National Organic Program, Sunset Review, 35177-35182 [05-12007]
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35177
Proposed Rules
Federal Register
Vol. 70, No. 116
Friday, June 17, 2005
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
[Docket Number TM–04–07]
National Organic Program, Sunset
Review
Agricultural Marketing Service,
USDA.
ACTION: Advance notice of proposed
rulemaking with request for comments.
AGENCY:
SUMMARY: As required by the Organic
Foods Production Act of 1990 (OFPA),
the allowed use of 165 synthetic and
non-synthetic substances in organic
production and handling will expire on
October 21, 2007. In addition,
prohibitions on the use of 9 nonsynthetic substances will expire in
organic production on October 21, 2007.
The Agricultural Marketing Service
(AMS) is publishing this advance notice
of proposed rulemaking (ANPR) to make
the public aware of this OFPA
requirement. AMS believes that public
comment is essential in the review
process to determine whether these
substances should continue to be
allowed or prohibited in the production
and handling of organic agricultural
products.
Comments must be submitted on
or before August 16, 2005.
ADDRESSES: Interested persons may
submit written comments on this ANPR
using the following addresses:
• Mail: Arthur Neal, Director,
Program Administration, National
Organic Program, USDA–AMS—TMP–
NOP, 1400 Independence Ave., SW.,
Room 4008—So., Ag Stop 0268,
Washington, DC 20250.
• E-mail: National.List@usda.gov.
• Fax: (202) 205–7808.
Written comments responding to this
ANPR should be identified with the
docket number TM–04–07. You should
clearly indicate your position to
continue or not continue the allowance
or prohibition of the substances
DATES:
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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 or prohibition 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,
whether submitted by mail, E-mail, or
fax, available for viewing on the
National Organic Program (NOP) homepage (https://www.ams.usda.gov/nop).
Comments submitted in response to this
ANPR will also be available for viewing
in person at USDA–AMS,
Transportation and Marketing Programs,
Room 4008–South Building, 1400
Independence Ave., SW., Washington,
DC 20250, 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:
Arthur Neal, Director, Program
Administration, National Organic
Program, USDA–AMS–TMP–NOP, 1400
Independence Ave., SW., Room 4008So. Bldg., Ag Stop 0268, Washington,
DC 20250. Telephone: (202) 720–3252;
Fax: (202) 205–7808. E-mail:
arthur.neal@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
The Organic Foods Production Act
(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
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(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 a synthetic
substance currently allowed for use in
organic production will no longer be
allowed for use after October 21, 2007;
a non-synthetic substance currently
prohibited from use in organic
production will be allowed after
October 21, 2007; and a synthetic or
nonsynthetic substance currently
allowed for use in organic handling will
be prohibited after October 21, 2007.
Expiration of the exempted or
prohibited use of substances is provided
for under the OFPA’s sunset provision.
This ANPR announces the sunset of 165
exempted and 9 prohibited substances
currently on the National List, which
became effective October 21, 2002. This
ANPR establishes October 21, 2007, as
the date by which the sunset review and
renewal process must be concluded and
also begins the public comment process
on whether the existing specific
exemptions or prohibitions 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 you to make your views
known.
The Sunset Process
As the first step in this process, we
invite public comment on the specific
exemptions or prohibitions 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 section 6517 (e) of the
OFPA, these substances must be
reviewed by the NOSB and renewed by
the Secretary for their use or prohibition
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to continue after 5 years of their
addition to the National List, which will
be October 21, 2007. Public comments
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
substances designated to sunset on
October 21, 2007, including the public
comments received during this review.
The NOSB will review each substance
on the National List 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
contained on the National List. After the
Secretary receives the NOSB’s
recommendations, the NOP will publish
a proposed rule containing the NOSB
recommendations. This proposed rule
will provide an additional opportunity
for you to express your 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.
Guidance on Submitting Your
Comments
Comments That Support Existing
Exemptions or Prohibitions
If you provide comments that support
the renewal of any or all existing
exemptions or prohibitions contained
on the National List, you should clearly
indicate this and provide your reasons
and any relevant documentation that
supports your position.
Comments That DO NOT Support
Continuing an Existing Exemption
If you provide comments that do not
support continuing an existing
exemption, you should provide reasons
why the use of the substance should no
longer be allowed in organic agricultural
production 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 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.
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 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.
In addition, comments that do not
support the continued use of a
substance(s) on the National List should
also provide the evidence concerning
viable alternatives for the substance you
believe should be discontinued. 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 also should
adequately demonstrate that the
alternative has a function and effect that
equals or surpasses the specific
exempted substance that you do not
want to be continued. Assertions about
an alternative substance except for those
alternatives that already appear on the
National List should, if possible include
the name and address of the
manufacturer of the alternative. Further,
your comments should include a copy
or the specific source of any supportive
literature, which could include product
or practice descriptions; performance
and test data; reference standards; name
and address of producers who have
used the alternative under similar
conditions and the date of use; and an
itemized comparison of the function
and effect of the proposed alternative(s)
with substance under review. The chart
below can help you describe
recommended alternatives for different
types of organic operations in place of
a current exempted substance that you
do not want to be continued.
If the currently listed substance is
used in . . .
And is a (an) . . .
