[Federal Register Volume 68, Number 73 (Wednesday, April 16, 2003)]
[Proposed Rules]
[Pages 18556-18560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9412]


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 Proposed Rules
                                                 Federal Register
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 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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  Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / 
Proposed Rules  

[[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.

-----------------------------------------------------------------------

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: 
[email protected].
    [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