                                                  rulings, delegations of authority, filing of
                                                                                                          responding to this request should be                  ingredients. Section 205.302(a)(1) states
                                                  petitions and applications and agency
                                                  statements of organization and functions are            identified with the document number                   the method of calculation as ‘‘[d]ividing
                                                  examples of documents appearing in this                 AMS–NOP–XX–XXXX; NOP–16–06.                           the total net weight (excluding water
                                                  section.                                                You should clearly indicate your                      and salt) of combined organic
                                                                                                          position and the reasons supporting                   ingredients at formulation by the total
                                                                                                          your position. If you are suggesting                  weight (excluding water and salt) of the
                                                  DEPARTMENT OF AGRICULTURE                               changes to the draft guidance document,               finished product.’’ Current
                                                                                                          you should include recommended                        interpretation of 205.302(a)(1) is to
                                                  Agricultural Marketing Service                          language changes, as appropriate, along               ‘‘[d]ivid[e] the total net weight
                                                  [Doc. No. AMS–NOP–16–0085; NOP–16–06]                   with any relevant supporting                          (excluding water and salt) of combined
                                                                                                          documentation. AMS is specifically                    organic ingredients at formulation by
                                                  National Organic Program: Notice of                     requesting that stakeholders comment                  the total weight (excluding water and
                                                  Draft Guidance for Calculating the                      and quantify any impacts that the                     salt) of all ingredients.’’ [Emphasis
                                                  Percentage of Organic Ingredients in                    guidance will have on certified                       added.]
                                                  Multi-Ingredient Products                               operations. AMS is also requesting                       The NOSB recommendation asked the
                                                                                                          comments from accredited certifying                   NOP to: (1) Correct the regulatory
                                                  AGENCY: Agricultural Marketing Service,                 agents on the policy related to the                   language at § 205.302(a) to clarify that
                                                  USDA.                                                   calculation of multi-ingredient                       organic percentages should be
                                                  ACTION: Notice of availability of draft                 ingredients. How is the industry                      calculated by dividing the total net
                                                  guidance with request for comments.                     currently calculating organic products                weight (excluding water and salt) of
                                                                                                          that use organic ingredients that contain             combined organic ingredients at
                                                  SUMMARY:   The Agricultural Marketing                   several ingredients? What are the sound               formulation by the total net weight
                                                  Service (AMS) is announcing the                         and sensible approaches currently being               (excluding water and salt) of all
                                                  availability of a draft guidance                        used?                                                 ingredients. The NOSB asked that the
                                                  document intended for use by                               USDA intends to make available all                 NOP clarify that the percentage of
                                                  accredited certifying agents and                        comments, including names and                         organic ingredients in a product should
                                                  certified handling operations. The draft                addresses when provided, regardless of                be calculated based on the net weight of
                                                  guidance document is entitled as                        submission procedure used, on                         ‘‘all ingredients’’ in that product, and
                                                  follows: Calculating Percentage Organic                 www.regulations.gov and at USDA,                      not the net weight of the ‘‘finished
                                                  in Multi-Ingredient Products (NOP                       AMS, NOP, Room 2646—South                             product’’ because most products lose
                                                  5037). This draft guidance document is                  building, 1400 Independence Ave. SW.,                 weight during processing; (2) Clarify
                                                  intended to inform the public of AMS’                   Washington, DC, from 9 a.m. to noon                   how to calculate the organic percentages
                                                  current thinking on this topic. AMS                     and from 1 to 4 p.m., Monday through                  of a multi-ingredient product that
                                                  invites organic producers, handlers,                    Friday (except official Federal holidays).            contains ingredients that are themselves
                                                  certifying agents, material evaluation                  Persons wanting to visit the USDA                     composed of more than one ingredient;
                                                  programs, consumers and other                           South building to view comments from                  (3) Clarify when to exclude salt and
                                                  interested parties to submit comments.                  the public to this notice are requested to            water from ingredients; (4) Provide
                                                  DATES: Comments must be submitted on                    make an appointment by calling (202)                  guidance on how to calculate raw
                                                  or before February 6, 2017.                             720–3252.                                             agricultural product and processed
                                                  ADDRESSES: Submit written requests for                  FOR FURTHER INFORMATION CONTACT: Paul                 single ingredient ingredients; and to (5)
                                                  hard copies of this draft guidance to                   I. Lewis, Ph.D., Standards Division                   Develop and publish example self-
                                                  Paul I. Lewis, Ph.D., Standards Division                Director, National Organic Program                    calculating forms on items related to the
                                                  Director, National Organic Program                      (NOP), USDA–AMS–NOP, 1400                             organic percentage of each ingredient
                                                  (NOP), USDA–AMS–NOP, 1400                               Independence Ave. SW., Room 2646—                     and the exclusion of salt and water. This
                                                  Independence Ave. SW., Room 2646—                       So., Ag Stop 0268, Washington, DC                     guidance addresses the NOSB
                                                  So., Ag Stop 0268, Washington, DC                       20250–0268; Telephone: (202) 720–                     recommendation.
