[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Rules and Regulations]
[Page 61987-61993]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-1]
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[[Page 61987]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM-02-03]
RIN 0581-AC19
National Organic Program; Amendments to the National List of
Allowed and Prohibited Substances
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This final rule amends the U.S. Department of Agriculture's
(USDA) National List of Allowed and Prohibited Substances (National
List) to reflect recommendations submitted to the Secretary by the
National Organic Standards Board (NOSB). Technical corrections have
also been included in this final rule to clarify specific sections of
the National List and adequately reflect previous NOSB recommendations.
Consistent with recommendations from the NOSB, this final rule would:
add ten substances, along with any restrictive annotations, to the
National List, revise the annotations of two substances, and make eight
technical revisions.
EFFECTIVE DATE: This rule becomes effective November 3, 2003.
FOR FURTHER INFORMATION CONTACT: Richard H. Mathews, Program Manager,
National Organic Program, Telephone: (202) 720-3252; Fax: (202) 205-
7808.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established, within the
National Organic Standards (NOS) (7 CFR part 205), the National List
(Sec. Sec. 205.600 through 205.607). The National List is the Federal
list that identifies synthetic substances and ingredients that are
allowed and nonsynthetic (natural) substances and ingredients that are
prohibited for use in organic production and handling. Since
established, the National List has not been amended. However, under the
authority of the Organic Foods Production Act of 1990 (OFPA), as
amended (7 U.S.C. 6501 et seq.), the National List can be amended by
the Secretary based on proposed amendments developed by the NOSB.
This final rule amends the National List to reflect recommendations
submitted to the Secretary by the NOSB from June 6, 2000 through
October 20, 2002. Between the specified time period, the NOSB has
recommended that the Secretary add ten substances to Sec. Sec. 205.601
through 205.603 of the National List based on petitions received from
industry participants. These substances were evaluated by the NOSB
using the criteria specified in OFPA (7 U.S.C. 6517 and 6518) and the
NOS. The NOSB also recommended that the Secretary revise the
annotations of two substances included within sections 205.602 and
205.605.
The NOSB has recommended that the Secretary add additional
substances to sections 205.603 and 205.605 which have not been included
in this final rule but are under review and, as appropriate, will be
included in future rulemaking.
In addition to the amendments made based on June 6, 2000 through
October 20, 2002, NOSB recommendations, this final rule also makes
technical revisions to specific sections of the National List that
provide clarity and adequately reflect the intent of the paragraphs
identified within those sections.
II. Overview of Amendments
The following provides an overview of the amendments made to
designated sections of the National List:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This final rule amends the introductory paragraph of Sec. 205.601
by adding language to clarify that synthetic substances used in crop
production must be used in a manner which does not contribute to
contamination of crops, soil, or water. The amendment further clarifies
that synthetic substances, except those in paragraphs (c), (j), (k),
and (l), may only be used when the provisions of Sec. 205.206(a)
through (d) prove insufficient to prevent or control the target pest.
This final rule amends paragraph (a) of Sec. 205.601 (as algicide,
disinfectants and sanitizers, including irrigation cleaning systems) by
adding the following materials:
Copper Sulfate, for use as an algicide, 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; and
Peracetic acid, for use in disinfecting equipment, seed, and
asexually propagated planting material.
Paragraph (a) is further amended by correcting the spelling of the
word ``demisters'' contained in subparagraph (a)(4) to ``demossers.''
This final rule amends paragraph (e) of Sec. 205.601 by adding the
following material:
Copper Sulfate, for use as tadpole shrimp control in 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.
This final rule amends paragraph (f) by changing ``As insect
attractants'' to ``As insect management.''
This final rule amends paragraph (i) of Sec. 205.601 (as plant
disease control) by adding the following substance:
Peracetic acid, for use to control fire blight bacteria.
Paragraph (i) is further amended by removing the annotation
contained in subparagraph (i)(3).
This final rule revises paragraph (k) of Sec. 205.601 (as plant
growth regulators) by inserting the word ``gas'' behind ``ethylene'' to
be consistent with the June 2000 NOSB recommendation for the substance.
Section 205.601(k) now reads ``As plant growth regulators--Ethylene
gas, for regulation of pineapple flowering.''
This final rule revises paragraph (m) of Sec. 205.601 by inserting
a new subpart (2) as follows:
(2) EPA List 3--Inerts of unknown toxicity--for use only in passive
pheromone dispensers.
[[Page 61988]]
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
This final rule amends Sec. 205.602 by adding the following
substance:
Calcium chloride, except as a brine-sourced foliar spray to treat
physiological disorders associated with calcium uptake.
