[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Pages 2328-2331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-573]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

[Doc. No. AMS-NOP-10-0045; NOP-10-03]


National Organic Program: Notice of Draft Guidance Concerning 
``Made With Organic (Specified Ingredients or Food Groups)'' Products: 
Product Composition and Use of Percentage Statements

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice with request for comments.

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SUMMARY: This notice announces draft guidance for the organic industry 
to address the labeling, composition of and use of percentage 
statements in ``made with organic (specified ingredients or food 
groups).'' Specifically, the draft guidance addresses (1) the use of 
non-organic ingredients in ``made with organic (specified ingredients 
or food groups)'' products, and (2) the use of statements about the 
percentage of organic ingredients within the ``made with organic 
(specified ingredients or food groups)'' labeling category.
    The guidance explains the policy of the National Organic Program 
(NOP) concerning the portions of the regulations in question, 
referenced herein. The NOP invites organic producers, handlers, 
certifying agents, consumers and other interested parties to submit 
comments about these guidance provisions. A notice of availability of 
final guidance on this topic will be issued upon its final approval. 
Once finalized, this guidance document will be available from the NOP 
through ``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 instructions that can assist them in complying with 
the

[[Page 2329]]

National Organic Program (NOP) regulations. The current edition of the 
Program Handbook is available online at http://www.ams.usda.gov/nop or 
in print upon request.

DATES: Comments must be submitted on or before March 14, 2011.

ADDRESSES: NOP invites interested persons to submit comments pertaining 
to guidance on ``made with organic (specified ingredients or food 
groups)'' labeling and composition addressed herein using the following 
procedures:
     Internet: http://www.regulations.gov.
     Mail: Comments may be submitted to Toni Strother, 
Agricultural Marketing Specialist, National Organic Program, USDA-AMS-
NOP, Room 2646-So., Ag Stop 0268, 1400 Independence Ave., SW., 
Washington, DC 20250-0268.
    Written comments responding to this request should be identified 
with the document number AMS-NOP-10-0045; NOP-10-03. Clearly indicate 
the provision you are addressing and your support for or opposition to 
it and the reason for your position. Please include only relevant 
information and data to support your position.
    USDA intends to make available all comments, including names and 
addresses when provided, regardless of submission procedure used, on 
http://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 request to make an 
appointment by calling (202) 720-3252.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Director, Standards 
Division, National Organic Program, USDA-AMS-NOP, 1400 Independence 
Ave., SW., Room 2646-So., Ag Stop 0268, Washington, DC 20250. 
Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

Purpose & Applicability

    The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. Section 
6501, et seq., as amended, and the NOP regulations implemented in 7 CFR 
part 205, National Organic Program (NOP) Final Rule, regulate the 
production, handling, processing, and labeling of all raw or processed 
agricultural products to be sold, labeled, or represented as organic in 
the United States.
    This guidance describes the policies for certified operations, 
certifying agents accredited by the U.S. Department of Agriculture 
(USDA), and approved State Organic Programs with respect to ``made with 
organic (specified ingredients or food group(s))'' products in the 
following two areas:
    1. Restrictions on the use of non-organic ingredients; and
    2. Statements about the percentage of organic ingredients.

I. Product Composition

Background

    The NOP regulations describe the composition requirements for 
products to be labeled as ``100% organic,'' ``organic,'' and ``made 
with organic (specified ingredients or food group(s)).'' The purpose of 
this section is to explain the allowances and restrictions on the use 
of non-organic ingredients that may comprise up to 30 percent of a 
``made with organic (specified ingredients or food group(s))'' product.
    According to Sec.  205.301(c) products within the ``made with 
organic (specified ingredients or food group(s))'' labeling category 
must contain at least 70 percent certified organic agricultural 
products. None of the ingredients in the final product may be produced 
using excluded methods (i.e., genetically modified organisms), sewage 
sludge or ionizing radiation.
    Multi-ingredient products labeled as ``made with organic (specified 
ingredients or food group(s))'' may contain up to 30 percent of the 
following: (1) Conventionally produced (non-organic) agricultural 
products such as fruits, spices and grains regardless of the synthetic 
substances which may have been used in their production or processing; 
and (2) natural and synthetic ingredients or processing aids listed in 
Sec.  205.605 Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food groups)).'' Any 
synthetic substance may be used to manufacture a substance on Sec.  
205.605; however, if the synthetic is present in the final Sec.  
205.605 substance, the synthetic must also be on the National List and 
allowed for the intended use.

