National Organic Program (NOP); Sunset Review (2008), 73667-73671 [E7-25270]
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Proposed Rules
Federal Register
Vol. 72, No. 248
Friday, December 28, 2007
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number AMS–TM–07–0124; TM–07–
12]
RIN 0581–AC76
National Organic Program (NOP);
Sunset Review (2008)
Agricultural Marketing Service,
USDA.
ACTION: Advance notice of proposed
rulemaking with request for comments.
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AGENCY:
SUMMARY: Sunset of the exempted or
prohibited use of substances under the
National Organic Program (NOP) is
required by the Organic Foods
Production Act of 1990 (OFPA). This
ANPR announces the sunset of 11
exempted substances and 1 prohibited
substance added to the National List on
November 3 and 4, 2003. This ANPR
establishes November 3, 2008, as the
date by which the sunset review and
renewal process must be concluded.
This advance notice of proposed rulemaking (ANPR) also begins the public
comment process on whether the
identified existing exemptions or
prohibitions should be continued.
Finally, this ANPR discusses how the
NOP will manage the sunset review and
renewal process.
DATES: Comments must be submitted on
or before January 28, 2008.
ADDRESSES: Interested persons may
submit written comments on this ANPR
using the following addresses:
• Mail: Robert Pooler, Agricultural
Marketing Specialist, National Organic
Program, USDA–AMS–TMP–NOP, 1400
Independence Avenue., SW., Room
4008–So., Ag Stop 0268, Washington,
DC 20250.
• Internet: www.regulations.gov.
Written comments responding to this
ANPR should be identified with the
docket number AMS–TM–07–0124. You
should clearly indicate your position to
continue the allowance or prohibition of
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the substances identified in this ANPR
and the reasons for your position. You
should include relevant information and
data to support your position (e.g.,
scientific, environmental,
manufacturing, industry impact
information, etc.). You should also
supply information on alternative
substances or alternative management
practices, where applicable, that
support a change from the current
exemption or prohibition of the
substance. Only the supporting material
relevant to your position will be
considered.
It is our intention to have all
comments concerning this ANPR,
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 ANPR 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
ANPR are requested to make an
appointment in advance by calling (202)
720–3252.
FOR FURTHER INFORMATION CONTACT:
Robert Pooler, Agricultural Marketing
Specialist, National Organic Program,
USDA/AMS/TM/NOP, Room 4008–So.,
Ag Stop 0268, 1400 Independence Ave.,
SW., Washington, DC 20250. Phone:
(202) 720–3252. Telephone: (202) 720–
3252. E-mail: Robert.pooler@usda.gov.
SUPPLEMENTARY INFORMATION: 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.
Background
The OFPA, 7 U.S.C. 6501 et seq.,
authorizes the establishment of the
National List of exempted and
prohibited substances. The National List
identifies synthetic substances
(synthetics) that are exempted (allowed)
and nonsynthetic substances
(nonsynthetics) that are prohibited in
organic crop and livestock production.
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The National List also identifies
nonsynthetics and synthetics that are
exempted for use in organic handling.
The exemptions and prohibitions
granted under the OFPA are required to
be reviewed every 5 years by the
National Organic Standards Board
(NOSB). The Secretary of Agriculture
has authority under the OFPA to renew
such exemptions and prohibitions. If
they are not reviewed by the NOSB and
renewed by the Secretary within 5 years
of their inclusion on the National List,
their authorized use or prohibition
expires. This means that synthetic
substances Copper sulfate, Ozone gas,
Peracetic acid, and EPA List 3 Inerts,
currently allowed for use in organic
crop production, will no longer be
allowed for use after November 3, 2008.
Calcium chloride currently prohibited
from use in organic crop production,
except as a foliar spray to treat a
physiological disorder associated with
calcium uptake, will be allowed after
November 3, 2008. This also means that
Agar-agar, Carageenan, and Tartaric
acid, currently allowed for use in
organic handling, will be prohibited
after November 3, 2008. Finally, Animal
enzymes, Calcium sulfate, Glucono
delta lactone, and Cellulose, currently
allowed for use in organic handling,
will no longer be allowed for use after
November 4, 2008.
Expiration of the exempted or
prohibited use of substances is provided
for under the OFPA’s sunset provision.
This ANPR announces the sunset of 11
exempted substances and 1 prohibited
substance added to the National List on
November 3 and 4, 2003. This ANPR
establishes November 3, 2008, as the
date by which the sunset review and
renewal process must be concluded.
Substances not renewed will be
removed from the National List. This
ANPR also begins the public comment
process on whether the existing specific
exemptions or prohibitions on the
National List should be continued. This
ANPR discusses how the NOP will
manage the sunset review and renewal
process.
Because these substances may be
critical to the production and handling
of a wide array of raw and processed
organic agricultural products, their
expiration could cause disruption of
well-established and accepted organic
production, handling, and processing
systems. Therefore, the NOP is initiating
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the sunset review and renewal process
now, in order to provide ample
opportunity for you to make your views
known.
Initially, Tartaric acid was
inadvertently included in the 2007
sunset process (70 FR 35177, June 17,
2005) and recommended for renewal by
the NOSB (November 17, 2005).
