National Organic Program; Amendment to the National List of Allowed and Prohibited Substances (Livestock), 51919-51924 [2010-20977]
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for about 35% of program revenue
before their fees were phased out by the
1995 Amendments to the Act. Today,
retailers account for 28.6% of all PACA
licensees. However, since only new
applicants pay a processing fee, retailers
contribute little to PACA’s annual
operating revenue. The fee increase will
have no impact on operating costs of
retailers and grocery wholesalers.
Therefore, retailers and grocery
wholesalers will not be unduly
burdened by the final rule.
Wholesalers, processors, food service
companies, commission merchants,
dealers, brokers, and truckers are
considered to be dealers and subject to
license when they buy or sell more than
2,000 pounds of fresh and/or frozen
fruits and vegetables in any given day.
This group represents the remaining
10,361 active, ‘‘paying’’ PACA licensees
and is the only group impacted by the
fee increase.
While the annual revenues of this
group of agricultural service firms is
unknown, we estimated a significant
percentage of these firms have annual
receipts less than $7,000,000. Therefore,
the businesses are ‘‘small businesses’’
within the meaning of that term in the
RFA. A large number of these small
agricultural service firms will be
impacted by the PACA license fee
increase. While the maximum amount
of the PACA license fee is to be $8,000,
this increase will impact a small
number of larger firms with multiple
branches. Currently, only 56 licensees
(or 0.0039%) of all PACA licensees
would pay the $8,000 maximum. The
fee structure in the final rule was
designed so most firms would only see
the annual fee increase from $550 per
year to $995. This $445 fee increase is
believed to be a minor increase in
operating costs to these firms and is
more than offset by the protection
provided to these firms under the
PACA. Larger firms operating at
multiple branch locations would face
larger fee increases. As the renewal of
PACA licenses has become highly
automated and renewal notices are sent
to all licensees well before the renewal
date, elimination of the option biennial
or triennial licenses should not impose
a substantial burden upon small
businesses holding such licenses.
All fruit and vegetable traders that
handle less than 2,000 pounds of fresh
and/or frozen fruits and vegetables are
exempt from the PACA license
requirement and would not be subject to
this fee increase. These firms would be
considered very small and handle a
relatively minor volume of total fresh
and/or frozen fruits and/or vegetables
marketed.
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On February 24, 2009 the USDA Fruit
and Vegetable Industry Advisory
Committee unanimously recommended
to the Secretary of Agriculture their
approval of the proposed license fee
increase.
Paperwork Reduction Act
In accordance with Office of
Management and Budget (OMB)
regulations (5 CFR part 1320) that
implement the Paperwork Reduction
Act of 1995 (44 U.S.C. Chapter 35), the
information collection and
recordkeeping requirements are
currently approved under OMB number
0581–0031. The forms covered under
this information collection require the
minimum information necessary to
effectively carry out the requirements of
the order, and their use is necessary to
fulfill the intent of the PACA as
expressed in the order, and the rules
and regulations issued under the order.
E-Government Act Compliance
AMS is committed to complying with
the E-Government Act, which requires
Government agencies in general to
provide the public the option of
submitting information or transacting
business electronically to the maximum
extent possible. License application
forms are available on our PACA Web
site at https://www.ams.usda.gov/PACA
and can be printed, completed, and
faxed. Currently, forms are transmitted
by fax machine and postal delivery. The
PACA Branch is working towards
furthering the availability of online
forms.
List of Subjects in 7 CFR Part 46
Agricultural commodities, Brokers,
Penalties, Reporting and recordkeeping
requirements.
■ For reasons set forth in the preamble,
7 CFR part 46 is amended as follows:
PART 46—[AMENDED]
1. The authority citation for part 46 is
revised to read as follows:
■
Authority: 7 U.S.C. 499a–499t.
2. In § 46.6, paragraphs (a) and (b) are
revised to read as follows:
■
§ 46.6
License fees.
(a) Retailers and grocery wholesalers
making an initial application for license
shall pay a $100 administrative
processing fee.
(b) For commission merchants,
brokers, and dealers (other than grocery
wholesalers and retailers) the annual
license fee is $995 plus $600 for each
branch or additional business facility. In
no case shall the aggregate annual fees
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51919
paid by any such applicant exceed
$8,000.
*
*
*
*
*
■ 3. In § 46.9, paragraph (k) is revised
and paragraph (l) is removed to read as
follows:
§ 46.9 Termination, suspension,
revocation, cancellation of licenses;
notices; renewal.
*
*
*
*
*
(k) Only a commission merchant,
broker, or dealer holding a multi-year
license, prior to phase out of this option,
will receive a refund if business
operations cease or a change in legal
status occurs that requires issuance of a
new license prior to the next license
renewal date. If a refund is due, it will
be issued for any remaining full-year
portion of advance fee paid, minus a
$100 processing fee.
Dated: August 17, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2010–20978 Filed 8–23–10; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–10–0051;
NOP–10–04IR]
RIN 0581–AD04
National Organic Program;
Amendment to the National List of
Allowed and Prohibited Substances
(Livestock)
Agricultural Marketing Service,
USDA.
ACTION: Interim rule with request for
comments.
AGENCY:
This interim rule amends the
U.S. Department of Agriculture’s
(USDA) National List of Allowed and
Prohibited Substances (National List) to
incorporate a recommendation
submitted to the Secretary of
Agriculture (Secretary) by the National
Organic Standards Board (NOSB) on
April 29, 2010. Consistent with the
recommendation from the NOSB, this
interim rule revises the annotation of
one substance on the National List,
methionine, to extend its use in organic
poultry production until October 1,
2012, at the following maximum levels
of synthetic methionine per ton of feed:
Laying chickens—4 pounds; broiler
chickens—5 pounds; turkeys and all
SUMMARY:
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other poultry—6 pounds. Comments are
requested on this interim rule.
On April 29, 2010, the NOSB also
recommended to extend the allowance
for synthetic methionine beyond
October 1, 2012, to October 1, 2015, and
decrease the maximum level of
synthetic methionine permitted per ton
of feed ration to the following levels: 2
pounds for laying and broiler chickens,
and 3 pounds for turkeys and all other
poultry. The NOSB further
recommended that consideration of
synthetic methionine after its
anticipated October 1, 2015 expiration
should take place through the Board’s
sunset review process rather than
through the petition process. The
Secretary intends to incorporate the
NOSB’s recommended reductions in
allowable levels in a subsequent
rulemaking to address the allowance for
synthetic methionine for the period
between October 1, 2012, and October
15, 2015.
