This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

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Rules and Regulations Federal Register

61987

Vol. 68, No. 211

Friday, October 31, 2003

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 (§§ 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 

§§ 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 § 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 § 205.206(a) 

through (d) prove insufficient to prevent 

or control the target pest. 

This final rule amends paragraph (a) 

of § 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 § 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 § 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 

§ 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 § 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. 

61988 Federal Register / Vol. 68, No. 211 / Friday, October 31, 2003 / Rules and Regulations 

Section 205.602 Nonsynthetic 

Substances Prohibited for Use in 

Organic Crop Production 

This final rule amends § 205.602 by 

adding the following substance: 

Calcium chloride, except as a brinesourced foliar spray to treat 

physiological disorders associated with 

calcium uptake. 

This final rule revises current 

paragraph (h) of § 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 § 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 § 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 § 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 § 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 § 205.603(d) 

reads ‘‘Trace minerals, used for 

enrichment or fortification when FDA 

approved.’’

This final rule amends current 

paragraph (e) of § 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 § 205.603 as 

subparagraph (1) under § 205.603(e). 

While drafting § 205.603 for final 

publication in the Federal Register, 

current paragraph (f) was intended to be 

designated as § 205.603(e)(1), however, 

its designation was not properly 

assigned. Therefore, this final rule 

redesignates current paragraph (f) of 

§ 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 § 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 § 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 § 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 § 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 

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

61990 Federal Register / Vol. 68, No. 211 / Friday, October 31, 2003 / Rules and Regulations 

removing the term algicides from 

205.601(a). We agree that the use of 

disinfectants and sanitizers listed in 

§ 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 § 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 rereview 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 

Federal Register / Vol. 68, No. 211 / Friday, October 31, 2003 / Rules and Regulations 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) DLMethionine; 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 § 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 § 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 

§ 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 

§ 205.605(a). The synthetic 

nonagricultural substance list should be 

denoted as § 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 § 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, 

§ 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, 

61992 Federal Register / Vol. 68, No. 211 / Friday, October 31, 2003 / Rules and Regulations 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation.

■ For the reasons set forth in the 

preamble, 7 CFR part 205, Subpart G is 

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. Revising paragraph (f).

■ h. Revising paragraph (i)(3).

■ i. Redesignating paragraphs (i)(7) 

through (i)(10) as paragraphs (i)(8) 

through (i)(11), respectively.

■ j. Adding a new paragraph (i)(7).

■ k. Revising paragraph (k).

■ l. Adding new paragraph (m)(2).

The revisions read as follows:

§ 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 

§ 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.

* * * * *

■ 3. Section 205.602 is revised to read as 

follows:

§ 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]

■ 4. Section 205.603 is amended by:

■ a. Revising paragraph (a).

■ b. Revising the word ‘‘chlorohexidine’’

in paragraph (a)(4) to read 

‘‘chlorhexidine’’.

■ c. Redesignating paragraphs (b)(1) 

through (b)(5) as (b)(2) through (b)(6), 

respectively and redesignating 

paragraph (b)(6) as paragraph (b)(1).

■ d. Revising newly redesignated 

paragraph (b)(4).

■ e. Redesignating paragraphs (d)(1) and 

(d)(2) as paragraphs (d)(2) and (d)(3), 

respectively.

■ f. Adding a new paragraph (d)(1).

■ g. Revising newly redesignated 

paragraph (d)(2).

■ h. Revising the designation for 

paragraph (f) to read ‘‘(e)(1)’’.

■ i. Reserving paragraphs (f)–(z).

The revisions and addition read as 

follows:

§ 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. 

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

* * * * *

■ 5. Section 205.605 is revised to read as 

follows:

§ 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 foodcontact 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]

■ 6. In § 205.607, paragraph (c) is revised 

to read as follows:

§ 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

DEPARTMENT OF ENERGY

Federal Energy Regulatory 

Commission 

18 CFR Parts 101, 141, 201, 260, 352, 

and 357 

[Docket Nos. RM02–14–000 and RM02–14–

001; Order No. 634–A] 

Regulation of Cash Management 

Practices 

October 23, 2003.

AGENCY: Federal Energy Regulatory 

Commission, Department of Energy.

ACTION: Final rule.

SUMMARY: The Federal Energy 

Regulatory Commission is amending its 

regulations to implement reporting 

requirements for FERC-regulated 

entities that participant in cash