National Organic Program, Sunset Review (2013), 31495-31499 [2011-13496]
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31495
Proposed Rules
Federal Register
Vol. 76, No. 105
Wednesday, June 1, 2011
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
[Doc. No. AMS–NOP–11–0003; NOP–10–13]
RIN 0581–AD13
National Organic Program, Sunset
Review (2013)
Agricultural Marketing Service,
USDA.
ACTION: Advance notice of proposed
rulemaking with request for comments.
AGENCY:
The Organic Foods
Production Act of 1990 (OFPA) requires
sunset (expiration) of the exempted or
prohibited use of substances on the
National List of Allowed and Prohibited
Substances (National List) under the
National Organic Program (NOP). The
exemptions and prohibitions granted on
the National List 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 the
substances are not reviewed by the
NOSB and renewed by the Secretary
within 5 years of their inclusion on the
National List, then their authorized use
or prohibition expires. As required by
the OFPA, the allowed use of 11
synthetic and nonsynthetic substances
in organic production and handling will
expire on November 3, 2013. A
prohibition on one nonsynthetic
substance in organic production will
expire on November 3, 2013. This
advance notice of proposed rulemaking
(ANPR) begins the public comment
process on whether the identified
existing exemptions or prohibition
should be continued. This ANPR also
establishes that the sunset review and
renewal process must be concluded by
November 3, 2013. Finally, this ANPR
discusses how the NOP will manage the
sunset review and renewal process.
DATES: Comments must be submitted on
or before August 1, 2011.
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SUMMARY:
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Interested persons may
submit written comments on this ANPR
using one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Toni Strother, Agricultural
Marketing Specialist, National Organic
Program, USDA–AMS–NOP, Room
2646–So., Ag Stop 0268, 1400
Independence Ave., SW., Washington,
DC 20250–0268.
Written comments responding to this
ANPR should be identified with the
docket number AMS–NOP–11–0003;
NOP–10–13. For detailed instructions
on submitting comments and additional
information on the rulemaking process,
see the ‘‘Guidance on Submitting Your
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document. The NOP intends to
have all comments concerning this
ANPR, including names and addresses
when provided, whether submitted by
mail or internet, available for viewing
on the Federal eRulemaking Portal
internet site, https://
www.regulations.gov. Comments
submitted in response to this ANPR will
also be available for viewing in person
at USDA–AMS, National Organic
Program, Room 2646–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:
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:
ADDRESSES:
Background
The Organic Foods Production Act of
1990 (OFPA), 7 U.S.C. 6501 et seq.,
authorizes the establishment of the
National List. The National List
identifies synthetic substances that are
exempted (allowed) and nonsynthetic
substances that are prohibited in organic
crop and livestock production. The
National List also identifies
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nonsynthetic and synthetic substances
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 the substances 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
under OFPA’s sunset provision.
This ANPR announces the sunset of
11 exempted substances and 1
prohibition added to the National List
on November 3, 2003 (68 FR 61987) and
November 4, 2003 (68 FR 62215), and
previously renewed under the sunset
process on November 3, 2008 (73 FR
59479). This ANPR establishes
November 3, 2013, as the date by which
the sunset review and renewal process
must be concluded. The exemptions and
prohibitions not renewed by this date
will be removed from the National List.
This ANPR also begins the public
comment process on whether the
existing specific exemptions 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 raw and processed organic
agricultural products, their expiration
could cause disruption of wellestablished and accepted organic
production, handling, and processing
systems. Therefore, the NOP is initiating
the sunset review and renewal process
now, to provide ample opportunity for
the public to make their views known
and to inform the decisions of the
NOSB.
Crops Production Substances
The NOSB Crops Committee will
review the continued exemption (use) of
six listings of synthetic substances
allowed for use in organic crop
production on § 205.601: copper sulfate
(2 listings), ozone gas, peracetic acid (2
listings), and EPA List 3 inert
ingredients. These six listings are
scheduled to sunset (expire) on
November 3, 2013. The Crops
Committee will also review the
continued prohibition of one
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Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules
nonsynthetic substance, calcium
chloride, listed on § 205.602, scheduled
to sunset on November 3, 2013. Table 1
contains the full listings of crop
production substances to be reviewed
under the 2013 sunset process.