DATES: Effective Date: This interim rule
becomes effective October 1, 2010. All
comments received by October 25, 2010
will be considered prior to the issuance
of a final rule. The agency will publish
the final rule no later than March 2011.
ADDRESSES: Interested persons may
submit written comments on this
interim rule using the following
addresses:
• Internet: https://
www.regulations.gov.
• 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.
Written comments responding to this
interim rule should be identified with
the docket number AMS–NOP–10–0051;
NOP–10–04. You should clearly state
whether you support the amendment of
the annotation for the continued
allowance of synthetic methionine in
poultry production until October 1,
2012, at the maximum levels per ton of
synthetic methionine in the feed ration,
with clearly indicated reason(s) for your
position. You should also offer any
recommended language changes that
would be appropriate for your position.
Please include relevant information and
data to support your position (e.g.,
scientific, environmental,
manufacturing, industry, impact
information, etc.). Only relevant
material supporting your position
should be submitted.
It is our intention to have all
comments concerning this interim rule,
including names and addresses when
provided, whether submitted by mail or
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Internet, available for viewing on the
Regulations.gov (https://
www.regulations.gov) Internet site.
Comments submitted in response to this
interim rule will also be available for
viewing in person at USDA, AMS,
National Organic Program, Room 2646–
South Building, Stop 0268, 1400
Independence Ave., SW., Washington,
DC 20250, 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 interim rule
are requested to make an appointment
in advance 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 20250–0268.
Telephone: (202) 720–3252.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary
established within the NOP [7 CFR part
205] the National List regulations
§§ 205.600 through 205.607. The
National List identifies synthetic
substances that may be used in organic
production and nonsynthetic (natural)
substances that may not be used. The
National List also identifies
nonagricultural nonsynthetic,
nonagricultural synthetic, and
nonorganic agricultural substances that
may be used in organic production and
handling.
The Organic Foods Production Act of
1990 (OFPA), as amended (7 U.S.C.
6501–6522), and NOP regulations
§ 205.105 specifically prohibit the use of
any synthetic substance for organic
production and handling unless
provided on the National List. Section
205.105 also requires that any
nonorganic agricultural or nonsynthetic
nonagricultural substance used in
organic handling be on the National
List. Under the OFPA, the NOSB
reviews exemptions for allowed
synthetic substances every 5 years. If the
NOSB recommends renewal, then the
Secretary has authority under the OFPA
to renew such exemptions. If they are
not reviewed by the NOSB and renewed
by the Secretary within 5 years of their
inclusion on the National List, their
authorized use expires.
Under the authority of the OFPA, 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 twelve times: October 31,
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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);
and July 6, 2010 (75 FR 38693).
Additionally, a proposed amendment to
the National List was published on June
3, 2009 (74 FR 26591).
II. Overview of Amendment
This interim rule amends the National
List to reflect a recommendation
adopted by the NOSB on April 29, 2010,
and subsequently forwarded to the
Secretary. The NOSB reviewed the use
of synthetic methionine in organic
poultry production using the evaluation
criteria specified in OFPA (7 U.S.C.
6517–6518) and the Secretary has
reviewed the NOSB’s recommendation.
The current listing of synthetic
methionine will expire on October 1,
2010. This rule is issued to ensure the
continued use of synthetic methionine
after this date and avoid any disruption
to the organic poultry market. A final
rule will be issued no later than March
2011. The record indicates that the
provision of methionine, the use of
which is currently allowed, remains an
essential dietary component for poultry
in organic production and issuance of
this interim rule maintains its use.
Section 205.603 Synthetic Substances
Allowed for Use in Organic Livestock
Production
This interim rule amends
§ 205.603(d)(1) by changing ‘‘October 1,
2010’’ to ‘‘October 1, 2012’’ and imposing
maximum levels based on each ton of
feed ration. Section 205.603(d)(1) now
reads 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, 2012, at
the following maximum levels of synthetic
methionine per ton of feed: Laying
chickens—4 pounds; broiler chickens—5
pounds; turkeys and all other poultry—6
pounds.
Methionine was originally included
on the National List on October 31,
2003, with an early expiration date of
October 21, 2005 (the normal allowance
for a substance added to the National
List is five years from the listing date).
It is a colorless or white crystalline
powder that is soluble in water.
Methionine is classified as an essential
amino acid because it cannot be
biologically produced by poultry and is
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necessary to maintain viability. Natural
feed sources with high percentages of
methionine include bloodmeal, fish
meal, crab meal, corn gluten meal, and
sunflower seed meal. It is regulated as
an animal feed nutritional supplement
by the Food and Drug Administration
(21 CFR 582.5475). Organic livestock
producers had petitioned the substance
as a part of the NOSB’s initial review of
synthetic amino acids. The petitioners
asserted that methionine was a
necessary dietary supplement for
organic poultry and that there was an
inadequate supply of allowable organic
feeds containing sufficient
concentrations of naturally occurring
methionine. Petitioners suggested that
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
animals’ health. After reviewing a
Technical Advisory Panel analysis of
the evaluation criteria provided in the
OFPA (7 U.S.C. 6517–6518), the NOSB
determined that the use of synthetic
methionine was consistent with a
system of organic production. On
October 16, 2001, the NOSB
recommended that the Secretary include
methionine on the National List of
Allowed Synthetics for use in organic
poultry production with an early
expiration date (October 21, 2005). The
NOSB recommended the early
expiration date to encourage organic
producers to phase out synthetic
methionine as a feed additive by
identifying and incorporating natural
and allowable sources into poultry
diets.
On January 10, 2005, two organic
poultry producers petitioned the NOSB
to extend the use of synthetic
methionine in organic poultry
production beyond October 21, 2005.
