National Organic Program, Sunset Review (2012), 14500-14509 [2010-6683]
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14500
Proposed Rules
Federal Register
Vol. 75, No. 58
Friday, March 26, 2010
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.
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)
emcdonald on DSK2BSOYB1PROD with PROPOSALS
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
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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 2624So., Ag Stop 0268, Washington, DC
20250–0268.
• Internet: https://
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 (https://
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
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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 2646So., 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
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Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules
emcdonald on DSK2BSOYB1PROD with PROPOSALS
in organic livestock production
scheduled to expire after December 13,
2012. Additionally, the NOP may try to
conclude the sunset and renewal
process for the 231 combined exempted
and prohibited substances used in
organic production and handling added
to the National List in 2007 by the
earliest respective date of June 27, 2012.
June 27, 2012 Sunset Materials
The Handling Committee will review
the continued exemption (use) of the
nonorganically produced agricultural
products allowed as ingredients in or on
processed products labeled as ‘‘organic’’
in § 205.606 depending on final
commercial availability determinations
performed by accredited certifying
agents scheduled to expire after June 27,
2012. They are as follows: Annatto
extract color (pigment CAS #1393–63–
1)—water and oil soluble; Beet juice
extract color (pigment CAS #7659–95–
2); Beta-Carotene extract color from
carrots (CAS #1393–63–1); Black currant
juice color (pigment CAS #’s: 528–58–5,
528–53–0, 643–84–5, 134–01–0, 1429–
30–7, and 134–04–3); Black/Purple
carrot juice color (pigment CAS #’s:
528–58–5, 528–53–0, 643–84–5, 134–
01–0, 1429–30–7, and 134–04–3);
Blueberry juice color (pigment CAS #’s:
528–58–5, 528–53–0, 643–84–5, 134–
01–0, 1429–30–7, and 134–04–3); Carrot
juice color (pigment CAS #1393–63–1);
Cherry juice color (pigment CAS #’s:
528–58–5, 528–53–0, 643–84–5, 134–
01–0, 1429–30–7, and 134–04–3);
Chokeberry—Aronia juice color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Elderberry juice color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Grape juice color (pigment
CAS #’s: 528–58–5, 528–53–0, 643–84–
5, 134–01–0, 1429–30–7, and 134–04–
3); Grape skin extract color (pigment
CAS #’s: 528–58–5, 528–53–0, 643–84–
5, 134–01–0, 1429–30–7, and 134–04–
3); Paprika color—dried powder and
vegetable oil extract (CAS #68917–78–
2); Pumpkin juice color (pigment CAS
#127–40–2); Purple potato juice color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Red cabbage extract color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Red radish extract color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Saffron extract color
(pigment CAS #1393–63–1), and
Turmeric extract color (CAS #458–37–
7).
The following are allowed as
ingredients or processing aids from
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agricultural products per § 205.606:
Casings, from processed intestines;
Celery powder; Chia (Salvia hispanica
L.); Dillweed oil (CAS #8006–75–5);
Fish oil (Fatty acid CAS #’s: 10417–94–
4, and 25167–62–8);
Fructooligosaccharides (CAS #308066–
66–2); Galangal, frozen; Gelatin (CAS
#9000–70–8); Hops (Humulus lupulus);
Inulin, oligofructose enriched (CAS
#9005–80–5); Konjac flour (CAS
#37220–17–0); Lemongrass, frozen;
Orange shellac, unbleached (CAS
#9000–59–3); Pepper, chipotle chile;
Sweet potato starch, for bean thread
production only; Turkish bay leaves;
Wakame seaweed (Undaria pinnatifida);
and Whey protein concentrate.
The exemptions and prohibitions
granted under the OFPA are required to
be reviewed every 5 years by the
National Organic Standards Board
(NOSB). The Secretary of Agriculture
has authority under the OFPA to renew
such exemptions and prohibitions. If
they are not reviewed by the NOSB and
renewed by the Secretary within 5 years
of their inclusion on the National List,
their authorized use or prohibition
expires.
