[Federal Register Volume 73, Number 135 (Monday, July 14, 2008)]
[Proposed Rules]
[Pages 40197-40201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15390]
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DEPARTMENT OF AGRICULTURE
Agriculture Marketing Service
7 CFR Part 205
[Docket Number AMS-TM-08-0025; TM-08-05PR]
RIN 0581-AC81
National Organic Program; Proposed Amendment to the National List
of Allowed and Prohibited Substances (Livestock)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would amend 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 proposed rule would revise the annotation of one
substance on the National List, Methionine, to extend its use in
organic poultry production until October 1, 2010.
DATES: Comments must be received by August 13, 2008.
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-TMP-NOP, 1400
[[Page 40198]]
Independence Ave., SW., Room 4008-So., Ag Stop 0268, Washington, DC
20250.
Internet: www.regulations.gov.
Written comments responding to this proposed rule should be
identified with the docket number AMS-TM-08-0025. You should clearly
indicate your position on the proposed continued allowance for the use
of methionine in poultry production until October 1, 2010. You should
clearly indicate 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.). Finally, you should also supply information on alternative
substances or alternative management practices, where applicable, that
support a change from the current exemption for methionine. 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
(www.regulations.gov) Internet site. Comments submitted in response to
this proposed rule will also be available for viewing in person at
USDA-AMS, Transportation and Marketing Programs, National Organic
Program, Room 4008--South Building, 1400 Independence Ave., SW.,
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: 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).
This proposed rule would amend the National List to reflect one
recommendation submitted to the Secretary by the NOSB on May 22, 2008.
Based on their evaluation of a petition submitted by industry
participants, the NOSB recommended that the Secretary amend Sec.
205.603(d)(1) of the National List by revising the annotation of
Methionine, a feed additive, to extend its use in organic poultry
production until October 1, 2010. The use of Methionine in organic
production was evaluated by the NOSB using the evaluation criteria
specified in OFPA (7 U.S.C. 6517-6518).
II. Overview of Proposed Amendment
The following provides an overview of the proposed amendment to
Sec. 205.603 of the National List:
Section 205.603 Synthetic Substances Allowed for Use in Organic
Livestock Production
This proposed rule would amend Sec. 205.603(d)(1) by changing
``2008'' to ``2010''. Section 205.603(d)(1) would now read as follows:
DL--Methionine, DL--Methionine-hydroxyl analog, and DL--Methionine-
hydroxyl analog calcium (CAS -59-51-8; 63-68-3; 348-67-4)--for
use only in organic poultry production until October 1, 2010.
Methionine was petitioned for its continued use as a synthetic feed
additive in organic poultry operations. Methionine is a colorless or
white crystalline powder that is soluble in water. It is classified as
an amino acid and considered to be an essential amino acid that is
regulated as an animal feed nutritional supplement by the Food and Drug
Administration (21 CFR 582.5475).
Methionine was originally included on the National List on October
31, 2003, with an early expiration date of October 21, 2005, (the
normal time period for the use of a substance contained in the National
List is five years, beginning with the date the substance appears on
the National List regulations). Methionine was petitioned by organic
livestock producers as a part of the NOSB's 1995 initial review of
synthetic amino acids considered for use in organic livestock
production. The petitioners asserted that Methionine was a necessary
dietary supplement for organic poultry, due to an inadequate supply of
organic feeds containing sufficient concentrations of naturally-
occurring Methionine. Petitioners suggested synthetic Methionine would
be fed as a dietary supplement to organic poultry at levels ranging
from 0.3 to 0.5 percent of the animal's total diet. The petitioners
also asserted that a prohibition on the use of synthetic Methionine
would contribute to nutritional deficiencies in organic poultry thereby
jeopardizing the animal's health. After consideration of the
justification provided for the inclusion of Methionine and an
assessment under the evaluation criteria provided in OFPA (7 U.S.C.
6517-6518), the NOSB considered the use of synthetic Methionine to be
consistent with OFPA and recommended its inclusion onto the National
List for use in organic poultry production with an early expiration on
its use (October 21, 2005). The NOSB recommended an early expiration on
the use of Methionine to encourage the organic poultry industry to
phase out the use of synthetic Methionine in poultry diets and develop
non-synthetic alternatives to its use as a feed additive.
On January 10, 2005, two organic poultry producers petitioned the
NOSB to extend the use of Methionine in organic poultry production
beyond October 21, 2005. The petition was filed because the organic
poultry industry had been unable to develop suitable non-synthetic
alternatives for synthetic Methionine in organic poultry diets. The
petition sought additional time for development of non-synthetic
alternatives. Preliminary research results on nonsynthetic alternatives
to synthetic Methionine was provided to the NOSB. Although considered
inconclusive, the preliminary results demonstrated that research trials
were underway to identify non-synthetic alternatives for phasing out
synthetic Methionine in organic poultry diets.
