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

25879 

Vol. 78, No. 86 

Friday, May 3, 2013 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–11–0003; 

NOP–10–13PR] 

RIN 0581–AD13 

National Organic Program (NOP); 

Sunset Review (2013) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

address recommendations submitted to 

the Secretary of Agriculture (Secretary) 

by the National Organic Standards 

Board (NOSB) following their November 

2011 and May 2012 meetings. These 

recommendations pertain to the 2013 

Sunset Review of substances on the U.S. 

Department of Agriculture’s (USDA) 

National List of Allowed and Prohibited 

Substances (National List). Consistent 

with the recommendations from the 

NOSB, this proposed rule would 

continue the allowed uses of multiple 

synthetic and nonsynthetic substances 

and the prohibition of one nonsynthetic 

substance on the National List (along 

with any restrictive annotations). This 

proposed rule would also remove one 

synthetic substance from the National 

List. 

DATES: Comments must be received by 

June 3, 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–11–0003; NOP–10–13PR, and/or 

Regulatory Information Number (RIN) 

0581–AD13 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 and any relevant background 

documents will be posted without 

change to http://www.regulations.gov. 

Document: For access to the 

document and to read background 

documents or comments received, go to 

http://www.regulations.gov. Comments 

submitted in response to this proposed 

rule will also be available for viewing in 

person at USDA–AMS, National Organic 

Program, 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 INFORMATION: 

I. Background 

The Organic Foods Production Act of 

1990 (OFPA) (7 U.S.C. 6501–6522) 

authorizes the establishment of the 

National List. The National List, 

codified within the USDA organic 

regulations at 7 CFR 205.600 through 

205.607, identifies synthetic substances 

that may be used in organic production 

and nonsynthetic (natural) substances 

that are prohibited in organic crop and 

livestock production. The National List 

also identifies nonagricultural 

nonsynthetic, nonagricultural synthetic 

and nonorganic agricultural substances 

that may be used in organic handling. 

The exemptions and prohibitions 

granted on the National List are required 

to be reviewed every 5 years under 

OFPA by the National Organic 

Standards Board (NOSB). The Secretary 

of Agriculture has authority under 

OFPA to renew such exemptions and 

prohibitions. If they are not reviewed by 

the NOSB within 5 years of their 

inclusion on the National List and 

renewed by the Secretary, their 

authorized use or prohibition expires. 

The Secretary published an Advanced 

Notice of Proposed Rulemaking (ANPR) 

(76 FR 31495) in the Federal Register on 

June 1, 2011, to announce the review of 

11 exempt substances and one 

prohibited nonsynthetic substance 

authorized under the USDA organic 

regulations. This ANPR established 

November 3, 2013, as the date by which 

the Sunset 2013 review and renewal 

process must be concluded. The ANPR 

explained that the exemptions and 

prohibitions not renewed by this date 

will be removed from the National List. 

This ANPR also requested public 

comment on the continued use or 

prohibition of these substances. The 

public comment period lasted 60 days. 

A list of these substances is provided as 

Table 1 in the Overview of Proposed 

Actions section. These substances were 

originally added to the National List on 

November 3, 2003 (68 FR 61987), and 

November 4, 2003 (68 FR 62215), and 

were previously renewed under the 

Sunset process on November 3, 2008 (73 

FR 59479). 

The Agricultural Marketing Service 

(AMS) received 25 comments on the 

substances in response to the ANPR. 

AMS received comments from 

producers, handlers, distributors, 

organic associations, a certifying agent, 

and various industry groups. Some of 

these comments addressed more than 

one substance. We received general 

comments stating that the listings 

should remain as they are currently 

codified. We received one general 

comment that did not address the 

substances under this Sunset review. 

Most comments indicated support for 

substances that the commenters’ 

promoted, represented, or relied upon. 

Comments specifically supported a 


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25880 Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Proposed Rules 

1EPA refers to the Environmental Protection 

Agency. 

2 In October 2010, the NOSB changed its Sunset 

policy to enable the NOSB to make 

recommendations to add or change annotations 

(restrictions) on applicable National List substances 

under Sunset review. This change in policy ensures 

that the NOSB can address new use patterns and 

scientific information on substances allowed in 

organic production. This policy limits such 

annotations to those which clarify the existing 

annotation or make the annotation more restrictive. 

The policy does not provide for an annotation 

change that would result in expanded use of an 

exempted material. This is described starting on p. 

56 of the NOSB Policies and Procedures Manual 

available on the NOP Web site at: http:// 

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

getfile?dDocName=STELDEV3013893. 

continued allowance for the following 

substances: copper sulfate, ozone gas, 

peracetic acid, EPA List 3 Inerts,1 agaragar, animal enzymes, calcium sulfate, 

carrageenan, glucono delta-lactone, 

tartaric acid, and cellulose. Two 

comments specifically supported a 

continued prohibition on calcium 

chloride as annotated on the National 

List. One commenter requested that the 

annotations for two listings of copper 

sulfate, one at section 205.601(a)(3) and 

one at section 205.601(e)(4) for use in 

aquatic rice systems, be amended to 

remove the restriction based on the 

number of applications during a 

specified timeframe. The commenter 

requested that the restriction limiting 

application rates to those which do not 

increase baseline soil test values for 

copper over a timeframe agreed upon by 

the producer and accredited certifying 

agent be maintained, but the restriction 

on number of applications during any 

24-month period be eliminated. 

