This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

2167 

Vol. 72, No. 11 

Thursday, January 18, 2007 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Docket No. AMS–TM–06–0223; TM–06–12] 

National Organic Program— 

Submission of Petitions of Substances 

for Inclusion on or Removal From the 

National List of Substances Allowed 

and Prohibited in Organic Production 

and Handling 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Notice of Guidelines on 

Procedures for Submitting National List 

Petitions. 

SUMMARY: This notice supersedes prior 

Department of Agriculture’s (USDA) 

National Organic Program’s (NOP) 

published guidelines used to submit 

petitions to amend the National List of 

Allowed and Prohibited Substances 

(National List). The National List 

identifies the synthetic substances that 

may be used and the non-synthetic 

substances that may not be used in 

organic production. The National List 

also identifies synthetic and nonsynthetic substances that may be used 

in organic handling. This notice 

provides guidance on who may submit 

petitions, what substances may be 

petitioned and the information that is 

required to be included within a 

submitted petition. Additionally, this 

notice establishes new commercial 

availability evaluation criteria that will 

be applied during the petition review of 

non-organic agricultural substances for 

inclusion onto or removal from 

§ 205.606 of the National List. 

DATES: Effective Date: These guidelines 

will be in effect on January 19, 2007. 

ADDRESSES: Petitions should be 

submitted in duplicate to: Program 

Manager, USDA/AMS/TM/NOP, Room 

4008-So., Ag Stop 0268, 1400 

Independence Ave., SW., Washington, 

DC 20250. Phone: (202) 720–3252. Fax: 

(202) 205–7808. To submit petitions 

electronically, contact the USDA NOP 

for additional instructions. 

FOR FURTHER INFORMATION CONTACT: 

National List Coordinator, National 

Organic Program, USDA/AMS/TM/ 

NOP, Room 4008–So., Ag Stop 0268, 

1400 Independence Ave., SW., 

Washington, DC 20250. Phone: (202) 

720–3252. Fax: (202) 720–3252. 

SUPPLEMENTARY INFORMATION: 

Background 

The Organic Foods Production Act of 

1990 (OFPA), as amended (7 U.S.C. 

6501 et seq.), authorizes the 

establishment of the NOP regulations 

including the National List of Allowed 

and Prohibited Substances (National 

List). This National List identifies the 

synthetic substances that may be used 

and the non-synthetic substances that 

may not be used in organic production, 

and also identifies synthetic and nonsynthetic substances that may be used 

in organic handling. The OFPA and 

NOP regulations, in § 205.105, 

specifically prohibit the use of any 

synthetic substance for organic 

production and handling unless the 

synthetic substance is on the National 

List. Section 205.105 also requires that 

any non-organic, non-synthetic 

substance used in organic handling 

must also be on the National List. Since 

the NOP regulations became effective on 

October 21, 2002, the National List can 

only be amended through rulemaking by 

either the National List Petition Process 

or the National List Sunset Process. The 

guidelines contained in this notice 

apply only to the National List Petition 

Process. 

The ability for any person to petition 

to amend the National List is authorized 

by the OFPA (7 U.S.C. 6518(n)) and the 

NOP regulations, in § 205.607. This 

authorization provides that any person 

may petition the National Organic 

Standards Board (NOSB) for the purpose 

of having a substance evaluated by the 

NOSB for recommendation to the 

Secretary for inclusion on or removal 

from the National List. The NOSB is 

authorized to review petitions under 

specified evaluation criteria in OFPA (7 

U.S.C 6518(m)), and forward 

recommendations for amending the 

National List to the Secretary. Since the 

NOP regulations became effective in 

October 2002, several petitions to 

include synthetic or non-synthetic 

substances in their respective sections 

of the National List have been reviewed 

by the NOSB. However, only a few of 

these petitions were for inclusion of 

non-organic agricultural substances onto 

the National List in § 205.606. 

