[Federal Register Volume 71, Number 127 (Monday, July 3, 2006)]
[Proposed Rules]
[Pages 37854-37857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10393]


 ========================================================================
 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. 71, No. 127 / Monday, July 3, 2006 / Proposed 
Rules  

[[Page 37854]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Docket Number TM-06-04]
RIN 0581-AC61


National Organic Program (NOP); Proposed Amendments to the 
National List of Allowed and Prohibited Substances (Crops and 
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) regulations to reflect recommendations submitted to the 
Secretary of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB) on August 17, 2005. Consistent with the recommendations 
from the NOSB, this proposed rule would add two substances, along with 
any restrictive annotations, to the National List.

DATES: Comments must be received by August 2, 2006.

ADDRESSES: Interested persons may comment on this proposed rule using 
the following procedures:
     Mail: Comments may be submitted by mail to: Bob Pooler, 
Agricultural Marketing Specialist, 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: 
[email protected].
     Internet: 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-06-04. 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 
also 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: Bob Pooler, Agricultural Marketing 
Specialist, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established, within the NOP [7 
CFR part 205], the National List regulations (Sec. Sec.  205.600 
through 205.607). The National List regulations identify synthetic 
substances and ingredients that are allowed and nonsynthetic (natural) 
substances and ingredients that are prohibited for use in organic 
production and handling. 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 three times, October 31, 2003 (68 FR 61987), November 
3, 2003 (68 FR 62215), and October 21, 2005 (70 FR 61217). 
Additionally, an amendment to the National List, proposed on September 
16, 2005 (70 FR 54660), is currently pending.
    This proposed rule would amend the National List to reflect 
recommendations submitted to the Secretary by the NOSB on August 17, 
2005. On August 17, 2005, the NOSB recommended that the Secretary add 
one substance to Sec.  205.601 and one substance to Sec.  205.603 of 
the National List regulations.

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:
    This proposed rule would amend paragraph (e) of Sec.  205.601 of 
the National List regulations by adding the following substance:
    Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-4). 
Sucrose octanoate esters (SOE) were petitioned for use in organic crop 
production as an insecticide/miticide. SOE exist as an amber-colored 
liquid. The mixture of esters is manufactured from two biochemicals--
sucrose (table sugar) and an octanoic acid ester (commonly found in 
plants and animals). Sucrose esters were isolated when researchers 
investigated the insecticidal properties of the leaf hairs on tobacco 
leaves. The active ingredient acts by dissolving the waxy protective 
coating (cuticle) of target pests, causing the insect or mite to dry 
out and die.
    Under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), the EPA has registered SOE as a biochemical that targets mites 
and certain soft-bodied insects (e.g., aphids) at three distinct 
commercial sites: Food and non-food crops, including certain 
ornamentals; media for growing mushrooms; and adult honey bees (http://www.epa.gov/oppbppd1/biopesticides/ingredients/factsheets/factsheet_035300.htm). In assessing risks to human health, the EPA has concluded 
that no risks to humans are expected from the use of SOE as a pesticide 
active ingredient. SOE are not toxic to mammals, but in high 
concentrations, they are corrosive to the eye. To avoid irreversible 
eye damage, exposed workers are required to wear appropriate protective 
clothing. In assessing risks to the environment, the EPA determined 
that no risks to the environment are expected from the use of SOE in 
pesticide products because: (a) The esters biodegrade rapidly and 
therefore do not persist in the

[[Page 37855]]