However, because Tartaric acid was not
scheduled to sunset until October 31,
2008, it was not included in the 2007
sunset proposed rule (72 FR 9872,
March 6, 2007). Consequently, Tartaric
acid will receive consideration under
this sunset review and the NOSB will
consider comments previously
submitted in response to the 2007
sunset ANPR.
DL-Methionine, DL-Methioninehydroxyl analog, and DL-Methioninehydroxyl analog calcium (CAS #—59–
51–8; 63–68–3; 348–67–4) were added
to the National List on November 3,
2003, for use in organic poultry
production. Initially these substances
carried an expiration date of October 21,
2005. Effective October 22, 2005, the
expiration date was amended to October
1, 2008. Because these substances have
an expiration date recommended by the
NOSB and established by rulemaking,
they are not included in this sunset
review. The NOP National List petition
process would have to be employed for
these substances to be authorized for
use after October 1, 2008.
The Sunset Process
As the first step in this process, we
invite public comment on the specific
exemptions or prohibitions currently on
the National List that are described in
this document. All substances currently
on the National List have been
previously evaluated and determined by
the NOSB for consistency with OFPA
and its implementing regulations.
According to § 6517(e) of the OFPA,
these substances must be reviewed by
the NOSB and renewed by the Secretary
for their use or prohibition to continue
after 5 years of their addition to the
National List which will be November 3,
2008. Public comments submitted will
be considered in the review and renewal
process.
The NOP will forward comments
received under this ANPR to the NOSB
for review. The NOSB will review the
exemptions and prohibitions of the
substances designated to sunset,
including the public comments received
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during this review. The NOSB will
review each of the substances listed in
this ANPR and may determine that
certain substances warrant a more indepth review and require additional
information or research that considers
new scientific data and technological
and market advances.
Following the NOSB’s review, the
NOSB will make a recommendation to
the Secretary about the continuation of
specific exemptions and prohibitions for
the substances listed in this ANPR.
After the Secretary receives the NOSB’s
recommendations, the NOP will publish
a proposed rule based on the NOSB
recommendations. This proposed rule
will provide an additional opportunity
for you to express your views.
Comments received on the proposed
rule will be used to develop a final rule.
Because the sunset review and renewal
process involves rulemaking, the NOP
believes it is appropriate to initiate the
process now with a thirty-day comment
period.
Guidance on Submitting Your
Comments
Comments That Support Existing
Exemptions or Prohibitions
If you provide comments that support
the renewal of any or all existing
exemptions or prohibitions included
within this ANPR, you should clearly
indicate this and provide your reasons
and any relevant documentation that
supports your position.
Comments That Do Not Support
Continuing an Existing Exemption
If you provide comments that do not
support continuing an existing
exemption, you should provide reasons
why the use of the substance should no
longer be allowed in organic agricultural
production and handling. The current
exemptions were originally
recommended by the NOSB based on
evidence available to the NOSB at the
time of review which demonstrated that
the substances were found to be: (1) Not
harmful to human health or the
environment, (2) necessary because of
the unavailability of wholly
nonsynthetic alternatives, and (3)
consistent and compatible with organic
practices. Therefore, comments against
the continued exemption of a substance
should demonstrate how the current
substance is: (1) Harmful to human
health or the environment, (2) not
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necessary to the production of the
agricultural products because of the
availability of wholly nonsynthetic
substitute products, or (3) inconsistent
with organic farming and handling.
An Appendix to this ANPR contains
worksheets to assist you in gathering
relevant information concerning these
issues. These worksheets are not
required to submit a comment. These
worksheets are used by the NOSB to
develop their recommendations to the
Secretary to include an exempted or
prohibited substance on the National
List. You do not have to answer the
questions on the worksheets; they are
intended only to help you provide
substantive comments to the NOSB
when you provide comments on the
specific substance.
In addition, comments that do not
support the continued use of a
substance(s) listed within this ANPR
should also provide evidence
concerning viable alternatives for the
substance you believe should be
discontinued. Viable alternatives
include, but are not limited to:
alternative management practices that
would eliminate the need for the
specific substance; other currently
exempted substances that are on the
National List which could eliminate the
need for this specific substance; and
other organic or nonorganic agricultural
substances. Such evidence also should
adequately demonstrate that the
alternative has a function and effect that
equals or surpasses the specific
exempted substance that you do not
want to be continued. Assertions about
an alternative substance except for those
alternatives that already appear on the
National List should, if possible include
the name and address of the
manufacturer of the alternative. Further,
your comments should include a copy
or the specific source of any supportive
literature, which could include product
or practice descriptions; performance
and test data; reference standards; name
and address of producers who have
used the alternative under similar
conditions and the date of use; and an
itemized comparison of the function
and effect of the proposed alternative(s)
with substance under review. The chart
below can help you describe
recommended alternatives for different
types of organic operations in place of
a current exempted substance that you
do not want to be continued.
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If the currently listed substance is
used in...
And is a (an). . .
Then the recommended alternative should be a (an). . .
Crop or Livestock Production ..........
Synthetic substance ......................
Crop or Livestock Production ..........
Handling ..........................................
Synthetic inert substance (pesticidal).
Synthetic substance ......................
Handling ..........................................
Nonsynthetic (non-ag) substance ..
Handling ..........................................
