1996 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

1Table 1 shows a simplified listing for each 

substance; use categories and any restrictive 

annotations are not included in this overview. 

§ 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)).’’ 

* * * * * 

(b) * * * 

* * * * * 

Vitamins and minerals. For food— 

vitamins and minerals identified as 

essential in 21 CFR 101.9. For infant 

formula—vitamins and minerals as 

required by 21 CFR 107.100 or § 107.10. 

* * * * * 

Dated: January 6, 2012. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–354 Filed 1–11–12; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–09–0074; 

NOP–09–01PR] 

RIN 0581–AC96 

National Organic Program (NOP); 

Sunset Review (2012) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

address recommendations submitted to 

the Secretary of Agriculture (Secretary) 

by the National Organic Standards 

Board (NOSB) on April 29, 2010, 

October 28, 2010, and April 29, 2011. 

These recommendations pertain to the 

2012 Sunset Review of substances on 

the U.S. Department of Agriculture’s 

(USDA) National List of Allowed and 

Prohibited Substances (National List). 

Consistent with the NOSB 

recommendations, the proposed rule 

would continue, without change, the 

exemptions (use) and prohibitions for 

multiple listings on the National List for 

5 years after their respective sunset 

dates. This proposed rule would amend 

the exemptions (use) or prohibition for 

7 substances and remove the exemption 

for 3 substances on the National List. 

DATES: Comments must be received by 

February 13, 2012. 

ADDRESSES: Interested persons may 

submit written comments on this 

proposed rule using the following 

addresses: 

• 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, 1400 

Independence Ave. SW., Room 2646– 

So., Ag Stop 0268, Washington, DC 

20250. 

Instructions: All submissions received 

must include the docket number AMS– 

NOP–09–0074; NOP–09–01, and/or 

Regulatory Information Number (RIN) 

0581–AC96 for this rulemaking. 

Commenters should identify the topic 

and section number of this proposed 

rule to which the comment refers. You 

should clearly indicate your position to 

continue, discontinue or further restrict 

the allowance of any substances as 

identified in this proposed rule 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 for the substance. Only the 

supporting material relevant to your 

position will be considered. All 

comments received will be posted 

without change to http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. Comments 

submitted in response to this proposed 

rule will also be available for viewing in 

person at USDA–AMS, National Organic 

Program, 1400 Independence Ave. SW., 

Room 2646–South Building, 

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 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, Telephone: (202) 

720–3252; Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Organic Foods Production Act of 

1990 (OFPA), 7 U.S.C. 6501–6522, 

authorizes the establishment of the 

National List. The National List 

identifies synthetic substances that are 

exempted (allowed) in organic 

production and nonsynthetic substances 

that are prohibited in organic crop and 

livestock production. The National List 

also identifies nonagricultural 

nonsynthetic, nonagricultural synthetic 

and nonorganic agricultural substances 

that may be used 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 within 5 years of their inclusion 

on the National List and addressed by 

the Secretary, then their authorized use 

or prohibition expires under OFPA’s 

sunset provision. 

In response to the sunset provisions 

in the OFPA, the Secretary published an 

Advanced Notice of Proposed 

Rulemaking (ANPR) in the Federal 

Register on March 26, 2010 (75 FR 

14500), announcing the review of 

exempted and prohibited substances 

codified at the National List of the 

National Organic Program (NOP) 

regulations and set to expire in 2012. A 

list of these substances is provided as 

Table 1 in the Overview of Proposed 

Actions section.1 The ANPR explained 

that, unless reviewed and recommended 

by the NOSB, a synthetic substance 

exempted for use on the National List in 

2007 and currently allowed for use in 

organic production would no longer be 

allowed for use after its respective 

sunset date in 2012; a nonsynthetic 

substance prohibited from use on the 

National List in 2007 and currently 

prohibited from use in organic 

production would be allowed after its 

respective sunset date in 2012; and a 

synthetic or nonsynthetic substance 

exempted for use on the National List in 

2007 and currently allowed for use in 

organic handling would be prohibited 

after its respective sunset date in 2012. 

The ANPR announced the upcoming 

review of these substances by the NOSB 

and the NOP’s intent to complete the 

sunset process based upon 

recommendations by the NOSB for all 

listings added to the National List in 

2007. The ANPR notified the public that 

this rulemaking would be completed by 

the earliest respective sunset date, June 

27, 2012. The ANPR also requested 

public comment on the continued use or 

prohibition of these substances. The 

public comment period lasted 60 days. 

The NOP received approximately 100 

comments in response to the ANPR. 

Comments were received from 

consumers, organic crop producers, 

academia, accredited certifying agents, 

trade associations, retailers and organic 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 1997 

2October 28, 2010, NOSB Recommendation on 

Sunset Review Process. Available at NOP Web site: 

http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5088004&acct=nosb. 

3April 14, 2011, Letter from FDA to NOP on the 

FDA Fortification Policy at 21 CFR 104.20. 

Available at NOP Web site: http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5090415. 

associations. Most comments voiced 

support for all substances considered 

under this sunset review. Some of these 

commenters provided specific 

information in support of one or more 

substances that they promoted, 

represented, or relied upon in organic 

production or handling. A few 

commenters recommended allowing a 

small number of substances to sunset. 

Some commenters also expressed the 

need for the clarification or further 

restrictions for a limited number of 

substances on the National List. These 

commenters recommended amending 

the listing or adding annotations as a 

potential approach for providing such 

clarifications. Some comments opposed 

the use of any synthetics in organic 

production, but did not provide 

documented support against individual 

substances for this position. 

The NOSB reviewed the comments 

received on the ANPR and developed 

recommendations regarding the 

continued use and prohibition of the 

substances under review. The NOSB 

received additional public comments 

concerning the pending sunset of these 

substances in response to three Federal 

Register notices announcing meetings of 

the NOSB and its planned deliberations 

for sunset 2012 recommendations. The 

notices were published in the Federal 

Register as follows: March 17, 2010 (75 

FR 12723), September 20, 2010 (75 FR 

57194), and March 4, 2011 (76 FR 

12013). The NOSB received further 

written and oral testimony at all three 

of these public business meetings which 

occurred in Woodland, CA on April 26– 

29, 2010, in Madison, WI on October 

25–28, 2010, and in Seattle, WA on 

April 26–29, 2011. The written 

comments can be retrieved via http:// 

www.regulations.gov by searching for 

the document ID numbers: AMS–NOP– 

10–0021 (May 2010 meeting); AMS– 

NOP–10–0068 (October 2010 meeting); 

and AMS–NOP–11–05 (April 2011 

meeting). The oral comments were 

recorded in the meeting transcripts 

available on the NOP Web site, http:// 

www.ams.usda.gov/nop. 

Prior to the October 2010 meeting, 

NOSB policy specified that 

recommendations for substances under 

sunset review were limited to two 

options: (1) Renewal, or continuation of 

each exemption or prohibition as 

codified in the NOP regulations; or (2) 

removal, allowing the exemption or 

prohibition to expire. In October 2010, 

the NOSB changed their sunset policy to 

allow a third option for issuing a 

recommendation.2 The third option 

enables the Board to add or change 

annotations (restrictions) on National 

List substances under sunset review. 

This change in policy ensures that the 

Board can address new use patterns and 

scientific information on substances 

allowed or prohibited in organic 

production. The policy limits such 

annotation changes under sunset to 

those which clarify an existing 

annotation or make the annotation more 

restrictive. The new policy does not 

authorize an annotation change during 

the sunset review process that would 

result in expanded use of an exempted 

substance. 

As a result of their meetings in April 

and October 2010, and April 2011, the 

NOSB recommended that the Secretary: 

(1) Renew, as currently codified in the 

NOP regulations, multiple listings for 

substances under the 2012 sunset 

review, (2) remove the exemption for 

three substances from the National List, 

and (3) amend the annotations for eight 

substances (seven exemptions and one 

prohibition) on the National List. For 

some annotation amendments, the 

NOSB recommendation on the 

amendment occurred concurrent to, 

rather than after, the institution of the 

new NOSB sunset policy in October 

2010. As a way to streamline the 

regulatory process and expedite 

implementation of the NOSB 

recommendations, the NOP proposes to 

address all of the annotation changes for 

substances under sunset review as part 

of this proposed rule. 

The NOSB also recommended 

renewal of the listing for nutrient 

vitamins and minerals, as codified, at 

their April 2011 meeting. During the 

NOSB’s deliberations on this substance, 

the NOP consulted with the Food and 

Drug Administration (FDA) about the 

regulatory citation that is currently 

incorporated by reference into the 

annotation for nutrient vitamins and 

minerals.3 As a result of this 

consultation, the NOP determined that 

current listing for nutrient vitamins and 

minerals was the result of a drafting 

error and that a correction to this listing 

is necessary to align the listing with the 

NOSB’s 1995 original recommendation. 

Therefore, the NOP plans to address the 

sunset review for nutrient vitamins and 

minerals and correct the drafting error 

through a separate proposed rule. 

USDA is engaging in this proposed 

rulemaking to reflect the 

recommendations of the NOSB from 

April 2010, October 2010 and April 

2011, for all listings for substances 

under sunset review, with the exception 

of nutrient vitamins and minerals and 

sodium nitrate which will be dealt with 

in separate actions. This rulemaking 

will solicit public comment on all 

renewals, removals, and annotation 

changes that are proposed. 

