This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

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

The Code of Federal Regulations is sold by

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new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

31815 

Vol. 78, No. 102 

Tuesday, May 28, 2013 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–12–0016; 

NOP–12–07FR] 

RIN 0581–AD27 

National Organic Program (NOP); 

Amendments to the National List of 

Allowed and Prohibited Substances 

(Crops and Processing) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

U.S. Department of Agriculture’s 

(USDA’s) National List of Allowed and 

Prohibited Substances (National List) to 

enact five recommendations submitted 

to the Secretary of Agriculture 

(Secretary) by the National Organic 

Standards Board (NOSB) on November 

5, 2009, and December 2, 2011. This 

final rule amends the exemptions (uses) 

for one substance, peracetic acid, for 

organic crop production. This final rule 

also amends the exemptions for three 

substances used in organic handling: 

potassium hydroxide, silicon dioxide, 

and beta-carotene extract color. This 

final rule also removes the allowance for 

nonorganic annatto extract color from 

the National List for organic handling. 

DATES: This rule is effective May 29, 

2013, except for the amendment in 

instruction 4 to ‘‘silicon dioxide’’ in 

§ 205.605(b) and the amendment in 

instruction 6 to, § 205.606(d), which are 

effective November 3, 2013. For more 

information on these effective dates, see 

SUPPLEMENTARY INFORMATION. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, National Organic 

Program, Telephone: (202) 720–3252; 

Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Secretary 

established within the National Organic 

Program (NOP) (7 CFR part 205) the 

National List regulations sections 

205.600 through 205.607. The 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 

nonsynthetic nonagricultural, synthetic 

nonagricultural, and nonorganic 

agricultural substances that may be used 

in organic handling. The Organic Foods 

Production Act of 1990 (OFPA), as 

amended (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 must also 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 final rule amends the National 

List to enact five recommendations 

submitted to the Secretary by the NOSB 

on November 5, 2009, and December 2, 

2011. 

II. Overview of Amendments 

The following provides an overview 

of the amendments made to designated 

sections of the National List regulations: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

This final rule amends subparagraphs 

(a)(6) and (i)(8) of section 205.601 by 

amending two listings for peracetic acid 

to read as follows: 

(a)(6) Peracetic acid—for use in 

disinfecting equipment, seed, and 

asexually propagated planting material. 

Also permitted in hydrogen peroxide 

formulations as allowed in § 205.601(a) 

at concentration of no more than 6% as 

indicated on the pesticide product label. 

(i)(8) Peracetic acid—for use to 

control fire blight bacteria. Also 

permitted in hydrogen peroxide 

formulations as allowed in § 205.601(i) 

at concentration of no more than 6% as 

indicated on the pesticide product label. 

After consideration of the comments 

received, AMS determined that the 

substance’s use annotation should be 

modified from the proposed rule. This 

final rule differs from the text originally 

proposed as follows for paragraph (a)(6) 

(emphasis added): ‘‘Also permitted in 

hydrogen peroxide formulations as 

allowed in § 205.601(a) at concentration 

of no more than 6% as indicated on the 

pesticide product label.’’ Similarly, the 

use annotation for paragraph (i)(8) was 

modified as follows: ‘‘Also permitted in 

hydrogen peroxide formulations as 

allowed in § 205.601(i) at concentration 

of no more than 6% as indicated on the 

pesticide product label.’’ Additional 

explanation for the modification is 

provided in the Comments Received 

section of this 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 

Groups(s)).’’ 

This final rule amends paragraph (b) 

of section 205.605 of the National List 

regulations by amending the 

annotations for potassium hydroxide 

and silicon dioxide to read as follows: 

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. 

Section 205.606 Nonorganically 

Produced Agricultural Products Allowed 

as Ingredients In or On Processed 

Products Labeled as ‘‘Organic.’’ 

This final rule amends section 

205.606 of the National List regulations 

by amending paragraph (d)(3) to read as 

follows: 

Beta-carotene extract color—derived 

from carrots or algae (pigment CAS# 

7235–40–7). 

This final rule also removes annatto 

extract color from paragraph (d)(1) and 

redesignates paragraphs (d)(2) through 


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31816 Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Rules and Regulations 

1Organic Trade Association. 2012. Organic 

Industry Survey. www.ota.com. 