Until recently, some producers, 

handlers and certifiers may have 

misinterpreted § 205.606 to mean that 

any non-organic agricultural product 

which was determined by an accredited 

certifying agent to be not commercially 

available in organic form could be used 

in organic products, without being 

individually listed pursuant to the 

National List procedures. In January 

2005, the First Circuit decision in 

Harvey v. Johanns held that such an 

interpretation is contrary to the plain 

meaning of the OFPA and ordered that 

7 CFR 205.606 shall not be interpreted 

to create a blanket exemption to the 

National List requirements specified in 

§§ 6517 and 6518 of the OFPA (7 U.S.C. 

6517–6518). Consistent with the district 

court’s final judgment and order, dated 

June 9, 2005, on July 1, 2005, the NOP 

published a notice regarding § 205.606 

(70 FR 38090), and on June 7, 2006, 

published a final rule revising § 205.606 

to clarify that the section shall be 

interpreted to permit the use of a nonorganically produced agricultural 

product only when the product has been 

listed in § 205.606 pursuant to National 

List procedures, and when an accredited 

certifying agent has determined that the 

organic form of the agricultural product 

is not commercially available (71 FR 

32803). As a result, industry 

information provided to the NOP 

indicates that there may be many nonorganic agricultural substances that are 

being used in organic products which 

will render currently certified products 

in non-compliance when the court final 

order and judgment on Harvey v. 

Johanns becomes fully effective on June 

9, 2007. 

This Federal Register Notice, 

developed in collaboration with the 

NOSB and based on its October 2006 

recommendation, modifies the 

information to be included in a petition 

to provide for the review of non-organic 

agricultural substances to be included 

onto § 205.606. This notice also clarifies 

the information to be submitted for all 

types of petitions submitted to amend 

the National List. 


jlentini on PROD1PC65 with RULES
2168 Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Rules and Regulations 

Procedures for Submitting National List 

Petitions 

Any person may submit a petition 

requesting a substance to be reviewed 

by the NOP and NOSB at any time. Each 

substance to be evaluated for the 

National List must be submitted in a 

separate petition. Only single 

substances may be petitioned for 

evaluation; formulated products cannot 

appear on the National List. When 

submitting petitions, an official petition 

contact should be designated for all 

correspondence and the petition should 

provide specific contact information 

including name, address, phone 

number, fax number and e-mail address. 

To facilitate timely NOP review and 

NOSB consideration of petitions, 

petitioners must provide concise yet 

comprehensive responses to the 

required petition information items 

described under the guideline heading 

‘‘Information to be included in a 

Petition.’’ Upon receipt, the NOP will 

review the petition for completeness of 

the required petition information. If the 

required petition information is 

incomplete, the petition will be 

returned to the petitioner with a request 

for additional information. 

Petitions for substance evaluations to 

add a substance onto, remove a 

substance from, or amend a substance 

presently on the National List involves 

a public and open process. Petition 

information not categorized and 

accepted by USDA, pursuant to 7 CFR 

1.27(d), as Confidential Business 

Information (CBI) will be considered 

available to the public for inspection. 

Published information usually cannot 

be claimed as confidential. When a 

petition is considered complete and 

forwarded for NOSB evaluation, except 

for CBI, the petition will be made 

available for public inspection. 

Substance petitions that are complete 

and under evaluation by the NOSB will 

be posted on the NOP Web site at: 

http://www.ams.usda.gov/nop. Public 

comments may be submitted to either 

the NOSB or the NOP for any petitioned 

substance being evaluated by the NOSB. 

Comments also will be posted on the 

NOP Web site. 

Overview of Petition Review by the 

NOSB 

For each completed petition, the 

responsible NOSB committee reviews 

petition information, technical reports 

and public comments, then develops the 

recommendation for full NOSB 

consideration at a scheduled public 

meeting. The NOSB determines when 

petitions will be reviewed at their 

public meetings and when 

recommendations are forwarded to the 

Secretary. 

