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

68505 

Vol. 75, No. 215 

Monday, November 8, 2010 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–10–0079; 

NOP–09–02PR] 

RIN 0581–AD06 

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) 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 May 22, 2008, November 19, 

2008, and May 6, 2009. The 

recommendations addressed in this 

proposed rule pertain to establishing 

exemptions (uses) for four substances in 

organic crop production and organic 

processing, amending an annotation for 

one allowed substance, and removing an 

exemption for one allowed substance. 

Consistent with the recommendations 

from the NOSB, this proposed rule 

would add the following four 

substances, along with any restrictive 

annotations, to the National List: 

Microcrystalline cheesewax; acidified 

sodium chlorite; dried orange pulp; and 

Pacific kombu seaweed. This proposed 

rule would also amend the annotation 

for lecithin—unbleached, and remove 

lecithin—bleached, from the National 

List. 

DATES: Comments must be received by 

January 7, 2011. 

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–NOP, Room 

2646–So., Ag Stop 0268, 1400 

Independence Ave., SW., Washington, 

DC 20250–0268. 

Written comments responding to this 

proposed rule should be identified with 

the document number AMS–NOP–10– 

0079; NOP–09–02. 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 action 

being proposed for any or all of the 

substances in this proposed rule. You 

should clearly indicate the reason(s) for 

your position. You should also offer any 

recommended language changes that 

would be appropriate for your position. 

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 USDA’s 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, 

National Organic Program, Room 2646– 

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: 

Melissa Bailey, Director, Standards 

Division, 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 the 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 thirteen 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), 

October 9, 2008 (73 FR 59479), July 6, 

2010 (75 FR 38693), and August 24, 

2010 (75 FR 51919). 

This proposed rule would amend the 

National List to reflect six 

recommendations submitted to the 

Secretary by the NOSB on May 22, 2008, 

November 19, 2008, and May 6, 2009. 

Based upon their evaluation of petitions 

submitted by industry participants, the 

NOSB recommended that the Secretary 

add one substance (microcrystalline 

cheesewax (CAS #s 64742–42–3, 8009– 

03–08, and 8002–74–2)) for organic crop 

production to § 205.601, one substance 

(acidified sodium chlorite) for organic 

processing to § 205.605(b), and two 

substances (orange pulp, dried, and 

Pacific kombu seaweed) for organic 

processing to § 205.606 of the National 

List. This proposed rule would amend 

§ 205.605(b) of the National List by 

removing one substance (lecithin— 

bleached). This proposed rule would 

also amend § 205.606 of the National 

List by amending one listing (lecithin— 

unbleached). The exemptions for use of 

each substance in organic production 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
68506 Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / Proposed Rules 

1The U.S. Food and Drug Administration (FDA) 

permits the addition of antioxidants permitted in 

food to petroleum wax (21 CFR 172.886(c)). 

were evaluated by the NOSB using the 

evaluation criteria specified in OFPA (7 

U.S.C. §§ 6517–6518). In addition, the 

amendment of one substance and 

removal of one substance were also 

evaluated by the NOSB using NOP 

criteria on commercial availability (72 

FR 2167). 

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: Designating paragraph 

(o) for the purpose of adding the 

following substance as a production aid: 

Microcrystalline cheesewax (CAS #s 

64742–42–3, 8009–03–08, and 8002–74– 

2). A petition to add microcrystalline 

cheesewax for use in organic crop 

production as a production aid in log 

grown mushroom culture was submitted 

in January 2007. Microcrystalline 

cheesewax is a colorless solid which is 

heated to its melting point and applied 

with a brush to inoculation sites on the 

mushroom production logs. This 

substance acts as a moisture barrier and 

is temporarily used to limit moisture 

loss from mushroom spawn inoculums 

and airborne contaminants from 

colonizing on the inoculation sites. On 

May 21, 2008, the NOSB recommended 

adding a blended form of 

microcrystalline cheesewax to the 

National List. This blended form is 

comprised of three synthetically-derived 

substances: Clay-treated 

microcrystalline wax (CAS # 64742–42– 

3), petrolatum (CAS # 8009–03–08), and 

paraffin wax (CAS # 8002–74–2). Claytreated microcrystalline wax, 

petrolatum and paraffin waxes range 

from solid to semi-solid state at room 

temperature, depending on the oil 

content. These three components are 

recovered from crude oil through a 

series of crystallization, filtration, 

solidification, and solvent extraction 

steps. According to the petition, all of 

the solvent is recovered during the 

extraction process and none of the 

solvent remains in the final product. 

