This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

18556

Vol. 68, No. 73

Wednesday, April 16, 2003

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Docket Number TM–02–03] 

RIN # 0581–AA40 

National Organic Program; Proposed 

Amendments to the National List of 

Allowed and Prohibited Substances

AGENCY: Agricultural Marketing Service, 

USDA.

ACTION: Proposed rule.

SUMMARY: This proposed rule would 

amend the U.S. Department of 

Agriculture’s (USDA) National List of 

Allowed and Prohibited Substances 

(National List) to reflect 

recommendations submitted to the 

Secretary by the National Organic 

Standards Board (NOSB) from June 6, 

2000 through October 20, 2002. 

Technical corrections have also been 

included in this proposed rule to clarify 

specific sections of the National List and 

adequately reflect previous NOSB 

recommendations. Consistent with 

recommendations from the NOSB, this 

proposed rule would: add ten 

substances, along with any restrictive 

annotations, to the National List, revise 

the annotations of two substances, and 

make eight technical revisions. In 

addition to amending the National List, 

this proposed rule would offer the 

opportunity for public comment on the 

use of ethylene in organic crop 

production.

DATES: Comments must be received by 

April 28, 2003.

ADDRESSES: Interested persons may 

comment on this proposed rule using 

the following procedures: 

• Mail: Comments may be submitted 

by mail to: Richard H. Mathews, 

Program Manager, National Organic 

Program, USDA–AMS–TMP–NOP, 1400 

Independence Ave., SW., Room 4008-

So., Ag Stop 0268, Washington, DC 

20250. 

• E-mail: Comments may be 

submitted via the internet to: 

National.List@usda.gov.

• Fax: Comments may be submitted 

by fax to: (202) 205–7808. 

• Written comments on this proposed 

rule should be identified with the 

docket number TMD–02–03. 

Commenters should identify the topic 

and section number of this proposed 

rule to which the comment refers. 

• Clearly indicate if you are for or 

against the proposed rule or some 

portion of it and your reason for it. 

Include recommended language changes 

as appropriate. 

• Include a copy of articles or other 

references that support your comments. 

Only relevant material should be 

submitted. 

It is our intention to have all 

comments to this proposed rule, 

whether submitted by mail, E-mail, or 

fax, available for viewing on the NOP 

homepage. Comments submitted in 

response to this proposed rule will be 

available for viewing in person at 

USDA–AMS, Transportation and 

Marketing, Room 4008-South Building, 

1400 Independence Ave., SW., 

Washington, DC, from 9 a.m. to 12 noon 

and from 1 p.m. to 4 p.m., Monday 

through Friday (except official Federal 

holidays). Persons wanting to visit the 

USDA South Building to view 

comments received in response to this 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252.

FOR FURTHER INFORMATION CONTACT: Toni 

A. Strother, Agricultural Marketing 

Specialist, Telephone: (202) 720–3252; 

Fax: (202) 205–7808.

SUPPLEMENTARY INFORMATION:

I. Background 

On December 21, 2000 the Secretary 

established, within the National Organic 

Standards (NOS) [7 CFR part 205], the 

National List (§§ 205.600 through 

205.607). The National List is the 

Federal list that identifies synthetic 

substances and ingredients that are 

allowed and nonsynthetic (natural) 

substances and ingredients that are 

prohibited for use in organic production 

and handling. Since established, the 

National List has not been amended. 

However, under the authority of the 

Organic Foods Production Act of 1990 

(OFPA), as amended (7 U.S.C. 6501 et 

seq.), the National List can be amended 

by the Secretary based on proposed 

amendments developed by the NOSB. 

This proposed rule would amend the 

National List to reflect 

recommendations submitted to the 

Secretary by the NOSB from June 6, 

2000 through October 20, 2002. Between 

the specified time period, the NOSB has 

recommended that the Secretary add ten 

substances to §§ 205.601 through 

205.603 of the National List based on 

petitions received from industry 

participants. These substances were 

evaluated by the NOSB using the 

criteria specified in OFPA (7 U.S.C. 