Under the authority of the OFPA, as 

amended, (7 U.S.C. 6501–6522), the 

National List can be amended by the 

Secretary based on recommendations 

developed by the NOSB. Since 

established, the NOP has published 

multiple amendments to the National 

List: October 31, 2003 (68 FR 61987), 

November 3, 2003 (68 FR 62215), 

October 21, 2005 (70 FR 61217), June 7, 

2006 (71 FR 32803), September 11, 2006 

(71 FR 53299), June, 27, 2007 (72 FR 

35137), October 16, 2007 (72 FR 58469), 

December 10, 2007 (72 FR 69569), 

December 12, 2007 (72 FR 70479), 

September 18, 2008 (73 FR 54057), 

October 9, 2008 (73 FR 59479), July 6, 

2010 (75 FR 38693), August 24, 2010 (75 

FR 51919), and December 13, 2010 (75 

FR 77521). Additionally, proposed 

amendments to the National List were 

published on November 8, 2010 (75 FR 

68505), May 5, 2011 (76 FR 25612) and 

on November 8, 2011 (76 FR 69141). 

II. Overview of Proposed Actions 

From April 26, 2010 through April 29, 

2011, the NOSB reviewed the listings 

for exemptions and prohibitions that are 

authorized on the National List and set 

to expire on June 27, 2012, October 21, 

2012, December 11, 2012, and December 

13, 2012. Using the evaluation criteria 

specified in the ANPR for sunset review, 

the NOSB reviewed these exemptions 

and prohibitions for continued 

authorization in organic agricultural 

production and handling. As a result of 

the NOSB’s review of public comment 

and meeting deliberations, the NOSB 

recommended that the Secretary renew 

most of the exemptions and 

prohibitions, with any restrictive 

annotations, as codified. In addition, the 

NOSB recommended that 3 exemptions 

not be renewed. The NOSB also 

recommended that exemptions or 

prohibition for 7 substances continue 

with amendment to their restrictive 

annotations. The Secretary is addressing 

these NOSB recommendations for 

sunset 2012 listings through this 

proposed rule as shown in Table 1. 

With respect to the criteria used to 

make recommendations regarding the 

continued authorization of exemptions 

and prohibitions, the NOSB’s decisions 

are based on public comments and 

applicable supporting evidence that 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
1998 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

4Table 1 shows a simplified listing for each 

substance; use categories and any restrictive 

annotations are not included in this overview. 

express a continued need for the use or 

prohibition of the substance(s). In voting 

to change its sunset policy to allow for 

amendments to annotations during 

sunset review, the NOSB agreed that 

this policy would enable the Board to 

consider, as part of their decision 

making, changes in use patterns and 

scientific information for substances 

under review. Consistent with decisions 

on continued authorizations of 

exemptions and prohibitions, such 

annotation changes can only be made if 

public comment and applicable 

evidence demonstrate that the 

substance, with any restrictive 

annotations, continues to meet the 

overall criteria for listing under the 

OFPA. 

Concerning criteria used to make 

recommendations regarding the 

discontinuation of an authorized 

exempted synthetic substance, the 

NOSB’s decision is based on public 

comments and applicable supporting 

evidence that demonstrates the 

currently authorized exempted 

substance is: (a) Harmful to human 

health or the environment; (b) no longer 

necessary for organic production due to 

the availability of alternative wholly 

nonsynthetic substitute products or 

practices; or (c) inconsistent with 

organic farming and handlingpractices. 

TABLE 1—OVERVIEW OF PROPOSED ACTIONS FOR SUNSET 2012 4

National list 

section Substance NOSB Meeting New sunset date Proposed action 

§ 205.601 Synthetic substances allowed for use 

in organic crop production.

Alcohols (Ethanol; 

Isopropanol).

Ammonium carbonate .......

Aquatic plant extracts 

(other than hydrolyzed).

April 2011 ..........................

April 2010 * ........................

April 2010 * ........................

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

Renew. 

Renew. 

Renew. 

Boric acid .......................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Chlorine materials (Calcium hypochlorite; chlorine dioxide; sodium hypochlorite).April 2011 .......................... October 21, 2017 .............. Amend: Chlorine materials—For pre-harvest 

use, residual chlorine 

levels in the water in direct crop contact or as 

water from cleaning irrigation systems applied 

to soil must not exceed 

the maximum residual 

disinfectant limit under 

the Safe Drinking Water 

Act, except that chlorine 

products may be used in 

edible sprout production 

according to EPA label 

directions. 

Coppers, fixed (Copper hydroxide; copper oxide; 

copper oxychloride).

April 2011 .......................... October 21, 2017 .............. Renew. 

Copper sulfate ................... April 2011 .......................... October 21, 2017 .............. Renew. 

Elemental sulfur (3 uses) .. April 2010 * ........................ October 21, 2017 .............. Renew. 

EPA List 4—Inerts of Minimal Concern.October 2010 .................... October 21, 2017 .............. Renew. 

Ethylene gas ..................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Herbicides, soap-based .... April 2010 * ........................ October 21, 2017 .............. Renew. 

Humic acids ...................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Hydrated lime .................... April 2011 .......................... October 21, 2017 .............. Renew. 

Hydrogen peroxide (2 

uses).

April 2010 * ........................ October 21, 2017 .............. Renew. 

Lignin sulfonate on 

§ 205.601(j)(4).

April 2011 .......................... October 21, 2017 .............. Amend: Lignin sulfonatechelating agent, dust 

suppressant. 

Lignin sulfonate on 

§ 205.601(l)(1).

April 2011 .......................... October 21, 2017 .............. Renew. 

Lime sulfur (2 uses) .......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Liquid fish products ........... April 2010 * ........................ October 21, 2017 .............. Renew. 

Magnesium sulfate ............ April 2011 .......................... October 21, 2017 .............. Renew. 

Micronutrients (Soluble 

boron products; Sulfates, carbonates, oxides, or silicates of zinc, 

copper, iron, manganese, molybdenum, 

selenium, and cobalt).

April 2010 * ........................ October 21, 2017 .............. Renew. 


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TABLE 1—OVERVIEW OF PROPOSED ACTIONS FOR SUNSET 2012 4—Continued 

National list 

section Substance NOSB Meeting New sunset date Proposed action 

Mulches (Newspapers or 

other recycled paper, 

without glossy or colored 

inks; Plastic mulch and 

covers).

April 2011 .......................... October 21, 2017 .............. Renew. 

Newspapers or other recycled paper, without 

glossy or colored inks.

April 2011 .......................... October 21, 2017 .............. Renew. 

Oils, horticultural-narrow 

range oils as dormant, 

suffocating, and summer 

oils (2 uses).

April 2010 * ........................ October 21, 2017 .............. Renew. 

Pheromones ...................... April 2011 .......................... October 21, 2017 .............. Renew. 

Potassium bicarbonate ..... April 2010 * ........................ October 21, 2017 .............. Renew. 

Soap-based algicide/ 

demossers.

April 2010 * ........................ October 21, 2017 .............. Renew. 

Soaps, ammonium ............ April 2010 * ........................ October 21, 2017 .............. Renew. 

Soaps, insecticidal ............ April 2010 * ........................ October 21, 2017 .............. Renew. 

Sodium silicate .................. April 2011 .......................... October 21, 2017 .............. Renew. 

Sticky traps/barriers .......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Streptomycin ..................... April 2011 .......................... ........................................... Amend: Streptomycin, for 

fire blight control in apples and pears only until 

October 21, 2014. 

Sucrose octanoate esters 

(CAS #s—42922–74–7; 

58064–47–4).

April 2010 * ........................ December 11, 2017 .......... Renew. 

Sulfur dioxide .................... April 2011 .......................... ........................................... Remove. 

Vitamin B1, C, and E ......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Vitamin D3 ......................... April 2011 .......................... October 21, 2017 .............. Renew. 

§ 205.602 Nonsynthetic 

substances prohibited for 

use in organic crop production.

Arsenic ..............................

Ash for manure burning ....

Lead salts ..........................

Potassium chloride ............

Sodium fluoaluminate 

(mined).

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

Renew. 

Renew. 

Renew. 

Renew. 

Sodium nitrate ................... April 2011 .......................... October 21, 2017 .............. Addressed in separate 

rulemaking action 

Strychnine ......................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Tobacco dust (nicotine sulfate).April 2010 * ........................ October 21, 2017 .............. Renew. 

§ 205.603 Synthetic substances allowed for use 

in organic livestock production.

Alcohols (Ethanol; 

Isopropanol).

Aspirin ...............................

Atropine (CAS #–51–55–8 

October 2010 ....................

October 2010 ....................

April 2010 * ........................

April 2010 * ........................

October 21, 2017 ..............

October 21, 2017 ..............

December 13, 2017 ..........

October 21, 2017 ..............

Renew. 

Renew. 

Renew. 

Renew. 

Biologics—Vaccines ..........

Butorphanol (CAS #– 

42408–82–2).

April 2010 * ........................ December 13, 2017 .......... Renew. 

Chlorhexidine .................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Chlorine materials (Calcium hypochlorite; chlorine dioxide; sodium hypochlorite).October 2010 .................... October 21, 2017 .............. Renew. 

Copper sulfate ................... October 2010 .................... October 21, 2017 .............. Renew. 

Electrolytes ........................ April 2010 * ........................ October 21, 2017 .............. Renew. 

EPA List 4—Inerts of Minimal Concern.October 2010 .................... October 21, 2017 .............. Renew. 

Excipients .......................... April 2010 * ........................ December 13, 2017 .......... Renew. 

Flunixin (CAS #–38677– 

85–9).

April 2010 * ........................ December 13, 2017 .......... Renew. 

Furosemide ....................... October 2010 .................... December 13, 2017 .......... Renew. 

Glucose ............................. October 2010 .................... October 21, 2017 .............. Renew. 

Glycerine ........................... October 2010 .................... October 21, 2017 .............. Renew. 

Hydrogen peroxide ............ April 2010 * ........................ October 21, 2017 .............. Renew. 

Iodine (2 uses) .................. April 2010 * ........................ October 21, 2017 .............. Renew. 