TABLE 1—CROPS COMMITTEE SUNSET 2013 SUBSTANCES
National list section
Substance listing
Sunset date
Synthetic substances allowed for use in organic crop production.
205.601(a)(3) .......................
205.601(a)(5) .......................
205.601(a)(6) .......................
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.
Ozone gas—for use as an irrigation system cleaner only .........................................................
205.601(i)(8) .........................
Peracetic acid—for use in disinfecting equipment, seed, and asexually propagated planting
material.
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.
Peracetic acid—for use to control fire blight bacteria ................................................................
205.601(m)(2) ......................
EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone dispensers ........
205.601(e)(4) .......................
November 3,
2013.
November 3,
2013.
November 3,
2013.
November 3,
2013.
November 3,
2013.
November 3,
2013.
Nonsynthetic substances prohibited for use in organic crop production.
205.602(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.
Handling Substances
The NOSB Handling Committee will
review the continued exemption (use) of
six nonagricultural (nonorganic),
nonsynthetic substances allowed as
ingredients in or on processed products
labeled as ‘‘organic’’ or ‘‘made with
organic (specified ingredients or food
groups(s)).’’ The allowed uses of the
following six substances listed on
§ 205.605(a) are scheduled to expire on
November 3, 2013: agar-agar, animal
enzymes, calcium sulfate, carrageenan,
glucono delta-lactone, and tartaric acid.
The Handling Committee will also
review the continued exemption (use) of
two nonagricultural (nonorganic),
synthetic substances allowed as
ingredients in or on processed products
November 3,
2013.
labeled as ‘‘organic’’ or ‘‘made with
organic (specified ingredients or food
groups(s)).’’ The allowed uses of the
following two substances listed on
§ 205.605(b) are scheduled to expire
November 3, 2013: cellulose and tartaric
acid. Table 2 contains the full listings of
handling substances that will be
reviewed under the 2013 sunset process.
TABLE 2—HANDLING COMMITTEE SUNSET 2013 SUBSTANCES
National list section
Substance listing
Nonsynthetics allowed:
205.605(a) ........................................
Agar-agar ................................................................................................................
205.605(a) ........................................
Sunset date
205.605(a) ........................................
Animal enzymes—(Rennet-animals derived; Catalase-bovine liver; Animal
lipase; Pancreatin; Pepsin; and Trypsin).
Calcium sulfate—mined ..........................................................................................
205.605(a) ........................................
Carrageenan ...........................................................................................................
205.605(a) ........................................
Glucono delta-lactone—production by the oxidation of D-glucose with bromine
water is prohibited.
Tartaric acid—made from grape wine ....................................................................
205.605(a) ........................................
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Synthetics allowed:
205.605(b) ........................................
205.605(b) ........................................
Cellulose—for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.
Tartaric acid—made from malic acid ......................................................................
The Sunset Process
All substances currently on the
National List have been previously
evaluated by the NOSB for consistency
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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
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November
2013.
November
2013.
November
2013.
November
2013.
November
2013.
November
2013.
3,
3,
3,
3,
3,
3,
November 3,
2013.
November 3,
2013.
to continue after 5 years of their
addition to the National List which will
be November 3, 2013. All substances
identified under this notice were
previously renewed under the sunset
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Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules
process on November 4, 2008 (73 FR
59479), and must be reviewed again by
November 3, 2013.
This notice requests public comments
about the continued use or prohibition
of the substances identified. Public
comments submitted will be considered
in the review and renewal process. The
NOP will forward comments received
under this notice to the NOSB for
review. The NOSB will review the
listings of allowed and prohibited
substances scheduled to sunset,
including the public comments received
during this review. The NOSB will
review each of the substances listed in
this notice 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 and reviews
the NOSB’s recommendations, the NOP
will publish a proposed rule regarding
the NOSB recommendations. This
proposed rule will provide an
additional opportunity for the public to
submit written comments. 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 for substances scheduled to sunset
in 2013.
