[Federal Register Volume 73, Number 182 (Thursday, September 18, 2008)]
[Rules and Regulations]
[Pages 54057-54059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21785]


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DEPARTMENT OF AGRICULTURE

Agriculture Marketing Service

7 CFR Part 205

[Docket Number AMS-TM-08-0025; TM-08-05FR]
RIN 0581-AC81


National Organic Program; Amendment to the National List of 
Allowed and Prohibited Substances (Livestock)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the U.S. Department of Agriculture's 
(USDA) National List of Allowed and Prohibited Substances (National 
List) to reflect one recommendation submitted to the Secretary of 
Agriculture (Secretary) by the National Organic Standards Board (NOSB) 
on May 22, 2008. Consistent with the recommendation from the NOSB, this 
final rule revises the annotation of one substance on the National 
List, Methionine, to extend its use in organic poultry production until 
October 1, 2010.

DATES: This rule becomes effective September 19, 2008.

FOR FURTHER INFORMATION CONTACT: Richard H. Mathews, Chief, Standards 
Development and Review Branch, Telephone: (202) 720-3252; Fax: (202) 
205-7808.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 21, 2000, the Secretary established, within the NOP [7 
CFR part 205], the National List regulations Sec. Sec.  205.600 through 
205.607. This National List identifies the synthetic substances that 
may be used and the nonsynthetic (natural) substances that may not be 
used in organic production. The National List also identifies 
synthetic, nonsynthetic nonagricultural and nonorganic agricultural 
substances that may be used in organic handling. The Organic Foods 
Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq.), and 
NOP regulations, in Sec.  205.105, specifically prohibit the use of any 
synthetic substance for organic production and handling unless the 
synthetic substance is on the National List. Section 205.105 also 
requires that any nonorganic agricultural and any nonsynthetic 
nonagricultural substance used in organic handling be 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 nine 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), and December 12, 2007 (72 FR 70479). Additionally, an 
amendment to the National List, proposed on July 14, 2008, (73 FR 
40194), is currently pending.
    This final rule amends the National List to reflect one 
recommendation submitted to the Secretary by the NOSB on May 22, 2008.

II. Overview of Proposed Amendment

    The following provides an overview of the proposed amendment to 
Sec.  205.603 of the National List:

[[Page 54058]]

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This final rule amends Sec.  205.603(d)(1) by changing ``2008'' to 
``2010''. Section 205.603(d)(1) now reads as follows:
    DL--Methionine, DL--Methionine--hydroxyl analog, and DL--
Methionine--hydroxyl analog calcium (CAS <greek-i>-59-51-8; 63-68-3; 
348-67-4)--for use only in organic poultry production until October 1, 
2010.

III. Related Documents

    On April 4, 2008, a notice was published in the Federal Register 
(73 FR 18491) announcing the meeting of the NOSB and its planned 
deliberations on recommendations involving the use of Methionine in 
organic poultry production. NOSB meetings are open to the public and 
allow for public participation. The recommendation to extend 
Methionine's use in organic poultry production included in this final 
rule was published as a proposed rule on July 14, 2008 (73 FR 40197).

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/Newsroom/FedReg01_18_07NationalList.pdf.

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. The final rule (68 
FR 61987), dated October 31, 2003, adding Methionine to the National 
List was reviewed under this Executive Order and no additional related 
information has been obtained since then. 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 
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 the 
Environmental Protection Agency 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 et seq.) 
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, 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 current approval for the use of Methionine in organic 
poultry production will expire October 1, 2008. The effect of this 
final rule is to allow the continued use of Methionine through October 
1, 2010. The AMS concludes that this action would have minimal economic 
impact on 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 $6,500,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    The U.S. organic industry at the end of 2001 included nearly 6,949 
certified organic crop and livestock operations. These operations 
reported certified acreage totaling more than 2.09 million acres of 
organic farm production. Data on the numbers of certified organic 
handling operations (any operation that transforms raw product into 
processed products using organic ingredients) were not available at the 
time of survey in 2001; but they were estimated to be in the thousands. 
By the end of 2005, the number of U.S. certified organic crop, 
livestock, and handling operations totaled about 8,500. Based on 2005 
USDA, Economic Research Service, data