This final rule revises current paragraph (h) of Sec. 205.602 by
amending its annotation to read as follows:
Sodium nitrate--unless use is restricted to no more than 20% of the
crop's total nitrogen requirement; use in spirulina production is
unrestricted until October 21, 2005.
Section 205.603 Synthetic Substances Allowed for Use in Organic
Livestock Production
This final rule revises current subparagraph (4) of Sec.
205.603(a) by correcting the spelling of the word ``chlorohexidine'' to
``chlorhexidine.''
This final rule revises paragraph (b)(4) by replacing ``Bordeaux
mixes'' with ``as external pest control.''
This final rule amends paragraph (d) of Sec. 205.603 (as feed
additives) by adding the following three substances:
DL--Methionine, DL--Methionine--Hydroxy Analog, and DL--
Methionine--Hydroxy Analog Calcium--for use only in organic poultry
production until October 21, 2005.
This final rule revises current subparagraph (1) of Sec.
205.603(d) by removing examples (i) and (ii) copper sulfate and
magnesium sulfate, as they are both approved for use by FDA and do not
need to be listed individually as examples. As currently published,
subparagraphs Sec. 205.603(d)(1)(i) and (ii) may have misled some
readers to believe that the use of trace minerals are limited only to
copper sulfate and magnesium sulfate. Therefore, the revision made in
this final rule for current subparagraph (1) of Sec. 205.603(d) reads
``Trace minerals, used for enrichment or fortification when FDA
approved.''
This final rule amends current paragraph (e) of Sec. 205.603 (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 active
pesticide ingredients in accordance with any limitations on the use of
such substances) by redesignating current paragraph (f) of Sec.
205.603 as subparagraph (1) under Sec. 205.603(e). While drafting
Sec. 205.603 for final publication in the Federal Register, current
paragraph (f) was intended to be designated as Sec. 205.603(e)(1),
however, its designation was not properly assigned. Therefore, this
final rule redesignates current paragraph (f) of Sec. 205.603 as
subparagraph (e)(1) of the same section.
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 Group(s))''
This final rule amends current paragraph (a) of Sec. 205.605 by
adding agar-agar, carageenan and tartaric acid as technical
corrections. These substances were included on the National List
proposed in the Federal Register on December 16, 1997, but were
inadvertently omitted from the National List published in the Federal
Register on March 13, 2000, and the final rule published on December
21, 2000, Final Rule (7 CFR part 205).
This final rule revises current paragraph (b)(10) of Sec. 205.605
by amending its annotation to read as follows:
Ethylene, allowed for postharvest ripening of tropical fruit and
degreening of citrus.
Paragraph (b) is further amended by adding tartaric acid as a
technical correction.
Ethylene, for organic crop production, was a substance that was
petitioned and reviewed for inclusion onto the National List after
promulgation of the proposed rule published in the Federal Register on
March 13, 2000. The NOSB approved and recommended that ethylene gas be
included on the National List with the annotation ``for regulation of
pineapple flowering.'' After receiving the NOSB recommendation for the
material, the NOP, while finalizing the NOS, included the material on
the National List without receiving public comment on the material
through the Federal rulemaking process. As a result, the proposed rule
requested public comment on the use of ethylene gas and this final rule
addresses comments that were received on the use of ethylene gas for
regulation of pineapple flowering.
III. Related Documents
Eight notices were published regarding the meetings of the NOSB and
its deliberations on recommendations and substances petitioned for
amending the National List. Substances and recommendations included in
this final rule were announced for NOSB deliberation in the following
Federal Register Notices: (1) 64 FR 54858, October 8, 1999, (Ethylene);
(2) 65 FR 33802, May 25, 2000, (Ethylene gas); (3) 65 FR 64657, October
30, 2000, (Calcium borogluconate and Peracetic acid); (4) 66 FR 10873,
February 20, 2001, (Poloxalene); (5) 66 FR 48654, September 21, 2001,
(Calcium chloride, Copper sulfate, Methionine); (6) 67 FR 19375, April
19, 2002, (Potassium sorbate and Sodium propionate); (7) 67 FR 54784,
August 26, 2002, (Ozone gas, Pheromones, Sodium (Chilean) nitrate,
Propylene glycol, Magnesium hydroxide/Magnesium oxide, Kaolin pectin,
Bismuth subsalicylate, Flunixin, Xylazine, Tolazoline, Butorphanol,
Mineral oil, Activated charcoal, Epinephrine); and (8) 67 FR 62950,
October 9, 2002, (Potassium sulfate and Calcium propionate).