                                                  20250–0268. See the SUPPLEMENTARY                       3252; Fax: (202) 260–9151; Email:                        The draft guidance is available from
                                                  INFORMATION section for electronic                      NOP.Guidance@ams.usda.gov; or visit                   AMS on its Web site at http://
                                                  access to the draft guidance document.                  the NOP Web site at:                                  www.ams.usda.gov/rules-regulations/
                                                    You may submit comments on this                       www.ams.usda.gov/nop.                                 organic/draft-guidance. If finalized, any
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                                                  draft guidance document by any of the                   SUPPLEMENTARY INFORMATION:                            final guidance would be available in
                                                  following methods:                                                                                            ‘‘The Program Handbook: Guidance and
                                                    • Federal eRulemaking Portal: http://                 I. Background                                         Instructions for Accredited Certifying
                                                  www.regulations.gov. Follow the                            The draft guidance document                        Agents (ACAs) and Certified
                                                  instructions for submitting comments.                   announced through this notice was                     Operations’’. This Handbook provides
                                                    • Mail: Paul I. Lewis, Ph.D.,                         developed to respond to an April 2013                 those who own, manage, or certify
                                                  Standards Division Director, National                   National Organic Standards Board                      organic operations with guidance and


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                                                                              Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices                                           87903

                                                  instructions that can assist them in                    DEPARTMENT OF AGRICULTURE                             card). This information collection is
                                                  complying with the USDA organic                                                                               necessary to comply with the
                                                  regulations. The current edition of the                 Office of the Secretary                               requirements outlined in Homeland
                                                  Program Handbook is available online at                                                                       Security Presidential Directive (HSPD)
                                                                                                          Notice of Request for Extension of a                  12, and Federal Information Processing
                                                  http://www.ams.usda.gov/rules-
                                                                                                          Currently Approved Information                        Standard (FIPS) 201–2. USDA must
                                                  regulations/organic/handbook.
                                                                                                          Collection                                            implement an identity proofing,
                                                  II. Significance of Guidance                                                                                  registration, and issuance process
                                                                                                          AGENCY: Office of Homeland Security
                                                                                                          and Emergency Coordination.                           consistent with the requirements
                                                     This draft guidance document is being
                                                                                                          ACTION: Notice and request for
                                                                                                                                                                outlined in FIPS 201–2. This
                                                  issued in accordance with the Office of
                                                                                                          comments.                                             information collection form was
                                                  Management and Budget (OMB)                                                                                   required as part of USDA’s identity
                                                  Bulletin on Agency Good Guidance                        SUMMARY:    In accordance with the                    proofing and registration process. After
                                                  Practices (GGPs) (January 25, 2007, 72                  Paperwork Reduction Act of 1995, this                 October 27, 2006, form AD–1197 has
                                                  FR 3432–3440).                                          notice announces the Office of                        been eliminated and the identity
                                                     The purpose of GGPs is to ensure that                Homeland Security and Emergency                       process has been streamlined with the
                                                  program guidance documents are                          Coordination’s (OHSEC) intention to                   addition of a web-based HSPD–12
                                                  developed with adequate public                          request an extension for and revision to              system. As USDA continues the HSPD–
                                                  participation, are readily available to the             a currently approved information                      12 program, one estimate of burden has
                                                  public, and are not applied as binding                  collection for the U.S. Department of                 been calculated and one process
                                                  requirements. The draft guidance, when                  Agriculture (USDA) Personal Identity                  description has been included.
                                                  finalized, will represent AMS’ current                  Verification (PIV) Request for                           Estimate of Burden: Public reporting
                                                  thinking on these topics. It does not                   Credential, the USDA Homeland                         burden for this collection of information
                                                  create or confer any rights for, or on, any             Security Presidential Directive 12                    is estimated to average 1.5 hours. The
                                                  person and does not operate to bind                     (HSPD–12) program. HSPD–12                            burden is estimated based on the three
                                                  AMS or the public. Guidance                             establishes a mandatory, Government-                  prerequisites for PIV Credential
                                                  documents are intended to provide a                     wide standard for secure and reliable                 issuance as well as the receipt of the PIV
                                                                                                          forms of identification (credentials)                 Credential itself.
