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

14500 

Vol. 75, No. 58 

Friday, March 26, 2010 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Doc. No. AMS–NOP–09–0074; NOP–09–01] 

RIN 0581–AC96 

National Organic Program, Sunset 

Review (2012) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Advance notice of proposed 

rulemaking with request for comments. 

SUMMARY: Sunset of the exempted or 

prohibited use of substances under the 

National Organic Program (NOP) is 

required by the Organic Foods 

Production Act of 1990 (OFPA). The 

exemptions and prohibitions granted 

under the OFPA are required to be 

reviewed every 5 years by the National 

Organic Standards Board (NOSB). The 

Secretary of Agriculture has authority 

under the OFPA to renew such 

exemptions and prohibitions. If they are 

not reviewed by the NOSB and renewed 

by the Secretary within 5 years of their 

inclusion on the National List, their 

authorized use or prohibition expires. 

This advance notice of proposed 

rulemaking (ANPR) announces the 

sunset of 37 exempted substances added 

to the National List for use in organic 

handling on June 27, 2007; the sunset of 

183 continued exemptions (use) and 

prohibitions of substances used in 

organic production and handling added 

to the list on October 21, 2007; the 

sunset of 2 exemptions of one substance 

for continued use in organic crop and 

livestock production added to the 

national list on December 11, 2007; and 

the sunset of 10 exempted substances 

for use in organic livestock production 

added to the national list on December 

13, 2007. This ANPR establishes June 

27, 2012, October 21, 2012, December 

11, 2012, and December 13, 2012, as the 

respective dates by which the sunset 

review and renewal process must be 

concluded. The NOP may try to 

conclude the sunset and renewal 

process for the 232 combined exempted 

and prohibited substances used in 

organic production and handling added 

to the National List in 2007 by the 

earliest respective date of June 27, 2012. 

This ANPR also begins the public 

comment process on whether the 

identified existing exemptions and 

prohibitions should be continued. 

Finally, this ANPR discusses how the 

NOP will manage the sunset review and 

renewal process. 

DATES: Comments must be submitted on 

or before May 25, 2010. 

ADDRESSES: Interested persons may 

submit written comments on this ANPR 

using the following addresses: 

• Mail: Comments may be sent by 

mail to: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–NOP, 1400 

Independence Ave., SW., Room 2624- 

So., Ag Stop 0268, Washington, DC 

20250–0268. 

• Internet: http:// 

www.regulations.gov. 

Written comments responding to this 

ANPR should be identified with the 

docket number AMS–NOP–09–0074; 

NOP–09–01. You should clearly 

indicate your position on continuing the 

allowance or prohibition of the 

substances identified in this ANPR and 

the reasons for your position. You 

should include relevant information and 

data to support your position (e.g., 

scientific, environmental, 

manufacturing, industry impact 

information, etc.). You should also 

supply information on alternative 

substances or alternative management 

practices, where applicable, that 

support a change from the current 

exemption of the substance. Only the 

supporting material relevant to your 

position will be considered. 

It is our intention to have all 

comments concerning this ANPR, 

including names and addresses when 

provided, whether submitted by mail or 

Internet, available for viewing on the 

Regulations.gov (http:// 

www.regulations.gov) internet site. 

Comments submitted in response to this 

ANPR 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 

ANPR are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Shannon H. Nally, Acting Director, 

Standards Division, National Organic 

Program, USDA–AMS–NOP, 1400 

Independence Ave., SW., Room 2646- 

So., Ag Stop 0268, Washington, DC 

20250–0268. Telephone: (202) 720– 

3252. 

SUPPLEMENTARY INFORMATION: 

Background 

The OFPA, 7 U.S.C. 6501 et seq., 

authorizes the establishment of the 

National List of exempted and 

prohibited substances. The National List 

identifies synthetic substances 

(synthetics) that are exempted (allowed) 

and nonsynthetic substances 

(nonsynthetics) that are prohibited in 

organic crop and livestock production. 

The National List also identifies 

nonsynthetics and synthetics that are 

exempted for use in organic handling. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary of Agriculture 

has authority under the OFPA to renew 

such exemptions and prohibitions. If 

they are not reviewed by the NOSB and 

renewed by the Secretary within 5 years 

of their inclusion on the National List, 

their authorized use or prohibition 

expires. 

The NOSB will review the continued 

exemption (use) of 37 agricultural 

products not commercially available as 

organic that are scheduled to expire 

after June 27, 2012. These products are 

allowed for use in organic handling in 

or on processed products based on final 

commercial availability determinations 

by accredited certifying agents. The 

NOSB will review the continued 

exemption (use) and prohibition of 183 

substance listings used in organic 

production and handling scheduled to 

expire after October 21, 2012. The 

NOSB will review the continued 

exemption (use) of 2 listings for one 

substance for use in organic crop and 

livestock production scheduled to 

expire after December 11, 2012. The 

NOSB will review the continued 

exemption (use) of 10 substances for use 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 14501 

in organic livestock production 

scheduled to expire after December 13, 

2012. Additionally, the NOP may try to 

conclude the sunset and renewal 

process for the 231 combined exempted 

and prohibited substances used in 

organic production and handling added 

to the National List in 2007 by the 

earliest respective date of June 27, 2012. 

June 27, 2012 Sunset Materials 

The Handling Committee will review 

the continued exemption (use) of the 

nonorganically produced agricultural 

products allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

in § 205.606 depending on final 

commercial availability determinations 

performed by accredited certifying 

agents scheduled to expire after June 27, 

2012. They are as follows: Annatto 

extract color (pigment CAS #1393–63– 

1)—water and oil soluble; Beet juice 

extract color (pigment CAS #7659–95– 

2); Beta-Carotene extract color from 

carrots (CAS #1393–63–1); Black currant 

juice color (pigment CAS #’s: 528–58–5, 

528–53–0, 643–84–5, 134–01–0, 1429– 

30–7, and 134–04–3); Black/Purple 

carrot juice color (pigment CAS #’s: 

528–58–5, 528–53–0, 643–84–5, 134– 

01–0, 1429–30–7, and 134–04–3); 

Blueberry juice color (pigment CAS #’s: 

528–58–5, 528–53–0, 643–84–5, 134– 

01–0, 1429–30–7, and 134–04–3); Carrot 

juice color (pigment CAS #1393–63–1); 

Cherry juice color (pigment CAS #’s: 

528–58–5, 528–53–0, 643–84–5, 134– 

01–0, 1429–30–7, and 134–04–3); 

Chokeberry—Aronia juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Elderberry juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Grape juice color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3); Grape skin extract color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3); Paprika color—dried powder and 

vegetable oil extract (CAS #68917–78– 

2); Pumpkin juice color (pigment CAS 

#127–40–2); Purple potato juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Red cabbage extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Red radish extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Saffron extract color 

(pigment CAS #1393–63–1), and 

Turmeric extract color (CAS #458–37– 

7). 