The producers stated that they had been
unable to develop suitable natural
alternatives for synthetic methionine in
organic poultry diets. The petitioners
requested the extension to provide
additional time for the development of
these alternatives. The petition included
preliminary research results on natural
sources of methionine that highlighted
the challenge of meeting the
maintenance requirements for poultry
with allowed organic and natural feed
ingredients. Although inconclusive, the
preliminary results demonstrated that
research trials were underway to
identify natural alternatives that could
lead to phasing out synthetic
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methionine from organic poultry
production. At its February 28–March 3,
2005, meeting in Washington, DC, the
NOSB received public comment on the
petition to extend the use of synthetic
methionine in organic poultry
production beyond October 21, 2005.
While concluding that synthetic
methionine was consistent with the
evaluation criteria of 7 U.S.C. 6517 and
6518 of the OFPA, the NOSB did not
recommend a full five-year allowance
for the material. The Board continued to
express its strong preference for the
development of natural methionine
sources for organic poultry production.
Therefore, the NOSB recommended that
synthetic methionine remain on the
National List but only until October 1,
2008. In response to this
recommendation, the Secretary
amended § 205.603(d)(1) of the National
List on October 21, 2005 (70 FR 61217),
to allow the use of synthetic methionine
in organic poultry production until
October 1, 2008.
In December 2007, a coalition of
producers identified as the Methionine
Task Force (MTF) filed a petition
requesting that § 205.603(d)(1) be
amended by removing the expiration
date of ‘‘October 1, 2008.’’ They also
requested that in the future methionine
receive the standard sunset review
process for materials on the National
List. Their petition addressed the status
of the most viable alternatives to
synthetic methionine and stated that
none of the alternatives were yet
commercially viable. Additionally, AMS
received six comments supporting the
re-listing of synthetic methionine in
response to the December 28, 2007 (72
FR 73667), Advanced Notice of
Proposed Rulemaking announcing the
2008 Sunset Review of 12 substances on
the National List. Because methionine
was due to expire on October 1, 2008,
as established by rulemaking, it was not
included among the 12 substances in
the 2008 Sunset Review.
The NOSB evaluated public comment
on the petition to extend the use of
synthetic methionine in organic poultry
production beyond October 1, 2008, and
also considered comments on the
subject from its November 2007
meeting. The NOSB determined that
while certain allowable organic and
natural sources of methionine existed,
they were not available in sufficient
supplies to meet poultry producers’
needs. Thus, the NOSB concluded that
synthetic methionine was a necessary
component of a nutritionally adequate
diet for organic poultry, and, therefore,
essential to organic production. The
Board also concluded that terminating
the allowance for its use would disrupt
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51921
the well-established organic poultry
market and cause substantial economic
harm to organic poultry producers but
did not recommend a full five-year
allowance for the material. The NOSB
and stakeholders including the MTF
agreed that the organic feed sector
would continue to research and develop
sufficient supplies of allowable organic
and natural sources in the interim and
thus the NOSB recommended to extend
the use of methionine for two more
years. The Secretary concurred with the
NOSB recommendation to extend the
use of synthetic methionine in poultry
production until October 1, 2010, and
amended the regulation accordingly on
September 18, 2008 (73 FR 54057).
The MTF submitted a new petition on
July 31, 2009, requesting a five-year
extension on the allowance for synthetic
methionine. The request proposed to
limit the total amount of synthetic
methionine to be fed over the life of the
bird calculated as the average pounds of
the material per ton of feed. The MTF
petition proposed these limits at 4
pounds for laying chickens, 5 pounds
for broiler chickens and 6 pounds for
turkeys and all other poultry per ton of
feed. The petitioners stated that these
levels of synthetic methionine are the
amount necessary to support the
animals’ basic maintenance
requirements and would not provide
growth enhancement. In requesting the
five-year allowance, the MTF cited
research efforts in recent years that have
attempted but failed to identify wholly
natural and allowable sources of
methionine capable of providing
poultry’s basic maintenance
requirement.
The NOSB Livestock Committee
reviewed the MTF petition and rejected
it. The Livestock Committee stated that
averaging the pounds of synthetic
methionine fed over the life of the bird
would result in the unacceptable
outcome of even higher levels being fed
at certain stages. The Livestock
Committee instead pointed towards
future modifications to the livestock
feed and living conditions practice
standards that would lead to higher
levels of natural methionine in poultry
feed rations. However, the Livestock
Committee agreed with the MTF that
wholly natural sources of methionine
are not now and would not likely be
widely available in the immediate
future and that extending the allowance
for the synthetic form was warranted.
The Livestock Committee proposed an
annotation to the synthetic methionine
listing that reflected their reservations
about the petitioner’s request, but
acknowledged that an allowance for the
synthetic form would be necessary
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throughout the next five years. They
proposed to extend the allowance for
synthetic methionine in organic poultry
production for five years until October
1, 2015, with a step down in the amount
allowed after two years. They proposed
limits per ton of feed of 4 pounds for
laying chickens, 5 pounds for broiler
chickens and 6 pounds for turkeys and
all other poultry until October 1, 2012,
followed by 2 pounds for laying and
broiler chickens and 3 pounds for
turkeys and all other poultry over the
final three years. The Livestock
Committee stated that it had consulted
with a number of poultry nutritionists
and feed mill operators and determined
that the rates it proposed were
consistent with the industry’s best
management practices. The Livestock
Committee also recommended that the
NOSB apply its sunset material review
process when considering the allowance
for synthetic methionine in anticipation
of its proposed October 1, 2015,
expiration. The NOSB approved the
Livestock Committee’s recommendation
in its entirety on April 29, 2010.
In the final rule published on
December 21, 2000 (65 FR 80570), the
NOP recognized the National Research
Council’s (NRC) Nutrient Requirements
of Domestic Animals series as the basis
for the livestock feed practice standard.
The applicable reference for nutritional
sufficiency in poultry production is the
NRC’s Nutrient Requirements of
Poultry, Ninth Revised Edition,
published in 1994. The MTF cited this
publication in its petition and stated
that its proposed allowances for
synthetic methionine were
approximately half of the NRC
recommended levels for maximum
growth and production. The MTF also
provided data indicating that
organically produced grains provide a
majority of the methionine requirement
in poultry starter feeds but that
supplementation with the synthetic
form is still necessary to achieve a
complete ration. The NOSB
fundamentally agreed with this
assessment when it accepted with a
modest adjustment the limits that the
MTF proposed for extending the
allowance for synthetic methionine.
