33290 Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations 

projected revenues sufficient to 

reasonably cover budgeted costs— 

adjusted for inflation—and allow for 

adequate operating reserves to be 

maintained. Costs considered in this 

method include salaries, costs of 

equipment and supplies, and other 

overhead costs, such as facility costs 

and costs for administration and 

supervision. In addition to covering 

expected costs, the user fee is set such 

that projected revenues will generate an 

operating reserve adequate to effectively 

manage uncertainties related to crop 

size and cash-flow timing while meeting 

minimum reserve requirements set by 

the Agricultural Marketing Service, 

which require maintenance of a reserve 

fund amount equal to at least four 

months of projected operating costs. 

The user fee charged to cotton 

producers for cotton classification in 

2012 is $2.20 per bale, which is the 

same fee charged for the 2011 crop. This 

fee is based on the preseason projection 

that 14,475,000 bales will be classed by 

the United States Department of 

Agriculture during the 2012 crop year. 

Accordingly, § 28.909, paragraph (b) 

reflects the continuation of the cotton 

classification fee at $2.20 per bale. 

As provided for in the 1987 Act, a 5 

cent per bale discount will continue to 

be applied to voluntary centralized 

billing and collecting agents as specified 

in § 28.909(c). 

Growers or their designated agents 

receiving classification data will 

continue to incur no additional fees if 

classification data is requested only 

once. The fee for each additional 

retrieval of classification data in 

§ 28.910 will remain at 5 cents per bale. 

The fee in § 28.910(b) for an owner 

receiving classification data from the 

National Database will remain at 5 cents 

per bale, and the minimum charge of 

$5.00 for services provided per monthly 

billing period will remain the same. The 

provisions of § 28.910(c) concerning the 

fee for new classification memoranda 

issued from the National Database for 

the business convenience of an owner 

without reclassification of the cotton 

will remain the same at 15 cents per 

bale or a minimum of $5.00 per sheet. 

The fee for review classification in 

§ 28.911 is maintained at $2.20 per bale. 

The fee for returning samples after 

classification in § 28.911 will remain at 

50 cents per sample. 

Summary of Comments 

A proposed rule was published in the 

Federal Register on April 11, 2012, with 

a comment period of April 11, 2012 

through April 26, 2012 (77 FR 21684). 

AMS received two comments: One from 

a national trade organization that 

represents approximately 80 percent of 

the U.S. cotton industry, including 

cotton producers, ginners, 

warehousemen, merchants, 

cooperatives, cottonseed processors, and 

textile manufacturers from Virginia to 

California; and one from a national trade 

organization comprised of eight state 

and regional membership organizations 

that represent approximately 680 

individual cotton ginning operations in 

17 cotton-producing states. Comments 

from the national trade organizations 

expressed support for the decision to 

maintain the fee at the level established 

for the 2011 crop. Comments may be 

viewed at www.regulations.gov. 

Pursuant to 5 U.S.C. 533, good cause 

exists for not postponing the effective 

date of this final rule until 30 days after 

publication in the Federal Register 

because this rule maintains uniform 

user fees for 2012 crop cotton 

classification services as mandated by 

the Cotton Statistics and Estimates Act, 

at the same level as 2011. 

List of Subjects in 7 CFR Part 28 

Administrative practice and 

procedure, Cotton, Reporting and 

recordkeeping requirements, 

Warehouses. 

For the reasons set forth in the 

preamble, 7 CFR part 28 is amended to 

read as follows: 

PART 28—[AMENDED] 

Subpart D—[Amended] 

■ 1. The authority citation for 7 CFR 

part 28, Subpart D, continues to read as 

follows: 

Authority: 7 U.S.C. 51–65; 7 U.S.C. 471– 

476. 

■ 2. In § 28.909, paragraph (b) is revised 

to read as follows: 

§ 28.909 Costs. 

* * * * * 

(b) The cost of High Volume 

Instrument (HVI) cotton classification 

service to producers is $2.20 per bale. 

* * * * * 

■ 3. In § 28.911, the last sentence of 

paragraph (a) is revised to read as 

follows: 

§ 28.911 Review classification. 

(a) * * * The fee for review 

classification is $2.20 per bale. 

* * * * * 

Dated: May 30, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–13527 Filed 6–5–12; 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–09–01FR] 

RIN 0581–AC96 

National Organic Program (NOP); 

Sunset Review (2012) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule addresses 

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, this 

final rule continues, without change, the 

exemptions (use) and prohibitions for 

multiple listings on the National List for 

5 years after their respective sunset 

dates. This final rule also amends the 

exemptions (use) for 7 substances and 

removes the exemptions for 3 

substances on the National List. 

DATES: Effective Dates: This rule is 

effective June 27, 2012, except for the 

amendments to §§ 205.601(g) and 

205.605(a), which are effective October 

21, 2012. For more information on these 

effective dates and renewals, see the 

SUPPLEMENTARY INFORMATION. 

FOR FURTHER INFORMATION CONTACT: 

Melissa R. 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 of Allowed and Prohibited 

Substances (National List). The National 

List identifies synthetic substances that 

may be used in organic production and 

nonsynthetic (natural) 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 


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1The Appendix shows a simplified listing for 

each substance; use categories and any restrictive 

annotations are not included in this overview. 

(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, this final rule addresses 

multiple recommendations submitted to 

the Secretary by the NOSB pertaining to 

substances due to expire from the 

National List in 2012. AMS published 

an Advanced Notice of Proposed 

Rulemaking (ANPR) in the Federal 

Register on March 26, 2010 (75 FR 

14500), announcing the NOSB’s review 

of exempted and prohibited substances 

codified at the National List of the 

National Organic Program (NOP) 

regulations and set to expire in 2012. 

AMS provided the comments received 

in response to the ANPR to the NOSB 

in advance of their review of these 

substances. Based upon the NOSB’s 

recommendations, AMS published a 

proposed rule in the Federal Register on 

January 12, 2012, (77 FR 1996) to 

address the continued use of these 

substances on the National List in 

organic production and handling. 

Consistent with the recommendations 

from the NOSB, this final rule renews, 

without change, multiple exemptions 

(uses) and prohibitions on the National 

List (along with any restrictive 

annotations) for 5 years. This final rule 

also amends the exemptions for 7 

substances and removes the exemptions 

for 3 substances on the National List. A 

list of these substances is provided in 

the Appendix to this final rule. As 

referenced in the proposed rule for this 

2012 Sunset Review, AMS notes that the 

listings for nutrient vitamins and 

minerals at section 205.605(b) and 

sodium nitrate at section 205.602 will 

be dealt with in separate actions. 

Under the authority of the OFPA, 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), December 13, 2010 (75 FR 

77521); March 14, 2011 (76 FR 13501); 

August 3, 2011 (76 FR 46595); and 

February 14, 2012 (77 FR 8089). 

Additionally, proposed amendments to 

the National List were published on 

May 5, 2011 (76 FR 25612); November 

8, 2011 (76 FR 69141); January 12, 2012 

(77 FR 1980); and February 6, 2012 (77 

FR 5717). 

II. Overview of Final Actions 

A complete overview of final actions 

for designated sections of the National 

List regulations is presented in the 

Appendix.1 In the proposed rule, AMS 

indicated that proposed actions for each 

listing would be effective on the sunset 

date in 2012 for that listing (e.g. a listing 

due to sunset on October 21, 2012 

would be renewed effective October 21, 

2012). However, AMS determined that 

the effective dates for this sunset review 

should be streamlined to the extent 

possible through this final rule. 

Therefore, the actions pertaining to all 

listings, with the exception of the 

amendment to yeast at section 

205.605(a) and the removal of sulfur 

dioxide at section 205.601, will be 

effective on one date, June 27, 2012. The 

effective date for each listing is 

specified in the Appendix. In 

accordance with the sunset provisions 

in the OFPA, the new sunset date for all 

listings is five years from the effective 

date of their renewal or amendment. 

Renewals 

Consistent with the NOSB 

recommendations and in consideration 

of the public comments received on the 

proposed rule (77 FR 1996), AMS is 

renewing multiple listings pertaining to 

the National List through this final rule. 

This final rule continues the 

exemptions at section 205.601, along 

with any restrictive annotations, for the 

synthetic substances allowed for use in 

organic crop production as shown in the 

Appendix. 

This final rule continues the 

prohibitions at section 205.602, along 

with any restrictive annotations, for the 

nonsynthetic substances prohibited for 

use in organic crop production as 

shown in the Appendix. It should be 

noted that the nonsynthetic, prohibited 

substance ‘‘Ash from manure burning’’ 

was listed incorrectly in Table 1 of the 

proposed rule as ‘‘Ash for manure 

burning’’ (emphasis added). The correct 

listing is included in the Appendix of 

this final rule. 

