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###### Department of Agriculture

###### Agricultural Marketing Service

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

# AGENCY:

Agricultural Marketing Service, USDA.

# ACTION:

Notice with request for comments.

# 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This notice announces draft guidance for the organic industry to address the labeling, composition of and use of percentage statements in “made with organic (specified ingredients or food groups).” Specifically, the draft guidance addresses (1) the use of non-organic ingredients in “made with organic (specified ingredients or food groups)” products, and (2) the use of statements about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                               ( print 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 § 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 § 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 § 205.605; however, if the synthetic is present in the final § 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 § 205.605.

2. Natural and synthetic ingredients or processing aids that are listed within § 205.605.
      ( print page 2330)    

## II. Statement of Percentage of Organic Ingredients

### Background

                    The NOP regulations (§§ 205.303(a) and 205.304(a)) state that products in packages described in §§ 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 §§ 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 § 205.301(c). As written in the NOP regulations, the section heading for § 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 § 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 § 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                           ( print 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