6517 and 6518) and the NOS. The NOSB 

also recommended that the Secretary 

revise the annotations of two substances 

included within sections 205.602 and 

205.605. 

The NOSB has recommended that the 

Secretary add additional substances to 

sections 205.603 and 205.605 which 

have not been included in this proposed 

rule but are under review and, as 

appropriate, will be included in future 

rulemaking. 

In addition to the amendments made 

based on June 6, 2000 through October 

20, 2002 NOSB recommendations, this 

proposed rule would also make 

technical revisions to specific sections 

of the National List that provide clarity 

and adequately reflect the intent of the 

paragraphs identified within those 

sections. 

II. Overview of Proposed Amendments 

The following provides an overview 

of the proposed amendments made to 

designated sections of the National List: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

This proposed rule would amend the 

introductory paragraph of § 205.601 by 

adding language which clarifies that 

synthetic substances used in crop 

production must be used in a manner 

which does not contribute to 

contamination of crops, soil, or water. 

The proposed amendment further 

clarifies that synthetic substances, 

except those in paragraphs (c), (j), (k), 

and (l), may only be used when the 

provisions of § 205.206(a) through (d) 

prove insufficient to prevent or control 

the target pest. 

This proposed rule would amend 

paragraph (a) of § 205.601 (as algicide, 

disinfectants and sanitizers, including 

Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules 18557

irrigation cleaning systems) by adding 

the following materials: Copper Sulfate, for use as an algicide, 

is limited to one application per field 

during any 24-month period. 

Application rates are limited to those 

which do not increase baseline soil test 

values for copper over a timeframe 

agreed upon by the producer and 

accredited certifying agent. Ozone Gas, for use as an irrigation 

system cleaner only; and Peracetic acid, for use in disinfecting 

equipment, seed, and asexually 

propagated planting material. Paragraph (a) is proposed to be further 

amended by correcting the spelling of 

the word ‘‘demisters’’ contained in 

subparagraph (a)(4) to ‘‘demossers.’’ This proposed rule would amend 

paragraph (e) of § 205.601 by adding the 

following material: Copper Sulfate, for use as tadpole 

shrimp control in rice production, is 

limited to one application per field 

during any 24-month period. 

Application rates are limited to levels 

which do not increase baseline soil test 

values for copper over a timeframe 

agreed upon by the producer and 

accredited certifying agent. This proposed rule would amend 

paragraph (i) of § 205.601 (as plant 

disease control) by adding the following 

substance: 

Peracetic acid, for use to control fire 

blight bacteria when approved by the 

Environmental Protection Agency (EPA) 

under a Special Local Need (24c) 

registration. This proposed rule would revise 

paragraph (k) of § 205.601 (as plant 

growth regulators) by inserting the word 

‘‘gas’’ behind ‘‘ethylene’’ to be 

consistent with the June 2000 NOSB 

recommendation for the substance. 

Section 205.601(k) will now read ‘‘As 

plant growth regulators—Ethylene gas, 

for regulation of pineapple flowering.’’ This proposed rule revises paragraph 

(m) of § 205.601 by inserting a new 

subpart (2) as follows: (2) EPA List 3—Inerts of unknown 

toxicity—for use only in passive 

pheromone dispensers. 

Section 205.602 Nonsynthetic 

Substances Prohibited for Use in 

Organic Crop Production 

This proposed rule would amend 

§ 205.602 by adding the following 

substance: 

Calcium chloride, except as a brinesourced foliar spray to treat 

physiological disorders associated with 

calcium uptake. This proposed 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 proposed rule would revise 

current subparagraph (4) of § 205.603 (a) 

by correcting the spelling of the word 

‘‘chlorohexidine’’ to ‘‘chlorhexidine.’’ This proposed rule would amend 

paragraph (d) of § 205.603 (as feed 

additives) by adding the following 

substances: 

DL—Methionine, DL—Methionine—

Hydroxy Analog, and DL—

Methionine—Hydroxy Analog 

Calcium—for use only in organic 

poultry production until October 21, 

2005. 

