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

31495 

Vol. 76, No. 105 

Wednesday, June 1, 2011 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Doc. No. AMS–NOP–11–0003; NOP–10–13] 

RIN 0581–AD13 

National Organic Program, Sunset 

Review (2013) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Advance notice of proposed 

rulemaking with request for comments. 

SUMMARY: The Organic Foods 

Production Act of 1990 (OFPA) requires 

sunset (expiration) of the exempted or 

prohibited use of substances on the 

National List of Allowed and Prohibited 

Substances (National List) under the 

National Organic Program (NOP). The 

exemptions and prohibitions granted on 

the National List 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 the 

substances are not reviewed by the 

NOSB and renewed by the Secretary 

within 5 years of their inclusion on the 

National List, then their authorized use 

or prohibition expires. As required by 

the OFPA, the allowed use of 11 

synthetic and nonsynthetic substances 

in organic production and handling will 

expire on November 3, 2013. A 

prohibition on one nonsynthetic 

substance in organic production will 

expire on November 3, 2013. This 

advance notice of proposed rulemaking 

(ANPR) begins the public comment 

process on whether the identified 

existing exemptions or prohibition 

should be continued. This ANPR also 

establishes that the sunset review and 

renewal process must be concluded by 

November 3, 2013. Finally, this ANPR 

discusses how the NOP will manage the 

sunset review and renewal process. 

DATES: Comments must be submitted on 

or before August 1, 2011. 

ADDRESSES: Interested persons may 

submit written comments on this ANPR 

using one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–NOP, Room 

2646–So., Ag Stop 0268, 1400 

Independence Ave., SW., Washington, 

DC 20250–0268. 

Written comments responding to this 

ANPR should be identified with the 

docket number AMS–NOP–11–0003; 

NOP–10–13. For detailed instructions 

on submitting comments and additional 

information on the rulemaking process, 

see the ‘‘Guidance on Submitting Your 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. The NOP intends to 

have all comments concerning this 

ANPR, including names and addresses 

when provided, whether submitted by 

mail or internet, available for viewing 

on the Federal eRulemaking Portal 

internet site, http:// 

www.regulations.gov. Comments 

submitted in response to this ANPR will 

also be available for viewing in person 

at USDA–AMS, National Organic 

Program, Room 2646–South Building, 

1400 Independence Ave., SW., 

Washington, DC, from 9 a.m. to 12 noon 

and from 1 p.m. to 4 p.m., Monday 

through Friday (except official Federal 

holidays). Persons wanting to visit the 

USDA South Building to view 

comments received in response to this 

ANPR are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Director, Standards 

Division, National Organic Program, 

USDA–AMS–NOP, 1400 Independence 

Ave., SW., Room 2646–So., Ag Stop 

0268, Washington, DC 20250–0268. 

Telephone: (202) 720–3252. 

SUPPLEMENTARY INFORMATION: 

Background 

The Organic Foods Production Act of 

1990 (OFPA), 7 U.S.C. 6501 et seq., 

authorizes the establishment of the 

National List. The National List 

identifies synthetic substances that are 

exempted (allowed) and nonsynthetic 

substances that are prohibited in organic 

crop and livestock production. The 

National List also identifies 

nonsynthetic and synthetic substances 

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 the substances 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 

under OFPA’s sunset provision. 

This ANPR announces the sunset of 

11 exempted substances and 1 

prohibition added to the National List 

on November 3, 2003 (68 FR 61987) and 

November 4, 2003 (68 FR 62215), and 

previously renewed under the sunset 

process on November 3, 2008 (73 FR 

59479). This ANPR establishes 

November 3, 2013, as the date by which 

the sunset review and renewal process 

must be concluded. The exemptions and 

prohibitions not renewed by this date 

will be removed from the National List. 

This ANPR also begins the public 

comment process on whether the 

existing specific exemptions on the 

National List should be continued. This 

ANPR discusses how the NOP will 

manage the sunset review and renewal 

process. 

