This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

8040 

Vol. 78, No. 24 

Tuesday, February 5, 2013 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–12–0016; 

NOP–12–07PR] 

RIN 0581–AD27 

National Organic Program; Proposed 

Amendments to the National List of 

Allowed and Prohibited Substances 

(Crops and Processing) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

amend the U.S. Department of 

Agriculture’s (USDA’s) National List of 

Allowed and Prohibited Substances 

(National List) to address 

recommendations submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB) on November 5, 2009, and 

December 2, 2011. One recommendation 

addressed in this proposed rule pertains 

to amending the annotations for two 

exemptions (uses) for peracetic acid in 

organic crop production. Additional 

NOSB recommendations addressed in 

this proposed rule pertain to changing 

the annotations for three substances, 

potassium hydroxide, silicon dioxide, 

and beta-carotene extract color, which 

are currently allowed for use in organic 

handling. This proposed rule would 

also address the NOSB recommendation 

to remove the allowance on the National 

List for the use of nonorganic annatto 

extract color in organic handling. 

DATES: Comments must be received by 

March 7, 2013. 

ADDRESSES: Interested persons may 

comment on the proposed rule using the 

following procedures: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–NOP, 1400 

Independence Ave. SW., Room 2646– 

So., Ag Stop 0268, Washington, DC 

20250–0268. 

Instructions: All submissions received 

must include the docket number AMS– 

NOP–12–0016; NOP–12–07PR, and/or 

Regulatory Information Number (RIN) 

0581–AD27 for this rulemaking. You 

should clearly indicate the topic and 

section number of this proposed rule to 

which your comment refers. You should 

clearly indicate whether you support 

the action being proposed for the 

substances in this proposed rule. You 

should clearly indicate the reason(s) for 

your position. You should also supply 

information on alternative management 

practices, where applicable, that 

support alternatives to the proposed 

action. You should also offer any 

recommended language change(s) that 

would be appropriate to your position. 

Please include relevant information and 

data to support your position (e.g. 

scientific, environmental, 

manufacturing, industry, impact 

information, etc.). Only relevant 

material supporting your position 

should be submitted. All comments 

received will be posted without change 

to http://www.regulations.gov. 

AMS is particularly interested in 

comments that identify any formulated 

hydrogen peroxide products labeled for 

agricultural use that contain more than 

5% peracetic acid and that may be 

impacted by this rulemaking action. 

AMS is also interested in comments that 

describe whether product reformulation 

will be necessary and the timeframe that 

will be needed to comply with the 

proposed amendment for silicon 

dioxide at section 205.605(b) and the 

proposed removal of annatto extract 

color from section 206.606. Such 

comments will be considered to 

determine appropriate effective dates for 

these changes to the National List if 

codified through a final rule. 

Document: For access to the 

document to read comments received or 

any related background documents, go 

to http://www.regulations.gov. 

Comments submitted in response to this 

proposed rule will also be available for 

viewing in person at USDA–AMS, 

National Organic Program, Room 2646– 

South Building, 1400 Independence 

Ave. SW., Washington, DC, from 9 a.m. 

to 12 noon and from 1 p.m. to 4 p.m., 

Monday through Friday (except official 

Federal holidays). Persons wanting to 

visit the USDA South Building to view 

comments received in response to this 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, Telephone: (202) 

720–3252; Fax: (202) 205–7808. 

SUPPLEMENTARY INFROMATION:

I. Background 

On December 21, 2000, the Secretary 

established, within the National Organic 

Program (NOP) (7 CFR part 205), the 

National List regulations in sections 

205.600 through 205.607. This National 

List identifies the synthetic substances 

that may be used and the nonsynthetic 

(natural) substances that may not be 

used in organic production. The 

National List also identifies synthetic, 

nonsynthetic nonagricultural and 

nonorganic agricultural substances that 

may be used in organic handling. The 

Organic Foods Production Act of 1990 

(OFPA) (7 U.S.C. 6501–6522), and 

USDA organic regulations, in section 

205.105, specifically prohibit the use of 

any synthetic substance in organic 

production and handling unless the 

synthetic substance is on the National 

List. Section 205.105 also requires that 

any nonorganic agricultural and any 

nonsynthetic nonagricultural substance 

used in organic handling be on the 

National List. 

Under the authority of the OFPA, the 

National List can be amended by the 

Secretary based on recommendations 

developed by the NOSB. Since 

established, AMS has published 

multiple amendments to the National 

List beginning on October 31, 2003 (68 

FR 61987). AMS published the most 

recent amendment to the National List 

on September 27, 2012 (77 FR 59287). 

This proposed rule would amend the 

National List to reflect one 

recommendation submitted to the 

Secretary by the NOSB on November 5, 

2009, and four recommendations 

submitted to the Secretary by the NOSB 

on December 2, 2011. Based upon their 

evaluation of petitions submitted by 

industry participants, public comments, 

market surveillance, and review of 

technical reports and previous NOSB 

recommendations, the NOSB 

recommended that the Secretary revise 

the annotations for two listings for 

peracetic acid for organic crop 

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Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Proposed Rules 8041 

1Technical advisory panel report for peracetic 

acid. November 6, 2000. Available in Petitioned 

Substances Database under ‘‘P,’’ at the NOP Web 

site: http://www.ams.usda.gov/AMSv1.0/getfile?

dDocName=STELPRDC5067081&acct=nopgeninfo. 

2The petition was submitted by BioSafe Systems 

LLC, and is available on the NOP Web site at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDoc

Name=STELPRDC5071775&acct=nopgeninfo. 

3Available on the NOP Web site at http://www.

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

STELPRDC5092050&acct=nosb. 

4Available on the NOP Web site at http://

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

STELPRDC5092052&acct=nosb. 

5The former list of EPA List 4 inert ingredients 

is available at http://www.epa.gov/opprd001/inerts/ 

cascomplete.pdf. This list was last updated in 

August 2004 and is no longer maintained by EPA. 