The following are allowed as 

ingredients or processing aids from 

agricultural products per § 205.606: 

Casings, from processed intestines; 

Celery powder; Chia (Salvia hispanica 

L.); Dillweed oil (CAS #8006–75–5); 

Fish oil (Fatty acid CAS #’s: 10417–94– 

4, and 25167–62–8); 

Fructooligosaccharides (CAS #308066– 

66–2); Galangal, frozen; Gelatin (CAS 

#9000–70–8); Hops (Humulus lupulus); 

Inulin, oligofructose enriched (CAS 

#9005–80–5); Konjac flour (CAS 

#37220–17–0); Lemongrass, frozen; 

Orange shellac, unbleached (CAS 

#9000–59–3); Pepper, chipotle chile; 

Sweet potato starch, for bean thread 

production only; Turkish bay leaves; 

Wakame seaweed (Undaria pinnatifida); 

and Whey protein concentrate. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary of Agriculture 

has authority under the OFPA to renew 

such exemptions and prohibitions. If 

they are not reviewed by the NOSB and 

renewed by the Secretary within 5 years 

of their inclusion on the National List, 

their authorized use or prohibition 

expires. 

This means that the following color 

ingredients from agricultural products: 

Annatto extract color (pigment CAS 

#1393–63–1)—water and oil soluble; 

Beet juice extract color (pigment CAS 

#7659–95–2); Beta-Carotene extract 

color from carrots (CAS #1393–63–1); 

Black currant juice color (pigment CAS 

#’s: 528–58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 134–04–3); 

Black/Purple carrot juice color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3); Blueberry juice color (pigment CAS 

#’s: 528–58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 134–04–3); 

Carrot juice color (pigment CAS #1393– 

63–1); Cherry juice color (pigment CAS 

#’s: 528–58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 134–04–3); 

Chokeberry—Aronia juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Elderberry juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Grape juice color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3); Grape skin extract color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3); Paprika color—dried powder and 

vegetable oil extract (CAS #68917–78– 

2); Pumpkin juice color (pigment CAS 

#127–40–2); Purple potato juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Red cabbage extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Red radish extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3); Saffron extract color 

(pigment CAS #1393–63–1), and 

Turmeric extract color (CAS #458–37– 

7), currently allowed for use in organic 

handling, will no longer be allowed for 

use after June 27, 2012. 

This also means that the following 

ingredients or processing aids from 

nonorganic agricultural products: 

Casings, from processed intestines; 

Celery powder; Chia (Salvia hispanica 

L.); Dillweed oil (CAS #8006–75–5); 

Fish oil (Fatty acid CAS #’s: 10417–94– 

4, and 25167–62–8); 

Fructooligosaccharides (CAS #308066– 

66–2); Galangal, frozen; Gelatin (CAS 

#9000–70–8); Hops (Humulus lupulus); 

Inulin, oligofructose enriched (CAS 

#9005–80–5); Konjac flour (CAS 

#37220–17–0); Lemongrass, frozen; 

Orange shellac, unbleached (CAS 

#9000–59–3); Pepper, chipotle chile; 

Sweet potato starch, for bean thread 

production only; Turkish bay leaves; 

Wakame seaweed (Undaria pinnatifida); 

and Whey protein concentrate, currently 

allowed for use in organic handling, 

will no longer be allowed for use after 

June 27, 2012. 

October 21, 2012 Sunset Materials 

The Crops Committee will review the 

continued exemption (use) of the 

following synthetic substances allowed 

for use in § 205.601 that are scheduled 

to expire after October 21, 2012, from 

use in organic crop production: Ethanol; 

Isopropanol; Calcium hypochlorite; 

Chlorine dioxide; Sodium hypochlorite; 

Hydrogen peroxide; Soap-based 

algicide/demossers; Herbicides, soapbased; Newspaper or other recycled 

paper, without glossy or colored inks (2 

uses); Plastic mulch and covers; Soaps, 

ammonium; Ammonium carbonate; 

Boric acid; Elemental sulfur (3 uses); 

Lime sulfur (2 uses); Oils, horticulturalnarrow range oils as dormant, 

suffocating, and summer oils (2 uses); 

Soaps, insecticidal; Sticky traps/ 

barriers; Pheromones; Sulfur dioxide; 

Vitamin D3; Copper hydroxide; Copper 

oxide; Copper oxychloride; Copper 

sulfate (2 uses); Hydrated lime; 

Hydrogen peroxide; Potassium 

bicarbonate; Streptomycin; Aquatic 

plant extracts (other than hydrolyzed); 

Humic acids; Lignin sulfonate (2 uses); 

Magnesium sulfate; Soluble boron 

products; Sulfates, carbonates, oxides, 

or silicates of zinc, copper, iron, 

manganese, molybdenum, selenium, 

and cobalt; Liquid fish products; 

Vitamin B1; Vitamin C; Vitamin E; 


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14502 Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 

Ethylene gas; Sodium silicate; and EPA 

List 4–Inerts of Minimal Concern. 

The Crops Committee will review the 

continued prohibition of the following 

nonsynthetic substances in § 205.602 

which are scheduled to expire and be 

allowed for use after October 21, 2012, 

in organic crop production: Ash from 

manure burning; Arsenic; Lead salts; 

Potassium chloride; Sodium 

fluoaluminate (mined); Sodium nitrate; 

Strychnine; and Tobacco dust (nicotine 

sulfate). 

The Livestock Committee will review 

the continued exemption (use) of the 

following synthetic substances allowed 

for use in organic livestock production 

in § 205.603 that are scheduled to expire 

after October 21, 2012: Ethanol; 

Isopropanol; Aspirin; Vaccines; 

Chlorhexidine; Calcium hypochlorite; 

Chlorine dioxide; Sodium hypochlorite; 

Electrolytes; Glucose; Glycerine; 

Hydrogen peroxide; Iodine (2 uses); 

Magnesium sulfate; Oxytocin; 

Ivermectin; Phosphoric acid; Copper 

sulfate; Lidocaine; Lime, hydrated; 

Mineral oil; Procaine; Trace minerals; 

Vitamins; and EPA List 4—Inerts of 

Minimal Concern. 

The Livestock Committee will also 

review the continued prohibition of the 

following nonsynthetic substance in 

§ 205.604 which is scheduled to expire 

and be allowed for use after October 21, 

2012, in organic livestock production: 

Strychnine. 

The Handling Committee will review 

the continued exemption (use) of the 

following nonagricultural (nonorganic) 

substances allowed as ingredients in or 

on processed products labeled as 

‘‘organic’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’ 

currently scheduled for expiration after 

October 21, 2012 from § 205.605 as (a) 

Nonsynthetics allowed: Acids (Alginic; 

Citric; and Lactic); Bentonite; Calcium 

carbonate; Calcium chloride; Dairy 

cultures; Diatomaceous earth; Enzymes; 

Flavors; Kaolin; Magnesium sulfate; 

Nitrogen; Oxygen; Perlite; Potassium 

chloride; Potassium iodide; Sodium 

bicarbonate; Sodium carbonate; Waxes; 

Yeast (Autolysate; Bakers; Brewers; 

Nutritional; and Smoked). 

The Handling Committee will review 

the continued exemption (use) of the 

following nonagricultural (nonorganic) 

substances allowed as ingredients in or 

on processed products labeled as 

‘‘organic’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’ 

currently scheduled for expiration after 

October 21, 2012, listed on § 205.605 as 

(b) Synthetics allowed: Alginates; 

Ammonium bicarbonate; Ammonium 

carbonate; Ascorbic acid; Calcium 

citrate; Calcium hydroxide; Calcium 

phosphates (monobasic, dibasic, and 

tribasic); Carbon dioxide; Chlorine 

materials (Calcium hypochlorite; 

Chlorine dioxide; and Sodium 

hypochlorite); Ethylene; Ferrous sulfate; 

Glycerides (mono and di); Glycerin; 

Hydrogen peroxide; Magnesium 

carbonate; Magnesium chloride; 

Magnesium stearate; Nutrient vitamins 

and minerals; Ozone; Pectin (lowmethoxy); Phosphoric acid; Potassium 

acid tartrate; Potassium carbonate; 

Potassium citrate; Potassium hydroxide; 

Potassium iodide; Potassium phosphate; 

Silicon dioxide; Sodium citrate; Sodium 

hydroxide; Sodium phosphates; Sulfur 

dioxide; Tocopherols; and Xanthan 

gum. 