Because these substances may be 

critical to the production and handling 

of raw and processed organic 

agricultural products, their expiration 

could cause disruption of wellestablished and accepted organic 

production, handling, and processing 

systems. Therefore, the NOP is initiating 

the sunset review and renewal process 

now, to provide ample opportunity for 

the public to make their views known 

and to inform the decisions of the 

NOSB. 

Crops Production Substances 

The NOSB Crops Committee will 

review the continued exemption (use) of 

six listings of synthetic substances 

allowed for use in organic crop 

production on § 205.601: copper sulfate 

(2 listings), ozone gas, peracetic acid (2 

listings), and EPA List 3 inert 

ingredients. These six listings are 

scheduled to sunset (expire) on 

November 3, 2013. The Crops 

Committee will also review the 

continued prohibition of one 


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31496 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules 

nonsynthetic substance, calcium 

chloride, listed on § 205.602, scheduled 

to sunset on November 3, 2013. Table 1 

contains the full listings of crop 

production substances to be reviewed 

under the 2013 sunset process. 

TABLE 1—CROPS COMMITTEE SUNSET 2013 SUBSTANCES

National list section Substance listing Sunset date 

Synthetic substances allowed for use in organic crop production. 

205.601(a)(3) ....................... Copper sulfate—for use as an algicide in aquatic rice systems, is limited to one application 

per field during any 24-month period. Application rates are limited to those which do not 

increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent.

November 3, 

2013. 

205.601(a)(5) ....................... Ozone gas—for use as an irrigation system cleaner only ......................................................... November 3, 

2013. 

205.601(a)(6) ....................... Peracetic acid—for use in disinfecting equipment, seed, and asexually propagated planting 

material.

November 3, 

2013. 

205.601(e)(4) ....................... Copper sulfate—for use as tadpole shrimp control in aquatic rice production, is limited to 

one application per field during any 24-month period. Application rates are limited to levels 

which do not increase baseline soil test values for copper over a timeframe agreed upon 

by the producer and accredited certifying agent.

November 3, 

2013. 

205.601(i)(8) ......................... Peracetic acid—for use to control fire blight bacteria ................................................................ November 3, 

2013. 

205.601(m)(2) ...................... EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone dispensers ........ November 3, 

2013. 

Nonsynthetic substances prohibited for use in organic crop production. 

205.602(c) ............................ Calcium chloride, brine process is natural and prohibited for use except as a foliar spray to 

treat a physiological disorder associated with calcium uptake.

November 3, 

2013. 

Handling Substances 

The NOSB Handling Committee will 

review the continued exemption (use) of 

six nonagricultural (nonorganic), 

nonsynthetic substances allowed as 

ingredients in or on processed products 

labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food 

groups(s)).’’ The allowed uses of the 

following six substances listed on 

§ 205.605(a) are scheduled to expire on 

November 3, 2013: agar-agar, animal 

enzymes, calcium sulfate, carrageenan, 

glucono delta-lactone, and tartaric acid. 

The Handling Committee will also 

review the continued exemption (use) of 

two nonagricultural (nonorganic), 

synthetic substances allowed as 

ingredients in or on processed products 

labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food 

groups(s)).’’ The allowed uses of the 

following two substances listed on 

§ 205.605(b) are scheduled to expire 

November 3, 2013: cellulose and tartaric 

acid. Table 2 contains the full listings of 

handling substances that will be 

reviewed under the 2013 sunset process. 

TABLE 2—HANDLING COMMITTEE SUNSET 2013 SUBSTANCES

National list section Substance listing Sunset date 

Nonsynthetics allowed: 

205.605(a) ........................................ Agar-agar ................................................................................................................ November 3, 

2013. 

205.605(a) ........................................ Animal enzymes—(Rennet-animals derived; Catalase-bovine liver; Animal 

lipase; Pancreatin; Pepsin; and Trypsin).

November 3, 

2013. 

205.605(a) ........................................ Calcium sulfate—mined .......................................................................................... November 3, 

2013. 

205.605(a) ........................................ Carrageenan ........................................................................................................... November 3, 

2013. 

205.605(a) ........................................ Glucono delta-lactone—production by the oxidation of D-glucose with bromine 

water is prohibited.

November 3, 

2013. 