Ivermectin .......................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Lidocaine ........................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Lime, hydrated .................. April 2010 * ........................ October 21, 2017 .............. Renew. 

Magnesium hydroxide 

(CAS #–1309–42–8).

April 2010 * ........................ December 13, 2017 .......... Renew. 

Magnesium sulfate ............ October 2010 .................... October 21, 2017 .............. Renew. 


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TABLE 1—OVERVIEW OF PROPOSED ACTIONS FOR SUNSET 2012 4—Continued 

National list 

section Substance NOSB Meeting New sunset date Proposed action 

Mineral oil .......................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Oxytocin ............................ April 2010 * ........................ October 21, 2017 .............. Renew. 

Peroxyacetic/peracetic 

acid (CAS #–79–21–0).

April 2010 * ........................ December 13, 2017 .......... Renew. 

Phosphoric acid ................ April 2010 * ........................ October 21, 2017 .............. Renew. 

Poloxalene (CAS #–9003– 

11–6).

April 2010 * ........................ December 13, 2017 .......... Renew. 

Procaine ............................ April 2010 * ........................ October 21, 2017 .............. Renew. 

Sucrose octanoate esters 

(CAS #s—42922–74–7; 

58064–47–4).

April 2010 * ........................ December 11, 2017 .......... Renew. 

Tolazoline (CAS #–59–98– 

3).

April 2010 * ........................ December 13, 2017 .......... Renew. 

Trace minerals .................. April 2010 * ........................ October 21, 2017 .............. Renew. 

Vitamins ............................ April 2010 * ........................ October 21, 2017 .............. Renew. 

Xylazine (CAS #–7361– 

61–7).

April 2010 * ........................ December 13, 2017 .......... Renew. 

§ 205.604 Nonsynthetic 

substances prohibited for 

use in organic livestock 

production.

Strychnine ......................... April 2010 * ........................ October 21, 2017 .............. Renew. 

§ 205.605(a) Nonsynthetic, nonagricultural 

substances allowed as 

ingredients in or on processed products labeled 

as ‘‘organic’’ or ‘‘made 

with organic (specified 

ingredients or food 

group(s))’’.

Acids (Alginic; citric; lactic) 

Bentonite ...........................

Calcium carbonate ............

Calcium chloride ...............

Dairy cultures ....................

diatomaceous earth ..........

Enzymes ...........................

Flavors ..............................

Kaolin ................................

Magnesium sulfate ............

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

October 2010 ....................

April 2010 * ........................

October 2010 ....................

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Nitrogen ............................. April 2010 * ........................ October 21, 2017 .............. Renew. 

Oxygen .............................. April 2010 * ........................ October 21, 2017 .............. Renew. 

Perlite ................................ April 2010 * ........................ October 21, 2017 .............. Renew. 

Potassium chloride ............ April 2010 * ........................ October 21, 2017 .............. Renew. 

Potassium iodide ............... April 2011 .......................... October 21, 2017 .............. Renew. 

Sodium bicarbonate .......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Sodium carbonate ............. April 2010 * ........................ October 21, 2017 .............. Renew. 

Waxes (Carnauba wax; 

Wood resin).

April 2010 * ........................ October 21, 2017 .............. Renew. 

Yeast (Autolysate; Bakers; 

Brewers; Nutritional; 

Smoked).

October 2010 .................... October 21, 2017 .............. Amend: Yeast—When 

used as food or a fermentation agent, yeast 

must be organic if its 

end use is for human 

consumption; nonorganic yeast may be 

used when equivalent 

organic yeast is not 

commercially available. 

Growth on petrochemical substrate and 

sulfite waste liquor is 

prohibited. For smoked 

yeast, nonsynthetic 

smoke flavoring process 

must be documented. 

§ 205.605(b) Synthetic, 

nonagricultural substances allowed as ingredients in or on processed products labeled 

as ‘‘organic’’ or ‘‘made 

with organic (specified 

ingredients or food 

group(s))’’.

Alginates ...........................

Ammonium bicarbonate ....

Ammonium carbonate .......

Ascorbic Acid ....................

Calcium citrate ..................

Calcium hydroxide ............

Calcium phosphates 

(monobasic; dibasic; 

tribasic).

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

October 21, 2017 ..............

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Carbon dioxide .................. April 2010 * ........................ October 21, 2017 .............. Renew. 

Chlorine materials (Calcium hypochlorite; chlorine dioxide; sodium hypochlorite).October 2010 .................... October 21, 2017 .............. Renew. 


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TABLE 1—OVERVIEW OF PROPOSED ACTIONS FOR SUNSET 2012 4—Continued 

National list 

section Substance NOSB Meeting New sunset date Proposed action 

Ethylene ............................ April 2011 .......................... October 21, 2017 .............. Renew. 

Ferrous sulfate .................. October 2010 .................... October 21, 2017 .............. Renew. 

Glycerides (mono; di) ........ April 2010 * ........................ October 21, 2017 .............. Renew. 

Glycerin ............................. April 2011 .......................... October 21, 2017 .............. Renew. 

Hydrogen peroxide ............ April 2010 * ........................ October 21, 2017 .............. Renew. 

Magnesium carbonate ...... April 2010 * ........................ October 21, 2017 .............. Renew. 

Magnesium chloride .......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Magnesium stearate ......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Nutrient vitamins and minerals.April 2011 .......................... ........................................... Addressed in separate 

rulemaking action. 

Ozone ................................ April 2010 * ........................ October 21, 2017 .............. Renew. 

Pectin (low-methoxy) ........ October 2010 .................... ........................................... Remove; included in 

amended § 205.606 listing of Pectin (nonamidated forms only). 

Phosphoric acid ................ October 2010 .................... October 21, 2017 .............. Renew. 

Potassium acid tartrate ..... April 2010 * ........................ October 21, 2017 .............. Renew. 

Potassium carbonate ........ April 2010 * ........................ October 21, 2017 .............. Renew. 

Potassium citrate .............. April 2010 * ........................ October 21, 2017 .............. Renew. 

Potassium hydroxide ......... April 2010 * ........................ October 21, 2017 .............. Renew. 

Potassium iodide ............... April 2011 .......................... ........................................... Remove. 

Potassium phosphate ....... April 2010 * ........................ October 21, 2017 .............. Renew. 

Silicon dioxide ................... October 2010 .................... October 21, 2017 .............. Renew. 

Sodium citrate ................... October 2010 .................... October 21, 2017 .............. Renew. 

Sodium hydroxide ............. October 2010 .................... October 21, 2017 .............. Renew. 

Sodium phosphates .......... October 2010 .................... October 21, 2017 .............. Renew. 

Sulfur dioxide .................... October 2010 .................... October 21, 2017 .............. Renew. 

Tocopherols ...................... April 2011 .......................... October 21, 2017 .............. Renew. 

Xanthan gum ..................... April 2010 * ........................ October 21, 2017 .............. Renew. 

§ 205.606 Nonorganically 

produced agricultural 

products allowed as ingredients in or on processed products labeled 

as ‘‘organic’’.

Casings, from processed 

intestines.

Celery powder ...................

Chia (Salvia hispanica L.)

Colors (Annatto extract 

color; Beet juice extract 

color; Beta-carotene extract color; Black currant 

juice color, Black/purple 

carrot juice color; Blueberry juice color; Carrot 

juice color; Cherry juice 

color; Chokeberry— 

Aronia juice color; Elderberry juice color; Grape 

juice color; Grape skin 

extract color; Paprika 

color; Pumpkin juice 

color; Purple potato juice 

color; Red cabbage extract color; Red radish 

extract color; Saffron extract color; Turmeric extract color). CAS numbers are provided in the 

Renewals with Amendment section..

April 2010 * ........................

April 2010 * ........................

April 2010 * ........................

October 2010 ....................

June 27, 2017 ...................

June 27, 2017 ...................

June 27, 2017 ...................

June 27, 2017 ...................

Renew. 

Renew. 

Renew. 

Amend: Colors derived 

from agricultural products—Must not be produced using synthetic 

solvents and carrier systems or any artificial preservative. 

Cornstarch (native) ........... October 2010 .................... October 21, 2017 .............. Renew. 

Dillweed oil (CAS #8006– 

75–5).

April 2010 * ........................ June 27, 2017 ................... Renew. 

Fish oil (Fatty acid CAS 

#’s 10417–94–4 and 

25167–62–8).

April 2010 * ........................ June 27, 2017 ................... Renew. 

Fructooligosaccharides 

(CAS #308066–66–2).

October 2010 .................... June 27, 2017 ................... Renew. 

Galangal, frozen ................ April 2010 * ........................ June 27, 2017 ................... Renew. 

Gelatin (CAS #9000–70–8) April 2010 * ........................ June 27, 2017 ................... Renew. 

Gums (Arabic; Guar; Locust bean; Carob bean).April 2010 * ........................ October 21, 2017 .............. Renew. 

Hops (Humulus luplus) ..... October 2010 .................... ........................................... Amend: Hops (Humulus 

lupulus) until January 1, 

2013. 


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2002 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

5Technical Report on Sulfur Dioxide. January 14, 

2011. Available at the NOP Web site: http:// 

www.ams.usda.gov/AMSv1.0/getfile?dDocName

=STELPRDC5089145&acct=nopgeninfo. 

TABLE 1—OVERVIEW OF PROPOSED ACTIONS FOR SUNSET 2012 4—Continued 

National list 

section Substance NOSB Meeting New sunset date Proposed action 

Inulin, oligofructose enriched (CAS #9005–80– 

5).

October 2010 .................... June 27, 2017 ................... Renew. 

Kelp ................................... April 2010 * ........................ October 21, 2017 .............. Renew. 