The Handling Committee will review 

the continued exemption (use) of the 

nonorganically produced agricultural 

products allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

in § 205.606 depending on final 

commercial availability determinations 

performed by accredited certifying 

agents that are scheduled to expire after 

October 21, 2012. They are as follows: 

Cornstarch (native); Gums-water 

extracted only (Arabic, Guar, Locust 

bean, Carob bean); Kelp; and Pectin 

(high-methoxy). 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary of Agriculture 

has authority under the OFPA to renew 

such exemptions and prohibitions. If 

they are not reviewed by the NOSB and 

renewed by the Secretary within 5 years 

of their inclusion on the National List, 

their authorized use or prohibition 

expires. 

This means that the following 

synthetic substances: Ethanol; 

Isopropanol; Calcium hypochlorite; 

Chlorine dioxide; Sodium hypochlorite; 

Hydrogen peroxide (2 uses); Soap-based 

algicide/demossers; Herbicides, soapbased; Newspaper or other recycled 

paper, without glossy or colored inks (2 

uses); Plastic mulch and covers; Soaps, 

ammonium; Ammonium carbonate; 

Boric acid; Elemental sulfur (3 uses); 

Lime sulfur (2 uses); Oils, horticulturalnarrow range oils as dormant, 

suffocating, and summer oils (2 uses); 

Soaps, insecticidal; Sticky traps/ 

barriers; Pheromones; Sulfur dioxide; 

Vitamin D3; Copper hydroxide; Copper 

oxide; Copper oxychloride; Copper 

sulfate (2 uses); Hydrated lime; 

Hydrogen peroxide; Potassium 

bicarbonate; Streptomycin; Aquatic 

plant extracts (other than hydrolyzed); 

Humic acids; Lignin sulfonate (2 uses); 

Magnesium sulfate; Soluble boron 

products; Sulfates, carbonates, oxides, 

or silicates of zinc, copper, iron, 

manganese, molybdenum, selenium, 

and cobalt; Liquid fish products; 

Vitamin B1; Vitamin C; Vitamin E; 

Ethylene gas; Lignin sulfonate; Sodium 

silicate; and EPA List 4—Inerts of 

Minimal Concern; currently allowed for 

use in organic crop production, will no 

longer be allowed for use after October 

21, 2012. 

This also means that the following 

nonsynthetic substances: Ash from 

manure burning; Arsenic; Lead salts; 

Potassium chloride; Sodium 

fluoaluminate (mined); Sodium nitrate; 

Strychnine; and Tobacco dust (nicotine 

sulfate); currently prohibited from use 

in organic crop production, will be 

allowed for use after October 21, 2012. 

This means that the following 

synthetic substances: Ethanol; 

Isopropanol; Aspirin; Vaccines; 

Chlorhexidine; Calcium hypochlorite; 

Chlorine dioxide; Sodium hypochlorite; 

Electrolytes; Glucose; Glycerine; 

Hydrogen peroxide; Iodine (2 uses); 

Magnesium sulfate; Oxytocin; 

Ivermectin; Phosphoric acid; Copper 

sulfate; Lidocaine; Lime, hydrated; 

Mineral oil; Procaine; Trace minerals; 

Vitamins; and EPA List 4—Inerts of 

Minimal Concern; currently allowed for 

use in organic livestock production, will 

no longer be allowed for use after 

October 21, 2012. 

This also means that the following 

nonsynthetic substance: Strychnine; 

currently prohibited from use in organic 

livestock production, will be allowed 

for use after October 21, 2012. 

This means that the following 

nonagricultural (nonorganic) 

substances: Acids (Alginic; Citric; and 

Lactic); Bentonite; Calcium carbonate; 

Calcium chloride; Dairy cultures; 

Diatomaceous earth; Enzymes; Flavors; 

Kaolin; Magnesium sulfate; Nitrogen; 

Oxygen; Perlite; Potassium chloride; 

Potassium iodide; Sodium bicarbonate; 

Sodium carbonate; Waxes; Yeast 

(Autolysate; Bakers; Brewers; 

Nutritional; and Smoked); currently 

allowed for use in organic handling, 

will no longer be allowed for use after 

October 21, 2012. 

This means that the following 

synthetic substances: Alginates; 

Ammonium bicarbonate; Ammonium 

carbonate; Ascorbic acid; Calcium 

citrate; Calcium hydroxide; Calcium 

phosphates (monobasic, dibasic, and 

tribasic); Carbon dioxide; Chlorine 

materials (Calcium hypochlorite; 

Chlorine dioxide; and Sodium 

hypochlorite); Ethylene; Ferrous sulfate; 

Glycerides (mono and di); Glycerin; 

Hydrogen peroxide; Magnesium 

carbonate; Magnesium chloride; 

Magnesium stearate; Nutrient vitamins 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 14503 

and minerals; Ozone; Pectin (lowmethoxy); Phosphoric acid; Potassium 

acid tartrate; Potassium carbonate; 

Potassium citrate; Potassium hydroxide; 

Potassium iodide; Potassium phosphate; 

Silicon dioxide; Sodium citrate; Sodium 

hydroxide; Sodium phosphates; Sulfur 

dioxide; Tocopherols; and Xanthan 

gum; currently allowed for use in 

organic handling, will no longer be 

allowed for use after October 21, 2012. 

This also means that the following 

ingredients or processing aids from 

nonorganic agricultural products: 

Cornstarch (native); Gums-water 

extracted only (Arabic, Guar, Locust 

bean, Carob bean); Kelp; and Pectin 

(high-methoxy); currently allowed for 

use in organic handling, will no longer 

be allowed for use after October 21, 

2012. 

December 11, 2012 Sunset Materials 

The Crops Committee will review the 

continued exemption (use) of the 

following synthetic substance allowed 

for use in organic crop production in 

§ 205.601 that is scheduled to expire 

after December 11, 2012: Sucrose 

octanoate esters. The Livestock 

Committee will review the continued 

use of the following synthetic substance 

allowed for use in organic livestock 

production in § 205.603 that is 

scheduled to expire after December 11, 

2012: Sucrose octanoate esters. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary of Agriculture 

has authority under the OFPA to renew 

such exemptions and prohibitions. If 

they are not reviewed by the NOSB and 

renewed by the Secretary within 5 years 

of their inclusion on the National List, 

their authorized use or prohibition 

expires. 

This means that the following listings 

of the synthetic substance: Sucrose 

octanoate esters (2 uses); currently 

allowed for use in organic crop and 

livestock production, will no longer be 

allowed for use after December 11, 2012. 