IV. Statutory and Regulatory Authority
The Organic Foods Production Act of 1990 (OFPA), as amended (7
U.S.C. 6501 et seq.), authorizes the Secretary, at Sec. 6517(d)(1), to
make amendments to the National List based on proposed amendments
developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA
authorize the NOSB to develop proposed amendments to the National List
for submission to the Secretary and establish a petition process by
which persons may petition the NOSB for the purpose of having
substances evaluated for inclusion onto or deletion from the National
List. The National List petition process is implemented under Sec.
205.607 of the NOS. The current petition process (65 FR 43259) can be
accessed through the NOP Web site at http://www.ams.usda.gov/nop.
A. Executive Order 12866
This action has been determined to be non-significant for purposes
of Executive Order 12866, and therefore, does not have to be reviewed
by the Office of Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. The final rule was
reviewed under this Executive Order and no additional related
information has been obtained since then. This final rule is not
intended to have a retroactive effect.
States and local jurisdictions are preempted under section 2115 of
the Organic Foods Production Act (OFPA) (7 U.S.C. 6514) from creating
programs of accreditation for private persons or State officials who
want to become certifying agents of organic farms or handling
operations. A governing State official would have to apply to USDA to
[[Page 61989]]
be accredited as a certifying agent, as described in section 2115(b) of
the OFPA (7 U.S.C. 6514(b)). States are also preempted under sections
2104 through 2108 of the OFPA (7 U.S.C. 6503 through 7 U.S.C. 6507)
from creating certification programs to certify organic farms or
handling operations unless the State programs have been submitted to,
and approved by, the Secretary as meeting the requirements of the OFPA.
Pursuant to section 2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a
State organic certification program may contain additional requirements
for the production and handling of organically produced agricultural
products that are produced in the State and for the certification of
organic farm and handling operations located within the State under
certain circumstances. Such additional requirements must: (a) Further
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c)
not be discriminatory toward agricultural commodities organically
produced in other States, and (d) not be effective until approved by
the Secretary.
Pursuant to section 2120 (f) of the OFPA (7 U.S.C. 6519(f)), this
regulation would not alter the authority of the Secretary under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.), concerning meat, poultry, and
egg products, nor any of the authorities of the Secretary of Health and
Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C.
301 et seq.), nor the authority of the Administrator of the
Environmental Protection Agency (EPA) under the Federal Insecticide,
Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary
to establish an expedited administrative appeals procedure under which
persons may appeal an action of the Secretary, the applicable governing
State official, or a certifying agent under this title that adversely
affects such person or is inconsistent with the organic certification
program established under this title. The OFPA also provides that the
U.S. District Court for the district in which a person is located has
jurisdiction to review the Secretary's decision.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.)
requires agencies to consider the economic impact of each rule on small
entities and evaluate alternatives that would accomplish the objectives
of the rule without unduly burdening small entities or erecting
barriers that would restrict their ability to compete in the market.
The purpose is to fit regulatory actions to the scale of businesses
subject to the action. Section 605 of the RFA allows an agency to
certify a rule, in lieu of preparing an analysis, if the rulemaking is
not expected to have a significant economic impact on a substantial
number of small entities.
Pursuant to the requirements set forth in the RFA, the Agricultural
Marketing Service (AMS) performed an economic impact analysis on small
entities in the final rule published in the Federal Register on
December 21, 2000. AMS has also considered the economic impact of this
action on small entities and has determined that this final rule will
have an impact on a substantial number of small entities. However, AMS
has determined that the impact on entities affected by this rule will
not be significant. The effect of this rule will be to allow the use of
additional substances in agricultural production and handling. This
action relaxes the regulations published in the final rule and provides
small entities with more tools to use in day-to-day operations. The AMS
concludes that the economic impact of this addition of allowed
substances, if any, will be minimal and entirely beneficial to small
agricultural service firms. Accordingly, the Administrator of the AMS
hereby certifies that this rule will not have a significant economic
impact on a substantial number of small entities.
Small agricultural service firms, which include producers,
handlers, and accredited certifying agents, have been defined by the
Small Business Administration (SBA) (13 CFR 121.201) as those having
annual receipts of less than $750,000 and small agricultural producers
are defined as those having annual receipts of less than $5,000,000.
The U.S. organic industry at the end of 2001 included nearly 6,600
certified crop and livestock operations, including organic production
and handling operations, producers, and handlers. These operations
reported certified acreage totaling more than 2.34 million acres,
72,209 certified livestock, and 5.01 million certified poultry. Data on
the numbers of certified handling operations are not yet available, but
likely number in the thousands, as they would include any operation
that transforms raw product into processed products using organic
ingredients. Growth in the U.S. organic industry has been significant
at all levels. From 1997 to 2001, the total organic acreage grew by 74
percent; livestock numbers certified organic grew by almost 300 percent
over the same period, and poultry certified organic increased by 2,118
percent over this time. Sales growth of organic products has been
equally significant, growing on average around 20 percent per year.