This final rule continues the 

exemptions at section 205.603, along 

with any restrictive annotations, for the 

synthetic substances allowed for use in 

organic livestock production as shown 

in the Appendix. 

This final rule continues the 

prohibition at section 205.604, for the 

nonsynthetic substance prohibited for 

use in organic livestock production as 

shown in the Appendix. 

This final rule continues the 

exemptions at section 205.605(a), along 

with any restrictive annotations, for the 

nonsynthetic, 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 the Appendix. 

This final rule continues the 

exemptions at section 205.605(b), along 

with any restrictive annotations, for the 

synthetic, 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 the Appendix. 

This final rule continues the 

exemptions at section 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 the Appendix. 

Nonrenewals 

This final rule amends the National 

List by removing the exemptions as 

shown in the Appendix for the 

following 3 substances in organic 

production and handling: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

This final rule amends section 

205.601 of the National List regulations 

by removing the exemption for sulfur 

dioxide at paragraph (g)(1) and 

redesignating current paragraph (g)(2) as 

(g) to read: (g) As rodenticides. Vitamin 

D3. This amendment is effective on the 

sunset date for sulfur dioxide, 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))’’ 

This final rule amends section 

205.605(b) of the National List 

regulations by removing the exemption 

for pectin (low-methoxy), and the 

exemption, along with its restrictive 

annotation, for potassium iodide. These 

amendments are effective on June 27, 

2012. 


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Renewals With Amendment 

This final rule amends the National 

List regulations by amending the 

exemptions as shown in the Appendix 

for the following 7 substances in organic 

production and handling: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production. 

This final rule amends the listing for 

chlorine materials at section 

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. (iii) 

Sodium hypochlorite. This amendment 

is effective on June 27, 2012. 

This final rule amends section 

205.601(i)(11) to add an expiration date 

to the listing for streptomycin to read as 

follows: Streptomycin, for fire blight 

control in apples and pears only until 

October 21, 2014. This amendment is 

effective on June 27, 2012. 

This final rule amends the listing for 

lignin sulfonate at section 205.601(j)(4) 

to remove the words ‘‘floatation agent.’’ 

The new listing will read: Lignin 

sulfonate—chelating agent, dust 

suppressant. This amendment is 

effective on June 27, 2012. It should be 

noted that the amendatory language for 

lignin sulfonate was incorrectly listed in 

the proposed rule as ‘‘Lignin sulfate— 

chelating agent, dust suppressant’’ 

(emphasis added). This error is 

corrected in this final rule. 

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)) ’’ 

This final rule amends the listing for 

yeast section 205.605(a) to read as 

follows: Yeast—When used as food or a 

fermentation agent in products labeled 

as ‘‘organic,’’ yeast must be organic if its 

end use is for human consumption; 

nonorganic yeast may be used when 

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 

is effective on the sunset date for yeast, 

October 21, 2012. 

Section 205.606 Nonorganically 

Produced Agricultural Products Allowed 

as Ingredients in or on Processed 

Products Labeled as ‘‘Organic ’’ 

This final rule adds a restrictive 

annotation to the listing for colors at 

section 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 is effective on the sunset 

date for colors derived from agricultural 

products, June 27, 2012. 

This final rule adds an expiration date 

to the listing for hops at section 

205.606(l) to read as follows: Hops 

(Humulus lupulus) until January 1, 

2013. This amendment is effective on 

the sunset date for hops, June 27, 2012. 

This final rule amends the listing for 

pectin at section 205.606(t) to read as 

follows: Pectin (non-amidated forms 

only). This amendment is effective on 

June 27, 2012. 

III. Related Documents 

An Advance Notice of Proposed 

Rulemaking with request for comments 

was published in the Federal Register 

on March 26, 2010 (75 FR 14500), to 

make the public aware that the 

exemptions and prohibitions for over 

200 listings of synthetic and 

nonsynthetic substances in organic 

production and handling would expire, 

if not reviewed by the NOSB and 

addressed by the Secretary. Substances 

and recommendations addressed 

through this final rule were announced 

for NOSB deliberation in the following 

Federal Register notices: (1) March 17, 

2010 (75 FR 12723); September 20, 2010 

(75 FR 57194); and (2) March 4, 2011 

(76 FR 12013). The proposal to address 

the substances in this final rule was 

published as a proposed rule in the 

Federal Register on January 12, 2012 

(77 FR 1996). 

IV. Statutory and Regulatory Authority 

The OFPA 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 section 

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. 

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 final 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 the 

OFPA (7 U.S.C. 6514(b)). States are also 

preempted by 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 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 the OFPA (7 U.S.C. 

6519(f)), this final 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. 

301–399), nor the authority of the 

Administrator of EPA under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA) (7 U.S.C. 136–136(y)). 


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2U.S. Department of Agriculture, Economic 

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

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. http:// 

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

3 Kirby, Elizabeth, and David Granatstein. Status 

of Organic Tree Fruit in Washington State—2009, 

Washington State University, March 2010. 

4U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers: Documentation. 

http://www.ers.usda.gov/Data/OrganicHandlers/ 

Documentation.htm. 

5 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, http://www.ers.usda.gov/Publications/ 

EIB58. 

6Organic Trade Association’s 2011 Organic 

Industry Survey, http://www.ota.com. 

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 

of the RFA is to fit regulatory actions to 

the scale of businesses subject to such 

actions in order that small business will 

not be unduly or disproportionately 

burdened. 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. 

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 final rule 

on small entities and has determined 

that this rule would not have a 

significant economic impact on a 

substantial number of small entities. 

The effect of this final rule would be to 

allow the continued use of multiple 

substances in agricultural production 

and handling. AMS concludes that the 

economic impact of the renewals and 

renewals with amendment of allowed 

substances, if any, would be minimal 

and beneficial to small agricultural 

service firms. For the substances 

removed or further restricted through 

this final action, AMS determined that 

their use is either not prevalent or that 

alternatives to their use are available to 

organic producers and handlers. 

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 NOP’s Accreditation and 

International Activities Division, the 

number of certified U.S. organic crop 

and livestock operations totaled over 

17,000 in 2010. According to USDA, 

Economic Research Service (ERS) data 

based on information from USDAaccredited certifying agents, certified 

organic acreage exceeded 4.8 million 

acres in 2008.2 In 2009, U.S. certified 

organic apple acreage exceeded 21,000 

acres, primarily concentrated in 

Washington and California.3 ERS, based 

upon the list of certified operations 

maintained by the NOP, estimated the 

number of certified handling operations 

was 3,225 in 2007.4 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 2008.5

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%.6

In addition, USDA has 93 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 final rule. 

Accordingly, OMB clearance is not 

required by the Paperwork Reduction 

Act of 1995, 44 U.S.C. 3501, Chapter 35. 

E. Executive Order 13175 

This final rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this regulation will not have substantial 

and direct effects on Tribal governments 

and will not have significant Tribal 

implications. 

F. Comments Received on Proposed 

Rule NOP–09–01 

AMS received approximately 40 

comments on the proposed rule. AMS 

received comments from consumers, 

organic producers and handlers, trade 

representatives, certifying agents, 

ingredient manufacturers, consultants, 

and an environmental organization. 

Most comments specifically addressed 

proposed amendments for individual 

substances. A few comments were 

received in support of multiple or all of 

the substances under this sunset review. 

A few comments presented concerns 

that were not within the scope of the 

sunset review action. 

All comments on the proposed 

amendments for hops and lignin 

sulfonate and the proposed removal of 

potassium iodide were supportive of the 

actions as proposed. Therefore, AMS is 

finalizing the amendments and 

removals as proposed through this final 

rule. 

Some comments suggested changes to 

the proposal rule for specific 

substances. These comments are 

described below in conjunction with 

AMS’ response, including any 

amendments that will be addressed 

through this final rule. 

Chlorine Materials 

AMS received six comments 

regarding the amendment for chlorine 

materials allowed in crop production at 

section 205.601(a)(2). Comments were 

received from trade associations, an 

environmental organization and a 

sprout producer. Four comments 

supported the proposed amendment for 

chlorine materials, while two comments 

raised issues associated with the use of 

chlorine in sprouts. 

AMS requested comments in the 

proposed rule on the use of chlorine in 

treatment of seeds for organic sprout 

production. Consistent with the NOSB 

recommendation, the proposed rule 

included an annotation change which, 

in part, intended to clarify the use of 

chlorine in edible sprout production. 