Then the recommended alternative should be a (an) . . .
Crop or Livestock Production ..............
Synthetic substance ............................
Crop or Livestock Production ..............
Synthetic inert substance (pesticidal)
Handling ...............................................
Synthetic substance ............................
Handling ...............................................
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,
however, be available from the research
community including universities, or
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other sources, including international
organic programs.
Comments that DO NOT Support
Continuing an Existing Prohibition
If you provide comments against the
continuation of a prohibition contained
on the National List, you should specify
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how the prohibited substance is now
consistent with the criteria in the OFPA
and the NOP regulation. When these
prohibitions were originally
recommended by the NOSB, they were
accepted because the evidence available
to the NOSB at the time of review
demonstrated that the substances were
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found to be harmful to human health or
the environment and were inconsistent
and not compatible with organic
practices. Therefore, any comments
against the continuation of an existing
prohibited substance that is currently on
the National List should provide new
information, including a copy of the
specific source of any supportive
literatures showing that the currently
prohibited substance is no longer
harmful to human health or the
environment and is consistent and
compatible with organic practices.
An Appendix to this ANPR contains
worksheets to assist you in gathering
relevant information concerning these
issues. These worksheets are not
required for you 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 to help you provide
substantive comments to the NOSB
when you provide comments on the
specific substance.
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
Allowed and Prohibited Substances for
organic agricultural production and
handling:
§ 205.601 Synthetic substances allowed
for use in organic crop production.
(a) As algicide, disinfectants, and
sanitizer, including irrigation system
cleaning systems.
(1) Alcohols.
(i) Ethanol.
(ii) Isopropanol.
(2) Chlorine materials—Except, That,
residual chlorine levels in the water
shall not exceed the maximum residual
disinfectant limit under the Safe
Drinking Water Act.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(4) Hydrogen peroxide.
(7) Soap-based algicide/demossers.
(b) As herbicides, weed barriers, as
applicable.
(1) Herbicides, soap-based—for use in
farmstead maintenance (roadways,
ditches, right of ways, building
perimeters) and ornamental crops.
(2) Mulches.
(i) Newspaper or other recycled
paper—without glossy or colored inks.
(ii) Plastic mulch and covers
(petroleum-based other than polyvinyl
chloride (PVC)).
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(c) As compost feedstocks—
Newspapers or other recycled paper—
without glossy or colored inks.
(d) As animal repellents—Soaps,
ammonium—for use as a large animal
repellant only, no contact with soil or
edible portion of crop.
(e) As insecticides (including
acaricides or mite control).
(1) Ammonium carbonate—for use as
bait in insect traps only, no direct
contact with crop or soil.
(2) Boric acid—structural pest control,
no direct contact with organic food or
crops.
(4) Elemental sulfur.
(5) Lime sulfur—including calcium
polysulfide.
(6) Oils, horticultural—narrow range
oils as dormant, suffocating, and
summer oils.
(7) Soaps, insecticidal.
(8) Sticky traps/barriers.
(f) As insect management.
Pheromones.
(g) As rodenticides.
(1) Sulfur dioxide—underground
rodent control only (smoke bombs).
(2) Vitamin D3.
(i) As plant disease control.
(1) Coppers, fixed—copper hydroxide,
copper oxide, copper oxychloride,
includes products exempted from EPA
tolerance, Provided, That, copper-based
materials must be used in a manner that
minimizes accumulation in the soil and
shall not be used as herbicides.
(2) Copper sulfate—Substance must
be used in a manner that minimizes
accumulation of copper in the soil.
(3) Hydrated lime.
(4) Hydrogen peroxide.
(5) Lime sulfur.
(6) Oils, horticultural, narrow range
oils as dormant, suffocating, and
summer oils.
(8) Potassium bicarbonate.
(9) Elemental sulfur.
(10) Streptomycin, for fire blight
control in apples and pears only.
(11) Tetracycline (oxytetracycline
calcium complex), for fire blight control
only.
(j) As plant or soil amendments.
(1) 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.
(2) Elemental sulfur.
(3) Humic acids—naturally occurring
deposits, water and alkali extracts only.
(4) Lignin sulfonate—chelating agent,
dust suppressant, floatation agent.
(5) Magnesium sulfate—allowed with
a documented soil deficiency.
(6) Micronutrients—not to be used as
a defoliant, herbicide, or desiccant.
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Those made from nitrates or chlorides
are not allowed. Soil deficiency must be
documented by testing.
(i) Soluble boron products.
(ii) Sulfates, carbonates, oxides, or
silicates of zinc, copper, iron,
manganese, molybdenum, selenium,
and cobalt.
(7) 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.
(8) Vitamins, B1, C, and E.
(k) As plant growth regulators.
Ethylene gas—for regulation of
pineapple flowering.
(l) As floating agents in postharvest
handling.
(1) Lignin sulfonate.
(2) Sodium silicate—for tree fruit and
fiber processing.
(m) 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.
(1) EPA List 4—Inerts of Minimal
Concern.
§ 205.602 Nonsynthetic substances
prohibited for use in organic crop
production.
(a) Ash from manure burning.
(b) Arsenic.
(d) Lead salts.
(e) Potassium chloride—unless
derived from a mined source and
applied in a manner that minimizes
chloride accumulation in the soil.