Sales of organic products were approximately $1 billion in 1993, but
are estimated to reach $13 billion this year, according to the Organic
Trade Association (the association that represents the U.S. organic
industry). In addition, USDA has accredited 85 certifying agents who
have applied to USDA to be accredited in order to provide certification
services to producers and handlers. A complete list of names and
addresses of accredited certifying agents may be found on the AMS NOP
Web site, at http://www.ams.usda.gov/nop. AMS believes that most of
these entities would be considered small entities under the criteria
established by the SBA.
D. Paperwork Reduction Act
Pursuant to the Paperwork Reduction Act of 1995, the existing
information collection requirements for the NOP are approved under OMB
number 0581-0181. No additional collection or recordkeeping
requirements are imposed on the public by this final rule. Accordingly,
OMB clearance is not required by section 350 (h) of the Paperwork
Reduction Act, 44 U.S.C. 3501, et seq., or OMB's implementing
regulation at 5 CFR part 1320.
E. Comments Received
Altogether, 23 comments were received on these proposed revisions
and amendments. Commenters included consumers, producers, processors,
the National Organic Standards Board (NOSB), certifying agents, food
industry organizations, State governments, and trade organizations.
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
No comments were opposed to the revision of the introductory text
concerning use of materials as required in 205.203(c) and 205.206(a)-
(d). One commenter, however, questioned whether every substance in
205.601 has to be measured against the criteria in 205.206(a)-(d). The
commenter pointed out that algicides should be measured against these
criteria in paragraphs 205.206(a)-(d), but that disinfectants,
sanitizers, and cleaning materials in irrigation systems should not
have to meet the criteria in (a)-(d). The commenter suggests revising
paragraph 205.601(b) to include algicides and
[[Page 61990]]
removing the term algicides from 205.601(a). We agree that the use of
disinfectants and sanitizers listed in Sec. 205.601(a) should not be
measured against the criteria in paragraphs 205.206 (a)-(d).
Accordingly, we have amended the introductory text to exclude
disinfectants and sanitizers. We disagree, however, with removing
algicides from Sec. 205.601(a). We recognize that there may be similar
types of changes that could be made to improve the organization of the
National List and the categories of materials and substances.
Therefore, we will request that the NOSB begin work on addressing such
organizational issues for inclusion in future rulemaking. One commenter
asked that the final rule be written in plain English so that an
average person will understand what is being said. We have made
considerable efforts to write these regulations in plain English, but
note that the regulations dealing with the National List are inherently
difficult to understand because of their technical nature.
(a) As algicides, disinfectants and sanitizers, including
irrigation cleaning systems--(3) Copper Sulfate. Two commenters opposed
the addition of copper sulfate to the National List when it was
published in December, 2000 and restated their opposition; one
commenter cited problems with harmonization with European standards
which do not allow the use of copper sulfate. USDA is currently engaged
in discussions with the European Union (EU) concerning harmonization
and mutual recognition of our respective standards for organic
production and processing, and we believe these issues will be
addressed in those discussions. Copper sulfate has been the subject of
considerable debate and review at more than one NOSB public meeting,
and the annotations restricting its use reflect an attempt by the NOSB
to address all of the concerns raised regarding the use of copper
sulfate in organic systems. Two commenters requested that the phrase
``in aquatic rice systems'' be added as it was stated in the NOSB
recommendation. These two comments have merit and we have made the
requested change.
(5) Ozone gas. No commenters opposed the addition of ozone gas.
(6) Peracetic acid. One commenter noted that many peracetic acid
formulations contain small amounts of toxic stabilizer compounds, and
that the National List should only be for formulations of this material
that do not have synthetic stabilizers in them. However, we believe the
NOSB understands the full nature of peracetic acid and its uses and
made its recommendation accordingly. The public is invited to petition
the NOSB to reconsider any material at any time that new information
becomes available. Such information should also be forwarded to the
NOSB prior to its re-review of any materials on the National List
before the sunset date of five years after being added to the List. One
commenter asked that this paragraph be further amended to require that
documentation be shown that alternatives including biocontrols have
been tried. However, with the revision to the introductory text in this
subsection, we believe the additional annotation is not necessary and
the final rule remains as proposed.
(e) As insecticides (including acaricides or mite control)--(3)
Copper Sulfate. The word ``aquatic'' will be added before the words
``rice production'' to be consistent with the revised wording in
paragraph (a) (3).