205.605(a) ........................................ Tartaric acid—made from grape wine .................................................................... November 3, 

2013. 

Synthetics allowed: 

205.605(b) ........................................ Cellulose—for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.November 3, 

2013. 

205.605(b) ........................................ Tartaric acid—made from malic acid ...................................................................... November 3, 

2013. 

The Sunset Process 

All substances currently on the 

National List have been previously 

evaluated by the NOSB for consistency 

with OFPA and its implementing 

regulations. According to § 6517(e) of 

the OFPA, these substances must be 

reviewed by the NOSB and renewed by 

the Secretary for their use or prohibition 

to continue after 5 years of their 

addition to the National List which will 

be November 3, 2013. All substances 

identified under this notice were 

previously renewed under the sunset 


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process on November 4, 2008 (73 FR 

59479), and must be reviewed again by 

November 3, 2013. 

This notice requests public comments 

about the continued use or prohibition 

of the substances identified. Public 

comments submitted will be considered 

in the review and renewal process. The 

NOP will forward comments received 

under this notice to the NOSB for 

review. The NOSB will review the 

listings of allowed and prohibited 

substances scheduled to sunset, 

including the public comments received 

during this review. The NOSB will 

review each of the substances listed in 

this notice and may determine that 

certain substances warrant a more indepth review and require additional 

information or research that considers 

new scientific data and technological 

and market advances. 

Following the NOSB’s review, the 

NOSB will make a recommendation to 

the Secretary about the continuation of 

specific exemptions and prohibitions for 

the substances listed in this ANPR. 

After the Secretary receives and reviews 

the NOSB’s recommendations, the NOP 

will publish a proposed rule regarding 

the NOSB recommendations. This 

proposed rule will provide an 

additional opportunity for the public to 

submit written comments. 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 for substances scheduled to sunset 

in 2013. 

Guidance on Submitting Your 

Comments 

Written comments responding to this 

ANPR should be identified with the 

docket number AMS–NOP–11–0003; 

NOP–10–13. You should clearly 

indicate your position on continuing the 

allowance or prohibition of the 

substances identified in this ANPR and 

the reasons for your position. You 

should include relevant information and 

data to support your position (e.g., 

scientific, environmental, 

manufacturing, industry impact 

information, etc.). 

Comments, regardless of whether they 

support or do not support the continued 

use of a substance(s) listed within this 

ANPR, should provide evidence 

concerning the viability of alternatives 

for the substance under sunset review. 

Viable alternatives include, but are not 

limited to, alternative management 

practices that would eliminate the need 

for the specific substance; other 

currently exempted substances that are 

on the National List, which could 

eliminate the need for this specific 

substance; and other organic or 

nonorganic agricultural substances. 

Such evidence should adequately 

address whether any alternatives have a 

function and effect equivalent to or 

better than the specific exempted 

substance, and whether you want the 

substance to be renewed or do not want 

its use to be continued. Assertions about 

alternative substances, 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; 

names and addresses of producers or 

handlers 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 the substance under 

review. The information provided in 

Table 3 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. 

An Appendix to this ANPR contains 

worksheets to assist you in gathering 

relevant information concerning these 

issues. These worksheets are not 

required to submit a comment. These 

worksheets are used by the NOSB to 

develop their recommendations to the 

Secretary to include an exempted 

substance on the National List. You do 

not have to answer the questions on the 

worksheets; they are intended only to 

help you provide substantive comments 

to the NOSB when you provide 

comments on the specific substance. 

Comments That Support Existing 

Exemptions and Prohibitions 

Comments in support of a continued 

exemption of a substance should 

demonstrate that the substance is: (1) 

Not harmful to human health or the 

environment, (2) necessary to the 

production of the agricultural products 

because of the unavailability of wholly 

nonsynthetic substitute products, and 

(3) consistent with organic production 

and handling. Comments in support of 

a continued prohibition should explain 

how the use of the substance would 

continue to be: (1) harmful to human 

health or the environment, or (2) 

inconsistent with organic farming and 

handling. 

Comments That DO NOT Support 

Continuing Existing Exemptions or 

Prohibitions 

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. 