December 13, 2012 Sunset Materials 

The Livestock Committee will review 

the continued exemptions (use) of the 

following synthetic substances for use 

in organic livestock production in 

§ 205.603 that are scheduled to expire 

after December 13, 2012: Atropine (CAS 

#–51–55–8); Butorphanol (CAS #– 

42408–82–2); Flunixin (CAS #–38677– 

85–9); Furosemide (CAS #–54–31–9); 

Magnesium hydroxide (CAS #–1309– 

42–8); Peroxyacetic/Peracetic acid (CAS 

#–79–21–0); Poloxalene (CAS #–9003– 

11–6); Tolazoline (CAS #–59–98–3); 

Xylazine (CAS #–7361–61–7); and 

Excipients. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the NOSB. 

The Secretary of Agriculture has 

authority under the OFPA to renew 

such exemptions and prohibitions. If 

they are not reviewed by the NOSB and 

renewed by the Secretary within 5 years 

of their inclusion on the National List, 

their authorized use or prohibition 

expires. 

This means that the following 

synthetic substances: Atropine (CAS #– 

51–55–8); Butorphanol (CAS #–42408– 

82–2); Flunixin (CAS #–38677–85–9); 

Furosemide (CAS #–54–31–9); 

Magnesium hydroxide (CAS #–1309– 

42–8); Peroxyacetic/Peracetic acid (CAS 

#–79–21–0); Poloxalene (CAS #–9003– 

11–6); Tolazoline (CAS #–59–98–3); 

Xylazine (CAS #–7361–61–7); and 

Excipients; currently allowed for use in 

organic livestock production, will no 

longer be allowed for use after 

December 13, 2012. 

Expiration of the exempted or 

prohibited use of substances is provided 

for under the OFPA’s sunset provision. 

This ANPR announces the sunset of 37 

exempted substances added to the 

National List for use in organic handling 

on June 27, 2007; the sunset of 183 

continued exemptions (use) and 

prohibitions of substances used in 

organic production and handling added 

to the list on October 21, 2007; the 

sunset of two exemptions of one 

substance for use in organic crop and 

livestock production added to the 

national list on December 11, 2007; and 

the sunset of 10 exempted substances 

for use in organic livestock production 

added to the national list on December 

13, 2007. This ANPR establishes June 

27, 2012, October 21, 2012, December 

11, 2012, and December 13, 2012, as the 

respective dates by which the sunset 

review and renewal process must be 

concluded. Additionally, the NOP may 

try to conclude the sunset and renewal 

process for the 232 combined exempted 

and prohibited listings used in organic 

production and handling added to the 

National List in 2007 by the earliest 

respective date of June 27, 2012. The 

exemptions and prohibitions not 

renewed by their respective dates will 

be removed from the National List. This 

ANPR also begins the public comment 

process on whether the existing specific 

exemptions on the National List should 

be continued. This ANPR discusses how 

the NOP will manage the sunset review 

and renewal process. 

Because these substances may be 

critical to the production and handling 

of a wide array of raw and processed 

organic agricultural products, their 

expiration could cause disruption of 

well-established and accepted organic 

production, handling, and processing 

systems. Therefore, the NOP is initiating 

the sunset review and renewal process 

now, in order to provide ample 

opportunity for the public to make their 

views known and to inform the 

decisions of the NOSB. 

The Sunset Process 

As the first step in this process, we 

invite public comment on the specific 

exemptions currently on the National 

List that are described in this document. 

All substances currently on the National 

List have been previously evaluated and 

determined by the NOSB for 

consistency with OFPA and its 

implementing regulations. According to 

§ 6517(e) of the OFPA, these substances 

must be reviewed by the NOSB and 

renewed by the Secretary for their use 

to continue after 5 years of their 

addition to the National List which will 

be June 27, 2012, October 21, 2012, 

December 11, 2012, and December 13, 

2012, respectively. The NOP may try to 

conclude the sunset and renewal 

process for the 232 combined exempted 

and prohibited listings used in organic 

production and handling added to the 

National List in 2007 by the earliest 

respective date of June 27, 2012. Public 

comments submitted will be considered 

in the review and renewal process. 

The NOP will forward comments 

received under this ANPR to the NOSB 

for review. The NOSB will review the 

exemptions and prohibitions of the 

listings designated to sunset, including 

the public comments received during 

this review. The NOSB will review each 

of the substances listed in this ANPR 

and may determine that certain 

substances warrant a more in-depth 

review and require additional 

information or research that considers 

new scientific data and technological 

and market advances. 

Following the NOSB’s review, the 

NOSB will make a recommendation to 

the Secretary about the continuation of 

specific exemptions and prohibitions for 

the substances listed in this ANPR. 

After the Secretary receives and reviews 

the NOSB’s recommendations, the NOP 

will publish a proposed rule regarding 

the NOSB recommendations. This 

proposed rule will provide an 

additional opportunity for the public to 

express their views. Comments received 

on the proposed rule will be used to 

develop a final rule. Because the sunset 

review and renewal process involves 

rulemaking, the NOP believes it is 

appropriate to initiate the process now. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
14504 Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 

Guidance on Submitting Your 

Comments 

If you provide comments that support 

the renewal of any or all existing 

exemptions and/or prohibitions 

included within this ANPR, you should 

clearly indicate this and provide your 

reasons and any relevant documentation 

that supports your position. 

Comments That Support Existing 

Exemptions and Prohibitions 

Comments in support of a continued 

exemption of a substance should 

demonstrate that the substance is: (1) 

Not harmful to human health or the 

environment, (2) necessary to the 

production of the agricultural products 

because of the unavailability of wholly 

nonsynthetic substitute products, and 

(3) consistent with organic farming and 

handling. Comments in support of a 

continued prohibition should explain 

how the use of the substance would 

continue to be: (1) Harmful to human 

health or the environment, or (2) 

inconsistent with organic farming and 

handling. 

Comments That DO NOT Support 

Continuing Existing Exemptions or 

Prohibitions 

If you provide comments that do not 

support continuing an existing 

exemption and/or prohibition, you 

should provide reasons why the use of 

the substance should no longer be 

allowed/prohibited in organic 

agricultural production and handling. 

Specifically, comments that support the 

removal of a substance from the 

National List should provide 

information to demonstrate that the 

substance is: (1) Harmful to human 

health or the environment; (2) 

unnecessary because of the availability 

of alternatives; or (3) inconsistent with 

organic farming or handling. Comments 

that do not support a continued 

prohibition should explain how the use 

of the substance would not be: (1) 

Harmful to human health or the 

environment, or (2) inconsistent with 

organic farming and handling. 

The current exemptions were 

originally recommended by the NOSB 

based on evidence available to the 

NOSB at the time of review which 

demonstrated that the substances were 

found to be: (1) Not harmful to human 

health or the environment, (2) necessary 

because of the unavailability of wholly 

nonsynthetic alternatives, and (3) 

consistent and compatible with organic 

practices. Therefore, comments against 

the continued exemption or supporting 

the continued prohibition of a substance 

should demonstrate how the current 

substance is: (1) Harmful to human 

health or the environment, (2) not 

necessary to the production of the 

agricultural products because of the 

availability of wholly nonsynthetic 

substitute products, or (3) inconsistent 

with organic farming and handling. 

All Comments 

An Appendix to this ANPR contains 

worksheets to assist you in gathering 

relevant information concerning these 

issues. These worksheets are not 

required to submit a comment. These 

worksheets are used by the NOSB to 

develop their recommendations to the 

Secretary to include an exempted 

substance on the National List. You do 

not have to answer the questions on the 

worksheets; they are intended only to 

help you provide substantive comments 

to the NOSB when you provide 

comments on the specific substance. 