(f) As insect attractants--Pheromones. Commenters pointed out that
the word ``attractants'' may be somewhat inaccurate. Pheromones may
also include mating disruption or other general confusion, not
necessarily synonymous with attraction. We have amended the paragraph
to state ``as insect management.'' We also received two comments urging
a policy guidance statement be issued to clarify types of pheromones
permitted as those that are EPA-exempt or EPA-registered without
additional synthetic toxicants (unless those are also on the List) or
those containing no List 1 or List 2 inerts. We will publish on our Web
site such policy guidance.
(i) As plant disease control--(3) Hydrated lime. Numerous
commenters pointed out that the annotation is incorrectly written in
the current regulations. As currently written, the annotation reads
``must be used in a manner that minimizes copper accumulation in the
soil.'' However, there is no copper in hydrated lime. The annotation
referred to an earlier reference to ``Bordeaux mixes'' that are a
combination of copper sulfate plus hydrated lime. Accordingly, we have
deleted the annotation altogether as suggested by the commenters.
(7) Peracetic acid. Commenters pointed out that the proposed
annotation referring to EPA approval is unnecessary, as the material is
currently regulated by EPA and it is unnecessary to restate EPA's
status in the NOP regulation. These comments have merit and we have
amended the annotation to read ``for use to control fire blight
bacteria.'' And one comment opposed the addition of additional
synthetic materials to the National List, specifically, the addition of
paracetic acid to section 205.601. The commenter raised concerns that
the addition of synthetic materials to the National List could continue
a disturbing trend of moving organic systems away from the basic
principles of minimizing use and dependence on purchased inputs,
especially synthetic substances. Congress recognized that synthetic
materials might be necessary for organic production to develop and that
is why the National List was created in the first place. Moreover, the
process of adding a material to the National List is sufficiently
rigorous that by itself, the process will provide a natural limit to
the number of materials that may be added to the List.
(k) As plant growth regulators. No commenters opposed to the
addition of ``gas'' behind ``ethylene.''
(m) As synthetic inert ingredients as classified by the 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--for use only in passive pheromone dispensers. One
commenter objected to the addition of any List 3 Inert unless a
Technical Advisory Panel (TAP) review is conducted and the NOSB
approved the substance for addition to the National List. However, we
believe the annotation accurately reflects the NOSB's understanding
that in passive pheromone dispensers, the allowance of List 3 Inerts
poses no significant harm to sustainable systems, including crops,
soil, and water. Accordingly, no change is made to this provision.
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
No comments were opposed to the addition of calcium chloride.
The language in the proposed rule on sodium nitrate differs in two
places, and may be misleading. The amendment to paragraph (g) should
read: Sodium nitrate--unless use is restricted to no more than 20
percent of the crop's total nitrogen requirement; use in spirulina
production is unrestricted until October 21, 2005.'' Two commenters
opposed the use of sodium nitrate in any amount, or for any crop
production, and one of those commenters cited problems with
harmonization with European standards for organic crop production. USDA
is currently engaged in discussions with the European Union (EU)
concerning harmonization and mutual recognition of our respective
standards for organic production and processing, and we
[[Page 61991]]
believe these issues will be addressed in those discussions. Sodium
nitrate was a subject of considerable debate and review at more than
one NOSB public meeting, and the annotation restricting its use
reflects an attempt by the NOSB to address all of the concerns that
were raised regarding the use of sodium nitrate in organic systems.
The NOSB also commented that the natural substance sodium chloride
(also known as salt) should be prohibited and added to 205.602, with
the annotation that it be permitted in organic cotton production to
comply with emergency spray programs or to prevent immediate loss of
crop. The NOSB pointed out that failure to add this material to 205.602
means that it may be used without restriction, when the NOSB
recommended its addition to the list of prohibited natural materials in
1995. However, we did not include this material for comment in the
proposed rule that was issued in April 2003. Therefore, we believe it
is inappropriate to add this material to this final rule without
offering the public a chance to comment on the NOSB's recommendation.
This material can be included in subsequent rulemaking so that the
public can comment on its proposed addition to 205.602, with the
annotation recommended by the NOSB.
Section 205.603 Synthetic Substances Allowed for Use in Organic
Livestock Production
(b) As topical treatment, external parasiticide or local anesthetic
as applicable--(4) hydrated lime. The annotation following hydrated
lime refers to Bordeaux mixes, which the NOSB correctly points out is a
crop protection material, not a livestock material. The NOSB
recommended changing the annotation to replace ``Bordeaux mixes'' with
``as external pest control.'' We agree and have revised the annotation
accordingly.
(d) As feed additives--(1) DL-Methionine; DL-Methionine--hydroxy
analog, and DL-Methionine--hydroxy analog calcium--for use only in
organic poultry production until October 21, 2005. We received two
comments in opposition to the addition of these three methionine
materials as a feed additive for organic poultry feed; one comment
cited problems with EU harmonization, which we have addressed above.