AMS specifically asked commenters to 

provide information on whether using 


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7FDA, Guidance for Industry: Microbial Food 

Safety Hazards for Sprouted Seeds. October 27, 

1999. http://www.fda.gov/Food/ 

GuidanceComplianceRegulatoryInformation/

GuidanceDocuments/ProduceandPlanProducts/ 

ucm120244.htm. 

the Environmental Protection Agency 

(EPA) labeled rate of chlorine for 

sprouts (20,000 ppm), followed by a 

rinse of potable water, is appropriate for 

organic production. AMS also sought 

input from commenters on whether 

there are other Food and Drug 

Administration (FDA) and EPA 

approved materials or methods suitable 

for sprout treatment. 

One commenter responded that 

methods to ensure sprout safety are 

complex and stated that no single 

practice will completely eliminate 

pathogens. This commenter supported 

the clarification on chlorine as proposed 

and urged further development of 

criteria and procedures for assessing 

alternatives that would be both 

acceptable to FDA and in organic 

products. 

One commenter stated that there are 

other equally effective alternatives that 

would be more consistent with organic 

principles. This commenter, however, 

noted that the 20,000 ppm soak in 

calcium hypochlorite, a chlorine 

material currently allowed under the 

NOP regulations, is the only treatment 

for sprouts addressed by FDA in their 

guidance document.7 This commenter 

recommended that FDA clarify other 

treatment options that are permitted and 

effective for sprout treatment. AMS 

believes that this comment is pertinent 

to FDA’s guidance, rather than AMS’ 

proposed amendment for chlorine. In 

the absence of comments demonstrating 

acceptable alternatives for treatment of 

seed for sprouting, AMS concludes that 

the annotation change on chlorine 

specifying its allowance in spout 

production is appropriate and will 

codify this change through this final 

rule. 

One commenter opposed all uses of 

chlorine in organic production, other 

than unavoidable residues of chlorine 

from its use in treated drinking water. 

This commenter stated that chlorine is 

a reactive chemical that can combine 

with organic matter to form persistent 

organochlorines and other disinfection 

byproducts. For this reason, the 

commenter felt that added chlorine 

should not be used in organic crop 

production. The commenter requested 

that AMS amend the annotation for 

chlorine to restrict all chlorine used in 

direct contact with crops, in irrigation 

systems, and in disinfection of 

equipment or tools to levels no greater 

than the maximum residual disinfectant 

limit under the Safe Drinking Water Act. 

AMS disagrees with the commenter 

on this issue. The NOSB reviewed and 

recommended chlorine for inclusion on 

the National List in 1995, 2003, 2006 

and 2011, according to the OFPA 

evaluation criteria in 7 U.S.C. 6517 and 

6518. In these reviews, the NOSB 

assessed the impact of using chlorine on 

the environment and human health, but 

concluded that the need for this 

substance in some instances is 

necessary to ensure prevention of food 

borne pathogens. Consistent with the 

April 2011 NOSB recommendation, 

AMS proposed an annotation to 

chlorine, which would limit its direct 

use on crops and in soil contact to levels 

no higher than those found in municipal 

drinking water. The NOSB has not 

recommended any limitation on the use 

of chlorine for disinfecting tools and 

equipment when necessary to prevent 

spread of plant diseases. Therefore, 

AMS is codifying the annotation change 

to chlorine as proposed through this 

final rule. 

Pheromones 

AMS received one comment about the 

continued allowance for pheromones for 

insect management at section 205.601(f). 

The commenter objected to the 

categorical relisting of pheromones and 

indicated that the NOSB acted without 

sufficient information. The commenter 

indicated that although pheromone 

products are valuable to organic 

producers, there are many types of 

pheromones, and that the different types 

of pheromones were not reviewed by 

the NOSB. The commenter also 

indicated that the NOSB should address 

the use of additional ingredients in 

pheromone product formulations. The 

commenter suggested that the 

annotation be changed to list 

pheromones for insect management on 

section 205.601, provided that they are 

exempt from regulation under FIFRA 

(7 U.S.C. 136–136(y)) by 40 CFR 

152.25(b). 

AMS disagrees with the commenter 

on this issue. The NOSB is responsible 

for reviewing generic materials, not 

specific product formulations. The 

NOSB has previously reviewed and 

recommended pheromones for inclusion 

on the National List according to the 

OFPA criteria. The NOP regulations 

currently allow the use of inert 

ingredients in pesticide formulations 

under a separate listing at section 

205.601(m). During their sunset 

deliberations, the NOSB reviewed 

pheromones against the evaluation 

criteria in 7 U.S.C. 6517 and 6518 of the 

OFPA and concluded that they remain 

essential to organic production since no 

organic alternatives exist. The NOSB 

recommended that the exemption for 

pheromones continue as previously 

allowed. AMS concurs with the NOSB’s 

evaluation and recommendation of this 

substance, and therefore, does not find 

that sufficient information was provided 

by the commenter to justify the addition 

of an annotation to the listing for 

pheromones on the National List. 

Consistent with the NOSB 

recommendation, AMS is renewing the 

listing for pheromones through this final 

rule as proposed. 

Sulfur Dioxide 

AMS received one comment that 

objected to the removal of sulfur dioxide 

from section 205.601(g) based upon its 

use for rodent control on organic farms. 

However, AMS did not receive any 

comments from organic producers that 

this substance is commonly used. 

Furthermore, as explained in the 

proposed rule, the NOSB determined 

that the EPA does not register any 

products for use as a rodenticide that 

contain sulfur dioxide as an active 

ingredient. Therefore, consistent with 

the NOSB recommendation, AMS is 

removing the listing for sulfur dioxide 

as a rodenticide from the National List 

through this final rule. 

EPA List 4—Inerts of Minimal Concern 

AMS received one comment about the 

continued allowance for synthetic inert 

ingredients under the listing at section 

205.601(m)(1) for ‘‘EPA List 4—Inerts of 

Minimal Concern.’’ The commenter 

opposes the inclusion of EPA List 4 as 

a category on the National List and 

indicated that all substances included 

on EPA List 4 should be individually 

considered by the NOSB. The 

commenter also objected to the use of 

the term ‘‘inert’’ in describing other 

ingredients in pesticide products. The 

commenter noted that ‘‘inert’’ 

ingredients may be biologically active or 

have toxicological affects. AMS 

disagrees with the commenter on this 

issue of redefining the term ‘‘inert 

ingredient’’ at this time. The term ‘‘inert 

ingredient,’’ is defined under the NOP 

regulations for consistency with EPA 

regulations under FIFRA. AMS does not 

conclude that sufficient information was 

provided by the commenter to justify 

the removal of this listing from the 

National List. Therefore, AMS is 

renewing the listing for EPA List 4 

through this final rule as proposed. 

The commenter also suggested that 

the NOSB adopt a policy to transition to 

the individual review of inert 

ingredients. This comment is outside 

the scope of this rulemaking; however, 


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8NOSB Formal Recommendation on 

Streptomycin Sunset. April 29, 2011. Available on 

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

AMSv1.0/getfile?dDocName=STELPRDC5091714. 

9Technical Report on Streptomycin. March 8, 

2011. Available in petitioned substances database, 

under ‘‘S,’’ at the NOP Web site: 

www.ams.usda.gov/nop. 

AMS notes that a working group is 

currently in place to address the 

allowance of inerts that were previously 

classified as EPA List 4, since the EPA 

is no longer maintaining this list. 

Streptomycin 

AMS received eight comments on the 

proposed rule to relist streptomycin at 

section 205.601(i)(11) with an 

expiration date of October 21, 2014. 

Comments were received from a 

university-affiliated researcher, an 

agricultural pest and disease 

management specialist, an apple 

producer, a trade association, certifying 

agents, a streptomycin product 

manufacturer and an environmental 

organization. 

One comment supported the proposal 

to set October 21, 2014, as the 

expiration date for the use of 

streptomycin as recommended by the 

NOSB.8 This comment cited the 

following factors in support of phasing 

out streptomycin in organic apple and 

pear production: (i) Potential for the 

substance’s continued use to result in 

antibiotic resistance in human 

pathogens; (ii) inconsistency with the 

prohibition on antibiotic use in organic 

livestock production; and, (iii) 

incompatibility with organic and 

sustainable agriculture. The commenter 

further clarified the third point by 

stating that streptomycin use 

discourages cultural and biological 

controls, such as disease-resistant 

varieties and rootstock, site selection, 

careful fertilization, adequate tree 

spacing, proper pruning, as well as 

newer biological control products. 