The Secretary has reviewed the
NOSB’s recommendation and concurs
that a two-year extension of the
allowance for synthetic methionine in
organic poultry production until
October 1, 2012, is warranted. The
Secretary accepts that the maximum
limits recommended by the NOSB and
as justified by the NOSB for the period
October 1, 2010–October 1, 2012, are
consistent with the industry’s best
management practices and would not
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result in significant adjustments to
comply with this action. Moreover, the
signatories to the MTF petition have
indicated that the current non-annotated
allowance for synthetic methionine has
stabilized use at consistent rates.
The Secretary acknowledges the
NOSB’s intention to lower the allowed
levels of synthetic methionine over the
five-year period for which the board
recommends that the material remain on
the National List. The Secretary intends
to incorporate the NOSB’s
recommended reductions in these levels
through subsequent rulemaking to
address the allowance for synthetic
methionine for the period between
October 1, 2012, and October 15, 2015.
As conveyed at the NOSB meeting and
documented in the transcripts, dividing
the NOSB’s recommendation into
separate rulemakings will allow for the
continued use of methionine beyond its
current expiration while also providing
the board with the opportunity to adjust
the maximum levels for the 2012–2015
period, if needed.
III. Related Documents
Since September 2001, four 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 four
notices were published in the Federal
Register as follows: September 21, 2001
(66 FR 48654), February 11, 2005 (70 FR
7224), April 4, 2008 (73 FR 18491), and
March 17, 2010 (75 FR 12723).
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), and the
annotation was amended by final rule in
the Federal Register on October 21,
2005 (70 FR 61217). A proposal to
amend the annotation once again was
published in the Federal Register on
July 14, 2008 (73 FR 40197), and the
annotation was amended by final rule
on September 18, 2008 (73 FR 54057).
IV. Statutory and Regulatory Authority
The OFPA 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
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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 § 205.607
of the NOP regulations. The current
petition process (January 18, 2007, 72
FR 2167) can be accessed through the
NOP Web site at https://
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
information related to Executive Order
12988 has been obtained since then.
This interim 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
§ 2115(b) of the OFPA (7 U.S.C.
6514(b)). States are also preempted
under §§ 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 § 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) be
consistent 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.
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Pursuant to § 2120(f) of the OFPA (7
U.S.C. 6519(f)), this interim rule would
not alter the authority of the Secretary
under the Federal Meat Inspection Act
(21 U.S.C. 601–695), the Poultry
Products Inspections Act (21 U.S.C.
451–472), or the Egg Products
Inspection Act (21 U.S.C. 1031–1056),
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. 301–397),
nor the authority of the Administrator of
the Environmental Protection Agency
under the Federal Insecticide, Fungicide
and Rodenticide Act (7 U.S.C. 136–
1364).
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 persons 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, 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). AMS has also considered
the economic impact of this action on
small entities. The impact on entities
affected by this interim rule would not
be significant. The current approval for
the use of synthetic methionine in
organic poultry production will expire
October 1, 2010. The effect of this
interim rule is to allow the continued
use of synthetic methionine through
October 1, 2012, at levels that are
consistent with current industry
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15:10 Aug 23, 2010
Jkt 220001
practices. 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,
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.
Based on USDA data from the
Economic Research Service (ERS), the
U.S. organic sector included nearly
13,000 certified organic crop and
livestock operations at the end of 2008.
These operations contained more than
4.8 million certified acres consisting of
2,665,382 acres of cropland and
2,160,577 acres of pasture and
rangeland. The total acreage under
organic management represents a twelve
percent increase from 2007. Organic
poultry production has steadily
contributed to the overall growth in the
organic food market. ERS estimated that
there were 5,538,011 laying chickens
and 9,015,984 broiler chickens raised
under organic management in 2008. ERS
estimated the number of certified
organic turkeys raised in the United
States in 2008 at 398,531.1 The
Nutrition Business Journal calculated
the market value for organic laying
chickens at $252,000,000 in 2008.2 In
addition to being sold as whole
products, organic eggs and poultry byproducts are used in the production of
organic processed products including
soups, broths, prepared meals, ice cream
and egg nog. The USDA accredits
certifying agents who provide
certification services to producers and
handlers. A complete list of names and
addresses of accredited certifying agents
may be found on the AMS NOP Web
site, at https://www.ams.usda.gov/nop.
AMS believes that most of these entities
would be considered small entities
under the criteria established by the
SBA.
D. Paperwork Reduction Act
No additional collection or
recordkeeping requirements are
imposed on the public by this interim
1 U.S. Department of Agriculture, Economic
Research Service. 2009. Data Sets: U.S. Certified
Organic Farmland Acreage, Livestock Numbers and
Farm Operations, 1992–2008. https://
www.ers.usda.gov/Data/Organic/.
2 Nutrition Business Journal. 2009. U.S. Organic
Food Sales by Product ($Mil) 1997–2008, 2009(e)–
2014(e)—Chart 22. Penton Media, Inc.
PO 00000
Frm 00007
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51923
rule. Accordingly, OMB clearance is not
required by § 350(h) of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520) 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 interim rule reflects a
recommendation submitted to the
Secretary by the NOSB for extending the
use of synthetic methionine in organic
poultry production until October 1,
2012. The NOSB evaluated this
substance using criteria in the OFPA in
response to 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. However, to
encourage a transition of industry
practices towards decreasing
dependence on synthetic sources of the
amino acid, the NOSB has
recommended extending the allowed
use of synthetic methionine in poultry
production until October 1, 2012, with
maximum allowable limits. The
Secretary has reviewed the
recommendation from the board.
Pursuant to 5 U.S.C. 553, it is found and
determined upon good cause that it is
impracticable and contrary to the public
interest to give preliminary notice prior
to putting this rule into effect in order
to ensure the continued use of synthetic
methionine after October 1, 2010, and
avoid any disruption to the organic
poultry market.
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
amended as follows:
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Federal Register / Vol. 75, No. 163 / Tuesday, August 24, 2010 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
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.
2. Section 205.603(d)(1) is revised to
read as follows:
■
§ 205.603 Synthetic substances allowed
for use in organic livestock production.