Guidance on Submitting Your
Comments
Written comments responding to this
ANPR should be identified with the
docket number AMS–NOP–11–0003;
NOP–10–13. You should clearly
indicate your position on continuing 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.).
Comments, regardless of whether they
support or do not support the continued
use of a substance(s) listed within this
ANPR, should provide evidence
concerning the viability of alternatives
for the substance under sunset review.
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 should adequately
address whether any alternatives have a
function and effect equivalent to or
better than the specific exempted
substance, and whether you want the
substance to be renewed or do not want
its use to be continued. Assertions about
alternative substances, 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;
names and addresses of producers or
handlers 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 the substance under
review. The information provided in
Table 3 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.
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
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
31497
to the NOSB when you provide
comments on the specific substance.
Comments That Support Existing
Exemptions and Prohibitions
Comments in support of a continued
exemption of a substance should
demonstrate that the substance is: (1)
Not harmful to human health or the
environment, (2) necessary to the
production of the agricultural products
because of the unavailability of wholly
nonsynthetic substitute products, and
(3) consistent with organic production
and handling. Comments in support of
a continued prohibition should explain
how the use of the substance would
continue to be: (1) harmful to human
health or the environment, or (2)
inconsistent with organic farming and
handling.
Comments That DO NOT Support
Continuing Existing Exemptions or
Prohibitions
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.
If you provide comments that do not
support continuing an existing
exemption or prohibition, you should
provide reasons why the use of the
substance should no longer be allowed
or prohibited in organic agricultural
production and handling. Specifically,
comments that support the removal of a
substance from the National List should
provide information to demonstrate that
the substance is: (1) Harmful to human
health or the environment; (2)
unnecessary because of the availability
of alternatives; or (3) inconsistent with
organic farming or handling. Comments
that do not support a continued
prohibition should explain how the use
of the substance would not be: (1)
harmful to human health or the
environment, or (2) inconsistent with
organic farming and handling.
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TABLE 3—GUIDANCE ON SUBMITTING COMMENTS FOR ALTERNATIVES TO SUBSTANCES ON THE NATIONAL LIST.
If the currently listed substance
is used in . . .
And is a . . .
Then the recommended alternative
should be a (an) . . .
Crop Production .........................
Synthetic substance .........................................................................
—Another currently listed synthetic substance;
—Nonsynthetic substance; or
—Management practice.
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TABLE 3—GUIDANCE ON SUBMITTING COMMENTS FOR ALTERNATIVES TO SUBSTANCES ON THE NATIONAL LIST.—
Continued
If the currently listed substance
is used in . . .
And is a . . .
Then the recommended alternative
should be a (an) . . .
Crop Production .........................
Synthetic inert substance (pesticidal) ..............................................
Handling .....................................
Nonsynthetic (non-agricultural) substance .......................................
Handling .....................................
Synthetic substance .........................................................................
—Another currently listed synthetic substance; or
—Nonsynthetic substance.
—Agricultural substance; or
—Management practice.
—Another currently listed synthetic substance;
—Nonsynthetic (non-agricultural) substance; or
—Management practice.
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.
Request for Comments
The NOP requests that you comment
whether the NOSB should continue to
recommend the exemptions and
prohibitions listed above on the
National List of Allowed and Prohibited
Substances for organic agricultural
production and handling. All comments
will be considered in the development
of the NOSB’s recommendations to the
Secretary.
Authority: 7 U.S.C. 6501–6522 and 7 CFR
part 205
Dated: May 24, 2011.
Rayne Pegg,
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 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.
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST
Question
Yes
No
Documentation
(TAP; petition; regulatory
agency; other)
N/A1
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Category 1. Adverse impacts on humans or the environment?