(f) Sodium fluoaluminate (mined).
(g) Sodium nitrate—unless use is
restricted to no more than 20% of the
crop’s total nitrogen requirement; use in
spirulina production is unrestricted
until October 21, 2005.
(h) Strychnine.
(i) Tobacco dust (nicotine sulfate).
§ 205.603 Synthetic substances allowed
for use in organic livestock production.
(a) As disinfectants, sanitizer, and
medical treatments as applicable.
(1) Alcohols.
(i) Ethanol—disinfectant and sanitizer
only, prohibited as a feed additive.
(ii) Isopropanol—disinfectant only.
(2) Aspirin—approved for health care
use to reduce inflammation.
(3) Biologics—Vaccines.
(4) 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.
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(5) 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.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(6) Electrolytes-without antibiotics.
(7) Glucose.
(8) Glycerine—Allowed as a livestock
teat dip, must be produced through the
hydrolysis of fats or oils.
(9) Hydrogen peroxide.
(10) Iodine.
(11) Magnesium sulfate.
(12) Oxytocin—use in postparturition
therapeutic applications.
(13) Paraciticides. 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.
(14) Phosphoric acid—allowed as an
equipment cleaner, Provided, That, no
direct contact with organically managed
livestock or land occurs.
(b) As topical treatment, external
parasiticide or local anesthetic as
applicable.
(1) Copper sulfate.
(2) Iodine.
(3) 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.
(4) Lime, hydrated—as an external
pest control, not permitted to cauterize
physical alterations or deodorize animal
wastes.
(5) Mineral oil—for topical use and as
a lubricant.
(6) 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.
(c) As feed supplements—Milk
replacers without antibiotics, as
emergency use only, no nonmilk
products or products from BST treated
animals.
(d) As feed additives.
(2) Trace minerals, used for
enrichment or fortification when FDA
approved.
(3) Vitamins, used for enrichment or
fortification when FDA approved.
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(e) As synthetic inert ingredients as
classified by the Environmental
Protection Agency (EPA), for use with
nonsynthetic substances or a synthetic
substances listed in this section and
used as an active pesticide ingredient in
accordance with any limitations on the
use of such substances.
(1) EPA List 4—Inerts of Minimal
Concern.
§ 205.604 Nonsynthetic substances
prohibited for use in organic livestock
production.
(a) Strychnine.
§ 205.605 Nonagricultural (nonorganic)
substances allowed as ingredients in or on
processed products labeled as ‘‘organic’’ or
‘‘made with organic (specified ingredients
or food groups(s)).’’
(a) Nonsynthetics allowed:
Acids (Alginic; Citric—produced by
microbial fermentation of carbohydrate
substances; and Lactic).
Agar-agar.
Bentonite.
Calcium carbonate.
Calcium chloride.
Carageenan.
Colors—nonsynthetic sources only.
Dairy cultures.
Diatomaceous earth—food filtering
aid only.
Enzymes—must be derived from
edible, nontoxic plants, nonpathogenic
fungi, or nonpathogenic bacteria.
Flavors—nonsynthetic sources only
and must not be produced using
synthetic solvents and carrier systems or
any artificial preservative.
Kaolin.
Magnesium sulfate, nonsynthetic
sources only.
Nitrogen—oil-free grades.
Oxygen—oil-free grades.
Perlite—for use only as a filter aid in
food processing.
Potassium chloride.
Potassium iodide.
Sodium bicarbonate.
Sodium carbonate.
Tartaric acid.
Waxes—nonsynthetic (Carnauba wax;
and Wood resin).
Yeast—nonsynthetic, growth on
petrochemical substrate and sulfite
waste liquor is prohibited (Autolysate;
Bakers; Brewers; Nutritional; and
Smoked—nonsynthetic smoke flavoring
process must be documented).
(b) Synthetics allowed:
Alginates.
Ammonium bicarbonate—for use only
as a leavening agent.
Ammonium carbonate—for use only
as a leavening agent.
Ascorbic acid.
Calcium citrate.
Calcium hydroxide.
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Calcium phosphates (monobasic,
dibasic, and tribasic).
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 (Calcium
hypochlorite; Chlorine dioxide; and
Sodium hypochlorite).
Ethylene—allowed for postharvest
ripening of tropical fruit and degreening
of citrus.
Ferrous sulfate—for iron enrichment
or fortification of foods when required
by regulation or recommended by an
independent organization.
Glycerides (mono and di)—for use
only in drum drying of food.
Glycerin—produced by hydrolysis of
fats and oils.
Hydrogen peroxide.
Lecithin—bleached.
Magnesium carbonate—for use only
in agricultural products labeled ‘‘made
with organic (specified ingredients or
food group(s)), ‘‘prohibited in
agricultural products labeled’’
‘‘organic’’.
Magnesium chloride—derived from
sea water.
Magnesium stearate—for use only in
agricultural products labeled ‘‘made
with organic (specified ingredients or
food group(s)),’’ prohibited in
agricultural products labeled ‘‘organic’’.
Nutrient vitamins and minerals, in
accordance with 21 CFR 104.20,
Nutritional Quality Guidelines for
Foods.
Ozone.
Pectin (low-methoxy).