This proposed rule would revise 

current subparagraph (1) of § 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 mislead readers to 

believe that the use of trace minerals are 

limited only to copper sulfate and 

magnesium sulfate. Therefore, the 

revision made in this proposed rule for 

current subparagraph (1) of § 205.603 (d) 

would read ‘‘Trace minerals, used for 

enrichment or fortification when FDA 

approved.’’ This proposed rule would amend 

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 new 

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 proposed 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 proposed rule would amend 

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 removed from the 

National List published in the Federal 

Register on March 13, 2000, proposed 

rule and on December 21, 2000, Final 

Rule (7 CFR Part 205). 

This proposed rule would revise 

current paragraph (b) (10) of § 205.605 

by amending its annotation to read as 

follows: 

Ethylene, allowed for postharvest 

ripening of tropical fruit and degreening 

of citrus.

III. Request for Public Comment on the 

Use of Ethylene 

Ethylene, for organic crop production, 

was a substance that was petitioned and 

reviewed for inclusion onto the National 

List after promulgation of the proposed 

rule published in the Federal Register

on March 13, 2000. The NOSB approved 

and recommended that ethylene gas be 

included on the National List with the 

annotation ‘‘for regulation of pineapple 

flowering.’’ After receiving the NOSB 

recommendation for the material, the 

NOP, while finalizing the NOS, 

included the material on the National 

List without receiving public comment 

on the material through the Federal 

rulemaking process. As a result, this 

proposed rule requests public comment 

on the use of ethylene gas for regulation 

of pineapple flowering. 

IV. Related Documents 

Eight notices were published 

regarding the meetings of the NOSB and 

its deliberations on recommendations 

and substances petitioned for amending 

the National List. Substances and 

recommendations included in this 

proposed rule were announced for 

NOSB deliberation in the following 

Federal Register Notices: (1) 64 FR 

54858, October 8, 1999 (Ethylene); (2) 

65 FR 33802, May 25, 2000, (Ethylene 

gas); (3) 65 FR 64657, October 30, 2000, 

(Calcium borogluconate and Peracetic 

acid); (4) 66 FR 10873, February 20, 

2001, (Poloxalene); (5) 66 FR 48654, 

September 21, 2001, (Calcium chloride, 

Copper sulfate, Methionine); (6) 67 FR 

19375, April 19, 2002, (Potassium 

sorbate and Sodium propionate); (7) 67 

FR 54784, August 26, 2002, (Ozone gas, 

Pheromones, Sodium (Chilean) nitrate, 

Propylene glycol, Magnesium 

hydroxide/Magnesium oxide, Kaolin 

pectin, Bismuth subsalicylate, Flunixin, 

Xylazine, Tolazoline, Butorphanol, 

Mineral oil, Activated charcoal, 

Epinephrine); and (8) 67 FR 62950,

18558 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules 

October 9, 2002, (Potassium sulfate and 

Calcium propionate). 

V. Statutory and Regulatory Authority 

The Organic Foods Production Act of 

1990 (OFPA), as amended (7 U.S.C. 

6501 et seq.), authorizes the Secretary, 

at section 6517(d)(1), to make 

amendments to the National List based 

on proposed amendments developed by 

the NOSB. Sections 6518(k)(2) and 

6518(n) of OFPA authorize the NOSB to 

develop proposed amendments to the 

National List for submission to the 

Secretary and establish a petition 

process by which persons may petition 

the NOSB for the purpose of having 

substances evaluated for inclusion onto 

or deletion from the National List. The 

National List petition process is 

implemented under § 205.607 of the 

NOS. The current petition process (65 

FR 43259) can be accessed through the 

NOP Web site at http://

www.ams.usda.gov/nop. 

A. Executive Order 12866 

This action has been determined to be 

non-significant for purposes of 

Executive Order 12866, and therefore, 

does not have to be reviewed by the 

Office of Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. The 

final rule was reviewed under this 

Executive Order and no additional 

related information has been obtained 

since then. This proposed rule is not 

intended to have a retroactive effect. 

