[Federal Register: April 16, 2003 (Volume 68, Number 73)]
[Proposed Rules]
[Page 18556-18560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap03-14]
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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.
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[[Page 18556]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM-02-03]
RIN 0581-AA40
National Organic Program; Proposed Amendments to the National
List of Allowed and Prohibited Substances
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would amend the U.S. Department of
Agriculture's (USDA) National List of Allowed and Prohibited Substances
(National List) to reflect recommendations submitted to the Secretary
by the National Organic Standards Board (NOSB) from June 6, 2000
through October 20, 2002. Technical corrections have also been included
in this proposed rule to clarify specific sections of the National List
and adequately reflect previous NOSB recommendations. Consistent with
recommendations from the NOSB, this proposed 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. In addition to amending the National List, this
proposed rule would offer the opportunity for public comment on the use
of ethylene in organic crop production.
DATES: Comments must be received by April 28, 2003.
ADDRESSES: Interested persons may comment on this proposed rule using
the following procedures:
[sbull] Mail: Comments may be submitted by mail to: Richard H.
Mathews, Program Manager, National Organic Program, USDA-AMS-TMP-NOP,
1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268, Washington,
DC 20250.
[sbull] E-mail: Comments may be submitted via the internet to:
National.List@usda.gov. [sbull] Fax: Comments may be submitted by fax to: (202) 205-7808.
[sbull] Written comments on this proposed rule should be identified
with the docket number TMD-02-03. Commenters should identify the topic
and section number of this proposed rule to which the comment refers.
[sbull] Clearly indicate if you are for or against the proposed
rule or some portion of it and your reason for it. Include recommended
language changes as appropriate.
[sbull] Include a copy of articles or other references that support
your comments. Only relevant material should be submitted.
It is our intention to have all comments to this proposed rule,
whether submitted by mail, E-mail, or fax, available for viewing on the
NOP homepage. Comments submitted in response to this proposed rule will
be available for viewing in person at USDA-AMS, Transportation and
Marketing, Room 4008-South Building, 1400 Independence Ave., SW.,
Washington, DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m.,
Monday through Friday (except official Federal holidays). Persons
wanting to visit the USDA South Building to view comments received in
response to this proposed rule are requested to make an appointment in
advance by calling (202) 720-3252.
FOR FURTHER INFORMATION CONTACT: Toni A. Strother, Agricultural
Marketing Specialist, 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 proposed rule would amend 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 proposed 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 proposed rule would also
make 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 Proposed Amendments
The following provides an overview of the proposed amendments made
to designated sections of the National List:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This proposed rule would amend the introductory paragraph of Sec.
205.601 by adding language which clarifies 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 proposed
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 proposed rule would amend paragraph (a) of Sec. 205.601 (as
algicide, disinfectants and sanitizers, including
[[Page 18557]]
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 proposed to be further amended by correcting the
spelling of the word ``demisters'' contained in subparagraph (a)(4) to
``demossers.''
This proposed rule would amend 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 proposed rule would amend paragraph (i) of Sec. 205.601 (as
plant disease control) by adding the following substance:
Peracetic acid, for use to control fire blight bacteria when
approved by the Environmental Protection Agency (EPA) under a Special
Local Need (24c) registration.
This proposed rule would revise 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) will now read ``As plant growth
regulators--Ethylene gas, for regulation of pineapple flowering.''
This proposed 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.
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic
Crop Production
This proposed rule would amend 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 proposed 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 proposed rule would revise current subparagraph (4) of Sec.
205.603 (a) by correcting the spelling of the word ``chlorohexidine''
to ``chlorhexidine.''
This proposed rule would amend paragraph (d) of Sec. 205.603 (as
feed additives) by adding the following 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 proposed rule would revise 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 mislead readers to
believe that the use of trace minerals are limited only to copper
sulfate and magnesium sulfate. Therefore, the revision made in this
proposed rule for current subparagraph (1) of Sec. 205.603 (d) would
read ``Trace minerals, used for enrichment or fortification when FDA
approved.''
This proposed rule would amend 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 new 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 proposed 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 proposed rule would amend 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 removed from the National List published in the Federal
Register on March 13, 2000, proposed rule and on December 21, 2000,
Final Rule (7 CFR Part 205).
This proposed rule would revise 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.