If you provide comments that do not 

support continuing an existing 

exemption or prohibition, you should 

provide reasons why the use of the 

substance should no longer be allowed 

or prohibited in organic agricultural 

production and handling. Specifically, 

comments that support the removal of a 

substance from the National List should 

provide information to demonstrate that 

the substance is: (1) Harmful to human 

health or the environment; (2) 

unnecessary because of the availability 

of alternatives; or (3) inconsistent with 

organic farming or handling. Comments 

that do not support a continued 

prohibition should explain how the use 

of the substance would not be: (1) 

harmful to human health or the 

environment, or (2) inconsistent with 

organic farming and handling. 

TABLE 3—GUIDANCE ON SUBMITTING COMMENTS FOR ALTERNATIVES TO SUBSTANCES ON THE NATIONAL LIST. 

If the currently listed substance 

is used in . . . And is a . . . Then the recommended alternative should be a (an) . . . 

Crop Production ......................... Synthetic substance ......................................................................... —Another currently listed synthetic substance; 

—Nonsynthetic substance; or 

—Management practice. 


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TABLE 3—GUIDANCE ON SUBMITTING COMMENTS FOR ALTERNATIVES TO SUBSTANCES ON THE NATIONAL LIST.— 

Continued 

If the currently listed substance 

is used in . . . And is a . . . Then the recommended alternative should be a (an) . . . 

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

—Nonsynthetic substance. 

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

—Management practice. 

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

—Nonsynthetic (non-agricultural) substance; or 

—Management practice. 

The NOP understands that supportive 

technical or scientific information for 

synthetic alternatives not currently on 

the National List may not be easily 

available to organic producers and 

handlers. Such information may, 

however, be available from the research 

community including universities, or 

other sources, including international 

organic programs. 

Request for Comments 

The NOP requests that you comment 

whether the NOSB should continue to 

recommend the exemptions and 

prohibitions listed above on the 

National List of Allowed and Prohibited 

Substances for organic agricultural 

production and handling. All comments 

will be considered in the development 

of the NOSB’s recommendations to the 

Secretary. 

Authority: 7 U.S.C. 6501–6522 and 7 CFR 

part 205 

Dated: May 24, 2011. 

Rayne Pegg, 

Administrator, Agricultural Marketing 

Service. 

Appendix 

This Appendix contains worksheets 

to assist you in gathering relevant 

information concerning the 

compatibility of substances with 

evaluation criteria of the OFPA. These 

worksheets are not required to submit a 

comment. These worksheets are used by 

the NOSB to develop their 

recommendations to the Secretary to 

include an exempted or prohibited 

substance on the National List. You do 

not have to answer the questions on the 

worksheets; they are intended only to 

help you provide substantive comments 

to the NOSB when you provide 

comments on the specific substance. 

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Question Yes No N/A1

Documentation 

(TAP; petition; regulatory 

agency; other) 

Category 1. Adverse impacts on humans or the environment? 

1. Are there adverse effects on environment from manufacture, use, or 

disposal? [§ 205.600 b.2].

2. Is there environmental contamination during manufacture, use, misuse, 

or disposal? [§ 6518 m.3].

3. Is the substance harmful to the environment? 

[§ 6517(c)(1)(A)(i);6517(c)(2)(A)(i)].

4. Does the substance contain List 1, 2, or 3 inerts? [§ 6517(c)(1)(B)(ii); 

§ 205.601(m)(2)].

5. Is there potential for detrimental chemical interaction with other materials used? [§ 6518(m)(1)].

6. Are there adverse biological and chemical interactions in agro-ecosystem? [§ 6518(m)(5)].

7. Are there detrimental physiological effects on soil organisms, crops, or 

livestock? [§ 6518(m)(5)].

8. Is there a toxic or other adverse action of the material or its breakdown products? [§ 6518(m)(2)].

9. Is there undesirable persistence or concentration of the material or 

breakdown products in environment?[§ 6518(m)(2)].

10. Is there any harmful effect on human health? [§ 6517(c)(1)(A)(i); 

§ 6517(c)(2)(A)(i); § 6518(m)(4)].