The NOSB reviewed the comments 

received from the ANPR and developed 

recommendations regarding the 

continued use and prohibition of the 

substances under review. The NOSB 

received additional public comments 

concerning the pending sunset of these 

substances in response to two Federal 

Register notices announcing meetings of 

the NOSB and its planned deliberations 

on Sunset 2013 recommendations. The 

notices were published in the Federal 

Register as follows: October 7, 2011 (76 

FR 62336), and April 9, 2012 (77 FR 

21067). The NOSB received further 

written and oral testimony at both of 

these public meetings which occurred 

in Savannah, GA on November 29– 

December 2, 2011, and Albuquerque, 

NM on May 22–25, 2012. The written 

comments can be retrieved via http:// 

www.regulations.gov by searching for 

the document ID numbers: AMS–NOP– 

11–0081 (November 2011 meeting) and 

AMS–NOP–12–0017 (May 2012 

meeting). The oral comments were 

recorded in the meeting transcripts 

which are available on the NOP Web 

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

At its November 2011 and May 2012 

meetings, the NOSB addressed multiple 

National List exemptions and a 

prohibition under the 2013 Sunset 

review. The NOSB recommended that 

the Secretary: (1) Renew multiple 

exemptions and one prohibition without 

change, (2) remove an exemption for 

one synthetic substance, tartaric acid, 

and (3) amend the exemptions for two 

synthetic substances, EPA List 3—Inerts 

of unknown toxicity and cellulose, and 

one nonsynthetic substance, 

carrageenan. In accordance with NOSB’s 

published policies and procedures, it 

also issued a second round of 

recommendations to renew the existing 

listings for EPA List 3—Inerts of 

unknown toxicity, cellulose, and 

carrageenan without change.2 These 

second recommendations authorize the 

Secretary to renew these three listings 

‘‘as is’’ considering the expiration date 

of November 3, 2013. 

Because the NOSB’s sole justification 

for restricting the allowance of 

carrageenan was on the basis of food 

safety concerns, despite the fact that 

FDA regulations provide for its use as a 

safe food additive when used in 

accordance with 21 CFR 172.5, 21 CFR 

172.620 and 21 CFR 172.626, AMS is 

renewing carrageenan as codified based 

on the NOSB’s second recommendation. 

Based on concern over the impact of 

changing the annotation for cellulose, 

AMS is renewing the listing for 

cellulose as codified based on the 

NOSB’s second recommendation. For 

EPA List 3—Inerts of unknown toxicity, 

AMS is concerned that including an 

expiration date as part of its annotation 

during the Sunset review would 

complicate the NOSB’s established 

inerts review process. Therefore, AMS is 

renewing the listing for EPA List 3— 

Inerts of unknown toxicity as codified 

based on the NOSB’s second 

recommendation. In summary, this rule 

proposes to renew multiple listings 

without change and remove one listing 

(tartaric acid—made from malic acid). 

Under the authority of OFPA, the 

National List can be amended by the 

Secretary based on proposed 

amendments 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). 

II. Overview of Proposed Actions 

At its November 2011 and May 2012 

meetings, the NOSB reviewed the 

listings set to sunset on November 3, 

2013, for multiple exemptions and one 

prohibition that are authorized on the 

National List. On December 2, 2011, the 

NOSB finalized its recommendations on 

the following substances: animal 

enzymes, calcium chloride, copper 

sulfate (two uses), glucono deltalactone, ozone gas, peracetic acid (two 

uses), and tartaric acid (two sources). 

On May 25, 2012, the NOSB finalized its 

recommendations on agar-agar, calcium 

sulfate, carrageenan, cellulose, and EPA 

List 3—Inerts of unknown toxicity. 

The NOSB’s recommendations to 

continue existing exemptions and 

prohibitions are based on consideration 

of public comments and applicable 

supporting evidence that express a 

continued need for the use or 

prohibition of the substance(s) as 

required by OFPA. 

Concerning OFPA criteria used to 

make recommendations regarding the 

discontinuation of an authorized 

exempted synthetic substance (7 U.S.C. 

6517(c)(1)), the NOSB’s decision is 

based on consideration of public 

comments and applicable supporting 

evidence that demonstrates the 

currently authorized exempted 

substance is: (a) Harmful to human 

health or the environment; (b) no longer 

necessary for organic production due to 

the availability of alternative wholly 

nonsynthetic substitute products or 

practices; and (c) inconsistent with 

organic farming and handling practices. 

Based on the NOSB 

recommendations, AMS’ proposed 

actions for the Sunset 2013 proposed 

rule are outlined in Table 1. 


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Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Proposed Rules 25881 

TABLE 1—OVERVIEW OF PROPOSED ACTIONS FOR SUNSET 2013 

National List Section Substance listing Proposed action 

Synthetic substances allowed for use in organic crop production. 

205.601(a)(3) ................................... Copper sulfate—for use as an algicide in aquatic rice systems, is limited to one application per field during any 24- 

month period. Application rates are limited to those which 

do not increase baseline soil test values for copper over 

a timeframe agreed upon by the producer and accredited 

certifying agent.

Renew. 

205.601(a)(5) ................................... Ozone gas—for use as an irrigation system cleaner only .... Renew. 

205.601(a)(6) ................................... Peracetic acid—for use in disinfecting equipment, seed, 

and asexually propagated planting material.

