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

43786

Vol. 70, No. 145

Friday, July 29, 2005

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Doc. No. TM–05–02] 

National Organic Program; Proposed 

Amendment to the National List of 

Allowed and Prohibited Substances 

(Livestock)

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 one 

recommendation submitted to the 

Secretary by the National Organic 

Standards Board (NOSB). Consistent 

with the recommendation from the 

NOSB, this proposed rule would revise 

the annotation of one substance on the 

National List, Methionine, to extend its 

use in organic poultry production until 

October 21, 2008.

DATES: Comments must be received by 

August 15, 2005.

ADDRESSES: Interested persons may 

comment on this proposed rule using 

the following procedures: 

• Mail: Comments may be submitted 

by mail to: Arthur Neal, Director of 

Program Administration, 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. or to http://

www.regulations.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 TM–05–02. 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 

National Organic Program (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:

Arthur Neal, Director of Program 

Administration, Telephone: (202) 720–

3252; Fax: (202) 205–7808.

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000 the Secretary 

established, within the NOP regulations 

[7 CFR part 205], the National List 

regulations (National List) (§§ 205.600 

through 205.607). The National List 

identifies synthetic substances that are 

allowed and nonsynthetic substances 

that are prohibited in organic crop and 

livestock production. The National List 

also identifies nonsynthetic and 

synthetic substances that are allowed for 

use in certified handling operations. 

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. 

Since established, the National List has 

been amended twice, October 31, 2003 

(68 FR 61987), and November 3, 2003 

(68 FR 62215). 

This proposed rule would amend the 

National List to reflect one 

recommendation submitted to the 

Secretary by the NOSB on March 3, 

2005. Based on their evaluation of a 

petition submitted by industry 

participants, the NOSB recommended 

that the Secretary amend § 205.603(d)(1) 

of the National List by revising the 

annotation of Methionine, a feed 

additive, to extend its use in organic 

poultry production until October 21, 

2008. The use of Methionine in organic 

production was evaluated by the NOSB 

using the evaluation criteria specified in 

OFPA (7 U.S.C. 6517–6518). 

A 15-day comment period has been 

deemed appropriate to allow interested 

persons to respond to this proposed 

rule. Fifteen days is deemed appropriate 

because, under the NOP regulations (7 

CFR part 205.603(d)), the authorized use 

of Methionine will expire for organic 

poultry operations on October 21, 2005. 

Final rulemaking to extend the use of 

Methionine in organic poultry 

production, if adopted, should be 

completed before October 21, 2005. Any 

comments that are received timely will 

be considered before a final 

determination is made in this matter. 

II. Overview of Proposed Amendment 

The following provides an overview 

of the proposed amendment made to 

§ 205.603 of the National List: 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production

This proposed rule would revise 

current paragraph (d)(1) of § 205.603 as 

follows: 

DL-Methionine, DL-Methioninehydroxyl analog, and DL-Methioninehydroxyl analog calcium (CAS #–59–

51–8; 63–68–3; 348–67–4)—for use only 

in organic poultry production until 

October 1, 2008. 

Methionine was petitioned for its 

continued use as a synthetic feed 

additive in organic poultry operations. 

Methionine is a colorless or white 

crystalline powder that is soluble in 

water. It is classified as an amino acid 

and considered to be an essential amino 

acid that is regulated as an animal feed 

nutritional supplement by the Food and 

Drug Administration (21 CFR 582.5475). 

Methionine was originally included 

on the National List on October 31, 2003 

with an early expiration date of October 

21, 2005, (the normal time period for the 

use of a substance contained in the 

National List is five years, beginning 

with the date the substance appears on 

the National List regulations).

Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Proposed Rules 43787

Methionine was petitioned by organic 

livestock producers as a part of the 

NOSB’s 1995 initial review of synthetic 

amino acids considered for use in 

organic livestock production. The 

petitioners asserted that Methionine was 

a necessary dietary supplement for 

organic poultry, due to an inadequate 

supply of organic feeds containing 

sufficient concentrations of naturallyoccurring Methionine. Petitioners 

suggested synthetic Methionine would 

be fed as a dietary supplement to 

organic poultry at levels ranging from 

0.3 to 0.5 percent of the animal’s total 

diet. The petitioners also asserted that a 

prohibition on the use of synthetic 

Methionine would contribute to 

nutritional deficiencies in organic 

poultry thereby jeopardizing the 

animal’s health After consideration of 

the justification provided for the 

inclusion of Methionine and an 

assessment under the evaluation criteria 

provided in OFPA (7 U.S.C. 6517–6518), 

the NOSB considered the use of 

synthetic Methionine to be consistent 

with OFPA and recommended its 

inclusion onto the National List for use 

in organic poultry production with an 

early expiration on its use (October 21, 

2005). The NOSB recommended an 

early expiration on the use of 

Methionine to encourage the organic 

poultry industry to phase out the use of 

synthetic Methionine in poultry diets 

and develop non-synthetic alternatives 

to its use as a feed additive. 