These substances are then decolored, 

deodorized, blended, and a synthetic 

antioxidant preservative, Butylated 

hydroxytoluene (BHT) (CAS # 9010–79– 

1), is added in a quantity less than 100 

parts per million.1

Each of the three components of 

microcrystalline cheesewax is classified 

by the Food and Drug Administration 

(FDA) as food-grade petroleum wax. The 

FDA defines petroleum wax as a 

mixture of solid hydrocarbons, 

paraffinic in nature, derived from 

petroleum, and refined to meet the 

specifications prescribed in 21 CFR 

172.886(b). The FDA has approved foodgrade petroleum wax for direct addition 

to chewing gum base, on cheese and raw 

fruits and vegetables, as a defoamer in 

food and as a component of 

microcapsules for spice-flavoring 

substances added to food for human 

consumption in accordance with 21 

CFR 172.886. Petroleum wax, in 

accordance with 21 CFR 178.3710, is 

also FDA-approved for use as an 

indirect food additive, i.e., a component 

of nonfood articles in contact with food. 

Occupational exposure to petroleum 

wax can result in dermal, eye, and 

respiratory irritation. This can be 

mitigated by the use of protective 

personal equipment and sufficient 

general local exhaust. References: NOSB 

final recommendations, May 21, 2008, 

http://tiny.cc/rrmr3; NOSB meeting 

transcripts, May 2008, http:// 

tinyurl.com/bqqzv8; Petition and 

Addendum for cheesewax, April and 

December 2006, http://tinyurl.com/ 

34lp8to. 

At its May 20–22, 2008, meeting in 

Baltimore, MD, the NOSB recommended 

adding microcrystalline cheesewax to 

the National List for use in organic crop 

production as a production aid in log 

grown mushroom culture. In this open 

meeting, the NOSB evaluated 

microcrystalline cheesewax 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 

recommendation also specified that the 

microcrystalline cheesewax must be 

made without either ethylene-propylene 

co-polymer, a thickener, or synthetic 

colors. 

The Secretary has reviewed the NOSB 

recommendation and, consistent with 

this recommendation, proposes to add 

Microcrystalline cheesewax for organic 

crop production by amending § 205.601 

of the National List by adding new 

paragraph (o) as follows: 

(o) As production aids. 

Microcrystalline cheesewax (CAS #’s 

64742–42–3, 8009–03–08, and 8002–74– 

2)—for use in log grown mushroom 

culture. Must be made without either 

ethylene-propylene co-polymer or 

synthetic colors. 

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 (b) of § 205.605 of the 

National List regulations by removing 

the exemption for the following 

substance: 

Lecithin—bleached. Bleached lecithin 

was included in § 205.605(b) of the 

National List as originally published on 

December 21, 2000 (FR 65 80548), as an 

allowed synthetic ingredient in or on 

processed products labeled as ‘‘organic’’ 

or ‘‘made with organic (specified 

ingredients or food group(s)).’’ 

In June 2008, a petition was submitted 

to the NOSB for the removal of bleached 

lecithin from § 205.605(b). The petition 

claimed that certified organic lecithins 

had become available and could replace 

non-organic bleached lecithin. 

Specifically, the petition cited the 

adequate supply of domestically-grown 

organic soybeans, and the use of lighter 

colored raw materials, reduced 

processing temperatures, and reduction 

of color pigments by filter media that 

enabled the production of an organic 

equivalent to conventional bleached 

lecithin. 

Lecithin is the primary emulsifier in 

a wide variety of organic products. Most 

commercial lecithin is made from 

soybeans. It can also be made from 

vegetable crops such as corn, canola and 

sunflower. Nonorganic soy lecithin is 

manufactured by using hexane to extract 

the oil from the soybeans. The fluid 

lecithin resulting from this extraction 

process can then be bleached with 

hydrogen peroxide or benzyl peroxide. 