Addressed through separate rulemaking action; see February 5, 2013 proposed rule 

(78 FR 8040). 

205.601(e)(4) ................................... Copper sulfate—for use as tadpole shrimp control in aquatic rice production, is limited to one application per field 

during any 24-month period Application rates are limited 

to levels which do not increase baseline soil test values 

for copper over a timeframe agreed upon by the producer and accredited certifying agent.

Renew. 

205.601(i)(8) .................................... Peracetic acid—for use to control fire blight bacteria ........... Addressed through separate rulemaking action; see February 5, 2013 proposed rule 

(78 FR 8040). 

205.601(m)(2) .................................. EPA List 3—Inerts of unknown toxicity—for use only in 

passive pheromone dispensers.

Renew. 

Nonsynthetic substances prohibited for use in organic crop production 

205.602(c) ....................................... Calcium chloride, brine process is natural and prohibited for 

use except as a foliar spray to treat a physiological disorder associated with calcium uptake.

Renew. 

Nonsynthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or 

‘‘made with organic (specified ingredients or food group(s)).’’ 

205.605(a) ....................................... Agar-agar ............................................................................... Renew. 

205.605(a) ....................................... Animal enzymes—(Rennet—animals derived; Catalase— 

bovine liver; Animal lipase; Pancreatin; Pepsin; and 

Trypsin).

Renew. 

205.605(a) ....................................... Calcium sulfate—mined ......................................................... Renew. 

205.605(a) ....................................... Carrageenan .......................................................................... Renew. 

205.605(a) ....................................... Glucono delta-lactone—production by the oxidation of Dglucose with bromine water is prohibited.Renew. 

205.605(a) ....................................... Tartaric acid—made from grape wine ................................... Renew. 

Synthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made 

with organic (specified ingredients or food group(s)).’’ 

205.605(b) ....................................... Cellulose—for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.Renew. NOSB recommendation for annotation change under consideration for a separate rulemaking action. 

205.605(b) ....................................... Tartaric acid—made from malic acid .................................... Remove. 

The following Renewals and 

Nonrenewals sections provide 

explanations for AMS’ proposed 

actions. 

Renewals 

AMS has reviewed and accepts the 

NOSB recommendations for the 

continued exemption or prohibition of 

certain substances. Accordingly, this 

proposed rule would: 

1. Renew the exemptions at section 

205.601, along with any restrictive 

annotations, for the following synthetic 

substances allowed for use in organic 

crop production as shown in Table 1: 

copper sulfate (2 uses), ozone gas, and 

EPA List 3 Inerts; 

2. Renew the prohibition at section 

205.602, along with its restrictive 

annotation, for the following 

nonsynthetic substance prohibited for 

use in organic crop production as 

shown in Table 1: calcium chloride; and 

3. Renew the exemptions at section 

205.605, along with any restrictive 

annotations, for the following 

nonagricultural (nonorganic) substances 

allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

or ‘‘made with organic (specified 

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

in Table 1: agar-agar, animal enzymes, 

carrageenan, cellulose, calcium sulfate, 

glucono delta-lactone, and tartaric acid 

made from grape wine. 

AMS is accepting NOSB’s second 

recommendations rather than the 

NOSB’s first recommendations to add or 

amend restrictive annotations for the 

following substances under Sunset 

review: EPA List 3 Inerts, carrageenan, 

and cellulose. The specific 

circumstances for implementing the 

NOSB’s second recommendations for 

these substances are outlined below. 

EPA List 3—Inerts of Unknown Toxicity 

An inert ingredient is defined in 

section 205.2 the USDA organic 


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3On September 30, 2010, NOP issued NOP 5008: 

Reassessed Inert Ingredients, a guidance document 

describing the applicability of NOP’s regulatory 

references to List 3 and 4 inerts (EPA is no longer 

using these lists in their classification system) used 

in pesticide products. Available at the NOP Web 

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

dDocName=STELPRDC5086874. 

4NOSB Recommendation on List 3 Inert 

Ingredients. May 2012. Available at the NOP Web 

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

getfile?dDocName=STELPRDC5098912. 

5This is the spelling provided at this regulatory 

reference. 

6This final rule added ‘‘carageenan’’ to the 

National List rather than the correct spelling 

‘‘carrageenan’’. The spelling for this substance was 

corrected as a technical correction in the final rule 

for the 2008 Sunset Review (73 FR 59480). 

7Technical Evaluation Report on Carrageenan. 

October 3, 2011. Available at the NOP Web site: 

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

getfile?dDocName=STELPRDC5096567. 

regulations as ‘‘any substance (or group 

of substances with similar chemical 

structures if designated by the 

Environmental Protection Agency) other 

than an active ingredient which is 

intentionally included in any pesticide 

product (40 CFR 152.3(m)).’’ There are 

currently two categories of inert 

ingredients allowed on the National List 

with restrictive annotations: EPA List 

3—Inerts of unknown toxicity (section 

205.601(m)), and EPA List 4—Inerts of 

minimal concern (sections 205.601(m) 

and 205.603(e)). 

In 2006, EPA reassessed all inert 

ingredients used in pesticide 

formulations allowed on food crops. 

This reassessment resulted in a new 

classification system which made the 

EPA List system obsolete. This means 

that the National List references to EPA 

List 3 and EPA List 4 inerts are now outof-date when compared with current 

EPA regulations.3 In June 2010, NOP 

convened an NOSB–NOP–EPA inerts 

working group (IWG) for the purpose of 

addressing these obsolete references to 

EPA inert lists. 

