[Federal Register Volume 73, Number 135 (Monday, July 14, 2008)]
[Proposed Rules]
[Pages 40194-40197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15389]


 ========================================================================
 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. 73, No. 135 / Monday, July 14, 2008 / 
Proposed Rules  

[[Page 40194]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Docket Number AMS-TM-07-0124; TM-07-12PR]
RIN 0581-AC76


National Organic Program (NOP); Sunset Review (2008)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would amend the U.S. Department of 
Agriculture's (USDA) National List of Allowed and Prohibited Substances 
(National List) regulations to reflect recommendations submitted to the 
Secretary of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB) on November 30, 2007, and May 22, 2008. The 
recommendations addressed in this proposed rule pertain to the 
continued exemption (use) and prohibition of 12 substances in organic 
production and handling. Consistent with the recommendations from the 
NOSB, this proposed rule would renew the 11 exemptions and 1 
prohibition on the National List (along with any restrictive 
annotations) and correct the Tartaric acid listings by adding 
annotations originally recommended to the Secretary on November 1, 
1995.

DATES: Comments must be received by August 13, 2008.

ADDRESSES: Interested persons may submit written comments on this 
proposed rule using the following addresses:
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-TMP-NOP, 1400 Independence Ave., 
SW., Room 4008-So., Ag Stop 0268, Washington, DC 20250.
     Internet: www.regulations.gov.
    Written comments responding to this proposed rule should be 
identified with the docket number AMS-TM-07-0124. You should clearly 
indicate your position to continue the allowance or prohibition of the 
substances identified in this proposed rule and the reasons for your 
position. You should include relevant information and data to support 
your position (e.g., scientific, environmental, manufacturing, industry 
impact information, etc.). You should also supply information on 
alternative substances or alternative management practices, where 
applicable, that support a change from the current exemption or 
prohibition of the substance. Only the supporting material relevant to 
your position will be considered.
    It is our intention to have all comments concerning this proposed 
rule, including, names and addresses when provided, whether submitted 
by mail or internet available for viewing on the Regulations.gov 
(www.regulations.gov) Internet site. Comments submitted in response to 
this proposed rule will also be available for viewing in person at 
USDA-AMS, Transportation and Marketing Programs, National Organic 
Program, 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: Richard H. Mathews, Chief, Standards 
Development and Review Branch, Telephone: (202) 720-3252; Fax: (202) 
205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    The OFPA, 7 U.S.C. 6501 et seq., authorizes the establishment of 
the National List of exempted and prohibited substances. The National 
List identifies synthetic substances (synthetics) that are exempted 
(allowed) and nonsynthetic substances (nonsynthetics) that are 
prohibited in organic crop and livestock production. The National List 
also identifies nonsynthetics and synthetics that are exempted for use 
in organic handling.
    The exemptions and prohibitions granted under the OFPA are required 
to be reviewed every 5 years by the National Organic Standards Board 
(NOSB). The Secretary of Agriculture has authority under the OFPA to 
renew such exemptions and prohibitions. If they are not reviewed by the 
NOSB within 5 years of their inclusion on the National List and renewed 
by the Secretary, their authorized use or prohibition expires. This 
means that synthetic substances Copper sulfate, Ozone gas, Peracetic 
acid, and EPA List 3 Inerts, currently allowed for use in organic crop 
production, will no longer be allowed for use after November 3, 2008. 
Calcium chloride currently prohibited from use in organic crop 
production, except as a foliar spray to treat a physiological disorder 
associated with calcium uptake, will be allowed after November 3, 2008. 
This also means that Agar-agar, Carrageenan, and Tartaric acid, 
currently allowed for use in organic handling, will be prohibited after 
November 3, 2008. Finally, Animal enzymes, Calcium sulfate, Glucono 
delta lactone, and Cellulose, currently allowed for use in organic 
handling, will no longer be allowed for use after November 4, 2008.
    In response to the sunset provisions in the OFPA, the Secretary 
published an Advanced Notice of Proposed Rulemaking (ANPR) (72 FR 
73667) in the Federal Register on December 28, 2007, to announce the 
review of 11 exemptions and 1 prohibition authorized under the National 
Organic Program regulations. This ANPR also requested public comment on 
the continued use or prohibition of such exemptions and prohibition. 
The public comment period lasted 30 days.
    We received 35 comments. Comments were received from producers, 
handlers, certifying agents, trade associations, organic associations, 
various industry groups, and a university. We received six comments 
urging that the current listings remain as they are currently stated. 
Most commenters provided specific support for substances that they 
promoted, represented, or relied upon. Specific support was received 
for the following substances (the number in parenthesis represents the 
number of specific support comments): Agar-agar (7), animal enzymes 
(2), calcium chloride (1), calcium sulfate (1), carrageenan (15), 
cellulose (10), List 3 inert ingredients in passive pheromone 
dispensers (1), ozone gas (3), and peracetic acid (1). One commenter