Comments, regardless of whether they 

support or do not support the continued 

use of a substance(s) listed within this 

ANPR, should provide evidence 

concerning the viability of alternatives 

for the substance you believe should be 

discontinued or renewed. Viable 

alternatives include, but are not limited 

to: Alternative management practices 

that would eliminate the need for the 

specific substance; other currently 

exempted substances that are on the 

National List which could eliminate the 

need for this specific substance; and 

other organic or nonorganic agricultural 

substances. Such evidence should 

adequately address whether any 

alternatives have a function and effect 

that equals or surpasses the specific 

exempted substance, whether that you 

want the substance to be renewed or do 

not want its use to be continued. 

Assertions about an alternative 

substance except for those alternatives 

that already appear on the National List 

should, if possible include the name 

and address of the manufacturer of the 

alternative. Further, your comments 

should include a copy or the specific 

source of any supportive literature, 

which could include product or practice 

descriptions; performance and test data; 

reference standards; name and address 

of producers who have used the 

alternative under similar conditions and 

the date of use; and an itemized 

comparison of the function and effect of 

the proposed alternative(s) with 

substance under review. The chart 

below can help you describe 

recommended alternatives for different 

types of organic operations in place of 

a current exempted substance that you 

do not want to be continued. 

If the currently listed substance is used in . . . And is a (an) . . . Then the recommended alternative should be 

a (an) . . . 

Crop or Livestock Production ............................. Synthetic substance ......................................... —Another currently listed synthetic substance; 

—Nonsynthetic substance; or 

—Management practice. 

Crop or Livestock Production ............................. Synthetic inert substance (pesticidal) .............. —Another currently listed synthetic substance; 

or 

—Nonsynthetic substance. 

Handling ............................................................. Synthetic substance ......................................... —Another currently listed synthetic substance; 

—Nonsynthetic (non-ag) substance; or 

—Management practice. 

Handling ............................................................. Nonsynthetic (non-ag) substance .................... —Agricultural substance; or 

—Management practice. 

Handling ............................................................. Nonorganic agricultural product ....................... —Organic agricultural product. 

The NOP understands that supportive 

technical or scientific information for 

synthetic alternatives not currently on 

the National List may not be easily 

available to organic producers and 

handlers. Such information may, 

however, be available from the research 

community including universities, or 

other sources, including international 

organic programs. 

Request for Comments 

The NOP requests that you comment 

whether the NOSB should continue to 

recommend the following exemptions 

and prohibitions on the National List of 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 14505 

Allowed and Prohibited Substances for 

organic agricultural production and 

handling. Comments must be submitted 

on or before May 25, 2010. 

Synthetic substances allowed for use 

in organic crop production. 

As algicide, disinfectants, and 

sanitizer, including irrigation system 

cleaning systems. 

Alcohols. 

(1) Ethanol. 

(2) Isopropanol. 

Chlorine materials— Except, That, 

residual chlorine levels in the water 

shall not exceed the maximum residual 

disinfectant limit under the Safe 

Drinking Water Act. 

(3) Calcium hypochlorite. 

(4) Chlorine dioxide. 

(5) Sodium hypochlorite. 

(6) Hydrogen peroxide. 

(7) Soap-based algicide/demossers. 

As herbicides, weed barriers, as 

applicable. 

(8) Herbicides, soap-based—for use in 

farmstead maintenance (roadways, 

ditches, rights of way, building 

perimeters) and ornamental crops. 

Mulches. 

(9) Newspaper or other recycled 

paper, without glossy or colored inks. 

(10) Plastic mulch and covers 

(petroleum-based other than polyvinyl 

chloride (PVC)). 

As compost feedstocks. 

(11) Newspapers or other recycled 

paper, without glossy or colored inks. 

As animal repellents. 

(12) Soaps, ammonium—for use as a 

large animal repellant only, no contact 

with soil or edible portion of crop. 

As insecticides (including acaricides 

or mite control). 

(13) Ammonium carbonate—for use as 

bait in insect traps only, no direct 

contact with crop or soil. 

(14) Boric acid—structural pest 

control, no direct contact with organic 

food or crops. 

(15) Elemental sulfur. 

(16) Lime sulfur—including calcium 

polysulfide. 

(17) Oils, horticultural—narrow range 

oils as dormant, suffocating, and 

summer oils. 

(18) Soaps, insecticidal. 

(19) Sticky traps/barriers. 

(20) Sucrose octanoate esters 

(CAS #s–42944–74–7; 58064–47–4)—in 

accordance with approved labeling. 

As insect management. 

(21) Pheromones. 

As rodenticides. 

(22) Sulfur dioxide—underground 

rodent control only (smoke bombs). 

(23) Vitamin D3. 

As plant disease control. 

Coppers, fixed 

(24) copper hydroxide 

(25) copper oxide 

(26) copper oxychloride 

(27) Copper sulfate—Substance must 

be used in a manner that minimizes 

accumulation of copper in the soil. 

(28) Hydrated lime. 

(29) Hydrogen peroxide. 

(30) Lime sulfur. 

(31) Oils, horticultural, narrow range 

oils as dormant, suffocating, and 

summer oils. 

(32) Potassium bicarbonate. 

(33) Elemental sulfur. 

(34) Streptomycin, for fire blight 

control in apples and pears only. 

As plant or soil amendments. 

(35) Aquatic plant extracts (other than 

hydrolyzed)—Extraction process is 

limited to the use of potassium 

hydroxide or sodium hydroxide; solvent 

amount used is limited to that amount 

necessary for extraction. 

(36) Elemental sulfur. 

(37) Humic acids—naturally occurring 

deposits, water and alkali extracts only. 

(38) Lignin sulfonate—chelating 

agent, dust suppressant, flotation agent. 

(39) Magnesium sulfate—allowed 

with a documented soil deficiency. 

Micronutrients—not to be used as a 

defoliant, herbicide, or desiccant. Those 

made from nitrates or chlorides are not 

allowed. Soil deficiency must be 

documented by testing. 

(40) Soluble boron products. 

(41) Sulfates of zinc 

(42) Sulfates of copper 

(43) Sulfates of iron 

(44) Sulfates of manganese 

(45) Sulfates of molybdenum 

(46) Sulfates of selenium 

(47) Sulfates of cobalt 

(48) Carbonates of zinc 

(49) Carbonates of copper 

(50) Carbonates of iron 

(51) Carbonates of manganese 

(52) Carbonates of molybdenum 

(53) Carbonates of selenium 

(54) Carbonates of cobalt 

(55) Oxides of zinc 

(56) Oxides of copper 

(57) Oxides of iron 

(58) Oxides of manganese 

(59) Oxides of molybdenum 

(60) Oxides of selemium 

(61) Oxides of cobalt 

(62) Silicates of zinc 

(63) Silicates of copper 

(64) Silicates of iron 

(65) Silicates of manganese 

(66) Silicates of molybdenum 

(67) Silicates of selenium 

(68) Silicates of cobalt. 

(69) Liquid fish products—can be pH 

adjusted with sulfuric, citric or 

phosphoric acid. The amount of acid 

used shall not exceed the minimum 

needed to lower the pH to 3.5. 

(70) Vitamin B1

(71) Vitamin C 

(72) Vitamin E 

As plant growth regulators. 