At the NOSB May 2012 meeting, the 

NOSB recommended several changes to 

the allowance for inerts as part of its 

Sunset review for EPA List 3 Inerts.4

The changes included: (1) Modification 

to the introductory text at section 

205.601(m); (2) amending the listing and 

annotation for EPA List 3 Inerts to read 

as follows: ‘‘Inert ingredients exempt 

from the requirement of a tolerance 

under 40 CFR 180.1122 that were 

formerly on EPA List 3 in passive 

polymeric dispenser products may be 

used until October 21, 2017;’’ and (3) 

amending section 205.2 to add a 

definition for ‘‘passive polymeric 

dispenser products’’ that is intended to 

be removed in coordination with the 

proposed expiration date of October 21, 

2017, at section 205.601(m). Concurrent 

with Sunset Review policy, the NOSB 

also issued a second recommendation to 

renew the existing listing for EPA List 

3 Inerts. 

On October 16, 2012, the NOSB 

passed a recommendation which 

outlined the procedure by which the 

NOSB would review both EPA List 3 

and EPA List 4 inerts over a four-year 

timespan, with the goal of completing 

the majority of the reviews by October 

2017, the sunset date for EPA List 4 

inerts. As of October 2012, the IWG had 

compiled a list of 16 classes or groups 

comprising 126 individual substances 

for review. In its recommendation, the 

NOSB acknowledged that, ‘‘Given the 

scope of [technical evaluation reports] 

and NOSB evaluation of these materials, 

it is recognized that the completion of 

this process will take substantial 

resources and time . . . Because of the 

challenge that this represents, the NOSB 

will assess the viability of the timeline 

after it completes the recommendation 

on the first few groups of materials.’’ 

AMS recognizes the recommendation’s 

intent to address the complex 

challenges presented by the out-of-date 

listings in a timely manner. However, a 

rulemaking action to add an expiration 

date at this time may be problematic in 

the event that the timeline for inerts 

review takes longer than the projected 

four years; therefore, we are not 

proposing the addition of an expiration 

date to the exemption for EPA List 3 

Inerts. This rule proposes to implement 

the NOSB’s second recommendation to 

renew the exemption for EPA List 3— 

Inerts of unknown toxicity at section 

205.601 as codified, along with its 

current restrictive annotation. This 

approach would meet the timeframe 

required by the sunset provision of 

OFPA and the listing for EPA List 3 

Inerts would subsequently have a sunset 

date of November 3, 2018. Furthermore, 

the IWG’s continuing review of inerts 

may result in additional outcomes 

beyond the NOSB’s other 

recommendations to modify the 

introductory text for section 205.601(m) 

and add a definition in section 205.2 for 

passive polymeric dispenser products. 

This may in turn influence AMS’ future 

considerations for a rulemaking on EPA 

List 3 Inerts. 

Carrageenan 

Carrageenan is currently permitted as 

a nonagricultural, nonsynthetic 

ingredient in organic handling in 

section 205.605(a) of the National List. 

Under U.S. Food and Drug 

Administration (FDA) regulations, 

carrageenan and its salts can be used as 

a food additive under the conditions 

specified at 21 CFR 172.5 (General 

Provisions for Direct Food Additives), 

and at 21 CFR 172.620 and 21 CFR 

172.626 (Specific Provisions for 

Carrageenan and Its Salts). In addition, 

Chondrus extract (carrageenin) 5 is listed 

as Generally Recognized as Safe at 21 

CFR 182.7255 when used in accordance 

with good manufacturing practice. 

Under FDA’s prescribed conditions, 

carrageenan can be safely used in the 

amount necessary as an emulsifier, 

stabilizer, or thickener in foods, except 

those standardized foods that do not 

provide for such use. 

Consistent with a 1995 NOSB 

recommendation, AMS first included 

carrageenan on the National List as an 

allowed nonsynthetic in organic 

processed products on November 3, 

2003 (68 FR 61987).6 The NOSB 

reviewed carrageenan again as part of 

the 2008 Sunset Review and 

recommended that its allowance in 

organic handling be renewed without 

any restrictive annotation. Based on the 

NOSB recommendation, AMS renewed 

the allowance for carrageenan through a 

final rule effective on November 3, 2008 

(73 FR 59479). In the November 3, 2008 

final rule, AMS described the comments 

received on substances under the 2008 

Sunset Review, citing that we received 

five comments specifically in support 

for renewing carrageenan on the 

National List. At that time, AMS did not 

receive any comments that opposed its 

continued use in organic processed 

products. 

On June 1, 2011, AMS published an 

ANPR to inform stakeholders that the 

NOSB would be reviewing carrageenan 

as part of its 2013 Sunset Review. AMS 

received 15 comments specifically 

supporting a continued allowance for 

carrageenan. Many comments cited 

carrageenan’s function as a unique 

stabilizer in a range of organic foods, 

particularly in dairy products, as the 

basis for their support. Three of these 

comments stated that carrageenan has 

been used safely as an ingredient in 

foods for many years. Two comments 

specifically referenced FDA as the 

regulatory agency that authorizes the 

use of carrageenan as a safe food 

additive under the conditions specified 

in FDA regulations. At that time, AMS 

did not receive any comments that 

opposed its continued use in organic 

processed products. 

