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