This means that the following color
ingredients from agricultural products:
Annatto extract color (pigment CAS
#1393–63–1)—water and oil soluble;
Beet juice extract color (pigment CAS
#7659–95–2); Beta-Carotene extract
color from carrots (CAS #1393–63–1);
Black currant juice color (pigment CAS
#’s: 528–58–5, 528–53–0, 643–84–5,
134–01–0, 1429–30–7, and 134–04–3);
Black/Purple carrot juice color (pigment
CAS #’s: 528–58–5, 528–53–0, 643–84–
5, 134–01–0, 1429–30–7, and 134–04–
3); Blueberry juice color (pigment CAS
#’s: 528–58–5, 528–53–0, 643–84–5,
134–01–0, 1429–30–7, and 134–04–3);
Carrot juice color (pigment CAS #1393–
63–1); Cherry juice color (pigment CAS
#’s: 528–58–5, 528–53–0, 643–84–5,
134–01–0, 1429–30–7, and 134–04–3);
Chokeberry—Aronia juice color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Elderberry juice color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Grape juice color (pigment
CAS #’s: 528–58–5, 528–53–0, 643–84–
5, 134–01–0, 1429–30–7, and 134–04–
3); Grape skin extract color (pigment
CAS #’s: 528–58–5, 528–53–0, 643–84–
5, 134–01–0, 1429–30–7, and 134–04–
3); Paprika color—dried powder and
vegetable oil extract (CAS #68917–78–
2); Pumpkin juice color (pigment CAS
#127–40–2); Purple potato juice color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Red cabbage extract color
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14501
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Red radish extract color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3); Saffron extract color
(pigment CAS #1393–63–1), and
Turmeric extract color (CAS #458–37–
7), currently allowed for use in organic
handling, will no longer be allowed for
use after June 27, 2012.
This also means that the following
ingredients or processing aids from
nonorganic agricultural products:
Casings, from processed intestines;
Celery powder; Chia (Salvia hispanica
L.); Dillweed oil (CAS #8006–75–5);
Fish oil (Fatty acid CAS #’s: 10417–94–
4, and 25167–62–8);
Fructooligosaccharides (CAS #308066–
66–2); Galangal, frozen; Gelatin (CAS
#9000–70–8); Hops (Humulus lupulus);
Inulin, oligofructose enriched (CAS
#9005–80–5); Konjac flour (CAS
#37220–17–0); Lemongrass, frozen;
Orange shellac, unbleached (CAS
#9000–59–3); Pepper, chipotle chile;
Sweet potato starch, for bean thread
production only; Turkish bay leaves;
Wakame seaweed (Undaria pinnatifida);
and Whey protein concentrate, currently
allowed for use in organic handling,
will no longer be allowed for use after
June 27, 2012.
October 21, 2012 Sunset Materials
The Crops Committee will review the
continued exemption (use) of the
following synthetic substances allowed
for use in § 205.601 that are scheduled
to expire after October 21, 2012, from
use in organic crop production: Ethanol;
Isopropanol; Calcium hypochlorite;
Chlorine dioxide; Sodium hypochlorite;
Hydrogen peroxide; Soap-based
algicide/demossers; Herbicides, soapbased; Newspaper or other recycled
paper, without glossy or colored inks (2
uses); Plastic mulch and covers; Soaps,
ammonium; Ammonium carbonate;
Boric acid; Elemental sulfur (3 uses);
Lime sulfur (2 uses); Oils, horticulturalnarrow range oils as dormant,
suffocating, and summer oils (2 uses);
Soaps, insecticidal; Sticky traps/
barriers; Pheromones; Sulfur dioxide;
Vitamin D3; Copper hydroxide; Copper
oxide; Copper oxychloride; Copper
sulfate (2 uses); Hydrated lime;
Hydrogen peroxide; Potassium
bicarbonate; Streptomycin; Aquatic
plant extracts (other than hydrolyzed);
Humic acids; Lignin sulfonate (2 uses);
Magnesium sulfate; Soluble boron
products; Sulfates, carbonates, oxides,
or silicates of zinc, copper, iron,
manganese, molybdenum, selenium,
and cobalt; Liquid fish products;
Vitamin B1; Vitamin C; Vitamin E;
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Ethylene gas; Sodium silicate; and EPA
List 4–Inerts of Minimal Concern.
