[Federal Register Volume 74, Number 105 (Wednesday, June 3, 2009)]
[Proposed Rules]
[Pages 26591-26596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12818]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

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. 74, No. 105 / Wednesday, June 3, 2009 / 
Proposed Rules

[[Page 26591]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-TM-09-0003; TM-08-06PR]
RIN 0581-AC91


National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances (Crops and Processing)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would amend the U.S. Department of 
Agriculture's (USDA's) National List of Allowed and Prohibited 
Substances (National List) 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 exemptions 
(uses) for six substances in organic crop production and organic 
processing. Consistent with the recommendations from the NOSB, this 
proposed rule would add six substances, along with any restrictive 
annotations, to the National List. This proposed rule would also remove 
one substance from the National List, as the exemption for use in 
organic crop production has expired.

DATES: Comments must be received by August 3, 2009.

ADDRESSES: Interested persons may comment on this proposed rule using 
the following procedures:
     Internet: http://www.regulations.gov.
     Mail: Comments may be submitted by mail to: Toni Strother, 
Agricultural Marketing Specialist, National Organic Program, USDA-AMS-
TMP-NOP, Room 4004-So., Ag Stop 0268, 1400 Independence Ave., SW., 
Washington, DC 20250.
    Written comments responding to this proposed rule should be 
identified with the document number AMS-TM-09-0003; TM-08-06. You 
should identify the topic and section number of this proposed rule to 
which your comment refers. You should clearly indicate whether or not 
you support the exemption for any or all of the substances in this 
proposed rule. You should clearly indicate the reason(s) for your 
position. You should also indicate recommended language changes as 
appropriate. Please include relevant information and data to support 
your position, (e.g. scientific, environmental, manufacturing, industry 
impact information, etc.). Only relevant material supporting your 
position should be submitted.
    It is our intention to have all comments concerning this proposed 
rule, including names and addresses when provided, regardless of 
submission procedure used, available for viewing on the Regulations.gov 
(http://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 4004-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

    On December 21, 2000, the Secretary established, within the 
National Organic Program (NOP) [7 CFR part 205], the National List 
regulations Sec. Sec.  205.600 through 205.607. This National List 
identifies the synthetic substances that may be used and the 
nonsynthetic (natural) substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural and nonorganic agricultural substances that may be used 
in organic handling. The Organic Foods Production Act of 1990, as 
amended, (7 U.S.C. 6501 et seq.), (OFPA), and NOP regulations, in Sec.  
205.105, specifically prohibit the use of any synthetic substance in 
organic production and handling unless the synthetic substance is on 
the National List. Section 205.105 also requires that any nonorganic 
agricultural and any nonsynthetic nonagricultural substance used in 
organic handling be on the National List.
    Under the authority of the OFPA, 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 eleven 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), December 12, 2007 (72 FR 
70479), September 18, 2008 (73 FR 54057), and October 9, 2008 (73 FR 
59479).
    This proposed rule would amend the National List to reflect six 
recommendations submitted to the Secretary by the NOSB on November 30, 
2007, and May 22, 2008. Based upon their evaluation of petitions 
submitted by industry participants, the NOSB recommended that the 
Secretary add two substances (aqueous potassium silicate and sodium 
carbonate peroxyhydrate) for organic crop production to Sec.  205.601, 
one substance (gellan gum) for organic processing to Sec.  205.605, and 
three substances (fortified cooking wine--marsala, fortified cooking 
wine--sherry, and tragacanth gum) for organic processing to Sec.  
205.606 of the National List. The use of each substance in organic 
production was evaluated by the NOSB using the evaluation criteria 
specified in OFPA (7 U.S.C. 6517-6518).
    This proposed rule would also remove one substance (Glycerine 
Oleate (Glycerol monooleate)) from Sec.  205.601 at paragraph 
(m)(2)(i). Glycerine Oleate (Glycerol monooleate) (CAS s 
37220-82-9) was added to the National List on September 11, 2006 (71 FR 
53299), as an inert ingredient with the annotation, for use only until 
December 31, 2006.