Phosphoric acid—cleaning of foodcontact surfaces and equipment only.
Potassium acid tartrate.
Potassium tartrate made from tartaric
acid.
Potassium carbonate.
Potassium citrate.
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.
Potassium iodide—for use only in
agricultural products labeled ‘‘made
with organic (specified ingredients or
food group(s)),’’ prohibited in
agricultural products labeled ‘‘organic’’.
Potassium phosphate—for use only in
agricultural products labeled ‘‘made
with organic (specified ingredients or
food group(s)),’’ prohibited in
agricultural products labeled ‘‘organic’’.
Silicon dioxide.
Sodium citrate.
Sodium hydroxide—prohibited for
use in lye peeling of fruits and
vegetables.
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Sodium phosphates—for use only in
dairy foods.
Sulfur dioxide—for use only in wine
labeled ‘‘made with organic grapes,’’
Provided, That, total sulfite
concentration does not exceed 100 ppm.
Tartaric acid.
Tocopherols—derived from vegetable
oil when rosemary extracts are not a
suitable alternative.
Xanthan gum.
§ 205.606 Nonorganically produced
agricultural products allowed as ingredients
in or on processed products labeled as
‘‘organic’’ or ‘‘made with organic (specified
ingredients or food group(s)).’’
(a) Cornstarch (native).
(b) Gums—water extracted only
(arabic, guar, locust bean, carob bean).
(c) Kelp—for use only as a thickener
and dietary supplement.
(d) Lecithin—unbleached.
(e) Pectin (high-methoxy).
All comments will be considered in
the development of the NOSB’s
recommendations to the Secretary.
Authority: 7 U.S.C. 6501 et seq. and 7 CFR
part 205.
Dated: June 13, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing
Service.
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.
Evaluation Criteria for Substances Added to
the National List
Appendix
This Appendix contains worksheets to
assist you in gathering relevant information
Question
Yes
No
N/A 1
Documentation
(TAP; petition; regulatory agency; other)
Category 1. Adverse impacts on humans or the environment?
1. Is there environmental contamination during manufacture, use,
misuse, or disposal? [§ 6518 m.3].
2. Is the substance harmful to the environment? [§ 6517c(1)(A)(i);
6517(c)(2)(A)i].
3. Does the substance contain List 1, 2, or 3 inerts?
[§ 6517c(1)(B)(ii)].
4. Is there potential for detrimental chemical interaction with other
materials used? [§ 6518 m.1].
5. Are there adverse biological and chemical interactions in agro-ecosystem? [§ 6518 m.5].
6. Are there detrimental physiological effects on soil organisms,
crops, or livestock? [§ 6518 m.5].
7. Is there a toxic or other adverse action of the material or its breakdown products? [§ 6518 m.2].
8. Is there undesirable persistence or concentration of the material or
breakdown products in environment? [§ 6518 m.2].
9. Is there any harmful effect on human health? [§ 6517c(1)(A)(i);
6517c(2)(A)i; § 6518 m.4].
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 wholly natural substitute product? [§ 6517c(1)(A)(ii)].
5. Is the substance used in handling, not synthetic, but not organically produced? [§ 6517c(1)(B)(iii)].
6. Is there any alternative substances? [§ 6518 m.6].
7. 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 consistent with organic farming and handling?
[§ 6517c(1)(A)(iii); 6517c(2)(A)(ii)].
2. Is the substance compatible with a system of sustainable agriculture? [§ 6518 m.7].
3. Is the substance used in production, and does it contain an active
synthetic ingredient in the following categories:
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Federal Register / Vol. 70, No. 116 / Friday, June 17, 2005 / Proposed Rules
Question
Yes
No
Documentation
(TAP; petition; regulatory agency; other)
N/A 1
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?
1 If
the substance under review is for crops or livestock production, all of the questions from 205.600(b) are N/A—not applicable.
[FR Doc. 05–12007 Filed 6–16–05; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 981
[Docket No. FV05–981–2 PR]
Almonds Grown in California;
Increased Assessment Rate
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
SUMMARY: This rule would increase the
assessment rate established for the
Almond Board of California (Board) for
the 2005–06 and subsequent crop years
from $0.025 to $0.030 per pound of
almonds received. Of the $0.030 per
pound assessment, 60 percent (or $0.018
per pound) would be available as creditback for handlers who conduct their
own promotional activities. The Board
locally administers the marketing order
which regulates the handling of
almonds grown in California.
Authorization to assess almond
handlers enables the Board to incur
expenses that are reasonable and
necessary to administer the program.
The crop year begins August 1 and ends
July 31. The assessment rate would
remain in effect indefinitely unless
modified, suspended, or terminated.
DATES: Comments must be received by
June 27, 2005.
ADDRESSES: Interested persons are
invited to submit written comments
concerning this rule. Comments must be
sent to the Docket Clerk, Marketing
Order Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 1400
Independence Avenue SW., STOP 0237,
Washington, DC 20250–0237; Fax: (202)
720–8938, E-mail:
moab.docketclerk@usda.gov, or Internet:
https://www.regulations.gov. Comments
should reference the docket number and
the date and page number of this issue
of the Federal Register and will be
available for public inspection in the
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Office of the Docket Clerk during regular
business hours, or can be viewed at:
https://www.ams.usda.gov/fv/moab.html.