In preparation for its Sunset 2013 

review, the NOSB Handling 

Subcommittee reviewed the comments 

submitted in response to the ANPR and 

obtained a new technical evaluation 

report for carrageenan.7 On February 21, 

2012, the NOSB Handling 


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8NOSB Handling Subcommittee Proposal on 

Carrageenan. February 21, 2012. Available at the 

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

getfile?dDocName=STELPRDC5097825&acct=nosb. 

9NOSB Recommendation on Carrageenan. May 

25, 2012. Available at the NOP Web site: http:// 

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

getfile?dDocName=STELPRDC5098921. 

10After 2003, the SCF was transferred to the 

European Food Safety Authority. http:// 

ec.europa.eu/food/committees/scientific/ 

index_en.htm. 

11Opinion of the Scientific Committee on Food 

on Carrageenan (2003). http://ec.europa.eu/food/fs/ 

sc/scf/out164_en.pdf. 

12Technical Advisory Panel Report on Cellulose. 

September 28, 2001. Available at the NOP Web site: 

Continued 

Subcommittee finalized its 2013 Sunset 

Review proposal for carrageenan; this 

proposal was published for public 

comment on April 9, 2012 in 

conjunction with the NOSB May 2012 

public meeting notice (77 FR 21067). In 

its proposal, the NOSB Handling 

Subcommittee proposal stated that the 

technical evaluation report confirmed 

the food uses of carrageenan have not 

changed substantially since the original 

Technical Advisory Panel (TAP) review 

was conducted in 1995. The proposal 

explained that carrageenan continues to 

be an important material used by the 

organic community. The NOSB 

Handling Subcommittee proposal also 

stated that carrageenan may be safely 

used as a food additive for human 

consumption as long as its use is in 

accordance with FDA requirements at 

21 CFR 172.620. The NOSB Handling 

Subcommittee further stated that, based 

on information in the 2011 technical 

evaluation report, it believed that 

different manufacturing methods of 

carrageenan could change the 

classification of the substance from 

nonsynthetic to synthetic.8

As a result of this information, the 

NOSB Handling Subcommittee 

proposed to continue the allowance for 

carrageenan in all organic processed 

products by removing carrageenan as an 

allowed nonsynthetic from section 

205.605(a) and instead listing 

carrageenan as an allowed synthetic 

without restriction under section 

205.605(b) of the National List. The 

NOSB Handling Subcommittee 

proposed this classification change to 

address the different manufacturing 

processes described by the 2011 

technical evaluation report. 

After publication of this NOSB 

Handling Subcommittee proposal, some 

public comments raised concerns 

regarding potential adverse health 

effects caused by the use of carrageenan, 

particularly degraded carrageenan, a 

low-molecular weight polysaccharide, 

in food. Other comments cited evidence 

in support of the safety of food-grade 

carrageenan in food, and stated that 

degraded carrageenan is not used in 

food products. Numerous other 

stakeholders stated that organic 

handlers producing a wide range of 

products that rely on carrageenan do not 

have functional alternatives to the 

substance. The comments in response to 

the NOSB Handling Subcommittee 

proposal can be retrieved at 

www.regulations.gov (search for docket 

number AMS–NOP–12–0017). 

At its May 2012 public meeting, the 

NOSB Handling Subcommittee chose to 

present a revised proposal. The NOSB 

Handling Subcommittee recommended 

to relist carrageenan as a nonsynthetic, 

rather than change its classification to 

synthetic, and to include new language 

in its listing that would specify the food 

grade forms of carrageenan using 

Chemical Abstract Service (CAS) 

numbers. The CAS numbers are 

intended to align with the forms that 

have been approved by FDA for use as 

food ingredients. The proposal also 

included an annotation that, if codified 

through rulemaking, would prohibit the 

use of any form of carrageenan in infant 

formula. The revised proposal from the 

NOSB Handling Subcommittee further 

stated that carrageenan would still be 

allowed in foods for older infants (older 

than six months) and ‘‘weaning foods’’ 

for ‘‘young children’’. The NOSB passed 

this proposal as its first 

recommendation with a vote of 10 ‘‘yes’’ 

and 5 ‘‘no.’’ Aligned with the NOSB’s 

Sunset Review policy, the NOSB also 

issued a second recommendation with a 

vote of 11 ‘‘yes’’ and 4 ‘‘no’’ to renew 

the existing listing for carrageenan 

which does not have any restrictive 

annotation.9

In its first recommendation, the NOSB 

stated that the restrictive annotation to 

prohibit the use of carrageenan in infant 

formula was based on concerns, 

specifically related to newborns, raised 

by a March 2003 opinion of the EU 

Scientific Committee on Food (SCF). 

The SCF provided scientific advice to 

the EU Commission.10 The NOSB stated 

that the SCF’s concern was based on 

facts from the Pediatric Nutrition 

Handbook, a publication of American 

Association of Pediatrics (AAP), in that 

newborn infants have immature 

digestive systems that may absorb 

macromolecules. 