Nonorganic agricultural product ....
—Another currently listed synthetic substance;
—Nonsynthetic substance; or
—Management practice.
—Another currently listed synthetic substance or;
—Nonsynthetic substance.
—Another currently listed synthetic substance;
—Nonsynthetic (non-ag)
substance; or
—Management practice.
—Agricultural substance; or
—Management practice.
—Organic agricultural product.
The NOP understands that supportive
technical or scientific information for
synthetic alternatives not currently on
the National List may not be easily
available to organic producers and
handlers. Such information may,
however, be available from the research
community including universities, or
other sources, including international
organic programs.
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Comments That Do Not Support
Continuing an Existing Prohibition
If you provide comments against
continuation of the prohibition on the
use of Calcium chloride, you should
specify how Calcium chloride is now
consistent with the criteria in the OFPA
and the NOP regulation. When this
prohibition was originally
recommended by the NOSB, it was
accepted because the evidence available
to the NOSB at the time of review
demonstrated that the substance, except
as annotated, was found to be harmful
to human health or the environment and
was inconsistent and not compatible
with organic practices. Therefore, any
comments against continuation of the
prohibition on the use of Calcium
chloride should provide new
information, including a copy of the
specific source of any supportive
literatures showing that Calcium
chloride is no longer harmful to human
health or the environment and is
consistent and compatible with organic
practices.
An Appendix to this ANPR contains
worksheets to assist you in gathering
relevant information concerning these
issues. These worksheets are not
required for you to submit a comment.
These worksheets are used by the NOSB
to develop their recommendations to the
Secretary to include an exempted or
prohibited substance on the National
List. You do not have to answer the
questions on the worksheets; they are
intended to help you provide
substantive comments to the NOSB
when you provide comments on the
specific substance.
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Request for Comments
The NOP requests that you comment
whether the NOSB should continue to
recommend the following exemptions
and prohibition on the National List of
Allowed and Prohibited Substances for
organic agricultural production and
handling:
Section 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production
(a) As algicide, disinfectants, and
sanitizer, including irrigation system
cleaning systems.
(3) Copper sulfate—for use as an
algicide in aquatic rice systems, is
limited to one application per field
during any 24-month period.
Application rates are limited to those
which do not increase baseline soil test
values for copper over a timeframe
agreed upon by the producer and
accredited certifying agent.
(5) Ozone gas—for use as an irrigation
system cleaner only.
(6) Peracetic acid—for use in
disinfecting equipment, seed, and
asexually propagated planting material.
(e) As insecticides (including
acaricides or mite control).
(3) Copper Sulfate—for use as tadpole
shrimp control in aquatic rice
production, is limited to one application
per field during any 24-month period.
Application rates are limited to levels
which do not increase baseline soil test
values for copper over a timeframe
agreed upon by the producer and
accredited certifying agent.
(i) As plant disease control.
(7) Peracetic acid—for use to control
fire blight bacteria.
(m) As synthetic inert ingredients as
classified by the Environmental
Protection Agency (EPA), for use with
nonsynthetic substances or synthetic
substances listed in this section and
used as an active pesticide ingredient in
accordance with any limitations on the
use of such substances.
(2) EPA List 3—Inerts of unknown
toxicity allowed:
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(ii) Inerts used in passive pheromone
dispensers.
Section 205.602 Nonsynthetic
Substances Prohibited for Use in
Organic Crop Production
(c) Calcium chloride, brine process is
natural and prohibited for use except as
a foliar spray to treat a physiological
disorder associated with calcium
uptake.
Section 205.605 Nonagricultural
(Nonorganic) Substances Allowed as
Ingredients in or on Processed Products
Labeled as ‘‘Organic’’ or ‘‘Made With
Organic (Specified Ingredients or Food
Groups(s))’’
(a) Nonsynthetics allowed:
Agar-agar.
Animal enzymes—(Rennet—animals
derived; Catalase—bovine liver; Animal
lipase; Pancreatin; Pepsin; and Trypsin).
Calcium sulfate—mined.
Carageenan.
Glucono delta-lactone—production by
the oxidation of D-glucose with bromine
water is prohibited.
Tartaric acid
(b) Synthetics allowed:
Cellulose—for use in regenerative
casings, as an anti-caking agent (nonchlorine bleached) and filtering aid.
Tartaric acid
All comments will be considered in
the development of the NOSB’s
recommendations to the Secretary.
Authority: 7 U.S.C. 6501 et seq. and 7 CFR
part 205.
Dated: December 21, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
Appendix
This Appendix contains worksheets to
assist you in gathering relevant information
concerning the compatibility of substances
with evaluation criteria of the OFPA. These
worksheets are not required to submit a
comment. These worksheets are used by the
NOSB to develop their recommendations to
the Secretary to include an exempted or
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prohibited substance on the National List.
You do not have to answer the questions on
the worksheets; they are intended only to
help you provide substantive comments to
the NOSB when you provide comments on
the specific substance.
EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST
Question
Yes
N/A1
No
Documentation
(TAP; petition; regulatory agency; other)
Category 1. Adverse impacts on humans or the environment?
1. Is there environmental contamination during
manufacture, use, misuse, or disposal?