The Crops Committee will review the
continued prohibition of the following
nonsynthetic substances in § 205.602
which are scheduled to expire and be
allowed for use after October 21, 2012,
in organic crop production: Ash from
manure burning; Arsenic; Lead salts;
Potassium chloride; Sodium
fluoaluminate (mined); Sodium nitrate;
Strychnine; and Tobacco dust (nicotine
sulfate).
The Livestock Committee will review
the continued exemption (use) of the
following synthetic substances allowed
for use in organic livestock production
in § 205.603 that are scheduled to expire
after October 21, 2012: Ethanol;
Isopropanol; Aspirin; Vaccines;
Chlorhexidine; Calcium hypochlorite;
Chlorine dioxide; Sodium hypochlorite;
Electrolytes; Glucose; Glycerine;
Hydrogen peroxide; Iodine (2 uses);
Magnesium sulfate; Oxytocin;
Ivermectin; Phosphoric acid; Copper
sulfate; Lidocaine; Lime, hydrated;
Mineral oil; Procaine; Trace minerals;
Vitamins; and EPA List 4—Inerts of
Minimal Concern.
The Livestock Committee will also
review the continued prohibition of the
following nonsynthetic substance in
§ 205.604 which is scheduled to expire
and be allowed for use after October 21,
2012, in organic livestock production:
Strychnine.
The Handling Committee will review
the continued exemption (use) of the
following nonagricultural (nonorganic)
substances allowed as ingredients in or
on processed products labeled as
‘‘organic’’ or ‘‘made with organic
(specified ingredients or food group(s))’’
currently scheduled for expiration after
October 21, 2012 from § 205.605 as (a)
Nonsynthetics allowed: Acids (Alginic;
Citric; and Lactic); Bentonite; Calcium
carbonate; Calcium chloride; Dairy
cultures; Diatomaceous earth; Enzymes;
Flavors; Kaolin; Magnesium sulfate;
Nitrogen; Oxygen; Perlite; Potassium
chloride; Potassium iodide; Sodium
bicarbonate; Sodium carbonate; Waxes;
Yeast (Autolysate; Bakers; Brewers;
Nutritional; and Smoked).
The Handling Committee will review
the continued exemption (use) of the
following nonagricultural (nonorganic)
substances allowed as ingredients in or
on processed products labeled as
‘‘organic’’ or ‘‘made with organic
(specified ingredients or food group(s))’’
currently scheduled for expiration after
October 21, 2012, listed on § 205.605 as
(b) Synthetics allowed: Alginates;
Ammonium bicarbonate; Ammonium
carbonate; Ascorbic acid; Calcium
citrate; Calcium hydroxide; Calcium
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phosphates (monobasic, dibasic, and
tribasic); Carbon dioxide; Chlorine
materials (Calcium hypochlorite;
Chlorine dioxide; and Sodium
hypochlorite); Ethylene; Ferrous sulfate;
Glycerides (mono and di); Glycerin;
Hydrogen peroxide; Magnesium
carbonate; Magnesium chloride;
Magnesium stearate; Nutrient vitamins
and minerals; Ozone; Pectin (lowmethoxy); Phosphoric acid; Potassium
acid tartrate; Potassium carbonate;
Potassium citrate; Potassium hydroxide;
Potassium iodide; Potassium phosphate;
Silicon dioxide; Sodium citrate; Sodium
hydroxide; Sodium phosphates; Sulfur
dioxide; Tocopherols; and Xanthan
gum.