In considering the May 2012 NOSB 

recommendation, AMS reviewed the 

March 2003 opinion of the EU SCF as 

NOSB’s justification for restricting the 

use of carrageenan. The EU SCF opinion 

cited in the May 2012 NOSB 

recommendation concluded that ‘‘there 

is no evidence of any adverse effects in 

humans from exposure to food-grade 

carrageenan, or that exposure to 

degraded carrageenan from use of foodgrade carrageenan is occurring’’ (p. 5).11

The EU SCF opinion cited in the May 

2012 NOSB recommendation further 

states that, given the absence of 

information on potential absorption of 

carrageenan in the digestive system of 

young infants, carrageenan in infant 

formula is ‘‘inadvisable’’ (p. 6). The EU 

SCF opinion, however, does not 

reference the AAP’s Pediatric Nutrition 

Handbook, and the Handbook does not 

reference any concerns with 

carrageenan. Therefore, it is unclear 

how the Handbook is linked to the EU 

SCF opinion or supportive of the 

NOSB’s proposed prohibition on the use 

of carrageenan in infant formula. 

In the U.S., carrageenan is allowed 

under FDA regulations at 21 CFR 

172.620 as a direct food additive and is 

considered safe when used in the 

amount necessary as an emulsifier, 

stabilizer, or thickener in foods, except 

those standardized foods that do not 

provide for such use. The FDA, as the 

U.S. food safety authority, has not 

prohibited the use of carrageenan in 

infant formula. If used in infant formula, 

FDA reviews carrageenan in a given 

formulation as part of the infant formula 

notification process required by section 

412 of the Federal Food, Drug, and 

Cosmetic Act (FFDCA) (21 U.S.C. 

350(a)). 

The NOSB’s recommendation to 

prohibit the use of carrageenan in infant 

formula was based solely on food safety 

concerns despite carrageenan’s status as 

a safe food additive when used as 

specified by FDA regulations and 

despite FDA’s review of carrageenan in 

infant formula formulations under the 

FFDCA. Therefore, AMS is not 

implementing this recommendation. 

This proposed rule would implement 

the NOSB’s second recommendation by 

renewing the exemption for carrageenan 

as currently listed as a nonsynthetic 

substance at section 205.605(a). 

Cellulose 

Cellulose is currently included on the 

National List in section 205.605(a) as an 

allowed nonagricultural, synthetic 

substance for use in organic handling. 

As part of the 2013 Sunset review, the 

NOSB Handling Subcommittee 

reviewed the original NOSB 

recommendation, the 2001 Technical 

Advisory Panel (TAP) review, historical 

documents, the 2007 Sunset 

recommendation, and public comments 

on cellulose.12 The NOSB Handling 


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25884 Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Proposed Rules 

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

Name=STELPRDC5066975&acct=nopgeninfo. 

13NOSB Handling Subcommittee Proposal on 

Cellulose. March 20, 2012. Available at the NOP 

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

getfile?dDocName=STELPRDC5097827&acct=nosb. 

14Transcript from the May 22–25, 2012 NOSB 

meeting is available under the NOSB section of the 

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

15NOSB Recommendation on Cellulose. May 25, 

2012. Available at the NOP Web site: http:// 

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

Name=STELPRDC5098923. 

16Technical Evaluation Report on Tartaric Acid. 

October 13, 2011. Available at the NOP Web site: 

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

Name=STELPRDC5094932. 

17The petition was submitted by Brenn-O-Kem 

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

www.ams.usda.gov/NOPPetitionedSubstances

Database. 

18The petition was submitted by BioSafe Systems 

LLC, and is available from the NOP Web site in the 

Petitioned Substances Database: 

http:www.ams.usda.gov/NOPPetitionedSubstances

Database. 

19NOSB Recommendation on Peracetic Acid. 

November 2009. Available at the NOP Web site: 

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

Name=STELPRDC5092050&acct=nosb. 

Subcommittee issued a proposal to 

renew the listing for cellulose at section 

205.605(b) that was considered by the 

NOSB at its May 2012 meeting.13 At this 

meeting, the NOSB received public 

comment in support of relisting. One 

commenter requested that the NOSB 

ensure the microcrystalline form of 

cellulose is not allowed, and another 

commenter requested a new technical 

review and opposed the listing of the 

microcrystalline form of cellulose.14

The NOSB responded that the 2001 TAP 

review examined three forms of 

cellulose that were considered for 

various uses: Powdered cellulose, 

regenerated cellulose casing, and 

microcrystalline cellulose, and the 

intent of the current annotation was to 

allow powdered cellulose and the form 

used in regenerative casings. At its 

meeting, the NOSB acknowledged that 

both powdered and microcrystalline 

cellulose can be used to serve the same 

functions, namely as a filtering aid or an 

anti-caking agent. The NOSB then 

recommended changing the annotation 

to explicitly state which forms are 

allowed, thereby prohibiting the use of 

the microcrystalline form.15 Concurrent 

with Sunset Review policy, the NOSB 

also issued a second recommendation to 

renew the existing listing for cellulose. 

Evidence gathered at the meeting 

suggested that the organic industry is 

not using the microcrystalline form of 

cellulose. However, AMS needs more 

information from the industry to 

confirm that the microcrystalline form 

of cellulose is not currently in use in 

organic processed products. Therefore, 

through this proposed rule, AMS is 

proposing to address the NOSB’s second 

recommendation to renew the 

exemption for cellulose as currently 

listed at section 205.605(b) and is 

seeking public comments on the NOSB’s 

first recommendation to restrict its use 

in organic processed products. This 

approach would meet the timeframe 

required by the Sunset provision of 

OFPA and, based on the public 

comment, enable AMS to consider a 

restriction on its use for a future 

rulemaking. 