Seven comments supported the 

proposal to relist streptomycin, but 

opposed the addition of the October 21, 

2014 expiration date. These commenters 

stated that a longer allowance time is 

needed and provided the following 

reasons for this opinion: (i) In practice, 

applications of streptomycin are 

coupled with management strategies to 

reduce susceptibility to fire blight and 

are generally limited to situations when 

computer models warn that an infection 

is likely to occur; (ii) there is a lack of 

viable, commercially available 

alternatives to streptomycin for fire 

blight control in apple and pear 

production; (iii) the research 

community is engaged in an ongoing 

effort to develop alternatives to 

antibiotics for controlling fire blight; (iv) 

streptomycin is particularly effective in 

humid areas where fire blight has not 

developed resistance; and, (v) without 

the availability of streptomycin to treat 

fire blight, some U.S. organic apple and 

pear producers may exit organic 

production and imported products 

could compensate for any decrease in 

U.S. production. 

These commenters further stated that 

there is no assurance that current 

research efforts will yield any 

commercially viable alternative(s) to 

streptomycin in time for the October 21, 

2014, expiration date. A number of 

commenters specifically cited a USDAOrganic Agriculture Research and 

Extension Initiative grant for the 

development of non-antibiotic programs 

for fire blight control in organic apple 

and pear production. Commenters 

explained that the findings of this 

project, which started in September 

2011, will not be available until 2016, 

and would enable the NOSB to assess 

the strategies for controlling fire blight 

without antibiotics after that time. 

Comments also addressed the efficacy 

of several of alternatives to 

streptomycin, including resistant 

rootstocks and varieties, and biological 

controls, all of which the NOSB cited in 

its justification for recommending an 

expiration date. Several commenters 

explained that resistant rootstocks are 

still in development and that resistance 

would not convey to the upper part of 

the tree where the fire blight infection 

takes hold. Some commenters stated 

that apple and pear varieties have 

varying degrees of susceptibility to fire 

blight, but none are immune. One 

commenter reported that consumers 

demand newer apple and pear varieties, 

which are susceptible to fire blight, and 

stated that there is no market for other 

varieties. One commenter noted the 

slow progress in developing new 

varieties that exhibit favorable eating 

and storage qualities, as well as fire 

blight resistance. Some comments 

described biological controls as a 

component of an overall fire blight 

management strategy, which are most 

effective when supplemented with 

antibiotics. Comments also contended 

that years of research have not yielded 

any biological control product that 

matches the effectiveness of 

streptomycin. 

Commenters specifically requested 

that the proposed expiration date for 

streptomycin be deleted. In effect, such 

an action would renew the current 

listing for streptomycin on the National 

List for five years, until 2017, when it 

would be subject to sunset review. 

Consistent with the NOSB 

recommendation, AMS is maintaining 

the proposed amendment to allow 

streptomycin for fire blight control in 

organic apple and pear production until 

October 21, 2014. During deliberations, 

the NOSB reviewed technical 

information on streptomycin in 

accordance with the criteria in OFPA 

(7 U.S.C. 6517–6518) and the NOP 

regulations for synthetic substances on 

the National List (§ 205.600). The 

Technical Report considered by the 

NOSB addressed the same issues raised 

by the commenters to the proposed rule 

concerning the efficacy of alternatives to 

streptomycin.9 These alternatives 

include biological controls, allowed 

synthetic substances, the selection of 

varieties with low susceptibility to fire 

blight, and agronomic practices 

including careful and timely pruning, 

maintaining well-drained soil, limiting 

or excluding the use of manure and 

blossom removal. The NOSB is 

mandated by OFPA to evaluate whether 

alternative practices make the use of a 

substance such as streptomycin 

unnecessary. In this case, the NOSB 

found widespread fire blight resistance 

to streptomycin in apple production and 

continued use of apple and pear 

varieties that are highly susceptible to 

fire blight. Ultimately, the NOSB 

recommendation conveyed the 

expectation that preparation for the 

removal of streptomycin would augment 

the development and use of resistant 

rootstocks and cultivars, preventive 

management methods and the use of 

allowed biological and chemical 

controls. 

The NOSB also considered additional 

factors in its decision, including 

antibiotic resistance in humans and the 

high susceptibility of leading varieties 

of organic apple and pears, in terms of 

acreage, to fire blight. Consistent with 

the OFPA, the NOSB evaluated the 

effects of the use of streptomycin upon 

human health. The NOSB considered 

information from the Technical Report 

that streptomycin sprays can leave 

detectable residues in apple cores and 

skins. Based on this information, the 

NOSB was concerned that the continued 

use of streptomycin could contribute to 

antibiotic resistance which would be 

inconsistent with the principles of 

organic production and the OFPA 

criteria. The NOSB also stated that 

consumers expect that organic products 

are not produced with antibiotics. 

At the April 2011 meeting, the NOSB 

Crops Committee put forth a proposal to 

extend the exemption for streptomycin 

until October 21, 2014. This proposal 

was intended to phase out use of this 


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10The NOSB sunset review process is described 

on pg. 54 of the NOSB Policy and Procedures 

Manual. Available at NOP Web site: http:// 

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

getfile?dDocName=STELDEV3013893. This process 

is further described in the October 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. 

11NOSB Recommendation on Streptomycin, 

April 29, 2011. Available at NOP Web site: 

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

getfile?dDocName=STELPRDC5091714. 

substance while providing a sufficient 

timeframe for industry members to 

prepare for the removal of streptomycin 

from the National List. At the April 

2011 NOSB meeting, the NOSB took two 

votes on the proposal for streptomycin: 

one vote on their recommendation to 

list streptomycin with the October 21, 

2014, expiration date, and one ‘‘back up 

vote’’ to relist streptomycin without 

restriction. The NOSB conducted these 

votes in accordance with their sunset 

review process.10 The April 2011 NOSB 

recommendation for streptomycin 

specified their intent to phase out use of 

the substance over time through 

addition of the October 21, 2014, 

expiration date.11 Therefore, consistent 

with the recommendation of the NOSB, 

AMS published a rule proposing the 

October 21, 2014, expiration date for 

streptomycin. 

While some commenters submitted 

comments advocating for relisting 

streptomycin without restriction, AMS 

did not receive any new information 

from commenters on this issue that the 

NOSB had not considered during their 

April 2011 deliberations on 

streptomycin. Furthermore, AMS 

believes that relisting streptomycin 

without an expiration date would not 

meet the intent of the NOSB to phase 

out the use of this substance in organic 

apple and pear production over time. 

Therefore, consistent with the NOSB 

recommendation, AMS is codifying the 

addition of an expiration date to the 

listing for streptomycin through this 

final rule. Finally, AMS notes that 

extending the allowance for the use of 

streptomycin after the October 21, 2014, 

expiration date would require a petition 

to the NOSB. This process can be 

initiated in accordance with the Notice 

of Guidelines on Procedures for 

Submitting National List Petitions 

(72 FR 2167). 

Flavors 

AMS received one comment from a 

trade association that specifically 

addressed the proposed relisting of 

flavors, nonsynthetic sources only, on 

section 205.605(a). The commenter 

supported the continued listing of 

nonsynthetic flavors with the existing 

restriction, ‘‘must not be produced using 

synthetic solvents and carrier system or 

any artificial preservatives.’’ AMS is 

renewing the listing for flavors as 

proposed through this final rule. 

The commenter, however, further 

requested that the NOP issue a guidance 

document to request that certifying 

agents use a standardized industry 

questionnaire to verify compliance of 

the use of nonsynthetic flavors in 

organic handling. AMS concludes this 

request is beyond the scope of this final 

rule. 

Yeast 

AMS received over twenty comments 

in response to the proposed amendment 

for yeast. The majority of comments 

were supportive of the amendment in 

the proposed rule. 

One commenter noted that the 

proposed amendment for yeast would 

require producers of products labeled 

‘‘made with organic (specified 

ingredients or food group(s))’’ to be 

subject to commercial availability before 

using a nonorganic ingredient, which is 

not required for products in this 

labeling category. Under section 

205.301(c) of the NOP regulations, 

products sold, labeled, or represented as 

‘‘made with organic (specified 

ingredients or food group(s))’’ are not 

subject to the requirement that the 

product must not be produced using 

nonorganic ingredients when organic 

ingredients are available. AMS 

concludes that a modification to the 

proposed amendment for yeast is 

necessary to ensure consistency with 

the NOP regulations. Therefore, AMS 

has amended the yeast annotation 

through this final rule to clarify that the 

requirement that yeast be organic when 

commercially available is only 

applicable to products labeled 

‘‘organic.’’ 