2U.S. Department of Agriculture, National 

Agricultural Statistics Service. October 2012. 2011 

Certified Organic Productions Survey. http:// 

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

OrganicProduction/OrganicProduction-10–04– 

2012.pdf. 

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

(d)(18). 

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 addressed by this 

final 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). The proposal to amend 

the annotation for four substances in 

this final rule, along with the removal 

of one substance, was published as a 

proposed rule in the Federal Register on 

February 5, 2013 (78 FR 8040). 

IV. Statutory and Regulatory Authority 

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

6501–6522), authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 

6518(k)(2) and 6518(n) of 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 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/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 (OMB). 

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 section 

6514(b) of the OFPA. States are also 

preempted under section 6503 through 

6507 of the OFPA 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 section 6507(b)(2) of the 

OFPA, 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 section 6519(f) of the 

OFPA, 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 the Environmental 

Protection Agency under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (7 U.S.C. 136–136(y)). 

Section 6520 of the OFPA 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.1 According to USDA, 

National Agricultural Statistics Service 

(NASS), certified organic acreage 

exceeded 3.5 million acres in 2011.2

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 84 

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. 

AMS considered the economic impact 

of this action on small entities. The 

effect of this final rule would be to 

expand the allowed uses of peracetic 

acid in organic crop production. AMS 

concluded that expanding the allowance 

for peracetic acid on the National List 

both addresses EPA relabeling issues for 

products used in organic crop 

production and enables organic 


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Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Rules and Regulations 31817 

producers to continue using a substance 

for sanitation and plant disease control 

on organic farms. Therefore, this action 

will be beneficial to small agricultural 

service firms. This final rule also 

expands the use of potassium hydroxide 

and beta-carotene extract color in 

organic handling. AMS concluded 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 final rule 

amends the allowance for synthetic 

silicon dioxide such that organic rice 

hulls would be required as an 

alternative to silicon dioxide when 

commercially available. The rule 

continues to allow the use of synthetic 

silicon dioxide as a defoamer. The rule 

also allows the continued use of 

synthetic silicon dioxide when organic 

rice hulls are not available in an 

appropriate form, quality, or quantity to 

fulfill an essential function in a system 

of organic handling. This flexibility is 

intended to minimize the impact on 

small entities by allowing synthetic 

silicon dioxide if organic rice hulls are 

not commercially available, while still 

meeting the requirement under section 

205.600(b)(1) that synthetic substances 

can be used only when there are no 

organic substitutes. This final rule also 

removes the allowance for one 

nonorganic agricultural substance, 

annatto extract color, in organic 

handling. The NOSB has determined 

that annatto extract color is 

commercially available in organic form 

in sufficient quantities for organic 

handling. AMS concluded 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 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 AMS–NOP–12–0016; NOP–12– 

07PR 

AMS received 43 comments on the 

proposed rule AMS–NOP–12–0016; 

NOP–12–07PR. Comments were 

received from organic producers and 

handlers, manufacturers of peracetic 

acid and silicon dioxide products, a 

nonprofit organization, an industry 

group, specialty food ingredient 

processors and distributors, specialty 

food products manufacturers, three 

trade associations, accredited certifying 

agents, an organic consultant, and 

private citizens. 

Most comments favored amending the 

National List with the changes 

described in the proposed rule. Four 

comments stated general opposition to 

the allowance of any substance on the 

National List, but did not provide 

specific comments on the proposed 

amendments. Comments received for 

each substance are further described 

below. One comment opposed the use of 

genetically modified organisms (GMOs), 

which is outside the scope of this 

rulemaking action and is already 

prohibited under the USDA organic 

regulations at section 205.105(e). 

Comments on the proposed 

amendment for beta-carotene extract 

color and removal of annatto extract 

color were supportive of the actions as 

proposed. Therefore, AMS is finalizing 

the amendment and removal of these 

substances, respectively, as proposed 

through this final rule. 

Changes Based on Comments 

Peracetic Acid 

AMS received 24 comments regarding 

the proposed change to peracetic acid. 

Most comments supported a continued 

allowance for peracetic acid in organic 

crop production. A few comments 

indicated that peracetic acid should not 

be allowed, but did not provide 

information on alternative practices or 

other materials that are available as 

alternatives to its use. 