1. Are there adverse effects on environment from manufacture, use, or
disposal? [§ 205.600 b.2].
2. Is there environmental contamination during manufacture, use, misuse,
or disposal? [§ 6518 m.3].
3.
Is
the
substance
harmful
to
the
environment?
[§ 6517(c)(1)(A)(i);6517(c)(2)(A)(i)].
4. Does the substance contain List 1, 2, or 3 inerts? [§ 6517(c)(1)(B)(ii);
§ 205.601(m)(2)].
5. Is there potential for detrimental chemical interaction with other materials used? [§ 6518(m)(1)].
6. Are there adverse biological and chemical interactions in agro-ecosystem? [§ 6518(m)(5)].
7. Are there detrimental physiological effects on soil organisms, crops, or
livestock? [§ 6518(m)(5)].
8. Is there a toxic or other adverse action of the material or its breakdown products? [§ 6518(m)(2)].
9. Is there undesirable persistence or concentration of the material or
breakdown products in environment?[§ 6518(m)(2)].
10. Is there any harmful effect on human health? [§ 6517(c)(1)(A)(i);
§ 6517(c)(2)(A)(i); § 6518(m)(4)].
11. Is there an adverse effect on human health as defined by applicable
Federal regulations? [§ 205.600(b)(3)].
12. Is the substance GRAS when used according to FDA’s good manufacturing practices? [§ 205.600(b)(5)].
13. Does the substance contain residues of heavy metals or other contaminants in excess of FDA tolerances? [§ 205.600(b)(5)].
1 If
the substance under review is for crop or livestock production, all of the questions from § 205.600(b) are N/A—not applicable.
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31499
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 natural source of the substance? [§ 205.600(b)(1)] ................
5. Is there an organic substitute? [§ 205.600(b)(1)] ....................................
6. Is the substance essential for handling of organically produced agricultural products? [§ 205.600(b)(6)].
7. Is there a wholly natural substitute product? [§ 6517(c)(1)(A)(ii)] ...........
8. Is the substance used in handling, not synthetic, but not organically
produced? [§ 6517(c)(1)(B)(iii)].
9. Is there any alternative substances? [§ 6518(m)(6)] ...............................
10. Is there another practice that would make the substance unnecessary? [§ 6518(m)(6)].
1 If
the substance under review is for crop or livestock production, all of the questions from § 205.600(b) are N/A—not applicable.
Category 3. Is the substance compatible with organic production practices?
1. Is the substance compatible with organic handling? [§ 205.600(b)(2)] ...
2. Is the substance consistent with organic farming and handling?
[§ 6517(c)(1)(A)(iii); § 6517(c)(2)(A)(ii)].
3. Is the substance compatible with a system of sustainable agriculture?
[§ 6518(m)(7)].
4. Is the nutritional quality of the food maintained with the substance?
[§ 205.600(b)(3)].
5. Is the primary use as a preservative? [§ 205.600(b)(4)] .........................
6. Is the primary use to recreate or improve flavors, colors, textures, or
nutritive values lost in processing (except when required by law, e.g.,
vitamin D in milk)? [§ 205.600(b)(4)].
7. 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 crop or livestock production, all of the questions from 205.600(b) are N/A—not applicable.
[FR Doc. 2011–13496 Filed 5–31–11; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 92, 93, 94, 96, and 98
[Docket No. APHIS–2009–0035]
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RIN 0579–AD05
Lists of Regions Classified With
Respect to Certain Animal Diseases
and States Approved To Receive
Certain Imported Horses
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
We are proposing to remove
lists of regions classified with respect to
certain animal diseases and pests from
SUMMARY:
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19:26 May 31, 2011
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our animal and animal product import
regulations and, instead, post them to
the Animal and Plant Health Inspection
Service’s (APHIS’) Web site. The
regulations would provide the Web
address and would explain APHIS’
criteria and process for adding a region
to, or removing a region from, each of
the lists. The technical criteria APHIS
uses to evaluate whether a region
should be added to or removed from a
list would not change. We are also
proposing to remove lists of States
approved to receive horses imported
from foreign regions where we consider
contagious equine metritis to exist and,
instead, post approved States to our
Web site. The criteria for approving a
State would not change. We would
continue to provide an opportunity for
public comment on changes to the lists.
