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contains regulatory documents having general

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Rules and Regulations Federal Register

45903 

Vol. 77, No. 149 

Thursday, August 2, 2012 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–11–0058; 

NOP–11–09FR] 

RIN 0581–AD15 

National Organic Program; 

Amendments to the National List of 

Allowed and Prohibited Substances 

(Crops, Livestock 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 recommendations submitted to 

the Secretary of Agriculture (Secretary) 

by the National Organic Standards 

Board (NOSB) on October 28, 2010, and 

April 29, 2011. This final rule amends 

the annotation for tetracycline for use in 

organic crop production and adds two 

substances: formic acid and attapulgite, 

along with any restrictive annotations, 

for use in organic livestock production 

and organic processing, respectively. 

DATES: Effective Date: This final rule is 

effective August 3, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, 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 §§ 205.600 

through 205.607. This National List 

identifies synthetic substances that may 

be used and nonsynthetic (natural) 

substances that may not be used in 

organic production. The National List 

also identifies nonagricultural synthetic, 

nonsynthetic 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 et 

seq.), and the NOP regulations, in 

§ 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, as 

amended (7 U.S.C. 6501–6522), the 

National List can be amended by the 

Secretary based on recommendations 

developed by the NOSB. Since 

established, the NOP has published 

multiple amendments to the National 

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

November 3, 2003 (68 FR 62215); 

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

2006 (71 FR 32803); September 11, 2006 

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

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

December 10, 2007 (72 FR 69569); 

December 12, 2007 (72 FR 70479); 

September 18, 2008 (73 FR 54057); 

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

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

FR 51919); December 13, 2010 (75 FR 

77521); March 14, 2011 (76 FR 13504); 

August 3, 2011 (76 FR 46595); February 

14, 2012 (77 FR 8089); May 15, 2012 (77 

FR 28472); and June 6, 2012 (77 FR 

33290). Additionally, proposed 

amendments to the National List were 

published on January 12, 2012 (77 FR 

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

5717). 

This final rule amends the National 

List to enact three recommendations 

submitted to the Secretary by the NOSB 

on October 28, 2010, and April 29, 2011. 

One recommendation addressed the 

annotation for tetracycline in organic 

crop production. The other 

recommendations pertained to the 

addition of two substances, formic acid 

for use in organic livestock production 

and attapulgite for use in organic 

handling. 

Tetracycline 

Tetracycline is a broad-spectrum 

antibiotic for control of bacteria, fungi 

and mycoplasma-like organisms which 

functions by inhibiting protein 

synthesis in bacteria and altering 

bacterial membranes so that vital 

genetic material is leaked. For 

regulatory purposes, Environmental 

Protection Agency (EPA) uses the term 

oxytetracycline to refer to pesticides 

containing either calcium 

oxytetracycline or hydroxytetracycline 

monohydrochloride (oxytetracycline 

hydrochloride). Oxytetracycline is 

registered with the EPA for the 

following agronomic uses: fire blight of 

apples, pears, peaches and nectarines; 

pear decline; bacterial spot on peaches 

and nectarines; lethal yellowing of 

coconut palm; and lethal decline of 

pritchardia palm. 

The current listing for tetracycline on 

the National List at § 205.601(i)(12) is as 

follows: 

Tetracycline, for fire blight control 

only and for use only until October 21, 

2012. 

Tetracycline (oxytetracycline calcium 

complex) was added to the National List 

by a final rule published in the Federal 

Register on December 21, 2000 (65 FR 

80548). Since 2000, four notices have 

been published announcing the 

meetings of the NOSB and its planned 

deliberations involving the use of 

tetracycline in organic crop production. 

The four notices were published in the 

Federal Register as follows: (1) 71 FR 

14493, March 22, 2006 (to consider the 

sunset recommendation for the 

continued listing of oxytetracycline 

calcium complex for fire blight control); 

(2) 73 FR 18491, April 4, 2008 (to 

consider a recommendation to add a 

second form of tetracycline, 

oxytetracycline hydrochloride, as plant 

disease control for all diseases on the 

crops registered by EPA); (3) 73 FR 

54781, September 23, 2008 (to consider 

a recommendation to add a second form 

of tetracycline, oxytetracycline 

hydrochloride, for fire blight control 

and to place an expiration date on the 

use of all forms); and (4) 76 FR 12013, 

March 4, 2011 (to consider removal of 

the expiration date of tetracycline for 

fire blight control). The most recent 

final rule pertaining to tetracycline 

added an allowance for the use of 

oxytetracycline hydrochloride, and 

added an expiration date of October 21, 

2012. This rule was published in the 

Federal Register on July 6, 2010 (75 FR 

38693). 


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1The petition was submitted by the Hawaii 

Department of Agriculture, and is retrievable from 

the NOP Web site in the Petitioned Substances 

Database: http://www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

2Tracheal mites lay eggs inside bees’ tracheal 

tubes, and their larvae feed on the bee after the eggs 

hatch. 

3 Due to the nonsynthetic classification of this 

substance, a petition for use as an additive for 

organic livestock feed is not required. 

