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Rules and Regulations Federal Register

46595 

Vol. 76, No. 149 

Wednesday, August 3, 2011 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–TM–07–0136; TM– 

07–14FR] 

RIN 0581–AC77 

National Organic Program (NOP); 

Sunset Review (2011) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule addresses 

recommendations submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB) on November 5, 2009, and April 

29, 2010. The recommendations 

addressed in this final rule pertain to 

the continued exemption (use) of 12 

substances in organic production and 

handling. Consistent with the 

recommendations from the NOSB, this 

final rule continues the exemption (use) 

of 12 substances (along with any 

restrictive annotations) on the U.S. 

Department of Agriculture’s (USDA) 

National List of Allowed and Prohibited 

Substances (National List). 

DATES: Effective Date: This final rule 

becomes effective September 12, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, PhD, 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 et seq., 

authorizes the establishment of the 

National List of Allowed and Prohibited 

Substances (National List). The National 

List identifies synthetic substances that 

may be used in organic production and 

nonsynthetic (natural) substances that 

are prohibited in organic crop and 

livestock production. The National List 

also identifies nonagricultural 

nonsynthetic, nonagricultural synthetic 

and nonorganic agricultural substances 

that may be used in organic handling. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary of Agriculture 

has authority under the 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. This means that 

synthetic substances Hydrogen chloride 

(CAS # 7647–01–0) and Ferric 

phosphate (CAS # 10045–86–0), 

currently allowed for use in organic 

crop production, will no longer be 

allowed for use after the sunset date, 

September 12, 2011. This also means 

that Egg white lysozyme (CAS # 9001– 

63–2), L-Malic acid (CAS # 97–67–6), 

Microorganisms, Activated charcoal 

(CAS #s 7440–44–0; 64365–11–3), 

Cyclohexylamine (CAS # 108–91–8), 

Diethylaminoethanol (CAS # 100–37–8), 

Octadecylamine (CAS # 124–30–1), 

Peracetic acid/Peroxyacetic acid (CAS # 

79–21–0), Sodium acid pyrophosphate 

(CAS # 7758–16–9), and Tetrasodium 

pyrophosphate (CAS # 7722–88–5), 

currently allowed for use in organic 

handling, will no longer be allowed for 

use after the sunset date, September 12, 

2011. 

This final rule reflects 

recommendations submitted to the 

Secretary by the NOSB concerning the 

continued use of 12 substances on the 

National List in organic production and 

handling. Consistent with the 

recommendations from the NOSB, this 

final rule renews 12 exemptions on the 

National List (along with any restrictive 

annotations). 

Under the authority of the OFPA, as 

amended (7 U.S.C. 6501 et seq.), the 

National List can be amended by the 

Secretary based on recommendations 

developed by the NOSB. Since 

established, the NOP has published 

fourteen amendments to the National 

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

November 3, 2003 (68 FR 62215); 

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

2006 (71 FR 32803); September 11, 2006 

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

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

December 10, 2007 (72 FR 69569); 

December 12, 2007 (72 FR 70479); 

September 18, 2008 (73 FR 54057); 

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

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

FR 51919); and December 13, 2010 (75 

FR 77521). Additionally, proposed 

amendments to the National List were 

published on November 8, 2010 (75 FR 

68505), and a final rule affirming a 

previous amendment was published on 

March 14, 2011 (76 FR 13504). 

II. Overview of Renewals 

The following provides an overview 

of the renewals for designated sections 

of the National List regulations: 

Renewals 

This final rule continues the 

exemptions at § 205.601, along with any 

restrictive annotations for the following 

synthetic substances allowed for use in 

organic crop production: Ferric 

phosphate (CAS # 10045–86–0); and 

Hydrogen chloride (CAS # 7647–01–0). 

This final rule continues the exemptions 

at § 205.605(a), along with any 

restrictive annotations, for the following 

nonsynthetic, nonagricultural 

(nonorganic) substances allowed as 

ingredients in or on processed products 

labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food 

groups(s))’’: Egg white lysozyme (CAS # 

9001–63–2); L-Malic acid (CAS # 97– 

67–6); and Microorganisms. This final 

rule continues the exemptions at 

§ 205.605(b), along with any restrictive 

annotations, for the following synthetic, 

nonagricultural (nonorganic) substances 

allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ 

or ‘‘made with organic (specified 

ingredients or food groups(s))’’: 

Activated charcoal (CAS #s 7440–44–0; 

64365–11–3); Cyclohexylamine (CAS # 

108–91–8); Diethylaminoethanol (CAS # 

100–37–8); Octadecylamine (CAS # 

124–30–1); Peracetic acid/Peroxyacetic 

acid (CAS # 79–21–0); Sodium acid 

pyrophosphate (CAS # 7758–16–9); and 

Tetrasodium pyrophosphate (CAS # 

7722–88–5). 