[[Page 40195]]

stated that they have found the standard of identity for passive 
pheromone dispenser to be undefined. As a result they requested, if the 
allowance for List 3 inerts in passive pheromone dispensers is renewed, 
that the AMS and the NOSB reexamine and clarify the meaning of 
``passive pheromone dispensers.'' The AMS is unaware of any problems 
with passive pheromone dispensers.
    Six of the commenters supported relisting DL-Methionine, DL-
Methionine-hydroxyl analog, and DL-Methionine-hydroxyl analog calcium 
(CAS --59-51-8; 63-68-3; 348-67-4). These substances were 
added to the National List on November 3, 2003, for use in organic 
poultry production. Initially these substances carried an expiration 
date of October 21, 2005. Effective October 22, 2005, the expiration 
date was amended to October 1, 2008. Because these substances have an 
expiration date recommended by the NOSB and established by rulemaking, 
they are not included in this sunset review.
    The Methionine Task Force, a commenter to the ANPR, submitted a 
petition on December 17, 2007, to amend Sec.  205.603(d)(1) by removing 
the annotation date of October 1, 2008. Rulemaking on this request is 
handled through a separate rulemaking action.
    The NOSB met November 27-30, 2007, in Arlington, VA, where they 
finalized recommendations to continue the listing of 11 of the 12 
substances due to sunset. The NOSB met again May 20-22, 2008, in 
Baltimore, MD, where they finalized their recommendations to continue 
the listings for Tartaric acid. The NOSB also recommended correcting 
the Tartaric acid listings by adding annotations originally recommended 
to the Secretary on November 1, 1995. Having reviewed the comments 
received on the ANPR, the NOSB also at the May meeting reaffirmed their 
recommendations from November 30, 2007. Both meetings were open to the 
public and additional comments were received during the meetings.
    As a result of the November 2007 and May 2008 NOSB meetings, and in 
consideration of the ANPR comments, the NOSB recommended that the 
Secretary renew the 11 exemptions and 1 prohibition on the National 
List (along with any restrictive annotations) and correct the Tartaric 
acid listings by adding annotations originally recommended to the 
Secretary on November 1, 1995. These recommendations are limited to the 
prohibition and exemptions originally included on the National List on 
November 3 and 4, 2003. The Secretary is engaging in this proposed 
rulemaking to reflect the recommendations of the NOSB, from November 
2007 and May 2008, and to request public comment.
    Under the authority of the 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 nine times, October 31, 2003 (68 FR 
61987), November 3, 2003 (68 FR 62215), October 21, 2005 (70 FR 61217), 
June 7, 2006 (71 FR 32803), September 11, 2006 (71 FR 53299), June, 27, 
2007 (72 FR 35137), October 16, 2007 (72 FR 58469), December 10, 2007 
(72 FR 69569), and December 12, 2007 (72 FR 70479).