Konjac flour (CAS 

#37220–17–0).

April 2010 * ........................ June 27, 2017 ................... Renew. 

Lemongrass, frozen .......... April 2010 * ........................ June 27, 2017 ................... Renew. 

Orange shellac—unbleached (CAS #9000– 

59–3).

April 2010 * ........................ June 27, 2017 ................... Renew. 

Pectin (high-methoxy) ....... October 2010 .................... October 21, 2017 .............. Amend: Pectin (nonamidated forms only). 

Peppers (chipotle chile) .... April 2010 * ........................ June 27, 2017 ................... Renew. 

Sweet potato starch .......... April 2010 * ........................ June 27, 2017 ................... Renew. 

Turkish bay leaves ............ April 2010 * ........................ June 27, 2017 ................... Renew. 

Wakame seaweed 

(Undaria pinnatifida).

April 2010 * ........................ June 27, 2017 ................... Renew. 

Whey protein concentrate October 2010 .................... June 27, 2017 ................... Renew. 

* The NOSB originally recommended that these substances be relisted during their April 2010 meeting. Since public comments were still being 

accepted for these substances, the NOSB decided to reaffirm their recommendations on these substances at the October 2010 meeting after 

analyzing all public comments. 

Renewals 

After considering all public comments 

and supporting evidence, the NOSB 

determined that many listings for 

exempted and prohibited substances 

demonstrated a continued need for 

authorization in organic agricultural 

production and handling. 

AMS has reviewed and accepts the 

NOSB recommendations for the 

continued exemption or prohibition of 

these listings. Accordingly, this 

proposed rule would renew the 

exemptions at § 205.601, along with any 

restrictive annotations, for the synthetic 

substances allowed for use in organic 

crop production as shown in Table 1. 

This proposed rule would renew the 

prohibitions at § 205.602, along with 

any restrictive annotations, for the 

nonsynthetic substances prohibited for 

use in organic crop production as 

shown in Table 1. 

This proposed rule would renew the 

exemptions at § 205.603, along with any 

restrictive annotations, for the synthetic 

substances allowed for use in organic 

livestock production as shown in Table 

1. 

This proposed rule would renew the 

prohibition at § 205.604, for the one 

nonsynthetic substance, strychnine, 

prohibited for use in organic livestock 

production as shown in Table 1. 

This proposed rule would renew the 

exemptions at § 205.605, along with any 

restrictive annotations, for the 

nonagricultural (nonorganic) substances 

allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

or ‘‘made with organic (specified 

ingredients or food group(s))’’ as shown 

in Table 1. 

This proposed rule would renew the 

exemptions at § 205.606, along with any 

restrictive annotations, for the 

nonorganically produced agricultural 

products allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

as shown in Table 1. 

Nonrenewals 

After considering all public comments 

and supporting evidence, the NOSB 

determined that three exemptions on 

the National List are no longer necessary 

for organic agricultural production and 

handling. 

The Agricultural Marketing Service 

(AMS) has reviewed and accepts the 

NOSB recommendations for removal of 

three exemptions from the National List. 

Based upon recommendations from the 

NOSB concerning substances identified 

for review under this sunset review 

process, this proposed rule would 

amend the USDA’s National List to 

remove the exemptions as shown in 

Table 1 for the following substances in 

organic agricultural production and 

handling: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

The NOP regulation currently 

includes an exemption for sulfur 

dioxide as a rodenticide for use in crop 

production at § 205.601(g)(1) as follows: 

Sulfur dioxide—underground rodent 

control only (smoke bombs). 

The Environmental Protection Agency 

(EPA) registers smoke bomb products 

for underground rodent control with the 

active ingredients sulfur, charcoal 

carbon, and sodium nitrate or potassium 

nitrate (saltpeter). Smoke bombs are 

placed into rodent burrows and 

detonated. The detonation process 

produces sulfur dioxide smoke from the 

combustion of sulfur in the product. 

Sulfur dioxide is not listed as the active 

ingredient on labels for smoke bomb 

products. According to a Technical 

Report prepared for the NOSB on this 

use of sulfur dioxide, the EPA does not 

register products with the active 

ingredient listed as sulfur dioxide.5

The NOSB Crops Committee 

considered the finding that EPA does 

not register products with sulfur dioxide 

as an active ingredient on the label 

sufficient justification for the removal of 

the exemption for this substance. The 

NOP agrees that the substances included 

on the National List should be named in 

the same convention that is used by 

other regulatory agencies that have 

jurisdiction, such as the EPA, to avoid 

confusion. 

A few public comments indicated that 

smoke bombs are an important part of 

rodent control for some organic crop 

operations. However, comments from 

one certifying agent indicated that they 

have not approved any smoke bomb 

products due to the presence of a 

detonator chemical in these products 

that contains a form of phosphorous that 

is not included on the National List. The 

NOSB expressed concern that 

exempting the effective substance, 

sulfur dioxide, on the National List 

instead of the EPA-recognized active 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 2003 

ingredients can be confusing and may 

contribute to inconsistency among 

certifying agents. 

The NOSB also discussed the variety 

of alternative methods and materials are 

used by organic growers for rodent 

control above and below ground. The 

NOSB noted that even though some 

organic growers may rely on smoke 

bombs in certain circumstances, other 

methods (such as trapping or baiting 

with approved materials from the 

National List) are available and could be 

used if sulfur dioxide is removed from 

the National List and smoke bombs 

became unavailable for use by organic 

growers. It was noted that the 

alternative use of Vitamin D3 bait-type 

control is preferred when rodent control 

is needed in the close proximity to a 

building. 

After considering all input from the 

public and any applicable evidence, the 

NOSB concluded that sulfur dioxide 

should not remain on the National List 

as an authorized substance for organic 

crop production, due to the 

acknowledgement that EPA registered 

smoke bomb products do not list sulfur 

dioxide as an active ingredient for 

smoke bombs, the availability of 

alternatives, and the lack of evidence 

that the substance is essential to organic 

production. 

AMS accepts the NOSB’s 

recommendation and proposes to 

remove the exemption for the use of 

sulfur dioxide. This proposed rule 

would amend § 205.601 of the National 

List by removing the exemption at 

paragraph (g)(1) and redesignating 

current paragraph (g)(2) as (g) to read as 

follows: (g) As rodenticides. Vitamin D3. 

This amendment would be effective 

on the substance’s current sunset date, 

October 21, 2012. 

Section 205.605 Nonagricultural 

(Nonorganic) Substances Allowed as 

Ingredients in or on Processed Products 

Labeled as ‘‘Organic’’ or Made With 

Organic (Specified Ingredients or Food 

Group(s))’’ Only in Accordance With 

Any Restrictions Specified in This 

Section 

The NOP regulation currently 

includes an exemption for pectin for use 

in organic handling at § 205.605(b) as 

follows: 

Pectin (low-methoxy). 

There are currently two exemptions 

for pectin on the National List. One 

exemption at § 205.605(b) is for lowmethoxy pectin as a synthetic, 

nonagricultural (nonorganic) substance 

allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

or ‘‘made with organic (specified 

ingredients or food groups(s)).’’ The 

other exemption at § 205.606 is for highmethoxy pectin as a nonorganically 

produced agricultural product allowed 

as ingredients in or on processed 

products labeled as ‘‘organic.’’ Highmethoxy pectin is only permitted in 

organic processed products when it is 

not commercially available in organic 

form. 

Both high-methoxy and low-methoxy 

pectin are derived from apple pomace or 

citrus rinds by a similar extraction 

process. The degree of esterification 

determines their classification as a highor low-methoxy pectin. Low-methoxy 

pectin is commonly produced by using 

acid solutions to remove methyl groups 

(CH3) from the complex polysaccharide 

chain, and has a lower molecular weight 

than high-methoxy pectin. In a 1995 

NOSB recommendation, the Board 

considered the longer extraction process 

and reduction in molecular weight to be 

a substantive chemical change, and 

therefore, classified low-methoxy pectin 

as synthetic. Some forms of lowmethoxy pectin may be manufactured 

by treating with ammonia to demethylate the pectin, replacing the 

methyl groups with an amine group, 

resulting in amidated pectin. The NOSB 

considered the amidated forms of pectin 

during their 1995 deliberations on this 

substance, but issued a final 

recommendation that low-methoxy 

pectin be allowed as a synthetic 

substance, without restricting use of the 

amidated forms. This recommendation 

resulted in a listing for low-methoxy 

pectin at § 205.605(b). In the same 

recommendation, the NOSB classified 

high-methoxy pectin as nonsynthetic. 

Both pectins are used in organic 

handling according to their different 

functions; low-methoxy pectin is used 

for low sugar jams and high-methoxy 

pectin is used in high sugar jams. 

In developing their October 2010 

recommendation for low-methoxy 

pectin, the NOSB Handling Committee 

considered public comments submitted 

by organic handlers. Organic handlers 

stated that there was no reason to use 

any form of amidated pectin in organic 

products, and that they supported the 

NOSB Handling Committee 

recommendation to reclassify nonamidated forms of low-methoxy pectin 

under § 205.606 as a nonsynthetic 

substance. During their October 2010 

deliberations, the NOSB also considered 

amidated forms of low-methoxy pectin 

to be synthetic. Because the NOSB 

recommended non-amidated, lowmethoxy pectin to be nonsynthetic and 

listed at § 205.606, the NOSB 

recommended the removal of the 

exemption for low-methoxy from 

§ 205.605(b), a section limited to 

synthetic, nonagricultural substances 

allowed in processed products. By 

deleting the exemption, the use of 

amidated, low-methoxy pectin would be 

prohibited in organic handling. 

During their deliberations, the NOSB 

clarified that all non-amidated forms of 

pectin, including low-methoxy, should 

continue to be allowed under an 

amended § 205.606 listing for pectin. 