6The NOSB recommendation for peracetic acid 

for Sunset 2013 is available on the NOP Web site 

Continued 

production at section 205.601, revise the 

annotations for two substances 

(potassium hydroxide, and silicon 

dioxide) for organic processing at 

section 205.605(b), and revise the 

annotation for one substance (betacarotene extract color) for organic 

processing at section 205.606. In 

addition, the NOSB recommended 

removing one substance (annatto extract 

color) for organic processing from 

section 205.606, which allows the 

nonorganic form to be used when the 

organic form is not commercially 

available. The exemptions for the use of 

each substance in organic crop 

production and handling were 

evaluated by the NOSB using the 

criteria specified in OFPA (7 U.S.C. 

6517–6518). 

II. Overview of Proposed Amendments 

The following provides an overview 

of the proposed amendments to 

designated sections of the National List 

regulations: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

This proposed rule would amend 

subparagraphs (a)(6) and (i)(8) of section 

205.601 by amending two annotations 

for the following substance: 

Peracetic acid. Peracetic acid is a 

clear, colorless liquid. It is an oxidizing 

agent formed by a reaction of hydrogen 

peroxide with acetic acid in water. The 

reaction used to produce peracetic acid 

proceeds until equilibrium is reached, 

and all three species (i.e., peracetic acid, 

hydrogen peroxide, and acetic acid) are 

always simultaneously present in any 

formulated peracetic acid product. 

Peracetic acid is often used in the food 

industry as a sanitizer and disinfects by 

oxidizing the outer cell membrane of 

vegetative bacterial cells, endospores, 

yeast, and mold spores.1

This proposed rule would implement 

a recommendation issued by the NOSB 

at its meeting on November 5, 2009, to 

amend two listings for peracetic acid in 

subparagraphs (a)(6) and (i)(8) in section 

205.601 of the National List. This rule 

proposes an amendment to the 

annotation for peracetic acid to clarify 

that peracetic acid is also permitted 

with certain restrictions in hydrogen 

peroxide formulations. This change is 

necessary to align the USDA organic 

regulations with an updated labeling 

requirement of the Environmental 

Protection Agency (EPA). The EPA 

labeling requirement specifies that 

peracetic acid needs to be listed as an 

active ingredient in some products that 

were previously labeled with hydrogen 

peroxide as the sole active ingredient. 

Peracetic acid was first added to 

section 205.601 of the National List on 

November 3, 2003 (68 FR 61987). AMS 

added peracetic acid to the National List 

for use in disinfecting equipment, seed, 

and asexually propagated plant material 

and for use to control fire blight 

bacteria. In 2007, the NOSB reviewed 

these two listings for peracetic acid 

under the five-year sunset process 

required by OFPA and, consistent with 

the NOSB recommendation, AMS 

renewed both listings on November 3, 

2008 (73 FR 59479). Following their 

renewal in 2008, these two listings for 

peracetic acid are scheduled to sunset 

from the National List on November 3, 

2013. 

On August 12, 2008, AMS received a 

petition from a manufacturer of sanitizer 

products requesting an amendment to 

the National List to expand the 

allowance for peracetic acid in organic 

crop production.2 The petition to amend 

the annotations for peracetic acid in 

sections 205.601(a)(6) and 205.601(i)(8) 

was submitted in response to a change 

in the EPA labeling requirements for 

certain products registered under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136– 

136(y)). These products were previously 

labeled with hydrogen peroxide as the 

sole active ingredient. Some hydrogen 

peroxide labeled products also contain 

a small amount of peracetic acid. 

Peracetic acid is produced from the in 

situ reaction of acetic acid, an inert 

ingredient permitted under section 

205.601(m) of the USDA organic 

regulations, with the active ingredient 

hydrogen peroxide. EPA now requires 

that these hydrogen peroxide products 

be relabeled to list both hydrogen 

peroxide and peracetic acid as active 

ingredients. 

Under the USDA organic regulations, 

hydrogen peroxide is permitted for 

plant disease control in organic crop 

production (§ 205.601(i)(5)). However, 

the allowance for peracetic acid for 

plant disease control under the USDA 

organic regulations is limited to fire 

blight control (§ 205.601(i)(8)). Since 

EPA now requires that peracetic acid be 

listed as an active ingredient on the 

product label in some hydrogen 

peroxide formulations, certifying agents 

and material evaluation programs have 

had to limit the use of these products to 

that for fire blight control in organic 

crop production. In the course of their 

product review, certifying agents and 

material evaluation programs identify 

the active ingredients on the product 

label (i.e. both hydrogen peroxide and 

peracetic acid) and ensure that the 

producer’s use aligns with the 

restrictive allowance for peracetic acid 

on the National List at section 

205.601(i)(8). 

At its November 2009 public meeting, 

the NOSB reviewed the petition and 

public comment and, in response to the 

petition, issued a recommendation to 

amend the restrictive annotation for 

both listings of peracetic acid.3 A 

second motion to list peracetic acid 

without any restrictive annotation under 

the USDA organic regulations did not 

receive the required two-thirds majority 

to pass.4

The NOSB indicated in its 

recommendation for peracetic acid that 

its intent was to amend the annotations 

for peracetic acid to continue the 

availability of certain hydrogen 

peroxide containing products that are 

now required by EPA to list peracetic 

acid as a second active ingredient on the 

label. The NOSB recommended that 

AMS amend the annotations for 

peracetic acid to limit the amount of 

peracetic acid to no more than 5% 

concentration in hydrogen peroxide 

products. Although the NOSB 

recommendation characterized the 

small amount of peracetic acid in 

hydrogen peroxide products as 

‘‘formerly allowed as inert,’’ peracetic 

acid is not an inert ingredient under 

section 205.601(m) of the USDA organic 

regulations, since peracetic acid was not 

classified as a List 4 inert ingredient 

under the former classification system 

used by EPA.5 Instead, the peracetic 

acid may have always been present in 

some products from the in situ reaction 

of acetic acid (a List 4 inert ingredient) 

with the active ingredient hydrogen 

peroxide. 

At its December 2, 2011, public 

meeting, the NOSB recommended that 

the listings for peracetic acid in section 

205.601 be renewed under the sunset 

process.6 The NOSB sunset 

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8042 Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Proposed Rules 

at http://www.ams.usda.gov/AMSv1.0/getfile?dDoc

Name=STELPRDC5097089. 