FOR FURTHER INFORMATION CONTACT:
Maureen T. Pello, Senior Marketing
Specialist, California Marketing Field
Office, Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 2202 Monterey Street,
suite 102B, Fresno, California 93721;
telephone: (559) 487–5901, Fax: (559)
487–5906; or George Kelhart, Technical
Advisor, Marketing Order
Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 1400
Independence Avenue SW., STOP 0237,
Washington, DC 20250–0237; telephone:
(202) 720–2491, Fax: (202) 720–8938.
Small businesses may request
information on complying with this
regulation by contacting Jay Guerber,
Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence
Avenue SW, STOP 0237, Washington,
DC 20250–0237; telephone: (202) 720–
2491, Fax: (202) 720–8938, or E-mail:
Jay.Guerber@usda.gov.
This rule
is issued under Marketing Order No.
981, as amended (7 CFR part 981),
regulating the handling of almonds
grown in California, hereinafter referred
to as the ‘‘order.’’ The order is effective
under the Agricultural Marketing
Agreement Act of 1937, as amended (7
U.S.C. 601–674), hereinafter referred to
as the ‘‘Act.’’
The Department of Agriculture
(USDA) is issuing this rule in
conformance with Executive Order
12866.
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. Under the marketing order now
in effect, California almond handlers are
subject to assessments. Funds to
administer the order are derived from
such assessments. It is intended that the
assessment rate as proposed herein
would be applicable to all assessable
almonds beginning August 1, 2005, and
continue until amended, suspended, or
terminated. This rule will not preempt
any State or local laws, regulations, or
SUPPLEMENTARY INFORMATION:
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policies, unless they present an
irreconcilable conflict with this rule.
The Act provides that administrative
proceedings must be exhausted before
parties may file suit in court. Under
section 608c(15)(A) of the Act, any
handler subject to an order may file
with USDA a petition stating that the
order, any provision of the order, or any
obligation imposed in connection with
the order is not in accordance with law
and request a modification of the order
or to be exempted therefrom.
Such handler is afforded the
opportunity for a hearing on the
petition. After the hearing USDA would
rule on the petition. The Act provides
that the district court of the United
States in any district in which the
handler is an inhabitant, or has his or
her principal place of business, has
jurisdiction to review USDA’s ruling on
the petition, provided an action is filed
not later than 20 days after the date of
the entry of the ruling.
This rule would increase the
assessment rate established for the
Board for the 2005–06 and subsequent
crop years from $0.025 to $0.030 per
pound of almonds received. Of the
$0.030 per pound assessment, 60
percent (or $0.018 per pound) would be
available as credit-back for handlers
who conduct their own promotional
activities.
The order provides authority for the
Board, with the approval of USDA, to
formulate an annual budget of expenses
and collect assessments from handlers
to administer the program. The
members of the Board are producers and
handlers of California almonds. They
are familiar with the Board’s needs and
with the costs for goods and services in
their local area and are thus in a
position to formulate an appropriate
budget and assessment rate. The
assessment rate is formulated and
discussed in a public meeting. Thus, all
directly affected persons have an
opportunity to participate and provide
input.
For the 2004–05 and subsequent crop
years, the Board recommended, and
USDA approved, an assessment rate that
would continue in effect from crop year
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]]>Agencies
[Federal Register Volume 70, Number 116 (Friday, June 17, 2005)]
[Proposed Rules]
[Pages 35177-35182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12007]
========================================================================
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. 70, No. 116 / Friday, June 17, 2005 /
Proposed Rules
[[Page 35177]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM-04-07]
National Organic Program, Sunset Review
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Advance notice of proposed rulemaking with request for
comments.
-----------------------------------------------------------------------
SUMMARY: As required by the Organic Foods Production Act of 1990
(OFPA), the allowed use of 165 synthetic and non-synthetic substances
in organic production and handling will expire on October 21, 2007. In
addition, prohibitions on the use of 9 non-synthetic substances will
expire in organic production on October 21, 2007. The Agricultural
Marketing Service (AMS) is publishing this advance notice of proposed
rulemaking (ANPR) to make the public aware of this OFPA requirement.
AMS believes that public comment is essential in the review process to
determine whether these substances should continue to be allowed or
prohibited in the production and handling of organic agricultural
products.
DATES: Comments must be submitted on or before August 16, 2005.
ADDRESSES: Interested persons may submit written comments on this ANPR
using the following addresses:
Mail: Arthur Neal, Director, Program Administration,
National Organic Program, USDA-AMS--TMP-NOP, 1400 Independence Ave.,
SW., Room 4008--So., Ag Stop 0268, Washington, DC 20250.
E-mail: National.List@usda.gov.
Fax: (202) 205-7808.
Written comments responding to this ANPR should be identified with
the docket number TM-04-07. You should clearly indicate your position
to continue or not continue 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 or
prohibition 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,
whether submitted by mail, E-mail, or fax, available for viewing on the
National Organic Program (NOP) home-page (https://www.ams.usda.gov/nop).
