[Federal Register Volume 76, Number 2 (Tuesday, January 4, 2011)]
[Proposed Rules]
[Pages 288-291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33138]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 76, No. 2 / Tuesday, January 4, 2011 / 
Proposed Rules  

[[Page 288]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-TM-07-0136; TM-07-14PR]
RIN 0581-AC77


National Organic Program (NOP); Sunset Review (2011)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would address recommendations submitted to 
the Secretary of Agriculture (Secretary) by the National Organic 
Standards Board (NOSB) on November 5, 2009, and April 29, 2010. The 
recommendations addressed in this proposed rule pertain to the 
continued exemption (use) of 12 substances in organic production and 
handling. Consistent with the recommendations from the NOSB, this 
proposed rule would continue the exemption (use) of 12 substances on 
the U.S. Department of Agriculture's (USDA) National List of Allowed 
and Prohibited Substances (National List) (along with any restrictive 
annotations). These substances were originally added to the National 
List on September 12, 2006.

DATES: Comments must be received by February 3, 2011.

ADDRESSES: Interested persons may submit written comments on this 
proposed rule using the following addresses:
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave., SW., 
Room 2646-So., Ag Stop 0268, Washington, DC 20250.
     Internet: http://www.regulations.gov.
    Written comments responding to this proposed rule should be 
identified with the docket number AMS-TM-07-0136; TM-07-14. You should 
clearly indicate your position to continue the allowance of the 
substances identified in this proposed rule and the reasons for your 
position. You should include relevant information and data to support 
your position (e.g., scientific, environmental, manufacturing, industry 
impact information, etc.). You should also supply information on 
alternative substances or alternative management practices, where 
applicable, that support a change from the current exemption for the 
substance. Only the supporting material relevant to your position will 
be considered.
    It is our intention to have all comments concerning this proposed 
rule, including, names and addresses when provided, whether submitted 
by mail or Internet available for viewing on the Regulations.gov 
(http://www.regulations.gov) Internet site. Comments submitted in 
response to this proposed rule will also be available for viewing in 
person at USDA-AMS, National Organic Program, 1400 Independence Ave., 
SW., Room 2646-South Building, Washington, DC, from 9 a.m. to 12 noon 
and from 1 p.m. to 4 p.m., Monday through Friday, (except official 
Federal holidays). Persons wanting to visit the USDA South Building to 
view comments received in response to this proposed rule are requested 
to make an appointment in advance by calling (202) 720-3252.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Director, Standards 
Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et 
seq., authorizes the establishment of the National List of exempted and 
prohibited substances. The National List identifies synthetic 
substances that may be used in organic production and nonsynthetic 
(natural) substances that are prohibited in organic crop and livestock 
production. The National List also identifies nonagricultural 
nonsynthetic, nonagricultural synthetic and nonorganic agricultural 
substances that may be used in organic handling.
    The exemptions and prohibitions granted under the OFPA are required 
to be reviewed every 5 years by the National Organic Standards Board 
(NOSB). The Secretary of Agriculture has authority under the OFPA to 
renew such exemptions and prohibitions. If they are not reviewed by the 
NOSB within 5 years of their inclusion on the National List and renewed 
by the Secretary, their authorized use or prohibition expires. This 
means that synthetic substances Hydrogen chloride (CAS  7647-
01-0) and Ferric phosphate (CAS  10045-86-0), currently 
allowed for use in organic crop production, will no longer be allowed 
for use after the sunset date, September 12, 2011. This also means that 
Egg white lysozyme (CAS  9001-63-2), L-Malic acid (CAS 
 97-67-6), Microorganisms, Activated charcoal (CAS s 
7440-44-0; 64365-11-3), Cyclohexylamine (CAS  108-91-8), 
Diethylaminoethanol (CAS  100-37-8), Octadecylamine (CAS 
 124-30-1), Peracetic acid/Peroxyacetic acid (CAS  
79-21-0), Sodium acid pyrophosphate (CAS  7758-16-9), and 
Tetrasodium pyrophosphate (CAS  7722-88-5), currently allowed 
for use in organic handling, will no longer be allowed for use after 
the sunset date, September 12, 2011.
    In response to the sunset provisions in the OFPA, the Secretary 
published an Advanced Notice of Proposed Rulemaking (ANPR) (73 FR 
13795) in the Federal Register on March 14, 2008, to announce the 
review of the 12 exemptions authorized under the National Organic 
Program (NOP) regulations. This ANPR also requested public comment on 
the continued use of such substances. The public comment period lasted 
60 days.
    We received 25 comments in response to the ANPR. Comments were 
received from producers, handlers, certifying agents, trade 
associations, organic associations, various industry groups, and a 
university. Some comments addressed more than one substance. We 
received general comments urging that the current listings remain as 
they are currently stated, and one general comment insisting that no 
chemicals should be allowed for use in organic products. Most 
commenters provided specific support for substances that they promoted, 
represented, or relied upon. Specific support was received for the 
following substances: Hydrogen chloride, Ferric phosphate, Egg white 
lysozyme, L-Malic acid, Microorganisms, Activated charcoal, 
Cyclohexylamine, Diethylaminoethanol,