                                                  uniform method for operations to
                                                                                                          issued by the Federal Government to its                  Respondents: New long term
                                                  comply that can reduce the burden of
                                                                                                          Federal employees, non-Federal                        contractors, affiliates, and employees
                                                  developing their own methods and
                                                                                                          employees and contractors. The Office                 must undergo the information collection
                                                  simplify audits and inspections.                        of Management and Budget (OMB)                        process. Existing contractors/
                                                  Alternative approaches that can                         mandated that these credentials be                    employees/affiliates must undergo the
                                                  demonstrate compliance with the                         issued to all Federal Government                      process to receive a PIV Credential.
                                                  Organic Foods Production Act (OFPA),                    employees, contractors, and other                        Estimated Number of Respondents:
                                                  as amended (7 U.S.C. 6501–6522), and                    applicable individuals who require                    Estimated Annual Number of
                                                  its implementing regulations are also                   long-term access to federally controlled              Respondents: 12,000.
                                                  acceptable. AMS strongly encourages                     facilities and/or information systems.                   Estimated Number of Responses per
                                                  industry to discuss alternative                         The HSPD–12 compliant program is                      Respondent: Each respondent should
                                                  approaches with the NOP before                          jointly owned and administered by the                 complete one response.
                                                  implementing them to avoid                              Office of the Chief Information Officer                  Estimated Total One-Time Burden on
                                                  unnecessary or wasteful expenditures of                 (OCIO) and OHSEC.                                     Respondents: 18,000 hours.
                                                  resources and to ensure the proposed                    DATES: Comments on this notice must be                   Comments are invited on: (1) Whether
                                                  alternative approach complies with the                  received by December 15, 2016, to be                  the proposed collection of information
                                                  Act and its implementing regulations.                   assured of consideration.                             is necessary for the proper performance
                                                                                                          FOR FURTHER INFORMATION CONTACT:                      of the functions of the agency, including
                                                  III. Electronic Access                                                                                        whether the information will have
                                                                                                          Richard Holman, Chief, Physical
                                                    Persons with access to Internet may                   Security Division, Office of Homeland                 practical utility; (2) the accuracy of the
                                                  obtain the draft guidance at either AMS’                Security and Emergency Coordination,                  agency’s estimate of the burden of the
                                                  Web site at http://www.ams.usda.gov/                    USDA, 1400 Independence Avenue                        proposed collection of information
                                                  nop or http://www.regulations.gov.                      SW., Room 1457, Washington DC 20250.                  including the validity of the
                                                  Requests for hard copies of the draft                   SUPPLEMENTARY INFORMATION:                            methodology and assumptions used; (3)
                                                                                                            Title: USDA PIV Request for                         ways to enhance the quality, utility, and
                                                  guidance documents can be obtained by
                                                                                                          Credential.                                           clarity of the information to be
                                                  submitting a written request to the
                                                                                                            OMB Number: 0505–0022.                              collected; and (4) ways to minimize the
                                                  person listed in the ADDRESSES section                                                                        burden of the collection of information
                                                                                                            Expiration Date of Approval: February
                                                  of this Notice.                                                                                               on those who are to respond, including
                                                                                                          28, 2017.
                                                     Authority: 7 U.S.C. 6501–6522.                         Type of Request: Extension and                      the use of appropriate automated,
                                                    Dated: November 30, 2016.                             revision of a currently approved                      electronic, mechanical, or other
                                                                                                          information collection.                               technological collection techniques or
                                                  Elanor Starmer,
                                                                                                            Abstract: The HSPD–12 information                   other forms of information technology.
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                                                  Administrator, Agricultural Marketing                   collection is required for establishing               Comments may be sent to Richard
                                                  Service.                                                the applicant’s identity for PIV                      Holman. All comments received will be
                                                  [FR Doc. 2016–29173 Filed 12–5–16; 8:45 am]             credential issuance. The information                  available for public inspection during
                                                  BILLING CODE 3410–02–P                                  requested must be provided by Federal                 regular business hours at the same
                                                                                                          employees, contractors and other                      address.
                                                                                                          applicable individuals when applying                     All responses to this notice will be
                                                                                                          for a USDA credential (identification                 summarized and included in the request


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Document Created: 2016-12-06 02:18:24
Document Modified: 2016-12-06 02:18:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability of draft guidance with request for comments.
DatesComments must be submitted on or before February 6, 2017.
ContactPaul I. Lewis, Ph.D., Standards Division Director, National Organic Program (NOP), USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2646--So., Ag Stop 0268, Washington, DC 20250-0268; Telephone: (202) 720-3252; Fax: (202) 260-9151; Email: [email protected]; or visit the NOP Web site at: www.ams.usda.gov/nop.
FR Citation81 FR 87902 

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