[[Page 54059]]

from USDA-accredited certifying agents, U.S. certified organic acreage 
increased to 4 million acres.
    The U.S. sales of organic food and beverages have grown from $1 
billion in 1990 to nearly $17 billion in 2006. The organic industry is 
viewed as the fastest growing sector of agriculture, representing 
almost 3 percent of overall food and beverage sales. Since 1990, 
organic retail sales have historically demonstrated a growth rate 
between 20 to 24 percent each year, including a 22 percent increase in 
2006.
    In 2005, U.S. retail sales of organic poultry products were $161 
million. The growth rate for organic poultry retail sales is estimated 
at between 23 and 38 percent per year. Organic egg sales were $161 
million in 2005 and are projected to grow at a rate of 8 to 13 percent 
per year. The organic industry, in 2005, raised approximately 13.8 
million birds. Organic poultry is raised in 40 of the 50 states. In 
addition to being sold as whole products, organic eggs and poultry are 
used in the production of organic processed products such as eggnog, 
ice cream, soups, broth, noodles, French toast, pancakes, waffles, 
tartar sauce, hollandaise sauce, mayonnaise, salad dressing, cookies, 
cakes, cheese cakes, bread, and other bakery goods.
    In addition, USDA has 95 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 entities 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 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.
    The AMS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies in general 
to provide the public the option of submitting information or 
transacting business electronically to the maximum extent possible.
    The AMS is committed to complying with the E-Government Act, to 
promote the use of the Internet and other information technologies to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

E. Discussion of Comments Received

    Six (6) comments were received on the proposed revision to extend 
the use of synthetic Methionine in organic poultry production until 
October 1, 2010. Comments were received from a consumer, a poultry 
producer, a trade association, a Cooperative, and 2 accredited 
certifying agents. Two (2) comments opposed and 4 supported extending 
the current authorization for the use of synthetic Methionine.
    One or more of the comments in support of the extension either 
acknowledged the need to continue to look for substitutes or find 
alternatives for Methionine or supported the Board's efforts in this 
regard. Comments in opposition were received from a consumer and a 
poultry producer associated with an accredited certifying agent who 
forwarded a comment from the accredited certifying agent. The consumer 
opposed the use of synthetic substances in organic production in 
general. The poultry producer opposed extended authorization for the 
use of Methionine and claims to be raising broiler and breeder chickens 
and turkeys without the use of Methionine. Neither commenter provided 
any evidence that the National Organic Standards Board's recommendation 
to extend the authorization for Methionine was in error or that wholly 
natural substitute products are presently available in sufficient 
supplies to meet poultry producer needs. After full consideration of 
these comments, we have determined that the record supports extension 
of the authorized use of Methionine until October 1, 2010. This 
extension will provide the organic feed sector with the time to create 
sufficient supplies of wholly natural substitute products.

F. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB for extending the use of Methionine, a synthetic substance, 
in organic poultry production until October 1, 2010. The NOSB evaluated 
this substance using criteria in the OFPA. The substance's evaluation 
was initiated by a petition from the Methionine Task Force.
    The NOSB determined that while wholly natural substitute products 
exist, they are not presently available in sufficient supplies to meet 
poultry producer needs. Therefore, synthetic Methionine is presently a 
necessary component of a nutritionally adequate diet for organic 
poultry. Loss of the use of Methionine, at this time, would disrupt the 
well-established organic poultry market and cause substantial economic 
harm to organic poultry operations, as well as to organic handling 
operations that rely on organic eggs and poultry in the production of 
organic processed products.
    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 because 
this rulemaking should be completed before the use of Methionine 
expires for organic poultry operations on October 1, 2008.

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.

0
For the reasons set forth in the preamble, 7 CFR part 205, subpart G is 
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

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


Sec.  205.603   [Amended]

0
2. Section 205.603(d)(1) is amended by removing ``2008'' and adding 
``2010''in its place.

    Dated: September 12, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E8-21785 Filed 9-17-08; 8:45 am]
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