[[Page 26592]]

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This proposed rule would amend Sec.  205.601 of the National List 
regulations by: (1) Redesignating paragraphs (e)(2) through (e)(9) and 
(i)(1) through (i)(11) as paragraphs (e)(3) through (e)(10) and (i)(2) 
through (i)(12) respectively; and (2) adding new paragraphs (a)(8), 
(e)(2), and (i)(1) for the purpose of adding the following substances:
    Aqueous potassium silicate (CAS --1312-76-1). Aqueous 
potassium silicate was petitioned for two separate uses in organic crop 
production: As an insecticide and as plant disease control. Potassium 
silicate is manufactured by fusing the naturally occurring compounds, 
silica sand and potassium carbonate, into glass at a high temperature. 
The glass can be cooled and ground into a colorless or yellowish, fine 
powder and dissolved in water at a high temperature to produce an 
aqueous solution.
    The Environmental Protection Agency (EPA) evaluated potassium 
silicate according to the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) and approved the unconditional registration of 
pesticide products containing potassium silicate as the sole active 
ingredient. The sites approved for the use of potassium silicate 
include agricultural crops, nuts, fruits, vines, turf and ornamentals. 
Potassium silicate functions as a desiccant and is used as a fungicide, 
insecticide or miticide. The target pests are mites, whiteflies and 
other insects, powdery mildew, botrytis, and root and turf diseases. 
Per the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act of 1996 (FQPA), the EPA determined that 
potassium silicate is exempt from tolerance in or on food commodities 
when the application rate does not exceed 1 percent by weight in 
aqueous solution and when used in the context of good agricultural 
practices (40 CFR 180.1268). See also 71 FR 34267, June 14, 2006.
    In its assessment of potassium silicate, the EPA concluded that 
toxicological risks to humans and non-target organisms, and the 
potential environmental/ecological effects from exposures to potassium 
silicate are negligible. The constituent materials, potassium and 
silica, are present in the terrestrial and aquatic environment at 
levels which exceed projected applications of potassium silicate. The 
breakdown products of potassium silicate, potassium and silicon 
dioxide, are not hazardous or persistent byproducts, and are ubiquitous 
in the environment. Dermal, eye and respiratory irritation that may 
occur through occupational exposures can be mitigated by the use of 
protective personal equipment and observance of re-entry interval 
restrictions. References: Potassium Silicate for use in crop 
production, Technical Advisory Panel Review Report, compiled by 
University of California Sustainable Agriculture Research and Education 
Program, September 4, 2003, http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057629; EPA Biopesticides Registration Action 
Document, Potassium Silicate, September 7, 2006, http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_072606.pdf; 
Potassium Silicate; Exemption for the Requirement of a Tolerance, 71 FR 
34267, June 14, 2006; NOSB final recommendations, November 30, 2007, 
http://tinyurl.com/bacvg8; NOSB meeting transcripts, November 2007, 
http://tinyurl.com/bqqzv8.
    At its November 27-30, 2007, meeting in Arlington, VA, the NOSB 
recommended adding aqueous potassium silicate to the National List for 
use in organic crop production as an insecticide and plant disease 
control. In this open meeting, the NOSB evaluated aqueous potassium 
silicate against the evaluation criteria of 7 U.S.C. 6517 and 6518 of 
the OFPA, received public comment, and concluded that the substance is 
consistent with the OFPA evaluation criteria. The NOSB specified the 
use of potassium silicate in the aqueous form, in order to exclude 
silica from sources other than naturally occurring sand, such as slag. 
To clarify the NOSB intent, Agricultural Marketing Service (AMS) 
proposes adding an annotation providing that the silica, used in the 
manufacture of potassium silicate, must be sourced from naturally 
occurring sand.
    The NOP engaged in consultations with the EPA and Food and Drug 
Administration (FDA). The EPA informed the NOP that the recommended use 
of aqueous potassium silicate is consistent with EPA regulations. 
Concerning the use of aqueous potassium silicate, the FDA deferred to 
EPA as the appropriate regulatory body. Therefore, after consultation 
with the EPA and FDA regarding NOSB's recommendation to permit the use 
of aqueous potassium silicate in organic crop production, the Secretary 
is proposing to accept the NOSB's recommendation and amend Sec.  
205.601 of the National List by adding aqueous potassium silicate at 
new paragraphs (e)(2) and (i)(1) as an insecticide and as plant disease 
control, respectively, as follows:
    Aqueous Potassium Silicate (CAS --1312-76-1)--The silica, 
used in the manufacture of potassium silicate, must be sourced from 
naturally occurring sand.
    Sodium carbonate peroxyhydrate (CAS --15630-89-4). Sodium 
carbonate peroxyhydrate was petitioned for use in organic crop 
production as an algaecide. This substance is a white, granular, 
crystalline powder which is extremely soluble in water and decomposes 
when heated. It is manufactured via a dry, wet or spray process from 
sodium carbonate and hydrogen peroxide, both of which are naturally 
occurring and chemically produced. Upon contact with water sodium 
carbonate peroxyhydrate dissociates into sodium carbonate and hydrogen 
peroxide. The hydrogen peroxide oxidizes critical cellular components 
of the target organisms and further breaks down into water and oxygen. 
Hydrogen peroxide is currently on the National List (Sec.  205.601) for 
use in organic crop production as an algaecide, disinfectant and 
sanitizer, and as a plant disease control substance.
    The EPA has classified sodium carbonate peroxyhydrate as a non-
complex chemical that targets algae, moss, liverworts, slime molds and 
their spores. The EPA has indicated that sodium carbonate peroxyhydrate 
is effectively hydrogen peroxide when applied to water, but has not 
established a formal tolerance or exemption from tolerance for sodium 
carbonate peroxyhydrate. The EPA determines the applicability for use 
in food crop production on a product-by-product basis where sodium 
carbonate peroxyhydrate is the active ingredient. At the time of 
publication of this proposed rule, the EPA has registered products 
containing the technical grade of the active ingredient sodium 
carbonate peroxyhydrate for applications in aquaculture, rice/wild rice 
fields and paddies, turf grasses, terrestrial landscapes, as well as 
commercial greenhouses, nurseries and garden centers. References: 
Sodium Carbonate Peroxyhydrate (128860) Products, http://www.epa.gov/pesticides/biopesticides/ingredients/product/prod_128860.htm; EPA 
Pesticide Product Label System (PPLS), http://oaspub.epa.gov/pestlabl/