7Technical Report on Potassium hydroxide. May 

21, 2001. Available in Petitioned Substances 

Database, under ‘‘P,’’ at the NOP Web site: http:// 

www.ams.usda.gov/NOPPetitionedSubstances

Database. 

8 In 1995, the NOSB recommended the addition 

of potassium hydroxide to section 205.605 for use 

in organic processing with an annotation 

prohibiting its use in the lye peeling of fruits and 

vegetables. The NOSB based the restriction on 

concerns about the environmental effects of the 

waste products of the lye peeling process, and their 

understanding that mechanical and non-chemical 

alternatives were available for peeling most fruits 

and vegetables. 

9The petition was submitted by Pacific Coast 

Producers, and is available in the Petitioned 

Substances Database, under ‘‘P,’’ at the NOP Web 

site: http://www.ams.usda.gov/NOPPetitioned

SubstancesDatabase. 

recommendation noted that the 2009 

NOSB recommendation to amend the 

listing for peracetic acid had not yet 

been implemented by AMS. Since both 

NOSB recommendations for peracetic 

acid are outstanding, AMS is proposing 

to implement the 2009 NOSB 

recommendation for peracetic acid 

through this proposed rule. AMS 

intends to complete rulemaking prior to 

the November 3, 2013, sunset date for 

both listings of peracetic acid in section 

205.601 of the National List. The 

amended listings for peracetic acid in 

section 205.601 would then be subject 

to review again within five years of their 

amendment, in accordance with the 

OFPA provision for the sunset of 

National List substances (7 U.S.C. 

6517(e)). 

The proposed changes are necessary 

to ensure that some formulated products 

that were previously compliant with the 

USDA organic regulations will continue 

to be permitted for many applications 

currently in use by organic crop 

producers. Such applications are in 

addition to those for disinfection of 

equipment, seed, and asexually 

propagated planting material, and for 

control of fire blight. Implementing the 

NOSB recommendation continues the 

use of certain hydrogen peroxide 

products for plant diseases which 

would not otherwise be permitted if the 

product has been relabeled in 

accordance with EPA requirements to 

list peracetic acid as an active 

ingredient. 

If this proposed amendment is not 

adopted as final, some hydrogen 

peroxide products that contain small 

amounts (i.e., 5% or less) of peracetic 

acid will become prohibited under the 

USDA organic regulations for most 

applications. Once these products are 

labeled in accordance with new EPA 

labeling guidelines, these products will 

be subject to the more restrictive 

allowances for peracetic acid under the 

USDA organic regulations. AMS has not 

identified any formulated hydrogen 

peroxide products which are labeled for 

agricultural use and contain more than 

5% peracetic acid as an active 

ingredient on the product label. 

Furthermore, under this proposed 

action, formulated peracetic acid 

products, including hydrogen peroxide 

products that contain more than 5% 

peracetic acid, would continue to be 

subject to the same restrictive 

annotations for peracetic acid under the 

USDA organic regulations. Formulated 

hydrogen peroxide products that do not 

contain peracetic acid are not impacted 

by this rulemaking. 

The NOSB recommended the addition 

of the following text to the current 

annotations for the peracetic acid 

listings in section 205.601: ‘‘Permitted 

in hydrogen peroxide formulations at 

concentration of no more than 5%.’’ In 

this proposed rule, AMS is proposing a 

modification to the NOSB’s 

recommended text as follows (emphasis 

added): ‘‘Permitted in hydrogen 

peroxide formulations at concentration 

of no more than 5% as indicated on the 

pesticide product label.’’ This 

amendment is intended to clarify the 

point that the 5% concentration of 

peracetic acid should be verified in the 

formulated product itself, not after the 

product has been diluted according to 

label directions prior to its application. 

AMS has reviewed and proposes to 

address the NOSB recommendations 

with the modification described. This 

proposed rule would amend 

subparagraphs (a)(6) and (i)(8) of section 

205.601 of the National List by adding 

the following text to the current 

annotations for peracetic acid: 

‘‘Permitted in hydrogen peroxide 

formulations at concentration of no 

more than 5% as indicated on the 

pesticide product label.’’ If finalized, the 

listings for peracetic acid in section 

205.601 would be subject to review 

within five years of their amendment, in 

accordance with the OFPA provision for 

the sunset of National List substances (7 

U.S.C. 6517(e)). 

AMS is particularly interested in 

comments that identify any impacted 

hydrogen peroxide products labeled for 

agricultural use that contain more than 

5% peracetic acid. 

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 

groups(s)).’’ 

This proposed rule would amend 

section 205.605(b) by changing an 

annotation to expand the use for the 

following substance: 

Potassium hydroxide. Potassium 

hydroxide is a white, caustic solid 

which is highly absorbent to the point 

that it dissolves into solution. It is 

alkaline in solution and available in 

pellets, flakes, sticks, lumps and 

powder. Commercially, food grade 

potassium hydroxide is obtained from 

the electrolysis of potassium chloride 

solution in the presence of a porous 

diaphragm. According to the Food and 

Drug Administration (FDA), potassium 

hydroxide is generally recognized as 

safe (GRAS) when used as a formulation 

aid, a pH control agent, a processing aid 

or a stabilizer and thickener (21 CFR 

184.1631). The FDA regulations further 

provide that substances generally 

regarded as safe in food may be used to 

wash or to assist in the peeling of fruits 

and vegetables (21 CFR 173.315).7 In the 

lye peeling of fruits and vegetables, 

potassium hydroxide works by 

weakening the glycolic bonds of pectin 

responsible for peel adhesion so that the 

peel can be removed by water spray and 

other mechanical methods. 