The NOSB recommended a change in 

annotation to the current listing for 

pectin on § 205.606, such that all nonamidated pectins, regardless of the 

methoxy level, would be available for 

use in organic products under § 205.606, 

subject to commercial availability. This 

change in annotation is proposed as part 

of this proposed rule and is addressed 

in an upcoming section of the preamble. 

There was no public comment 

opposing the NOSB’s approach for 

addressing the use of pectin in organic 

handling. Organic jam makers indicated 

unanimous support of the Board’s 

recommendation. The NOSB’s 

recommendation was also supported by 

a petition from an organic jam maker 

who proposed adding non-amidated, 

low-methoxy pectin to § 205.606. The 

petitioner suggested that amidated 

forms of pectin are unnecessary in 

organic handling because non-amidated 

forms are currently available for use in 

jam and low sugar fruit spreads and 

preparations. 

AMS accepts the NOSB’s 

recommendation. This proposed rule 

would amend § 205.605(b) of the 

National List by removing the 

exemption for pectin (low-methoxy). 

This amendment would be effective 

on the substance’s current sunset date, 

October 21, 2012. 

The NOP regulation currently 

includes an exemption for potassium 

iodide for use in organic handling at 

§ 205.605(b) as follows: 

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 iodide has two listings on 

§ 205.605 for use in organic handling. It 

is listed as nonsynthetic on § 205.605(a) 

and it is listed as synthetic on 

§ 205.605(b) of the National List. Under 

this sunset review, the NOSB voted 

unanimously to continue listing the 

substance on § 205.605(a), as naturally 

mined potassium iodide is used in some 

organic products. One commenter 

supported the continued exemption for 

potassium iodide at § 205.605(a) 

because the substance is also used as a 

sanitizer in some organic handling 

operations. 


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2004 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

6NOSB, 1995. Final Minutes of the NOSB Full 

Board Meeting, Austin TX, Oct. 31–Nov. 4 1995. 

Page 18, line 611. Available at the NOP Web site: 

http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5057496. 

7NOSB, 2003. Summary of Meeting Minutes, 

NOSB Meeting—May 13–14, 2003, page 4. 

Available at the NOP Web site: http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5058538; NOSB, 

2003. Measuring Effluent: Clarification of Chlorine 

Contact with Organic Food, NOSB Processing 

Committee April 30, 2003. Available at the NOP 

Web site: http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELDEV3104548. 

8NOP 5026. Guidance: The Use of Chlorine 

Materials in Organic Production and Handling. May 

9, 2011. Available at the NOP Web site: http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5090760. 

9FDA. Guidance for Industry: Microbial Food 

Safety Hazards for Sprouted Seeds. October 27, 

1999. Available at the FDA Web site: http:// 

www.fda.gov/Food/ 

GuidanceComplianceRegulatoryInformation/ 

GuidanceDocuments/ProduceandPlanProducts/ 

ucm120244.htm. 

The listing as a synthetic on 

§ 205.605(b) restricts its use to products 

in the ‘‘made with organic (specified 

ingredients or food groups(s)),’’ labeling 

category. The NOSB concluded that the 

synthetic listing for potassium iodide at 

§ 205.605(b) is redundant and that its 

annotation is in conflict with the 

allowance for potassium iodide as a 

nutrient additive under a separate 

listing. Synthetic potassium iodide is 

the primary form of iodide allowed for 

fortification of food, and would be 

permitted under the listing for vitamins 

and minerals at § 205.605(b). Therefore, 

the NOSB determined that a separate 

listing for synthetic potassium iodide 

was not necessary. 

AMS accepts the NOSB’s 

recommendation. This proposed rule 

would amend § 205.605(b) of the 

National List by removing the 

exemption, along with its restrictive 

annotation, for potassium iodide. 

This amendment would be effective 

on the substance’s current sunset date, 

October 21, 2012. 

Renewals With Amendment 

After considering all public comments 

and supporting evidence, the NOSB 

identified seven exemptions and one 

prohibition for which renewal is critical 

to organic agricultural production and 

handling, but for which amendments 

are needed to the current listings for 

these substances to clarify or restrict 

their use. 

AMS has reviewed and accepts the 

NOSB recommendations to renew, with 

amendment, seven exemptions and one 

prohibition on the National List. Based 

upon these recommendations from the 

NOSB, this proposed rule would amend 

the USDA’s National List as shown in 

Table 1 for the following substances in 

organic agricultural production and 

handling: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

The NOP regulation currently 

includes an exemption for chlorine 

materials for use in crop production at 

§ 205.601(a)(2) as follows: 

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. 

The NOSB Crops Committee reviewed 

comments received on chlorine 

materials in response to the ANPR 

published on March 26, 2010 (75 FR 

14500), and issued a committee 

recommendation on March 7, 2011. The 

Board noted that the current annotation 

does not accurately represent the 1995 

NOSB recommendation for chlorine 

materials, which stated that chlorine 

may be used to disinfect and sanitize 

food contact surfaces and that ‘‘residual 

chlorine levels for wash water in direct 

crop or food contact and in flush water 

from cleaning irrigation systems that is 

applied to crops or fields cannot exceed 

the maximum residual disinfectant limit 

under the Safe Drinking Water Act 

(currently 4 mg/L expressed as Cl2).’’ 6

The NOSB Crops Committee also 

discussed a 2003 NOSB 

recommendation that suggested 

modification of the chlorine materials 

annotation to reflect the NOSB’s 

intention that water in direct crop or 

soil contact should not have higher 

levels of chlorine than those permitted 

for municipal drinking water.7 The NOP 

concurs with the NOSB that the current 

annotations for chlorine materials do 

not align precisely with the 1995 or 

2003 recommendations of the Board. 

At the April 2011 NOSB meeting, the 

Board received public comments on this 

issue and recommended the following 

change to the annotation for chlorine 

materials: ‘‘For pre-harvest use, residual 

chlorine levels in the water in direct 

crop contact or as water from cleaning 

irrigation systems applied to soil must 

not exceed the maximum residual 

disinfectant limit under the Safe 

Drinking Water Act. For disinfecting or 

sanitizing equipment or tools or in 

edible sprout production, chlorine 

products may be used up to maximum 

labeled rates.’’ The NOSB stated that 

this revised annotation would clarify 

the allowance for chlorine materials and 

align with past NOSB recommendations 

and NOP policy. 

The NOP agrees that this language 

addresses the intent of the NOSB to 

specify that water in direct contact with 

crops during production should not 

contain more chlorine than is permitted 

in municipal drinking water. The NOP 

issued final guidance (NOP 5026) on 

May 6, 2011, that is consistent with the 

April 2011 NOSB recommendation on 

chlorine materials for crop use.8 This 

guidance document also clarifies that 

chlorine products may be used at 

labeled rates to disinfect or sanitize 

tools. The NOP also acknowledges that, 

while chlorine materials also have 

similar listings under § 205.603(a) for 

use in livestock operations, and 

§ 205.605(b) for use in handling, the 

NOSB only voted to change the 

annotation for the use of chlorine in 

crops production. 

The NOSB’s recommended annotation 

change includes a clarification on the 

use of chlorine in edible sprout 

production. The NOP proposes to 

amend the chlorine listing to include 

the Board’s clarification on edible 

sprouts. However, the NOP consulted 

the EPA and learned that a number of 

calcium hypochlorite products are 

labeled for use in disinfecting seeds 

used for sprouts. EPA label directions 

for sprout seed state that seed should be 

soaked at 20,000 ppm available chlorine 

followed by a rinse with potable water. 

The NOP is seeking comments on the 

appropriateness of this type of chlorine 

treatment for organic sprout production. 

The NOP also seeks information 

regarding other FDA and EPA approved 

materials or methods that can be used 

to comply with FDA guidance regarding 

safety of sprouts.9 These specific uses 

and alternatives were not addressed by 

commenters in detail and may require 

additional clarification in the final rule. 

AMS accepts the NOSB’s 

recommendation, with a slight 

modification. The NOP clarified the use 

of chlorine on tools and equipment 

through guidance and, therefore, finds 

that including this language in the 

annotation change is unnecessary. This 

proposed rule would amend 

§ 205.601(a)(2) to read as follows: 

Chlorine materials—For pre-harvest 

use, residual chlorine levels in the water 

in direct crop contact or as water from 

cleaning irrigation systems applied to 

soil must not exceed the maximum 

residual disinfectant limit under the 

Safe Drinking Water Act, except that 

chlorine products may be used in edible 

sprout production according to EPA 

label directions. 

(i) Calcium hypochlorite. 

(ii) Chlorine dioxide. 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 2005 

10Technical Report on Streptomycin. March 8, 

2011. Available at the NOP Web site: http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5090468. 

11May 2011 Letters submitted by NOP to USDA 

ARS and NIFA on fire blight research. Available at 

the NOP Web site: http://www.ams.usda.gov/ 

AMSv1.0/getfile?dDocName=STELPRDC5091325. 

(iii) Sodium hypochlorite. 

This amendment would be effective 

on the substance’s current sunset date, 

October 21, 2012. 

The National List currently includes 

an exemption for streptomycin for plant 

disease control in organic crop 

production at § 205.601(i)(11) as 

follows: 

Streptomycin, for fire blight control in 

apples and pears only. 