As provided for in OFPA (7 U.S.C 

6518(m)), when evaluating petitioned 

substances for amendment of the 

National List, the NOSB shall consider: 

(1) The potential of such substances 

for detrimental chemical interactions 

with other materials used in organic 

farming systems; 

(2) The toxicity and mode of action of 

the substance and of its breakdown 

products or any contaminants, and their 

persistence and areas of concentration 

in the environment; 

(3) The probability of environmental 

contamination during manufacture, use, 

misuse or disposal of such substance; 

(4) The effect of the substance on 

human health; 

(5) The effects of the substance on 

biological and chemical interactions in 

the agroecosystem, including the 

physiological effects of the substance on 

soil organisms (including the salt index 

and solubility of the soil), crops and 

livestock; 

(6) The alternatives to using the 

substance in terms of practices or other 

available materials; and 

(7) Its compatibility with a system of 

sustainable agriculture. 

If an agricultural substance is 

petitioned for amendment onto 

§ 205.606 of the National List, the NOSB 

shall verify that the material is 

agricultural. Once the substance is 

verified to be agricultural, the NOSB 

will determine if the substance is 

potentially commercially unavailable. 

The NOSB will consider: 

(A) Why the substance should be 

permitted in the production or handling 

of an organic product; 

(B) The current industry information 

regarding availability of and history of 

unavailability of an organic form in the 

appropriate form, quality, or quantity of 

the substance. Industry information 

includes, but is not limited to the 

following: (1) Regions of production, 

including factors such as climate and 

number of regions; (2) Number of 

suppliers and amount produced; (3) 

Current and historical supplies related 

to weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; (4) Trade related 

issues such as evidence of hoarding, 

war, trade barriers, or civil unrest that 

may temporarily restrict supplies, and 

(5) Other issues which may present a 

challenge to a consistent supply. 

After considering the petition at a 

scheduled public meeting, the NOSB 

will forward its recommendation to the 

Secretary. Upon receipt, the Secretary 

will evaluate the recommendation for 

inclusion onto or removal from the 

National List. Proposed amendments to 

the National List are published in the 

Federal Register as a Proposed Rule. 

After considering and responding to 

public comments on the proposed rule, 

amendments to the National List are 

effective only after publication in the 

Federal Register as a Final Rule. A 

substance that has been petitioned and 

recommended to be allowed for use by 

the NOSB is not allowed for use in 

organic production or handling until the 

final rule for amending the National 

List, if any, is effective. 

When a substance is added onto the 

National List, it will remain on the List 

for 5 years after final rule becomes 

effective. As required by the Sunset 

provision in OFPA (7 U.S.C 6517(e)), 

the NOSB must review substances 

added to the National List at least once 

every 5 years per the National List 

Sunset Process, to reaffirm or not 

reaffirm, the status of each substance on 

the National List. Petitions to reevaluate 

prior NOSB recommendations to 

include a substance onto or remove a 

substance from the National List will be 

considered by the NOSB when 

substantial new petition substance 

information is provided. 

Submitting Petitions for § 205.606 

When submitting petitions to include 

a non-organic agricultural substance 

onto § 205.606, the petitioner must state 

in the petition justification statement, 

why the substance should be permitted 

in the production or handling of an 

organic product. Specifically, the 

petition must include current industry 

information on availability of, and 

history of unavailability of an organic 

form of the substance. When providing 

information on commercial availability 

of the organic form of an agricultural 

product, petitioners must be aware that 

the global market is the universe of 

supply; commercial availability is not 

dependent upon geographic location or 

local market conditions. 

For petitions to remove a non-organic 

agricultural substance from § 205.606, 

the petitioner must state why the 

substance should be prohibited from use 

in a non-organic form. Any information 

acquired since the original petition to 

add the substance to the National List 

should be provided. 

Information To Be Included in a 

Petition 

The guidelines for required 

information to be included in a petition 

are as follows: 

Item A—Please indicate which 

section or sections the petitioned 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Rules and Regulations 2169 

substance will be included on and/or 

removed from the National List. 

• Synthetic substances allowed for 

use in organic crop production, 

§ 205.601. 

• Non-synthetic substances 

prohibited for use in organic crop 

production, § 205.602. 

• Synthetic substances allowed for 

use in organic livestock production, 

§ 205.603. 