(73) Ethylene gas—for regulation of 

pineapple flowering. 

As floating agents in postharvest 

handling. 

(74) Lignin sulfonate. 

(75) Sodium silicate—for tree fruit 

and fiber processing. 

As synthetic inert ingredients as 

classified by the Environmental 

Protection Agency (EPA), for use with 

nonsynthetic substances or synthetic 

substances listed in this section and 

used as an active pesticide ingredient in 

accordance with any limitations on the 

use of such substances. 

(76) EPA List 4—Inerts of Minimal 

Concern. 

Nonsynthetic substances prohibited 

for use in organic crop production. 

(77) Ash from manure burning. 

(78) Arsenic. 

(79) Lead salts. 

(80) Potassium chloride—unless 

derived from a mined source and 

applied in a manner that minimizes 

chloride accumulation in the soil. 

(81) Sodium fluoaluminate (mined). 

(82) Sodium nitrate—unless use is 

restricted to no more than 20% of the 

crop’s total nitrogen requirement. 

(83) Strychnine. 

(84) Tobacco dust (nicotine sulfate). 

Synthetic substances allowed for use 

in organic livestock production. 

As disinfectants, sanitizer, and 

medical treatments as applicable. 

Alcohols. 

(85) Ethanol-disinfectant and sanitizer 

only, prohibited as a feed additive. 

(86) Isopropanol-disinfectant only. 

(87) Aspirin-approved for health care 

use to reduce inflammation. 

(88) Atropine (CAS #–51–55–8)— 

federal law restricts this drug to use by 

or on the lawful written or oral order of 

a licensed veterinarian, in full 

compliance with the AMDUCA and 21 

CFR part 530 of the Food and Drug 

Administration regulations. Also, for 

use under 7 CFR part 205, the NOP 

requires: (i) Use by or on the lawful 

written order of a licensed veterinarian; 

and (ii) A meat withdrawal period of at 

least 56 days after administering to 

livestock intended for slaughter; and a 

milk discard period of at least 12 days 

after administering to dairy animals. 

Biologics. 

(89) Vaccines. 

(90) Butorphanol (CAS #–42408–82– 

2)—federal law restricts this drug to use 

by or on the lawful written or oral order 

of a licensed veterinarian, in full 

compliance with the AMDUCA and 21 

CFR part 530 of the Food and Drug 

Administration regulations. Also, for 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
14506 Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 

use under 7 CFR part 205, the NOP 

requires: (i) Use by or on the lawful 

written order of a licensed veterinarian; 

and (ii) A meat withdrawal period of at 

least 42 days after administering to 

livestock intended for slaughter; and a 

milk discard period of at least 8 days 

after administering to dairy animals. 

(91) Chlorhexidine—Allowed for 

surgical procedures conducted by a 

veterinarian. Allowed for use as a teat 

dip when alternative germicidal agents 

and/or physical barriers have lost their 

effectiveness. 

Chlorine materials—disinfecting and 

sanitizing facilities and equipment. 

Residual chlorine levels in the water 

shall not exceed the maximum residual 

disinfectant limit under the Safe 

Drinking Water Act. 

(92) Calcium hypochlorite. 

(93) Chlorine dioxide. 

(94) Sodium hypochlorite. 

(95) Electrolytes—without antibiotics. 

(96) Flunixin (CAS #–38677–85–9)— 

in accordance with approved labeling; 

except that for use under 7 CFR part 

205, the NOP requires a withdrawal 

period of at least two-times that 

required by the FDA. 

(97) Furosemide (CAS #–54–31–9)— 

in accordance with approved labeling; 

except that for use under 7 CFR part 

205, the NOP requires a withdrawal 

period of at least two-times that 

required that required by the FDA. 

(98) Glucose. 

(99) Glycerine—Allowed as a 

livestock teat dip, must be produced 

through the hydrolysis of fats or oils. 

(100) Hydrogen peroxide. 

(101) Iodine. 

(102) Magnesium hydroxide (CAS #– 

1309–42–8)—federal law restricts this 

drug to use by or on the lawful written 

or oral order of a licensed veterinarian, 

in full compliance with the AMDUCA 

and 21 CFR part 530 of the Food and 

Drug Administration regulations. Also, 

for use under 7 CFR part 205, the NOP 

requires use by or on the lawful written 

order of a licensed veterinarian. 

(103) Magnesium sulfate. 

(104) Oxytocin—use in 

postparturition therapeutic applications. 

Paraciticides. 

(105) Ivermectin—prohibited in 

slaughter stock, allowed in emergency 

treatment for dairy and breeder stock 

when organic system plan-approved 

preventive management does not 

prevent infestation. Milk or milk 

products from a treated animal cannot 

be labeled as provided for in subpart D 

of this part for 90 days following 

treatment. In breeder stock, treatment 

cannot occur during the last third of 

gestation if the progeny will be sold as 

organic and must not be used during the 

lactation period for breeding stock. 

(106) Peroxyacetic/peracetic acid 

(CAS #–79–21–0)—for sanitizing facility 

and processing equipment. 

(107) Phosphoric acid—allowed as an 

equipment cleaner, Provided, That, no 

direct contact with organically managed 

livestock or land occurs. 

(108) Poloxalene (CAS #–9003–11– 

6)—for use under 7 CFR Part 205, the 

NOP requires that poloxalene only be 

used for the emergency treatment of 

bloat. 

(109) Tolazoline (CAS #–59–98–3)— 

federal law restricts this drug to use by 

or on the lawful written or oral order of 

a licensed veterinarian, in full 

compliance with the AMDUCA and 21 

CFR part 530 of the Food and Drug 

Administration regulations. Also, for 

use under 7 CFR part 205, the NOP 

requires: (i) Use by or on the lawful 

written order of a licensed veterinarian; 

(ii) Use only to reverse the effects of 

sedation and analgesia caused by 

Xylazine; and (iii) A meat withdrawal 

period of at least 8 days after 

administering to livestock intended for 

slaughter; and a milk discard period of 

at least 4 days after administering to 

dairy animals. 

(110) Xylazine (CAS #–7361–61–7)— 

federal law restricts this drug to use by 

or on the lawful written or oral order of 

a licensed veterinarian, in full 

compliance with the AMDUCA and 21 

CFR part 530 of the Food and Drug 

Administration regulations. Also, for 

use under 7 CFR Part 205, the NOP 

requires: (i) Use by or on the lawful 

written order of a licensed veterinarian; 

(ii) The existence of an emergency; and 

(iii) A meat withdrawal period of at 

least 8 days after administering to 

livestock intended for slaughter; and a 

milk discard period of at least 4 days 

after administering to dairy animals. As 

topical treatment, external parasiticide 

or local anesthetic as applicable. 

(111) Copper sulfate. 

(112) Iodine. 

(113) Lidocaine—as a local anesthetic. 

Use requires a withdrawal period of 90 

days after administering to livestock 

intended for slaughter and 7 days after 

administering to dairy animals. 

(114) Lime, hydrated—as an external 

pest control, not permitted to cauterize 

physical alterations or deodorize animal 

wastes. 

(115) Mineral oil—for topical use and 

as a lubricant. 

(116) Procaine—as a local anesthetic, 

use requires a withdrawal period of 90 

days after administering to livestock 

intended for slaughter and 7 days after 

administering to dairy animals. 