Policy Statement

    Products within the ``made with organic (specified ingredients or 
food group(s))'' labeling category must contain at least 70 percent 
certified organic agricultural products. The remaining 30 percent may 
include:
    1. Agricultural ingredients which are conventionally produced. 
These ingredients must not have been produced using excluded methods 
(genetically modified organisms), sewage sludge, or ionizing radiation, 
but may be produced using synthetic substances not appearing on the 
National List at Sec.  205.605.
    2. Natural and synthetic ingredients or processing aids that are 
listed within Sec.  205.605.

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[GRAPHIC] [TIFF OMITTED] TN13JA11.000

II. Statement of Percentage of Organic Ingredients

Background

    The NOP regulations (Sec. Sec.  205.303(a) and 205.304(a)) state 
that products in packages described in Sec. Sec.  205.301(a), (b), and 
(c), may display the terms, ``100 percent organic,'' ``organic,'' and 
``made with organic (specified ingredients or food group(s)),'' 
respectively, as applicable. These provisions also state these products 
may display the percentage of organic ingredients in the product.
    Accordingly, the NOP has received questions about whether a 
percentage statement may appear without a product composition statement 
(``100% organic,'' ``organic,'' ``made with organic (specified 
ingredients or food groups)'' on a product package. For example, may a 
soup label state, ``75 percent organic ingredients'' on the principal 
display panel without a ``made with organic vegetables'' statement?
    The purpose of this section is to clarify (a) the display of 
product composition and percentage statements on packaged products, and 
(b) whether percentage statements can be used when the percent of the 
organic ingredients exceeds the product composition category. For 
example, may a soup label state ``95 percent organic ingredients'' when 
the soup qualifies only for a ``made with organic vegetables'' claim?

Policy Statement

    The ``made with organic (specified ingredients or food group(s))'' 
statement is essential to clarify the product category and may be used 
without the percentage statement. The statements, ``made with organic 
ingredients,'' or ``made with (insert number)% organic ingredients,'' 
do not comply with Sec. Sec.  205.304(a)(1)(i) or (ii) and are not 
acceptable variations of a ``made with organic'' statement. The correct 
formats for ``made with organic'' statements are: ``made with organic 
(specified ingredients); or (specified food groups),'' provided that 
the statement does not list more than three organically produced 
ingredients or food groups.
    A percentage statement must be accompanied by the statement, ``made 
with organic (specified ingredients or food group(s))'' when displayed 
on packages of products in this category, which are described in Sec.  
205.301(c). As written in the NOP regulations, the section heading for 
Sec.  205.304, ``Packaged products labeled ``made with organic 
(specified ingredients or food group(s)),'' implies that a ``made with 
organic (specified ingredients or food group(s))'' statement is present 
on the product, and, therefore, the product must contain at least 70 
percent certified organic agricultural products. The ``made with 
(specified ingredients or food group(s))'' statement is particularly 
important when the product contains 95 percent or more organic 
ingredients; without it, a consumer cannot determine the appropriate 
product category and could be misled to assume that the product 
qualifies for the ``organic'' labeling category.
    A claim of ``100% organic'' should only be used for products that 
qualify under Sec.  205.301(a). The ``100% organic'' claim refers to a 
particular labeling category within the NOP regulations and should not 
be used in combination with other NOP labeling categories. For example, 
a ``made with 100% organic (specified ingredients or foods groups)'' 
label may lead consumers into thinking that the ``made with'' product 
qualifies for the ``100% organic'' category.
    Acceptable variations of percentage statements include: ``X% 
Organic,'' ``X% Organic Ingredients,'' ``Contains X% Organic 
Ingredients,'' ``Made with X% Organic Ingredients.'' Each of the above 
versions of a percentage statement need to appear with a proper ``made 
with organic'' statement. Additional versions of percentage claim 
statements may be acceptable as long as they are not misleading. 
Percentage statements must appear without highlighting and in the same 
type size, font and color in its entirety. The size of a percentage 
statement must not exceed one-half of the largest type size on the 
display panel, in accordance with Sec.  205.304(a)(2).

III. 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 the NOP's current thinking on 
these topics. It does not create or confer any rights for, or on, any 
person and does not operate to bind the NOP or the public. Guidance 
documents are intended to provide a

[[Page 2331]]

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.
    The NOP strongly encourages the 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.

    Authority: 7 U.S.C. 6501, et seq.; 7 CFR part 205.

    Dated: January 7, 2011.
David R. Shipman,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2011-573 Filed 1-12-11; 8:45 am]
BILLING CODE 3410-02-P