Nonrenewals 

The NOSB determined that a 

continuing need was demonstrated for 

the authorization of the 12 exemptions. 

In addition, most comments received on 

the proposed rule (76 FR 2880) 


srobinson on DSK4SPTVN1PROD with RULES
46596 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 

1U.S. Department of Agriculture, Economic 

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

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. http:// 

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

2U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers: Documentation. 

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

Documentation.htm. 

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

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

Consumers, Economic Information Bulletin No. 58, 

U.S. Department of Agriculture, Economic Research 

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

EIB58. 

supported renewal of all 12 exemptions. 

Accordingly, there are no nonrenewals. 

III. Related Documents 

One advanced notice of proposed 

rulemaking with request for comments 

was published in the Federal Register 

on March 14, 2008 (73 FR 13795), to 

make the public aware that the 

allowance for 12 synthetic and 

nonsynthetic substances in organic 

production and handling will expire, if 

not reviewed by the NOSB and renewed 

by the Secretary. The proposed rule for 

this final rule was published in the 

Federal Register on January 4, 2011 (76 

FR 288). 

IV. Statutory and Regulatory Authority 

The OFPA, as amended (7 U.S.C. 6501 

et seq.), authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 

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

authorize the NOSB to develop 

proposed amendments to the National 

List for submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having substances evaluated 

for inclusion on or deletion from the 

National List. The National List petition 

process is implemented under § 205.607 

of the NOP regulations. The current 

petition process (72 FR 2167, January 

18, 2007) can be accessed through the 

NOP Web site at http:// 

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

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This final rule is not intended to have 

a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 

§ 2115(b) of the OFPA (7 U.S.C. 

6514(b)). States are also preempted 

under §§ 2104 through 2108 of the 

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

from creating certification programs to 

certify organic farms or handling 

operations unless the State programs 

have been submitted to, and approved 

by, the Secretary as meeting the 

requirements of the OFPA. 

Pursuant to § 2108(b)(2) of the OFPA 

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

certification program may contain 

additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to § 2120(f) of the OFPA (7 

U.S.C. 6519(f)), this final rule would not 

alter the authority of the Secretary 

under the Federal Meat Inspection Act 

(21 U.S.C. 601 et seq.), the Poultry 

Products Inspections Act (21 U.S.C. 451 

et seq.), or the Egg Products Inspection 

Act (21 U.S.C. 1031 et seq.), concerning 

meat, poultry, and egg products, nor any 

of the authorities of the Secretary of 

Health and Human Services under the 

Federal Food, Drug and Cosmetic Act 

(21 U.S.C. 301 et seq.), nor the authority 

of the Administrator of EPA under the 

Federal Insecticide, Fungicide and 

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

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

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

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

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 

Pursuant to the requirements set forth 

in the RFA, the 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). The AMS has also 

considered the economic impact of this 

action on small entities. The impact on 

entities affected by this final rule would 

not be significant. The effect of this final 

rule would be to allow the continued 

use of additional substances in 

agricultural production and handling. 

The AMS concludes that the economic 

impact of this addition of allowed 

substances, if any, would be minimal 

and beneficial to small agricultural 

service firms. Accordingly, USDA 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $7,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

According to USDA, Economic 

Research Service (ERS) data based on 

information from USDA-accredited 

certifying agents, the number of certified 

U.S. organic crop and livestock 

operations totaled nearly 13,000 and 

certified organic acreage exceeded 4.8 

million acres in 2008.1 ERS, based upon 

the list of certified operations 

maintained by the NOP, estimated the 

number of certified handling operations 

was 3,225 in 2007.2 AMS believes that 

most of these entities would be 

considered small entities under the 

criteria established by the SBA. 

The U.S. sales of organic food and 

beverages have grown from $3.6 billion 

in 1997 to nearly $21.1 billion in 2008.3

The organic industry is viewed as the 

fastest growing sector of agriculture, 

representing over 3 percent of overall 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 46597 

4Organic Trade Association’s 2011 Organic 

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

food sales in 2009. Between 1990 and 

2008, organic food sales historically 

demonstrated a growth rate between 15 

to 24 percent each year. In 2010, organic 

food sales grew 7.7%.4

In addition, USDA has 94 accredited 

certifying agents who provide 

certification services to producers and 

handlers. A complete list of names and 

addresses of accredited certifying agents 

may be found on the AMS NOP Web 

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

AMS believes that most of these 

accredited certifying agents would be 

considered small entities under the 

criteria established by the SBA. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this final rule. 

Accordingly, OMB clearance is not 

required by § 350(h) of the Paperwork 

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

et seq., or OMB’s implementing 

regulations at 5 CFR part 1320. 