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Octadecylamine, Peracetic acid/Peroxyacetic acid, Sodium acid 
pyrophosphate, and Tetrasodium pyrophosphate.
    The NOSB received additional public comment concerning the pending 
sunset of the 12 substances in response to three Federal Register 
Notices announcing meetings of the NOSB and its planned deliberations 
on recommendations involving Sunset 2011 substances. The three notices 
were published in the Federal Register as follows: March 20, 2009 (74 
FR 11904), September 9, 2009 (74 FR 46411), and March 17, 2010 (75 FR 
12723). The NOSB received further written and oral testimony at these 
public business meetings which occurred in Washington, DC on May 4-6, 
2009, and November 3-5, 2009, and in Woodland, CA on April 26-29, 2010. 
The written comments can be retrieved via http://www.regulations.gov by 
searching for the document ID numbers: AMS-TM-09-0014 (May 2009 
meeting); AMS-TM-09-0060 (November 2009 meeting); and AMS-NOP-10-0021 
(April 2010). The oral comments were recorded in the meeting 
transcripts which are available on the NOP Web site, http://www.ams.usda.gov/nop.
    As a result of the May 2009, November 2009, and April 2010, NOSB 
meetings, and in consideration of the comments received from the ANPR, 
the NOSB recommended that the Secretary renew the 12 exemptions on the 
National List (along with any restrictive annotations). The Secretary 
is issuing this proposed rule to reflect the recommendations of the 
NOSB, from November 2009 and April 2010, and to request public comment 
on the continued exemption (use) of 12 substances on the National List.
    Under the authority of the OFPA, as amended, (7 U.S.C. 6501 et 
seq.), the National List can be amended by the Secretary based on 
proposed amendments developed by the NOSB. Since established, the 
National List has been amended fourteen times, October 31, 2003 (68 FR 
61987), November 3, 2003 (68 FR 62215), October 21, 2005 (70 FR 61217), 
June 7, 2006 (71 FR 32803), September 11, 2006 (71 FR 53299), June 27, 
2007 (72 FR 35137), October 16, 2007 (72 FR 58469), December 10, 2007 
(72 FR 69569), December 12, 2007 (72 FR 70479), September 18, 2008 (73 
FR 54057), October 9, 2008 (73 FR 59479), July 6, 2010 (75 FR 38693), 
August 24, 2010 (75 FR 51919), and December 13, 2010 (75 FR 77521). 
Additionally, proposed amendments to the National List were published 
on November 8, 2010 (75 FR 68505).