[§ 6518 m.3]
2. Is the substance harmful to the environment?
[§ 6517c(1)(A)(i);6517(c)(2)(A)i]
3. Does the substance contain List 1, 2, or 3
inerts? [§ 6517 c (1)(B)(ii)]
4. Is there potential for detrimental chemical
interaction with other materials used? [§ 6518
m.1]
5. Are there adverse biological and chemical
interactions in agro-ecosystem? [§ 6518 m.5]
6. Are there detrimental physiological effects on
soil organisms, crops, or livestock? [§ 6518
m.5]
7. Is there a toxic or other adverse action of the
material or its breakdown products? [§ 6518
m.2]
8. Is there undesirable persistence or concentration of the material or breakdown products in
environment?[§ 6518 m.2]
9. Is there any harmful effect on human health?
[§ 6517 c (1)(A)(i) ; 6517 c(2)(A)i; § 6518 m.4]
Category 2. Is the Substance Essential for Organic Production?
1. Is the substance formulated or manufactured
by a chemical process? [6502 (21)]
2. Is the substance formulated or manufactured
by a process that chemically changes a substance extracted from naturally occurring plant,
animal, or mineral, sources? [6502 (21)]
3. Is the substance created by naturally occurring biological processes? [6502 (21)]
4. Is there a wholly natural substitute product?
[§ 6517 c (1)(A)(ii)]
5. Is the substance used in handling, not synthetic, but not organically produced? [§ 6517 c
(1)(B)(iii)]
6. Is there any alternative substances? [§ 6518
m.6]
7. Is there another practice that would make the
substance unnecessary? [§ 6518 m.6]
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Category 3. Is the substance compatible with organic production practices?
1. Is the substance consistent with organic farming and handling? [§ 6517 c (1)(A)(iii); 6517 c
(2)(A)(ii)]
2. Is the substance compatible with a system of
sustainable agriculture? [§ 6518 m.7]
3. Is the substance used in production, and does
it contain an active synthetic ingredient in the
following categories:
a. copper and sulfur compounds;
b. toxins derived from bacteria;
c. pheromones, soaps, horticultural oils, fish
emulsions, treated seed, vitamins and
minerals?
d. livestock parasiticides and medicines?
e. production aids including netting, tree
wraps and seals, insect traps, sticky barriers, row covers, and equipment cleaners?
1
If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
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[FR Doc. E7–25270 Filed 12–27–07; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 981
[Docket No. AO–214–A7; AMS–FV–07–0050;
FV07–981–1]
Almonds Grown in California;
Recommended Decision on Proposed
Amendment of Marketing Order No.
981
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule and opportunity
to file exceptions.
AGENCY:
SUMMARY: This is a recommended
decision regarding proposed
amendments to Marketing Order No.
981 (order), which regulates the
handling of almonds grown in
California. Two amendments were
proposed by the Almond Board of
California (Board), which is responsible
for local administration of the order.
These proposed amendments would:
authorize the establishment of specific
outgoing quality requirements for
different markets; and authorize the
establishment of container marking and
labeling requirements. The proposals
are intended to provide additional
flexibility in administering the quality
control provisions of the order and
provide the industry with additional
tools to aid in the marketing of almonds.
This recommended decision invites
written exceptions on the proposed
amendments.
Written exceptions must be filed
by January 17, 2008.
ADDRESSES: Written exceptions should
be filed with the Hearing Clerk, U.S.
Department of Agriculture, Room 1081–
S, Washington, DC 20250–9200, Fax:
(202) 720–9776 or via the Internet at
http:\\www.regulations.gov. All
comments should reference the docket
number and the date and page number
of this issue of the Federal Register.
Comments will be made available for
public inspection in the Office of the
Hearing Clerk during regular business
hours, or can be viewed at:
http:\\www.regulations.gov.
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DATES:
FOR FURTHER INFORMATION CONTACT:
Martin Engeler, Marketing Order
Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 2202
Monterey Street, Suite 102–B, Fresno,
California 93721; Telephone: (559) 487–
5110, Fax: (559) 487–5906, or E-mail:
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Martin.Engeler@usda.gov; or Laurel
May, Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence
Avenue, SW., Stop 0237, Washington,
DC 20250–0237; Telephone: (202) 720–
1509, Fax: (202) 720–8938, or E-mail:
Laurel.May@usda.gov.
Small businesses may request
information on this proceeding by
contacting Jay Guerber, Marketing Order
Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 1400
Independence Avenue, SW., Stop 0237,
Washington, DC 20250–0237;
Telephone: (202) 720–2491, Fax: (202)
720–8938, E-mail:
Jay.Guerber@usda.gov.
SUPPLEMENTARY INFORMATION: Prior
document in this proceeding: Notice of
Hearing issued on June 29, 2007, and
published in the July 6, 2007, issue of
the Federal Register (72 FR 36900).
This action is governed by the
provisions of sections 556 and 557 of
title 5 of the United States Code and is
therefore excluded from the
requirements of Executive Order 12866.
Preliminary Statement
Notice is hereby given of the filing
with the Hearing Clerk of this
recommended decision with respect to
the proposed amendments to Marketing
Order 981 regulating the handling of
almonds grown in California, and the
opportunity to file written exceptions
thereto. Copies of this decision can be
obtained from Martin Engeler, whose
address is listed above.