The Handling Committee will review
the continued exemption (use) of the
nonorganically produced agricultural
products allowed as ingredients in or on
processed products labeled as ‘‘organic’’
in § 205.606 depending on final
commercial availability determinations
performed by accredited certifying
agents that are scheduled to expire after
October 21, 2012. They are as follows:
Cornstarch (native); Gums-water
extracted only (Arabic, Guar, Locust
bean, Carob bean); Kelp; and Pectin
(high-methoxy).
The exemptions and prohibitions
granted under the OFPA are required to
be reviewed every 5 years by the
National Organic Standards Board
(NOSB). The Secretary of Agriculture
has authority under the OFPA to renew
such exemptions and prohibitions. If
they are not reviewed by the NOSB and
renewed by the Secretary within 5 years
of their inclusion on the National List,
their authorized use or prohibition
expires.
This means that the following
synthetic substances: Ethanol;
Isopropanol; Calcium hypochlorite;
Chlorine dioxide; Sodium hypochlorite;
Hydrogen peroxide (2 uses); Soap-based
algicide/demossers; Herbicides, soapbased; Newspaper or other recycled
paper, without glossy or colored inks (2
uses); Plastic mulch and covers; Soaps,
ammonium; Ammonium carbonate;
Boric acid; Elemental sulfur (3 uses);
Lime sulfur (2 uses); Oils, horticulturalnarrow range oils as dormant,
suffocating, and summer oils (2 uses);
Soaps, insecticidal; Sticky traps/
barriers; Pheromones; Sulfur dioxide;
Vitamin D3; Copper hydroxide; Copper
oxide; Copper oxychloride; Copper
sulfate (2 uses); Hydrated lime;
Hydrogen peroxide; Potassium
bicarbonate; Streptomycin; Aquatic
plant extracts (other than hydrolyzed);
Humic acids; Lignin sulfonate (2 uses);
Magnesium sulfate; Soluble boron
products; Sulfates, carbonates, oxides,
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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
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and minerals; Ozone; Pectin (lowmethoxy); Phosphoric acid; Potassium
acid tartrate; Potassium carbonate;
Potassium citrate; Potassium hydroxide;
Potassium iodide; Potassium phosphate;
Silicon dioxide; Sodium citrate; Sodium
hydroxide; Sodium phosphates; Sulfur
dioxide; Tocopherols; and Xanthan
gum; currently allowed for use in
organic handling, will no longer be
allowed for use after October 21, 2012.
This also means that the following
ingredients or processing aids from
nonorganic agricultural products:
Cornstarch (native); Gums-water
extracted only (Arabic, Guar, Locust
bean, Carob bean); Kelp; and Pectin
(high-methoxy); currently allowed for
use in organic handling, will no longer
be allowed for use after October 21,
2012.
emcdonald on DSK2BSOYB1PROD with PROPOSALS
December 11, 2012 Sunset Materials
The Crops Committee will review the
continued exemption (use) of the
following synthetic substance allowed
for use in organic crop production in
§ 205.601 that is scheduled to expire
after December 11, 2012: Sucrose
octanoate esters. The Livestock
Committee will review the continued
use of the following synthetic substance
allowed for use in organic livestock
production in § 205.603 that is
scheduled to expire after December 11,
2012: Sucrose octanoate esters.
The exemptions and prohibitions
granted under the OFPA are required to
be reviewed every 5 years by the
National Organic Standards Board
(NOSB). The Secretary of Agriculture
has authority under the OFPA to renew
such exemptions and prohibitions. If
they are not reviewed by the NOSB and
renewed by the Secretary within 5 years
of their inclusion on the National List,
their authorized use or prohibition
expires.
This means that the following listings
of the synthetic substance: Sucrose
octanoate esters (2 uses); currently
allowed for use in organic crop and
livestock production, will no longer be
allowed for use after December 11, 2012.