Streptomycin is derived from the soil 

bacterium Streptomyces griseus and can 

be used to control bacterial disease in 

crops.10 In organic production, 

streptomycin is currently allowed as a 

synthetic substance to treat fire blight in 

apple and pear orchards. Streptomycin 

is one of two antibiotics (the other 

substance being tetracycline) on the 

National List that organic apple and 

pear growers can use for fire blight 

control. Fire blight is caused by the 

bacterium Erwinia amylovora, which is 

native to North America and lives on 

alternate hosts such as hawthorne and 

crabapple. It infects apple and pear 

blossoms and can spread rapidly 

through the tree vascular system to kill 

shoots and destroy trees. The bacterium 

can be moved from plant to plant by 

honeybees, other insects, birds, rain, 

wind, and hail. 

As part of their review of the current 

exemption for streptomycin on the 

National List, the NOSB considered 

written comments received in response 

to the ANPR published on March 26, 

2010 (75 FR 14500), and oral comments 

from their April 2011 public meeting. 

Some commenters expressed concerns 

about the potential for antibiotic 

overuse, potential for development of 

antibiotic resistance, and the impact of 

antibiotic use on the environment. Some 

commenters stated that there are some 

rootstocks (e.g. the Geneva series) that 

may provide resistance to fire blight, 

which, if used by organic growers, could 

reduce the need for streptomycin in 

organic production systems. The 

majority of the NOSB Crops Committee 

stated that selection of fire blight 

resistant varieties suitable for organic 

production should be a grower’s first 

choice for disease control, rather than 

the use of streptomycin. 

However, the NOSB also heard from 

other commenters who stated that 

research into alternatives to 

streptomycin for fire blight control is 

ongoing but has yet to deliver suitable 

alternatives. Public testimony at the 

April 2011 NOSB meeting suggested 

that, while there are apple varieties and 

rootstocks with differing degrees of 

resistance to fire blight, there is a lack 

of varieties that meet commercial 

demand for both good fruit quality and 

disease resistance. Other commenters 

pointed out that resistance is relative 

and all apple varieties are susceptible to 

fire blight to some extent. Red Delicious 

and Macoun are the least susceptible, 

with all newer commercial varieties 

being more susceptible. It was also 

pointed out that the resistance in the 

rootstock does not translate to resistance 

in the scion, leaving the tree vulnerable 

to infection. Varieties are normally 

replaced every 10–15 years and thus 

cannot be switched like changing a 

spray product; the cost of replanting an 

orchard can exceed $20,000 per acre. 

Pears tend to be uniformly more 

susceptible to fire blight than apples, 

and resistant germplasm does not 

appear to be available. Many organic 

apple and pear growers as well as 

disease specialists stated that fire blight 

management is very challenging and 

additional research is needed to develop 

effective alternatives to antibiotics. 

Researchers who commented at the 

NOSB meeting described one such tool, 

a new yeast product that may be 

effective to control fire blight as an 

alternative to streptomycin; however, 

this product has only had preliminary 

field trials, is not commercially 

available, and has not received 

registration from the EPA. 

Organic growers further explained in 

their testimony to the NOSB that 

growers do not routinely apply 

streptomycin as a preventive every year, 

but only when conditions indicate risk 

of infection is high. Most growers use a 

predictive model such as Cougarblight 

or Maryblight to time antibiotic 

application with potential infection 

periods. Growers also stated that, while 

streptomycin has become ineffective in 

some growing areas due to resistance of 

the pathogen, it remains a critical tool 

in other regions of the U.S. 

Given that proven effective 

alternatives are limited, and the impact 

that failing to renew the allowance for 

streptomycin would have on the organic 

apple and pear industry, the NOSB 

recommended extending the allowance 

of streptomycin for a limited time 

period. This limited extension is 

intended to allow for further 

development of alternative methods or 

substances for fire blight control in 

organic production. While some 

commenters explained that 

development of alternatives to 

streptomycin is 3 to 5 years from 

commercialization, the NOSB did not 

agree that the exemption for 

streptomycin should continue for 

another 5 years until the next sunset 

review in 2017. The NOSB opted to 

support a change in the annotation that 

would allow the use of streptomycin 

only until October 21, 2014. The NOSB 

anticipates that this expiration date will 

promote industry collaboration on the 

development of alternatives and prompt 

growers to use resistant varieties and 

other management practices for fire 

blight control on organic pear and apple 

operations. In response to the requests 

by the NOSB and the industry for 

additional resources to support research 

on alternatives to fire blight, the NOP 

issued letters to the USDA Agricultural 

Research Service (ARS) and National 

Institute of Food and Agriculture (NIFA) 

in May 2011 to request their assistance 

in prioritizing research on such 

alternatives.11

AMS accepts the NOSB’s 

recommendation. This proposed rule 

would amend § 205.601(i)(11) to read as 

follows: 

Streptomycin, for fire blight control in 

apples and pears only until October 21, 

2014. 

This amendment would be effective 

on the substance’s current sunset date, 

October 21, 2012. 

The National List currently includes 

an exemption for lignin sulfonate as a 

plant or soil amendment in organic crop 

production at § 205.601(j)(4) as follows: 

Lignin sulfonate—chelating agent, 

dust suppressant, floatation agent. 

Lignin sulfonate is listed twice on the 

National List under § 205.601; the first 

listing is for use as a plant or soil 

amendment, the second listing is for use 

as a floatation agent in post-harvest 

handling. During the sunset review for 

lignin sulfonate, the NOSB noted that 

including ‘‘floatation agent’’ as an 

allowable use under the first listing is 

incorrect. The substance is not used as 

a floatation agent for plant or soil 

amendments. Public comment also 

stated that lignin sulfonate is used as a 

floatation agent for post-harvest 

handling, and this use is currently 

allowed under the second listing for the 

substance at § 205.601(l)(1). Therefore, 

the NOSB recommended the first listing 

for lignin sulfonate at § 205.601(j)(4) be 

corrected to remove the language 

‘‘floatation agent’’ from the annotation. 

The change to this annotation has no 

effect on the allowance of lignin 

sulfonate as a floatation agent for postharvest handling under § 205.601(l)(1). 

The Secretary accepts the NOSB’s 

recommendation. This proposed rule 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
2006 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

12The NOP issued guidance on March 2, 2010, 

(NOP 5014: Certification of Organic Yeast) to clarify 

that yeast may be labeled as organic provided 

certain guidelines are met. Available at the NOP 

Web site: http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5087121. 

13The petition was submitted by Marroquin 

International Organic Commodity Services, Inc., 

and is available at the NOP Web site: http:// 

www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

would amend § 205.601(j)(4) to read as 

follows: 

Lignin sulfonate—chelating agent, 

dust suppressant. 

This amendment would be effective 

on the substance’s current sunset date, 

October 21, 2012. 

Section 205.605 Nonagricultural 

(Nonorganic) Substances Allowed as 

Ingredients in or on Processed Products 

Labeled as ‘‘Organic’’ or ‘‘Made With 

Organic (Specified Ingredients or Food 

Group(s))’’ 

The National List currently includes a 

listing for yeast as a nonsynthetic for 

use in or on processed products at 

§ 205.605(a) as follows: 

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). 

At their October 2010 public meeting, 

the NOSB issued a recommendation for 

yeast under sunset review and a 

recommendation on a petition to change 

the current listing for yeast. The NOP is 

responding to both recommendations 

through a single action in this proposed 

rule to streamline and efficiently 

address the regulatory changes 

requested by the NOSB. 

When the NOSB issued their 1995 

recommendation for yeast, organic 

sources of yeast were not available. 

More recently, manufacturers have 

developed methods of production and 

obtained organic certification for yeast 

products.12 Manufacturers have since 

advocated that yeast should be 

considered an agricultural substance 

and included on § 205.606, rather than 

on § 205.605(a). Inclusion of yeast on 

§ 205.606 would require food processors 

to use organic yeast when it was 

commercially available. In August 2006, 

a petition was submitted to the NOSB 

requesting that yeast be removed from 

§ 205.605(a) and listed on § 205.606.13

In their October 2010 deliberations on 

the status of yeast on the National List, 

the NOSB Handling Committee favored 

the potential for expanded use of 

organic yeast in processed organic 

products. However, the NOSB also 

expressed concern that moving yeast to 

§ 205.606 would classify it as an 

agricultural nonsynthetic substance, a 

classification that would impact the 

status of yeast used in the livestock feed 

industry. Under the NOP regulations at 

§ 205.237(a), all agricultural ingredients 

included in additives and supplements 

of livestock feed rations must be 

organic. If the NOSB were to 

recommend inclusion of yeast on 

§ 205.606, then all yeast used in 

livestock feed supplements would need 

to be organic. This action would not 

serve the interests of livestock 

producers who feed yeast to livestock as 

a non-agricultural, non-synthetic feed 

supplement. 

Based upon these considerations, the 

NOSB recommended an annotation 

change to the current listing for yeast at 

§ 205.605(a). This annotation change is 

intended to lead to greater demand for 

organic products in both the handling 

and crop categories without elimination 

of an important source of supplements 

for organic livestock rations. In the 

recommendation, yeast would remain 

on § 205.605(a) with an amended 

annotation that would require yeast 

used as food or a fermentation agent to 

be organic if the end use is for human 

consumption, but would allow use of 

nonorganic yeast when equivalent 

organic yeast is not commercially 

available. Most comments received on 

yeast were supportive of this annotation 

change. 

AMS accepts the NOSB’s 

recommendation. This proposed rule 

would amend § 205.605(a) to read as 

follows: 

Yeast—When used as food or a 

fermentation agent, yeast must be 

organic if its end use is for human 

consumption; nonorganic yeast may be 

used when equivalent organic yeast is 

not commercially available. Growth on 

petrochemical substrate and sulfite 

waste liquor is prohibited. For smoked 

yeast, nonsynthetic smoke flavoring 

process must be documented. 

This amendment would be effective 

on the listing’s current sunset date, 

October 21, 2012. 