• Non-synthetic substances 

prohibited for use in organic livestock 

production, § 205.604. 

• Non-agricultural (non-organic) 

substances allowed in or on processed 

products labeled as ‘‘organic’’ or ‘‘made 

with organic (specified ingredients),’’

§ 205.605. 

• Non-organic agricultural substances 

allowed in or on processed products 

labeled as ‘‘organic,’’ § 205.606. 

Item B—Please provide concise and 

comprehensive responses in providing 

all of the following information items on 

the substance being petitioned: 

1. The substance’s chemical or 

material common name. 

2. The manufacturer’s or producer’s 

name, address and telephone number 

and other contact information of the 

manufacturer/producer of the substance 

listed in the petition. 

3. The intended or current use of the 

substance such as use as a pesticide, 

animal feed additive, processing aid, 

nonagricultural ingredient, sanitizer or 

disinfectant. If the substance is an 

agricultural ingredient, the petition 

must provide a list of the types of 

product(s) (e.g., cereals, salad dressings) 

for which the substance will be used 

and a description of the substance’s 

function in the product(s) (e.g., 

ingredient, flavoring agent, emulsifier, 

processing aid). 

4. A list of the crop, livestock or 

handling activities for which the 

substance will be used. If used for crops 

or livestock, the substance’s rate and 

method of application must be 

described. If used for handling 

(including processing), the substance’s 

mode of action must be described. 

5. The source of the substance and a 

detailed description of its 

manufacturing or processing procedures 

from the basic component(s) to the final 

product. Petitioners with concerns for 

confidential business information may 

follow the guidelines in the Instructions 

for Submitting CBI listed in #13. 

6. A summary of any available 

previous reviews by State or private 

certification programs or other 

organizations of the petitioned 

substance. If this information is not 

available, the petitioner should state so 

in the petition. 

7. Information regarding EPA, FDA, 

and State regulatory authority 

registrations, including registration 

numbers. If this information does not 

exist, the petitioner should state so in 

the petition. 

8. The Chemical Abstract Service 

(CAS) number or other product numbers 

of the substance and labels of products 

that contains the petitioned substance. If 

the substance does not have an assigned 

product number, the petitioner should 

state so in the petition. 

9. The substance’s physical properties 

and chemical mode of action including 

(a) Chemical interactions with other 

substances, especially substances used 

in organic production; (b) toxicity and 

environmental persistence; (c) 

environmental impacts from its use and/ 

or manufacture; (d) effects on human 

health; and, (e) effects on soil 

organisms, crops, or livestock. 

10. Safety information about the 

substance including a Material Safety 

Data Sheet (MSDS) and a substance 

report from the National Institute of 

Environmental Health Studies. If this 

information does not exist, the 

petitioner should state so in the 

petition. 

11. Research information about the 

substance which includes 

comprehensive substance research 

reviews and research bibliographies, 

including reviews and bibliographies 

which present contrasting positions to 

those presented by the petitioner in 

supporting the substance’s inclusion on 

or removal from the National List. For 

petitions to include non-organic 

agricultural substances onto the 

National List, this information item 

should include research concerning 

why the substance should be permitted 

in the production or handling of an 

organic product, including the 

availability of organic alternatives. 

Commercial availability does not 

depend upon geographic location or 

local market conditions. If research 

information does not exist for the 

petitioned substance, the petitioner 

should state so in the petition. 

12. A ‘‘Petition Justification 

Statement’’ which provides justification 

for any of the following actions 

requested in the petition: 

A. Inclusion of a Synthetic on the 

National List, §§ 205.601, 205.603, 

205.605(b) 

• Explain why the synthetic 

substance is necessary for the 

production or handling of an organic 

product. 

• Describe any non-synthetic 

substances, synthetic substances on the 

National List or alternative cultural 

methods that could be used in place of 

the petitioned synthetic substance. 

• Describe the beneficial effects to the 

environment, human health, or farm 

ecosystem from use of the synthetic 

substance that support its use instead of 

the use of a non-synthetic substance or 

alternative cultural methods. 