This recommended decision is issued
pursuant to the provisions of the
Agricultural Marketing Agreement Act
of 1937, as amended (7 U.S.C. 601–674),
hereinafter referred to as the ‘‘Act,’’ and
the applicable rules of practice and
procedure governing the formulation of
marketing agreements and orders (7 CFR
Part 900).
The proposed amendments are based
on the record of a public hearing held
August 2, 2007, in Modesto, California.
Notice of this hearing was published in
the Federal Register on July 6, 2007 (72
FR 36900). The notice of hearing
contained the two proposals submitted
by the Board.
The proposed amendments were
recommended by the Board following
deliberations at public meetings on
November 28, 2006, and February 27,
2007, and were submitted to the
Agricultural Marketing Service (AMS)
on March 12, 2007. After reviewing the
recommendation and other information
submitted by the Board, AMS
determined to proceed with the formal
rulemaking process and schedule the
matter for hearing.
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The Board’s proposed amendments to
the order would: (1) Authorize the
establishment of different outgoing
almond quality requirements for
different markets; and (2) authorize the
establishment of container marking and
labeling requirements.
USDA also proposed to make such
changes to the order as may be
necessary, if any of the proposed
changes are adopted, so that all of the
order’s provisions conform to the
effectuated amendments.
Eleven industry witnesses testified at
the hearing. These witnesses
represented almond producers and
handlers in the production area, as well
as Board staff, and all were supportive
of the proposed amendments. The
witnesses emphasized the need to equip
the industry with updated and more
comprehensive tools for the marketing
of California almonds, and testified that
the two proposed amendments would
assist in this matter.
Witnesses offered testimony in
support of the Board’s recommendation
to add authority for different outgoing
quality requirements for shipments to
different markets. Under that authority,
the Board could recommend the
establishment of outgoing quality
requirements to meet the specifications
of particular markets. According to
testimony, this would assure delivery of
a consistent quality product, which
would help maintain customer
confidence and market share.
Witnesses also supported the
recommendation to add general
authority for container marking and
labeling requirements. If implemented,
this authority would enable the Board to
recommend the establishment of
container marking and labeling
regulations to aid in the orderly
marketing of almonds. Such container
marking or labeling could include
information about the product’s origin,
product handling instructions, or other
information responsive to market
demands.
At the conclusion of the hearing, the
Administrative Law Judge established a
deadline of September 24, 2007, for
interested persons to file proposed
findings and conclusions or written
arguments and briefs based on the
evidence received at the hearing. The
filing deadline was extended to
September 26, 2007. Two briefs were
filed during that period: one brief
summarized witness testimony from the
hearing and supported adoption of the
proposed order amendments; and the
second brief provided a brief history of
the California almond industry, clarified
the intent of the Board’s proposed
amendment regarding container
E:\FR\FM\28DEP1.SGM
28DEP1
]]>Agencies
[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Proposed Rules]
[Pages 73667-73671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25270]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 /
Proposed Rules
[[Page 73667]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number AMS-TM-07-0124; TM-07-12]
RIN 0581-AC76
National Organic Program (NOP); Sunset Review (2008)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Advance notice of proposed rulemaking with request for
comments.
-----------------------------------------------------------------------
SUMMARY: Sunset of the exempted or prohibited use of substances under
the National Organic Program (NOP) is required by the Organic Foods
Production Act of 1990 (OFPA). This ANPR announces the sunset of 11
exempted substances and 1 prohibited substance added to the National
List on November 3 and 4, 2003. This ANPR establishes November 3, 2008,
as the date by which the sunset review and renewal process must be
concluded. This advance notice of proposed rule-making (ANPR) also
begins the public comment process on whether the identified existing
exemptions or prohibitions should be continued. Finally, this ANPR
discusses how the NOP will manage the sunset review and renewal
process.
DATES: Comments must be submitted on or before January 28, 2008.
ADDRESSES: Interested persons may submit written comments on this ANPR
using the following addresses:
Mail: Robert Pooler, Agricultural Marketing Specialist,
National Organic Program, USDA-AMS-TMP-NOP, 1400 Independence Avenue.,
SW., Room 4008-So., Ag Stop 0268, Washington, DC 20250.
Internet: www.regulations.gov.
Written comments responding to this ANPR should be identified with
the docket number AMS-TM-07-0124. You should clearly indicate your
position to continue the allowance or prohibition of the substances
identified in this ANPR and the reasons for your position. You should
include relevant information and data to support your position (e.g.,
scientific, environmental, manufacturing, industry impact information,
etc.). You should also supply information on alternative substances or
alternative management practices, where applicable, that support a
change from the current exemption or prohibition of the substance. Only
the supporting material relevant to your position will be considered.
It is our intention to have all comments concerning this ANPR,
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 ANPR 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 ANPR are
requested to make an appointment in advance by calling (202) 720-3252.
FOR FURTHER INFORMATION CONTACT: Robert Pooler, Agricultural Marketing
Specialist, National Organic Program, USDA/AMS/TM/NOP, Room 4008-So.,
Ag Stop 0268, 1400 Independence Ave., SW., Washington, DC 20250. Phone:
(202) 720-3252. Telephone: (202) 720-3252. E-mail:
Robert.pooler@usda.gov.