The majority of commenters requested 

that AMS revise the proposed 

annotation for peracetic acid to include 

the word ‘‘also’’ at the beginning of the 

second sentence, and to cite the listings 

for hydrogen peroxide at sections (a)(4) 

and (i)(5). This amendment was 

suggested to clarify that peracetic acid 

in hydrogen peroxide formulas at 

concentrations less than the stated 

percentage will not be subject to the 

peracetic acid use restrictions. AMS 

agrees and has accepted this change, 

with modification. AMS has included 

the word ‘‘also’’ and the paragraphs 

letters that were requested, i.e., (a) and 

(i). AMS did not include the subsequent 

number in paragraph letter (i.e., (a)(6) or 

(i)(8)) in order to avoid the need to 

renumber these listings if substances are 

added or removed from paragraphs (a) 

or (i) of section 205.601 at a later date. 

In the proposed rule, AMS 

specifically requested comments that 

identified any formulated hydrogen 

peroxide products labeled for 

agricultural use that contain more than 

5% peracetic acid and that may be 

impacted by the rulemaking action. 

Three comments addressed this topic. 

AMS received one comment from an 

organic mushroom producer that uses a 

formulated product that contains 5.6% 

peracetic acid. AMS also received two 

comments from chemical suppliers that 

requested that the percentage of 

peracetic acid be raised to 6% and 17%. 

In reviewing the comments, AMS 

considered the intent of the NOSB 

recommendation to restrict the amount 

of peracetic acid by annotation to only 

allow hydrogen peroxide products that 

contain a small amount of peracetic acid 

and that are subject to new labeling 

requirements under EPA. The intent of 

the NOSB was not to allow organic 

peroxide products containing high 

levels of peracetic acid up to 17%. After 

consideration of the comments, AMS 

has amended the annotation for the final 

rule to increase the percentage of 

peracetic acid included in the 

annotation from 5% to 6% as indicated 

on the pesticide product label. AMS has 

increased this percentage up to 6% to 

ensure that the formulated products 

currently used in the marketplace 

would continue to be allowed in organic 

production. 

Implementation Periods 

In the proposed rule, AMS requested 

comments that described 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 205.606. 

AMS received seven comments 

regarding the timeframe that organic 

handlers need to implement the 

amendment to silicon dioxide, ranging 

from immediately to four years. Two 

commenters requested an effective date 

of two years. One commenter requested 

3–4 years, and another requested 4–6 

months. One distributor of organic rice 

bran products in the EU did not suggest 

a specific timeframe, but noted that in 

general, its customers who use organic 

rice hulls as a replacement for silicon 


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31818 Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Rules and Regulations 

3The petition for peracetic acid is available on 

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

AMSv1.0/getfile?dDocName=STELPRDC5071775

&acct=nopgeninfo. 

4NOSB Final Recommendation on Peracetic Acid 

(Expanded Use). November 2009. Available in 

Petitioned Substances Database under ‘‘P,’’ at the 

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

getfile?dDocName=STELPRDC5067081&acct

=nopgeninfo. 

dioxide are rather quick to implement 

this change. The commenter noted that 

adjustment may be needed to find the 

right replacement amount, since it may 

vary from application to application. 

One commenter indicated that they use 

rice hulls as a flavor carrier and anticaking agent and indicated that they 

were able to implement this ingredient 

substitution within a few weeks. 

Another commenter indicated their 

initial substitution trials for replacing 

silicon dioxide with organic rice 

concentrate took several months to 

collect and approve all data and update 

packaging. This handler now uses the 

rice substitute product in all new 

product development, and as such, and 

did not request additional time for 

implementation. After considering the 

comments received, AMS has 

established an effective date of 

November 3, 2013, for this action to 

ensure that industry is provided 

advanced notification of the change to 

the listing for silicon dioxide. In 

addition, based on comments that some 

product testing and reformulation will 

be needed, AMS considers a one year 

period from the effective date (i.e., until 

November 3, 2014) as reasonable and 

appropriate for the industry to 

reformulate products. This 

implementation period is intended to 

ensure that the amendment is effectively 

and rationally implemented by allowing 

time for handlers to test organic rice 

hulls as a replacement for silicon 

dioxide, and to allow for reformulation 

and label changes, if needed. AMS will 

be conducting outreach to the industry 

and training for certifying agents as 

appropriate. 

