[Federal Register Volume 68, Number 99 (Thursday, May 22, 2003)]
[Proposed Rules]
[Pages 27941-27943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12803]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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.
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 

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

[[Page 27941]]



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:
    [sbull] 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.
    [sbull] E-mail: Comments may be submitted via the Internet to: 
[email protected].
    [sbull] Fax: Comments may be submitted by fax to: (202) 205-7808.
    [sbull] 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.
    [sbull] 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.
    [sbull] 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 (Sec. Sec.  
205.600 through 205.607). The National List is the Federal list that 
identifies synthetic substances and ingredients that are allowed and 
nonsynthetic (natural) substances and ingredients that are prohibited 
for use in organic production and handling. Since established, the 
National List has not been amended. However, under the authority of the 
Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501 
et seq.), the National List can be amended by the Secretary based on 
proposed amendments developed by the NOSB.
    This 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 
Sec.  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:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''

    This proposed rule would amend paragraph (a) of Sec.  205.605 by 
adding calcium sulfate--mined and glucono delta-lactone. This proposed 
rule would also amend paragraph (b) of Sec.  205.605 by adding animal 
enzymes--without Lysosyme, cellulose, and tetrasodium pyrophosphate.
    This proposed rule would revise current paragraph (b) of Sec.  
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 
delta-lactone, and Tetrasodium pyrophosphate).

[[Page 27942]]

IV. Statutory and Regulatory Authority

    The Organic Foods Production Act of 1990 (OFPA), as amended (7 
U.S.C. 6501 et seq.), authorizes the Secretary, at Sec.  6517 (d)(1), 
to make amendments to the National List based on proposed amendments 
developed by the NOSB. Sections 6518 (k)(2) and 6518 (n) of OFPA 
authorize the NOSB to develop proposed amendments to the National List 
for submission to the Secretary and establish a petition process by 
which persons may petition the NOSB for the purpose of having 
substances evaluated for inclusion onto or deletion from the National 
List. The National List petition process is implemented under Sec.  
205.607 of the NOS. The current petition process (65 FR 43259) can be 
accessed through the NOP Web site at http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined to be non-significant for purposes 
of Executive Order 12866, and therefore, does not have to be reviewed 
by the Office of Management and Budget.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. The final rule was 
reviewed under this Executive Order and no additional related 
information has been obtained since then. This 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

[[Page 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:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''

* * * * *
    (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 
(non-chlorine 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