11. Is there an adverse effect on human health as defined by applicable 

Federal regulations? [§ 205.600(b)(3)].

12. Is the substance GRAS when used according to FDA’s good manufacturing practices? [§ 205.600(b)(5)].

13. Does the substance contain residues of heavy metals or other contaminants in excess of FDA tolerances? [§ 205.600(b)(5)].

1 If the substance under review is for crop or livestock production, all of the questions from § 205.600(b) are N/A—not applicable. 


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Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules 31499 

Category 2. Is the substance essential for organic production? 

1. Is the substance formulated or manufactured by a chemical process? 

[§ 6502(21)].

2. Is the substance formulated or manufactured by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral, sources? [§ 6502(21)].

3. Is the substance created by naturally occurring biological processes? 

[§ 6502(21)].

4. Is there a natural source of the substance? [§ 205.600(b)(1)] ................

5. Is there an organic substitute? [§ 205.600(b)(1)] ....................................

6. Is the substance essential for handling of organically produced agricultural products? [§ 205.600(b)(6)].

7. Is there a wholly natural substitute product? [§ 6517(c)(1)(A)(ii)] ...........

8. Is the substance used in handling, not synthetic, but not organically 

produced? [§ 6517(c)(1)(B)(iii)].

9. Is there any alternative substances? [§ 6518(m)(6)] ...............................

10. Is there another practice that would make the substance unnecessary? [§ 6518(m)(6)].

1 If the substance under review is for crop or livestock production, all of the questions from § 205.600(b) are N/A—not applicable. 

Category 3. Is the substance compatible with organic production practices? 

1. Is the substance compatible with organic handling? [§ 205.600(b)(2)] ...

2. Is the substance consistent with organic farming and handling? 

[§ 6517(c)(1)(A)(iii); § 6517(c)(2)(A)(ii)].

3. Is the substance compatible with a system of sustainable agriculture? 

[§ 6518(m)(7)].

4. Is the nutritional quality of the food maintained with the substance? 

[§ 205.600(b)(3)].

5. Is the primary use as a preservative? [§ 205.600(b)(4)] .........................

6. Is the primary use to recreate or improve flavors, colors, textures, or 

nutritive values lost in processing (except when required by law, e.g., 

vitamin D in milk)? [§ 205.600(b)(4)].

7. Is the substance used in production, and does it contain an active synthetic ingredient in the following categories:.

a. copper and sulfur compounds; .........................................................

b. toxins derived from bacteria; ............................................................

c. pheromones, soaps, horticultural oils, fish emulsions, treated 

seed, vitamins and minerals? 

d. livestock parasiticides and medicines? ............................................

e. production aids including netting, tree wraps and seals, insect 

traps, sticky barriers, row covers, and equipment cleaners? 

1 If the substance under review is for crop or livestock production, all of the questions from 205.600(b) are N/A—not applicable.

[FR Doc. 2011–13496 Filed 5–31–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 92, 93, 94, 96, and 98 

[Docket No. APHIS–2009–0035] 

RIN 0579–AD05 

Lists of Regions Classified With 

Respect to Certain Animal Diseases 

and States Approved To Receive 

Certain Imported Horses 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing to remove 

lists of regions classified with respect to 

certain animal diseases and pests from 

our animal and animal product import 

regulations and, instead, post them to 

the Animal and Plant Health Inspection 

Service’s (APHIS’) Web site. The 

regulations would provide the Web 

address and would explain APHIS’ 

criteria and process for adding a region 

to, or removing a region from, each of 

the lists. The technical criteria APHIS 

uses to evaluate whether a region 

should be added to or removed from a 

list would not change. We are also 

proposing to remove lists of States 

approved to receive horses imported 

from foreign regions where we consider 

contagious equine metritis to exist and, 

instead, post approved States to our 

Web site. The criteria for approving a 

State would not change. We would 

continue to provide an opportunity for 

public comment on changes to the lists. 

This action would enable the Agency to 

respond more quickly to changes in the 

disease status of regions. 

DATES: We will consider all comments 

that we receive on or before August 1, 

2011. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS2009-0035 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS–2009–0035, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2009–0035. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 


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