States and local jurisdictions are 

preempted under section 2115 of the 

Organic Foods Production Act (OFPA) 

(7 U.S.C. 6514) from creating programs 

of accreditation for private persons or 

State officials who want to become 

certifying agents of organic farms or 

handling operations. A governing State 

official would have to apply to USDA to 

be accredited as a certifying agent, as 

described in section 2115(b) of the 

OFPA (7 U.S.C. 6514(b)). States are also 

preempted under sections 2104 through 

2108 of the OFPA (7 U.S.C. 6503 

through 6507) from creating certification 

programs to certify organic farms or 

handling operations unless the State 

programs have been submitted to, and 

approved by, the Secretary as meeting 

the requirements of the OFPA. 

Pursuant to section 2108(b)(2) of the 

OFPA (7 U.S.C. 6507(b)(2)), a State 

organic certification program may 

contain additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to section 2120(f) of the 

OFPA (7 U.S.C. 6519(f)), this regulation 

would not alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601 et seq.), 

the Poultry Products Inspections Act (21 

U.S.C. 451 et seq.), or the Egg Products 

Inspection Act (21 U.S.C. 1031 et seq.), 

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 

and Cosmetic Act (21 U.S.C. 301 et 

seq.), nor the authority of the 

Administrator of the Environmental 

Protection Agency (EPA) under the 

Federal Insecticide, Fungicide and 

Rodenticide Act (7 U.S.C. 136 et seq.).

Section 2121 of the OFPA (7 U.S.C. 

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601 et seq.) requires agencies 

to consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. 

Pursuant to the requirements set forth 

in the RFA, the Agricultural Marketing 

Service (AMS) performed an economic 

impact analysis on small entities in the 

final rule published in the Federal 

Register on December 21, 2000. AMS 

has also considered the economic 

impact of this action on small entities. 

Due to the changes reflected in this 

proposed rule that allow the use of 

additional substances in agricultural 

production and handling, the 

Administrator of AMS certifies that this 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities. This action 

relaxes the regulations published in the 

final rule and provides small entities 

with more tools to use in day-to-day 

operations. Small agricultural service 

firms, which include producers, 

handlers, and accredited certifying 

agents, have been defined by the Small 

Business Administration (SBA) (13 CFR 

121.201) as those having annual receipts 

of less than $750,000 and small 

agricultural producers are defined as 

those having annual receipts of less than 

$5,000,000. 

The U.S. organic industry at the end 

of 2001 included nearly 6,600 certified 

crop and livestock operations, including 

organic production and handling 

operations, producers, and handlers. 

These operations reported certified 

acreage totaling more than 2.34 million 

acres, 72,209 certified livestock, and 

5.01 million certified poultry. Data on 

the numbers of certified handling 

operations are not yet available, but 

likely number in the thousands, as they 

would include any operation that 

transforms raw product into processed 

products using organic ingredients. 

Growth in the U.S. organic industry has 

been significant at all levels. From 1997 

to 2001, the total organic acreage grew 

by 74 percent; livestock numbers 

certified organic grew by almost 300 

percent over the same period, and 

poultry certified organic increased by 

2,118 percent over this time. Sales 

growth of organic products has been 

equally significant, growing on average 

around 20 percent per year. Sales of 

organic products were approximately $1 

billion in 1993, but are estimated to 

reach $13 billion this year, according to 

the Organic Trade Association (the 

association that represents the U.S. 

organic industry). In addition, USDA 

has accredited 81 certifying agents who 

have applied to USDA to be accredited 

in order to provide certification services 

to producers and handlers. A complete 

list of names and addresses of 

accredited certifying agents may be 

found on the AMS NOP Web site, at 

http://www.ams.usda.gov/nop. AMS 

believe that most of these entities would 

be considered small entities under the 

criteria established by the SBA. 

Additional regulatory flexibility 

analysis beyond the regulatory 

flexibility analysis published in the 

NOP final rule on December 21, 2000, 

is not required for the purposes of this 

proposed rule. Comments from small 

entities affected by parts of this 

Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules 18559

proposed rule will be considered in 

relation to the requirements of the RFA. 

These comments must be submitted 

separately and cite 5 U.S.C. 609 in the 

correspondence. 