An allowance for potassium 

hydroxide was codified on the National 

List on December 21, 2000 (65 FR 

80548). The allowance permitted 

potassium hydroxide in organic 

processing but prohibited its use in lye 

peeling of fruits and vegetables.8 On 

November 3, 2003, AMS published a 

final rule which amended the 

annotation for potassium hydroxide to 

allow its use for peeling peaches during 

the Individually Quick Frozen (IQF) 

production process (68 FR 62215). AMS 

based this amendment on a 2001 NOSB 

recommendation to allow potassium 

hydroxide for IQF peaches. The NOSB 

recommendation stated that there were 

no commercially viable alternatives to 

lye peeling of peaches. The NOSB also 

concluded that the low pH of the 

peaches would help neutralize the pH of 

the wastewater from organic processing 

and, therefore, mitigate any potentially 

adverse environmental effects of the 

potassium hydroxide use. 

On April 19, 2011, AMS received a 

petition requesting that potassium 

hydroxide be permitted as a processing 

aid in the lye peeling of fresh peaches 

for canning.9 The petition explained 

that the peeling processes for freezing or 

canning peaches are identical. 

Therefore, the petition claimed that an 

allowance to use potassium hydroxide 

to peel peaches for canning is consistent 

with the existing allowance for the use 

of potassium hydroxide in peeling of 

organic peaches for frozen products. 

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Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Proposed Rules 8043 

10There are multiple references in the FDA 

regulations that are relevant to silicon dioxide and 

its authorized use in food for human consumption. 

These are cited in the Technical Report prepared for 

the NOSB and include 21 CFR 172.480, 21 CFR 

172.230, 21 CFR 73.340, 21 CFR 160.105, 21 CFR 

160.185, and 21 CFR 182.90. See Technical Report 

on Silicon Dioxide. November 12, 2010. Available 

in Petitioned Substances Database, under ‘‘S,’’ at 

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

PetitionedSubstancesDatabase. 

The petition also stated that no other 

treatment or process is equivalent to 

potassium hydroxide for peeling 

peaches, in terms of minimal loss of 

texture, flavor, appearance and aroma. 

At its November 29–December 2, 2011 

meeting, the NOSB considered the 

petition to amend the annotation for 

potassium hydroxide to allow its use in 

lye peeling of peaches to be canned. In 

its deliberations, the NOSB noted a lack 

of commercially viable alternatives for 

peeling peaches and stated that the 

acidity of the fruit and on-site buffering 

would mitigate any potential 

environmental impact of alkaline waste 

from a peach processing facility using 

potassium hydroxide. The NOSB also 

reasoned that freezing and canning are 

the primary commercial processes for 

peaches and that these processes are 

identical until the last step. Based upon 

the information in the petition and 

technical report, and prior NOSB action 

regarding potassium hydroxide, the 

NOSB recommended that potassium 

hydroxide be allowed for any peach 

peeling in organic processing, rather 

than limiting the allowance to peaches 

to be frozen using the IQF process. 

AMS has reviewed and proposes to 

address the NOSB recommendation 

through this proposed rule. Consistent 

with the NOSB recommendation, this 

proposed rule would amend the listing 

for potassium hydroxide in section 

205.605(b) by deleting the words, 

‘‘during the Individually Quick Frozen 

(IQF) production process’’. This change 

would, in effect, allow the use of 

potassium hydroxide in lye peeling of 

peaches for all types of organic peach 

processing, including canning and the 

IQF process. If finalized, the listing for 

potassium hydroxide in section 

205.605(b) would be subject to review 

within five years of its amendment, in 

accordance with the OFPA provision for 

the sunset of National List substances (7 

U.S.C. 6517(e)). 

This proposed rule would further 

amend section 205.605(b) by adding an 

annotation to specify the permitted use 

of the following substance: 

Silicon dioxide. Silicon dioxide is 

currently listed as an allowed synthetic 

in organic processing in section 

205.605(b). In accordance with 

applicable FDA requirements for its use 

as a food additive,10 the substance can 

serve many technical, functions 

including as an anti-caking agent, a 

defoamer, a stabilizer, or an adjuvant. 

At its meeting November 29– 

December 2, 2011, the NOSB considered 

a petition requesting the removal of 

silicon dioxide from section 205.605(b) 

of the National List. The petition was 

submitted by a manufacturer of an 

organic product derived from rice hulls. 

The petitioner stated that the rice hull 

product is an organic alternative for the 

use of synthetic silicon dioxide in some 

applications. The petitioner requested 

that silicon dioxide be removed from 

the National List based on the criteria 

provided under section 205.600(b)(1) of 

the USDA organic regulations. Section 

205.600(b)(1) specifies that any 

synthetic substance used as a processing 

aid or adjuvant on the National List 

must be evaluated under the criteria that 

the substance cannot be produced from 

a natural source and there are no 

organic substitutes. 

During its deliberations, the NOSB 

stated that the alternative organic 

product, derived from organic rice hulls, 

could be a replacement for silicon 

dioxide in some, but not all, current 

applications of silicon dioxide in 

organic handling. Specifically, the 

NOSB noted that the alternative organic 

product does not function as a 

replacement for synthetic silicon 

dioxide as a defoamer. In addition, the 

NOSB also noted that there may be 

other applications where the continued 

use of silicon dioxide may be necessary 

if the alternative organic product does 

not provide the functionality needed. 

In order to recognize the availability 

of the alternative organic product as a 

substitute for some uses of silicon 

dioxide, the NOSB recommended that 

an annotation be added to the listing for 

silicon dioxide at section 205.605(b) as 

follows: ‘‘Silicon dioxide—allowed for 

use as a defoamer. May be used in other 

applications when non-synthetic 

alternatives are not commercially 

available.’’ 

AMS understands that the intent of 

the NOSB’s recommendation is to allow 

the continued use of silicon dioxide as 

a defoamer and to require the use of a 

nonsynthetic substance instead of 

silicon dioxide when possible. To 

ensure clarity and consistency within 

the USDA organic regulations, AMS is 

proposing a modification to the NOSB’s 

recommendation by proposing an 

annotation which would read as 

follows: ‘‘Silicon dioxide—Permitted as 

a defoamer. Allowed for other uses 

when organic rice hulls are not 

commercially available.’’ 

AMS is proposing this modification to 

specify the specific alternative 

substance (i.e., organic rice hulls) that 

the NOSB considered during its review, 

rather than including the general term 

‘‘nonsynthetic alternatives.’’ AMS has 

specified the particular nonsynthetic 

alternative within the annotation so that 

certifying agents can consistently verify 

that organic handlers are in compliance 

with the regulations. The clarification 

also reduces the burden on organic 

handlers since they would not be 

required to demonstrate that all 

nonsynthetic inputs were considered 

prior to the use of silicon dioxide. 