Methionine has been the subject of considerable debate and review at
more than one NOSB meeting, and the annotation restricting its use
reflects an attempt by the NOSB to address all of the concerns raised
regarding the use of methionine in organic systems.
(2) Trace minerals, used for enrichment or fortification when FDA
approved. We received two comments raising concerns on this proposed
change. One commenter seemed to think that we were eliminating trace
minerals from allowed synthetic materials for use in livestock
production. We are not eliminating their use; rather we eliminated the
references to copper sulfate and magnesium sulfate to eliminate the
perception that only those two trace minerals could be used since they
were the only two examples listed. As long as the trace mineral is
approved by FDA for use in feed supplements for the purpose of
enrichment or fortification, the trace mineral is allowed under these
regulations. Notwithstanding their allowed use in paragraph (d)(2),
producers are also bound to comply with paragraphs (a) and (b) of Sec.
205.237 dealing with livestock feed, including paragraph (b)(2) and
(b)(6), which prohibit a producer from providing feed supplements or
additives in amounts above those needed for adequate nutrition and
health maintenance for the species at its specific stage of life or use
feed additives and supplements in violation of the Federal Food, Drug,
and Cosmetic Act. These livestock feed standards are also why we did
not take the recommended changes of the second commenter that wanted a
two-year period of use for minerals approved by the NOSB after a TAP
review is conducted, and questioned NOP's policy with respect to trace
minerals for animal feeds. This commenter cited an NOSB statement in
1995 that nutrients should come from organic sources, followed by non-
synthetic sources if organic is unavailable, and only allowing
synthetic sources of minerals if natural sources are unavailable. We
believe that the regulations as written, especially Sec. 205.237(a)
addresses this concern by requiring feed to be 100 percent organic,
with exceptions for nonsynthetic substances and synthetic substances as
allowed under Sec. 205.603(d).
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 Group(s))''
The proposed rule contained a typographical error, listing both
nonsynthetic and synthetic lists as Sec. 205.605(a). The synthetic
nonagricultural substance list should be denoted as Sec. 205.605(b).
(b) Synthetics allowed--Tartaric acid. As noted in the proposed
rule, tartaric acid was one of three materials that were inadvertently
omitted from publication on the National List in the final regulations
that were published on December 21, 2000, and the proposed rule would
amend the National List to include tartaric acid in Sec. 205.605(a).
However, the NOSB pointed out in their comments that the NOSB had
approved both synthetic and nonsynthetic forms of tartaric acid.
Accordingly, Sec. 205.605(a) and (b) are amended to include tartaric
acid.
Ethylene--we received one comment asking why this is not in the
list of synthetic materials approved for crop production, since it
deals with ripening for fruit. However, its use is clearly intended for
fruit that has left the farm and is enroute to final consumers and is
more appropriately considered part of a processing function to prepare
the fruit for final purchase. Three commenters opposed its addition to
the National List, citing general concerns about adding more synthetic
materials to the National List and degrading the status of organic
products and one of those comments cited problems with European
harmonization.
Congress recognized that synthetic materials might be necessary for
organic production to develop and that is why the National List was
created in the first place. Moreover, the process of adding a material
to the National List is sufficiently rigorous that by itself, the
process will provide a natural limit to the number of materials that
may be added to the List.
The USDA is currently engaged in discussions with the European
Union (EU) concerning harmonization and mutual recognition of our
respective standards for organic production and processing, and we
believe these issues will be addressed in those discussions.
Pursuant to 5 U.S.C. 553, it is found and determined that good
course exists for not postponing the effective date of this action
until 30 days after publication in the Federal Register.
This rule reflects recommendations submitted to the Secretary by
the NOSB. The ten substances proposed to be added to the National List
were based on petitions from the industry and evaluated by the NOSB
using criteria in the Act and the regulations. Because these substances
are critical to organic production and handling operations, the
National List should be amended as soon as possible.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Animals,
Archives and records, Imports, Labeling, Organically produced products,
Plants,
[[Page 61992]]
Reporting and recordkeeping requirements, Seals and insignia, Soil
conservation.
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For the reasons set forth in the preamble, 7 CFR part 205, Subpart G is
amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
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2. Section 205.601 is amended by:
0
a. Revising the introductory text.
0
b. Redesignating paragraphs (a)(3) and (a)(4) as paragraphs (a)(4) and
(a)(7), respectively.
0
c. Adding new paragraphs (a)(3), (a)(5), and (a)(6).
0
d. Revising the word ``demisters'' in newly redesignated paragraph
(a)(7) to read ``demossers.''