One commenter noted that the use of 

the term ‘‘equivalent organic yeast’’ in 

the proposed amendment was unclear 

since ‘‘equivalent’’ was not defined. The 

commenter noted that organic yeast may 

have lower leavening activity than 

conventional yeast, or may only be 

available in a specific form (e.g. dry and 

not fresh), and therefore would not be 

considered ‘‘equivalent.’’ AMS notes 

that the amendment allows the use of 

conventional yeast when organic yeast 

is not commercially available. Under the 

NOP regulations, ‘‘commercially 

available’’ is defined as the ability to 

obtain a production input in an 

appropriate form, quality, or quantity to 

fulfill an essential function in a system 

of organic production or handling, as 

determined by the certifying agent in 

the course of reviewing the organic 

plan. Thus, organic yeast is not required 

to be used if it is not available in the 

appropriate form or quality, as noted in 

the commenter’s examples. To reduce 

confusion over the use of the term 

‘‘equivalent,’’ AMS has removed this 

term from the amendment in the final 

rule as we believe the inclusion is 

redundant with the existing criteria for 

commercial availability. 

One commenter requested that AMS 

develop guidelines specifically for 

changes to the National List for which 

label revisions will be necessary. The 

commenter specifically noted that an 

operator presently using nonorganic 

yeast that successfully sources organic 

yeast will need to update the ingredient 

statement in their product labels to 

indicate the yeast is organic. The 

commenter suggested these guidelines 

allow at least one year for label 

revisions. 

AMS notes that the effective date of 

this amendment requires that product 

formulations be compliant by October 

21, 2012. The publication of this final 

rule provides almost four months of 

notice to the industry about this change. 

Sections 205.304–205.306 of the NOP 

regulations require that each organic 

ingredient in the ingredient statement 

be identified with the word, ‘‘organic,’’ 

or with an asterisk or other reference 

mark which is defined below the 

ingredient statement to indicate the 

ingredient is organically produced. 

Therefore, if product formulations must 

be compliant by October 21, 2012, then 

the labels for these products should also 

be compliant with the regulations at 

sections 205.304–205.306 by the 

effective date for this amendment. 

Products entering the stream of 

commerce prior to the effective date do 

not have to be relabeled. AMS further 

notes that development of broad 

guidelines on label use up for any 

National List change is beyond the 

scope of this rulemaking. 

Two commenters requested that yeast 

be moved from section 205.605 of the 

National List to section 205.606, as an 

agricultural product. One commenter 

noted that listing yeast on section 

205.605 would allow products labeled 

‘‘made with organic (specified 

ingredients or food group(s))’’ to use 

non-organic yeast without the 

requirements for documenting 

commercial availability. The NOP has 

addressed the concerns for products 

labeled ‘‘made with organic (specified 

ingredients or food group(s))’’ by 

clarifying that the annotation which 

requires organic yeast is applicable only 

to products labeled ‘‘organic.’’ One 

commenter noted that yeast is an 


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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations 33297 

12This process is also described in the 2009 

Technical Report for Non Amidated Low Methoxyl 

Pectin. Available at NOP Web site: http:// 

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

getfile?dDocName=STELPRDC5087206. 

organism grown for food and that it 

should be considered an agricultural 

product for listing on section 205.606, 

rather than section 205.605. Based on 

review of the record, the NOSB 

considered this perspective during its 

deliberations before issuing its formal 

recommendation to the NOP; therefore, 

AMS has chosen to retain the listing on 

section 205.605, as recommended by the 

NOSB, rather than moving the listing to 

section 205.606. 

One commenter was opposed to the 

proposed amendment for yeast and 

supported the existing listing. The 

commenter noted that organic yeast is 

only available in dry form, not fresh. In 

addition, the commenter claimed that 

leavening activity in organic yeast is 

much lower than conventional yeast 

and that organic yeast is costly, and, 

therefore, is not equivalent in 

performance and cost. AMS notes that 

the current annotation permits the use 

of nonorganic yeast when organic yeast 

is not commercially available. Under the 

NOP regulations, section 205.2, 

commercially available is defined as the 

ability to obtain a production input in 

an appropriate form, quality, or quantity 

to fulfill an essential function in a 

system of organic production or 

handling, as determined by the 

certifying agent in the course of 

reviewing the organic plan. The 

commenter’s concern about sourcing an 

appropriate form (e.g. fresh, rather than 

dry) or quality (e.g. better leavening 

activity) could be considered by the 

certifying agent to determine whether 

nonorganic yeast would be allowed 

under the regulations in specific 

applications. The higher cost of organic 

yeast is not one of the permitted criteria 

for determining commercial availability 

under the NOP regulations. The NOSB 

considered the issues raised by the 

commenters, and AMS concludes that 

the inclusion of a commercial 

availability clause addresses the 

commenter’s concern about the 

allowance for conventional yeast when 

organic yeast is not available in an 

appropriate form, quality, or quantity. 

Silicon Dioxide 

The NOP received one comment 

stating that the listing for silicon 

dioxide at section 205.605(b) should be 

amended to reflect a December 2011 

NOSB recommendation on this 

substance. In their December 2011 

recommendation, the NOSB 

recommended the addition of a 

restrictive annotation to specify that 

silicon dioxide, a synthetic used in 

processed products, could only be used 

if a nonsynthetic alternative for certain 

uses is not commercially available. 

However, the December 2011 NOSB 

recommendation was not available 

when drafting the proposed rule for this 

2012 Sunset Review. Therefore, 

consistent with the October 2010 NOSB 

recommendation pertaining to the 2012 

Sunset Review for this substance, AMS 

published a proposed rule on January 

12, 2012, to renew silicon dioxide at 

section 205.605(b) as currently listed 

(i.e. without annotation). Because the 

proposal to amend the annotation for 

silicon dioxide was not included in the 

proposed rule and AMS did not receive 

public comment on such a change, AMS 

is not amending the annotation in this 

final rule. AMS is, therefore, renewing 

the existing listing for silicon dioxide 

through this final rule as proposed. 

AMS intends to address the December 

2011 NOSB recommendation for this 

substance through a separate 

rulemaking action for National List 

amendments. 

Xanthan Gum 

AMS received one comment from a 

trade association in support of relisting 

xanthan gum; however, this commenter 

also suggested reclassifying the 

substance as nonsynthetic and relisting 

it at section 205.605(a) of the National 

List. This commenter describes xanthan 

gum as a natural extracellular 

polysaccharide. The NOSB reviewed 

xanthan gum in April 2010 and did not 

propose any change in classification at 

that time. Therefore, AMS is renewing 

the listing for xanthan gum as codified. 

Pectin 

In accordance with the October 2010 

NOSB recommendation, the NOP 

proposed to remove the listing of 

synthetic pectin (low methoxy) at 

section 205.605(b), and to amend the 

listing for pectin (high-methoxy) at 

section 205.606(t) to ‘‘Pectin (nonamidated forms only).’’ The NOP 

received five comments in support of 

these proposed changes from trade 

associations, a beverage and dairy 

products manufacturer, and a consulting 

firm. The commenters agreed generally 

that non-amidated forms of pectin are 

adequate for use in organic products. 

One commenter opposed the 

proposed changes for technical reasons. 

This commenter disagreed with the 

October 2010 NOSB recommendation 

that considered both low-methoxy and 

high-methoxy pectin to be derived from 

a similar non-synthetic extraction 

process, with the difference in the final 

substance resulting from a longer 

extraction period. The commenter 

pointed out that the low-methoxy pectin 

is produced as a result of esterification 

(by removal of methyl groups, or 

demethylation) of high-methoxy pectin 

which is initially derived from citrus 

peel or apple pomace.12 This 

commenter agreed that amidated forms 

of pectin (forms treated with ammonia) 

are not necessary for use in organic 

production, but noted that only lowmethoxy pectin is available in amidated 

form. This commenter suggested that 

the listing at section 205.605(b) be 

amended to: ‘‘Low-methoxy pectin, nonamidated forms only’’ and that the 

existing listing for high-methoxy pectin 

be retained at section 205.606. 

While AMS believes that the 

commenter has merit regarding 

technical classification of the substance, 

the intent of the NOSB was to require 

that all forms of pectin used in organic 

products be subject to the requirement 

that organic sources be used when 

commercially available. Therefore, 

consistent with the intent of the NOSB, 

we have retained the proposed 

amendments for pectin in this final rule. 

