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[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Rules and Regulations]
[Pages 46595-46597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19659]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

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Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / 
Rules and Regulations

[[Page 46595]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

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

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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule addresses 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 final rule pertain to the continued 
exemption (use) of 12 substances in organic production and handling. 
Consistent with the recommendations from the NOSB, this final rule 
continues the exemption (use) of 12 substances (along with any 
restrictive annotations) on the U.S. Department of Agriculture's (USDA) 
National List of Allowed and Prohibited Substances (National List).

DATES: Effective Date: This final rule becomes effective September 12, 
2011.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, PhD, 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 Allowed and 
Prohibited Substances (National List). 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.
    This final rule reflects recommendations submitted to the Secretary 
by the NOSB concerning the continued use of 12 substances on the 
National List in organic production and handling. Consistent with the 
recommendations from the NOSB, this final rule renews 12 exemptions on 
the National List (along with any restrictive annotations).
    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 
recommendations developed by the NOSB. Since established, the NOP has 
published fourteen amendments to the National List: 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), and a final rule affirming 
a previous amendment was published on March 14, 2011 (76 FR 13504).

II. Overview of Renewals

    The following provides an overview of the renewals for designated 
sections of the National List regulations:

Renewals

    This final rule continues 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 final rule continues 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 final rule continues 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).

Nonrenewals

    The NOSB determined that a continuing need was demonstrated for the 
authorization of the 12 exemptions. In addition, most comments received 
on the proposed rule (76 FR 2880)

[[Page 46596]]

supported renewal of all 12 exemptions. Accordingly, there are no 
nonrenewals.

III. Related Documents

    One advanced notice of proposed rulemaking with request for 
comments was published in the Federal Register on March 14, 2008 (73 FR 
13795), to make the public aware that the allowance for 12 synthetic 
and nonsynthetic substances in organic production and handling will 
expire, if not reviewed by the NOSB and renewed by the Secretary. The 
proposed rule for this final rule was published in the Federal Register 
on January 4, 2011 (76 FR 288).

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/AMSv1.0/.

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 and revised regulations 
in order to avoid unduly burdening the court system. This final 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 
final 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 final rule 
would not be significant. The effect of this final 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

[[Page 46597]]

food sales in 2009. Between 1990 and 2008, organic food sales 
historically demonstrated a growth rate between 15 to 24 percent each 
year. In 2010, organic food sales grew 7.7%.\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 2011 Organic Industry Survey, 
http://www.ota.com.
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    In addition, USDA has 94 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 final rule. Accordingly, OMB clearance is not 
required by Sec.  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. Comments Received on Proposed Rule AMS-TM-07-0136

    AMS received nine comments on proposed rule AMS-TM-07-0136. 
Comments were received from an organic producer, trade associations, 
handlers, and private citizens. Most comments expressed positions in 
support of the 12 substances considered under this sunset review. One 
individual did not refer to subjects within the scope of this 
rulemaking.
    Some commenters specifically supported substances that they 
promote, represent, or rely on. A comment submitted in support of 
Ferric phosphate emphasized the importance of the substance to reduce 
snail damage on organic crops. A comment received on Hydrogen chloride 
voiced that there are no good alternatives to the use of the substance 
for removal of residual lint from ginned cottonseed, a process 
necessary to facilitate mechanical planting. A comment received on Egg 
white lysozyme stated that the substance is essential for organic wine 
production. A comment submitted in support of L-Malic acid underscored 
that no alternatives exist for this substance and stated its importance 
as a processing aid for pH adjustment in organic products. Multiple 
comments received on Microorganisms emphasized the critical need for 
microorganisms in organic food processing for production of dairy, 
bread, fruit, vegetable, and meat products. Comments received in 
support of the allowance for Activated charcoal confirmed the necessity 
of this substance as a filtering aid in organic processing. Comments 
submitted supporting the allowance for the substances Cyclohexylamine, 
Diethylaminoethanol, and Octadecylamine, all boiler water additives, 
stated that these substances are important for packaging sterilization. 
Comments supporting the use of Peracetic acid/Peroxyacetic acid for 
sanitizing food contact surfaces indicated that there are no 
alternative materials with equivalent functionality. One comment 
submitted in support of Sodium acid pyrophosphate stated that without 
the allowance for this substance as a leavening agent, many organic 
baked goods would no longer be available because a satisfactory 
alternative does not exist. The same commenter also emphasized the 
necessity of Tetrasodium pyrophosphate in the manufacturing of meat 
analog products to facilitate proper flow in the extrusion process and 
ensure the development of suitable product texture. Overall, at least 
one comment was received in favor of renewal for all 12 substances 
considered under this sunset review.
Changes Requested But Not Made
    One commenter opposed the continued use of six of the 12 
substances: Cyclohexylamine, Diethylaminoethanol, Octadecylamine, 
Peracetic acid/Peroxyacetic acid, Sodium acid pyrophosphate, and 
Tetrasodium pyrophosphate. The commenter based their objection on the 
safety of the substances as described in the material safety data 
sheets (MSDS) for each substance and recommended removal of these 
substances from the National List. However, the NOSB reviewed these 
substances against the evaluation criteria in 7 U.S.C. 6517 and 6518 of 
the OFPA, and found that when these substances are used as limited by 
the annotations for each substance, they do not pose any danger to the 
environment or to manufacturing personnel or consumers. The NOSB 
concluded that these substances remain essential to organic production 
since no organic alternatives exist and recommended that the exemption 
for these substances on the National List continue. The NOP concurs 
with the NOSB's evaluation and recommendation of these substances and, 
therefore, does not find that sufficient information was provided by 
the commenter to justify the removal of these substances from the 
National List.

F. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C. 
6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the NOSB to 
review each substance on the National List within 5 years of its 
publication. The substances being reauthorized for use on the National 
List were initially authorized for use in organic agriculture on 
September 12, 2006. Because these substances are critical to organic 
production and handling operations, producers and handlers should be 
able to continue to use these substances for a full 5-year period 
beyond their expiration date of September 12, 2011.
    Accordingly, pursuant to 5 U.S.C. 553, it is found and determined 
that good cause exists for not postponing the effective date of this 
rule until 30 days after publication in the Federal Register. This rule 
shall be effective on September 12, 2011.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals, 
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: July 28, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2011-19659 Filed 8-2-11; 8:45 am]
BILLING CODE 3410-02-P
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