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.

Proposed Rules Federal Register

35177

Vol. 70, No. 116

Friday, June 17, 2005

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 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.

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) homepage (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: 

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 

35178 Federal Register / Vol. 70, No. 116 / Friday, June 17, 2005 / Proposed Rules 

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 ............................ —Another currently listed synthetic substance; 

—Nonsynthetic substance; or 

—Management practice. 

Crop or Livestock Production .............. Synthetic inert substance (pesticidal) —Another currently listed synthetic substance or 

—Nonsynthetic substance. 

Handling ............................................... Synthetic substance ............................ —Another currently listed synthetic substance; 

—Nonsynthetic (non-ag) substance; or 

—Management practice. 

Handling ............................................... Nonsynthetic (non-ag) substance ....... —Agricultural substance; or 

—Management practice. 

Handling ............................................... Nonorganic agricultural product .......... —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 

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 

Federal Register / Vol. 70, No. 116 / Friday, June 17, 2005 / Proposed Rules 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:

§ 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.

§ 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. 

35180 Federal Register / Vol. 70, No. 116 / Friday, June 17, 2005 / Proposed Rules 

(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.

§ 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. 

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. 

Federal Register / Vol. 70, No. 116 / Friday, June 17, 2005 / Proposed Rules 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.

§ 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

Question Yes No N/A1 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: 

35182 Federal Register / Vol. 70, No. 116 / Friday, June 17, 2005 / Proposed Rules 

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other) 

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

AGENCY: Agricultural Marketing Service, 

USDA.

ACTION: Proposed rule.

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: 

http://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 

Office of the Docket Clerk during regular 

business hours, or can be viewed at: 

http://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.

SUPPLEMENTARY INFORMATION: 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 

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