[Federal Register Volume 68, Number 211 (Friday, October 31, 2003)]
[Rules and Regulations]
[Pages 61987-61993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27415]



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  Federal Register / Vol. 68, No. 211 / Friday, October 31, 2003 / 
Rules and Regulations  

[[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.

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

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.

0
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.


0
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.
* * * * *

0
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]

0
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).
0
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.
* * * * *

0
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]

0
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