(117) Sucrose octanoate esters (CAS 

#s–42922–74–2; 58064–47–4)—in 

accordance with approved labeling. 

As feed additives. 

(118) Trace minerals, used for 

enrichment or fortification when FDA 

approved. 

(119) Vitamins, used for enrichment 

or fortification when FDA approved. 

As synthetic inert ingredients as 

classified by the Environmental 

Protection Agency (EPA), for use with 

nonsynthetic substances or synthetic 

substances listed in this section and 

used as an active pesticide ingredient in 

accordance with any limitations on the 

use of such substances. 

(120) EPA List 4—Inerts of Minimal 

Concern. 

(121) Excipients, only for use in the 

manufacture of drugs used to treat 

organic livestock when the excipient is: 

Identified by the FDA as Generally 

Recognized As Safe; Approved by the 

FDA as a food additive; or Included in 

the FDA review and approval of a New 

Animal Drug Application or New Drug 

Application. 

Nonsynthetic substances prohibited 

for use in organic livestock production. 

(122) Strychnine. 

Nonagricultural (nonorganic) 

substances allowed as ingredients in or 

on processed products labeled as 

‘‘organic’’ or ‘‘made with organic 

(specified ingredients or food group(s)).’’ 

Nonsynthetics allowed: 

(123) Alginic acid. 

(124) Citric acid—produced by 

microbial fermentation of carbohydrate 

substances. 

(125) Lactic acid. 

(126) Bentonite. 

(127) Calcium carbonate. 

(128) Calcium chloride. 

(129) Dairy cultures. 

(130) Diatomaceous earth—food 

filtering aid only. 

(131) Enzymes—must be derived from 

edible, nontoxic plants, nonpathogenic 

fungi, or nonpathogenic bacteria. 

(132) Flavors, nonsynthetic sources 

only and must not be produced using 

synthetic solvents and carrier systems or 

any artificial preservative. 

(133) Kaolin. 

(134) Magnesium sulfate, 

nonsynthetic sources only. 

(135) Nitrogen—oil-free grades. 

(136) Oxygen—oil-free grades. 

(137) Perlite—for use only as a filter 

aid in food processing. 

(138) Potassium chloride. 

(139) Potassium iodide. 

(140) Sodium bicarbonate. 

(141) Sodium carbonate. 

(142) Carnauba wax—nonsynthetic. 

(143) Wood resin wax—nonsynthetic. 

Yeast—nonsynthetic, growth on 

petrochemical substrate and sulfite 

waste liquor is prohibited. 

(144) Autolysate. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 14507 

(145) Bakers. 

(146) Brewers. 

(147) Nutritional. 

(148) Smoked—nonsynthetic smoke 

flavoring process must be documented. 

Synthetics allowed: 

(149) Alginates. 

(150) Ammonium bicarbonate—for 

use only as a leavening agent. 

(151) Ammonium carbonate—for use 

only as a leavening agent. 

(152) Ascorbic acid. 

(153) Calcium citrate. 

(154) Calcium hydroxide. 

(155) Calcium phosphates monobasic. 

(156) Calcium phosphates dibasic. 

(157) Calcium phosphates tribasic. 

(158) Carbon dioxide. 

Chlorine materials—disinfecting and 

sanitizing food contact surfaces, Except, 

That, residual chlorine levels in the 

water shall not exceed the maximum 

residual disinfectant limit under the 

Safe Drinking Water Act. 

(159) Calcium hypochlorite. 

(160) Chlorine dioxide. 

(161) Sodium hypochlorite. 

(162) Ethylene—allowed for 

postharvest ripening of tropical fruit 

and degreening of citrus. 

(163) Ferrous sulfate—for iron 

enrichment or fortification of foods 

when required by regulation or 

recommended (independent 

organization). 

(164) Monoglycerides—for use only in 

drum drying of food. 

(165) Diglycerides—for use only in 

drum drying of food. 

(166) Glycerin—produced by 

hydrolysis of fats and oils. 

(167) Hydrogen peroxide. 

(168) Magnesium carbonate—for use 

only in agricultural products labeled 

‘‘made with organic (specified 

ingredients or food group(s)),’’ 

prohibited in agricultural products 

labeled ‘‘organic’’. 

(169) Magnesium chloride—derived 

from sea water. 

(170) Magnesium stearate—for use 

only in agricultural products labeled 

‘‘made with organic (specified 

ingredients or food group(s)),’’ 

prohibited in agricultural products 

labeled ‘‘organic’’. 

(171) Nutrient vitamins in accordance 

with 21 CFR 104.20, Nutritional Quality 

Guidelines For Foods. 

(172) Nutrient minerals in accordance 

with 21 CFR 104.20, Nutritional Quality 

Guidelines For Foods. 

(173) Ozone. 

(174) Pectin (low-methoxy). 

(175) Phosphoric acid—cleaning of 

food-contact surfaces and equipment 

only. 

(176) Potassium acid tartrate. 

(177) Potassium carbonate. 

(178) Potassium citrate. 

(179) Potassium hydroxide— 

prohibited for use in lye peeling of fruits 

and vegetables except when used for 

peeling peaches during the Individually 

Quick Frozen (IQF) production process. 

(180) Potassium iodide—for use only 

in agricultural products labeled ‘‘made 

with organic (specified ingredients or 

food group(s)),’’ prohibited in 

agricultural products labeled ‘‘organic’’. 

(181) Potassium phosphate—for use 

only in agricultural products labeled 

‘‘made with organic (specific ingredients 

or food group(s)),’’ prohibited in 

agricultural products labeled ‘‘organic’’. 

(182) Silicon dioxide. 

(183) Sodium citrate. 

(184) Sodium hydroxide—prohibited 

for use in lye peeling of fruits and 

vegetables. 

(185) Sodium phosphates—for use 

only in dairy foods. 

(186) Sulfur dioxide—for use only in 

wine labeled ‘‘made with organic 

grapes,’’ Provided, That, total sulfite 

concentration does not exceed 100 ppm. 

(187) Tocopherols—derived from 

vegetable oil when rosemary extracts are 

not a suitable alternative. 

(188) Xanthan gum. 

Nonorganically produced agricultural 

products allowed as ingredients in or on 

processed products labeled as ‘‘organic.’’ 

(189) Casings, from processed 

intestines. 

(190) Celery powder. 

(191) Chia (Salvia hispanica L.). 

Colors derived from agricultural 

products— 

(192) Annatto extract color (pigment 

CAS #1393–63–1)—water and oil 

soluble. 

(193) Beet juice extract color (pigment 

CAS #7659–95–2). 

(194) Beta-carotene extract color, 

derived from carrots (CAS #1393–63–1). 

(195) Black currant juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3). 

(196) Black/Purple carrot juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3). 

(197) Blueberry juice color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3). 

(198) Carrot juice color (pigment CAS 

#1393–63–1). 

(199) Cherry juice color (pigment CAS 

#’s: 528–58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 134–04–3). 

(200) Chokeberry—Aronia juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3). 

(201) Elderberry juice color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3). 

(202) Grape juice color (pigment CAS 

#’s: 528–58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 134–04–3). 

(203) Grape skin extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3). 

(204) Paprika color (CAS #68917–78– 

2)—dried, and oil extracted. 

(205) Pumpkin juice color (pigment 

CAS #127–40–2). 

(206) Purple potato juice (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3). 

(207) Red cabbage extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3). 