AMS has also specified in the 

annotation that the rice hulls must be 

organic, since the use of conventional 

(i.e., nonorganic) rice and rice products 

is not permitted in products labeled as 

‘‘organic’’ under the USDA organic 

regulations. Section 205.606 of the 

National List specifies the 

nonorganically produced agricultural 

products that may be used as 

ingredients in or on processed products 

labeled as ‘‘organic.’’ Substances 

included in section 205.606 are only 

permitted when the product is not 

commercially available in organic form. 

Rice and rice hulls are not included at 

section 205.606 of the National List; 

therefore, the use of nonorganic rice 

products would not be permitted in 

products labeled as ‘‘organic.’’ This 

proposed rule does not change this 

requirement. Because section 205.606 

does not apply to products labeled 

‘‘made with organic (specified 

ingredients or food group(s)),’’ organic 

or nonorganic rice hulls would be 

permitted as a substitute for silicon 

dioxide in the 30 percent nonorganic 

content of a ‘‘made with organic 

(specified ingredients or food 

group(s)),’’ product under section 

205.301(c) of the USDA organic 

regulations. 

AMS understands that the NOSB 

recommendation intended for silicon 

dioxide to continue to be allowed in 

applications when organic rice hulls do 

not adequately substitute for the 

functionality provided by silicon 

dioxide. Commercially available is 

defined under section 205.2 of the 

USDA organic regulations 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.’’ Linking the use of silicon dioxide 

by annotation to the commercial 

availability of organic rice hulls reflects 

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8044 Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Proposed Rules 

11Technical Report on Beta-carotene extract 

color. July 15, 2011. Available in Petitioned 

Substances Database, under ‘‘C’’ for colors, at the 

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

PetitionedSubstancesDatabase. 

12The interim final rule was superseded by a 

final rule published June 6, 2012 (77 FR 33290) 

which renewed the listing for beta-carotene extract 

color as part of the 2012 sunset review. The final 

rule was effective June 27, 2012. 

13 In April 2007, the NOSB recommended adding 

beta-carotene color extract derived from carrots to 

205.606. The NOSB concluded that this substance 

was not available in organic form because the 

specific varieties of carrots grown for beta-carotene 

production were not produced organically in 

sufficient quantities. NOSB Formal 

Recommendation on Beta-carotene color derived 

from carrots. April 21, 2007. Available at the NOP 

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

getfile?dDocName=STELPRDC5061991. 

14The petition was submitted by D.D. Williamson 

& Co., Inc., and is available from the NOP Web site 

in the Petitioned Substances Database: http://www.

ams.usda.gov/NOPPetitionedSubstancesDatabase. 

A separate petition has been submitted by the 

International Formula Council for the use of the 

synthetic form of beta-carotene in organic 

processing. 

15NOSB Formal Recommendation on Colors 

derived from agricultural ingredients. October 2010. 

Available at the NOP Web site: http://www.ams.

usda.gov/AMSv1.0/getfile?dDocName=STELPRDC

5088018&acct=nosb. 

16NOSB Formal Recommendation on Annatto 

Extract Color. December 2, 2011. Available at the 

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

getfile?dDocName=STELPRDC5097101. 

the NOSB’s intent to permit the use of 

synthetic silicon dioxide when organic 

rice hulls do not fulfill an essential 

function in a system of organic 

handling, as determined by the 

certifying agent in the course of 

reviewing the organic plan. A difference 

in cost between synthetic silicon 

dioxide and organic rice hulls would 

not be considered a permitted 

justification for use of synthetic silicon 

dioxide under the proposed annotation. 

AMS has reviewed and proposes to 

address the NOSB recommendation 

with the modification described. This 

proposed rule would amend section 

205.605(b) by adding an annotation for 

silicon dioxide to read as follows: 

‘‘Silicon dioxide—Permitted as a 

defoamer. Allowed for other uses when 

organic rice hulls are not commercially 

available.’’ AMS is seeking comments 

that describe whether product 

reformulation will be necessary and the 

timeframe that will be needed to comply 

with this change. Such comments will 

inform an appropriate effective date for 

this amendment if finalized. If finalized, 

the listing for silicon dioxide in section 

205.605 would be subject to review 

within five years of its amendment, in 

accordance with the OFPA provision for 

the sunset of National List substances (7 

U.S.C. 6517(e)). 

Section 205.606 Nonorganically 

Produced Agricultural Products Allowed 

as Ingredients in or on Processed 

Products Labeled as ‘‘Organic’’ 

This proposed rule would amend 

subparagraph (d)(3), redesignated under 

this proposed action as (d)(2), of section 

205.606 by changing the annotation to 

correct the Chemical Abstracts Service 

(CAS) number and to allow an 

additional source of the following 

substance: 

Beta-carotene extract color. Betacarotene is a carotenoid. Carotenoids are 

natural pigments synthesized by plants 

that aid in photosynthesis by absorbing 

light and protect the plant from 

photosensitization. Carotenoids 

commonly exhibit antioxidant activity 

in food. In the human body, betacarotene is converted to vitamin A. 

Beta-carotene is the most common 

carotenoid and the major colorant in 

carrot and palm oil seed extracts and is 

also found in cantaloupes, apricots, 

sweet potatoes and other orange, red 

and dark green fruits and vegetables.11

Beta-carotene can be produced 

through various methods including 

chemical synthesis, fermentation of 

microorganisms (fungi, yeasts, or 

bacteria), and extraction from certain 

algae (Dunnaliella salina) and 

vegetables. Obtaining beta-carotene from 

natural sources generally involves 

propagation and harvest of the source 

and solvent extraction of the betacarotene. According to the 2011 

Technical Report for beta-carotene, only 

one preparation of crystalline betacarotene from carrots is commercially 

available and the substance is not yet 

obtained commercially from other 

vegetable sources. 