Bleached lecithin is functionally 

equivalent to unbleached lecithin, but is 

used when a lighter color is preferred. 

At its May 4–6, 2009, meeting in 

Washington, DC, the NOSB considered 

public comments and determined that 

organic light-colored lecithins are 

commercially available in the 

appropriate form, quality, and quantity 

to fulfill essential uses in organic 

handling. Additionally, the NOSB noted 

that there are conventional nonsynthetic gums that can serve the same 

or similar functions as bleached 

lecithin. 

The Secretary has reviewed the NOSB 

recommendation and, consistent with 

this recommendation, proposes to 

remove the exemption for lecithin— 


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Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / Proposed Rules 68507 

2The FDA states that acidified sodium chlorite 

solutions are produced by mixing an aqueous 

solution of sodium chlorite and any GRAS acid. For 

the purposes of the NOP, only citric acid is 

permitted in acidified sodium chlorite for use in 

organic handling. 

3For other uses of acidified sodium chlorite in 

poultry and red meat processing, the FSIS Directive 

7120.1 refers to the concentration and pH 

requirements provided in FDA regulation 21 CFR 

173.325. 

4The NOSB recommended the listing of this 

substance as sodium chlorite, acidified. In this 

proposed rule, ‘‘acidified’’ was moved to precede 

sodium chlorite for consistency with the use of this 

term in other Federal regulations. 

bleached in paragraph (b) of § 206.605. 

The Board has recommended to 

continue to allow nonorganic de-oiled 

lecithin when an organic version is not 

commercially available—see § 205.606 

discussion below. This proposed action 

would not prohibit nonorganic forms of 

bleached, de-oiled lecithin, nor would it 

prohibit bleaching of organic fluid 

lecithin with hydrogen peroxide, a 

bleaching agent, which is allowed for 

use in organic handling per 

§ 205.605(b). References: NOSB 

recommendations, May 2009, http:// 

tiny.cc/9wgkp; NOSB meeting 

transcripts, May 2009, http:// 

tinyurl.com/bqqzv8; Petition to remove 

bleached lecithin, June 2008, http:// 

tinyurl.com/32e638e. 

This proposed rule would further 

amend paragraph (b) of § 205.605 of the 

National List regulations to add the 

following substance: 

Acidified sodium chlorite. In October 

2006, a petition was submitted to the 

NOSB for the use of acidified sodium 

chlorite as a synthetic processing aid in 

organic handling in wash and rinse 

water, as well as, for direct food contact 

and food contact surfaces. This 

substance contains an aqueous solution 

of sodium chlorite and citric acid, both 

of which are listed as generally 

recognized as safe (GRAS) in 21 CFR 

186.1750 and 21 CFR 184.1033, 

respectively. Acidified sodium chlorite 

solution is a colorless to light green 

solution that has a slight chlorine-like 

odor. 

The use of acidified sodium chlorite 

is regulated by other Federal agencies. 

The FDA permits uses of acidified 

sodium chlorite as a secondary direct 

food additive in accordance with the 

concentrations and other specified 

conditions in 21 CFR 173.325.2 The 

FDA-approved uses for acidified sodium 

chlorite as secondary direct 

antimicrobial food treatment include the 

processing of poultry, red meat, 

comminuted and formed meat products, 

seafood, and raw and processed fruits 

and vegetables. Acidified sodium 

chlorite is also permitted as a sanitizing 

agent on food-processing equipment, 

utensils and other food contact surfaces 

including dairy-processing equipment 

(21 CFR 178.1010(b)(46)). The EPA has 

approved the use of acidified sodium 

chlorite (as an oxychloro species) as an 

ingredient in antimicrobial pesticide 

formulations applied to dairyprocessing equipment, food-processing 

equipment and utensils, if the end-use 

concentration does not exceed 200 ppm 

chlorine dioxide, per 40 CFR 180.940(b) 

and (c). Finally, the USDA Food Safety 

and Inspection Service (FSIS) 

recognizes the use of acidified sodium 

chlorite for processing red meat and 

poultry. The FSIS Directive 7120.1 

specifies that acidified sodium chlorite 

applied as spray or dip in red meat 

processing, must have pH of 5.0–7.5 and 

concentrations of sodium chlorite and 

chlorine dioxide must not exceed 1200 

and 300 ppm respectively.3 References: 