II. Overview of Proposed Renewals

    From May 4, 2009, through April 29, 2010, the NOSB reviewed 12 
exemptions that are authorized on the National List and set to expire 
on September 12, 2011. Using the evaluation criteria specified in the 
ANPR for sunset review, the NOSB reviewed these exemptions for 
continued authorization in organic agricultural production and 
handling. As a result of the NOSB's review, the NOSB recommended that 
the Secretary renew the 12 exemptions.
    With respect to the criteria used to make recommendations regarding 
the continued authorization of exemptions and prohibitions, the NOSB's 
decision is based on public comments and applicable supporting evidence 
that expresses a continued need for the use or prohibition of the 
substance(s).
    Concerning criteria used to make recommendations regarding the 
discontinuation of an authorized exempted synthetic substance or 
prohibited nonsynthetic substance, the NOSB's decision, for the 
exempted synthetic substance, is based on public comments and 
applicable supporting evidence that demonstrates the currently 
authorized exempted substance is: (a) Harmful to human health or the 
environment, (b) not necessary to the production of the agricultural 
products because of the availability of wholly nonsynthetic substitute 
products, or (c) inconsistent with organic farming and handling.

Renewals

    After considering all public comments and supporting evidence, the 
NOSB determined that the 12 exemptions demonstrated a continued need 
for authorization in organic agricultural production and handling. On 
November 5, 2009, the NOSB finalized its recommendations on 11 of the 
12 exemptions, and on April 29, 2010, the NOSB finalized its 
recommendation on Ferric phosphate.
    The Agricultural Marketing Service (AMS) has reviewed and concurs 
with the NOSB recommendations. Accordingly, this proposed rule would 
continue the exemptions at Sec.  205.601, along with any restrictive 
annotations, for the following synthetic substances allowed for use in 
organic crop production: Ferric phosphate (CAS  10045-86-0); 
and Hydrogen chloride (CAS  7647-01-0). This proposed rule 
would continue the exemptions at Sec.  205.605(a), along with any 
restrictive annotations, for the following nonsynthetic, 
nonagricultural (nonorganic) substances allowed as ingredients in or on 
processed products labeled as ``organic'' or ``made with organic 
(specified ingredients or food groups(s))'': Egg white lysozyme (CAS 
 9001-63-2); L-Malic acid (CAS  97-67-6); and 
Microorganisms. This proposed rule would continue the exemptions at 
Sec.  205.605(b), along with any restrictive annotations, for the 
following synthetic, nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food groups(s))'': 
Activated charcoal (CAS s 7440-44-0; 64365-11-3); 
Cyclohexylamine (CAS  108-91-8); Diethylaminoethanol (CAS 
 100-37-8); Octadecylamine (CAS  124-30-1); Peracetic 
acid/Peroxyacetic acid (CAS  79-21-0); Sodium acid 
pyrophosphate (CAS  7758-16-9); and Tetrasodium pyrophosphate 
(CAS  7722-88-5).

III. Related Documents

    One advanced notice of proposed rulemaking with request for 
comments was published in Federal Register 73 FR 13795 on March 14, 
2008, to make the public aware that the allowance of 12 synthetic and 
non-synthetic substances in organic production and handling will 
expire, if not reviewed by the NOSB and renewed by the Secretary.

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the 
Secretary to make amendments to the National List based on proposed 
amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of 
OFPA authorize the NOSB to develop proposed amendments to the National 
List for submission to the Secretary and establish a petition process 
by which persons may petition the NOSB for the purpose of having 
substances evaluated for inclusion on or deletion from the National 
List. The National List petition process is implemented under Sec.  
205.607 of the NOP regulations. The current petition process (72 FR 
2167, January 18, 2007) can be accessed through the NOP Web site at: 
http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined not significant for purposes of 
Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new