D. Paperwork Reduction Act 

Pursuant to the Paperwork Reduction 

Act of 1995, the existing information 

collection requirements for the NOP are 

approved under OMB number 0581–

0181. No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by section 350(h) of the 

Paperwork Reduction Act, 44 U.S.C. 

3501, et seq., or OMB’s implementing 

regulation at 5 CFR part 1320. 

E. General Notice of Public Rulemaking 

This proposed rule reflects 

recommendations submitted to the 

Secretary by the NOSB. The ten 

substances proposed to be added to the 

National List were based on petitions 

from the industry and evaluated by the 

NOSB using criteria in the Act and the 

regulations. Because these substances 

are critical to organic production and 

handling operations, producers and 

handlers should be able to use them in 

their operations as soon as possible. 

Accordingly, AMS believes that a 10-

day period for interested persons to 

comment on this rule is appropriate.

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation.

For the reasons set forth in the 

preamble, 7 CFR Part 205, Subpart G is 

proposed to be amended as follows:

PART 205—NATIONAL ORGANIC 

PROGRAM 

1. The authority citation for 7 CFR 

Part 205 continues to read as follows:

Authority: 7 U.S.C. 6501–6522.

2. Section 205.601 is amended by: 

a. Revising the introductory text. 

b. Redesignating paragraphs (a)(3) and 

(a)(4) as paragraphs (a)(4) and (a)(7), 

respectively. 

c. Adding new paragraphs (a)(3), 

(a)(5), and (a)(6). 

d. Revising the word ‘‘demisters’’ in 

newly redesignated paragraph (a)(7) to 

read ‘‘demossers’’. 

e. Redesignating paragraphs (e)(3) 

through (e)(7) as paragraphs (e)(4) 

through (e)(8). 

f. Adding a new paragraph (e)(3). 

g. Redesignating paragraphs (i)(7) 

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

through (i)(11), respectively. 

h. Adding a new paragraph (i)(7). 

i. Revising paragraph (k). 

j. Adding new paragraph (m)(2). 

The revisions read as follows:

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

In accordance with restrictions 

specified in this section, the following 

synthetic substances may be used in 

organic crop production: Provided, 

That, use of such substances do not 

contribute to contamination of crops, 

soil, or water. Substances allowed by 

this section, except those in paragraphs 

(c), (j), (k), and (l) of this section, may 

only be used when the provisions set 

forth in § 205.206(a) through (d) prove 

insufficient to prevent or control the 

target pest. 

(a) * * * 

(3) Copper sulfate—for use as an 

algicide, is limited to one application 

per field during any 24-month period. 

Application rates are limited to those 

which do not increase baseline soil test 

values for copper over a timeframe 

agreed upon by the producer and 

accredited certifying agent.

* * * * *

(5) Ozone gas—for use as an irrigation 

system cleaner only. 

(6) Peracetic acid—for use in 

disinfecting equipment, seed, and 

asexually propagated planting material.

* * * * *

(e) * * * 

(3) Copper Sulfate—for use as tadpole 

shrimp control in rice production, is 

limited to one application per field 

during any 24-month period. 

Application rates are limited to levels 

which do not increase baseline soil test 

values for copper over a timeframe 

agreed upon by the producer and 

accredited certifying agent.

* * * * *

(i) * * * 

(7) Peracetic acid—for use to control 

fire blight bacteria when approved by 

the Environmental Protection Agency 

(EPA) under a Special Local Need (24c) 

registration.

* * * * *

(k) As plant growth regulators. 

Ethylene gas—for regulation of 

pineapple flowering.

* * * * *

(m) * * * 

(2) EPA List 3—Inerts of unknown 

toxicity—for use only in passive 

pheromone dispensers.

* * * * *

3. Section 205.602 is revised to read 

as follows:

§ 205.602 Nonsynthetic substances 

prohibited for use in organic crop 

production. 

The following nonsynthetic 

substances may not be used in organic 

crop production: 

(a) Ash from manure burning. 

(b) Arsenic. 