This action would enable the Agency to
respond more quickly to changes in the
disease status of regions.
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We will consider all comments
that we receive on or before August 1,
2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2009-0035 to submit or view comments
and to view supporting and related
materials available electronically.
• Postal Mail/Commercial Delivery:
Please send one copy of your comment
to Docket No. APHIS–2009–0035,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2009–0035.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room is located in room 1141 of the
DATES:
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]]>Agencies
[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Proposed Rules]
[Pages 31495-31499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13496]
========================================================================
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. 76, No. 105 / Wednesday, June 1, 2011 /
Proposed Rules
[[Page 31495]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. AMS-NOP-11-0003; NOP-10-13]
RIN 0581-AD13
National Organic Program, Sunset Review (2013)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Advance notice of proposed rulemaking with request for
comments.
-----------------------------------------------------------------------
SUMMARY: The Organic Foods Production Act of 1990 (OFPA) requires
sunset (expiration) of the exempted or prohibited use of substances on
the National List of Allowed and Prohibited Substances (National List)
under the National Organic Program (NOP). The exemptions and
prohibitions granted on the National List 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 the substances are not
reviewed by the NOSB and renewed by the Secretary within 5 years of
their inclusion on the National List, then their authorized use or
prohibition expires. As required by the OFPA, the allowed use of 11
synthetic and nonsynthetic substances in organic production and
handling will expire on November 3, 2013. A prohibition on one
nonsynthetic substance in organic production will expire on November 3,
2013. This advance notice of proposed rulemaking (ANPR) begins the
public comment process on whether the identified existing exemptions or
prohibition should be continued. This ANPR also establishes that the
sunset review and renewal process must be concluded by November 3,
2013. Finally, this ANPR discusses how the NOP will manage the sunset
review and renewal process.
DATES: Comments must be submitted on or before August 1, 2011.
ADDRESSES: Interested persons may submit written comments on this ANPR
using one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Toni Strother, Agricultural Marketing Specialist,
National Organic Program, USDA-AMS-NOP, Room 2646-So., Ag Stop 0268,
1400 Independence Ave., SW., Washington, DC 20250-0268.
Written comments responding to this ANPR should be identified with
the docket number AMS-NOP-11-0003; NOP-10-13. For detailed instructions
on submitting comments and additional information on the rulemaking
process, see the ``Guidance on Submitting Your Comments'' heading of
the SUPPLEMENTARY INFORMATION section of this document. The NOP intends
to have all comments concerning this ANPR, including names and
addresses when provided, whether submitted by mail or internet,
available for viewing on the Federal eRulemaking Portal internet site,
https://www.regulations.gov. Comments submitted in response to this ANPR
will also be available for viewing in person at USDA-AMS, National
Organic Program, Room 2646-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: 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:
Background
The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et
seq., authorizes the establishment of the National List. The National
List identifies synthetic substances that are exempted (allowed) and
nonsynthetic substances that are prohibited in organic crop and
livestock production. The National List also identifies nonsynthetic
and synthetic substances 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 the substances 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 under OFPA's sunset provision.
This ANPR announces the sunset of 11 exempted substances and 1
prohibition added to the National List on November 3, 2003 (68 FR
61987) and November 4, 2003 (68 FR 62215), and previously renewed under
the sunset process on November 3, 2008 (73 FR 59479). This ANPR
establishes November 3, 2013, as the date by which the sunset review
and renewal process must be concluded. The exemptions and prohibitions
not renewed by this date will be removed from the National List. This
ANPR also begins the public comment process on whether the existing
specific exemptions 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 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 the sunset review and renewal process now, to provide
ample opportunity for the public to make their views known and to
inform the decisions of the NOSB.