[[Page 40199]]
The NOSB, at its February 28-March 3, 2005, meeting in Washington,
DC, received and evaluated public comment on the petition to extend the
use of Methionine in organic poultry production beyond October 21,
2005. The NOSB concluded that Methionine is consistent with the
evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA; however, the
NOSB maintained that non-synthetic alternatives must be developed
during the additional extension on the use of synthetic Methionine in
organic poultry diets. Therefore, the NOSB recommended Methionine be
added to the National List for use only in organic poultry production
until October 1, 2008, so that the organic poultry industry could
continue its research to develop non-synthetic alternatives for the use
of synthetic Methionine.
In response to the NOSB recommendation of March 3, 2005, Sec.
205.603(d)(1) of the National List was amended (Friday, October 21,
2005, 70 FR 61217) to allow the use of Methionine in organic poultry
production until October 1, 2008.
This proposed rule reflects recommendations submitted to the
Secretary by the NOSB, at its May 2008 meeting, for extending the use
of Methionine in organic poultry production until October 1, 2010. The
NOSB evaluated this substance using criteria in the OFPA.
The substance's evaluation was initiated after receipt, by
Agricultural Marketing Service (AMS), of a petition filed in December
2007 by the Methionine Task Force (MTF). The MTF requested that Sec.
205.603(d)(1) be amended by removing the annotation date of ``October
8, 2008.'' They also requested that Methionine, in the future, undergo
the standard sunset process for review of materials on the National
List. The MTF petition addresses the status of the most viable
alternatives to synthetic Methionine and agrees that none of the
alternatives are currently commercially available.
Additionally, in response to the December 28, 2007, Advanced Notice
of Proposed Rulemaking (ANPR) (72 FR 73667) announcing the 2008 sunset
review of 12 substances on the National List, AMS received six comments
supporting the relisting of DL--Methionine, DL--Methionine-hydroxyl
analog, and DL--Methionine-hydroxyl analog calcium (CAS --59-
51-8; 63-68-3; 348-67-4). Because these substances have an expiration
date (October 1, 2008) recommended by the NOSB and established by
rulemaking, they were not included in the 2008 sunset review. These
comments, however, have been considered by the NOSB in developing their
recommendation and by the AMS in developing this proposed rule.
The NOSB, at its May 20-22, 2008, meeting in Baltimore, Maryland,
received and evaluated public comment on the petition to extend the use
of Methionine in organic poultry production beyond October 1, 2008. The
NOSB also considered comments received, regarding the need for
Methionine, at its November 2007 meeting in Washington, DC.
The NOSB has determined that while wholly natural substitute
products exist, they are not presently available in sufficient supplies
to meet poultry producers needs. Thus, the NOSB concluded that
synthetic Methionine remains 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. To
prevent disruption to the organic poultry market, while the organic
feed sector creates sufficient supplies of wholly natural substitute
products, the NOSB has recommended extending the allowed use of
Methionine in poultry production until October 1, 2010.
AMS has reviewed and concurs with the NOSB's recommendation.
The organic industry, in 2005, raised approximately 13.8 million
birds, had organic poultry products sales of $161 million and organic
egg sales of another $161 million. In addition to being sold as whole
products, organic eggs and poultry are sold for use 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. Accordingly, it is not just the organic poultry
market that would be adversely impacted should producers lose the use
of Methionine at this time. Processors would likely be faces with
sourcing conventional eggs and poultry, the use of which would
disqualify their products from being labeled ``organic.'' Only organic
agricultural ingredients are allowed in products labeled as ``organic''
unless the agricultural ingredient has been added to the National List
and determined commercially unavailable.
III. Related Documents
Since September 2001 three notices have been published announcing
meetings of the NOSB and its planned deliberations on recommendations
involving the use of Methionine in organic poultry production. The
three notices were published in the Federal Register as follows: (1)
September 21, 2001 (66 FR 48654), (2) February 11, 2005 (70 FR 7224),
and (3) April 4, 2008 (73 FR 18491). Methionine was first proposed for
addition to the National List in the Federal Register on April 16, 2003
(68 FR 18556). Methionine was added to the National List by final rule
in the Federal Register on October 31, 2003 (68 FR 61987). A proposal
to amend the annotation for Methionine was published in the Federal
Register on July 29, 2005 (70 FR 43786). The annotation for Methionine
was amended by final rule in the Federal Register on October 21, 2005
(70 FR 61217).
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
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
[[Page 40200]]
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 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 proposed 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
proposed rule would be 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 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 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.
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. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted to the
Secretary by the NOSB for extending the
[[Page 40201]]
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 MTF.
The NOSB has 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. Thus, 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. Accordingly,
the NOSB has recommended extending the allowed use of synthetic
Methionine in poultry production until October 1, 2010.
AMS believes that a 30-day period for interested persons to comment
on this rule is appropriate because the continued use of Methionine is
critical to organic production, and this rulemaking should be completed
before October 1, 2008, to avoid any disruptions to the market place.
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.
For the reasons set forth in the preamble, 7 CFR part 205, subpart
G is proposed to be amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
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]
2. Section 205.603(d)(1) is amended by removing ``2008'' and adding
``2010'' in its place.
Dated: July 1, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E8-15390 Filed 7-11-08; 8:45 am]
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