[[Page 26593]]

ppls.home, search by product registration numbers.
    Due to the rapid breakdown of sodium carbonate peroxyhydrate in the 
environment, the EPA has determined that this substance does not 
present ecological hazards when applied in accordance with the label 
directions. The EPA also found that toxicological risks from human 
exposure to sodium carbonate peroxyhydrate were negligible. Sodium 
carbonate peroxyhydrate is a corrosive material and wearing protective 
gear during handling can prevent potential skin damage and eye 
irritation. References: Sodium Carbonate Peroxyhydrate Technical 
Evaluation Report compiled by ICF International for the NOP, August 11, 
2006, http://tinyurl.com/an8qmv; EPA Biopesticides Registration Action 
Document, Sodium Carbonate Peroxyhydrate, September 16, 2002, http://www.epa.gov/pesticides/biopesticides/ingredients/tech_docs/brad_128860.pdf; NOSB final recommendation, November 30, 2007, http://tinyurl.com/bacvg8; NOSB meeting transcripts, November 2007, http://tinyurl.com/bqqzv8.
    At its November 27-30, 2007, meeting in Arlington, VA, the NOSB 
recommended adding sodium carbonate peroxyhydrate to the National List 
for use in organic crop production as an algaecide. In this open 
meeting, the NOSB evaluated sodium carbonate peroxyhydrate against the 
evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received 
public comment, and concluded that sodium carbonate peroxyhydrate is 
consistent with the OFPA evaluation criteria.
    The NOP engaged in consultations with the EPA and FDA. The EPA 
informed the NOP that the use of this substance would be consistent 
with EPA regulations only when applied in accordance with the product 
label. Further, the EPA explained that applications in organic food 
crop production must be consistent with the approved food uses which 
are identified on a product label. Product labels for algaecides 
containing sodium carbonate peroxyhydrate are approved for use by the 
EPA. To clarify this requirement, AMS proposes adding an annotation 
providing that federal law restricts the use of this substance in food 
crop production to approved food uses identified on the product label.
    Concerning the use of sodium carbonate peroxyhydrate, the FDA 
deferred to EPA as the appropriate regulatory body. Therefore, after 
consultation with the EPA and FDA regarding NOSB's recommendation to 
permit the use of sodium carbonate peroxyhydrate in organic crop 
production, the Secretary is proposing to accept the NOSB's 
recommendation and amend Sec.  205.601(a) of the National List by 
adding sodium carbonate peroxyhydrate at new paragraph (a)(8) as an 
algaecide as follows:
    Sodium carbonate peroxyhydrate (CAS --15630-89-4)--federal 
law restricts the use of this substance in food crop production to 
approved food uses identified on the product label.
    This proposed rule would further amend Sec.  205.601 of the 
National List by (1) removing the expired exemption at paragraph 
(m)(2)(i); and (2) redesignating current paragraph (m)(2)(ii) as 
(m)(2). Glycerine Oleate (Glycerol monooleate) (CASs 37220-82-
9)--for use only until December 31, 2006, is currently listed at 
(m)(2)(i). Removal of this substance has no new regulatory effect. When 
this exemption was enacted on September 11, 2006 (71 FR 53299), 
Glycerine oleate was classified by EPA as a List 3 inert (Inerts of 
Unknown Toxicity). The EPA has not reclassified this form of Glycerine 
oleate as a List 4--Inerts of Minimal Concern, which are allowed in 
organic crop production unless individually prohibited, and therefore, 