Crops Production Substances
The NOSB Crops Committee will review the continued exemption (use)
of six listings of synthetic substances allowed for use in organic crop
production on Sec. 205.601: copper sulfate (2 listings), ozone gas,
peracetic acid (2 listings), and EPA List 3 inert ingredients. These
six listings are scheduled to sunset (expire) on November 3, 2013. The
Crops Committee will also review the continued prohibition of one
[[Page 31496]]
nonsynthetic substance, calcium chloride, listed on Sec. 205.602,
scheduled to sunset on November 3, 2013. Table 1 contains the full
listings of crop production substances to be reviewed under the 2013
sunset process.
Table 1--Crops Committee Sunset 2013 Substances
----------------------------------------------------------------------------------------------------------------
National list section Substance listing Sunset date
----------------------------------------------------------------------------------------------------------------
Synthetic substances allowed for use in organic crop production.
----------------------------------------------------------------------------------------------------------------
205.601(a)(3)..................... Copper sulfate--for use as an algicide in November 3, 2013.
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.
205.601(a)(5)..................... Ozone gas--for use as an irrigation system November 3, 2013.
cleaner only.
205.601(a)(6)..................... Peracetic acid--for use in disinfecting November 3, 2013.
equipment, seed, and asexually propagated
planting material.
205.601(e)(4)..................... Copper sulfate--for use as tadpole shrimp November 3, 2013.
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.
205.601(i)(8)..................... Peracetic acid--for use to control fire blight November 3, 2013.
bacteria.
205.601(m)(2)..................... EPA List 3--Inerts of unknown toxicity--for November 3, 2013.
use only in passive pheromone dispensers.
----------------------------------------------------------------------------------------------------------------
Nonsynthetic substances prohibited for use in organic crop production.
----------------------------------------------------------------------------------------------------------------
205.602(c)........................ Calcium chloride, brine process is natural and November 3, 2013.
prohibited for use except as a foliar spray
to treat a physiological disorder associated
with calcium uptake.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Handling Substances
The NOSB Handling Committee will review the continued exemption
(use) of six nonagricultural (nonorganic), nonsynthetic substances
allowed as ingredients in or on processed products labeled as
``organic'' or ``made with organic (specified ingredients or food
groups(s)).'' The allowed uses of the following six substances listed
on Sec. 205.605(a) are scheduled to expire on November 3, 2013: agar-
agar, animal enzymes, calcium sulfate, carrageenan, glucono delta-
lactone, and tartaric acid.
The Handling Committee will also review the continued exemption
(use) of two nonagricultural (nonorganic), synthetic substances allowed
as ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food groups(s)).'' The
allowed uses of the following two substances listed on Sec. 205.605(b)
are scheduled to expire November 3, 2013: cellulose and tartaric acid.
Table 2 contains the full listings of handling substances that will be
reviewed under the 2013 sunset process.
Table 2--Handling Committee Sunset 2013 Substances
----------------------------------------------------------------------------------------------------------------
National list section Substance listing Sunset date
----------------------------------------------------------------------------------------------------------------
Nonsynthetics allowed:
205.605(a).................... Agar-agar..................................... November 3, 2013.
205.605(a).................... Animal enzymes--(Rennet-animals derived; November 3, 2013.
Catalase-bovine liver; Animal lipase;
Pancreatin; Pepsin; and Trypsin).
205.605(a).................... Calcium sulfate--mined........................ November 3, 2013.
205.605(a).................... Carrageenan................................... November 3, 2013.
205.605(a).................... Glucono delta-lactone--production by the November 3, 2013.
oxidation of D-glucose with bromine water is
prohibited.
205.605(a).................... Tartaric acid--made from grape wine........... November 3, 2013.
Synthetics allowed:
205.605(b).................... Cellulose--for use in regenerative casings, as November 3, 2013.
an anti-caking agent (non-chlorine bleached)
and filtering aid.
205.605(b).................... Tartaric acid--made from malic acid........... November 3, 2013.