*
*
*
*
*
(d) * * *
(1) DL–Methionine, DL–Methionine—
hydroxy analog, and DL–Methionine—
hydroxy analog calcium (CAS #–59–51–
8; 63–68–3; 348–67–4)—for use only in
organic poultry production until
October 1, 2012, at the following
maximum levels of synthetic
methionine per ton of feed: laying
chickens—4 pounds; broiler chickens—
5 pounds; turkeys and all other
poultry—6 pounds.
*
*
*
*
*
Dated: August 17, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2010–20977 Filed 8–23–10; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 922
[Doc. No. AMS–FV–10–0050; FV10–922–1
FR]
Apricots Grown in Designated
Counties in Washington; Increased
Assessment Rate
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This rule increases the
assessment rate established for the
Washington Apricot Marketing
Committee (Committee) for the 2010–11
and subsequent fiscal periods from
$1.00 to $1.50 per ton for Washington
apricots. The Committee is responsible
for local administration of the marketing
order regulating the handling of apricots
grown in designated counties in
Washington. Assessments upon
handlers of apricots are used by the
Committee to fund reasonable and
necessary expenses of the program. The
fiscal period for the marketing order
begins April 1 and ends March 31. The
assessment rate would remain in effect
indefinitely unless modified, suspended
or terminated.
DATES: Effective Date: August 25, 2010.
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SUMMARY:
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Jkt 220001
Robert Curry or Gary Olson, Northwest
Marketing Field Office, Marketing Order
Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 1220
SW. Third Avenue, Suite 385, Portland,
OR 97204; Telephone: (503) 326–2724;
Fax: (503) 326–7440; or E-mail:
Robert.Curry@ams.usda.gov or
GaryD.Olson@ams.usda.gov.
Small businesses may request
information on complying with this
regulation by contacting Antoinette
Carter, Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence, SW.,
STOP 0237, Washington, DC 20250–
0237; Telephone: (202) 690–3919; Fax:
(202) 720–8938; or E-mail:
Antoinette.Carter@ams.usda.gov.
This rule
is issued under Marketing Order No.
922 (7 CFR part 922), as amended,
regulating the handling of apricots
grown in designated counties in
Washington, hereinafter referred to as
the ‘‘order.’’ The order is effective under
the Agricultural Marketing Agreement
Act of 1937, as amended (7 U.S.C. 601–
674), hereinafter referred to as the ‘‘Act.’’
The Department of Agriculture
(USDA) is issuing this rule in
conformance with Executive Order
12866.
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. Under the marketing order now
in effect, apricot handlers in designated
counties in Washington are subject to
assessments. Funds to administer the
order are derived from such
assessments. It is intended that the
assessment rate as issued herein will be
applicable to all assessable Washington
apricots beginning April 1, 2010, and
continue until amended, suspended, or
terminated.
The Act provides that administrative
proceedings must be exhausted before
parties may file suit in court. Under
section 608c(15)(A) of the Act, any
handler subject to an order may file
with USDA a petition stating that the
order, any provision of the order, or any
obligation imposed in connection with
the order is not in accordance with law
and request a modification of the order
or to be exempted therefrom. Such
handler is afforded the opportunity for
a hearing on the petition. After the
hearing USDA would rule on the
petition. The Act provides that the
district court of the United States in any
district in which the handler is an
inhabitant, or has his or her principal
place of business, has jurisdiction to
review USDA’s ruling on the petition,
provided an action is filed not later than
SUPPLEMENTARY INFORMATION:
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Sfmt 4700
20 days after the date of the entry of the
ruling.
This rule increases the assessment
rate established for the Committee for
the 2010–11 and subsequent fiscal
periods from $1.00 to $1.50 per ton for
Washington apricots handled under the
order.
The order provides authority for the
Committee, with the approval of USDA,
to formulate an annual budget of
expenses and collect assessments from
handlers to administer the program. The
members of the Committee are
producers and handlers of apricots in
designated counties in Washington.
They are familiar with the Committee’s
needs and with the costs for goods and
services in their local area and are thus
in a position to formulate an appropriate
budget and assessment rate. The
assessment rate is formulated and
discussed at a public meeting. Thus, all
directly affected persons have an
opportunity to participate and provide
input.
For the 2009–10 and subsequent fiscal
periods, the Committee recommended,
and the USDA approved, an assessment
rate of $1.00 per ton of apricots handled.
This rate continues in effect from fiscal
period to fiscal period unless modified,
suspended, or terminated by USDA
upon recommendation and information
submitted by the Committee or other
information available to USDA.
The Committee met on May 19, 2010,
and unanimously recommended 2010–
11 expenditures of $8,145. In
comparison, last year’s budgeted
expenditures were $7,843. In addition,
the Committee recommended that the
$1.00 per ton assessment rate be
increased by $0.50 to $1.50 per ton of
apricots handled. Committee members
reported that apricot production this
season may be lower than that of last
season since portions of the Washington
apricot production area experienced
freezing weather in October 2009, and
high winds in April of this year. As a
result, the Committee has estimated that
shipments of fresh apricots will
approximate 5,550 tons this season—
somewhat less than the 6,860 tons of
fresh apricots reported last season. The
Committee thus recommended that the
assessment rate be increased by $0.50 to
help ensure that budgeted expenses are
adequately covered.
The major expenditures
recommended by the Committee for the
2010–11 fiscal period include $4,800 for
the management fee, $1,300 for
Committee travel, $100 for compliance,
$750 for the annual audit review, and
$1,195 for equipment maintenance,
insurance, bonds, and miscellaneous
expenses. In comparison, major
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]]>Agencies
[Federal Register Volume 75, Number 163 (Tuesday, August 24, 2010)]
[Rules and Regulations]
[Pages 51919-51924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20977]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-10-0051; NOP-10-04IR]
RIN 0581-AD04
National Organic Program; Amendment to the National List of
Allowed and Prohibited Substances (Livestock)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Interim rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: This interim rule amends the U.S. Department of Agriculture's
(USDA) National List of Allowed and Prohibited Substances (National
List) to incorporate a recommendation submitted to the Secretary of
Agriculture (Secretary) by the National Organic Standards Board (NOSB)
on April 29, 2010. Consistent with the recommendation from the NOSB,
this interim rule revises the annotation of one substance on the
National List, methionine, to extend its use in organic poultry
production until October 1, 2012, at the following maximum levels of
synthetic methionine per ton of feed: Laying chickens--4 pounds;
broiler chickens--5 pounds; turkeys and all
[[Page 51920]]
other poultry--6 pounds. Comments are requested on this interim rule.
