This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

26591 

Vol. 74, No. 105 

Wednesday, June 3, 2009 

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 §§ 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 

§ 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 § 205.601, one substance 

(gellan gum) for organic processing to 

§ 205.605, and three substances 

(fortified cooking wine—marsala, 

fortified cooking wine—sherry, and 

tragacanth gum) for organic processing 

to § 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 § 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. 


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26592 Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Proposed Rules 

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 

§ 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 nontarget 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 

§ 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 (§ 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 noncomplex 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/ 


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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 § 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 § 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) (CAS#s 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 § 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 § 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 


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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 

§ 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 nonbeverage 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 § 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 nonbeverage 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 

§ 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 § 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 

§ 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). 


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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 § 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 


sroberts on PROD1PC70 with PROPOSALS
26596 Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Proposed Rules 

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: 

§ 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: 

§ 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: 

§ 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 

DEPARTMENT OF ENERGY 

10 CFR Part 431 

[Docket No. EERE–2008–BT–STD–0013] 

RIN 1904–AB83 

Energy Conservation Program for 

Certain Industrial Equipment: Energy 

Conservation Standards for 

Commercial Heating, Air-Conditioning, 

and Water-Heating Equipment 

AGENCY: Office of Energy Efficiency and 

Renewable Energy, Department of 

Energy. 

ACTION: Notice of data availability and 

request for public comment. 

SUMMARY: The U.S. Department of 

Energy (DOE) is announcing the 

availability of an environmental 

assessment (EA) to accompany its notice 

of proposed rulemaking (NOPR) 

considering potential energy 

conservation standards for certain 

commercial and industrial equipment, 

including commercial heating, airconditioning, and water-heating 

equipment, published in the Federal 

Register on March 20, 2009. 

Specifically, this EA includes a concise 

examination of the impacts of emission 

reductions likely to result from the 

proposed standards for commercial 

packaged boilers and water-cooled and 

evaporatively-cooled commercial 

package air conditioners and heat 

pumps with a cooling capacity at or 

above 240,000 Btu/h and less than 

760,000 Btu/h. The EA has been 

incorporated as Chapter 8 in the NOPR 

technical support document (TSD). In 

addition, Chapter 9 of the NOPR TSD 

provides the results of DOE’s 

monetization analysis of these potential 

emission reductions. These materials 

are available online (see ADDRESSES). 

DOE specifically requests that interested 

members of the public, Tribes, and 

States comment on the EA. 

DATES: DOE will accept comments, data, 

and information regarding the subject 

matter of this NODA submitted no later 

than June 18, 2009. 

ADDRESSES: Any comments submitted 

must identify the NODA for Energy 

Conservation Standards for ASHRAE 

Products, and provide the docket 

number EERE–2008–BT–STD–0013 

and/or Regulatory Information Number 


sroberts on PROD1PC70 with PROPOSALS