----------------------------------------------------------------------------------------------------------------
The Sunset Process
All substances currently on the National List have been previously
evaluated 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, 2013. All substances identified
under this notice were previously renewed under the sunset
[[Page 31497]]
process on November 4, 2008 (73 FR 59479), and must be reviewed again
by November 3, 2013.
This notice requests public comments about the continued use or
prohibition of the substances identified. Public comments submitted
will be considered in the review and renewal process. The NOP will
forward comments received under this notice to the NOSB for review. The
NOSB will review the listings of allowed and prohibited substances
scheduled to sunset, including the public comments received during this
review. The NOSB will review each of the substances listed in this
notice 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 and reviews the NOSB's recommendations, the NOP will
publish a proposed rule regarding the NOSB recommendations. This
proposed rule will provide an additional opportunity for the public to
submit written comments. 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 for substances scheduled to sunset in 2013.
Guidance on Submitting Your Comments
Written comments responding to this ANPR should be identified with
the docket number AMS-NOP-11-0003; NOP-10-13. You should clearly
indicate your position on continuing 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.).
Comments, regardless of whether they support or do not support the
continued use of a substance(s) listed within this ANPR, should provide
evidence concerning the viability of alternatives for the substance
under sunset review. 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 should adequately address whether any alternatives have a
function and effect equivalent to or better than the specific exempted
substance, and whether you want the substance to be renewed or do not
want its use to be continued. Assertions about alternative substances,
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; names and addresses of producers or handlers 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 the substance under review. The information
provided in Table 3 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.
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 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.
Comments That Support Existing Exemptions and Prohibitions
Comments in support of a continued exemption of a substance should
demonstrate that the substance is: (1) Not harmful to human health or
the environment, (2) necessary to the production of the agricultural
products because of the unavailability of wholly nonsynthetic
substitute products, and (3) consistent with organic production and
handling. Comments in support of a continued prohibition should explain
how the use of the substance would continue to be: (1) harmful to human
health or the environment, or (2) inconsistent with organic farming and
handling.
Comments That DO NOT Support Continuing Existing Exemptions or
Prohibitions
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.
If you provide comments that do not support continuing an existing
exemption or prohibition, you should provide reasons why the use of the
substance should no longer be allowed or prohibited in organic
agricultural production and handling. Specifically, comments that
support the removal of a substance from the National List should
provide information to demonstrate that the substance is: (1) Harmful
to human health or the environment; (2) unnecessary because of the
availability of alternatives; or (3) inconsistent with organic farming
or handling. Comments that do not support a continued prohibition
should explain how the use of the substance would not be: (1) harmful
to human health or the environment, or (2) inconsistent with organic
farming and handling.
Table 3--Guidance on Submitting Comments for Alternatives to Substances on the National List.
----------------------------------------------------------------------------------------------------------------
If the currently listed Then the recommended alternative should be a (an) .
substance is used in . . . And is a . . . . .
----------------------------------------------------------------------------------------------------------------
Crop Production............... Synthetic substance........ --Another currently listed synthetic substance;
--Nonsynthetic substance; or
--Management practice.
[[Page 31498]]
Crop Production............... Synthetic inert substance --Another currently listed synthetic substance; or
(pesticidal). --Nonsynthetic substance.
Handling...................... Nonsynthetic (non- --Agricultural substance; or
agricultural) substance. --Management practice.
Handling...................... Synthetic substance........ --Another currently listed synthetic substance;
--Nonsynthetic (non-agricultural) substance; or
--Management practice.
----------------------------------------------------------------------------------------------------------------
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.
Request for Comments
The NOP requests that you comment whether the NOSB should continue
to recommend the exemptions and prohibitions listed above on the
National List of Allowed and Prohibited Substances for organic
agricultural production and handling. All comments will be considered
in the development of the NOSB's recommendations to the Secretary.
Authority: 7 U.S.C. 6501-6522 and 7 CFR part 205
Dated: May 24, 2011.