December 13, 2012 Sunset Materials
The Livestock Committee will review
the continued exemptions (use) of the
following synthetic substances for use
in organic livestock production in
§ 205.603 that are scheduled to expire
after December 13, 2012: Atropine (CAS
#–51–55–8); Butorphanol (CAS #–
42408–82–2); Flunixin (CAS #–38677–
85–9); Furosemide (CAS #–54–31–9);
Magnesium hydroxide (CAS #–1309–
42–8); Peroxyacetic/Peracetic acid (CAS
#–79–21–0); Poloxalene (CAS #–9003–
11–6); Tolazoline (CAS #–59–98–3);
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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
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organic agricultural products, their
expiration could cause disruption of
well-established and accepted organic
production, handling, and processing
systems. Therefore, the NOP is initiating
the sunset review and renewal process
now, in order to provide ample
opportunity for the public to make their
views known and to inform the
decisions of the NOSB.
The Sunset Process
As the first step in this process, we
invite public comment on the specific
exemptions currently on the National
List that are described in this document.
All substances currently on the National
List have been previously evaluated and
determined by the NOSB for
consistency with OFPA and its
implementing regulations. According to
§ 6517(e) of the OFPA, these substances
must be reviewed by the NOSB and
renewed by the Secretary for their use
to continue after 5 years of their
addition to the National List which will
be June 27, 2012, October 21, 2012,
December 11, 2012, and December 13,
2012, respectively. The NOP may try to
conclude the sunset and renewal
process for the 232 combined exempted
and prohibited listings used in organic
production and handling added to the
National List in 2007 by the earliest
respective date of June 27, 2012. Public
comments submitted will be considered
in the review and renewal process.
The NOP will forward comments
received under this ANPR to the NOSB
for review. The NOSB will review the
exemptions and prohibitions of the
listings designated to sunset, including
the public comments received during
this review. The NOSB will review each
of the substances listed in this ANPR
and may determine that certain
substances warrant a more in-depth
review and require additional
information or research that considers
new scientific data and technological
and market advances.
Following the NOSB’s review, the
NOSB will make a recommendation to
the Secretary about the continuation of
specific exemptions and prohibitions for
the substances listed in this ANPR.
After the Secretary receives and reviews
the NOSB’s recommendations, the NOP
will publish a proposed rule regarding
the NOSB recommendations. This
proposed rule will provide an
additional opportunity for the public to
express their views. Comments received
on the proposed rule will be used to
develop a final rule. Because the sunset
review and renewal process involves
rulemaking, the NOP believes it is
appropriate to initiate the process now.
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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.
And is a (an) . . .
Then the recommended alternative should be
a (an) . . .
Crop or Livestock Production .............................
Synthetic substance .........................................
Crop or Livestock Production .............................
Synthetic inert substance (pesticidal) ..............
Handling .............................................................
Synthetic substance .........................................
Handling .............................................................
emcdonald on DSK2BSOYB1PROD with PROPOSALS
If the currently listed substance is used in . . .
Nonsynthetic (non-ag) substance ....................
Handling .............................................................
Nonorganic agricultural product .......................
—Another currently listed synthetic substance;
—Nonsynthetic substance; or
—Management practice.
—Another currently listed synthetic substance;
or
—Nonsynthetic substance.
—Another currently listed synthetic substance;
—Nonsynthetic (non-ag) substance; or
—Management practice.
—Agricultural substance; or
—Management practice.
—Organic agricultural product.
The NOP understands that supportive
technical or scientific information for
synthetic alternatives not currently on
the National List may not be easily
available to organic producers and
handlers. Such information may,
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however, be available from the research
community including universities, or
other sources, including international
organic programs.
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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
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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
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(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
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14505
(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
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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.
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(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.
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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.
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(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.
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(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–
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5, 134–01–0, 1429–30–7, and 134–04–
3).
(202) Grape juice color (pigment CAS
#’s: 528–58–5, 528–53–0, 643–84–5,
134–01–0, 1429–30–7, and 134–04–3).
(203) Grape skin extract color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).
(204) Paprika color (CAS #68917–78–
2)—dried, and oil extracted.
(205) Pumpkin juice color (pigment
CAS #127–40–2).