AMS received two comments 

addressing the time needed to 

implement the removal of annatto 

extract color from the National List. One 

commenter suggested 24 months from 

the date the final rule is released; the 

other suggested a minimum of two 

years. In consideration of the comments, 

AMS has established an effective date of 

November 3, 2013 for this removal. 

Further, AMS considers a one year 

period from the effective date (i.e., until 

November 3, 2014) as reasonable and 

appropriate for the industry to comply 

with this final rule. This 

implementation period is intended to 

ensure that the amendment is effectively 

and rationally implemented by allowing 

time for handlers to source organic 

annatto extract and to allow for 

ingredient substitution and label 

changes, if needed. AMS will be 

conducting outreach to the industry and 

training for certifying agents as 

appropriate. 

Changes Requested But Not Made 

Peracetic Acid 

One commenter indicated that it is 

not clear why peracetic acid should be 

allowed, but did not provide 

information on the availability of 

alternative practices or materials. AMS 

received many comments from certified 

organic growers indicating the need for 

this substance; therefore, this material 

should continue to be permitted in 

organic crop production. 

One commenter supported the 

proposed action, but indicated that 

limiting the allowance of peracetic acid 

to fire blight is not expansive enough, 

and that it should be allowed without 

any restriction. An expanded allowance 

for peracetic acid was requested in the 

petition considered by the NOSB.3 The 

expanded allowance requested was not 

recommended by the NOSB due to 

concerns over the impact of broad 

spectrum use on soil microbes. Upon 

review, AMS concurs with the NOSB 

recommendation and has not accepted 

the commenter’s suggestion for an 

expanded use.4

One commenter supported the 

proposed action and proposed language 

that would add ‘‘must be followed by a 

fresh water rinse’’ to the text of the 

annotations for peracetic acid at 

paragraphs (a)(6) and (a)(8) of 205.601. 

However, no rationale for this addition 

was provided. We have not accepted 

this suggestion. This substance is used 

in organic crop production as sanitizer 

and fungicide and there is no 

requirement on the label for a 

freshwater rinse. Further, the added 

process of a freshwater rinse could 

diminish the effectiveness of the 

substance for its intended use. 

One commenter indicated that AMS 

should not restrict the percentage and 

use of peracetic acid, as the higher the 

percentage of peracetic acid, the less 

costly it is to use for a farmer that needs 

the substance in volume. In this action, 

AMS has retained a stated percentage of 

peracetic acid in the rule, in an effort to 

maintain the intent of the NOSB’s 

recommendation to continue to allow 

hydrogen peroxide products that 

contain a small amount of peracetic 

acid. The allowance of higher 

concentrations of peracetic acid for 

control of fire blight and for use in 

disinfecting equipment, seed, and 

asexually propagated planting material 

are not impacted by this action. 

Potassium hydroxide 

AMS received eight comments 

regarding the proposed change to 

potassium hydroxide. Some 

commenters supported the change as 

proposed. Some commenters opposed 

any expansion of the use of this 

substance in organic handling, but did 

not include data on available alternative 

materials or practices for peeling 

peaches. 

One commenter indicated that the 

allowance for potassium hydroxide 

should not be expanded since this 

material is toxic to human health and 

that its use has adverse effects on the 

environment. The commenter also noted 

that potassium hydroxide is not allowed 

in organic handling in the European 

Union or by the International Federation 

of Organic Agriculture Movements 

(IFOAM) standards. AMS has 

considered the comment, as well as the 

status of potassium hydroxide under the 

regulatory authority of the Food and 

Drug Administration (FDA). According 

to 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). As 

such, AMS agrees with the NOSB 

recommendation that the annotation for 

potassium hydroxide should be revised 

to allow its use in any peach processing 

(e.g., frozen, canned), as there are no 

commercially viable alternatives for 

peeling peaches. In comparison to the 

previous allowance for this substance to 

peel peaches that would be individually 

quick frozen, there is no additional risk 

to the human health or the environment 

by expanding the allowance of 

potassium hydroxide for peeling 

peaches for other types of processing 

(e.g., canning). Therefore, AMS has 

adopted the proposed annotation for 

potassium hydroxide as final rule 

without change. 

The same commenter indicated that 

they did not support the proposed rule 

because they believe there is a conflict 

of interest, suggesting that a contributor 

to the 2001 technical advisory panel 

(TAP) that informed the Board’s 

recommendation on this substance 

worked on the petition related to the 

same substance ten years later in 2011. 