Colors 

AMS received four comments in 

support of the proposed amendment to 

the listing for colors at section 

205.606(d). The proposed listing was 

‘‘Colors derived from agricultural 

products—Must not be produced using 

synthetic solvents and carrier systems or 

any artificial preservative.’’ These 

commenters, however, requested that 

AMS clarify whether synthetic 

substances allowed under section 

205.605(b) for solvent extraction, or as 

carriers, preservatives or stabilizers, and 

which are currently allowed for use in 

organic colors, would also be allowed 

for use in nonorganic colors at section 

205.606. Commenters specifically 

referenced ascorbic acid, carbon 

dioxide, glycerin, silicon dioxide and 

tocopherols, as examples of substances 

listed at section 205.605(b), which are 

currently allowed to produce organic 

colors. These substances were 

previously recommended by the NOSB 

and are currently codified as allowed 

synthetics at section 205.605(b) of the 

National List. The commenters 

requested clarification as to whether 

such substances at section 205.605(b) 

would still be allowed in the production 

of nonorganic colors under the proposed 

amendment. 

At their October 2010 meeting, the 

NOSB discussed the need for an 

annotation to clarify the allowance of 

synthetic solvents in the preparation of 


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33298 Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations 

13This NOSB discussion is available on the NOP 

Web site in the meeting transcript for Oct. 26, 2010 

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

getfile?dDocName=STELPRDC5088302&acct=nosb. 

the colors listed on section 205.606.13

The NOSB recommended an 

amendment to restrict the use of 

synthetic solvents, carrier systems and 

artificial preservatives in the production 

of colors. However, in their 

recommendation, the NOSB did not 

address whether this restriction would 

apply to synthetics already listed at 

section 205.605(b). 

The NOSB has already reviewed and 

recommended the synthetics listed at 

section 205.605(b) of the National List. 

Therefore, the synthetics listed at 

section 205.605(b) of the National List 

are already allowed in organic 

processed products, including in the 

formulation of colors. AMS believes the 

intent of the NOSB recommendation for 

colors is to prevent the use of synthetic 

substances that are not on the National 

List in the formulation of colors. 

Substances at section 205.605(b) of the 

National List will still be allowed in the 

production of nonorganic colors under 

the amendment. 

One commenter stated that 

unrestricted use of synthetic solvents or 

carriers permitted by FDA should be 

acceptable in colors used for organic 

production. AMS disagrees with this 

comment. While certain synthetic 

solvents or carriers may be permitted by 

FDA, these synthetics would need to be 

petitioned and reviewed by the NOSB 

for inclusion on the National List under 

the NOP regulations. 

Some commenters requested that 

AMS provide a one year compliance 

date from the effective date of the 

amendment to colors. Commenters 

stated that, while they believe that 

colors that comply with the amendment 

are available, manufacturers will need 

time to reformulate products that 

contained colors produced with 

synthetic solvents or carrier systems no 

longer allowed under the amendment. 

Based on the comments received, AMS 

understands that some product 

reformulation may be necessary. The 

effective date for this amendment is 

June 27, 2012, the sunset date for the 

current listing for colors. While this 

amendment is effective on June 27, 

2012, AMS considers a one year period 

from that date as reasonable and 

appropriate for the industry to 

reformulate products in order to ensure 

that the amendment is effectively and 

rationally implemented. AMS will be 

conducting outreach to the industry and 

training for certifying agents as 

appropriate. 

Cornstarch 

AMS received one comment opposed 

to the continued listing of cornstarch 

(native) at section 205.606(w)(1) of the 

National List. This commenter cited 

several sources for organic cornstarch 

that include a number of types for 

different applications, and suggested 

that nonorganic cornstarch should no 

longer be given an exemption for 

organic use. The commenter also 

believes that nonorganic cornstarch 

should not be included on the National 

List since most nonorganic sources 

could be derived from genetically 

engineered corn. 

During the October 2010 NOSB 

deliberations on the 2012 Sunset 

Review for cornstarch, the NOSB did 

not receive public comments objecting 

to relisting of cornstarch, and received 

several in support of relisting on section 

205.606. In their review, the NOSB did 

not identify risks to the environment, 

human or animal health resulting from 

the use or manufacture of the substance. 

Based upon the NOSB’s 

recommendation, AMS is relisting 

cornstarch as codified at section 

205.606. AMS notes that all nonorganic 

ingredients, including cornstarch, used 

in products labeled ‘‘organic’’ or ‘‘made 

with organic (specified ingredients or 

food group(s)’’ must not be produced 

using excluded methods, and that 

organic cornstarch should be used if 

commercially available. 

F. Effective Date 

This final rule reflects 

recommendations submitted to the 

Secretary by the NOSB for the purpose 

of fulfilling the requirements of 7 U.S.C. 

6517(e) of the OFPA. Section 7 U.S.C. 

6517(e) requires the NOSB to review 

each substance on the National List 

within 5 years of its publication. The 

substances being renewed or 

reauthorized with amended annotations 

on the National List were most recently 

reauthorized for use in organic 

agriculture on June 27, 2007, October 

21, 2007, December 11, 2007, and 

December 13, 2007. In the case of 

substances reauthorized for use on June 

27, 2007 and due to expire on June 27, 

2012, the substances being renewed and 

amended are critical to organic 

production and handling operations. 

Accordingly, pursuant to 5 U.S.C. 

553, it is found and determined that 

good cause exists for not postponing the 

effective date for amendments and 

renewals contained in this rule that are 

due to expire on June 27, 2012, until 30 

days after publication in the Federal 

Register. The effective dates for all 

substances are indicated in the 

Appendix. 

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 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. Revising paragraph (a)(2); 

■ B. Revising paragraph (g); 

■ C. Revising paragraph (i)(11); and 

■ D. Revising 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 sulfonate—chelating agent, 

dust suppressant. 

* * * * * 

■ 3. Section 205.605 is amended by: 

■ A. Revising the annotation for ‘‘Yeast’’ 

under paragraph (a); 

■ B. Removing ‘‘Pectin (low-methoxy)’’ 

from paragraph (b); and 

■ C. Removing the paragraph for 

‘‘Potassium iodide’’ from paragraph (b). 

The revision reads as follows: 


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14This Appendix 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 group(s)).’’ 

* * * * * 

(a) * * * 

* * * * * 

Yeast—When used as food or a 

fermentation agent in products labeled 

as ‘‘organic,’’ yeast must be organic if its 

end use is for human consumption; 

nonorganic yeast may be used when 

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. 

* * * * * 

■ 4. Section 205.606 is amended by: 

■ A. Revising paragraph (d); 

■ B. Revising paragraph (l); and 

■ C. Revising paragraph (t). 

■ The revisions read as follows: 

§ 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. 

* * * * * 

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

* * * * * 

Dated: May 30, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

Note: The following Appendix will 

not appear in the Code of Federal 

Regulations. 

APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14

National list section Substance NOSB meeting Effective date Final 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 * ............

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

Renew. 

Renew. 

Renew. 

Boric acid .................................. April 2010 * ............ June 27, 2012 ....... Renew. 

Chlorine materials at 

§ 205.601(a)(2) (Calcium 

hypochlorite; chlorine dioxide; 

sodium hypochlorite).

April 2011 .............. June 27, 2012 ....... 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, includes products exempted from EPA tolerance).

April 2011 .............. June 27, 2012 ....... Renew. 

Copper sulfate ........................... April 2011 .............. June 27, 2012 ....... Renew. 

Elemental sulfur (3 uses) .......... April 2010 * ............ June 27, 2012 ....... Renew. 

EPA List 4—Inerts of Minimal 

Concern.

October 2010 ........ June 27, 2012 ....... Renew. 

Ethylene gas ............................. April 2011 .............. June 27, 2012 ....... Renew. 

Herbicides, soap-based ............ April 2010 * ............ June 27, 2012 ....... Renew. 

Humic acids .............................. April 2010 * ............ June 27, 2012 ....... Renew. 

Hydrated lime ............................ April 2010 * ............ June 27, 2012 ....... Renew. 

Hydrogen peroxide (2 uses) ..... April 2010 * ............ June 27, 2012 ....... Renew. 

Lignin sulfonate at 

§ 205.601(j)(4).

April 2011 .............. June 27, 2012 ....... Amend: Lignin sulfonate— 

chelating agent, dust suppressant. 

Lignin sulfonate at 

§ 205.601(l)(1).

April 2011 .............. June 27, 2012 ....... Renew. 

Lime sulfur (2 uses) .................. April 2010 * ............ June 27, 2012 ....... Renew. 

Liquid fish products ................... April 2010 * ............ June 27, 2012 ....... Renew. 

Magnesium sulfate .................... April 2011 .............. June 27, 2012 ....... Renew. 

Micronutrients (Soluble boron 

products; Sulfates, carbonates, oxides, or silicates of 

zinc, copper, iron, manganese, molybdenum, selenium, and cobalt).

April 2010 * ............ June 27, 2012 ....... Renew. 