On April 29, 2010, the NOSB also recommended to extend the
allowance for synthetic methionine beyond October 1, 2012, to October
1, 2015, and decrease the maximum level of synthetic methionine
permitted per ton of feed ration to the following levels: 2 pounds for
laying and broiler chickens, and 3 pounds for turkeys and all other
poultry. The NOSB further recommended that consideration of synthetic
methionine after its anticipated October 1, 2015 expiration should take
place through the Board's sunset review process rather than through the
petition process. The Secretary intends to incorporate the NOSB's
recommended reductions in allowable levels in a subsequent rulemaking
to address the allowance for synthetic methionine for the period
between October 1, 2012, and October 15, 2015.
DATES: Effective Date: This interim rule becomes effective October 1,
2010. All comments received by October 25, 2010 will be considered
prior to the issuance of a final rule. The agency will publish the
final rule no later than March 2011.
ADDRESSES: Interested persons may submit written comments on this
interim rule using the following addresses:
Internet: https://www.regulations.gov.
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.
Written comments responding to this interim rule should be
identified with the docket number AMS-NOP-10-0051; NOP-10-04. You
should clearly state whether you support the amendment of the
annotation for the continued allowance of synthetic methionine in
poultry production until October 1, 2012, at the maximum levels per ton
of synthetic methionine in the feed ration, with clearly indicated
reason(s) for your position. You should also offer any recommended
language changes that would be appropriate for your position. Please
include relevant information and data to support your position (e.g.,
scientific, environmental, manufacturing, industry, impact information,
etc.). Only relevant material supporting your position should be
submitted.
It is our intention to have all comments concerning this interim
rule, including names and addresses when provided, whether submitted by
mail or Internet, available for viewing on the Regulations.gov (https://www.regulations.gov) Internet site. Comments submitted in response to
this interim rule will also be available for viewing in person at USDA,
AMS, National Organic Program, Room 2646-South Building, Stop 0268,
1400 Independence Ave., SW., Washington, DC 20250, 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 interim rule are requested
to make an appointment in advance 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 20250-0268.
Telephone: (202) 720-3252.
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. The National List identifies synthetic substances that may be
used in organic production and nonsynthetic (natural) substances that
may not be used. The National List also identifies nonagricultural
nonsynthetic, nonagricultural synthetic, and nonorganic agricultural
substances that may be used in organic production and handling.
The Organic Foods Production Act of 1990 (OFPA), as amended (7
U.S.C. 6501-6522), and NOP regulations Sec. 205.105 specifically
prohibit the use of any synthetic substance for organic production and
handling unless provided on the National List. Section 205.105 also
requires that any nonorganic agricultural or nonsynthetic
nonagricultural substance used in organic handling be on the National
List. Under the OFPA, the NOSB reviews exemptions for allowed synthetic
substances every 5 years. If the NOSB recommends renewal, then the
Secretary has authority under the OFPA to renew such exemptions. If
they are not reviewed by the NOSB and renewed by the Secretary within 5
years of their inclusion on the National List, their authorized use
expires.
Under the authority of the OFPA, 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 twelve 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); and July 6, 2010 (75 FR 38693). Additionally, a proposed
amendment to the National List was published on June 3, 2009 (74 FR
26591).
II. Overview of Amendment
This interim rule amends the National List to reflect a
recommendation adopted by the NOSB on April 29, 2010, and subsequently
forwarded to the Secretary. The NOSB reviewed the use of synthetic
methionine in organic poultry production using the evaluation criteria
specified in OFPA (7 U.S.C. 6517-6518) and the Secretary has reviewed
the NOSB's recommendation.
The current listing of synthetic methionine will expire on October
1, 2010. This rule is issued to ensure the continued use of synthetic
methionine after this date and avoid any disruption to the organic
poultry market. A final rule will be issued no later than March 2011.
The record indicates that the provision of methionine, the use of which
is currently allowed, remains an essential dietary component for
poultry in organic production and issuance of this interim rule
maintains its use.
Section 205.603 Synthetic Substances Allowed for Use in Organic
Livestock Production
This interim rule amends Sec. 205.603(d)(1) by changing ``October
1, 2010'' to ``October 1, 2012'' and imposing maximum levels based on
each ton of feed ration. Section 205.603(d)(1) now reads 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, 2012, at the following maximum levels of synthetic methionine per
ton of feed: Laying chickens--4 pounds; broiler chickens--5 pounds;
turkeys and all other poultry--6 pounds.
Methionine was originally included on the National List on October
31, 2003, with an early expiration date of October 21, 2005 (the normal
allowance for a substance added to the National List is five years from
the listing date). It is a colorless or white crystalline powder that
is soluble in water. Methionine is classified as an essential amino
acid because it cannot be biologically produced by poultry and is
[[Page 51921]]
necessary to maintain viability. Natural feed sources with high
percentages of methionine include bloodmeal, fish meal, crab meal, corn
gluten meal, and sunflower seed meal. It is regulated as an animal feed
nutritional supplement by the Food and Drug Administration (21 CFR
582.5475). Organic livestock producers had petitioned the substance as
a part of the NOSB's initial review of synthetic amino acids. The
petitioners asserted that methionine was a necessary dietary supplement
for organic poultry and that there was an inadequate supply of
allowable organic feeds containing sufficient concentrations of
naturally occurring methionine. Petitioners suggested that 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 animals' health. After reviewing a
Technical Advisory Panel analysis of the evaluation criteria provided
in the OFPA (7 U.S.C. 6517-6518), the NOSB determined that the use of
synthetic methionine was consistent with a system of organic
production. On October 16, 2001, the NOSB recommended that the
Secretary include methionine on the National List of Allowed Synthetics
for use in organic poultry production with an early expiration date
(October 21, 2005). The NOSB recommended the early expiration date to
encourage organic producers to phase out synthetic methionine as a feed
additive by identifying and incorporating natural and allowable sources
into poultry diets.