NOSB recommendations, May 2009, 

http://tiny.cc/lq2gx; NOSB meeting 

transcripts, May 2009, http:// 

tinyurl.com/bqqzv8; Petition for 

acidified sodium chlorite, October 2006, 

http://tinyurl.com/3x2wxpk; Acidified 

Sodium Chlorite Technical Advisory 

Panel Report compiled by AMS Science 

and Technology Program, July 21, 2008, 

http://tinyurl.com/359zdke. 

At its May 4–6, 2009, meeting in 

Washington, DC, the NOSB 

recommended adding acidified sodium 

chlorite to § 205.605(b) of the National 

List regulations for secondary direct 

antimicrobial food treatment and 

indirect food contact surface sanitizing, 

with the restriction that only citric acid 

can be used for acidification. The Board 

considered that acidified sodium 

chlorite can have a short contact time 

with the product being treated, does not 

produce chloromethanes or 

chlorohalogen, and breaks down upon 

use to water, citric acid and sodium 

chloride with no resulting residual 

chlorine levels in water. During this 

open meeting, the NOSB evaluated 

acidified sodium chlorite 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 Secretary has reviewed the NOSB 

recommendation and, consistent with 

this recommendation, proposes to 

accept the NOSB’s recommendation and 

amend § 205.605(b) of the National List 

by adding acidified sodium chlorite as 

follows: 

Acidified sodium chlorite— 

Secondary direct antimicrobial food 

treatment and indirect food contact 

surface sanitizing. Acidified with citric 

acid only.4

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) Revising the 

annotation at paragraph (p); (2) 

redesignating paragraphs (r) through (t) 

and paragraphs (u) through (y), as 

paragraphs (s) through (u) and (w) 

through (aa) respectively; and (3) adding 

new paragraphs (r) and (v) for the 

purpose of amending and adding the 

following substances: 

Lecithin—unbleached. Unbleached 

lecithin was included in § 205.606 of 

the National List as originally published 

on December 21, 2000 (65 FR 80548), as 

an allowed nonorganic agricultural 

ingredient in ‘‘organic’’ products, when 

the organic version is not commercially 

available. In August 2008, a petition was 

submitted to amend the listing for 

unbleached lecithin to reflect the 

availability of organic fluid lecithins. 

Lecithin is available in fluid or de-oiled 

form. After extraction from the raw 

material, fluid lecithin can further be 

de-oiled with acetone as the solvent. 

Both fluid and de-oiled lecithin may be 

bleached or unbleached. De-oiled 

lecithin imparts crumb softening and 

dough lubricating and conditioning 

characteristics. De-oiled lecithin is the 

only form of lecithin appropriate for 

certain products such as cakes, cookies, 

doughs, sauces, chocolates, frostings, 

and canned meat products. References: 

NOSB recommendations, May 2009, 

http://tiny.cc/6jmsq; NOSB meeting 

transcripts, May 2009, http:// 

tinyurl.com/bqqzv8; Petition to remove 

fluid lecithin from the general category 

of unbleached lecithin, August 2008, 

http://tinyurl.com/25zcry9. 

At its May 4–6, 2009, meeting in 

Washington, DC, the NOSB evaluated 

lecithin 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 de-oiled lecithin is 

consistent with the OFPA evaluation 

criteria. The NOSB acknowledged that 

the de-oiling process, rather than 

bleaching, differentiates the types of 

lecithin. Based upon the petition and 

public comments, the NOSB determined 

that de-oiled lecithin is not 

commercially available in organic form 

and recommended revising the 

annotation of the listing for Lecithin— 

unbleached in § 205.606 to Lecithin— 

de-oiled. This proposed action would 

prohibit the use of nonorganic fluid 

lecithin and allow the use of bleached 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
68508 Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / Proposed Rules 

or unbleached nonorganic de-oiled 

lecithin when an organic version is not 

commercially available. 