Nonrenewals 

Tartaric Acid 

As indicated in Table 1, there are two 

sources of tartaric acid currently on the 

National List: Nonsynthetic tartaric acid 

made from grape wine on section 

205.605(a), and synthetic tartaric acid 

made from malic acid on section 

205.605(b). As part of its Sunset 2013 

review, the NOSB requested and 

obtained a new technical evaluation 

report for tartaric acid.16 The NOSB 

Handling Subcommittee also received a 

petition to remove the synthetic source 

of tartaric acid.17 The petition argued 

that: (1) The annotation for synthetic 

tartaric acid is incorrect; (2) the two 

listings of tartaric acid are the same 

form and serve the same function; and 

(3) tartaric acid made from grape wine 

is widely commercially available. The 

technical evaluation report findings 

confirmed the petitioner’s three 

arguments: (1) Synthetic tartaric acid is 

typically manufactured from maleic 

anhydride, not malic acid as written in 

the current annotation; (2) both the 

nonsynthetic and synthetic listings are 

the same form of tartaric acid, which is 

generally referred to as the ‘dextro 

form’; and (3) tartaric acid from grape 

wine is commercially available from a 

large number of distributors throughout 

the world. Based on review of the 

technical report and public comment, 

the NOSB agreed there is insufficient 

evidence to support the continued need 

for the synthetic form of tartaric acid 

and recommended its removal from the 

National List at section 205.605(b). This 

rule proposes removal of this substance 

as part of this Sunset 2013 rulemaking. 

Peracetic Acid 

On August 12, 2008, a petition was 

submitted to NOP requesting that the 

annotation for peracetic acid be 

amended on the National List.18 The 

petition was submitted to ensure that 

hydrogen peroxide products can also 

list peracetic acid as an active 

ingredient on the product label. This 

would be consistent with EPA labeling 

requirements. The NOSB reviewed the 

petition in 2009 and issued a 

recommendation for an annotation 

change for the two peracetic acid 

listings at section 205.601.19 To date, 

AMS has not implemented these 

recommendations for peracetic acid. 

During its Sunset 2013 deliberations, 

the NOSB received public comments in 

support of the continued need for 

peracetic acid. As a result, the NOSB 

recommended renewing the two listings 

for peracetic acid in organic crop 

production at section 205.601 of the 

National List. Given that OFPA 

recognizes the authority of the 

Administrator of the Environmental 

Protection Agency under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA) (7 U.S.C. 136–136(y)), AMS 

addressed the two listings for peracetic 

acid in a proposed rule (78 FR 8040) 

published on February 5, 2013 to 

implement the 2009 NOSB 

recommendation and ensure the listings 

for peracetic acid on the National List 

allow for conformance to EPA labeling 

requirements. AMS intends to conclude 

that rulemaking prior to the November 

3, 2013 sunset date. As a result, the 

renewals for peracetic acid are not 

addressed in this proposed rule for 

Sunset 2013. 

III. Related Documents 

An advanced notice of proposed 

rulemaking with request for comments 

was published in Federal Register on 

June 1, 2011 (76 FR 31495) to notify the 

public that the listings discussed in this 

proposed rule would expire on 

November 3, 2013 if not reviewed by the 

NOSB and renewed by the Secretary. 

IV. Statutory and Regulatory Authority 

OFPA, as amended (7 U.S.C. 6501– 

6522), authorizes the Secretary to make 

amendments to the National List based 

on proposed amendments developed by 

the NOSB. Sections 6518(k)(2) and 

6518(n) of OFPA authorize the NOSB to 

develop proposed amendments to the 

National List for submission to the 

Secretary and establish a petition 

process by which persons may petition 

the NOSB for the purpose of having 

substances evaluated for inclusion on or 

deletion from the National List. The 

National List petition process is 

implemented under section 205.607 of 

the USDA organic regulations. The 

current petition process was published 

on January 18, 2007 (72 FR 2167) and 

can be accessed through the NOP Web 

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


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Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Proposed Rules 25885 

20U.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. 

21Organic Trade Association. 2012. Organic 

Industry Survey. www.ota.com. 

A. Executive Order 12866 

This action has been determined to be 

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 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 

2115(b) of OFPA (7 U.S.C. 6514(b)). 

States are also preempted under section 

2104 through 2108 of 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 OFPA. 

Pursuant to section 2108(b)(2) of 

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 OFPA, (b) not 

be inconsistent with 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 2120(f) of OFPA 

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

would not alter the authority of the 

Secretary under the Federal Meat 

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

Poultry Products Inspection Act (21 

U.S.C. 451–471), or the Egg Products 

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

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 

and Cosmetic Act (21 U.S.C. 301–399), 

nor the authority of the Administrator of 

EPA under the Federal Insecticide, 

Fungicide, and Rodenticide Act (7 

U.S.C. 136–136(y)). 

Section 2121 of 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. OFPA also provides that the 

U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

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

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

of the RFA is to fit regulatory actions to 

the scale of businesses subject to 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. 

Pursuant to the requirements set forth 

in the RFA, AMS performed an 

economic impact analysis on small 

entities in the final rule published in the 

Federal Register on December 21, 2000 

(65 FR 80548). AMS has also considered 

the economic impact of this action on 

small entities. The impact on entities 

affected by this proposed rule would not 

be significant. The effect of this 

proposed rule would be to allow the 

continued use of additional substances 

in agricultural production and handling. 