On January 10, 2005, two organic poultry producers petitioned the
NOSB to extend the use of synthetic methionine in organic poultry
production beyond October 21, 2005. The producers stated that they had
been unable to develop suitable natural alternatives for synthetic
methionine in organic poultry diets. The petitioners requested the
extension to provide additional time for the development of these
alternatives. The petition included preliminary research results on
natural sources of methionine that highlighted the challenge of meeting
the maintenance requirements for poultry with allowed organic and
natural feed ingredients. Although inconclusive, the preliminary
results demonstrated that research trials were underway to identify
natural alternatives that could lead to phasing out synthetic
methionine from organic poultry production. At its February 28-March 3,
2005, meeting in Washington, DC, the NOSB received public comment on
the petition to extend the use of synthetic methionine in organic
poultry production beyond October 21, 2005. While concluding that
synthetic methionine was consistent with the evaluation criteria of 7
U.S.C. 6517 and 6518 of the OFPA, the NOSB did not recommend a full
five-year allowance for the material. The Board continued to express
its strong preference for the development of natural methionine sources
for organic poultry production. Therefore, the NOSB recommended that
synthetic methionine remain on the National List but only until October
1, 2008. In response to this recommendation, the Secretary amended
Sec. 205.603(d)(1) of the National List on October 21, 2005 (70 FR
61217), to allow the use of synthetic methionine in organic poultry
production until October 1, 2008.
In December 2007, a coalition of producers identified as the
Methionine Task Force (MTF) filed a petition requesting that Sec.
205.603(d)(1) be amended by removing the expiration date of ``October
1, 2008.'' They also requested that in the future methionine receive
the standard sunset review process for materials on the National List.
Their petition addressed the status of the most viable alternatives to
synthetic methionine and stated that none of the alternatives were yet
commercially viable. Additionally, AMS received six comments supporting
the re-listing of synthetic methionine in response to the December 28,
2007 (72 FR 73667), Advanced Notice of Proposed Rulemaking announcing
the 2008 Sunset Review of 12 substances on the National List. Because
methionine was due to expire on October 1, 2008, as established by
rulemaking, it was not included among the 12 substances in the 2008
Sunset Review.
The NOSB evaluated public comment on the petition to extend the use
of synthetic methionine in organic poultry production beyond October 1,
2008, and also considered comments on the subject from its November
2007 meeting. The NOSB determined that while certain allowable organic
and natural sources of methionine existed, they were not available in
sufficient supplies to meet poultry producers' needs. Thus, the NOSB
concluded that synthetic methionine was a necessary component of a
nutritionally adequate diet for organic poultry, and, therefore,
essential to organic production. The Board also concluded that
terminating the allowance for its use would disrupt the well-
established organic poultry market and cause substantial economic harm
to organic poultry producers but did not recommend a full five-year
allowance for the material. The NOSB and stakeholders including the MTF
agreed that the organic feed sector would continue to research and
develop sufficient supplies of allowable organic and natural sources in
the interim and thus the NOSB recommended to extend the use of
methionine for two more years. The Secretary concurred with the NOSB
recommendation to extend the use of synthetic methionine in poultry
production until October 1, 2010, and amended the regulation
accordingly on September 18, 2008 (73 FR 54057).
The MTF submitted a new petition on July 31, 2009, requesting a
five-year extension on the allowance for synthetic methionine. The
request proposed to limit the total amount of synthetic methionine to
be fed over the life of the bird calculated as the average pounds of
the material per ton of feed. The MTF petition proposed these limits at
4 pounds for laying chickens, 5 pounds for broiler chickens and 6
pounds for turkeys and all other poultry per ton of feed. The
petitioners stated that these levels of synthetic methionine are the
amount necessary to support the animals' basic maintenance requirements
and would not provide growth enhancement. In requesting the five-year
allowance, the MTF cited research efforts in recent years that have
attempted but failed to identify wholly natural and allowable sources
of methionine capable of providing poultry's basic maintenance
requirement.
The NOSB Livestock Committee reviewed the MTF petition and rejected
it. The Livestock Committee stated that averaging the pounds of
synthetic methionine fed over the life of the bird would result in the
unacceptable outcome of even higher levels being fed at certain stages.
The Livestock Committee instead pointed towards future modifications to
the livestock feed and living conditions practice standards that would
lead to higher levels of natural methionine in poultry feed rations.
However, the Livestock Committee agreed with the MTF that wholly
natural sources of methionine are not now and would not likely be
widely available in the immediate future and that extending the
allowance for the synthetic form was warranted.
The Livestock Committee proposed an annotation to the synthetic
methionine listing that reflected their reservations about the
petitioner's request, but acknowledged that an allowance for the
synthetic form would be necessary
[[Page 51922]]
throughout the next five years. They proposed to extend the allowance
for synthetic methionine in organic poultry production for five years
until October 1, 2015, with a step down in the amount allowed after two
years. They proposed limits per ton of feed of 4 pounds for laying
chickens, 5 pounds for broiler chickens and 6 pounds for turkeys and
all other poultry until October 1, 2012, followed by 2 pounds for
laying and broiler chickens and 3 pounds for turkeys and all other
poultry over the final three years. The Livestock Committee stated that
it had consulted with a number of poultry nutritionists and feed mill
operators and determined that the rates it proposed were consistent
with the industry's best management practices. The Livestock Committee
also recommended that the NOSB apply its sunset material review process
when considering the allowance for synthetic methionine in anticipation
of its proposed October 1, 2015, expiration. The NOSB approved the
Livestock Committee's recommendation in its entirety on April 29, 2010.
In the final rule published on December 21, 2000 (65 FR 80570), the
NOP recognized the National Research Council's (NRC) Nutrient
Requirements of Domestic Animals series as the basis for the livestock
feed practice standard. The applicable reference for nutritional
sufficiency in poultry production is the NRC's Nutrient Requirements of
Poultry, Ninth Revised Edition, published in 1994. The MTF cited this
publication in its petition and stated that its proposed allowances for
synthetic methionine were approximately half of the NRC recommended
levels for maximum growth and production. The MTF also provided data
indicating that organically produced grains provide a majority of the
methionine requirement in poultry starter feeds but that
supplementation with the synthetic form is still necessary to achieve a
complete ration. The NOSB fundamentally agreed with this assessment
when it accepted with a modest adjustment the limits that the MTF
proposed for extending the allowance for synthetic methionine.