The Secretary has reviewed the NOSB 

recommendation and, consistent with 

this recommendation, proposes to 

amend § 205.606 of the National List 

regulations to allow the use of de-oiled 

lecithin as a nonorganically produced 

agricultural substance allowed as an 

ingredient in or on processed products 

labeled as ‘‘organic’’ as follows: 

Lecithin—de-oiled. 

Orange pulp, dried. In February 2008, 

dried orange pulp was petitioned for use 

as a nonorganic agricultural ingredient 

in or on processed products labeled as 

‘‘organic.’’ Dried orange pulp, which 

may also be identified as citrus flour or 

citrus fiber, is used in various processed 

products including fresh and frozen 

baked goods, pastas, salad dressings, 

confectionery, processed cheese 

spreads, frozen food entrees, and 

processed meat and poultry products. 

Dried orange pulp is a yellowish light 

and fluffy powder. It is a byproduct of 

the extraction of raw oranges for orange 

juice production. The remaining raw 

pulp is washed with water, stabilized 

with heat, mixed, dried and milled. No 

chemical extraction or treatment is used 

in its manufacture. It functions to retain 

moisture in baked goods, pastas, salad 

dressings, confectionery, processed 

cheese spreads, frozen food entrees, 

processed meat and poultry products 

and seasoning brines for meat and 

poultry products. It also functions as a 

flavor enhancing agent in noncarbonated beverages and fruit drinks. 

In June 2004, the petitioner informed 

the FDA that this material is GRAS 

(GRAS Notice no. GRN000154). Dried 

orange pulp is also considered a 

moisture retention agent and binder for 

use in ground meat and poultry 

products. The USDA FSIS permits the 

use of dried orange pulp as a binder 

provided it does not exceed 3.5% of the 

product formulation. Dried orange pulp 

may also be used in various ground 

meat and poultry products where 

binders are permitted as described in 

USDA, FSIS Directive 7120.1. 

References: NOSB recommendations, 

November 2008, http://tiny.cc/agsu7; 

NOSB meeting transcripts, November 

2008, http://tinyurl.com/bqqzv8; 

Petition for dried orange pulp, January 

2008, http://tinyurl.com/238e7lj. 

At its November 17–19, 2008, meeting 

in Washington, DC, the NOSB 

recommended adding dried orange pulp 

to § 205.606 of the National List 

regulations for use in organic handling 

as a nonorganic agricultural ingredient 

when the organic form of dried orange 

pulp is determined to be commercially 

unavailable. The Board determined that 

the demand for the organic dried orange 

pulp exceeded the availability of 

organic oranges in quantities to yield 

sufficient organic dried orange pulp. 

Specifically, the NOSB considered that 

most pulp is incorporated into orange 

juice and the low yield ratio of raw to 

dried pulp. The Board also considered 

the potential for this substance to 

replace certain synthetic substances 

which are allowed in organic handling. 

In this open meeting, the NOSB 

evaluated dried orange pulp against the 

evaluation criteria of 7 U.S.C. 6517 and 

6518 of the OFPA and the NOP criteria 

(72 FR 2167, January 18, 2007) on 

commercial availability, received public 

comment, and concluded that the 

substance is consistent with the OFPA 

evaluation criteria. 

The Secretary has reviewed the NOSB 

recommendation and, consistent with 

this recommendation, proposes to 

amend § 205.606 of the National List 

regulations to allow dried orange pulp, 

at new paragraph (r) as a nonorganically 

produced agricultural product allowed 

as an ingredient in or on processed 

products labeled as ‘‘organic’’ as follows: 

Orange pulp, dried. 

Seaweed, Pacific kombu. Pacific 

kombu seaweed was petitioned in 

August 2007, for use as a nonorganic 

agricultural ingredient in or on 

processed products labeled as ‘‘organic.’’ 

Pacific kombu seaweed has been 

consumed for centuries in Japan and is 

used for stock in traditional Japanese 

foods. Pacific kombu species impart a 

unique flavor, which is attributed to the 

glutamic acid content, and which is not 

achievable with other seaweed species 

or sea vegetables. Pacific kombu 

seaweed is wild harvested along the 

coast of Japan. After harvest, the 

seaweed is hot water extracted, 

condensed, heat sterilized and filtered. 