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APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14—Continued 

National list section Substance NOSB meeting Effective date Final action 

Mulches (Newspapers or other 

recycled paper, without 

glossy or colored inks; Plastic 

mulch and covers).

April 2011 .............. June 27, 2012 ....... Renew. 

Newspapers or other recycled 

paper, without glossy or colored inks.

April 2011 .............. June 27, 2012 ....... Renew. 

Oils, horticultural-narrow range 

oils as dormant, suffocating, 

and summer oils (2 uses).

April 2010 * ............ June 27, 2012 ....... Renew. 

Pheromones .............................. April 2011 .............. June 27, 2012 ....... Renew. 

Potassium bicarbonate ............. April 2010 * ............ June 27, 2012 ....... Renew. 

Soap-based algicide/demossers April 2010 * ............ June 27, 2012 ....... Renew. 

Soaps, ammonium .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Soaps, insecticidal .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Sodium silicate .......................... April 2011 .............. June 27, 2012 ....... Renew. 

Sticky traps/barriers .................. April 2010 * ............ June 27, 2012 ....... Renew. 

Streptomycin ............................. April 2011 .............. June 27, 2012 ....... 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 * ............ June 27, 2012 ....... Renew. 

Sulfur dioxide ............................ April 2011 .............. October 21, 2012 .. Remove. 

Vitamin B1, C, and E ................. April 2010 * ............ June 27, 2012 ....... Renew. 

Vitamin D3 ................................. April 2011 .............. June 27, 2012 ....... Renew. 

§ 205.602 Nonsynthetic substances prohibited for use in 

organic crop production.

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

Ash from manure burning .........

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

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

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

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

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

Renew. 

Renew. 

Renew. 

Potassium chloride .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Sodium fluoaluminate (mined) .. April 2010 * ............ June 27, 2012 ....... Renew. 

Sodium nitrate ........................... April 2011 .............. ............................ Addressed in separate rulemaking action. 

Strychnine ................................. April 2010 * ............ June 27, 2012 ....... Renew. 

Tobacco dust (nicotine sulfate) April 2010 * ............ June 27, 2012 ....... Renew. 

§ 205.603 Synthetic substances allowed for use in organic livestock production.Alcohols (Ethanol; Isopropanol) 

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

Atropine (CAS #–51–55–8) .......

Biologics—Vaccines ..................

October 2010 ........

October 2010 ........

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

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

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

Renew. 

Renew. 

Renew. 

Renew. 

Butorphanol (CAS #–42408– 

82–2).

April 2010 * ............ June 27, 2012 ....... Renew. 

Chlorhexidine ............................ April 2010 * ............ June 27, 2012 ....... Renew. 

Chlorine materials (Calcium hypochlorite; chlorine dioxide; 

sodium hypochlorite).

October 2010 ........ June 27, 2012 ....... Renew. 

Copper sulfate ........................... October 2010 ........ June 27, 2012 ....... Renew. 

Electrolytes ................................ April 2010 * ............ June 27, 2012 ....... Renew. 

EPA List 4—Inerts of Minimal 

Concern.

October 2010 ........ June 27, 2012 ....... Renew. 

Excipients .................................. April 2010 * ............ June 27, 2012 ....... Renew. 

Flunixin (CAS #–38677–85–9) .. April 2010 * ............ June 27, 2012 ....... Renew. 

Furosemide ............................... October 2010 ........ June 27, 2012 ....... Renew. 

Glucose ..................................... October 2010 ........ June 27, 2012 ....... Renew. 

Glycerine ................................... October 2010 ........ June 27, 2012 ....... Renew. 

Hydrogen peroxide .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Iodine (2 uses) .......................... April 2010 * ............ June 27, 2012 ....... Renew. 

Ivermectin .................................. April 2010 * ............ June 27, 2012 ....... Renew. 

Lidocaine ................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Lime, hydrated .......................... April 2010 * ............ June 27, 2012 ....... Renew. 

Magnesium hydroxide (CAS #– 

1309–42–8).

April 2010 * ............ June 27, 2012 ....... Renew. 

Magnesium sulfate .................... October 2010 ........ June 27, 2012 ....... Renew. 

Mineral oil .................................. April 2010 * ............ June 27, 2012 ....... Renew. 

Oxytocin .................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Peroxyacetic/peracetic acid 

(CAS #–79–21–0).

April 2010 * ............ June 27, 2012 ....... Renew. 

Phosphoric acid ........................ April 2010 * ............ June 27, 2012 ....... Renew. 

Poloxalene (CAS #–9003–11– 

6).

April 2010 * ............ June 27, 2012 ....... Renew. 

Procaine .................................... April 2010 * ............ June 27, 2012 ....... Renew. 


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APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14—Continued 

National list section Substance NOSB meeting Effective date Final action 

Sucrose octanoate esters (CAS 

#s—42922–74–7; 58064–47– 

4).

April 2010 * ............ June 27, 2012 ....... Renew. 

Tolazoline (CAS #–59–98–3) .... April 2010 * ............ June 27, 2012 ....... Renew. 

Trace minerals .......................... April 2010 * ............ June 27, 2012 ....... Renew. 

Vitamins .................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Xylazine (CAS #–7361–61–7) .. April 2010 * ............ June 27, 2012 ....... Renew. 

§ 205.604 Nonsynthetic substances prohibited for use in 

organic livestock production.

Strychnine ................................. April 2010 * ............ June 27, 2012 ....... 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 ........................................

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

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

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

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

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

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

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

October 2010 ........

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

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Magnesium sulfate .................... October 2010 ........ June 27, 2012 ....... Renew. 

Nitrogen ..................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Oxygen ...................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Perlite ........................................ April 2010 * ............ June 27, 2012 ....... Renew. 

Potassium chloride .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Potassium iodide ....................... April 2011 .............. June 27, 2012 ....... Renew. 

Sodium bicarbonate .................. April 2010 * ............ June 27, 2012 ....... Renew. 

Sodium carbonate ..................... April 2010 * ............ June 27, 2012 ....... Renew. 

Waxes (Carnauba wax; Wood 

resin).

April 2010 * ............ June 27, 2012 ....... Renew. 

Yeast (Autolysate; Bakers; 

Brewers; Nutritional; Smoked).

October 2010 ........ October 21, 2012 .. Amend: Yeast—When used as 

food or a fermentation agent 

in products labeled ‘‘organic’’, 

yeast must be organic if its 

end use is for human consumption; nonorganic yeast 

may be used when 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).

Carbon dioxide ..........................

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

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

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

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

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

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

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

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

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Renew. 

Chlorine materials (Calcium hypochlorite; chlorine dioxide; 

sodium hypochlorite).

October 2010 ........ June 27, 2012 ....... Renew. 

Ethylene .................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Ferrous sulfate .......................... October 2010 ........ June 27, 2012 ....... Renew. 

Glycerides (mono; di) ................ April 2010 * ............ June 27, 2012 ....... Renew. 

Glycerin ..................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Hydrogen peroxide .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Magnesium carbonate .............. April 2010 * ............ June 27, 2012 ....... Renew. 

Magnesium chloride .................. April 2010 * ............ June 27, 2012 ....... Renew. 

Magnesium stearate ................. April 2010 * ............ June 27, 2012 ....... Renew. 

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

Ozone ........................................ April 2010 * ............ June 27, 2012 ....... Renew. 

Pectin (low-methoxy) ................ October 2010 ........ June 27, 2012 ....... Remove. 

Phosphoric acid ........................ October 2010 ........ June 27, 2012 ....... Renew. 

Potassium acid tartrate ............. April 2010 * ............ June 27, 2012 ....... Renew. 

Potassium carbonate ................ April 2010 * ............ June 27, 2012 ....... Renew. 

Potassium citrate ...................... April 2010 * ............ June 27, 2012 ....... Renew. 

Potassium hydroxide ................. April 2010 * ............ June 27, 2012 ....... Renew. 


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APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14—Continued 

National list section Substance NOSB meeting Effective date Final action 

Potassium iodide ....................... April 2011 .............. June 27, 2012 ....... Remove. 

Potassium phosphate ............... April 2010 * ............ June 27, 2012 ....... Renew. 

Silicon dioxide ........................... October 2010 ........ June 27, 2012 ....... Renew. 

Sodium citrate ........................... October 2010 ........ June 27, 2012 ....... Renew. 

Sodium hydroxide ..................... October 2010 ........ June 27, 2012 ....... Renew. 

Sodium phosphates .................. October 2010 ........ June 27, 2012 ....... Renew. 

Sulfur dioxide ............................ October 2010 ........ June 27, 2012 ....... Renew. 