this substance has been prohibited from use in organic crop production 
since December 31, 2006.

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)).''

    This proposed rule would amend paragraph (a) of Sec.  205.605 of 
the National List regulations by adding the following substance:
    Gellan gum (CAS --71010-52-1). Gellan gum was petitioned 
for use as a food additive in organic processing. It is a water 
soluble, off-white powder that forms gels in the presence of positively 
charged ions. Gellan gum functions as a thickening agent to produce a 
wide range of textures in products, such as: Bakery fillings, 
confections, dairy products, dessert gels, frostings, icings and 
glazes, jams and jellies, puddings, sauces, and others. The gum is a 
high molecular weight polysaccharide which is produced through 
fermentation. The substance is deacylated and then precipated from the 
fermentation medium with isopropyl alcohol. The thickness of the gel 
can be manipulated for specific functions by the addition of potassium, 
magnesium, calcium, and/or sodium salts. Reference: Technical 
Evaluation Report compiled by ICF International for the USDA NOP, 
February 10, 2006, http://tinyurl.com/bpuryq.
    The FDA has determined that gellan gum may be safely used in food 
in accordance with the prescribed conditions at 21 CFR 172.665. That 
regulation stipulates specific guidelines for the manufacturing 
process, specifications of the finished product, including maximum 
residual levels of isopropyl alcohol, and labeling requirements for its 
container. Gellan gum falls within FDA's definition of stabilizers and 
thickeners which may be used to achieve the technical and functional 
effects listed in 21 CFR 170.3(o)(28).
    At its November 27-30, 2007, meeting in Arlington, VA, the NOSB 
recommended adding gellan gum as a nonsythetic substance for use in 
organic handling. In this open meeting, the NOSB evaluated gellan gum 
against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, 
received public comment, and concluded that gellan gum is consistent 
with the OFPA evaluation criteria. In response to the NOSB 
recommendation regarding gellan gum in organic handling, the Secretary 
is proposing to amend Sec.  205.605(a) of the National List regulations 
to allow the use of gellan gum as a nonsynthetic nonagricultural 
substance allowed as an ingredient in or on processed products labeled 
as ``organic'' or ``made with organic specified ingredients or food 
group(s))'' as follows:
    Gellan gum (CAS --71010-52-1).
    Gellan gum was petitioned for addition to the National List as a 
synthetic substance. The NOSB handling committee recommended that the 
material be added to the National List in Section 205.605, as a 
synthetic substance due to parallels in the manufacturing processes 
between xanthan gum and gellan gum, specifically, the use of 
fermentation and isopropyl alcohol (IPA) extraction in the production 
processes. Xanthan gum is currently listed as a synthetic substance on 
the National List. At the November 2007 meeting, the full NOSB voted to 
recommend gellan gum as a nonsynthetic substance. In this decision, the 
majority of NOSB members accepted that a substance does not qualify as 
a synthetic based solely upon the use of synthetic processing aid, IPA, 
in its manufacture. Further, the majority of the NOSB members agreed 
that the decision regarding gellan gum was not predicated upon that for 
xanthan gum. References: NOSB recommendations, November 30, 2007, 
http://tinyurl.com/ajnvbq; NOSB meeting transcripts, March 2007 and