The FDA has classified Pacific kombu as 

brown algae and affirmed that brown 

algae is a GRAS direct food substance. 

Its use in spices, seasonings, and 

flavorings as a flavor enhancer and 

flavor adjuvant in food is regulated by 

the FDA at 21 CFR 184.1120. 

References: NOSB recommendations, 

May 2008, http://tiny.cc/0e1xo; NOSB 

meeting transcripts, May 2008, http:// 

tinyurl.com/bqqzv8; Petition for kombu 

seaweed, August 2007, http:// 

tinyurl.com/29l4oug. 

At its May 20–22, 2008, meeting in 

Baltimore, MD, the NOSB recommended 

adding Pacific kombu seaweed to 

§ 205.606 of the National List 

regulations for use in organic handling 

as a nonorganic agricultural ingredient 

when the organic form of Pacific kombu 

seaweed is determined to be 

commercially unavailable. In this open 

meeting, the NOSB evaluated Pacific 

kombu seaweed 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 substance is 

consistent with the OFPA evaluation 

criteria. 

The Secretary has reviewed the NOSB 

recommendation and, consistent with 

this recommendation, proposes to 

amend § 205.606 of the National List 

regulations to allow Pacific kombu 

seaweed, at new paragraph (v) as a 

nonorganically produced agricultural 

product allowed as an ingredient in or 

on processed products labeled as 

‘‘organic’’ as follows: 

Seaweed, Pacific kombu. 

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) 74 FR 

11904, March 20, 2009, (bleached 

lecithin, acidified sodium chlorite, 

unbleached fluid lecithin); (2) 73 FR 

54781, September 23, 2008, (dried 

orange pulp, acidified sodium chlorite); 

and (3) 73 FR 18491, April 4, 2008, 

(microcrystalline cheesewax, acidified 

sodium chlorite, Pacific kombu 

seaweed). 

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/nop. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / Proposed Rules 68509 

5U.S. Department of Agriculture, Economic 

Research Service. 2009. Data Sets: U.S. Certified 

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. http:// 

www.ers.usda.gov/Data/Organic/. 

6U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers: Documentation. 

http://www.ers.usda.gov/Data/OrganicHandlers/

Documentation.htm. 

7 Dimitri, C., and L. Oberholtzer. 2009. Marketing 

U.S. Organic Foods: Recent Trends from Farms to 

Consumers, Economic Information Bulletin No. 58, 

U.S. Department of Agriculture, Economic Research 

Service, http://www.ers.usda.gov/Publications/ 

EIB58. 

8Organic Trade Association’s 2010 Organic 

Industry Survey, http://www.ota.com. 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 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 § 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 § 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 

removal of lecithin-bleached is not 

expected to have a significant economic 

impact on small entities as alternative 

forms of lecithin are commercially 

available. 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 number of certified 

U.S. organic crop and livestock 

operations totaled nearly 13,000 and 

certified organic acreage exceeded 4.8 

million acres in 2008.5 ERS, based upon 

the list of certified operations 

maintained by the National Organic 

Program, estimated the number of 

certified handling operations was 3,225 

in 2007.6 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 $3.6 billion 

in 1997 to nearly $21.1 billion in 2008.7

The organic industry is viewed as the 

fastest growing sector of agriculture, 

representing over 3 percent of overall 

food sales in 2009. Between 1990 and 

2008, organic food sales have 

historically demonstrated a growth rate 

between 15 to 24 percent each year. In 

2009, organic food sales grew 5.1%.8

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
68510 Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / Proposed Rules 

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 

adding paragraph (o) to read as follows: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

* * * * * 

(o) As production aids. 

Microcrystalline cheesewax (CAS #’s 

64742–42–3, 8009–03–08, and 8002–74– 

2)—for use in log grown mushroom 

culture. Must be made without either 

ethylene-propylene co-polymer or 

synthetic colors. 