Beta-carotene is used as a color 

additive and as a nutritive supplement 

in a variety of foods including dairy 

products, fats and oils, and processed 

fruits and fruit juices. As a colorant, it 

adds a deep orange to light yellow color 

to the food depending upon the 

concentration. The FDA regulations 

provide that beta-carotene, prepared 

synthetically or obtained from natural 

sources, may be safely used for coloring 

foods in amounts consistent with good 

manufacturing practices. It may not be 

used in foods for which there is an FDA 

standard of identity unless that standard 

of identity authorizes its use (21 CFR 

73.95). 

On June 27, 2007, a listing for betacarotene extract color, derived from 

carrots, was added to section 205.606 of 

the National List through an interim 

final rule (72 FR 35137).12 This 

allowance provides for the use of the 

nonorganic form of beta-carotene extract 

color, derived from carrots, in organic 

processing when an organic form is not 

commercially available.13

On July 20, 2009, AMS received a 

petition to amend the annotation for 

beta-carotene extract color derived from 

carrots.14 The petition requested two 

changes to the listing for beta-carotene 

extract color: (i) Correction of the CAS 

number; and (ii) the inclusion of algae 

as a source of beta-carotene extract 

color. The petition indicated that the 

CAS number listed for beta-carotene 

extract color (CAS #1393–63–1) is 

incorrect and refers to the pigment 

found in annatto extract color. The 

petition also stated that algae provide 

the only source of beta-carotene that can 

be produced with allowed solvents, 

such as nonsynthetic ethanol, vegetable 

oil, and carbon dioxide. 

At its November 29–December 2, 2011 

meeting, the NOSB considered the 

petition to amend the listing for betacarotene extract color. In its 

deliberations, the NOSB considered its 

October 2010 recommendation to 

prohibit the use of synthetic solvents 

and carrier systems or any artificial 

preservative in the production of colors 

used in organic processing. The October 

2010 NOSB recommendation specified 

that the listing for colors derived from 

agricultural products at section 205.606 

should include the following 

annotation: ‘‘Must not be produced 

using synthetic solvents and carrier 

systems or any artificial preservative.15

This NOSB recommendation was 

codified through a final rule published 

on June 6, 2012 (77 FR 33290). The 

NOSB accepted the petition’s 

justification for revision of the listing for 

beta-carotene extract color, which stated 

that the only method to extract betacarotene from carrots uses synthetic 

solvents and would not comply with the 

revised requirements for colors derived 

from agricultural products in section 

205.606. The NOSB concluded that the 

production of beta-carotene color from 

algae, as described in the petition, could 

comply with the amended annotation 

for colors in section 205.606 and be an 

acceptable source of beta-carotene 

extract color in organic products when 

an organic form was not commercially 

available. The NOSB also recommended 

that the CAS number be corrected to 

7235–40–7 for this listing.16

AMS has reviewed and proposes to 

address the NOSB recommendation 

through this proposed rule. Consistent 

with the NOSB recommendation, this 

proposed rule would amend paragraph 

(d)(3), redesignated under this action as 

paragraph (d)(2), of section 205.606 of 

the National List by: (i) Replacing the 

text, ‘‘(CAS #1393–63–1)’’ with the text 

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17Food and Agriculture Organization of the 

United Nations. 1995. Non-Wood Forest Products, 

Natural Colourants and Dyestuffs, http://www.fao.

org/docrep/v8879e/V8879e00.htm. 

18The interim final rule was superseded by a 

final rule published June 6, 2012 (77 FR 33290) 

which renewed the listing for annatto extract color 

as part of the 2012 sunset review. The final rule was 

effective June 27, 2012. 

19The petition was submitted by D.D. Williamson 

& Co., Inc. and is available from the NOP Web site 

in the Petitioned Substances Database under ‘‘C’’ for 

colors: http://www.ams.usda.gov/NOPPetitioned

SubstancesDatabase. 

20NOSB Formal Recommendation: Colors 

derived from agricultural products—Annotation 

Change. October 28, 2010. Available at the NOP 

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

getfile?dDocName=STELPRDC5088018&acct=nosb. 

21NOSB Handling Committee recommendation 

on Annatto extract color. September 29, 2011. 

Available at the NOP Web site: http:// 

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

STELPRDC5094391. 

22NOSB Formal recommendation on Annatto 

extract color, December 2, 2011. Available at the 

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

getfile?dDocName=STELPRDC5097099. 

‘‘(pigment CAS #7235–40–7)’’; and (ii) 

adding the words, ‘‘or algae’’ between 

‘‘carrots’’ and ‘‘(pigment CAS #7235– 

40–7).’’ If finalized, the listing for betacarotene extract color at section 205.606 

would be subject to review within five 

years of its amendment, in accordance 

with the OFPA provision for the sunset 

of National List substances (7 U.S.C. 

6517(e)). 

This proposed rule would further 

amend paragraph (d) of section 205.606 

by removing the exemption for the 

following substance: 

Annatto extract color. Annatto extract 

color is made from the dried seed of 

Bixa orellana L., an evergreen shrub 

native to Central and tropical South 

America, which is cultivated globally in 

tropical areas. The seed’s coating 

contains carotenoid pigments, 

principally bixin, which are used to 

impart a deep orange to light yellow 

color, depending upon the 

concentration, to foods and beverages. 

The water soluble form is used as a 

colorant in foods, such as hard cheeses, 

bakery products, sauces, and sugar and 

flour confectionary. This form is 

available spray-dried on a carrier or is 

available in an aqueous solution. The oil 

soluble form is used in foods with a 

high fat content, such as salad dressings. 

This form is available dried or 

suspended in vegetable oil.17 Organic 

annatto extract seeds are hulled, 

crushed into small pieces and 

physically ground together in vegetable 

oil or mildly alkaline water. The oil and 

water are filtered and concentrated, and 

retain the pigments contained in the 

seed. 

According to FDA, annatto extract 

may be safely used for coloring foods 

generally in amounts consistent with 

good manufacturing practices, except 

where a standard of identity does not 

authorize its use. The FDA has also 

determined that annatto extract color is 

exempt from color certification (21 CFR 

73.30). Under section 721(c) of the 

Federal Food, Drug and Cosmetic Act 

(FFDCA), the FDA exempts certain color 

additives from certification if FDA 

approval is not necessary for the 

protection of the public health. 