II. Overview of Proposed Amendments

    From November 27, 2007, through May 22, 2008, the NOSB reviewed 11 
exemptions and 1 prohibition that are authorized on the National List 
and set to expire on November 3 and 4, 2007. Using the evaluation 
criteria specified in the ANPR for sunset review, the NOSB reviewed 
these exemptions and prohibition for continued authorization in organic 
agricultural production and handling. As a result of the NOSB's review, 
the NOSB recommended that the Secretary renew the 11 exemptions and 1 
prohibition on the National List (along with any restrictive 
annotations) and correct the Tartaric acid listings by adding 
annotations originally recommended to the Secretary on November 1, 
1995.
    With respect to the criteria used to make recommendations regarding 
the continued authorization of exemptions and prohibitions, that 
decision making is based on public comments and applicable supporting 
evidence that expresses a continued need for the use or prohibition of 
the substance(s).
    Concerning criteria used to make recommendations regarding the 
discontinuation of an authorized exempted synthetic substance or 
prohibited nonsynthetic substance, that decision making, for the 
exempted synthetic substance, is based on public comments and 
applicable supporting evidence that demonstrates the currently 
authorized exempted substance is: (a) Harmful to human health or the 
environment, (b) not necessary to the production of the agricultural 
products because of the availability of wholly nonsynthetic substitute 
products, or (c) inconsistent with organic farming and handling.
    In the case of recommendations to discontinue prohibitions of 
nonsynthetic substances, that decision making is based on public 
comments and applicable supporting evidence demonstrating that the 
prohibited nonsynthetic substance is no longer harmful to human health 
or the environment and is consistent and compatible with organic 
practices.

Renewals

    After considering all public comments and supporting evidence, the 
NOSB determined that the 11 exemptions and 1 prohibition demonstrated a 
continued need for authorization in organic agricultural production and 
handling. On May 22, 2008, the NOSB finalized its recommendation on 
Tartaric acid and reaffirmed its recommendations of November 30, 2007, 
on the other 11 substances.
    In addition to recommending the continued listing of Tartaric acid 
in paragraphs (a) and (b) of Sec.  205.605, the NOSB recommended that 
the listings be corrected to include the annotations originally 
recommended by the NOSB on November 1, 1995. The NOSB recommended that 
the listing for Tartaric acid at Sec.  205.605(a) be corrected to read, 
``Tartaric acid--made from organic grape wine.'' The NOSB recommended 
that the listing for tartaric acid at Sec.  205.605(b) be corrected to 
read, ``Tartaric acid--made from malic acid.'' These annotations were 
inadvertently left out of the rulemaking which added Tartaric acid to 
the National List on October 31, 2003 (68 FR 61987).
    The Agricultural Marketing Service (AMS) has reviewed and concurs 
with the NOSB recommendations. Accordingly, this proposed rule would 
continue the 11 exemptions and 1 prohibition in 7 CFR 205.601, 205.602, 
and 205.605 of the following substances in organic agricultural 
production and handling and amend the USDA's national regulations (7 
CFR part 205) to add annotations to the Tartaric acid listings of Sec.  
205.605:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production
    (a) As algicide, disinfectants, and sanitizer, including irrigation 
system cleaning systems.
    (3) Copper sulfate--for use as an algicide in aquatic rice systems, 
is limited to one application per field during any 24-month period. 
Application rates are limited to those which do not increase baseline 
soil test values for copper over a timeframe agreed upon by the 
producer and accredited certifying agent.
    (5) Ozone gas--for use as an irrigation system cleaner only.

[[Page 40196]]

    (6) Peracetic acid--for use in disinfecting equipment, seed, and 
asexually propagated planting material.
    (e) As insecticides (including acaricides or mite control).
    (3) Copper Sulfate--for use as tadpole shrimp control in aquatic 
rice production, is limited to one application per field during any 24-
month period. Application rates are limited to levels which do not 
increase baseline soil test values for copper over a timeframe agreed 
upon by the producer and accredited certifying agent.
    (i) As plant disease control.
    (7) Peracetic acid--for use to control fire blight bacteria.
    (m) 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 
an active pesticide ingredient in accordance with any limitations on 
the use of such substances.
    (2) EPA List 3--Inerts of unknown toxicity allowed:
    (ii) Inerts used in passive pheromone dispensers.
Section 205.602 Nonsynthetic Substances Prohibited for Use in Organic 
Crop Production
    (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.
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))''
    (a) Nonsynthetics allowed:
    Agar-agar.
    Animal enzymes--(Rennet--animals derived; Catalase--bovine liver; 
Animal lipase; Pancreatin; Pepsin; and Trypsin).
    Calcium sulfate--mined.
    Carrageenan.
    Glucono delta-lactone--production by the oxidation of D-glucose 
with bromine water is prohibited.
    Tartaric acid--made from organic grape wine.
    (b) Synthetics allowed:
    Cellulose--for use in regenerative casings, as an anti-caking agent 
(non-chlorine bleached) and filtering aid.
    Tartaric acid--made from malic acid.