AMS does not agree that this is a 

conflict of interest. In its deliberations, 


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5Technical 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. 

the NOSB considers a wide range of 

information to make a recommendation 

on a particular substance. This includes 

the petition, any technical information 

such as TAPs and Technical Reports, 

and public comments. The comment 

also indicated that AMS should not 

implement the change for potassium 

hydroxide because the NOSB did not 

request a new technical report. 

However, the NOSB is not required to 

request a new or updated technical 

report for all petitioned substances. In 

this case, existing information was 

available in the form of a technical 

report, and the report was available on 

the NOP Web site to the NOSB and the 

public in advance of the public meeting 

at which the NOSB recommended that 

potassium hydroxide be allowed in any 

peach peeling process.5

One commenter proposed language 

that would add the following additional 

text to the proposed annotation for 

potassium hydroxide (emphasis added): 

‘‘Potassium hydroxide—prohibited for 

use in lye peeling of fruits and 

vegetables, except when used for 

peeling peaches. In this instance, 

potassium hydroxide is to be permitted 

and allowed for any peach peeling in 

organic process, including freezing and 

canning processes.’’ No explanation was 

provided on the need for this additional 

clarification. AMS believes the text, as 

proposed and finalized through this 

rule, is adequate as the substance can be 

used to peel peaches, regardless of the 

type of processing (e.g., canned, frozen). 

Silicon Dioxide 

AMS received 20 comments regarding 

the proposed amendment to the listing 

for silicon dioxide. One commenter 

indicated that silicon dioxide should 

not be allowed in any organic foods, but 

did not provide information on 

availability of alternative practices or 

materials. 

Several comments from organic 

handling operations indicated that AMS 

should not adopt the proposed rule, 

since organic rice hulls do not 

adequately substitute for silicon dioxide 

in all applications, and that that organic 

rice hulls may substitute for the use of 

silicon dioxide only in limited 

circumstances. Commenters indicated 

that rice hulls do not function as a onefor-one replacement for silicon dioxide, 

and that substitution may compromise 

quality, appearance, and stability of 

organic products or ingredients. 

Commenters also indicated that silicon 

dioxide is widely used in many food 

and beverage applications, including, 

dried fruit and vegetable powders, 

ground chili products, fish oil, soup 

powders, sugars, cake mixes, non-dairy 

creamers, salt, spices, hot chocolate, and 

many yeast/flour-based powdered 

mixes. Other commenters who 

supported the rule indicated that 

organic rice hulls were able to substitute 

for silicon dioxide in their applications. 

AMS believes the rule, as proposed 

and as adopted as final rule through this 

action, provides the flexibility that is 

needed by organic handlers. As 

indicated in the proposed rule, the 

annotation for silicon dioxide allows for 

the continued use of silicon dioxide in 

handling applications if organic rice 

hulls do not adequately substitute for 

the functionality provided by silicon 

dioxide. The term ‘‘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 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. Inclusion of 

the commercial availability clause for 

organic rice hulls in the annotation 

provides the flexibility that was 

intended by the NOSB and does not 

exclude handlers from using silicon 

dioxide or other organic products in 

those applications where organic rice 

hulls do not provide the functionality 

needed. The annotation requires 

handlers to use organic rice hulls in 

place of silicon dioxide when it is 

available to substitute for synthetic 

silicon dioxide. In addition, the rule 

provides flexibility for handlers by 

allowing the continued use of silicon 

dioxide in those applications where 

organic rice hulls do not provide the 

functionality needed (e.g., as a 

defoamer). This rule implements the 

intent of the NOSB to limit the 

allowance of silicon dioxide to those 

functions where it is essential for the 

handling of organically produced 

agricultural products, as required by 

section 205.600(b)(6). 

One commenter indicated concerns 

regarding the exclusive acceptability of 

organic rice hulls as the only acceptable 

anticaking agent because it may not 

perform in the applications in which 

silicon dioxide has been proven 

effective. AMS disagrees with this 

interpretation. The rule does not restrict 

the use of other organic ingredients as 

a substitute for silicon dioxide in 

organic product formulation. Instead, 

the rule implements a requirement that 

an organic alternative must be used in 

place of a synthetic substance on the 

National List when the organic 

alternative is commercially available. 