[[Page 26594]]

November 2007, http://tinyurl.com/bqqzv8.

Section 205.606 Nonorganically Produced Agricultural Products Allowed 
as Ingredients in or on Processed Products Labeled as ``Organic.''

    This proposed rule would amend Sec.  205.606 of the National List 
regulations by (1) redesignating paragraphs (g) through (t) and (u) 
through (w) as paragraphs (h) through (u) and (w) through (y) 
respectively; and (2) adding new paragraphs (g) and (v) for the purpose 
of adding the following substances:
    Fortified cooking wine--Marsala. Marsala cooking wine was 
petitioned for use as a nonorganic agricultural ingredient in or on 
processed products labeled as ``organic.'' This ingredient is used to 
impart a unique flavor to a variety of foods. Marsala is a dessert, or 
fortified wine, which is produced by adding yeast to the juice of 
crushed and pressed grapes. The addition of grape spirits stops the 
fermentation process at the desired sugar level. The wine is then 
heated for a specific time to reach a certain temperature and salt is 
added to prevent or slow further fermentation that would turn the 
Marsala wine into vinegar. The Marsala wine becomes a non-beverage, 
cooking wine with the addition of salt. The production of non-beverage 
wines is regulated by the Alcohol and Tobacco Tax and Trade Bureau (27 
CFR 24.215) and the labeling falls within the jurisdiction of the FDA.
    At its May 20-22, 2008, meeting in Baltimore, MD, the NOSB 
recommended adding fortified cooking wine--Marsala, to the National 
List for use in organic handling as a nonorganic agricultural 
ingredient when the organic form of Marsala cooking wine is determined 
to be commercially unavailable. In this open meeting, the NOSB 
evaluated Marsala cooking wine against the evaluation criteria of 7 
U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167, January 
18, 2007) on commercial availability, received public comment, and 
concluded that the use of the substance in organic handling is 
consistent with the OFPA evaluation criteria and NOP commercial 
availability criteria. Specifically in regard to commercial 
availability, the NOSB cited scarcity of production as determined by an 
extensive search among fortified wine producers and organic wine 
producers. Therefore, in response to the NOSB recommendation regarding 
Marsala cooking wine in organic handling, the Secretary is proposing to 
amend Sec.  205.606 of the National List regulations to allow fortified 
cooking wine--Marsala, at new paragraph (g) as a nonorganically 
produced agricultural product allowed as an ingredient in or on 
processed products labeled as ``organic'' as follows:
    Fortified cooking wines.
    (1) Marsala.
    Fortified cooking wine--Sherry. Sherry cooking wine was petitioned 
for use as a nonorganic agricultural ingredient in or on processed 
products labeled as ``organic.'' This ingredient is used to impart a 
unique flavor to a variety of foods such as soups and entrees. Sherry 
is a dessert or fortified wine that is produced with the addition of 
spirits after fermentation. Fining and filtering of the wine occurs 
both before and after it is heated or baked. The addition of salt 
prevents the wine from turning to vinegar and produces a non-beverage 
cooking wine. The production of non-beverage wines is regulated by the 
Alcohol and Tobacco Tax and Trade Bureau (27 CFR 24.215) and the 
labeling falls within the jurisdiction of the FDA.
    At its May 20-22, 2008, meeting in Baltimore, MD, the NOSB 
recommended adding fortified cooking wine--Sherry, to the National List 
for use in organic handling as a nonorganic agricultural ingredient 
where the organic form of Sherry cooking wine is considered 
commercially unavailable. In this open meeting, the NOSB evaluated 
