[Federal Register Volume 75, Number 58 (Friday, March 26, 2010)]
[Proposed Rules]
[Pages 14500-14509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6683]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

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

[[Page 14500]]



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

[[Page 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 Sec.  
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 Sec.  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 Sec.  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, soap-based; 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, horticultural-narrow 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;

[[Page 14502]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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 
Sec.  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 (low-methoxy); 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 Sec.  
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, soap-based; 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, horticultural-narrow 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

[[Page 14503]]

and minerals; Ozone; Pectin (low-methoxy); 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.

[[Page 14504]]

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.

------------------------------------------------------------------------
                                                    Then the recommended
   If the currently listed     And is a (an) . . .   alternative should
 substance is used in . . .                            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       --Another currently
                               substance             listed synthetic
                               (pesticidal).         substance; or
                                                    --Nonsynthetic
                                                     substance.
Handling....................  Synthetic substance.  --Another currently
                                                     listed synthetic
                                                     substance;
                                                    --Nonsynthetic (non-
                                                     ag) substance; or
                                                    --Management
                                                     practice.
Handling....................  Nonsynthetic (non-    --Agricultural
                               ag) substance.        substance; or
                                                    --Management
                                                     practice.
Handling....................  Nonorganic            --Organic
                               agricultural          agricultural
                               product.              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

[[Page 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

[[Page 14506]]

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.

[[Page 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, Sec. Sec.  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.


[[Page 14508]]


    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
------------------------------------------------------------------------
                                                          Documentation
                                                         (TAP; petition;
     Question          Yes          No        N/A \1\      regulatory
                                                         agency; other)
------------------------------------------------------------------------
        Category 1. Adverse impacts on humans or the environment?
------------------------------------------------------------------------
1. Are there       ...........  ..........  ..........  ................
 adverse effects
 on environment
 from
 manufacture,
 use, or
 disposal? [Sec.
  205.600 b.2]
2. Is there        ...........  ..........  ..........  ................
 environmental
 contamination
 during
 manufacture,
 use, misuse, or
 disposal? [Sec.
  6518 m.3]
3. Is the          ...........  ..........  ..........  ................
 substance
 harmful to the
 environment?
 [Sec.   6517
 c(1)(A)(i);
 6517(c)(2)(A)i]
4. Does the        ...........  ..........  ..........  ................
 substance
 contain List 1,
 2, or 3 inerts?
 [Sec.   6517
 c(1)(B)(ii);
 205.601(m)2]
5. Is there        ...........  ..........  ..........  ................
 potential for
 detrimental
 chemical
 interaction with
 other materials
 used? [Sec.
 6518 m.1]
6. Are there       ...........  ..........  ..........  ................
 adverse
 biological and
 chemical
 interactions in
 agro-ecosystem?
 [Sec.   6518
 m.5]
7. Are there       ...........  ..........  ..........  ................
 detrimental
 physiological
 effects on soil
 organisms,
 crops, or
 livestock? [Sec.
   6518 m.5]
8. Is there a      ...........  ..........  ..........  ................
 toxic or other
 adverse action
 of the material
 or its breakdown
 products? [Sec.
  6518 m.2]
9. Is there        ...........  ..........  ..........  ................
 undesirable
 persistence or
 concentration of
 the material or
 breakdown
 products in
 environment?
 [Sec.   6518
 m.2]
10. Is there any   ...........  ..........  ..........  ................
 harmful effect
 on human health?
 [Sec.   6517
 c(1)(A)(i); 6517
 c(2)(A)i; Sec.
 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? [Sec.
   205.600 b.5]
13. Does the       ...........  ..........  ..........  ................
 substance
 contain residues
 of heavy metals
 or other
 contaminants in
 excess of FDA
 tolerances?
 [Sec.   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? [Sec.
   205.600 b.1]
5. Is there an     ...........  ..........  ..........  ................
 organic
 substitute?
 [Sec.   205.600
 b.1]
6. Is the          ...........  ..........  ..........  ................
 substance
 essential for
 handling of
 organically
 produced
 agricultural
 products? [Sec.
  205.600 b.6]
7. Is there a      ...........  ..........  ..........  ................
 wholly natural
 substitute
 product? [Sec.
 6517 c
 (1)(A)(ii)]
8. Is the          ...........  ..........  ..........  ................
 substance used
 in handling, not
 synthetic, but
 not organically
 produced? [Sec.
  6517
 c(1)(B)(iii)]
9. Is there any    ...........  ..........  ..........  ................
 alternative
 substances?
 [Sec.   6518
 m.6]
10. Is there       ...........  ..........  ..........  ................
 another practice
 that would make
 the substance
 unnecessary?
 [Sec.   6518
 m.6]
------------------------------------------------------------------------
     Category 3. Is the substance compatible with organic production
                               practices?
------------------------------------------------------------------------
1. Is the          ...........  ..........  ..........  ................
 substance
 compatible with
 organic
 handling? [Sec.
  205.600 b.2]

[[Page 14509]]

 
2. Is the          ...........  ..........  ..........  ................
 substance
 consistent with
 organic farming
 and handling?
 [Sec.   6517
 c(1)(A)(iii);
 6517
 c(2)(A)(ii)]
3. Is the          ...........  ..........  ..........  ................
 substance
 compatible with
 a system of
 sustainable
 agriculture?
 [Sec.   6518
 m.7]
4. Is the          ...........  ..........  ..........  ................
 nutritional
 quality of the
 food maintained
 with the
 substance? [Sec.
   205.600 b.3]
5. Is the primary  ...........  ..........  ..........  ................
 use as a
 preservative?
 [Sec.   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,
     horticultura
     l oils, fish
     emulsions,
     treated
     seed,
     vitamins and
     minerals?
    d. livestock   ...........  ..........  ..........  ................
     parasiticide
     s 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? [Sec.   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?
------------------------------------------------------------------------
\1\If 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