B. Removal of a Synthetic From the 

National List, §§ 205.601, 205.603, 

205.605(b) 

• Explain why the synthetic 

substance is no longer necessary or 

appropriate for the production or 

handling of an organic product. 

• Describe any non-synthetic 

substances, synthetic substances on the 

National List or alternative cultural 

methods that could be used in place of 

the petitioned synthetic substance. 

C. Inclusion of a Prohibition of a NonSynthetic, §§ 205.602 and 205.604 

• Explain why the non-synthetic 

substance should not be permitted in 

the production of an organic product. 

• Describe other non-synthetic 

substances or synthetic substances on 

the National List or alternative cultural 

methods that could be used in place of 

the petitioned substance. 

D. Removal of a Prohibited NonSynthetic From the National List, 

§§ 205.602 and 205.604 

• Explain why the non-synthetic 

substance should be permitted in the 

production of an organic product. 

• Describe the beneficial effects to the 

environment, human health, or farm 

ecosystem from use of the non-synthetic 

substance that supports its use instead 

of the use of other non-synthetic or 

synthetic substances on the National 

List or alternative cultural methods. 

E. Inclusion of a Non-Synthetic, NonAgricultural Substance Onto the 

National List, § 205.605(a) 

• Explain why the substance is 

necessary for use in organic handling. 

• Describe non-synthetic or synthetic 

substances on the National List or 

alternative cultural methods that could 

be used in place of the petitioned 

synthetic substance. 

• Describe any beneficial effects on 

the environment, or human health from 

the use of the substance that support its 

use instead of the use of non-synthetic 

or synthetic substances on the National 

List or alternative cultural methods. 

F. Removal of a Non-Synthetic, NonAgricultural Substance From the 

National List, § 205.605(a) 

• Explain why the substance is no 

longer necessary for use in organic 

handling. 


jlentini on PROD1PC65 with RULES
2170 Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Rules and Regulations 

• Describe any non-synthetic or 

synthetic substances on the National 

List or alternative cultural methods that 

could be used in place of the petitioned 

substance. 

G. Inclusion of a Non-Organically 

Produced Agricultural Substance Onto 

the National List, § 205.606 

• Provide a comparative description 

on why the non-organic form of the 

substance is necessary for use in organic 

handling. 

• Provide current and historical 

industry information/research/evidence 

that explains how or why the substance 

cannot be obtained organically in the 

appropriate form, appropriate quality, 

and appropriate quantity to fulfill an 

essential function in a system of organic 

handling. 

• Describe industry information on 

substance non-availability of organic 

sources including but not limited to the 

following guidance regarding 

commercial availability evaluation 

criteria: (1) Regions of production, 

including factors such as climate and 

number of regions; (2) Number of 

suppliers and amount produced; (3) 

Current and historical supplies related 

to weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; (4) Trade related 

issues such as evidence of hoarding, 

war, trade barriers, or civil unrest that 

may temporarily restrict supplies, and 

(5) Other issues which may present a 

challenge to a consistent supply. 

H. Removal of a Non-Organically 

Produced Agricultural Substance From 

the National List, § 205.606 

• Provide a comparative description 

as to why the non-organic form of the 

substance is not necessary for use in 

organic handling. 

• Provide current and historical 

industry information/research/evidence 

that explains how or why the substance 

can be obtained organically in the 

appropriate form, appropriate quality, 

and appropriate quantity to fulfill an 

essential function in a system of organic 

handling. 

• Provide new industry information 

on substance availability of organic 

sources including but not limited to the 

following guidance commercial 

availability evaluation criteria: (1) 

Region of production, including factors 

such as climate and number of regions; 

(2) Number of suppliers and amount 

produced; (3) Current and historical 

supplies related to weather events such 

as hurricanes, floods, or droughts that 

temporarily halt production or destroy 

crops or supplies; (4) Trade related 

issues such as evidence of hoarding, 

war, trade barriers, and civil unrest that 

may temporarily restrict supplies and; 

(5) Any other issues which may present 

a challenge to a consistent supply. 