0
e. Redesignating paragraphs (e)(3) through (e)(7) as paragraphs (e)(4)
through (e)(8).
0
f. Adding a new paragraph (e)(3).
0
g. Revising paragraph (f).
0
h. Revising paragraph (i)(3).
0
i. Redesignating paragraphs (i)(7) through (i)(10) as paragraphs (i)(8)
through (i)(11), respectively.
0
j. Adding a new paragraph (i)(7).
0
k. Revising paragraph (k).
0
l. Adding new paragraph (m)(2).
The revisions read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
In accordance with restrictions specified in this section, the
following synthetic substances may be used in organic crop production:
Provided, That, use of such substances do not contribute to
contamination of crops, soil, or water. Substances allowed by this
section, except disinfectants and sanitizers in paragraph (a) and those
substances in paragraphs (c), (j), (k), and (l) of this section, may
only be used when the provisions set forth in Sec. 205.206(a) through
(d) prove insufficient to prevent or control the target pest.
(a) * * *
(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) * * *
(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.
* * * * *
(f) As insect management. Pheromones.
* * * * *
(i) * * *
(3) Hydrated lime.
(7) Peracetic acid--for use to control fire blight bacteria.
* * * * *
(k) As plant growth regulators. Ethylene gas--for regulation of
pineapple flowering.
* * * * *
(m) * * *
(2) EPA List 3--Inerts of unknown toxicity--for use only in passive
pheromone dispensers.
* * * * *
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3. Section 205.602 is revised to read as follows:
Sec. 205.602 Nonsynthetic substances prohibited for use in organic
crop production.
The following nonsynthetic substances may not be used in organic
crop production:
(a) Ash from manure burning.
(b) Arsenic.
(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.
(d) Lead salts.
(e) Potassium chloride--unless derived from a mined source and
applied in a manner that minimizes chloride accumulation in the soil.
(f) Sodium fluoaluminate (mined).
(g) Sodium nitrate--unless use is restricted to no more than 20% of
the crop's total nitrogen requirement; use in spirulina production is
unrestricted until October 21, 2005.
(h) Strychnine.
(i) Tobacco dust (nicotine sulfate).
(j)-(z) [Reserved]
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4. Section 205.603 is amended by:
0
a. Revising paragraph (a).
0
b. Revising the word ``chlorohexidine'' in paragraph (a)(4) to read
``chlorhexidine''.
0
c. Redesignating paragraphs (b)(1) through (b)(5) as (b)(2) through
(b)(6), respectively and redesignating paragraph (b)(6) as paragraph
(b)(1).
0
d. Revising newly redesignated paragraph (b)(4).
0
e. Redesignating paragraphs (d)(1) and (d)(2) as paragraphs (d)(2) and
(d)(3), respectively.
0
f. Adding a new paragraph (d)(1).
0
g. Revising newly redesignated paragraph (d)(2).
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h. Revising the designation for paragraph (f) to read ``(e)(1)''.
0
i. Reserving paragraphs (f)-(z).
The revisions and addition read as follows:
Sec. 205.603 Synthetic substances allowed for use in organic
livestock production.
* * * * *
(a) As disinfectants, sanitizer, and medical treatments as
applicable.
(1) Alcohols.
(i) Ethanol--disinfectant and sanitizer only, prohibited as a feed
additive.
(ii) Isopropanol--disinfectant only.
(2) Aspirin--approved for health care use to reduce inflammation.
(3) Biologics--Vaccines.
(4) Chlorhexidine--Allowed for surgical procedures conducted by a
veterinarian. Allowed for use as a teat dip when alternative germicidal
agents and/or physical barriers have lost their effectiveness.
(5) Chlorine materials--disinfecting and sanitizing facilities and
equipment. Residual chlorine levels in the water shall not exceed the
maximum residual disinfectant limit under the Safe Drinking Water Act.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(6) Electrolytes--without antibiotics.
(7) Glucose.
(8) Glycerine--Allowed as a livestock teat dip, must be produced
through the hydrolysis of fats or oils.
(9) Hydrogen peroxide.
(10) Iodine.
(11) Magnesium sulfate.
(12) Oxytocin--use in postparturition therapeutic applications.
(13) Parasiticides. Ivermectin--prohibited in slaughter stock,
allowed in emergency treatment for dairy and breeder stock when organic
system plan-approved preventive management does not prevent
infestation. Milk or milk products from a treated animal cannot be
labeled as provided for in subpart D of this part for 90 days following
treatment. In breeder stock, treatment cannot occur during the last
third of gestation if the progeny will be sold as organic and must not
be used during the lactation period of breeding stock.