SUPPLEMENTARY INFORMATION: 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.
Background
The OFPA, 7 U.S.C. 6501 et seq., authorizes the establishment of
the National List of exempted and prohibited substances. The National
List identifies synthetic substances (synthetics) that are exempted
(allowed) and nonsynthetic substances (nonsynthetics) that are
prohibited in organic crop and livestock production. The National List
also identifies nonsynthetics and synthetics that are exempted for use
in organic handling.
The exemptions and prohibitions granted under the OFPA are required
to be reviewed every 5 years by the National Organic Standards Board
(NOSB). The Secretary of Agriculture has authority under the OFPA to
renew such exemptions and prohibitions. If they are not reviewed by the
NOSB and renewed by the Secretary within 5 years of their inclusion on
the National List, their authorized use or prohibition expires. This
means that synthetic substances Copper sulfate, Ozone gas, Peracetic
acid, and EPA List 3 Inerts, currently allowed for use in organic crop
production, will no longer be allowed for use after November 3, 2008.
Calcium chloride currently prohibited from use in organic crop
production, except as a foliar spray to treat a physiological disorder
associated with calcium uptake, will be allowed after November 3, 2008.
This also means that Agar-agar, Carageenan, and Tartaric acid,
currently allowed for use in organic handling, will be prohibited after
November 3, 2008. Finally, Animal enzymes, Calcium sulfate, Glucono
delta lactone, and Cellulose, currently allowed for use in organic
handling, will no longer be allowed for use after November 4, 2008.
Expiration of the exempted or prohibited use of substances is
provided for under the OFPA's sunset provision. This ANPR announces the
sunset of 11 exempted substances and 1 prohibited substance added to
the National List on November 3 and 4, 2003. This ANPR establishes
November 3, 2008, as the date by which the sunset review and renewal
process must be concluded. Substances not renewed will be removed from
the National List. This ANPR also begins the public comment process on
whether the existing specific exemptions or prohibitions on the
National List should be continued. This ANPR discusses how the NOP will
manage the sunset review and renewal process.
Because these substances may be critical to the production and
handling of a wide array of raw and processed organic agricultural
products, their expiration could cause disruption of well-established
and accepted organic production, handling, and processing systems.
Therefore, the NOP is initiating
[[Page 73668]]
the sunset review and renewal process now, in order to provide ample
opportunity for you to make your views known.
Initially, Tartaric acid was inadvertently included in the 2007
sunset process (70 FR 35177, June 17, 2005) and recommended for renewal
by the NOSB (November 17, 2005). However, because Tartaric acid was not
scheduled to sunset until October 31, 2008, it was not included in the
2007 sunset proposed rule (72 FR 9872, March 6, 2007). Consequently,
Tartaric acid will receive consideration under this sunset review and
the NOSB will consider comments previously submitted in response to the
2007 sunset ANPR.
DL-Methionine, DL-Methionine-hydroxyl analog, and DL-Methionine-
hydroxyl analog calcium (CAS --59-51-8; 63-68-3; 348-67-4)
were added to the National List on November 3, 2003, for use in organic
poultry production. Initially these substances carried an expiration
date of October 21, 2005. Effective October 22, 2005, the expiration
date was amended to October 1, 2008. Because these substances have an
expiration date recommended by the NOSB and established by rulemaking,
they are not included in this sunset review. The NOP National List
petition process would have to be employed for these substances to be
authorized for use after October 1, 2008.
The Sunset Process
As the first step in this process, we invite public comment on the
specific exemptions or prohibitions currently on the National List that
are described in this document. All substances currently on the
National List have been previously evaluated and determined by the NOSB
for consistency with OFPA and its implementing regulations. According
to Sec. 6517(e) of the OFPA, these substances must be reviewed by the
NOSB and renewed by the Secretary for their use or prohibition to
continue after 5 years of their addition to the National List which
will be November 3, 2008. Public comments submitted will be considered
in the review and renewal process.
The NOP will forward comments received under this ANPR to the NOSB
for review. The NOSB will review the exemptions and prohibitions of the
substances designated to sunset, including the public comments received
during this review. The NOSB will review each of the substances listed
in this ANPR and may determine that certain substances warrant a more
in-depth review and require additional information or research that
considers new scientific data and technological and market advances.
Following the NOSB's review, the NOSB will make a recommendation to
the Secretary about the continuation of specific exemptions and
prohibitions for the substances listed in this ANPR. After the
Secretary receives the NOSB's recommendations, the NOP will publish a
proposed rule based on the NOSB recommendations. This proposed rule
will provide an additional opportunity for you to express your views.
Comments received on the proposed rule will be used to develop a final
rule. Because the sunset review and renewal process involves
rulemaking, the NOP believes it is appropriate to initiate the process
now with a thirty-day comment period.
Guidance on Submitting Your Comments
Comments That Support Existing Exemptions or Prohibitions
If you provide comments that support the renewal of any or all
existing exemptions or prohibitions included within this ANPR, you
should clearly indicate this and provide your reasons and any relevant
documentation that supports your position.