On June 27, 2007, a listing for annatto 

extract color (pigment CAS #1393–63– 

1), water and oil soluble, was added in 

section 205.606 of the National List 

through an interim final rule (72 FR 

35137).18 This allowance provides for 

the use of the nonorganic forms of water 

and oil soluble annatto extract color in 

organic processing when an organic 

form is not commercially available. The 

2007 rule stated that the global supply 

production of annatto seeds was 

insufficient to consistently provide 

organic sources of this substance. 

In September 2010, AMS received a 

petition for the removal of annatto 

extract color from the National List.19

The petition stated that the use of 

nonorganic annatto extract in organic 

processing was no longer warranted 

because there is an adequate supply of 

organic annatto seed from which 

organic annatto extract can be produced. 

The petition explained that the 

geographic diversity in organic annatto 

seed production protects the supply 

from interruptions due to weather. In 

addition, the petition indicated that the 

availability of water soluble, oil soluble, 

oil soluble suspensions and powdered 

forms of annatto extract are adequate for 

the needs of the organic industry. 

On June 6, 2012, AMS published a 

final rule, renewing the listing for 

annatto extract color at section 205.606, 

prior to its sunset date on June 27, 2012 

(77 FR 33290). The final rule is 

consistent with the October 2010 NOSB 

sunset recommendation to continue the 

allowance for the use of nonorganic 

annatto extract color. In the justification 

for recommending renewal in 2010, the 

NOSB explained its uncertainty about 

the commercial availability of organic 

powdered annatto extract based upon 

public comment at that time. The NOSB 

indicated that it would address the 

commercially availability of liquid and 

dry forms of annatto extract color during 

its future consideration of the 

September 2010 petition to remove 

annatto extract color from the National 

List.20

At the November 29–December 2, 

2011 NOSB meeting, the NOSB 

considered the September 2010 petition 

to remove annatto extract from the 

National List. The NOSB Handling 

Committee conducted market research 

to verify that the forms of annatto 

extract used by organic handlers are 

available organically. Their findings 

indicated that liquid forms of organic 

annatto extract were widely available, 

and the powdered form of organic 

annatto extract was available, but not 

widely used. The NOSB Handling 

Committee proposed that the annotation 

for annatto extract be revised from water 

and oil soluble to liquid and powdered 

forms to reflect the forms found in the 

marketplace. To ensure that the NOSB 

considered all forms of annatto extract 

needed by organic handlers, the 

Committee solicited public comment on 

any specific needs for a continued 

allowance of nonorganic annatto 

extract.21 During the November 29– 

December 2, 2011, NOSB meeting, the 

Handling Committee explained that it 

had not received public comment 

indicating that nonorganic forms of 

annatto extract were needed. Therefore, 

the NOSB approved a recommendation 

to remove annatto extract color from 

section 205.606(d).22

AMS has reviewed and proposes to 

address the NOSB’s recommendation 

through this proposed rule. Consistent 

with the NOSB recommendation, this 

proposed rule would amend paragraph 

(d) of section 205.606 by removing 

annatto extract color (pigment CAS 

#1393–63–1)—water and oil soluble and 

redesignating paragraphs (d)(2) through 

(d)(19) as paragraphs (d)(1) through 

(d)(18). AMS is seeking comments that 

describe whether product reformulation 

will be necessary and the timeframe that 

will be needed to comply with this 

change. Such comments will inform an 

appropriate effective date for this 

amendment if finalized. 

III. Related Documents 

Two notices were published regarding 

meetings of the NOSB and its 

deliberations on recommendations and 

substances petitioned for amending the 

National List. Substances and 

recommendations included in this 

proposed rule were announced for 

NOSB deliberation in the following 

Federal Register notices: (1) 74 FR 

46411, September 9, 2009 (peracetic 

acid); and (2) 76 FR 62336, October 17, 

2011 (potassium hydroxide, silicon 

dioxide, beta-carotene extract color, and 

annatto extract color). 

IV. Statutory and Regulatory Authority 

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

6501–6522), authorizes the Secretary to 

make amendments to the National List 

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8046 Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Proposed Rules 

23Organic Trade Association. 2012. Organic 

Industry Survey. www.ota.com. 

24U.S. Department of Agriculture, National 

Agricultural Statistics Service. October 2012. 2011 

Certified Organic Productions Survey. http:// 

usda01.library.cornell.edu/usda/current/Organic

Production/OrganicProduction-10-04-2012.pdf. 

based on proposed amendments 

developed by the NOSB. Sections 

6518(k) and 6518(n) of the 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 USDA organic 

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/AMSv1.0/ 

nop. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 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 proposed rule would not 

alter the authority of the Secretary 

under the Federal Meat Inspection Act 

(21 U.S.C. 601–624), the Poultry 

Products Inspection Act (21 U.S.C. 451– 

471), or the Egg Products Inspection Act 

(21 U.S.C. 1031–1056), concerning meat, 

poultry, and egg products, nor any of 

the authorities of the Secretary of Health 

and Human Services under the FFDCA 

(21 U.S.C. 301–399), nor the authority of 

the Administrator of EPA under the 

FIFRA (7 U.S.C. 136–136(y)). 

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 

final decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

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

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 

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. 

U.S. sales of organic food and nonfood have grown from $1 billion in 1990 

to $31.4 billion in 2011. Sales in 2011 

represented 9.5 percent growth over 

2010 sales.23 According to USDA, 

National Agricultural Statistics Service 

(NASS), certified organic acreage 

exceeded 3.5 million acres in 2011.24

According to NOP’s Accreditation and 

International Activities Division, the 

number of certified organic operations 

in the U.S. has more than doubled over 

time from approximately 7,000 

operations in 2000 to over 17,000 

operations by the end of 2011. Of these 

operations, over 4,900 are organic 

handlers, over 10,000 are organic crop 

producers, and over 1,900 are organic 

livestock producers. AMS believes that 

most of these entities would be 

considered small entities under the 

criteria established by the SBA. 