One commenter suggested text to 

replace ‘‘organic rice hulls’’ with ‘‘nonsynthetic alternatives.’’ As indicated in 

the proposed rule, AMS has specified 

the one particular nonsynthetic 

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

was evaluated by the NOSB 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 alternatives to 

synthetic silicon dioxide were 

considered prior to its use. 

One commenter indicated that 

commercial availability should not 

apply to section 205.605 of the National 

List and that applying the rule to silicon 

dioxide would not be consistent with 

other materials on the list. AMS 

disagrees, as the listing for yeast on 

section 205.605(a) of the National List 

includes a clause regarding commercial 

availability. In addition, the NOSB 

recommendation to include commercial 

availability within the annotation for 

silicon dioxide was drafted after 

significant public comment to address 

the concerns from organic handlers that 

the alternative organic rice product may 

not function as a substitute for silicon 

dioxide in all applications. AMS 

concurs with the NOSB’s justification 

for inclusion of this text regarding 

commercial availability; therefore, we 

have not accepted the suggestion of the 

commenter to remove this text. 

One commenter was concerned about 

the effect of the allowance of silicon 

dioxide in downstream products for 

companies that purchase ingredients 

that contain silicon dioxide, and the 

number of downstream products that 

may need to be reformulated based on 

this action. This commenter also 

indicated that their operation has 

conducted significant amounts of 

research and development in the past to 

find a way to incorporate rice hulls into 

their products as a viable substitute for 

silicon dioxide. The commenter 

indicated that organic rice hulls do not 

perform like silicon dioxide and that 

rice hulls do not serve the required 

purpose within the type of organic 


wreier-aviles on DSK5TPTVN1PROD with RULES
31820 Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Rules and Regulations 

6 ‘‘Arsenic in Your Food,’’ Consumer Reports 

Magazine, November 2012. Available at http:// 

www.consumerreports.org/cro/magazine/2012/11/ 

arsenic-in-your-food/index.htm 

7Questions & Answers: FDA’s Analysis of 

Arsenic in Rice and Rice Products; available at 

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

FoodborneIllnessContaminants/Metals/ 

ucm319948.htm 

products that they produce. As 

previously stated, the new annotation 

would allow the continued use of 

silicon dioxide when organic rice hulls 

are not commercially available to 

perform an essential function in organic 

handling. 

One commenter did not support the 

rule, but indicated that, if implemented, 

AMS should modify the proposed 

annotation as follows (emphasis added): 

‘‘Silicon dioxide—Permitted as a 

defoamer. Allowed for other uses when 

organic rice hulls are not commercially 

available or do not function adequately 

in the product application.’’ AMS 

believes that the annotation adopted in 

this final rule provides the flexibility 

that is intended by the commenter’s 

suggestion. The definition of 

‘‘commercially available’’ under section 

205.2 already includes 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. We 

find the phrases ‘‘fulfill an essential 

function’’ and ‘‘function adequately’’ to 

be equivalent; therefore, the suggested 

text has not been adopted. 

One commenter noted that there are 

various forms of silicon dioxide, 

including precipitated silica, fumed 

silicas, aerogels, naturally occurring 

silicas, and mined mineral silicas. The 

commenter indicated that AMS should 

reach out to other industry groups and 

document other various silica types 

currently approved for use in the 

organic industry before a decision to 

eliminate one silica dioxide form. AMS 

understands that there may be multiple 

types of silicon dioxide in use in 

organic products, as the regulations do 

not specify Chemical Abstracts Service 

(CAS) numbers for different forms of 

silicon dioxide on the National List. As 

this action does not restrict the forms of 

synthetic silicon dioxide that are 

permitted for use, we have not accepted 

the suggestion of the commenter on this 

issue. 

One commenter indicated that they 

support the use of agricultural products 

as a replacement for silicon dioxide, but 

expressed concerns about the levels of 

arsenic in rice products. The commenter 

indicated that additional testing and 

review should be required prior to its 

approval and implementation. The 

commenter cited data published in 

November 2012 by Consumer Reports of 

arsenic levels in rice products.6 Under 

section 205.602(b) of the USDA organic 

regulations, the use of arsenic is 

prohibited in the production of organic 

crops, including rice. AMS understands 

that as a result of the study cited by the 

commenter, the U.S. Food and Drug 

Administration (FDA) is currently 

investigating arsenic levels in foods.7 As 

all food must comply with FDA food 

safety requirements, AMS did not adopt 

the suggestion of the commenter to 

require additional testing and review of 

organic rice hulls used in organic 

products prior to implementation of this 

rule. 