Nonrenewals

    The NOSB determined that the 11 exemptions and 1 prohibition 
demonstrated a continued need for authorization. Accordingly there are 
no nonrenewals.

Technical Correction

    This proposed rule would amend Sec.  205.605(a) by changing 
``Carageenan'' to ``Carrageenan'' to correct the spelling of this 
allowed substance.

III. Related Documents

    One advanced notice of proposed rulemaking with request for 
comments was published in Federal Register Notice 72 FR 73667, December 
28, 2007, to make the public aware that the allowance of 12 synthetic 
and non-synthetic substances in organic production and handling will 
expire, if not reviewed by the NOSB and renewed by the Secretary.

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the 
Secretary 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 on or deletion from the National 
List. The National List petition process is implemented under Sec.  
205.607 of the NOP regulations. The current petition process (72 FR 
2167, January 18, 2007) can be accessed through the NOP Web site at: 
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5048809&acct=nopgeninfo.

A. Executive Order 12866

    This action has been determined not significant for purposes of 
Executive Order 12866, and therefore, has not been 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. This proposed rule 
is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under the OFPA 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 Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  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 Sec.  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 Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
proposed rule 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 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

[[Page 40197]]

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 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. The impact on entities affected by this proposed 
rule would not be significant. The effect of this proposed rule would 
be to allow the continued use of substances currently listed for use in 
organic agricultural production and handling. The AMS concludes that 
this action would have minimal economic impact on small agricultural 
service firms. Accordingly, USDA 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 $6,500,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000. This proposed rule would have an impact on a substantial 
number of small entities.
    The U.S. organic industry at the end of 2001 included nearly 6,949 
certified organic crop and livestock operations. These operations 
reported certified acreage totaling more than 2.09 million acres of 
organic farm production. Data on the numbers of certified organic 
handling operations (any operation that transforms raw product into 
processed products using organic ingredients) were not available at the 
time of survey in 2001; but they were estimated to be in the thousands. 
By the end of 2005, the number of U.S. certified organic crop, 
livestock, and handling operations totaled about 8,500. Based on 2005 
USDA, Economic Research Service, data from USDA-accredited certifying 
agents, U.S. certified organic acreage increased to 4 million acres.
    The U.S. sales of organic food and beverages have grown from $1 
billion in 1990 to nearly $17 billion in 2006. The organic industry is 
viewed as the fastest growing sector of agriculture, representing 
almost 3 percent of overall food and beverage sales. Since 1990, 
organic retail sales have historically demonstrated a growth rate 
between 20 to 24 percent each year, including a 22 percent increase in 
2006.
    In addition, USDA has 95 accredited certifying agents who provide 
certification services to producers and handlers. A complete list of 
names and addresses of accredited certifying agents may be found on the 
AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that 
most of these entities would be considered small entities under the 
criteria established by the SBA.

D. Paperwork Reduction Act

    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 of 1995, 44 
U.S.C. 3501, et seq., or OMB's implementing regulations at 5 CFR part 
1320.
    The AMS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies in general 
to provide the public the option of submitting information or 
transacting business electronically to the maximum extent possible.
    The AMS is committed to complying with the E-Government Act, to 
promote the use of the Internet and other information technologies to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

E. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB for the continuation of 11 exemptions and 1 
prohibition contained on the National List of Allowed and Prohibited 
Substances. A 30-day period for interested persons to comment on this 
rule is provided. Thirty days is deemed appropriate because the 
expiration of these 12 substances has been widely publicized, their 
continued use or prohibition is critical to organic production, and 
this rulemaking should be completed before November 3, 2008.

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.


Sec.  205.605  [Amended]

    2. Section 205.605(a) is amended by removing ``Carageenan'' and 
adding ``Carrageenan'' in its place, and by removing ``Tartaric acid'' 
and adding ``Tartaric acid--made from grape wine'' in its place.
    3. Section 205.605(b) is amended by removing ``Tartaric acid'' and 
adding ``Tartaric acid--made from malic acid'' in its place.

    Dated: July 1, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E8-15389 Filed 7-11-08; 8:45 am]
BILLING CODE 3410-02-P