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

27941

Vol. 68, No. 99

Thursday, May 22, 2003

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Docket Number TM–03–02] 

RIN 0581–AC27 

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 

November 15, 2000 through September 

17, 2002. Consistent with 

recommendations from the NOSB, this 

proposed rule would: add five 

substances, along with any restrictive 

annotations, to the National List, and 

revise the annotation of one substance.

DATES: Comments must be received by 

June 2, 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–03–02. 

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 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 November 

15, 2000 through September 17, 2002. 

Between the specified time period, the 

NOSB has recommended that the 

Secretary add five substances to 

§ 205.605 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 annotation of one substance 

included within section 205.605. 

The NOSB has recommended that the 

Secretary add additional substances to 

sections 205.605 and 205.606 which 

have not been included in this proposed 

rule but are under review and, as 

appropriate, will be included in future 

rulemaking. 

II. Overview of Proposed Amendments 

The following provides an overview 

of the proposed amendments made to 

designated sections of the National List:

§ 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 

paragraph (a) of § 205.605 by adding 

calcium sulfate—mined and glucono 

delta-lactone. This proposed rule would 

also amend paragraph (b) of § 205.605 

by adding animal enzymes—without 

Lysosyme, cellulose, and tetrasodium 

pyrophosphate. 

This proposed rule would revise 

current paragraph (b) of § 205.605 by 

amending an annotation to read as 

follows: 

Potassium hydroxide—prohibited for 

use in lye peeling of fruits and 

vegetables except when used for peeling 

peaches during the Individually Quick 

Frozen (IQP) production process. 

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 

proposed rule were announced for 

NOSB deliberation in the following 

Federal Register Notices: (1) 65 FR 

64657, October 30, 2000, (Animal 

enzymes); (2) 66 FR 10873, February 20, 

2001, (Calcium sulfate); (3) 66 FR 48654, 

September 21, 2001, (Cellulose, and 

Potassium hydroxide); and (4) 67 FR 

54784, August 26, 2002, (Glucono deltalactone, and Tetrasodium 

pyrophosphate).

27942 Federal Register / Vol. 68, No. 99 / Thursday, May 22, 2003 / Proposed Rules 

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 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 

proposed rule will be considered in 

relation to the requirements of the RFA. 

These comments must be submitted

Federal Register / Vol. 68, No. 99 / Thursday, May 22, 2003 / Proposed Rules 27943

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 five 

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 205.605 (proposed to be 

revised at 68 FR 18560, April 16, 2003) 

is amended by: 

a. Adding two substances to 

paragraph (a). 

b. Adding three substances to 

paragraph (b). 

c. Revising Potassium hydroxide in 

paragraph (b). 

The additions and revisions 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)).’’

* * * * *

(a) * * *

* * * * *

Calcium sulfate—mined.

* * * * *

Glucono delta-lactone.

* * * * *

(b) * * * 

Animal enzymes—(Rennet—animals 

derived; Catalase—bovine liver; Animal 

lipase; Pancreatin; Pepsin; and Trypsin).

* * * * *

Cellulose—for use in regenerative 

casings, as an anti-caking agent (nonchlorine bleached) and filtering aid.

* * * * *

Potassium hydroxide—prohibited for 

use in lye peeling of fruits and 

vegetables except when used for peeling 

peaches during the Individually Quick 

Frozen (IQP) production process.

* * * * *

Tetrasodium pyrophosphate—for use 

only in textured meat analog products.

* * * * *

Dated: May 16, 2003. 

Kenneth C. Clayton, 

Acting Administrator, Agricultural Marketing 

Services.

[FR Doc. 03–12803 Filed 5–21–03; 8:45 am] 

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service 

7 CFR Part 930 

[Docket No. FV03–930–2 PR] 

Tart Cherries Grown in the States of 

Michigan, et al.; Increased Assessment 

Rate

AGENCY: Agricultural Marketing Service, 

USDA.

ACTION: Proposed rule.

SUMMARY: This proposed rule would 

increase the assessment rate for tart 

cherries that are utilized in the 

production of tart cherry products other 

than juice, juice concentrate, or puree 

from $0.00175 to $0.0019 per pound. It 

would also increase the assessment rate 

for cherries utilized for juice, juice 

concentrate, or puree from $0.000875 to 

$0.0019 per pound. The single 

assessment rate for all assessable tart 

cherries was recommended by the 

Cherry Industry Administrative Board 

(Board) under Marketing Order No. 930 

for the 2002–2003 and subsequent fiscal 

periods. The Board is responsible for 

local administration of the marketing 

order which regulates the handling of 

tart cherries grown in the production 

area. Authorization to assess tart cherry 

handlers enables the Board to incur 

expenses that are reasonable and 

necessary to administer the program. 

The fiscal period began July 1, 2002, 

and ends June 30, 2003. The assessment 

rate would remain in effect indefinitely 

unless modified, suspended, or 

terminated.

DATES: Comments must be received by 

June 2, 2003.

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this proposed action. 

Comments must be sent to the Docket 

Clerk, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; Fax: (202) 720–8938, or 

E-mail: moabdocket.clerk@usda.gov. All 

comments should reference the docket 

number and the date and page number 

of this issue of the Federal Register and 

will be made available for public 

inspection in the Office of the Docket 

Clerk during regular business hours or 

can be viewed at: http://www.ams/

usda.gov/fv/moab/html.

FOR FURTHER INFORMATION CONTACT:

Patricia A. Petrella or Kenneth G. 

Johnson, Marketing Order 

Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA, Suite 

2A04, Unit 155, 4700 River Road, 

Riverdale, MD 20737, telephone: (301) 

734–5243, or Fax: (301)–734–5275; or 

George Kelhart, Technical Advisor, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; telephone: (202) 720–

2491, or Fax: (202) 720–8938. 

Small businesses may request 

information on complying with this 

regulation by contacting Jay Guerber, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; telephone: (202) 720–

2491, Fax: (202) 720–8938, or e-mail: 

Jay.Guerber@usda.gov.

SUPPLEMENTARY INFORMATION: This 

proposed rule is issued under Marketing 

Agreement and Order No. 930 (7 CFR 

part 930), regulating the handling of tart 

cherries grown in the States of 

Michigan, New York, Pennsylvania, 

Oregon, Utah, Washington, and 

Wisconsin, hereinafter referred to as the 

‘‘order.’’ The marketing agreement and 

order are effective under the 

Agricultural Marketing Agreement Act 

of 1937, as amended (7 U.S.C. 601–674), 

hereinafter referred to as the ‘‘Act.’’

The Department of Agriculture 

(USDA) is issuing this proposed rule in