(206) Purple potato juice (pigment
CAS #’s: 528–58–5, 528–53–0, 643–84–
5, 134–01–0, 1429–30–7, and 134–04–
3).
(207) Red cabbage extract color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).
(208) Red radish extract color
(pigment CAS #’s: 528–58–5, 528–53–0,
643–84–5, 134–01–0, 1429–30–7, and
134–04–3).
(209) Saffron extract color (pigment
CAS #1393–63–1).
(210) Turmeric extract color (CAS
#458–37–7).
(211) Dillweed oil (CAS #8006–75–5).
(212) Fish oil (Fatty acid CAS #’s:
10417–94–4, and 25167–62–8)—
stabilized with organic ingredients or
only with ingredients on the National
List, §§ 205.605 and 205.606.
(213) Fructooligosaccharides (CAS
#308066–66–2).
(214) Galangal, frozen.
(215) Gelatin (CAS #9000–70–8).
Gums—water extracted only.
(216) Arabic.
(217) Guar.
(218) Locust bean.
(219) Carob bean.
(220) Hops (Humulus luplus).
(221) Inulin-oligofructose enriched
(CAS #9005–80–5).
(222) Kelp—for use only as a
thickener and dietary supplement.
(223) Konjac flour (CAS #7220–17–0).
(224) Lemongrass—frozen.
(225) Orange shellac-unbleached
(CAS #9000–59–3).
(226) Pectin (high-methoxy).
(227) Peppers (Chipotle chile).
Starches.
(228) Cornstarch (native).
(229) Sweet potato starch—for bean
thread production only.
(230) Turkish bay leaves.
(231) Wakame seaweed (Undaria
pinnatifida).
(232) Whey protein concentrate.
Authority: 7 U.S.C. 6501–6522 et seq. and
7 CFR part 205.
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Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Proposed Rules
Dated: March 22, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing
Service.
Appendix
This Appendix contains worksheets
to assist you in gathering relevant
information concerning the
compatibility of substances with
evaluation criteria of the OFPA. These
worksheets are not required to submit a
comment. These worksheets are used by
the NOSB to develop their
recommendations to the Secretary to
include an exempted or prohibited
substance on the National List. You do
not have to answer the questions on the
worksheets; they are intended only to
help you provide substantive comments
to the NOSB when you provide
comments on the specific substance.
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST
Question
Yes
No
N/A 1
Documentation
(TAP; petition; regulatory agency; other)
Category 1. Adverse impacts on humans or the environment?
1. Are there adverse effects on environment from
manufacture, use, or disposal? [§ 205.600 b.2]
2. Is there environmental contamination during manufacture, use, misuse, or disposal? [§ 6518 m.3]
3. Is the substance harmful to the environment?
[§ 6517 c(1)(A)(i); 6517(c)(2)(A)i]
4. Does the substance contain List 1, 2, or 3 inerts?
[§ 6517 c(1)(B)(ii); 205.601(m)2]
5. Is there potential for detrimental chemical interaction with other materials used? [§ 6518 m.1]
6. Are there adverse biological and chemical interactions in agro-ecosystem? [§ 6518 m.5]
7. Are there detrimental physiological effects on soil
organisms, crops, or livestock? [§ 6518 m.5]
8. Is there a toxic or other adverse action of the material or its breakdown products? [§ 6518 m.2]
9. Is there undesirable persistence or concentration of
the material or breakdown products in environment?
[§ 6518 m.2]
10. Is there any harmful effect on human health?
[§ 6517 c(1)(A)(i); 6517 c(2)(A)i; § 6518 m.4]
11. Is there an adverse effect on human health as defined by applicable Federal regulations? [205.600
b.3]
12. Is the substance GRAS when used according to
FDA’s good manufacturing practices? [§ 205.600
b.5]
13. Does the substance contain residues of heavy
metals or other contaminants in excess of FDA tolerances? [§ 205.600 b.5]
emcdonald on DSK2BSOYB1PROD with PROPOSALS
Category 2. Is the Substance Essential for Organic Production?