(c) Calcium chloride, brine process is 

natural and prohibited for use except as 

a foliar spray to treat a physiological 

disorder associated with calcium 

uptake. 

(d) Lead salts. 

(e) Potassium chloride—unless 

derived from a mined source and 

applied in a manner that minimizes 

chloride accumulation in the soil. 

(f) Sodium fluoaluminate (mined). 

(g) Sodium nitrate—unless use is 

restricted to no more than 20% of the 

crop’s total nitrogen requirement, or 

until October 21, 2005; for unrestricted 

use in spirulina production. 

(h) Strychnine. 

(i) Tobacco dust (nicotine sulfate). 

(j)–(z) [Reserved] 

4. Section 205.603 is amended by: 

a. Revising paragraph (a). 

b. Revising the word 

‘‘chlorohexidine’’ in paragragh (a)(4) to 

read ‘‘chlorhexidine’’. 

c. Redesignating paragraphs (b)(1) 

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

through (b)(6) and (b)(1), respectively. 

(d) Redesignating paragraphs (d)(1) 

and (d)(2) as paragraphs (d)(2) and 

(d)(3), resepectively. 

e. Adding a new paragraph (d)(1). 

f. Revising newly redesignated 

paragraph (d)(2). 

g. Redesignating paragraph (f) as 

paragraph (e)(1) and reserving paragraph 

(e)(2); 

h. Reserving paragraphs (f)–(z). 

The revisions and addition read as 

follows:

§ 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 

18560 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules 

shall not exceed the maximum residual 

disinfectant limit under the Safe 

Drinking Water Act. 

(i) Calcium hypochlorite. 

(ii) Chlorine dioxide. 

(iii) Sodium hypochlorite. 

(6) Electrolytes-without antibiotics. 

(7) Glucose. 

(8) Glycerine-Allowed as a livestock 

teat dip, must be produced through the 

hydrolysis of fats or oils. 

(9) Hydrogen peroxide. 

(10) Iodine. 

(11) Magnesium sulfate. 

(12) Oxytocin-use in postparturition 

therapeutic applications. 

(13) Parasiticides. Ivermectin—

prohibited in slaughter stock, allowed in 

emergency treatment for dairy and 

breeder stock when organic system 

plan-approved preventive management 

does not prevent infestation. Milk or 

milk products from a treated animal 

cannot be labeled as provided for in 

subpart D of this part for 90 days 

following treatment. In breeder stock, 

treatment cannot occur during the last 

third of gestation if the progeny will be 

sold as organic and must not be used 

during the lactation period of breeding 

stock. 

(14) Phosphoric acid-allowed as an 

equipment cleaner, Provided, That, no 

direct contact with organically managed 

livestock or land occurs.

* * * * *

(d) * * * 

(1) DL—Methionine, DL—

Methionine—hydroxy analog, and DL—

Methionine—hydroxy analog calcium—

for use only in organic poultry 

production until October 21, 2005. 

(2) Trace minerals, used for 

enrichment or fortification when FDA 

approved.

* * * * *

5. Section 205.605 is revised to read 

as follows: 

§ 205.605 Nonagricultural 

(nonorganic) substances allowed as 

ingredients in or on processed products 

labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food 

group(s)).’’

The following nonagricultural 

substances may be used as ingredients 

in or on processed products labeled as 

‘‘organic’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’

only in accordance with any restrictions 

specified in this section. 

(a) Nonsynthetics allowed:

Acids (Alginic; Citric—produced by 

microbial fermentation of carbohydrate 

substances; and Lactic). 

Agar-agar. 

Bentonite. 

Calcium carbonate. 

Calcium chloride. 

Carageenan. 

Colors, nonsynthetic sources only. 

Dairy cultures. 

Diatomaceous earth—food filtering aid only. 

Enzymes—must be derived from edible, 

nontoxic plants, nonpathogenic fungi, or 

nonpathogenic bacteria. 

Flavors, nonsynthetic sources only and must 

not be produced using synthetic solvents 

and carrier systems or any artificial 

preservative. 

Kaolin. 

Magnesium sulfate, nonsynthetic sources 

only. 