environment, (b) the esters are not toxic to mammals or other non-
target organisms, (c) organisms are already exposed because these 
sucrose esters are found in plants, and (d) the tiny amounts used in 
pesticide products are not expected to substantially increase the 
amount of these esters in the environment.
    At its August 17, 2005, meeting in Washington, DC, the NOSB 
recommended adding SOE to the National List for use in organic crop 
production as an insecticide/miticide. In this open meeting, the NOSB 
evaluated SOE against the evaluation criteria of 7 U.S.C. 6517 and 6518 
of the OFPA, received public comment, and concluded that SOE is 
consistent with the OFPA evaluation criteria.
    The NOP consulted with the EPA and Food and Drug Administration 
(FDA) to ensure that the NOSB recommendation for the use of SOE in 
organic crop production would be consistent with Federal regulations 
governing the use of the substance. The EPA informed the NOP that the 
recommended use of SOE in organic crop production is consistent with 
EPA regulations. The FDA confirmed that the referenced sucrose 
octanoate ester product is appropriately licensed by the EPA for its 
use. Therefore, after consultation with the EPA and FDA concerning the 
NOSB's recommendation to permit the use of SOE in organic crop 
production, the Secretary is proposing to accept the NOSB's 
recommendation and amend Sec.  205.601(e) of the National List by 
adding SOE as an insecticide as follows:
    Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-4)--
in accordance with approved labeling.
    This proposed rule would amend paragraph (b) of Sec.  205.603 of 
the National List regulations by adding the following substance:
    Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-4). 
Sucrose octanote esters (SOE) were petitioned for use in organic 
livestock production as an insecticide/miticide for honeybees. Sucrose 
octanoate esters exist as an amber-colored liquid. The mixture of 
esters is manufactured from two biochemicals-sucrose (table sugar) and 
an octanoic acid ester (commonly found in plants and animals). Sucrose 
esters were isolated when researchers investigated the insecticidal 
properties of the leaf hairs on tobacco leaves. The active ingredient 
acts by dissolving the waxy protective coating (cuticle) of target 
pests, causing the insect or mite to dry out and die.
    Under FIFRA, the EPA has registered SOE as a biochemical that 
targets mites and certain soft-bodied insects (e.g., aphids) at three 
distinct commercial sites: food and non-food crops, including certain 
ornamentals; media for growing mushrooms; and adult honey bees (http://www.epa.gov/oppbppd1/biopesticides/ingredients/factsheets/factsheet_035300.htm). In assessing risks to human health, the EPA has concluded 
that no risks to humans are expected from the use of SOE as a pesticide 
active ingredient. SOE are not toxic to mammals, but in high 
concentrations are corrosive to the eye. To avoid irreversible eye 
damage, exposed workers are required to wear appropriate protective 
clothing. In assessing risks to the environment, the EPA determined 
that no risks to the environment are expected from the use of SOE in 
pesticide products because: (a) The esters biodegrade rapidly and 
therefore do not persist in the environment, (b) the esters are not 
toxic to mammals or other non-target organisms, (c) organisms are 
already exposed because these sucrose esters are found in plants, and 
(d) the tiny amounts used in pesticide products are not expected to 
substantially increase the amount of these esters in the environment.
    At its August 17, 2005, meeting in Washington, DC, the NOSB 
recommended adding SOE to the National List for use in organic 
livestock production as an insecticide/miticide. In this open meeting, 
the NOSB evaluated SOE against the evaluation criteria of 7 U.S.C. 6517 
and 6518 of the OFPA, received public comment, and concluded that SOE 
is consistent with the OFPA evaluation criteria.
    The NOP consulted with the EPA and FDA to ensure that the NOSB 
recommendation for the use of SOE in organic livestock production would 
be consistent with Federal regulations governing the use of the 
substance. The EPA informed the NOP that the recommended use of SOE in 
organic livestock production is consistent with EPA regulations. The 
FDA confirmed that the referenced sucrose octanoate ester product is 
appropriately licensed by the EPA for such use. Therefore, after 
consultation with the EPA and FDA concerning the NOSB's recommendation 
to permit the use of SOE in organic livestock production, the Secretary 
is proposing to accept the NOSB's recommendation and amend Sec.  
205.603(b) of the National List by adding SOE as an external 
parasiticide as follows:
    Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-4)--
in accordance with approved labeling.

