[Federal Register Volume 70, Number 116 (Friday, June 17, 2005)]
[Proposed Rules]
[Pages 35177-35182]
From the Federal Register Online via the Government Publishing 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: [email protected].
     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 (http://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: 
[email protected].

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?
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\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