National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified Ingredients or Food Groups)” Products: Product Composition and Use of Percentage Statements, 2328-2331 [2011-573]

Download as PDF 2328 Notices Federal Register Vol. 76, No. 9 Thursday, January 13, 2011 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. DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request srobinson on DSKHWCL6B1PROD with NOTICES January 7, 2011. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency’s estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), OIRA_Submission@OMB.EOP.GOV or fax (202) 395–5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250– 7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling (202) 720–8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to VerDate Mar<15>2010 16:15 Jan 12, 2011 Jkt 223001 the collection of information unless it displays a currently valid OMB control number. Frequency of Responses: Reporting: On occasion. Total Burden Hours: 752. Animal and Plant Health Inspection Service Ruth Brown, Departmental Information Collection Clearance Officer. Title: Dairy Heifer Raiser 2010 Study. OMB Control Number: 0579–NEW. Summary of Collection: Collection and dissemination of animal health data and information is mandated by 7 U.S.C. 391, the Animal Industry Act of 1884, which established the precursor of the Animal and Plant Health Inspection Service (APHIS), Veterinary Service, and the Bureau of Animal Industry. Legal requirements for examining and reporting on animal disease control methods were further mandated by 7 U.S.C. 8308 of the Animal Health Protection Act, ‘‘Detection, Control, and Eradication of Diseases and Pests,’’ May 13, 2002. This submission is a request for approval to initiate the National Animal Health Monitoring Systems (NAHMS) Dairy Heifer Raiser 2010 Study, an information collection by the Animal and Plant Health Inspection Service (APHIS). The study will be conducted with the assistance of State Animal Health Officials using NAHMS– 242, ‘‘Dairy Heifer Raiser Questionnaire.’’ The Dairy Heifer Raiser 2010 Study is a part of an ongoing series of NAHMS studies on the U.S. dairy population. Need and Use of the Information: The information collected through the Dairy Heifer Raiser 2010 Study will be analyzed and organized into descriptive reports. APHIS will use the data collected to: (1) Provide the first comprehensive information on animal health and management practices for heifer-raising operations; (2) Evaluate the biosecurity risks associated with heifer-raising operations (e.g., commingling cattle from multiple operations, exposing young cattle to Mexican cattle); and (3) Assist in the development of a biosecurity assessment that can be used to evaluate the risk of disease transmission (e.g., Tuberculosis, Bovine Viral diarrhea, etc.). Without this type of data, the ability to detect trends in management, production, and health status, either directly or indirectly, would be reduced or nonexistent. Description of Respondents: Business or other for-profit. Number of Respondents: 800. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 [FR Doc. 2011–571 Filed 1–12–11; 8:45 am] BILLING CODE 3410–34–P 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 Agricultural Marketing Service, USDA. ACTION: Notice with request for comments. AGENCY: 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 nonorganic 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 SUMMARY: E:\FR\FM\13JAN1.SGM 13JAN1 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices srobinson on DSKHWCL6B1PROD with NOTICES National Organic Program (NOP) regulations. The current edition of the Program Handbook is available online at https://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: https:// 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 https:// 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 VerDate Mar<15>2010 16:15 Jan 12, 2011 Jkt 223001 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 nonorganic 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 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 2329 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. E:\FR\FM\13JAN1.SGM 13JAN1 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices srobinson on DSKHWCL6B1PROD with NOTICES 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, VerDate Mar<15>2010 16:15 Jan 12, 2011 Jkt 223001 ‘‘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 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 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 E:\FR\FM\13JAN1.SGM 13JAN1 EN13JA11.000</GPH> 2330 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 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] FOR FURTHER INFORMATION CONTACT: Tracy Hollingshead, DFO, USDA, Bridger-Teton National Forest, Hwy 189 North, Kemmerer, WY 83101; (307) 877–4415; E-mail thollingshead@fs.fed.us. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday. SUPPLEMENTARY INFORMATION: The meeting is open to the public. The following business will be conducted: (1) Approve minutes from November 29, 2010 meeting. (2) Review and discuss project applications. (3) Update on potential additional Resource Advisory Committee applicants; and (4) Public Comment. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Dated: January 7, 2011. Tracy Hollingshead, Designated Federal Officer. BILLING CODE 3410–02–P DEPARTMENT OF AGRICULTURE [FR Doc. 2011–662 Filed 1–12–11; 8:45 am] Forest Service BILLING CODE 3410–11–P Bridger-Teton National Forest Resource Advisory Committee DEPARTMENT OF AGRICULTURE Forest Service, USDA. Notice of Meeting. AGENCY: ACTION: The Bridger-Teton Resource Advisory Committee will meet in Kemmerer, Wyoming. The committee is meeting as authorized under the Secure Rural Schools and Community SelfDetermination Act (Pub. L. 110–343) and in compliance with the Federal Advisory Committee Act. The purpose is to review project applications. DATES: The meeting will be held on February 14, 2011, and will begin at 5 p.m. ADDRESSES: The meeting will be held at the Kemmerer Ranger District Office, 308 U.S. Highway 189 North, Kemmerer, WY. Written comments should be sent to Tracy Hollingshead, Bridger-Teton National Forest, 308 Hwy 189 North, Kemmerer, WY 83101. Comments may also be sent via e-mail to thollingshead@fs.fed.us, or via facsimile to 307–828–5135. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at BridgerTeton National Forest, Hwy 189 North, Kemmerer, WY 83101. Visitors are encouraged to call ahead to 307–877– 4415 to facilitate entry into the building. SUMMARY: srobinson on DSKHWCL6B1PROD with NOTICES Forest Service VerDate Mar<15>2010 16:15 Jan 12, 2011 Jkt 223001 Pike & San Isabel Resource Advisory Committee Forest Service, USDA. Notice of meeting. AGENCY: ACTION: The Pike & San Isabel Resource Advisory Committee will meet in Pueblo, Colorado. The committee is meeting as authorized under the Secure Rural Schools and Community SelfDetermination Act (Pub. L. 110–343) and in compliance with the Federal Advisory Committee Act. The purpose of the conference call is for project coordination and understanding. DATES: The meeting will be held on February 10, 2011, and will begin at 9 a.m. ADDRESSES: The conference call will be held at the Supervisor’s Office of the Pike & San Isabel National Forests, Cimarron and Comanche National Grasslands (PSICC) at 2840 Kachina Dr., Pueblo, Colorado. Written comments should be sent to Barbara Timock, PSICC, 2840 Kachina Dr., Pueblo, CO 81008. Comments may also be sent via e-mail to btimock@fs.fed.us, or via facsimile to 719–553–1416. All comments, including names and addresses when provided, are placed in SUMMARY: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 2331 the record and are available for public inspection and copying. The public may inspect comments received at PSICC, 2840 Kachina Dr., Pueblo, CO 81008. Visitors are encouraged to call ahead to 719–553–1415 to facilitate entry into the building. FOR FURTHER INFORMATION CONTACT: Barbara Timock, RAC coordinator, USDA, Pike & San Isabel National Forests, 2840 Kachina Dr., Pueblo, CO 81008; (719) 553–1415; E-mail btimock@fs.fed.us. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday. SUPPLEMENTARY INFORMATION: To understand project proposals and coordination efforts, the PSI–RAC will convene a conference call. No decisions will be made during this call and the RAC will report out at the next meeting. The February 10 conference call is open to the public. The following business will be conducted: (1) Review projects submitted to the Web site, (2) Discuss RAC member liaison efforts, (3) Public Comment. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by February 7, 2011 will have the opportunity to address the Committee at those sessions. Dated: January 7, 2011. John F. Peterson, Designated Federal Official. [FR Doc. 2011–670 Filed 1–12–11; 8:45 am] BILLING CODE 3410–11–P DEPARTMENT OF AGRICULTURE Forest Service Notice of Idaho Panhandle Resource Advisory Committee Meeting Forest Service, USDA. Notice of meeting. AGENCY: ACTION: Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92–463) and under the Secure Rural Schools and Community SelfDetermination Act of 2000 (Pub. L. 110–343) the Idaho Panhandle Resource Advisory Committee will meet Friday, January 21, 2011, at 9 a.m. in Coeur d’Alene, Idaho for a business meeting. The business meeting is open to the public. SUMMARY: DATES: E:\FR\FM\13JAN1.SGM January 21, 2011. 13JAN1

Agencies

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


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

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.

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

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 https://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: https://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 
https://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.

[[Page 2330]]

[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
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