Comments submitted in response to this ANPR will also be available for
viewing in person at USDA-AMS, Transportation and Marketing Programs,
Room 4008-South Building, 1400 Independence Ave., SW., Washington, DC
20250, 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: Arthur Neal, Director, Program
Administration, National Organic Program, USDA-AMS-TMP-NOP, 1400
Independence Ave., SW., Room 4008-So. Bldg., Ag Stop 0268, Washington,
DC 20250. Telephone: (202) 720-3252; Fax: (202) 205-7808. E-mail:
arthur.neal@usda.gov.
SUPPLEMENTARY INFORMATION: Background
The Organic Foods Production Act (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. This
means that a synthetic substance currently allowed for use in organic
production will no longer be allowed for use after October 21, 2007; a
non-synthetic substance currently prohibited from use in organic
production will be allowed after October 21, 2007; and a synthetic or
nonsynthetic substance currently allowed for use in organic handling
will be prohibited after October 21, 2007.
Expiration of the exempted or prohibited use of substances is
provided for under the OFPA's sunset provision. This ANPR announces the
sunset of 165 exempted and 9 prohibited substances currently on the
National List, which became effective October 21, 2002. This ANPR
establishes October 21, 2007, as the date by which the sunset review
and renewal process must be concluded and also begins the public
comment process on whether the existing specific exemptions or
prohibitions 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 you to make your views
known.
The Sunset Process
As the first step in this process, we invite public comment on the
specific exemptions or prohibitions 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 section 6517 (e) of the OFPA, these substances must be reviewed by
the NOSB and renewed by the Secretary for their use or prohibition
[[Page 35178]]
to continue after 5 years of their addition to the National List, which
will be October 21, 2007. Public comments 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
substances designated to sunset on October 21, 2007, including the
public comments received during this review. The NOSB will review each
substance on the National List 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 contained on the National List. After the Secretary
receives the NOSB's recommendations, the NOP will publish a proposed
rule containing the NOSB recommendations. This proposed rule will
provide an additional opportunity for you to express your 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.
Guidance on Submitting Your Comments
Comments That Support Existing Exemptions or Prohibitions
If you provide comments that support the renewal of any or all
existing exemptions or prohibitions contained on the National List, you
should clearly indicate this and provide your reasons and any relevant
documentation that supports your position.
Comments That DO NOT Support Continuing an Existing Exemption
If you provide comments that do not support continuing an existing
exemption, you should provide reasons why the use of the substance
should no longer be allowed in organic agricultural production 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 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.
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 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.
In addition, comments that do not support the continued use of a
substance(s) on the National List should also provide the evidence
concerning viable alternatives for the substance you believe should be
discontinued. 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 also should adequately demonstrate that the alternative
has a function and effect that equals or surpasses the specific
exempted substance that you do not want 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 be
substance is used in . . . . a (an) . . .
------------------------------------------------------------------------
Crop or Livestock Production.. Synthetic --Another currently
substance. 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 --Another currently
substance. 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.
Comments that DO NOT Support Continuing an Existing Prohibition
If you provide comments against the continuation of a prohibition
contained on the National List, you should specify how the prohibited
substance is now consistent with the criteria in the OFPA and the NOP
regulation. When these prohibitions were originally recommended by the
NOSB, they were accepted because the evidence available to the NOSB at
the time of review demonstrated that the substances were
[[Page 35179]]
found to be harmful to human health or the environment and were
inconsistent and not compatible with organic practices. Therefore, any
comments against the continuation of an existing prohibited substance
that is currently on the National List should provide new information,
including a copy of the specific source of any supportive literatures
showing that the currently prohibited substance is no longer harmful to
human health or the environment and is consistent and compatible with
organic practices.
An Appendix to this ANPR contains worksheets to assist you in
gathering relevant information concerning these issues. These
worksheets are not required for you 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 to help you provide substantive comments
to the NOSB when you provide comments on the specific substance.
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 Allowed and Prohibited Substances for organic agricultural
production and handling:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
(a) As algicide, disinfectants, and sanitizer, including irrigation
system cleaning systems.
(1) Alcohols.
(i) Ethanol.
(ii) Isopropanol.
(2) Chlorine materials--Except, That, residual chlorine levels in
the water shall not exceed the maximum residual disinfectant limit
under the Safe Drinking Water Act.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(4) Hydrogen peroxide.
(7) Soap-based algicide/demossers.
(b) As herbicides, weed barriers, as applicable.
(1) Herbicides, soap-based--for use in farmstead maintenance
(roadways, ditches, right of ways, building perimeters) and ornamental
crops.
(2) Mulches.
(i) Newspaper or other recycled paper--without glossy or colored
inks.
(ii) Plastic mulch and covers (petroleum-based other than polyvinyl
chloride (PVC)).
(c) As compost feedstocks--Newspapers or other recycled paper--
without glossy or colored inks.
(d) As animal repellents--Soaps, ammonium--for use as a large
animal repellant only, no contact with soil or edible portion of crop.
(e) As insecticides (including acaricides or mite control).
(1) Ammonium carbonate--for use as bait in insect traps only, no
direct contact with crop or soil.
(2) Boric acid--structural pest control, no direct contact with
organic food or crops.
(4) Elemental sulfur.
(5) Lime sulfur--including calcium polysulfide.
(6) Oils, horticultural--narrow range oils as dormant, suffocating,
and summer oils.
(7) Soaps, insecticidal.