1. Is the substance formulated or manufactured by a
chemical process? [6502 (21)]
2. Is the substance formulated or manufactured by a
process that chemically changes a substance extracted from naturally occurring plant, animal, or
mineral, sources? [6502 (21)]
3. Is the substance created by naturally occurring biological processes? [6502 (21)]
4. Is there a natural source of the substance?
[§ 205.600 b.1]
5. Is there an organic substitute? [§ 205.600 b.1]
6. Is the substance essential for handling of organically produced agricultural products? [§ 205.600 b.6]
7. Is there a wholly natural substitute product? [§ 6517
c (1)(A)(ii)]
8. Is the substance used in handling, not synthetic,
but not organically produced? [§ 6517 c(1)(B)(iii)]
9. Is there any alternative substances? [§ 6518 m.6]
10. Is there another practice that would make the substance unnecessary? [§ 6518 m.6]
Category 3. Is the substance compatible with organic production practices?
1. Is the substance compatible with organic handling?
[§ 205.600 b.2]
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14509
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST—Continued
Yes
No
N/A 1
Documentation
(TAP; petition; regulatory agency; other)
Yes
Question
No
N/A
Comments on information provided (sufficient,
plausible, reasonable, thorough, complete, unknown)
2. Is the substance consistent with organic farming
and handling? [§ 6517 c(1)(A)(iii); 6517 c(2)(A)(ii)]
3. Is the substance compatible with a system of sustainable agriculture? [§ 6518 m.7]
4. Is the nutritional quality of the food maintained with
the substance? [§ 205.600 b.3]
5. Is the primary use as a preservative? [§ 205.600
b.4]
6. Is the primary use to recreate or improve flavors,
colors, textures, or nutritive values lost in processing (except when required by law, e.g., vitamin
D in milk)? [205.600 b.4]
7. Is the substance used in production, and does it
contain an active synthetic ingredient in the following categories:
a. copper and sulfur compounds;
b. toxins derived from bacteria;
c. pheromones, soaps, horticultural oils, fish
emulsions, treated seed, vitamins and minerals?
d. livestock parasiticides and medicines?
e. production aids including netting, tree wraps
and seals, insect traps, sticky barriers, row covers, and equipment cleaners?
Question
emcdonald on DSK2BSOYB1PROD with PROPOSALS
Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially unavailable? [§ 6610, 6518, 6519,
205.2, 205.105 (d), 205.600 (c), 205.2, 205.105 (d), 205.600 (c)]
1. Is the comparative description provided as to why
the non-organic form of the material/substance is
necessary for use in organic handling?
2. Does the current and historical industry information,
research, or evidence provided explain how or why
the material/substance cannot be obtained organically in the appropriate form to fulfill an essential
function in a system of organic handling?
3. Does the current and historical industry information,
research, or evidence provided explain how or why
the material/substance cannot be obtained organically in the appropriate quality to fulfill an essential
function in a system of organic handling?
4. Does the current and historical industry information,
research, or evidence provided explain how or why
the material/substance cannot be obtained organically in the appropriate quantity to fulfill an essential
function in a system of organic handling?
5. Does the industry information provided on material/
substance non-availability as organic, include ( but
not limited to) the following:
a. Regions of production (including factors such
as climate and number of regions);
b. Number of suppliers and amount produced;
c. Current and historical supplies related to
weather events such as hurricanes, floods, and
droughts that may temporarily halt production
or destroy crops or supplies;
d. Trade-related issues such as evidence of
hoarding, war, trade barriers, or civil unrest that
may temporarily restrict supplies; or
e. Are there other issues which may present a
challenge to a consistent supply?
1If
the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
[FR Doc. 2010–6683 Filed 3–25–10; 8:45 am]
BILLING CODE P
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]]>Agencies
[Federal Register Volume 75, Number 58 (Friday, March 26, 2010)]
[Proposed Rules]
[Pages 14500-14509]
From the Federal Register Online via the Government Printing 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: https://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 (https://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. ........... .......... .......... ................