Sherry cooking wine against the evaluation criteria of 7 U.S.C. 6517 
and 6518 of the OFPA and NOP criteria (72 FR 2167, January 18, 2007) on 
commercial availability, received public comment, and concluded that 
the use of the substance in organic handling is consistent with the 
OFPA evaluation criteria and NOP commercial availability criteria. 
Specifically in regard to commercial availability, the NOSB cited a 
dearth of production among an extensive list of fortified wine 
producers and organic wine producers. Therefore, in response to the 
NOSB recommendation regarding Sherry cooking wine in organic handling, 
the Secretary is proposing to amend Sec.  205.606 of the National List 
regulations to allow fortified cooking wine--Sherry, at new paragraph 
(g) as a nonorganically produced agricultural product allowed as an 
ingredient in or on processed products labeled as ``organic'' as 
follows:
    Fortified cooking wines.
    (2) Sherry.
    Tragacanth gum (CAS --9000-65-1). Tragacanth gum was 
petitioned for use as a nonorganic agricultural ingredient in or on 
processed products labeled as ``organic.'' Tragacanth gum is used to 
provide texture, viscosity and emulsion stability in foods such as 
salad dressings and sauces. Tragacanth gum has superior stability in 
acidic conditions and over a broader temperature range than other 
water-soluble gums. Tragacanth gum is harvested from the stems and 
branches of Astragalus gummifer Labillardiere and other Asiatic species 
of Astragalus (Fam. Leguminosae) in the desert and arid areas of the 
Middle East, specifically Iran and neighboring countries. The dried gum 
that exudes from the plant is cleaned, mechanically cut, dissolved in 
water and filtered. Tragacanth gum is a polysaccharide composed of 2 
fractions, one of which is water soluble. It is typically available as 
a spray-dried powder which forms a gel when rehydrated with water, or 
oil prior to water, and agitated. The FDA has affirmed that tragacanth 
gum is a generally regarded as safe (GRAS) substance and established 
maximum usage levels according to the type of food (21 CFR 184.1351).
    At its May 20-22, 2008, meeting in Baltimore, MD, the NOSB 
recommended adding tragacanth gum to the National List for use in 
organic handling as a nonorganic agricultural ingredient where the 
organic form of tragacanth gum is considered commercially unavailable. 
In this open meeting, the NOSB evaluated tragacanth gum against the 
evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA and NOP 
criteria (72 FR 2167, January 18, 2007) on commercial availability, 
received public comment, and concluded that the use of the substance in 
organic handling is consistent with the OFPA evaluation criteria and 
NOP commercial availability criteria. Specifically with regard to the 
commercial availability criteria, the NOSB cited trade difficulties as 
the major challenge to a consistent supply, as the global supply of 
this ingredient is produced in Iran and neighboring countries. The NOSB 
recommended placement of tragacanth gum on the National List at Sec.  
205.606(j), Gums--water extracted only. As an exudate, the raw 
tragacanth gum is not harvested or processed using extraction. 
Accordingly, the NOP has determined that tragacanth gum does not belong 
in paragraph (j) but should have its own paragraph. Therefore, in 
response to the NOSB recommendation regarding tragacanth gum in organic 
handling, the Secretary is proposing to amend Sec.  205.606 of the 
National List regulations to allow tragacanth gum at new paragraph (v) 
as a nonorganically produced agricultural product allowed as an 
ingredient in or on processed products labeled as ``organic'' as 
follows:
    Tragacanth gum (CAS --9000-65-1).