The Secretary has reviewed the NOSB's recommendation and concurs
that a two-year extension of the allowance for synthetic methionine in
organic poultry production until October 1, 2012, is warranted. The
Secretary accepts that the maximum limits recommended by the NOSB and
as justified by the NOSB for the period October 1, 2010-October 1,
2012, are consistent with the industry's best management practices and
would not result in significant adjustments to comply with this action.
Moreover, the signatories to the MTF petition have indicated that the
current non-annotated allowance for synthetic methionine has stabilized
use at consistent rates.
The Secretary acknowledges the NOSB's intention to lower the
allowed levels of synthetic methionine over the five-year period for
which the board recommends that the material remain on the National
List. The Secretary intends to incorporate the NOSB's recommended
reductions in these levels through subsequent rulemaking to address the
allowance for synthetic methionine for the period between October 1,
2012, and October 15, 2015. As conveyed at the NOSB meeting and
documented in the transcripts, dividing the NOSB's recommendation into
separate rulemakings will allow for the continued use of methionine
beyond its current expiration while also providing the board with the
opportunity to adjust the maximum levels for the 2012-2015 period, if
needed.
III. Related Documents
Since September 2001, four 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 four
notices were published in the Federal Register as follows: September
21, 2001 (66 FR 48654), February 11, 2005 (70 FR 7224), April 4, 2008
(73 FR 18491), and March 17, 2010 (75 FR 12723).
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), and the annotation was amended by final rule in the Federal
Register on October 21, 2005 (70 FR 61217). A proposal to amend the
annotation once again was published in the Federal Register on July 14,
2008 (73 FR 40197), and the annotation was amended by final rule on
September 18, 2008 (73 FR 54057).
IV. Statutory and Regulatory Authority
The OFPA 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 (January 18, 2007, 72 FR
2167) can be accessed through the NOP Web site at https://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
information related to Executive Order 12988 has been obtained since
then. This interim 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) be consistent 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.
[[Page 51923]]
Pursuant to Sec. 2120(f) of the OFPA (7 U.S.C. 6519(f)), this
interim rule would not alter the authority of the Secretary under the
Federal Meat Inspection Act (21 U.S.C. 601-695), the Poultry Products
Inspections Act (21 U.S.C. 451-472), or the Egg Products Inspection Act
(21 U.S.C. 1031-1056), 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. 301-397), nor
the authority of the Administrator of the Environmental Protection
Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7
U.S.C. 136-1364).
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 persons 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, 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). AMS has
also considered the economic impact of this action on small entities.
The impact on entities affected by this interim rule would not be
significant. The current approval for the use of synthetic methionine
in organic poultry production will expire October 1, 2010. The effect
of this interim rule is to allow the continued use of synthetic
methionine through October 1, 2012, at levels that are consistent with
current industry practices. 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, 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.
Based on USDA data from the Economic Research Service (ERS), the
U.S. organic sector included nearly 13,000 certified organic crop and
livestock operations at the end of 2008. These operations contained
more than 4.8 million certified acres consisting of 2,665,382 acres of
cropland and 2,160,577 acres of pasture and rangeland. The total
acreage under organic management represents a twelve percent increase
from 2007. Organic poultry production has steadily contributed to the
overall growth in the organic food market. ERS estimated that there
were 5,538,011 laying chickens and 9,015,984 broiler chickens raised
under organic management in 2008. ERS estimated the number of certified
organic turkeys raised in the United States in 2008 at 398,531.\1\ The
Nutrition Business Journal calculated the market value for organic
laying chickens at $252,000,000 in 2008.\2\ In addition to being sold
as whole products, organic eggs and poultry by-products are used in the
production of organic processed products including soups, broths,
prepared meals, ice cream and egg nog. The USDA accredits certifying
agents who provide certification services to producers and handlers. A
complete list of names and addresses of accredited certifying agents
may be found on the AMS NOP Web site, at https://www.ams.usda.gov/nop.
AMS believes that most of these entities would be considered small
entities under the criteria established by the SBA.
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\1\ U.S. Department of Agriculture, Economic Research Service.
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. https://www.ers.usda.gov/Data/Organic/.
\2\ Nutrition Business Journal. 2009. U.S. Organic Food Sales by
Product ($Mil) 1997-2008, 2009(e)-2014(e)--Chart 22. Penton Media,
Inc.
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D. Paperwork Reduction Act
No additional collection or recordkeeping requirements are imposed
on the public by this interim rule. Accordingly, OMB clearance is not
required by Sec. 350(h) of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) 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 interim rule reflects a recommendation submitted to the
Secretary by the NOSB for extending the use of synthetic methionine in
organic poultry production until October 1, 2012. The NOSB evaluated
this substance using criteria in the OFPA in response to 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. However, to encourage
a transition of industry practices towards decreasing dependence on
synthetic sources of the amino acid, the NOSB has recommended extending
the allowed use of synthetic methionine in poultry production until
October 1, 2012, with maximum allowable limits. The Secretary has
reviewed the recommendation from the board. Pursuant to 5 U.S.C. 553,
it is found and determined upon good cause that it is impracticable and
contrary to the public interest to give preliminary notice prior to
putting this rule into effect in order to ensure the continued use of
synthetic methionine after October 1, 2010, and avoid any disruption to
the organic poultry market.
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:
[[Page 51924]]
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.
0
2. Section 205.603(d)(1) is revised to read as follows:
Sec. 205.603 Synthetic substances allowed for use in organic
livestock production.
* * * * *
(d) * * *
(1) DL-Methionine, DL-Methionine--hydroxy analog, and DL-
Methionine--hydroxy analog calcium (CAS -59-51-8; 63-68-3;
348-67-4)--for use only in organic poultry production until October 1,
2012, at the following maximum levels of synthetic methionine per ton
of feed: laying chickens--4 pounds; broiler chickens--5 pounds; turkeys
and all other poultry--6 pounds.
* * * * *
Dated: August 17, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing Service.
[FR Doc. 2010-20977 Filed 8-23-10; 8:45 am]
BILLING CODE 3410-02-P