E. Comments Received on Proposed 

Rule AMS–TM–07–0136 

AMS received nine comments on 

proposed rule AMS–TM–07–0136. 

Comments were received from an 

organic producer, trade associations, 

handlers, and private citizens. Most 

comments expressed positions in 

support of the 12 substances considered 

under this sunset review. One 

individual did not refer to subjects 

within the scope of this rulemaking. 

Some commenters specifically 

supported substances that they promote, 

represent, or rely on. A comment 

submitted in support of Ferric 

phosphate emphasized the importance 

of the substance to reduce snail damage 

on organic crops. A comment received 

on Hydrogen chloride voiced that there 

are no good alternatives to the use of the 

substance for removal of residual lint 

from ginned cottonseed, a process 

necessary to facilitate mechanical 

planting. A comment received on Egg 

white lysozyme stated that the 

substance is essential for organic wine 

production. A comment submitted in 

support of L-Malic acid underscored 

that no alternatives exist for this 

substance and stated its importance as 

a processing aid for pH adjustment in 

organic products. Multiple comments 

received on Microorganisms 

emphasized the critical need for 

microorganisms in organic food 

processing for production of dairy, 

bread, fruit, vegetable, and meat 

products. Comments received in 

support of the allowance for Activated 

charcoal confirmed the necessity of this 

substance as a filtering aid in organic 

processing. Comments submitted 

supporting the allowance for the 

substances Cyclohexylamine, 

Diethylaminoethanol, and 

Octadecylamine, all boiler water 

additives, stated that these substances 

are important for packaging 

sterilization. Comments supporting the 

use of Peracetic acid/Peroxyacetic acid 

for sanitizing food contact surfaces 

indicated that there are no alternative 

materials with equivalent functionality. 

One comment submitted in support of 

Sodium acid pyrophosphate stated that 

without the allowance for this substance 

as a leavening agent, many organic 

baked goods would no longer be 

available because a satisfactory 

alternative does not exist. The same 

commenter also emphasized the 

necessity of Tetrasodium pyrophosphate 

in the manufacturing of meat analog 

products to facilitate proper flow in the 

extrusion process and ensure the 

development of suitable product 

texture. Overall, at least one comment 

was received in favor of renewal for all 

12 substances considered under this 

sunset review. 

Changes Requested But Not Made 

One commenter opposed the 

continued use of six of the 12 

substances: Cyclohexylamine, 

Diethylaminoethanol, Octadecylamine, 

Peracetic acid/Peroxyacetic acid, 

Sodium acid pyrophosphate, and 

Tetrasodium pyrophosphate. The 

commenter based their objection on the 

safety of the substances as described in 

the material safety data sheets (MSDS) 

for each substance and recommended 

removal of these substances from the 

National List. However, the NOSB 

reviewed these substances against the 

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

6518 of the OFPA, and found that when 

these substances are used as limited by 

the annotations for each substance, they 

do not pose any danger to the 

environment or to manufacturing 

personnel or consumers. The NOSB 

concluded that these substances remain 

essential to organic production since no 

organic alternatives exist and 

recommended that the exemption for 

these substances on the National List 

continue. The NOP concurs with the 

NOSB’s evaluation and 

recommendation of these substances 

and, therefore, does not find that 

sufficient information was provided by 

the commenter to justify the removal of 

these substances from the National List. 

F. Effective Date 

This final rule reflects 

recommendations submitted to the 

Secretary by the NOSB for the purpose 

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

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

6517(e) requires the NOSB to review 

each substance on the National List 

within 5 years of its publication. The 

substances being reauthorized for use on 

the National List were initially 

authorized for use in organic agriculture 

on September 12, 2006. Because these 

substances are critical to organic 

production and handling operations, 

producers and handlers should be able 

to continue to use these substances for 

a full 5-year period beyond their 

expiration date of September 12, 2011. 

Accordingly, pursuant to 5 U.S.C. 

553, it is found and determined that 

good cause exists for not postponing the 

effective date of this rule until 30 days 

after publication in the Federal 

Register. This rule shall be effective on 

September 12, 2011. 

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. 

The authority citation for 7 CFR part 

205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

Dated: July 28, 2011. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2011–19659 Filed 8–2–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–1307; Directorate 

Identifier 2010–NM–049–AD; Amendment 

39–16671; AD 2011–09–09] 

RIN 2120–AA64 

Airworthiness Directives; Bombardier, 

Inc. Model CL–600–2A12 (CL–601) and 

CL–600–2B16 (CL–601–3A, CL–601– 

3R, and CL–604 Variants) Airplanes 

Correction 

In rule document 2011–17402 

appearing on page 41653–41657, in the 

issue of Friday, July 15, 2011, make the 

following correction: 


srobinson on DSK4SPTVN1PROD with RULES