(8) Sticky traps/barriers.
(f) As insect management. Pheromones.
(g) As rodenticides.
(1) Sulfur dioxide--underground rodent control only (smoke bombs).
(2) Vitamin D3.
(i) As plant disease control.
(1) Coppers, fixed--copper hydroxide, copper oxide, copper
oxychloride, includes products exempted from EPA tolerance, Provided,
That, copper-based materials must be used in a manner that minimizes
accumulation in the soil and shall not be used as herbicides.
(2) Copper sulfate--Substance must be used in a manner that
minimizes accumulation of copper in the soil.
(3) Hydrated lime.
(4) Hydrogen peroxide.
(5) Lime sulfur.
(6) Oils, horticultural, narrow range oils as dormant, suffocating,
and summer oils.
(8) Potassium bicarbonate.
(9) Elemental sulfur.
(10) Streptomycin, for fire blight control in apples and pears
only.
(11) Tetracycline (oxytetracycline calcium complex), for fire
blight control only.
(j) As plant or soil amendments.
(1) 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.
(2) Elemental sulfur.
(3) Humic acids--naturally occurring deposits, water and alkali
extracts only.
(4) Lignin sulfonate--chelating agent, dust suppressant, floatation
agent.
(5) Magnesium sulfate--allowed with a documented soil deficiency.
(6) 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.
(i) Soluble boron products.
(ii) Sulfates, carbonates, oxides, or silicates of zinc, copper,
iron, manganese, molybdenum, selenium, and cobalt.
(7) 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.
(8) Vitamins, B1, C, and E.
(k) As plant growth regulators. Ethylene gas--for regulation of
pineapple flowering.
(l) As floating agents in postharvest handling.
(1) Lignin sulfonate.
(2) Sodium silicate--for tree fruit and fiber processing.
(m) 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.
(1) EPA List 4--Inerts of Minimal Concern.
Sec. 205.602 Nonsynthetic substances prohibited for use in organic
crop production.
(a) Ash from manure burning.
(b) Arsenic.
(d) Lead salts.
(e) Potassium chloride--unless derived from a mined source and
applied in a manner that minimizes chloride accumulation in the soil.
(f) Sodium fluoaluminate (mined).
(g) Sodium nitrate--unless use is restricted to no more than 20% of
the crop's total nitrogen requirement; use in spirulina production is
unrestricted until October 21, 2005.
(h) Strychnine.
(i) Tobacco dust (nicotine sulfate).
Sec. 205.603 Synthetic substances allowed for use in organic
livestock production.
(a) As disinfectants, sanitizer, and medical treatments as
applicable.
(1) Alcohols.
(i) Ethanol--disinfectant and sanitizer only, prohibited as a feed
additive.
(ii) Isopropanol--disinfectant only.
(2) Aspirin--approved for health care use to reduce inflammation.
(3) Biologics--Vaccines.
(4) 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.
[[Page 35180]]
(5) 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.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
(6) Electrolytes-without antibiotics.
(7) Glucose.
(8) Glycerine--Allowed as a livestock teat dip, must be produced
through the hydrolysis of fats or oils.
(9) Hydrogen peroxide.
(10) Iodine.
(11) Magnesium sulfate.
(12) Oxytocin--use in postparturition therapeutic applications.
(13) Paraciticides. 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.
(14) Phosphoric acid--allowed as an equipment cleaner, Provided,
That, no direct contact with organically managed livestock or land
occurs.
(b) As topical treatment, external parasiticide or local anesthetic
as applicable.
(1) Copper sulfate.
(2) Iodine.
(3) 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.
(4) Lime, hydrated--as an external pest control, not permitted to
cauterize physical alterations or deodorize animal wastes.
(5) Mineral oil--for topical use and as a lubricant.
(6) 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.
(c) As feed supplements--Milk replacers without antibiotics, as
emergency use only, no nonmilk products or products from BST treated
animals.
(d) As feed additives.
(2) Trace minerals, used for enrichment or fortification when FDA
approved.
(3) Vitamins, used for enrichment or fortification when FDA
approved.
(e) As synthetic inert ingredients as classified by the
Environmental Protection Agency (EPA), for use with nonsynthetic
substances or a synthetic substances listed in this section and used as
an active pesticide ingredient in accordance with any limitations on
the use of such substances.
(1) EPA List 4--Inerts of Minimal Concern.
Sec. 205.604 Nonsynthetic substances prohibited for use in organic
livestock production.
(a) Strychnine.
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food groups(s)).''
(a) Nonsynthetics allowed:
Acids (Alginic; Citric--produced by microbial fermentation of
carbohydrate substances; and Lactic).
Agar-agar.
Bentonite.
Calcium carbonate.
Calcium chloride.
Carageenan.
Colors--nonsynthetic sources only.
Dairy cultures.
Diatomaceous earth--food filtering aid only.
Enzymes--must be derived from edible, nontoxic plants,
nonpathogenic fungi, or nonpathogenic bacteria.
Flavors--nonsynthetic sources only and must not be produced using
synthetic solvents and carrier systems or any artificial preservative.
Kaolin.
Magnesium sulfate, nonsynthetic sources only.
Nitrogen--oil-free grades.
Oxygen--oil-free grades.
Perlite--for use only as a filter aid in food processing.