One commenter proposed language 

that would add the following additional 

text to the proposed annotation for 

silicon dioxide: ‘‘In food products, 

concentration limited to 5 mg per 

serving.’’ We have not accepted the 

suggestion of the commenter as no 

explanation was provided on the need 

for this limitation. 

Two commenters noted that the 

proposed text did not specify that the 

use of organic rice hulls is only required 

in products making an ‘‘organic claim,’’ 

and recommended that the annotation 

be amended since commercial 

availability does not apply to products 

in the ‘‘made with organic (specified 

ingredients or food group(s))’’ labeling 

category. AMS has not adopted this 

suggestion. As specified under section 

205.600, synthetic substances are 

evaluated under the criteria specified by 

OFPA; in addition, processing aids and 

adjuvants are evaluated against 

additional criteria, including the 

availability of organic alternatives. 

OFPA and the USDA organic 

regulations do not include separate 

criteria for evaluation of synthetic 

substances used in the different labeling 

categories. As explained in the proposed 

rule, AMS 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. Organic or nonorganic rice 

hulls would be permitted as a substitute 

for silicon dioxide in a ‘‘made with 

organic (specified ingredients or food 

group(s)),’’ product under section 

205.301(c) of the USDA organic 

regulations. 

One commenter, who supported the 

proposed action, expressed concern 

regarding certifying agents that may 

permit an overly liberal reading of the 

commercial availability clause. AMS 

believes the existing accreditation 

requirements for certifying agents are 

sufficient for NOP to address any 

compliance issues with certifying agents 

who are not adequately implementing 

the USDA organic regulations, including 

annotations for substances on the 

National List. 

G. Effective Date 

This final rule reflects 

recommendations submitted to the 

Secretary by the NOSB. The substances 

being amended or removed from on the 

National List were based upon petitions 

from the industry and were evaluated by 

the NOSB using criteria in the OFPA 

and the USDA organic regulations. 

Because these substances have been 

subject to such extensive discussion and 

comment, AMS believes that producers 

should be able to use the expanded 

allowances for peracetic acid, potassium 

hydroxide, and beta-carotene extract 

color in their operations as soon as 

possible. Further, the harvest season for 

organic peaches will begin in June; 

without this final action, potassium 

hydroxide can only be used to peel 

peaches for frozen product. This final 

rule will enable organic peach 

producers to commercially process and 

market canned organic peaches. It is 

also important for AMS to expeditiously 

address EPA relabeling issues for 

hydrogen peroxide products used in 

organic crop production, and this will 

be achieved by finalizing the 

amendment to peracetic acid. 

Accordingly, AMS finds good cause 

exists under 5 U.S.C. 553(d)(3) for not 

postponing the effective date of this rule 

for these three substances until 30 days 

after publication in the Federal 

Register. 

As discussed above in Section F, the 

effective date for the new annotation for 

silicon dioxide and for removal of 

annatto extract color is established as 

November 3, 2013. 

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 

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. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Rules and Regulations 31821 

■ 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. 

Also permitted in hydrogen peroxide 

formulations as allowed in § 205.601(a) 

at concentration of no more than 6% as 

indicated on the pesticide product label. 

* * * * * 

(i) * * * 

(8) Peracetic acid—for use to control 

fire blight bacteria. Also permitted in 

hydrogen peroxide formulations as 

allowed in § 205.601(i) at concentration 

of no more than 6% as indicated on the 

pesticide product label. 

* * * * * 

■ 3. In § 205.605, the entry for 

‘‘potassium hydroxide’’ in paragraph (b) 

is revised 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. 

* * * * * 

■ 4. In § 205.605, effective November 3, 

2013, the entry for ‘‘silicon dioxide’’ in 

paragraph (b) is revised 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) * * * 

Silicon dioxide—Permitted as a 

defoamer. Allowed for other uses when 

organic rice hulls are not commercially 

available. 