Rayne Pegg,
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
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.
NOSB Evaluation Criteria for Substances Added to the National List
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation (TAP; petition; regulatory
Question Yes No N/A\1\ agency; other)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Category 1. Adverse impacts on humans or the environment?
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Are there adverse effects on environment
from manufacture, use, or disposal? [Sec.
205.600 b.2].
2. Is there environmental contamination
during manufacture, use, misuse, or
disposal? [Sec. 6518 m.3].
3. Is the substance harmful to the
environment? [Sec.
6517(c)(1)(A)(i);6517(c)(2)(A)(i)].
4. Does the substance contain List 1, 2, or
3 inerts? [Sec. 6517(c)(1)(B)(ii); Sec.
205.601(m)(2)].
5. Is there potential for detrimental
chemical interaction with other materials
used? [Sec. 6518(m)(1)].
6. Are there adverse biological and chemical
interactions in agro-ecosystem? [Sec.
6518(m)(5)].
7. Are there detrimental physiological
effects on soil organisms, crops, or
livestock? [Sec. 6518(m)(5)].
8. Is there a toxic or other adverse action
of the material or its breakdown products?
[Sec. 6518(m)(2)].
9. Is there undesirable persistence or
concentration of the material or breakdown
products in environment?[Sec. 6518(m)(2)].
10. Is there any harmful effect on human
health? [Sec. 6517(c)(1)(A)(i); Sec.
6517(c)(2)(A)(i); Sec. 6518(m)(4)].
11. Is there an adverse effect on human
health as defined by applicable Federal
regulations? [Sec. 205.600(b)(3)].
12. Is the substance GRAS when used
according to FDA's good manufacturing
practices? [Sec. 205.600(b)(5)].
13. Does the substance contain residues of
heavy metals or other contaminants in
excess of FDA tolerances? [Sec.
205.600(b)(5)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ If the substance under review is for crop or livestock production, all of the questions from Sec. 205.600(b) are N/A--not applicable.
[[Page 31499]]
Category 2. Is the substance essential for organic production?
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Is the substance formulated or
manufactured by a chemical process? [Sec.
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? [Sec. 6502(21)].
3. Is the substance created by naturally
occurring biological processes? [Sec.
6502(21)].
4. Is there a natural source of the
substance? [Sec. 205.600(b)(1)].
5. Is there an organic substitute? [Sec.
205.600(b)(1)].
6. Is the substance essential for handling
of organically produced agricultural
products? [Sec. 205.600(b)(6)].
7. Is there a wholly natural substitute
product? [Sec. 6517(c)(1)(A)(ii)].
8. Is the substance used in handling, not
synthetic, but not organically produced?
[Sec. 6517(c)(1)(B)(iii)].
9. Is there any alternative substances?
[Sec. 6518(m)(6)].
10. Is there another practice that would
make the substance unnecessary? [Sec.
6518(m)(6)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ If the substance under review is for crop or livestock production, all of the questions from Sec. 205.600(b) are N/A--not applicable.
Category 3. Is the substance compatible with organic production practices?
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Is the substance compatible with organic
handling? [Sec. 205.600(b)(2)].
2. Is the substance consistent with organic
farming and handling? [Sec.
6517(c)(1)(A)(iii); Sec.
6517(c)(2)(A)(ii)].
3. Is the substance compatible with a system
of sustainable agriculture? [Sec.
6518(m)(7)].
4. Is the nutritional quality of the food
maintained with the substance? [Sec.
205.600(b)(3)].
5. Is the primary use as a preservative?
[Sec. 205.600(b)(4)].
6. Is the primary use to recreate or improve
flavors, colors, textures, or nutritive
values lost in processing (except when
required by law, e.g., vitamin D in milk)?
[Sec. 205.600(b)(4)].
7. 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 crop or livestock production, all of the questions from 205.600(b) are N/A--not applicable.
[FR Doc. 2011-13496 Filed 5-31-11; 8:45 am]
BILLING CODE 3410-02-P