* * * * * 

3. Section 205.605, paragraph (b), is 

amended by: 

A. Removing ‘‘Lecithin—bleached.’’; 

and 

B. Adding one new substance to 

paragraph (b) 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)).’’ 

* * * * * 

(b) * * * 

Acidified sodium chlorite— 

Secondary direct antimicrobial food 

treatment and indirect food contact 

surface sanitizing. Acidified with citric 

acid only. 

* * * * * 

4. Section 205.606 is amended by: 

A. Revising paragraph (p); 

B. Redesignating paragraphs (r) 

through (t) and paragraphs (u) through 

(y) as paragraphs (s) through (u) and (w) 

through (aa) respectively; and 

C. Adding new paragraphs (r) and (v) 

to read as follows: 

§ 205.606 Nonorganically produced 

agricultural products allowed as ingredients 

in or on processed products labeled as 

‘‘organic.’’ 

* * * * * 

(p) Lecithin—de-oiled. 

* * * * * 

(r) Orange pulp, dried. 

* * * * * 

(v) Seaweed, Pacific kombu. 

* * * * * 

Dated: November 2, 2010. 

David R. Shipman, 

Acting Administrator. 

[FR Doc. 2010–28042 Filed 11–5–10; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 924 

[Doc. No. AMS–FV–10–0053; FV10–924–1 

PR] 

Fresh Prunes Grown in Designated 

Counties in Washington and in 

Umatilla County, OR; Termination of 

Marketing Order 924 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This rule invites comments 

on the proposed termination of the 

Federal marketing order regulating the 

handling of fresh prunes grown in 

designated counties in Washington and 

in Umatilla County, Oregon, and the 

rules and regulations issued thereunder. 

Marketing Order No. 924 is 

administered locally by the WashingtonOregon Fresh Prune Marketing 

Committee (Committee), which 

unanimously recommended termination 

of the marketing order at a meeting held 

on June 1, 2010. This recommendation 

is based on the Committee’s 

determination that this order is no 

longer an effective marketing tool for the 

fresh prune industry, and that 

termination would best serve the 

current needs of the industry while also 

eliminating the costs associated with the 

operation of the marketing order. 

DATES: Comments must be received by 

January 7, 2011. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this proposal. Comments 

must be sent to the Docket Clerk, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; Fax: (202) 720–8938; or 

Internet: http://www.regulations.gov. All 

comments should reference the 

document number and the date and 

page number of this issue of the Federal 

Register and will be made available for 

public inspection in the Office of the 

Docket Clerk during regular business 

hours, or can be viewed at: http:// 

www.regulations.gov. All comments 

submitted in response to this rule will 

be included in the record and will be 

made available to the public. Please be 

advised that the identity of the 

individuals or entities submitting the 

comments will be made public on the 

Internet at the address provided above. 

FOR FURTHER INFORMATION CONTACT: 

Martin Engeler, Marketing Order 

Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA, 2202 

Monterey Street, Suite 102–B, Fresno, 

California 93721, Telephone: (559) 487– 

5110, Fax: (559) 487–5906, or E-mail: 

Martin.Engeler@ams.usda.gov; or Robert 

Curry, Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1220 SW Third Avenue, 

Suite 385, Portland, Oregon 97068, 

Telephone: (503) 326–2724, Fax: (503) 

326–7440, or E-mail: 

Robert.Curry@ams.usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Antoinette 

Carter, Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; telephone: (202) 720– 

2491, Fax: (202) 720–8938, or E-mail: 

Antoinette.Carter@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed rule is governed by 

§ 608c(16)(A) of the Agricultural 

Marketing Agreement Act of 1937, as 

amended (7 U.S.C. 601–674), hereinafter 

referred to as the ‘‘Act’’, and § 924.64 of 

Marketing Agreement and Order No. 

924, both as amended (7 CFR part 924), 

effective under the Act and hereinafter 

referred to as the ‘‘order’’. 

The Department of Agriculture 

(USDA) is issuing this rule in 

conformance with Executive Order 

12866. 

This proposal to terminate the order 

has been reviewed under Executive 

Order 12988, Civil Justice Reform. This 

rule is not intended to have retroactive 

effect. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 


emcdonald on DSK2BSOYB1PROD with PROPOSALS