* * * * * 

■ 5. In § 205.606, paragraph (d)(3) is 

revised to read as follows: 

§ 205.606 Nonorganically produced 

agricultural products allowed as ingredients 

in or on processed products labeled as 

‘‘organic.’’ 

* * * * * 

(d) * * * 

(3) Beta-carotene extract color— 

derived from carrots or algae (pigment 

CAS# 7235–40–7). 

* * * * * 

§ 205.606 [Amended] 

■ 6. In § 205.606, effective November 3, 

2013, paragraph (d) is amended by 

removing paragraph (d)(1) and 

redesignating (d)(2) through (19) as 

(d)(1) through (18). 

* * * * * 

Dated: May 21, 2013. 

Rex A. Barnes, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2013–12504 Filed 5–24–13; 8:45 am] 

BILLING CODE 3410–02–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 

37, 39, 51, 71, and 73 

[NRC–2008–0120; NRC–2010–0194] 

RIN 3150–AI12 

Physical Protection of Byproduct 

Material 

Correction 

In rule document 2013–5895 

appearing on pages 16922–17022 in the 

issue of March 19, 2013, make the 

following correction: 

§ 37.77 [Corrected] 

On page 17017, in § 37.77, in the third 

column, in the first full paragraph, in 

the 25th line through 26th, 

‘‘RAMQC&_SHIPMENTS@

nrc.gov’’ should read ‘‘RAMQC_

SHIPMENTS@nrc.gov’’. 

[FR Doc. C1–2013–05895 Filed 5–24–13; 8:45 am] 

BILLING CODE 1505–01–D 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 73 

[NRC–2010–0340; NRC–2009–0163] 

RIN 3150–AI64 

Physical Protection of Shipments of 

Irradiated Reactor Fuel 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: NUREG; issuance. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is issuing Revision 2 

of NUREG–0561, ‘‘Physical Protection of 

Shipments of Irradiated Reactor Fuel.’’ 

This revised document sets forth means, 

methods, and procedures that the NRC 

staff considers acceptable for satisfying 

the requirements for the physical 

protection of spent nuclear fuel (SNF) 

during transportation by road, rail, and 

water; and for satisfying the 

requirements for background 

investigations of individuals granted 

unescorted access to SNF during 

transportation. 

DATES: Revision 2 of NUREG–0561 is 

effective on August 19, 2013. 

ADDRESSES: Please refer to Docket ID 

NRC–2010–0340 when contacting the 

NRC about the availability of 

information regarding this document. 

You may access information related to 

this document, which the NRC 

possesses and is publicly available, 

using any of the following methods: 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2010–0340. Address 

questions about NRC dockets to Carol 

Gallagher; telephone: 301–492–3668; 

email: Carol.Gallagher@nrc.gov. For 

technical questions, contact the 

individuals listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may access publicly 

available documents online in the NRC 

Library at http://www.nrc.gov/readingrm/adams.html. To begin the search, 

select ‘‘ADAMS Public Documents’’ and 

then select ‘‘Begin Web-based ADAMS 

Search.’’ For problems with ADAMS, 

please contact the NRC’s Public 

Document Room (PDR) reference staff at 

1–800–397–4209, 301–415–4737, or by 

email to pdr.resource@nrc.gov. The 

ADAMS Accession number for Revision 

2 of NUREG–0561 is ML13120A230. 

• NRC’s PDR: You may examine and 

purchase copies of public documents at 

the NRC’s PDR, Room O1–F21, One 

White Flint North, 11555 Rockville 

Pike, Rockville, Maryland 20852. 

• NRC’s Public Web site: Go to 

http://www.nrc.gov/reading-rm/doccollections/ and search for NUREG– 

0561 under ‘‘NUREG-Series 

Publications.’’ 

The NRC’s NUREGs are not 

copyrighted, and NRC approval is not 

required to reproduce them. 

FOR FURTHER INFORMATION CONTACT: R. 

Clyde Ragland, Office of Nuclear 

Security and Incident Response, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001; telephone: 

301–415–7008; or email: 

Clyde.Ragland@nrc.gov. 

SUPPLEMENTARY INFORMATION: The NRC 

published a final rule in the Federal 

Register on May 20, 2013 (78 FR 29519) 

(RIN 3150–AI64), that amended its 

security regulations for the transport of 

irradiated reactor fuel at § 73.37 of Title 

10 of the Code of Federal Regulations 


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