AMS concludes that the economic 

impact of continuing the allowance for 

Sunset 2013 substances would avoid 

market disruption and would be 

beneficial to small agricultural service 

firms. The effect of the removal of one 

substance, tartaric acid, would be 

minimal to small agricultural firms 

since another form of tartaric acid from 

grape wine is commercially available 

and is proposed to be renewed under 

this rule. Accordingly, AMS certifies 

that this rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $7,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

According to USDA, National 

Agricultural Statistics Service (NASS), 

certified organic acreage exceeded 3.5 

million acres in 2011.20 According to 

NOP’s Accreditation and International 

Activities Division, the number of 

certified U.S. organic crop and livestock 

operations totaled over 17,750 in 2012. 

AMS believes that most of these entities 

would be considered small entities 

under the criteria established by the 

SBA. 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.21 In addition, the USDA has 

85 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 25,000 certified 

operations worldwide in 2012. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by section 350(h) of the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501, Chapter 35, or OMB’s 

implementing regulations at 5 CFR part 

1320. 

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 reflects 

recommendations submitted to the 

Secretary by the NOSB for substances 

on the National List of Allowed and 

Prohibited Substances that, under the 

Sunset review provisions of OFPA, 

would otherwise expire on November 3, 

2013. A 30-day period for interested 


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25886 Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Proposed Rules 

persons to comment on this rule is 

provided. Thirty days is deemed 

appropriate because the review of these 

listings was widely publicized through 

an ANPR and two NOSB meeting 

notices; the use or prohibition of these 

substances, as applicable, are critical to 

organic production and handling; and 

this rulemaking must be completed 

before the sunset date of 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 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. 

§ 205.605 [Amended] 

■ 2. Section 205.605 is amended by 

removing ‘‘Tartaric acid—made from 

malic acid’’ from paragraph (b). 

Dated: April 30, 2013. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2013–10556 Filed 5–2–13; 8:45 am] 

BILLING CODE 3410–02–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 2 

RIN 3150–AI30 

[NRC–2009–0044] 

Revisions to the Petition for 

Rulemaking Process 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is proposing to 

amend its regulations to streamline its 

process for addressing petitions for 

rulemaking (PRMs). The proposed 

amendments are intended to improve 

transparency and make the PRM process 

more efficient and effective. 

DATES: Submit comments by July 17, 

2013. Comments received after this date 

will be considered if it is practical to do 

so, but the NRC is able to assure 

consideration only for comments 

received on or before this date. 

ADDRESSES: You may submit comments 

by any of the following methods (unless 

this document describes a different 

method for submitting comments on a 

specific subject): 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2009–0044. 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. 

• Email comments to: 

Rulemaking.Comments@nrc.gov. If you 

do not receive an automatic email reply 

confirming receipt, then contact us at 

301–415–1677. 

• Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at 301– 

415–1101. 

• Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

FOR FURTHER INFORMATION CONTACT: 

Christina England, Office of Nuclear 

Reactor Regulation, telephone: 301– 

415–3138, email: 

Christina.England@nrc.gov, or Cindy 

Bladey, Office of Administration, 

telephone: 301–492–3667, email: 

Cindy.Bladey@nrc.gov; U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001. 

SUPPLEMENTARY INFORMATION: 

I. Accessing Information and Submitting 

Comments 

II. Background 

III. Discussion 

IV. Availability of Documents 

V. Section-by-Section Analysis 

VI. Plain Writing 

VII. Voluntary Consensus Standards 

VIII. Environmental Impact: Categorical 

Exclusion 

IX. Paperwork Reduction Act Statement 

X. Regulatory Analysis 

XI. Regulatory Flexibility Certification 

XII. Backfitting and Issue Finality 

I. Accessing Information and 

Submitting Comments 

A. Accessing Information 

Please refer to Docket ID NRC–2009– 

0044 when contacting the NRC about 

the availability of information for this 

proposed rule. You may access 

information related to this proposed 

rule, which the NRC possesses and is 

publicly available, by any of the 

following methods: 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2009–0044. 

• 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. In 

addition, for the convenience of the 

reader, the ADAMS accession numbers 

are provided in a table in the section of 

this document entitled, Availability of 

Documents. 

• 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. 

B. Submitting Comments 

Please include Docket ID NRC–2009– 

0044 in the subject line of your 

comment submission, in order to ensure 

that the NRC is able to make your 

comment submission available to the 

public in this docket. 

The NRC cautions you not to include 

identifying or contact information that 

you do not want to be publicly 

disclosed in your comment submission. 

The NRC will post all comment 

submissions at http:// 

www.regulations.gov as well as enter the 

comment submissions into ADAMS. 

The NRC does not routinely edit 

comment submissions to remove 

identifying or contact information. 

If you are requesting or aggregating 

comments from other persons for 

submission to the NRC, then you should 

inform those persons not to include 

identifying or contact information that 

they do not want to be publicly 

disclosed in their comment submission. 

Your request should state that the NRC 

does not routinely edit comment 

submissions to remove such information 

before making the comment 

submissions available to the public or 

entering the comment submissions into 

ADAMS. 

II. Background 

The NRC’s requirements, policies, and 

practices governing the PRM process 

have remained substantially unchanged 

since their initial issuance in 1979 (44 

FR 61322; October 25, 1979). During the 

past 20 years, the NRC has received an 

average of nine PRMs per year and plans 

its budget and assigns resources based 


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