Tocopherols .............................. April 2011 .............. June 27, 2012 ....... Renew. 

Xanthan gum ............................. April 2010 * ............ June 27, 2012 ....... 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; Betacarotene 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, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

June 27, 2012 .......

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 ........ June 27, 2012 ....... Renew. 

Dillweed oil (CAS # 8006–75–5) April 2010 * ............ June 27, 2012 ....... Renew. 

Fish oil (Fatty acid CAS #’s 

10417–94–4 and 25167–62– 

8).

April 2010 * ............ June 27, 2012 ....... Renew. 

Fructooligosaccharides (CAS # 

308066–66–2).

October 2010 ........ June 27, 2012 ....... Renew. 

Galangal, frozen ........................ April 2010 * ............ June 27, 2012 ....... Renew. 

Gelatin (CAS # 9000–70–8) ..... April 2010 * ............ June 27, 2012 ....... Renew. 

Gums (Arabic; Guar; Locust 

bean; Carob bean).

April 2010 * ............ June 27, 2012 ....... Renew. 

Hops (Humulus luplus) at 

§ 205.606(l).

October 2010 ........ June 27, 2012 ....... Amend: Hops (Humulus 

lupulus) until January 1, 

2013. 

Inulin, oligofructose enriched ....

(CAS # 9005–80–5) ..................

October 2010 ........ June 27, 2012 ....... Renew. 

Kelp ........................................... April 2010 * ............ June 27, 2012 ....... Renew. 

Konjac flour (CAS # 37220–17– 

0).

April 2010 * ............ June 27, 2012 ....... Renew. 

Lemongrass, frozen .................. April 2010 * ............ June 27, 2012 ....... Renew. 

Orange shellac—unbleached 

(CAS # 9000–59–3).

April 2010 * ............ June 27, 2012 ....... Renew. 

Pectin (high-methoxy) ............... October 2010 ........ June 27, 2012 ....... Amend: Pectin (non-amidated 

forms only). 

Peppers (chipotle chile) ............ April 2010 * ............ June 27, 2012 ....... Renew. 

Sweet potato starch .................. April 2010 * ............ June 27, 2012 ....... Renew. 

Turkish bay leaves .................... April 2010 * ............ June 27, 2012 ....... Renew. 

Wakame seaweed (Undaria 

pinnatifida).

April 2010 * ............ June 27, 2012 ....... Renew. 

Whey protein concentrate ......... October 2010 ........ June 27, 2012 ....... 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. 

[FR Doc. 2012–13523 Filed 6–5–12; 8:45 am] 

BILLING CODE 3410–02–P 


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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations 33303 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 930 

[Doc. No. AO–370–A9; 11–0093; AMS–FV– 

10–0087; FV10–930–5] 

Tart Cherries Grown in the States of 

Michigan, New York, Pennsylvania, 

Oregon, Utah, Washington, and 

Wisconsin; Order Amending Marketing 

Order No. 930 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule amends 

Marketing Order No. 930 (order), which 

regulates the handling of tart cherries 

grown in Michigan, New York, 

Pennsylvania, Oregon, Utah, 

Washington, and Wisconsin. These 

amendments were proposed by the 

Cherry Industry Administrative Board 

(CIAB), which is responsible for local 

administration of the order. These 

amendments revise: the definition of 

‘‘Handle’’; and regulations concerning 

‘‘Marketing Policy’’ and ‘‘Grower 

Diversion Privilege.’’ The amendments 

are intended to improve the operation 

and administration of the order. 

DATES: This rule is effective June 7, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Parisa Salehi, Marketing Order and 

Agreement Division, Fruit and 

Vegetable Program, AMS, USDA, 1400 

Independence Avenue SW., Stop 0237, 

Washington, DC 20250–0237; 

Telephone: (202) 270–9918, Fax: (202) 

720–8938, or Email: 

Parisa.Salehi@ams.usda.gov; or Martin 

Engeler, Marketing Order and 

Agreement Division, Fruit and 

Vegetable Program, AMS, USDA, 2202 

Monterey Street, Fresno, California, 

93721; Telephone: (559) 487–5110, Fax: 

(559) 487–5110, or Email: 

Martin.Engeler@ams.usda.gov. 

Small businesses may request 

information on this proceeding by 

contacting Laurel May, Marketing Order 

and Agreement Division, Fruit and 

Vegetable Program, AMS, USDA, 1400 

Independence Avenue SW., Stop 0237, 

Washington, DC 20250–0237; 

Telephone: (202) 720–2491, Fax: (202) 

720–8938, or Email: 

Laurel.May@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: Prior 

documents in this proceeding: Notice of 

Hearing issued on March 4, 2011, and 

published in the March 14, 2011, issue 

of the Federal Register (76 FR 13528). 

The Recommended Decision was issued 

on November 3, 2011, and published in 

the November 9, 2011, issue of the 

Federal Register (76 FR 69673), and a 

Secretary’s Decision and Referendum 

Order issued on February 28, 2012, and 

published in the March 5, 2012 issue of 

the Federal Register (77 FR 13015). 

This action is governed by the 

provisions of sections 556 and 557 of 

title 5 of the United States Code and is 

therefore excluded from the 

requirements of Executive Order 12866. 

Preliminary Statement 

This final rule was formulated on the 

record of a public hearing held April 20 

and 21, 2011, in Grand Rapids, 

Michigan, and a second public hearing 

held April 26, 2011, in Provo, Utah. The 

hearing was held pursuant to the 

provisions of the Agricultural Marketing 

Agreement Act of 1937, as amended (7 

U.S.C. 601–674), hereinafter referred to 

as the ‘‘Act’’, and the applicable rules of 

practice and procedure governing the 

formulation of marketing agreements 

and orders (7 CFR Part 900). Notice of 

this hearing was published in the 

Federal Register on March 14, 2011 (76 

FR 13528). The notice of hearing 

contained the proposal submitted by 

CIAB and one proposal by the 

Agricultural Marketing Service (AMS). 

Upon the basis of evidence 

introduced at the hearings and the 

record thereof, the Administrator of 

AMS issued a Recommended Decision 

published in the Federal Register on 

November 9, 2011 (76 FR 69673). An 

opportunity to file written exceptions 

was provided through November 25, 

2011. Two comments were received 

during that period in support of these 

amendments. 

A Secretary’s Decision and 

Referendum Order was issued on 

February 28, 2012, and published in the 

March 5, 2012, issue of the Federal 

Register (77 FR 13015). This document 

directed that a referendum among tart 

cherry growers and processors be 

conducted during the period March 19, 

2012, through March 30, 2012, to 

determine whether they favor the 

proposed amendments to the order. To 

become effective, the amendments had 

to be approved by at least two-thirds of 

the growers voting in the referendum or 

two thirds of the production represented 

by such growers. In addition, processors 

who had frozen or canned at least fifty 

percent of the volume of tart cherries 

had to vote in favor of the amendments 

for them to become effective. All of the 

proposed amendments were approved 

by growers and processors. The 

amendments included in this final order 

will: 

1. Amendment 1 revises the term 

‘‘handle’’ within the order. This 

amendment revises existing section 

930.10, Handle, to exclude handler 

acquisition of grower diversion 

certificates from the definition of 

handle. 

2. Amendment 2 revises the 

‘‘marketing policy’’ provisions in 

section 930.50 of the order so that 

grower-diverted cherries are not 

counted as production in the volume 

control formula. 

3. Amendment 3 revises the existing 

section 930.58, so grower-diverted 

cherries are not treated as actual 

harvested cherries. 

In addition to the proposed 

amendments to the order, AMS 

proposed to make any additional 

changes to the order as may be 

necessary to conform to any amendment 

that may result from the hearings. 

A marketing agreement was 

subsequently mailed to all tart cherry 

handlers in the production area for their 

approval. The marketing agreement was 

approved by handlers representing more 

than 50 percent of the volume of tart 

cherries handled by all handlers during 

the representative period of July 1, 2010, 

to June 30, 2011. 

Small Business Considerations 

Pursuant to the requirements set forth 

in the Regulatory Flexibility Act (RFA), 

AMS has considered the economic 

impact of this action on small entities. 

Accordingly, AMS has prepared this 

final regulatory flexibility analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

business subject to such actions so that 

small businesses will not be unduly or 

disproportionately burdened. Marketing 

orders and amendments thereto are 

unique in that they are normally 

brought about through group action of 

essentially small entities for their own 

benefit. 

There are approximately 40 handlers 

of tart cherries subject to regulation 

under the order and approximately 600 

producers of tart cherries in the 

regulated area. Small agricultural 

service firms, which include handlers, 

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. A majority of the tart cherry 


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