Recommendation Not Accepted

    Chitosan (Poly-D Glucosamine) (CAS --9012-76-04). Chitosan 
was petitioned for use in organic crop production as an adhesive 
adjuvant to be used with fungicides approved for use under the NOP 
regulations. Chitosan is a polymer of glucosamine sugars, specifically 
glucosamine and N-acetyl-glucosamine. Its structure and composition are 
similar to both cellulose (i.e., the primary structural component of 
plant fiber) and chitin. Like chitin, chitosan is found naturally in 
the shells of all crustaceans and insects, as well as certain other 
organisms such as many fungi, algae, and yeast. Chitosan is a 
chemically stable, white to pale yellow powder or flake. It has a 
strong positive charge, which is the basis of its use as a ``sticking'' 
agent (i.e., an adhesive adjuvant). The positively charged molecules 
adhere to negatively charged pesticides and plant surfaces. In the 
petition for the use of chitosan, as an adjuvant, the proposed rate of 
application is 0.011 pounds of chitosan per 20 gallons of water; it is 
adequate to apply on 1 acre.
    Under the FIFRA, the EPA has registered chitosan as a biopesticide 
that is used primarily as a plant growth enhancer, and as a substance 
that boosts the ability of plants to defend against fungal infections, 
including early and late blight, downy and powdery mildew, and gray 
mold. The EPA has approved its use outdoors and indoors on many plants 
grown commercially and by consumers. Chitosan is normally sprayed on 
leaves of plants throughout growing season, with applications every one 
to two weeks as needed. In assessing risks to human health, the EPA has 
concluded that no risks to humans are expected when products containing 
chitosan are used according to label directions. In assessing risks to 
the environment, the EPA determined that no risks to the environment 
are expected because chitosan has not shown toxicity in mammals, it is 
abundant in nature, and it is used in tiny amounts.
    At its August 17, 2005, meeting in Washington, DC, the NOSB 
recommended adding chitosan to the National List for use in organic 
crop production as an insecticide, with the restriction that it only be 
used as an adjuvant. In this open meeting, the NOSB evaluated chitosan 
against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, 
received public comment, and concluded that chitosan is consistent with 
the OFPA evaluation criteria.

[[Page 37856]]

    The NOSB restricted the use of chitosan to an adjuvant only, due to 
the fact that chitosan could also be used as a plant defense booster 
and plant growth enhancer. As a plant growth enhancer, the mode of 
action is believed to be that chitosan is taken up by plant cells where 
it enters the cell nucleus and stimulates messenger ribonucleic acid 
and enzyme production. This action stimulates the plant to produce more 
lignin in the stems, resulting in stronger stems. However, as an 
adjuvant, the application rate of chitosan would be approximately 0.011 
pounds per 20 gallons of water. At such a rate, chitosan would be 
unlikely to act as a defense booster and plant growth enhancer. It is 
also unlikely that it would create unacceptable changes in soil 
temperature, water availability, pH levels, nutrient availability, or 
salt concentration.
    The NOP consulted with the EPA concerning the NOSB's recommendation 
to include chitosan on the National List. The EPA informed the NOP that 
for the petitioned use of chitosan, as an adjuvant, the substance would 
not be considered an active ingredient, but an inert ingredient. The 
EPA further stated that, in addition to chitosan being registered as an 
active ingredient, it is also approved as an EPA List 4B inert 
ingredient. The NOP regulations, at Sec.  205.601(m), permits the use 
of EPA List 4 inert ingredients with nonsynthetic substances or 
synthetic substances approved for use under the NOP regulations as an 
active pesticide ingredient. As a result, the NOP will not propose to 
specifically add chitosan to the National List as an adjuvant; it is 
already permitted for use at Sec.  205.601(m) of the National List 
regulations.

III. Related Documents

    One notice was published regarding the meeting 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 Federal Register 
Notice 70 FR 43116, July 26, 2005.

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 (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 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 section 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 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 
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 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. 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, USDA certifies that this rule 
will not have a significant

[[Page 37857]]

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 2004, the number of certified organic crop, livestock, 
and handling operations totaled nearly 11,400 operations. Based on 2003 
data, certified organic acreage increased to 2.2 million acres.
    U.S. sales of organic food and beverages have grown from $1 billion 
in 1990 to an estimated $12.2 billion in 2004. Organic food sales are 
projected to reach $14.5 billion for 2005; total U.S. organic sales, 
including nonfood uses, are expected to reach $15 billion in 2005. The 
organic industry is viewed as the fasting growing sector of 
agriculture, representing 2 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. This growth rate is 
projected to decline and fall to a rate of 5 to 10 percent in the 
future.
    In addition, USDA has accredited 94 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 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.
    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.

E. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB. The 2 substances proposed to be added to the 
National List were based on petitions from the industry. The NOSB 
evaluated each petition using criteria in the OFPA. 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. A 30 day period for interested persons to comment 
on this rule is provided.

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. In Sec.  205.601 a new paragraph (e)(9) is added to read as 
follows:


Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (e) * * *
    (9) Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-
4)--in accordance with approved labeling.
* * * * *
    3. In Sec.  205.603 a new paragraph (b)(7) is added to read as 
follows:


Sec.  205.603  Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (b) * * *
    (7) Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-
4)--in accordance with approved labeling.
* * * * *

    Dated: June 26, 2006.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
 [FR Doc. E6-10393 Filed 6-30-06; 8:45 am]
BILLING CODE 3410-02-P