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and revised regulations in order to avoid unduly burdening the court 
system. This proposed rule is not intended to have a retroactive 
effect.
    States and local jurisdictions are preempted under the OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A governing State official would have to apply to 
USDA to be accredited as a certifying agent, as described in Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) 
from creating certification programs to certify organic farms or 
handling operations unless the State programs have been submitted to, 
and approved by, the Secretary as meeting the requirements of the OFPA.
    Pursuant to Sec.  2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a 
State organic certification program may contain additional requirements 
for the production and handling of organically produced agricultural 
products that are produced in the State and for the certification of 
organic farm and handling operations located within the State under 
certain circumstances. Such additional requirements must: (a) Further 
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) 
not be discriminatory toward agricultural commodities organically 
produced in other States, and (d) not be effective until approved by 
the Secretary.
    Pursuant to Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
proposed rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.), concerning meat, poultry, and 
egg products, nor any of the authorities of the Secretary of Health and 
Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
301 et seq.), nor the authority of the Administrator of EPA under the 
Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 
seq.).
    Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary 
to establish an expedited administrative appeals procedure under which 
persons may appeal an action of the Secretary, the applicable governing 
State official, or a certifying agent under this title that adversely 
affects such person or is inconsistent with the organic certification 
program established under this title. The OFPA also provides that the 
U.S. District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on small entities 
and evaluate alternatives that would accomplish the objectives of the 
rule without unduly burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose is 
to fit regulatory actions to the scale of businesses subject to the 
action. Section 605 of the RFA allows an agency to certify a rule, in 
lieu of preparing an analysis, if the rulemaking is not expected to 
have a significant economic impact on a substantial number of small 
entities.
    Pursuant to the requirements set forth in the RFA, the AMS 
performed an economic impact analysis on small entities in the final 
rule published in the Federal Register on December 21, 2000 (65 FR 
80548). The AMS has also considered the economic impact of this action 
on small entities. The impact on entities affected by this proposed 
rule would not be significant. The effect of this proposed rule would 
be to allow the continued use of additional substances in agricultural 
production and handling. The AMS concludes that the economic impact of 
this addition of allowed substances, if any, would be minimal and 
beneficial to small agricultural service firms. Accordingly, USDA 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, Economic Research Service (ERS) data based on 
information from USDA-accredited certifying agents, the number of 
certified U.S. organic crop and livestock operations totaled nearly 
13,000 and certified organic acreage exceeded 4.8 million acres in 
2008.\1\ ERS, based upon the list of certified operations maintained by 
the NOP, estimated the number of certified handling operations was 
3,225 in 2007.\2\ AMS believes that most of these entities would be 
considered small entities under the criteria established by the SBA.
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    \1\ U.S. Department of Agriculture, Economic Research Service. 
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock 
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
    \2\ U.S. Department of Agriculture, Economic Research Service, 
2009. Data Sets: Procurement and Contracting by Organic Handlers: 
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
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    The U.S. sales of organic food and beverages have grown from $3.6 
billion in 1997 to nearly $21.1 billion in 2008.\3\ The organic 
industry is viewed as the fastest growing sector of agriculture, 
representing over 3 percent of overall food sales in 2009. Between1990 
and 2008, organic food sales have historically demonstrated a growth 
rate between 15 to 24 percent each year. In 2009, organic food sales 
grew 5.1%.\4\
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    \3\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. 
Organic Foods: Recent Trends from Farms to Consumers, Economic 
Information Bulletin No. 58, U.S. Department of Agriculture, 
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
    \4\ Organic Trade Association's 2010 Organic Industry Survey, 
http://www.ota.com.
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    In addition, USDA has 98 accredited certifying agents who provide 
certification services to producers and handlers. A complete list of 
names and addresses of accredited certifying agents may be found on the 
AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that 
most of these accredited certifying agents would be considered small 
entities under the criteria established by the SBA.

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by section 350(h) of the Paperwork Reduction Act of 1995, 44 
U.S.C. 3501, et seq., or OMB's implementing regulations at 5 CFR part 
1320.

E. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB for the continuation of 12 exemptions contained 
on the National List of Allowed and Prohibited Substances. A 30-day 
period for interested persons to comment on this rule is provided. 
Thirty days is deemed appropriate because the expiration of these 12 
substances has been widely publicized, their continued use is critical 
to organic production, and this rulemaking should be completed before 
September 12, 2011.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals,

[[Page 291]]

Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

    The authority citation for 7 CFR part 205 continues to read as 
follows:

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

    Dated: December 22, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing Service.
[FR Doc. 2010-33138 Filed 1-3-11; 8:45 am]
BILLING CODE 3410-02-P