Nitrogen—oil-free grades. 

Oxygen—oil-free grades. 

Perlite—for use only as a filter aid in food 

processing. 

Potassium chloride. 

Potassium iodide. 

Sodium bicarbonate.

Sodium carbonate. 

Tartaric acid. 

Waxes—nonsynthetic (Carnauba wax; and 

Wood resin). 

Yeast—nonsynthetic, growth on 

petrochemical substrate and sulfite waste 

liquor is prohibited (Autolysate; Bakers; 

Brewers; Nutritional; and Smoked—

nonsynthetic smoke flavoring process must 

be documented).

(a) Synthetics allowed:

Alginates. 

Ammonium bicarbonate—for use only as a 

leavening agent. 

Ammonium carbonate—for use only as a 

leavening agent. 

Ascorbic acid. 

Calcium citrate. 

Calcium hydroxide. 

Calcium phosphates (monobasic, dibasic, and 

tribasic). 

Carbon dioxide. 

Chlorine materials—disinfecting and 

sanitizing food contact surfaces, Except, 

That, residual chlorine levels in the water 

shall not exceed the maximum residual 

disinfectant limit under the Safe Drinking 

Water Act (Calcium hypochlorite; Chlorine 

dioxide; and Sodium hypochlorite). 

Ethylene—allowed for postharvest ripening 

of tropical fruit and degreening of citrus. 

Ferrous sulfate—for iron enrichment or 

fortification of foods when required by 

regulation or recommended (independent 

organization). 

Glycerides (mono and di)—for use only in 

drum drying of food. 

Glycerin—produced by hydrolysis of fats and 

oils. 

Hydrogen peroxide. 

Lecithin—bleached. 

Magnesium carbonate—for use only in 

agricultural products labeled ‘‘made with 

organic (specified ingredients or food 

group(s)),’’ prohibited in agricultural 

products labeled ‘‘organic’’. 

Magnesium chloride—derived from sea 

water. 

Magnesium stearate—for use only in 

agricultural products labeled ‘‘made with 

organic (specified ingredients or food 

group(s)),’’ prohibited in agricultural 

products labeled ‘‘organic’’. 

Nutrient vitamins and minerals, in 

accordance with 21 CFR 104.20, 

Nutritional Quality Guidelines For Foods. 

Ozone. 

Pectin (low-methoxy). 

Phosphoric acid—cleaning of food-contact 

surfaces and equipment only. 

Potassium acid tartrate. 

Potassium tartrate made from tartaric acid. 

Potassium carbonate. 

Potassium citrate. 

Potassium hydroxide—prohibited for use in 

lye peeling of fruits and vegetables. 

Potassium iodide—for use only in 

agricultural products labeled ‘‘made with 

organic (specified ingredients or food 

group(s)),’’ prohibited in agricultural 

products labeled ‘‘organic’’. 

Potassium phosphate—for use only in 

agricultural products labeled ‘‘made with 

organic (specific ingredients or food 

group(s)),’’ prohibited in agricultural 

products labeled ‘‘organic’’. 

Silicon dioxide. 

Sodium citrate. 

Sodium hydroxide—prohibited for use in lye 

peeling of fruits and vegetables. 

Sodium phosphates—for use only in dairy 

foods. 

Sulfur dioxide—for use only in wine labeled 

‘‘made with organic grapes,’’ Provided,

That, total sulfite concentration does not 

exceed 100 ppm. 

Tocopherols—derived from vegetable oil 

when rosemary extracts are not a suitable 

alternative. 

Xanthan gum.

(c)–(z) [Reserved] 

6. In § 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: April 11, 2003. 

A.J. Yates, 

Administrator, Agricultural Marketing 

Services.

[FR Doc. 03–9412 Filed 4–15–03; 10:52 am] 

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service 

9 CFR Parts 317 and 381 

[Docket No. 00–046P] 

Nutrition Labeling: Nutrient Content 

Claims on Multi-Serve, Meal-Type Meat 

and Poultry Products

AGENCY: Food Safety and Inspection 

Service, USDA.

ACTION: Proposed rule.