[[Page 26595]]

III. Related Documents

    Three 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) 72 FR 10972, March 12, 2007, 
(Gellan gum); (2) 72 FR 58046, October 12, 2007, (Potassium silicate, 
Sodium carbonate peroxyhydrate, Gellan gum); and (3) 73 FR 18491, April 
4, 2008, (Marsala cooking wine, Sherry cooking wine, Tragacanth gum).

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 
the 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 (OMB).

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 section 
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
section 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 the 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 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 
beneficial to 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 $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, Economic Research Service (ERS) data based on 
information from USDA-accredited certifying agents, the U.S. organic 
industry included nearly 6,949 certified organic crop and livestock 
operations at the end of 2001. These operations reported certified 
acreage totaling more than 2.09 million acres of organic farm 
production. By the end of 2005, the number of U.S. certified organic 
crop and livestock operations totaled about 8,500 and certified organic 
acreage exceeded 4 million acres. ERS, based upon information provided 
by domestic accredited certifying agents, estimated the number of 
certified handling operations as exceeding 2,790 in 2004. AMS believes 
that most of these entities would be considered small entities under 
the criteria established by the SBA.
    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

[[Page 26596]]

demonstrated a growth rate between 20 to 24 percent each year, 
including a 22 percent increase in 2006.
    In addition, USDA has 97 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 accredited certifying agents 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 regulation 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.

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 205.601 is amended by:
    A. Adding new paragraph (a)(8);
    B. Redesignating paragraphs (e)(2) through (e)(9) as (e)(3) through 
(e)(10) and adding new paragraph (e)(2);
    C. Redesignating paragraphs (i)(1) through (i)(11) as (i)(2) 
through (i)(12); and adding new paragraph (i)(1); and
    D. Revising paragraph (m)(2).
    The additions and revision read as follows:


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

* * * * *
    (a) * * *
    (8) Sodium carbonate peroxyhydrate (CAS --15630-89-4)--
federal law restricts the use of this substance in food crop production 
to approved food uses identified on the product label.
* * * * * *
    (e) * * *
    (2) Aqueous potassium silicate (CAS --1312-76-1)--The 
silica, used in the manufacture of potassium silicate, must be sourced 
from naturally occurring sand.
* * * * *
    (i) * * *
    (1) Aqueous potassium silicate (CAS --1312-76-1)--The 
silica, used in the manufacture of potassium silicate, must be sourced 
from naturally occurring sand.
* * * * *
    (m) * * *
    (2) EPA List 3--Inerts of unknown toxicity--for use only in passive 
pheromone dispensers.
* * * * *
    2. Section 205.605 is amended by adding one new substance in 
alphabetical order to paragraph (a) to 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) * * *
* * * * *
    Gellan gum (CAS --71010-52-1)
* * * * *
    3. Section 205.606 is amended by:
    A. Redesignating paragraphs (g) through (t) and (u) through (w) as 
paragraphs (h) through (u) and (w) through (y) respectively;
    B. Adding new paragraphs (g) and (v) to read as follows:


Sec.  205.606  Nonorganically produced agricultural products allowed as 
ingredients in or on processed products labeled as ``organic.''

* * * * *
    (g) Fortified cooking wines.
    (1) Marsala.
    (2) Sherry.
* * * * *
    (v) Tragacanth gum (CAS --9000-65-1).
* * * * *

    Dated: May 28, 2009.
Robert C. Keeney,
Acting Associate Administrator.
[FR Doc. E9-12818 Filed 6-2-09; 8:45 am]
BILLING CODE 3410-02-P