Since the inclusion of Methionine on 

§ 205.603(d)(1) of the National List on 

October 31, 2003, the organic poultry 

industry has been unable to develop 

suitable non-synthetic alternatives for 

the substitution of synthetic Methionine 

in organic poultry diets. As a result, on 

January 10, 2005, the two organic 

poultry producers petitioned the NOSB 

to extend the use of Methionine in 

organic poultry production beyond 

October 21, 2005, to provide additional 

time for development of non-synthetic 

alternatives. Preliminary research 

results on nonsynthetic alternatives to 

synthetic Methionine was provided to 

the NOSB. Although considered 

inconclusive, the preliminary results 

have demonstrated that research trials 

were underway to identify nonsynthetic alternatives for phasing out 

synthetic Methionine in organic poultry 

diets. 

The NOSB, at its February 28–March 

3, 2005, meeting in Washington, DC, 

received and evaluated public comment 

on the petition to extend the use of 

Methionine in organic poultry 

production beyond October 21, 2005. 

The NOSB concluded that Methionine 

is consistent with the evaluation criteria 

of 7 U.S.C. 6517 and 6518 of the OFPA; 

however, the NOSB maintained that 

non-synthetic alternatives must be 

developed during the additional 

extension on the use of synthetic 

Methionine in organic poultry diets. 

Therefore, the NOSB recommended 

Methionine be added to the National 

List for use only in organic poultry 

production until October 1, 2008, so 

that the organic poultry industry could 

continue its research to develop nonsynthetic alternatives for the use of 

synthetic Methionine. 

In response to the NOSB 

recommendation regarding the use of 

DL-Methionine in organic livestock 

production, this action proposes to 

amend § 205.603(d)(1) of the National 

List regulation as follows: 

DL-Methionine, DL-Methioninehydroxyl analog, and DLMethioninehydroxyl analog calcium 

(CAS #–59–51–8; 63–68–3; 348–67–4)—

for use in organic poultry production 

until October 1, 2008. 

III. Related Documents 

Two notices were published regarding 

the meeting of the NOSB and its 

deliberations on the recommendation 

and substance petitioned for amending 

the National List. The substance and 

recommendation included in this 

proposed rule were announced for 

NOSB deliberation in the following 

Federal Register Notices: (1) 66 FR 

48654, September 21, 2001, and (2) 70 

FR 7224, February 11, 2005, 

(Methionine). The substance and 

recommendation in this proposed rule 

was initially submitted for proposed 

rulemaking in the Federal Register

Notice, FR 68 18556, April 16, 2003, 

and added to the National List as final 

rule in the Federal Register Notice, FR 

68 61987, October 31, 2003. 

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 NOP regulations. The current 

petition process (65 FR 43259, July 13, 

2000) 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 adding Methionine to the 

National List 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 § 2115 of the 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 § 2115(b) of the OFPA (7 

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

preempted under §§ 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 § 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 § 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 Inspection 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

43788 Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Proposed Rules 

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 (65 FR 

80548). The AMS has also considered 

the economic impact of this action on 

small entities and has determined that 

this proposed rule would have an 

impact on a substantial number of small 

entities. However, AMS has determined 

that the impact on entities affected by 

this proposed rule would not be 

significant. The effect of this proposed 

rule would be to allow the use of 

additional substances in agricultural 

production and handling. This action 

would relax the regulations published 

in the final rule and would provide 

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, would 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 $6,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

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 reached $15 billion 

in 2004. In addition, since the 

implementation of OPFA on October 21, 

2002, USDA has accredited 97 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. 

D. Paperwork Reduction Act 

Pursuant to the Paperwork Reduction 

Act of 1995, 44 U.S.C. 3501, et seq., 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, 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 for extending the 

use of Methionine, a synthetic 

substance, in organic poultry 

production until October 21, 2008. The 

NOSB evaluated this substance using 

criteria in the OFPA. The substance’s 

evaluation was initiated by a petition 

from two organic poultry producers. 

The NOSB has determined that no 

wholly natural substitute product is 

presently available. Loss of the use of 

this substance would disrupt many 

well-established and accepted organic 

poultry operations. Therefore, this 

substance is presently a necessary 

component of a nutritionally adequate 

diet for organic poultry. Accordingly, 

AMS believes that a 15-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 205.603, paragraph (d)(1) is 

revised to read as follows:

§ 205.603 Synthetic substances allowed 

for use in organic livestock production.

* * * * *

(d) * * * 

(1) DL-Methionine, DL-Methioninehydroxyl analog, and DL-Methioninehydroxyl analog calcium (CAS #—59–

51–8; 63–68–3; 348–67–4)—for use in 

organic poultry production until 

October 1, 2008.

* * * * *

Dated: July 25, 2005. 

Kenneth C. Clayton, 

Acting Administrator, Agricultural Marketing 

Service.

[FR Doc. 05–14987 Filed 7–28–05; 8:45 am] 

BILLING CODE 3410–02–P