Section 205.606 Nonorganically 

Produced Agricultural Products Allowed 

as Ingredients in or on Processed 

Products Labeled as ‘‘Organic’’ 

The National List currently includes a 

listing for colors allowing their use in or 

on processed products at § 205.606(d) as 

follows: 

Colors derived from agricultural 

products. 

At their October 2010 public meeting, 

the NOSB issued a recommendation for 

colors under sunset review and a 

recommendation for an annotation 

change to the current listing for colors. 

The NOP is responding to both 

recommendations through a single 

action in this proposed rule to 

streamline and efficiently address the 

regulatory changes requested by the 

NOSB. 

In March 2007, the NOSB 

recommended the addition of colors 

from agricultural products to § 205.606 

of the National List. Their action was 

the result of several petitions submitted 

after the colors had been allowed to 

sunset from § 205.605(a) in 2007. 

When the NOSB approved colors for 

addition to § 205.606, the Board did not 

consider including a restriction on the 

use of synthetics solvents in color 

extraction because the petitions 

specified colors that were only oil or 

water extracted using physical 

processing such as cutting, drying, or 

grinding. Some NOSB members also felt 

it was not possible to place restrictions 

on a nonorganic substance listed as 

permitted under § 205.606. At that time, 

some NOSB members emphasized that 

annotations on nonorganic substances 

should be limited to those which restrict 

the use of the listed substance instead 

of the process of producing it. 

Because of the lack in specificity in 

the colors annotation, stakeholders have 

advised the NOSB through public 

comment that there is confusion as to 

whether synthetic solvents may be used 

to extract colors and whether use of 

synthetic solvents in the preparation of 

the colors listed on § 205.606 is within 

the intent of the listing. In response to 

this concern, the NOSB Handling 

Committee reviewed transcripts from 

the March 2007 meeting, petitions, and 

committee recommendations and 

concluded that the use of synthetic 

solvents was not reviewed by the NOSB 

and is, therefore, clearly outside of the 

intent of the current listing. In addition, 

the Handling Committee stated that 

solvent extraction of these colors is not 

necessary given that each color was 

petitioned as being available in the 

marketplace without synthetic solvent 

extraction. Public comments received at 

the October 2010 NOSB meeting also 

supported the NOSB’s recommendation 

to change the annotation to prohibit 

solvent extraction and use of synthetic 

carriers or preservatives. 

As part of their October 2010 

recommendation, the NOSB also 

requested that the NOP review the 

Chemical Abstract Service (CAS) 

registration numbers for each of these 

food colors for accuracy and make any 

technical corrections necessary. The 

NOP agrees that, in some cases, the CAS 

numbers are incorrect as they refer to 

pigments that can be produced from a 

variety of sources rather than the 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 2007 

14The petition was submitted by the American 

Organic Hop Growers Association and is available 

at the NOP Web site: http://www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

nonsynthetic colors derived from 

agricultural sources that the NOSB 

reviewed. The NOP plans to correct 

these numbers through a future 

rulemaking action. This proposed rule 

would not amend the CAS numbers for 

colors; all CAS numbers for colors 

included under § 205.606(d) would 

continue to be listed as follows: Annatto 

extract color (pigment CAS # 1393–63– 

1)—water and oil soluble 107, Beet juice 

extract color (pigment CAS # 7659–95– 

2), Beta-carotene extract color from 

carrots (CAS # 1393–63–1), Black 

currant juice color (pigment CAS #’s: 

528–58–5, 528–53–0, 643–84–5, 134– 

01–0, 1429–30–7, and 134–04–3), Black/ 

purple carrot juice color (pigment CAS 

#’s: 528–58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 134–04–3), 

Blueberry juice color (pigment CAS #’s: 

528–58–5, 528–53–0, 643–84–5, 134– 

01–0, 1429–30–7, and 134–04–3), Carrot 

juice color (pigment CAS # 1393–63–1), 

Cherry juice color (pigment CAS #’s: 

528–58–5, 528–53–0, 643–84–5, 134– 

01–0, 1429–30–7, and 134–04–3), 

Chokeberry—Aronia juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3), Elderberry juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3), Grape juice color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3), Grape skin extract color (pigment 

CAS #’s: 528–58–5, 528–53–0, 643–84– 

5, 134–01–0, 1429–30–7, and 134–04– 

3), Paprika color—dried powder and 

vegetable oil extract (CAS # 68917–78– 

2), Pumpkin juice color (pigment CAS # 

127–40–2), Purple potato juice color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3), Red cabbage extract color 

(pigment CAS #’s: 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3), Red radish extract color 

(pigment CAS #’s 528–58–5, 528–53–0, 

643–84–5, 134–01–0, 1429–30–7, and 

134–04–3), Saffron extract color 

(pigment CAS # 1393–63–1), and 

Turmeric extract color (CAS # 458–37– 

7). 

AMS accepts the NOSB’s 

recommendation to change the 

annotation for colors. This proposed 

rule would amend § 205.606(d) to read 

as follows: 

Colors derived from agricultural 

products—Must not be produced using 

synthetic solvents and carrier systems or 

any artificial preservative. 

This amendment would be effective 

on the listing’s current sunset date, June 

27, 2012. 

The Secretary specifically seeks 

comments on this proposed amendment 

with regard to the extent of use of 

carbon dioxide, a synthetic solvent that 

is on the National List at § 205.605(b), 

which may be used in a liquid state 

(supercritical carbon dioxide) to extract 

colors. 

The National List currently includes a 

listing for hops allowing its use in or on 

processed products at § 205.606(l) as 

follows: 

Hops (Humulus luplus). 

At their October 2010 public meeting, 

the NOSB issued a recommendation for 

hops under sunset review and a 

recommendation on a petition to add an 

expiration date to the current listing for 

hops. The NOP is responding to both 

recommendations through a single 

action in this proposed rule to 

streamline and efficiently address the 

regulatory changes requested by the 

NOSB. 

Hops are a perennial crop that is 

customarily grown under contract. Most 

hops are sold on forward contracts 

before planting. Hops plantings do not 

reach optimum production in one 

season of growth, so growers are unable 

to switch varieties on an annual basis. 

The variety of hops used dramatically 

influences the flavor of different beers, 

and the different varieties of hops grown 

distinguish many styles of beers. 

Hops was added to the National List 

at § 205.206 in 2007 to enable brewers 

to make organic beer with 

conventionally grown hops in the 

absence of a commercially available 

supply of organically grown hops. At 

that time, industry comments indicated 

that a sufficient volume of organic hops 

in the varieties needed did not exist. 

After the 2007 listing of hops on 

§ 205.606, grower expectations that 

brewers would begin to seek additional 

organic hops contracts did not 

materialize. In December 2009, growers 

petitioned the NOSB to remove hops 

from § 205.606 to expedite growth in the 

organic hops market.14 This petition 

was reviewed by the NOSB concurrently 

with the sunset listing for hops. 

The initial recommendation from the 

NOSB Handling Committee concerning 

hops was to renew its listing on 

§ 205.606 of the National List without 

change. When this recommendation was 

published in the October 2010 NOSB 

meeting notice with a request for public 

comments (FR 75 57194), over 100 

comments against the continuation of 

hops on § 205.606 were submitted by 

consumers, growers, organic 

associations, and academics. Hops 

brokers and growers commented that 

few brewers actively sought organic 

hops and voiced dissatisfaction with 

this situation, as it was commonly 

described as an effort to maximize profit 

by the brewers who wanted to produce 

organic beer at a premium price, but did 

not seek organic hops for their beer. 

At their October 2010 public meeting, 

the NOSB heard comments from some 

organic brewers who stated they always 

used organic hops, and that there was 

no difficulty in obtaining the specific 

varieties of hops needed in commercial 

quantities. These brewers supported the 

removal of hops from § 205.606, and felt 

that sourcing all organic hops would not 

impede the growth and progress of their 

business. Other comments also 

indicated that, since organic beer labels 

are not required to list ingredients, 

customers and purveyors of beer rarely 

know whether the hops in their organic 

beer are organic. A majority of these 

commenters supported the removal of 

hops from § 205.606 so that consumers 

could be assured that organic hops is 

used in organic beer. 

Many commenters also indicated that 

the availability of organic hops is now 

sufficient to supply the organic beer 

market. A few comments were received 

from brewers who maintained that an 

adequate organic supply of the varieties 

of hops needed for their beer varieties 

could not be sourced by the June 27, 

2012, sunset date for hops. 

In consideration of the comments 

received, and in acknowledgement of 

the time needed to establish a perennial 

crop and forward contracts, the NOSB 

determined that the best approach 

would be to relist hops on the National 

List at § 205.606 until January 1, 2013. 

This extension of the listing would 

allow brewers to source, when organic 

hops is not commercially available, 

from the 2011 and 2012 year supply of 

conventional hops, while fostering the 

development of purchasing 

arrangements for organic varieties from 

crops in 2013. 

AMS accepts the NOSB’s 

recommendation. The NOP also 

proposes a spelling correction to the 

binomial name for hops, currently 

misspelled at § 205.606. This proposed 

rule would amend § 205.606(l) to read 

as follows: 

Hops (Humulus lupulus) until January 

1, 2013. 

This amendment would be effective 

on the current sunset date for hops, June 

27, 2012. 

The National List currently includes a 

listing for pectin allowing its use in or 

on processed products at § 205.606(s) as 

follows: 

Pectin (high-methoxy). 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
2008 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

15The petition was submitted by Crofters Food 

Ltd. and is available at the NOP Web site: http:// 

www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

16Technical Report on Non Amidated Low 

Methoxyl Pectin. August 17, 2009. Available at the 

NOP Web site: http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5087206; 

Supplemental Report on Non Amidated Low 

Methoxyl Pectin. July 30, 2010. Available at the 

NOP Web site: http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5087205. 