III. Request for Public Comment on the Use of Ethylene
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, this proposed rule
requests public comment on the use of ethylene gas for regulation of
pineapple flowering.
IV. 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 proposed 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,
[[Page 18558]]
October 9, 2002, (Potassium sulfate and Calcium propionate).
V. 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 section 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 proposed 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
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 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.
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. Due to the changes reflected in this proposed
rule that allow the use of additional substances in agricultural
production and handling, the Administrator of AMS certifies that this
proposed rule will not have a significant economic impact on a
substantial number of small entities. This action relaxes the
regulations published in the final rule and provides small entities
with more tools to use in day-to-day operations. 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 81 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 believe that most of
these entities would be considered small entities under the criteria
established by the SBA.
Additional regulatory flexibility analysis beyond the regulatory
flexibility analysis published in the NOP final rule on December 21,
2000, is not required for the purposes of this proposed rule. Comments
from small entities affected by parts of this
[[Page 18559]]
proposed rule will be considered in relation to the requirements of the
RFA. These comments must be submitted separately and cite 5 U.S.C. 609
in the correspondence.
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 proposed 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. General Notice of Public Rulemaking
This proposed 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, producers and handlers should be able to use them in their
operations as soon as possible. Accordingly, AMS believes that a 10-day
period for interested persons to comment on this rule is appropriate.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Animals,
Archives and records, Imports, Labeling, Organically produced products,
Plants, Reporting and recordkeeping requirements, Seals and insignia,
Soil conservation.
For the reasons set forth in the preamble, 7 CFR Part 205, Subpart
G is proposed to be amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
1. The authority citation for 7 CFR Part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
2. Section 205.601 is amended by:
a. Revising the introductory text.
b. Redesignating paragraphs (a)(3) and (a)(4) as paragraphs (a)(4)
and (a)(7), respectively.
c. Adding new paragraphs (a)(3), (a)(5), and (a)(6).
d. Revising the word ``demisters'' in newly redesignated paragraph
(a)(7) to read ``demossers''.
e. Redesignating paragraphs (e)(3) through (e)(7) as paragraphs
(e)(4) through (e)(8).
f. Adding a new paragraph (e)(3).
g. Redesignating paragraphs (i)(7) through (i)(10) as paragraphs
(i)(8) through (i)(11), respectively.
h. Adding a new paragraph (i)(7).
i. Revising paragraph (k).
j. 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 those 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, 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 rice
production, is limited to one application per field during any 24-month
period. Application rates are limited to levels which do not increase
baseline soil test values for copper over a timeframe agreed upon by
the producer and accredited certifying agent.
* * * * *
(i) * * *
(7) Peracetic acid--for use to control fire blight bacteria when
approved by the Environmental Protection Agency (EPA) under a Special
Local Need (24c) registration.
* * * * *
(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.
* * * * *
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, or until October 21, 2005; for
unrestricted use in spirulina production.
(h) Strychnine.
(i) Tobacco dust (nicotine sulfate).
(j)-(z) [Reserved]
4. Section 205.603 is amended by:
a. Revising paragraph (a).
b. Revising the word ``chlorohexidine'' in paragragh (a)(4) to read
``chlorhexidine''.
c. Redesignating paragraphs (b)(1) through (b)(5) and (b)(6) as
(b)(2) through (b)(6) and (b)(1), respectively.
(d) Redesignating paragraphs (d)(1) and (d)(2) as paragraphs (d)(2)
and (d)(3), resepectively.
e. Adding a new paragraph (d)(1).
f. Revising newly redesignated paragraph (d)(2).
g. Redesignating paragraph (f) as paragraph (e)(1) and reserving
paragraph (e)(2);
h. 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
[[Page 18560]]
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.
(14) Phosphoric acid-allowed as an equipment cleaner, Provided,
That, no direct contact with organically managed livestock or land
occurs.
* * * * *
(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.
* * * * *
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).
(a) 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.
Tocopherols--derived from vegetable oil when rosemary extracts are
not a suitable alternative.
Xanthan gum.
(c)-(z) [Reserved]
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: April 11, 2003.
A.J. Yates,
Administrator, Agricultural Marketing Services.
[FR Doc. 03-9412 Filed 4-15-03; 10:52 am]
BILLING CODE 3410-02-P