13. A Confidential Business 

Information Statement which describes 

the specific required information 

contained in the petition that is 

considered to be Confidential Business 

Information (CBI) or confidential 

commercial information and the basis 

for that determination. Petitioners 

should limit their submission of 

confidential information to that needed 

to address the areas for which this 

notice requests information. Final 

determination regarding whether to 

afford CBI treatment to submitted 

petitions will be made by USDA 

pursuant to 7 CFR 1.27(d). Instructions 

for submitting CBI to the National List 

Petition process are presented in the 

instructions below: 

(a) Financial or commercial 

information the petitioner does not want 

disclosed for competitive reasons may 

be claimed as CBI. Applicants must 

submit a written justification to support 

each claim. 

(b) ‘‘Trade secrets’’ (information 

relating to the production process, such 

as formulas, processes, quality control 

tests and data, and research 

methodology) may be claimed as CBI. 

This information must be (1) 

commercially valuable, (2) used in the 

applicant’s business, and (3) maintained 

in secrecy. 

(c) Each page containing CBI material 

must have ‘‘CBI Copy’’ marked in the 

upper right corner of the page. In the 

right margin, mark the CBI information 

with a bracket and ‘‘CBI.’’

(d) The CBI-deleted copy should be a 

facsimile of the CBI copy, except for 

spaces occurring in the text where CBI 

has been deleted. Be sure that the CBIdeleted copy is paginated the same as 

the CBI copy (The CBI-deleted copy of 

the application should be made from the 

same copy of the application which 

originally contained CBI). Additional 

material (transitions, paraphrasing, or 

generic substitutions, etc.) should not be 

included in the CBI-deleted copy. 

(e) Each page with CBI-deletions 

should be marked ‘‘CBI-deleted’’ at the 

upper right corner of the page. In the 

right margin, mark the place where the 

CBI material has been deleted with a 

bracket and ‘‘CBI-deleted.’’

(f) If several pages are CBI-deleted, a 

single page designating the numbers of 

deleted pages may be substituted for 

blank pages. (For example, ‘‘pages 7 

through 10 have been CBI-deleted.’’) 

(g) All published references that 

appear in the CBI copy should be 

included in the reference list of the CBIdeleted copy. Published information 

cannot be claimed as confidential. 

(h) Final determination regarding 

whether to afford CBI treatment to 

submitted petitions will be made by 

USDA pursuant to 7 CFR 1.27(d). If a 

determination is made to deny CBI 

treatment, the petitioner will be 

afforded an opportunity to withdraw the 

submission. 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this rule. 

Accordingly, OMB clearance is not 

required by § 305(h) of the Paperwork 

Reduction Act of 1995, 44 U.S.C. 3501, 

et seq., or OMB’s implementation 

regulation at 5 CFR, part 1320. 

Authority: 7 U.S.C. 6501–6522. 

Dated: January 10, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E7–596 Filed 1–17–07; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 980 

[Docket No. FV06–980–1 FR] 

Vegetables, Import Regulations; Partial 

Exemption to the Minimum Grade 

Requirements for Fresh Tomatoes 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This rule provides a partial 

exemption to the minimum grade 

requirements under the tomato import 

regulation. The import regulation is 

authorized under section 8e of the 

Agricultural Marketing Agreement Act 

of 1937 (Act). Section 8e requires 

imported tomatoes to meet the same or 

comparable grade and size requirements 

as those in effect under Federal 

Marketing Order No. 966 (order). The 

order regulates the handling of tomatoes 

grown in Florida. A separate rule to 

amend the rules and regulations under 

the order to exempt UglyRipeTM

(UglyRipe) tomatoes from the shape 

requirements associated with the U.S. 

No. 2 grade is being issued by 

Department of Agriculture (USDA). This 

rule provides the same partial 

exemption under the import regulation 

so it will conform to the regulations for 

Florida tomatoes under the order. 

DATES: Effective Date: This final rule 

becomes effective January 19, 2007. 


jlentini on PROD1PC65 with RULES