[[Page 61993]]
(14) Phosphoric acid--allowed as an equipment cleaner, Provided,
That, no direct contact with organically managed livestock or land
occurs.
(b) * * *
(4) Lime, hydrated--as external pest control, not permitted to
cauterize physical alterations or deodorize animal wastes.
* * * * *
(d) * * *
(1) DL-Methionine, DL-Methionine--hydroxy analog, and DL-
Methionine--hydroxy analog calcium--for use only in organic poultry
production until October 21, 2005.
(2) Trace minerals, used for enrichment or fortification when FDA
approved.
* * * * *
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5. Section 205.605 is revised to read as follows:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
The following nonagricultural substances may be used as ingredients
in or on processed products labeled as ``organic'' or ``made with
organic (specified ingredients or food group(s))'' only in accordance
with any restrictions specified in this section.
(a) Nonsynthetics allowed:
Acids (Alginic; Citric--produced by microbial fermentation of
carbohydrate substances; and Lactic).
Agar-agar.
Bentonite.
Calcium carbonate.
Calcium chloride.
Carageenan.
Colors, nonsynthetic sources only.
Dairy cultures.
Diatomaceous earth--food filtering aid only.
Enzymes--must be derived from edible, nontoxic plants,
nonpathogenic fungi, or nonpathogenic bacteria.
Flavors, nonsynthetic sources only and must not be produced using
synthetic solvents and carrier systems or any artificial preservative.
Kaolin.
Magnesium sulfate, nonsynthetic sources only.
Nitrogen--oil-free grades.
Oxygen--oil-free grades.
Perlite--for use only as a filter aid in food processing.
Potassium chloride.
Potassium iodide.
Sodium bicarbonate.
Sodium carbonate.
Tartaric acid.
Waxes--nonsynthetic (Carnauba wax; and Wood resin).
Yeast--nonsynthetic, growth on petrochemical substrate and sulfite
waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional;
and Smoked--nonsynthetic smoke flavoring process must be documented).
(b) Synthetics allowed:
Alginates.
Ammonium bicarbonate--for use only as a leavening agent.
Ammonium carbonate--for use only as a leavening agent.
Ascorbic acid.
Calcium citrate.
Calcium hydroxide.
Calcium phosphates (monobasic, dibasic, and tribasic).
Carbon dioxide.
Chlorine materials--disinfecting and sanitizing food contact
surfaces, Except, That, residual chlorine levels in the water shall not
exceed the maximum residual disinfectant limit under the Safe Drinking
Water Act (Calcium hypochlorite; Chlorine dioxide; and Sodium
hypochlorite).
Ethylene--allowed for postharvest ripening of tropical fruit and
degreening of citrus.
Ferrous sulfate--for iron enrichment or fortification of foods when
required by regulation or recommended (independent organization).
Glycerides (mono and di)--for use only in drum drying of food.
Glycerin--produced by hydrolysis of fats and oils.
Hydrogen peroxide.
Lecithin--bleached.
Magnesium carbonate--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Magnesium chloride--derived from sea water.
Magnesium stearate--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Nutrient vitamins and minerals, in accordance with 21 CFR 104.20,
Nutritional Quality Guidelines For Foods.
Ozone.
Pectin (low-methoxy).
Phosphoric acid--cleaning of food-contact surfaces and equipment
only.
Potassium acid tartrate.
Potassium tartrate made from tartaric acid.
Potassium carbonate.
Potassium citrate.
Potassium hydroxide--prohibited for use in lye peeling of fruits
and vegetables.
Potassium iodide--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Potassium phosphate--for use only in agricultural products labeled
``made with organic (specific ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Silicon dioxide.
Sodium citrate.
Sodium hydroxide--prohibited for use in lye peeling of fruits and
vegetables.
Sodium phosphates--for use only in dairy foods.
Sulfur dioxide--for use only in wine labeled ``made with organic
grapes,'' Provided, That, total sulfite concentration does not exceed
100 ppm.
Tartaric acid.
Tocopherols--derived from vegetable oil when rosemary extracts are
not a suitable alternative.
Xanthan gum.
(c)-(z) [Reserved]
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6. In Sec. 205.607, paragraph (c) is revised to read as follows:
Sec. 205.607 Amending the National List.
* * * * *
(c) A petition to amend the National List must be submitted to:
Program Manager, USDA/AMS/TMP/NOP, 1400 Independence Ave., SW., Room
4008-So., Ag Stop 0268, Washington, DC 20250.
* * * * *
Dated: October 27, 2003.
A.J. Yates,
Administrator, Agricultural Marketing Service.
[FR Doc. 03-27415 Filed 10-30-03; 8:45 am]
BILLING CODE 3410-02-P