(208) Red radish extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3). 

(209) Saffron extract color (pigment 

CAS #1393–63–1). 

(210) Turmeric extract color (CAS 

#458–37–7). 

(211) Dillweed oil (CAS #8006–75–5). 

(212) Fish oil (Fatty acid CAS #’s: 

10417–94–4, and 25167–62–8)— 

stabilized with organic ingredients or 

only with ingredients on the National 

List, §§ 205.605 and 205.606. 

(213) Fructooligosaccharides (CAS 

#308066–66–2). 

(214) Galangal, frozen. 

(215) Gelatin (CAS #9000–70–8). 

Gums—water extracted only. 

(216) Arabic. 

(217) Guar. 

(218) Locust bean. 

(219) Carob bean. 

(220) Hops (Humulus luplus). 

(221) Inulin-oligofructose enriched 

(CAS #9005–80–5). 

(222) Kelp—for use only as a 

thickener and dietary supplement. 

(223) Konjac flour (CAS #7220–17–0). 

(224) Lemongrass—frozen. 

(225) Orange shellac-unbleached 

(CAS #9000–59–3). 

(226) Pectin (high-methoxy). 

(227) Peppers (Chipotle chile). 

Starches. 

(228) Cornstarch (native). 

(229) Sweet potato starch—for bean 

thread production only. 

(230) Turkish bay leaves. 

(231) Wakame seaweed (Undaria 

pinnatifida). 

(232) Whey protein concentrate. 

Authority: 7 U.S.C. 6501–6522 et seq. and 

7 CFR part 205. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
14508 Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 

Dated: March 22, 2010. 

Rayne Pegg, 

Administrator, Agricultural Marketing 

Service. 

Appendix 

This Appendix contains worksheets 

to assist you in gathering relevant 

information concerning the 

compatibility of substances with 

evaluation criteria of the OFPA. These 

worksheets are not required to submit a 

comment. These worksheets are used by 

the NOSB to develop their 

recommendations to the Secretary to 

include an exempted or prohibited 

substance on the National List. You do 

not have to answer the questions on the 

worksheets; they are intended only to 

help you provide substantive comments 

to the NOSB when you provide 

comments on the specific substance. 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

Category 1. Adverse impacts on humans or the environment? 

1. Are there adverse effects on environment from 

manufacture, use, or disposal? [§ 205.600 b.2] 

2. Is there environmental contamination during manufacture, use, misuse, or disposal? [§ 6518 m.3] 

3. Is the substance harmful to the environment? 

[§ 6517 c(1)(A)(i); 6517(c)(2)(A)i] 

4. Does the substance contain List 1, 2, or 3 inerts? 

[§ 6517 c(1)(B)(ii); 205.601(m)2] 

5. Is there potential for detrimental chemical interaction with other materials used? [§ 6518 m.1] 

6. Are there adverse biological and chemical interactions in agro-ecosystem? [§ 6518 m.5] 

7. Are there detrimental physiological effects on soil 

organisms, crops, or livestock? [§ 6518 m.5] 

8. Is there a toxic or other adverse action of the material or its breakdown products? [§ 6518 m.2] 

9. Is there undesirable persistence or concentration of 

the material or breakdown products in environment? 

[§ 6518 m.2] 

10. Is there any harmful effect on human health? 

[§ 6517 c(1)(A)(i); 6517 c(2)(A)i; § 6518 m.4] 

11. Is there an adverse effect on human health as defined by applicable Federal regulations? [205.600 

b.3] 

12. Is the substance GRAS when used according to 

FDA’s good manufacturing practices? [§ 205.600 

b.5] 

13. Does the substance contain residues of heavy 

metals or other contaminants in excess of FDA tolerances? [§ 205.600 b.5] 

Category 2. Is the Substance Essential for Organic Production? 

1. Is the substance formulated or manufactured by a 

chemical process? [6502 (21)] 

2. Is the substance formulated or manufactured by a 

process that chemically changes a substance extracted from naturally occurring plant, animal, or 

mineral, sources? [6502 (21)] 

3. Is the substance created by naturally occurring biological processes? [6502 (21)] 

4. Is there a natural source of the substance? 

[§ 205.600 b.1] 

5. Is there an organic substitute? [§ 205.600 b.1] 

6. Is the substance essential for handling of organically produced agricultural products? [§ 205.600 b.6] 

7. Is there a wholly natural substitute product? [§ 6517 

c (1)(A)(ii)] 

8. Is the substance used in handling, not synthetic, 

but not organically produced? [§ 6517 c(1)(B)(iii)] 

9. Is there any alternative substances? [§ 6518 m.6] 

10. Is there another practice that would make the substance unnecessary? [§ 6518 m.6] 

Category 3. Is the substance compatible with organic production practices? 

1. Is the substance compatible with organic handling? 

[§ 205.600 b.2] 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules 14509 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST—Continued 

Question Yes No N/A1 Documentation 

(TAP; petition; regulatory agency; other) 

2. Is the substance consistent with organic farming 

and handling? [§ 6517 c(1)(A)(iii); 6517 c(2)(A)(ii)] 

3. Is the substance compatible with a system of sustainable agriculture? [§ 6518 m.7] 

4. Is the nutritional quality of the food maintained with 

the substance? [§ 205.600 b.3] 

5. Is the primary use as a preservative? [§ 205.600 

b.4] 

6. Is the primary use to recreate or improve flavors, 

colors, textures, or nutritive values lost in processing (except when required by law, e.g., vitamin 

D in milk)? [205.600 b.4] 

7. Is the substance used in production, and does it 

contain an active synthetic ingredient in the following categories: 

a. copper and sulfur compounds; 

b. toxins derived from bacteria; 

c. pheromones, soaps, horticultural oils, fish 

emulsions, treated seed, vitamins and minerals? 

d. livestock parasiticides and medicines? 

e. production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleaners? 

Question Yes No N/A Comments on information provided (sufficient, 

plausible, reasonable, thorough, complete, unknown) 

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially unavailable? [§ 6610, 6518, 6519, 

205.2, 205.105 (d), 205.600 (c), 205.2, 205.105 (d), 205.600 (c)] 

1. Is the comparative description provided as to why 

the non-organic form of the material/substance is 

necessary for use in organic handling? 

2. Does the current and historical industry information, 

research, or evidence provided explain how or why 

the material/substance cannot be obtained organically in the appropriate form to fulfill an essential 

function in a system of organic handling? 

3. Does the current and historical industry information, 

research, or evidence provided explain how or why 

the material/substance cannot be obtained organically in the appropriate quality to fulfill an essential 

function in a system of organic handling? 

4. Does the current and historical industry information, 

research, or evidence provided explain how or why 

the material/substance cannot be obtained organically in the appropriate quantity to fulfill an essential 

function in a system of organic handling? 

5. Does the industry information provided on material/ 

substance non-availability as organic, include ( but 

not limited to) the following: 

a. Regions of production (including factors such 

as climate and number of regions); 

b. Number of suppliers and amount produced; 

c. Current and historical supplies related to 

weather events such as hurricanes, floods, and 

droughts that may temporarily halt production 

or destroy crops or supplies; 

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil unrest that 

may temporarily restrict supplies; or 

e. Are there other issues which may present a 

challenge to a consistent supply? 

1If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

[FR Doc. 2010–6683 Filed 3–25–10; 8:45 am] 

BILLING CODE P 


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