In addition, the USDA has 87 

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. Certifying agents reported 

approximately 29,000 certified 

operations worldwide in 2011. 

AMS has considered the economic 

impact of this action on small entities. 

The effect of this proposed rule would 

be to expand the allowed uses of 

peracetic acid in organic crop 

production. AMS concludes that 

expanding the allowance for peracetic 

acid on the National List both addresses 

EPA relabeling issues for products used 

in organic crop production and 

continues access to a substance used for 

plant disease control on organic farms. 

Therefore, this action will be beneficial 

to small agricultural service firms. This 

proposed rule also would expand the 

use of potassium hydroxide and betacarotene extract color in organic 

handling. AMS concludes that 

expanding the allowance for these 

substances on the National List provides 

organic handlers with more tools for 

processing organic products and, 

therefore, will be beneficial to small 

agricultural service firms. This proposed 

rule would amend the allowance for 

synthetic silicon dioxide such that 

organic rice hulls would be required as 

an alternative to silicon dioxide when 

commercially available. The proposal 

would continue to allow the use of 

silicon dioxide as a defoamer and would 

allow the use of silicon dioxide when 

organic rice hulls are not available in an 

appropriate form, quality, or quantity to 

fulfill an essential function in a system 

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Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Proposed Rules 8047 

of organic handling. This flexibility is 

intended to minimize the impact on 

small entities. This proposed rule would 

also remove the allowance for one 

nonorganic agricultural substance, 

annatto extract, in organic handling. 

The NOSB has determined that annatto 

extract is commercially available in 

organic form in sufficient quantities for 

organic handling. AMS concludes that 

the economic impact of this amendment 

to the National List, if any, would be 

minimal to small agricultural service 

firms and may spur further development 

of organic annatto production. 

Accordingly, AMS certifies that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by the Paperwork Reduction 

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

Chapter 35. 

E. Executive Order 13175 

This proposed 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. General Notice of Public Rulemaking 

This proposed rule addresses 

recommendations submitted to the 

Secretary by the NOSB for substances 

on the National List of Allowed and 

Prohibited Substances. A 30-day period 

for interested persons to comment on 

this rule is provided. Thirty days is 

deemed appropriate because potential 

changes to these listings were widely 

publicized through two NOSB meetings. 

Further, certain proposed amendments, 

one for potassium hydroxide in organic 

handling, and those for peracetic acid in 

organic crop production, are considered 

time sensitive and critical to organic 

production. The proposed amendment 

to the listing for potassium hydroxide 

would provide more tools for organic 

peach processors by allowing use of this 

substance to peel peaches for canning, 

in addition to its current allowance to 

peel peaches for frozen products. The 

proposed amendments to the listings for 

peracetic acid would ensure consistency 

with EPA labeling requirements for 

hydrogen peroxide products containing 

peracetic acid. 

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, Subpart G is 

proposed to be amended as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

■ 1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

■ 2. Section 205.601 is amended by 

revising paragraphs (a)(6) and (i)(8) to 

read as follows: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

* * * * * 

(a) * * * 

(6) Peracetic acid—for use in 

disinfecting equipment, seed, and 

asexually propagated planting material. 

Permitted in hydrogen peroxide 

formulations at concentration of no 

more than 5% as indicated on the 

pesticide product label. 

* * * * * 

(i) * * * 

(8) Peracetic acid—for use to control 

fire blight bacteria. Permitted in 

hydrogen peroxide formulations at 

concentration of no more than 5% as 

indicated on the pesticide product label. 

* * * * * 

■ 3. In § 205.605 paragraph (b), revise 

the entry for ‘‘Potassium hydroxide’’ 

and ‘‘Silicon dioxide’’ to read as 

follows: 

§ 205.605 Nonagricultural (nonorganic) 

substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or 

‘‘made with organic (specified ingredients 

or food group(s)).’’ 

* * * * * 

(b) * * * 

Potassium hydroxide—prohibited for 

use in lye peeling of fruits and 

vegetables except when used for peeling 

peaches. 

* * * * * 

Silicon dioxide—Permitted as a 

defoamer. Allowed for other uses when 

organic rice hulls are not commercially 

available. 

* * * * * 

■ 4. Section 205.606 is amended by: 

■ A. Removing paragraph (d)(1); 

■ B. Redesignating (d)(2) through (d)(19) 

as (d)(1) through (d)(18); and 

■ C. Revising paragraph (d)(2) to read as 

follows: 

§ 205.606 Nonorganically produced 

agricultural products allowed as ingredients 

in or on processed products labeled as 

‘‘organic.’’ 

* * * * * 

(d) * * * 

(2) Beta-carotene extract color— 

derived from carrots or algae (pigment 

CAS# 7235–40–7). 

* * * * * 

Dated: January 30, 2013. 

Rex A. Barnes, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2013–02398 Filed 2–4–13; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 959 

[Doc. No. AMS–FV–12–0039; FV12–959–1 

PR] 

Onions Grown in South Texas; 

Increased Assessment Rate 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This rule would increase the 

assessment rate established for the 

South Texas Onion Committee 

(Committee) for the 2012–13 and 

subsequent fiscal periods from $0.025 to 

$0.03 per 50-pound equivalent of onions 

handled. The Committee locally 

administers the marketing order which 

regulates the handling of onions grown 

in South Texas. Assessments upon 

onion handlers are used by the 

Committee to fund reasonable and 

necessary expenses of the program. The 

fiscal period begins August 1 and ends 

July 31. The assessment rate would 

remain in effect indefinitely unless 

modified, suspended, or terminated. 

DATES: Comments must be received by 

February 15, 2013. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this rule. Comments must be 

sent to the Docket Clerk, Marketing 

Order and Agreement Division, Fruit 

and Vegetable Program, AMS, USDA, 

1400 Independence Avenue SW., STOP 

0237, Washington, DC 20250–0237; Fax: 

(202) 720–8938; or Internet: http:// 

www.regulations.gov. Comments should 

reference the document number and the 

date and page number of this issue of 

the Federal Register and will be 

available for public inspection in the 

Office of the Docket Clerk during regular 

business hours, or can be viewed at: 

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