Comments That Do Not Support Continuing an Existing Exemption
If you provide comments that do not support continuing an existing
exemption, you should provide reasons why the use of the substance
should no longer be allowed in organic agricultural production and
handling. The current exemptions were originally recommended by the
NOSB based on evidence available to the NOSB at the time of review
which demonstrated that the substances were found to be: (1) Not
harmful to human health or the environment, (2) necessary because of
the unavailability of wholly nonsynthetic alternatives, and (3)
consistent and compatible with organic practices. Therefore, comments
against the continued exemption of a substance should demonstrate how
the current substance is: (1) Harmful to human health or the
environment, (2) not necessary to the production of the agricultural
products because of the availability of wholly nonsynthetic substitute
products, or (3) inconsistent with organic farming and handling.
An Appendix to this ANPR contains worksheets to assist you in
gathering relevant information concerning these issues. These
worksheets are not required to submit a comment. These worksheets are
used by the NOSB to develop their recommendations to the Secretary to
include an exempted or prohibited substance on the National List. You
do not have to answer the questions on the worksheets; they are
intended only to help you provide substantive comments to the NOSB when
you provide comments on the specific substance.
In addition, comments that do not support the continued use of a
substance(s) listed within this ANPR should also provide evidence
concerning viable alternatives for the substance you believe should be
discontinued. Viable alternatives include, but are not limited to:
alternative management practices that would eliminate the need for the
specific substance; other currently exempted substances that are on the
National List which could eliminate the need for this specific
substance; and other organic or nonorganic agricultural substances.
Such evidence also should adequately demonstrate that the alternative
has a function and effect that equals or surpasses the specific
exempted substance that you do not want to be continued. Assertions
about an alternative substance except for those alternatives that
already appear on the National List should, if possible include the
name and address of the manufacturer of the alternative. Further, your
comments should include a copy or the specific source of any supportive
literature, which could include product or practice descriptions;
performance and test data; reference standards; name and address of
producers who have used the alternative under similar conditions and
the date of use; and an itemized comparison of the function and effect
of the proposed alternative(s) with substance under review. The chart
below can help you describe recommended alternatives for different
types of organic operations in place of a current exempted substance
that you do not want to be continued.
[[Page 73669]]
------------------------------------------------------------------------
Then the recommended
If the currently listed And is a (an). . alternative should be
substance is used in... . a (an). . .
------------------------------------------------------------------------
Crop or Livestock Production.. Synthetic --Another currently
substance. listed synthetic
substance;
--Nonsynthetic
substance; or
--Management
practice.
Crop or Livestock Production.. Synthetic inert --Another currently
substance listed synthetic
(pesticidal). substance or;
--Nonsynthetic
substance.
Handling...................... Synthetic --Another currently
substance. listed synthetic
substance;
--Nonsynthetic (non-
ag)
substance; or
--Management
practice.
Handling...................... Nonsynthetic (non- --Agricultural
ag) substance. substance; or
--Management
practice.
Handling...................... Nonorganic --Organic
agricultural agricultural
product. product.
------------------------------------------------------------------------
The NOP understands that supportive technical or scientific
information for synthetic alternatives not currently on the National
List may not be easily available to organic producers and handlers.
Such information may, however, be available from the research community
including universities, or other sources, including international
organic programs.
Comments That Do Not Support Continuing an Existing Prohibition
If you provide comments against continuation of the prohibition on
the use of Calcium chloride, you should specify how Calcium chloride is
now consistent with the criteria in the OFPA and the NOP regulation.
When this prohibition was originally recommended by the NOSB, it was
accepted because the evidence available to the NOSB at the time of
review demonstrated that the substance, except as annotated, was found
to be harmful to human health or the environment and was inconsistent
and not compatible with organic practices. Therefore, any comments
against continuation of the prohibition on the use of Calcium chloride
should provide new information, including a copy of the specific source
of any supportive literatures showing that Calcium chloride is no
longer harmful to human health or the environment and is consistent and
compatible with organic practices.
An Appendix to this ANPR contains worksheets to assist you in
gathering relevant information concerning these issues. These
worksheets are not required for you to submit a comment. These
worksheets are used by the NOSB to develop their recommendations to the
Secretary to include an exempted or prohibited substance on the
National List. You do not have to answer the questions on the
worksheets; they are intended to help you provide substantive comments
to the NOSB when you provide comments on the specific substance.
Request for Comments
The NOP requests that you comment whether the NOSB should continue
to recommend the following exemptions and prohibition on the National
List of Allowed and Prohibited Substances for organic agricultural
production and handling:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
(a) As algicide, disinfectants, and sanitizer, including irrigation
system cleaning systems.
(3) Copper sulfate--for use as an algicide in aquatic rice systems,
is limited to one application per field during any 24-month period.
Application rates are limited to those which do not increase baseline
soil test values for copper over a timeframe agreed upon by the
producer and accredited certifying agent.
(5) Ozone gas--for use as an irrigation system cleaner only.
(6) Peracetic acid--for use in disinfecting equipment, seed, and
asexually propagated planting material.
(e) As insecticides (including acaricides or mite control).
(3) Copper Sulfate--for use as tadpole shrimp control in aquatic
rice production, is limited to one application per field during any 24-
month period. Application rates are limited to levels which do not
increase baseline soil test values for copper over a timeframe agreed
upon by the producer and accredited certifying agent.
(i) As plant disease control.