At their October 2010 public meeting, 

the NOSB issued a recommendation for 

pectin (high-methoxy) under sunset 

review and a recommendation on a 

petition to change the forms of pectin 

allowed in organic handling. As 

discussed in the Removals section on 

low-methoxy pectin, the NOP is 

responding to both recommendations 

through a single action in this proposed 

rule. This is intended to streamline and 

efficiently address the regulatory 

changes requested by the NOSB. The 

result of this proposed rule would list 

all non-amidated (nonsynthetic) forms 

of pectin on § 205.606. 

During the 2012 sunset review, the 

NOSB reviewed a petition requesting 

that the listing at § 205.605(b) for lowmethoxy pectin be moved to § 205.606. 

The petitioner proposed that nonamidated forms of low-methoxy pectin 

are not synthetic.15 The petitioner 

explained that the use of ammonia in 

the extraction process for producing 

pectin is limited to amidated forms of 

pectin and, therefore, only amidated 

forms should be considered synthetic. 

In consideration of this petition, the 

NOSB reviewed a Technical Report and 

a Supplemental Technical Report, both 

of which supported the petitioner’s 

position.16 The NOSB determined that 

amidation is a better indicator of 

whether the pectin is synthetic. Since 

all forms of pectin currently on the 

National List are available in nonamidated (nonsynthetic) form, the 

NOSB recommended that a single listing 

for non-amidated forms of pectin on 

§ 205.606 would be more appropriate. If 

implemented, all amidated forms of 

pectin would be prohibited. Comments 

by organic food processors supported 

the NOSB recommendation and agreed 

that amidated pectin is not needed for 

organic processing. 

AMS accepts the NOSB’s 

recommendation. This proposed rule 

would amend § 205.606(s) to read as 

follows: 

Pectin (non-amidated forms only). 

This amendment would be effective 

on the current sunset date for pectin 

(high-methoxy), October 21, 2012. 

III. Related Documents 

An Advance Notice of Proposed 

Rulemaking (ANPR) was published in 

the Federal Register on March 26, 2010, 

(75 FR 14500) to make the public aware 

that the exemptions and prohibitions for 

232 listings of synthetic and nonsynthetic substances in organic 

production and handling will expire, if 

not reviewed by the NOSB and renewed 

by the USDA. 

IV. Statutory and Regulatory Authority 

The OFPA, as amended (7 U.S.C. 

6501–6522), authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 

6518(k)(2) and 6518(n) of OFPA 

authorize the NOSB to develop 

proposed amendments to the National 

List for submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having substances evaluated 

for inclusion on or deletion from the 

National List. The National List petition 

process is implemented under § 205.607 

of the NOP regulations. The current 

petition process (72 FR 2167, January 

18, 2007) can be accessed through the 

NOP Web site at: http:// 

www.ams.usda.gov/nop. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 2104 through 2108 of the 

OFPA (7 U.S.C. 6503 through 6507) 

from creating certification programs to 

certify organic farms or handling 

operations unless the State programs 

have been submitted to, and approved 

by, the Secretary as meeting the 

requirements of the OFPA. 

Pursuant to § 2108(b)(2) of the OFPA 

(7 U.S.C. 6507(b)(2)), a State organic 

certification program may contain 

additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to § 2120(f) of the OFPA (7 

U.S.C. 6519(f)), this proposed rule 

would not alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601–624), the 

Poultry Products Inspection Act (21 

U.S.C. 451–471), or the Egg Products 

Inspection Act (21 U.S.C. 1031–1056), 

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 

and Cosmetic Act (21 U.S.C. 301 et 

seq.), nor the authority of the 

Administrator of EPA under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (7 U.S.C. 136 et seq.). 

Section 2121 of the OFPA (7 U.S.C. 

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) requires agencies to 

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 2009 

17U.S. Department of Agriculture, Economic 

Research Service. 2009. Data Sets: U.S. Certified 

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. Available at: http:// 

www.ers.usda.gov/Data/Organic/. 

18U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers: Documentation. 

Available at: http://www.ers.usda.gov/Data/ 

OrganicHandlers/Documentation.htm. 

19 Dimitri, C., and L. Oberholtzer. 2009. Marketing 

U.S. Organic Foods: Recent Trends from Farms to 

Consumers, Economic Information Bulletin No. 58, 

U.S. Department of Agriculture, Economic Research 

Service. Available at: http://www.ers.usda.gov/ 

Publications/EIB58. 

20Organic Trade Association’s 2011 Organic 

Industry Survey. Available at: http://www.ota.com. 

Pursuant to the requirements set forth 

in the RFA, AMS performed an 

economic impact analysis on small 

entities in the final rule published in the 

Federal Register on December 21, 2000 

(65 FR 80548). AMS has also considered 

the economic impact of this action on 

small entities. The impact on entities 

affected by this proposed rule would not 

be significant. The effect of this 

proposed rule would be to allow the 

continued use of additional substances 

in agricultural production and handling. 

AMS concludes that the economic 

impact of this addition of allowed 

substances, if any, would be minimal 

and beneficial to small agricultural 

service firms. Accordingly, USDA 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $7,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

According to USDA, Economic 

Research Service (ERS) data based on 

information from USDA-accredited 

certifying agents, the number of certified 

U.S. organic crop and livestock 

operations totaled nearly 13,000 and 

certified organic acreage exceeded 4.8 

million acres in 2008.17 ERS, based 

upon the list of certified operations 

maintained by the NOP, estimated the 

number of certified handling operations 

was 3,225 in 2007.18 AMS believes that 

most of these entities would be 

considered small entities under the 

criteria established by the SBA. 

The U.S. sales of organic food and 

beverages have grown from $3.6 billion 

in 1997 to nearly $21.1 billion in 

2008.19 The organic industry is viewed 

as the fastest growing sector of 

agriculture, representing over 3 percent 

of overall food sales in 2009. Between 

1990 and 2008, organic food sales 

historically demonstrated a growth rate 

between 15 to 24 percent each year. In 

2010, organic food sales grew 7.7%.20

In addition, USDA has 94 accredited 

certifying agents who provide 

certification services to producers and 

handlers. A complete list of names and 

addresses of accredited certifying agents 

may be found on the AMS NOP web 

site, at http://www.ams.usda.gov/nop. 

AMS believes that most of these 

accredited certifying agents would be 

considered small entities under the 

criteria established by the SBA. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by section 350(h) of the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501–3520, or OMB’s 

implementing regulations at 5 CFR part 

1320. 

E. General Notice of Public Rulemaking 

This proposed rule reflects 

recommendations submitted to the 

Secretary by the NOSB for substances 

on the National List of Allowed and 

Prohibited Substances that, under the 

sunset review provisions of OFPA, 

would otherwise expire in 2012. A 30- 

day period for interested persons to 

comment on this rule is provided. 

Thirty days is deemed appropriate 

because the review of these listings was 

widely publicized through three NOSB 

meetings and an ANPR, the use, 

prohibition, and amendments to these 

substances, as applicable, are critical to 

organic production, and this rulemaking 

should be completed before the earliest 

2012 sunset date, June 27, 2012. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205, is proposed 

to be amended as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

2. Section 205.601 is amended by: 

A. Revise paragraph (a)(2); 

B. Revise paragraph (g); 

C. Revise paragraph (i)(11); and 

D. Revise paragraph (j)(4) to read as 

follows: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

(a) * * * 

(2) Chlorine materials—For preharvest use, residual chlorine levels in 

the water in direct crop contact or as 

water from cleaning irrigation systems 

applied to soil must not exceed the 

maximum residual disinfectant limit 

under the Safe Drinking Water Act, 

except that chlorine products may be 

used in edible sprout production 

according to EPA label directions. 

(i) Calcium hypochlorite. 

(ii) Chlorine dioxide. 

(iii) Sodium hypochlorite. 

* * * * * 

(g) As rodenticides. Vitamin D3. 

* * * * * 

(i) * * * 

(11) Streptomycin, for fire blight 

control in apples and pears only until 

October 21, 2014. 

* * * * * 

(j) * * * 

(4) Lignin sulfate—chelating agent, 

dust suppressant. 

* * * * * 

4. Section 205.605 is amended by: 

A. Revise the annotation for ‘‘Yeast’’ 

under paragraph (a); 

B. Remove ‘‘Pectin (low-methoxy)’’ 

from paragraph (b); and 

C. Remove ‘‘Potassium iodide’’ from 

paragraph (b). The revision reads as 

follows: 

§ 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) * * * 

* * * * * 

Yeast—When used as food or a 

fermentation agent, yeast must be 

organic if its end use is for human 

consumption; nonorganic yeast may be 

used when equivalent organic yeast is 

not commercially available. Growth on 

petrochemical substrate and sulfite 

waste liquor is prohibited. For smoked 

yeast; nonsynthetic smoke flavoring 

process must be documented. 

* * * * * 

5. Section 205.606 is amended by: 

A. Revise paragraph (d); 

B. Revise paragraph (l); and 

C. Revise paragraph (s), the revisions 

read as follows: 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
2010 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

§ 205.606 Nonorganically produced 

agricultural products allowed as ingredients 

in or on processed products labeled 

‘‘organic’’. 

* * * * * 

(d) Colors derived from agricultural 

products—Must not be produced using 

synthetic solvents and carrier systems or 

any artificial preservative. 

* * * 

* * * * * 

(l) Hops (Humulus lupulus) until 

January 1, 2013. 

* * * * * 

(s) Pectin (non-amidated forms only). 

* * * * * 

Dated: January 6, 2012. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–362 Filed 1–11–12; 8:45 am] 

BILLING CODE 3410–02–P 


tkelley on DSK3SPTVN1PROD with PROPOSALS2