Potassium chloride.
Potassium iodide.
Sodium bicarbonate.
Sodium carbonate.
Tartaric acid.
Waxes--nonsynthetic (Carnauba wax; and Wood resin).
Yeast--nonsynthetic, growth on petrochemical substrate and sulfite
waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional;
and Smoked--nonsynthetic smoke flavoring process must be documented).
(b) Synthetics allowed:
Alginates.
Ammonium bicarbonate--for use only as a leavening agent.
Ammonium carbonate--for use only as a leavening agent.
Ascorbic acid.
Calcium citrate.
Calcium hydroxide.
Calcium phosphates (monobasic, dibasic, and tribasic).
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 (Calcium hypochlorite; Chlorine dioxide; and Sodium
hypochlorite).
Ethylene--allowed for postharvest ripening of tropical fruit and
degreening of citrus.
Ferrous sulfate--for iron enrichment or fortification of foods when
required by regulation or recommended by an independent organization.
Glycerides (mono and di)--for use only in drum drying of food.
Glycerin--produced by hydrolysis of fats and oils.
Hydrogen peroxide.
Lecithin--bleached.
Magnesium carbonate--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),
``prohibited in agricultural products labeled'' ``organic''.
Magnesium chloride--derived from sea water.
Magnesium stearate--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Nutrient vitamins and minerals, in accordance with 21 CFR 104.20,
Nutritional Quality Guidelines for Foods.
Ozone.
Pectin (low-methoxy).
Phosphoric acid--cleaning of food-contact surfaces and equipment
only.
Potassium acid tartrate.
Potassium tartrate made from tartaric acid.
Potassium carbonate.
Potassium citrate.
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.
Potassium iodide--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Potassium phosphate--for use only in agricultural products labeled
``made with organic (specified ingredients or food group(s)),''
prohibited in agricultural products labeled ``organic''.
Silicon dioxide.
Sodium citrate.
Sodium hydroxide--prohibited for use in lye peeling of fruits and
vegetables.
[[Page 35181]]
Sodium phosphates--for use only in dairy foods.
Sulfur dioxide--for use only in wine labeled ``made with organic
grapes,'' Provided, That, total sulfite concentration does not exceed
100 ppm.
Tartaric acid.
Tocopherols--derived from vegetable oil when rosemary extracts are
not a suitable alternative.
Xanthan gum.
Sec. 205.606 Nonorganically produced agricultural products allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
(a) Cornstarch (native).
(b) Gums--water extracted only (arabic, guar, locust bean, carob
bean).
(c) Kelp--for use only as a thickener and dietary supplement.
(d) Lecithin--unbleached.
(e) Pectin (high-methoxy).
All comments will be considered in the development of the NOSB's
recommendations to the Secretary.
Authority: 7 U.S.C. 6501 et seq. and 7 CFR part 205.
Dated: June 13, 2005.
Kenneth C. Clayton,
Acting 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.
Evaluation Criteria for Substances Added to the National List
----------------------------------------------------------------------------------------------------------------
Documentation (TAP;
Question Yes No N/A \1\ petition; regulatory
agency; other)
----------------------------------------------------------------------------------------------------------------
Category 1. Adverse impacts on humans or the environment?
----------------------------------------------------------------------------------------------------------------
1. Is there environmental
contamination during manufacture,
use, misuse, or disposal? [Sec.
6518 m.3].
2. Is the substance harmful to the
environment? [Sec.
6517c(1)(A)(i); 6517(c)(2)(A)i].
3. Does the substance contain List
1, 2, or 3 inerts? [Sec.
6517c(1)(B)(ii)].
4. Is there potential for
detrimental chemical interaction
with other materials used? [Sec.
6518 m.1].
5. Are there adverse biological and
chemical interactions in agro-
ecosystem? [Sec. 6518 m.5].
6. Are there detrimental
physiological effects on soil
organisms, crops, or livestock?
[Sec. 6518 m.5].
7. Is there a toxic or other adverse
action of the material or its
breakdown products? [Sec. 6518
m.2].
8. Is there undesirable persistence
or concentration of the material or
breakdown products in environment?
[Sec. 6518 m.2].
9. Is there any harmful effect on
human health? [Sec.
6517c(1)(A)(i); 6517c(2)(A)i; Sec.
6518 m.4].
-------------------------------------
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 wholly natural
substitute product? [Sec.
6517c(1)(A)(ii)].
5. Is the substance used in
handling, not synthetic, but not
organically produced? [Sec.
6517c(1)(B)(iii)].
6. Is there any alternative
substances? [Sec. 6518 m.6].
7. 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 consistent with
organic farming and handling? [Sec.
6517c(1)(A)(iii);
6517c(2)(A)(ii)].
2. Is the substance compatible with
a system of sustainable
agriculture? [Sec. 6518 m.7].
3. Is the substance used in
production, and does it contain an
active synthetic ingredient in the
following categories:
[[Page 35182]]
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?
----------------------------------------------------------------------------------------------------------------
\1\ If the substance under review is for crops or livestock production, all of the questions from 205.600(b) are
N/A--not applicable.
[FR Doc. 05-12007 Filed 6-16-05; 8:45 am]
BILLING CODE 3410-02-P