(7) Peracetic acid--for use to control fire blight bacteria.
(m) As synthetic inert ingredients as classified by the
Environmental Protection Agency (EPA), for use with nonsynthetic
substances or synthetic substances listed in this section and used as
an active pesticide ingredient in accordance with any limitations on
the use of such substances.
(2) EPA List 3--Inerts of unknown toxicity allowed:
(ii) Inerts used in passive pheromone dispensers.
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
(c) Calcium chloride, brine process is natural and prohibited for
use except as a foliar spray to treat a physiological disorder
associated with calcium uptake.
Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as
Ingredients in or on Processed Products Labeled as ``Organic'' or
``Made With Organic (Specified Ingredients or Food Groups(s))''
(a) Nonsynthetics allowed:
Agar-agar.
Animal enzymes--(Rennet--animals derived; Catalase--bovine liver;
Animal lipase; Pancreatin; Pepsin; and Trypsin).
Calcium sulfate--mined.
Carageenan.
Glucono delta-lactone--production by the oxidation of D-glucose
with bromine water is prohibited.
Tartaric acid
(b) Synthetics allowed:
Cellulose--for use in regenerative casings, as an anti-caking agent
(non-chlorine bleached) and filtering aid.
Tartaric acid
All comments will be considered in the development of the NOSB's
recommendations to the Secretary.
Authority: 7 U.S.C. 6501 et seq. and 7 CFR part 205.
Dated: December 21, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
Appendix
This Appendix contains worksheets to assist you in gathering
relevant information concerning the compatibility of substances with
evaluation criteria of the OFPA. These worksheets are not required
to submit a comment. These worksheets are used by the NOSB to
develop their recommendations to the Secretary to include an
exempted or
[[Page 73670]]
prohibited substance on the National List. You do not have to answer
the questions on the worksheets; they are intended only to help you
provide substantive comments to the NOSB when you provide comments
on the specific substance.
Evaluation Criteria for Substances Added to the National List
----------------------------------------------------------------------------------------------------------------
Documentation (TAP; petition;
Question Yes No N/A\1\ regulatory agency; other)
----------------------------------------------------------------------------------------------------------------
Category 1. Adverse impacts on humans or the environment?
----------------------------------------------------------------------------------------------------------------
1. Is there environmental contamination
during manufacture, use, misuse, or
disposal? [Sec. 6518 m.3]
2. Is the substance harmful to the
environment? [Sec.
6517c(1)(A)(i);6517(c)(2)(A)i]
3. Does the substance contain List 1, 2,
or 3 inerts? [Sec. 6517 c (1)(B)(ii)]
4. Is there potential for detrimental
chemical interaction with other
materials used? [Sec. 6518 m.1]
5. Are there adverse biological and
chemical interactions in agro-
ecosystem? [Sec. 6518 m.5]
6. Are there detrimental physiological
effects on soil organisms, crops, or
livestock? [Sec. 6518 m.5]
7. Is there a toxic or other adverse
action of the material or its breakdown
products? [Sec. 6518 m.2]
8. Is there undesirable persistence or
concentration of the material or
breakdown products in environment?[Sec.
6518 m.2]
9. Is there any harmful effect on human
health? [Sec. 6517 c (1)(A)(i) ; 6517
c(2)(A)i; Sec. 6518 m.4]
----------------------------------------------------------------------------------------------------------------
Category 2. Is the Substance Essential for Organic Production?
----------------------------------------------------------------------------------------------------------------
1. Is the substance formulated or
manufactured by a chemical process?
[6502 (21)]
2. Is the substance formulated or
manufactured by a process that
chemically changes a substance
extracted from naturally occurring
plant, animal, or mineral, sources?
[6502 (21)]
3. Is the substance created by naturally
occurring biological processes? [6502
(21)]
4. Is there a wholly natural substitute
product? [Sec. 6517 c (1)(A)(ii)]
5. Is the substance used in handling,
not synthetic, but not organically
produced? [Sec. 6517 c (1)(B)(iii)]
6. Is there any alternative substances?
[Sec. 6518 m.6]
7. Is there another practice that would
make the substance unnecessary? [Sec.
6518 m.6]
----------------------------------------------------------------------------------------------------------------
Category 3. Is the substance compatible with organic production practices?
----------------------------------------------------------------------------------------------------------------
1. Is the substance consistent with
organic farming and handling? [Sec.
6517 c (1)(A)(iii); 6517 c (2)(A)(ii)]
2. Is the substance compatible with a
system of sustainable agriculture?
[Sec. 6518 m.7]
3. Is the substance used in production,
and does it contain an active synthetic
ingredient in the following categories:
a. copper and sulfur compounds;
b. toxins derived from bacteria;
c. pheromones, soaps, horticultural
oils, fish emulsions, treated seed,
vitamins and minerals?
d. livestock parasiticides and
medicines?
e. production aids including
netting, tree wraps and seals,
insect traps, sticky barriers, row
covers, and equipment cleaners?
----------------------------------------------------------------------------------------------------------------
\1\ If the substance under review is for crops or livestock production, all of the questions from 205.600 (b)
are N/A--not applicable.
[[Page 73671]]
[FR Doc. E7-25270 Filed 12-27-07; 8:45 am]
BILLING CODE 3410-02-P