4Technical Report on Attapulgite. February 1, 

2010. A copy of this report is available in the 

petitioned substances database, http:// 

www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

In October 2010, a petition was 

submitted to the NOSB to remove the 

expiration date for tetracycline. In 

effect, the petitioner requested an 

allowance for the use of tetracycline to 

control fire blight in organic apples and 

pears beyond the substance’s current 

expiration date of October 21, 2012. On 

April 29, 2011, the NOSB issued a 

recommendation to extend the use of 

tetracycline to control fire blight in 

apples and pears only until October 21, 

2014, by a vote of 13 in favor and 1 

against. Consistent with this NOSB 

recommendation, AMS published a 

proposal on November 8, 2011 to amend 

the annotation for tetracycline by 

extending its use for fire blight control 

in apples and pears only until October 

21, 2014 (76 FR 61941). 

Formic Acid 

Formic acid was petitioned for use in 

May 2010, as a pesticide for suppression 

of Varroa mites.1 The Environmental 

Protection Agency (EPA) has exempted 

synthetic formic acid from the 

requirement of a tolerance in or on 

honey and honeycomb when used to 

control tracheal mites and suppress 

Varroa mites in bee colonies, and 

applied in accordance with label use 

directions (40 CFR 180.1178).2

At its October 25–28, 2010, meeting, 

the NOSB recommended adding formic 

acid to the National List for use in 

organic livestock production solely as a 

pesticide within honeybee hives. 

Consistent with this NOSB 

recommendation, AMS published a 

proposal on November 8, 2011 to amend 

§ 205.603(b) of the National List by 

adding formic acid, with a restrictive 

annotation (76 FR 61941). 

Attapulgite 

Attapulgite was petitioned in May 

2009 for two uses: (1) as a nonsynthetic 

processing aid in organic handling for 

purifying vegetable and animal oils; and 

(2) as a livestock feed additive.3 The 

FDA has listed this substance in the 

database, ‘‘Everything Added to Food in 

the United States (EAFUS) (Doc. No. 

1943)’’ and references this substance 

among those generally regarded as safe 

in 21 CFR Part 582.99 when used as an 

adjuvant for pesticide chemicals. The 

EPA permits attapulgite as an inert 

ingredient eligible in minimum risk 

pesticides applied for food and nonfood uses which are exempt from 

federal registration under Section 25(b) 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA). The EPA 

has determined that attapulgite is 

exempt from the requirement of a 

tolerance when used as an inert 

ingredient in pesticide formulations 

applied pre- and post-harvest per 40 

CFR 180.910.4

At its April 26–29, 2011, meeting, the 

NOSB recommended adding attapulgite 

to the National List for use as a 

processing aid in organic handling of 

plant and animal oils. Consistent with 

this NOSB recommendation, AMS 

published a proposal on November 8, 

2011, to amend § 205.605(b) the 

National List by adding attapulgite, with 

a restrictive annotation (76 FR 61941). 

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 

§ 205.601(i)(12) of the National List 

regulations by: (1) Inserting the 

qualifying words ‘‘in apples and pears’’; 

between the words ‘‘control’’ and 

‘‘only,’’ in the current annotation and 

(2) replacing the current expiration date 

of ‘‘October 21, 2012’’ with the new 

expiration date, ‘‘October 21, 2014’’, 

after which tetracycline may not be used 

in organic crop production. 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

This final rule amends § 205.603 of 

the National List regulations by 

redesignating current paragraphs (b)(2) 

through (b)(7) as paragraphs (b)(3) 

through (b)(8) for the purpose of adding 

the following substance as an external 

parasiticide at (b)(2): 

Formic acid (CAS #64–18–6)—for use 

as a pesticide solely within honeybee 

hives. 

Section 205.605 Nonagricultural 

(Nonorganic) Substances Allowed as 

Ingredients in or on Processed Products 

Labeled as ‘‘Organic’’ or ‘‘Made With 

Organic (Specified Ingredients or Food 

Group(s))’’ 

This final rule amends § 205.605(a) of 

the National List by adding attapulgite 

as follows: 

Attapulgite—as a processing aid in 

the handling of plant and animal oils. 

III. 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 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/nop. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This 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 sections 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 


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5U.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/. 

6 Kirby, Elizabeth, and David Granatstein. Status 

of Organic Tree Fruit in Washington State—2009, 

Washington State University, March 2010. 

7U.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. 

8Organic Trade Association. 2011. Organic 

Industry Survey. www.ota.com. 

9NOSB’s Principles of Organic Production and 

Handling, Adopted October 17, 2001. http:// 

Continued 

requirements for the production and 

handling of organically produced 

agricultural products that are produced 

in the State and for the certification of 

organic farm and handling operations 

located within the State under certain 

circumstances. Such additional 

requirements must: (a) Further the 

purposes of the OFPA, (b) not be 

inconsistent with the OFPA, (c) not be 

discriminatory toward agricultural 

commodities organically produced in 

other States, and (d) not be effective 

until approved by the Secretary. 

Pursuant to the OFPA (7 U.S.C. 

6519(f)), this final rule would not alter 

the authority of the Secretary under the 

Federal Meat Inspection Act (21 U.S.C. 

601–624), the Poultry Products 

Inspection Act (21 U.S.C. 451–471), or 

the Egg Products Inspection Act (21 

U.S.C. 1031–1056), concerning meat, 

poultry, and egg products, nor any of 

the authorities of the Secretary of Health 

and Human Services under the Federal 

Food, Drug and Cosmetic Act (21 U.S.C. 

301–399), nor the authority of the 

Administrator of the EPA 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 

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 Agricultural Marketing 

Service (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 final rule would not be 

significant. The effect of this final rule 

would be to allow the use of additional 

substances in agricultural production 

and handling. This action would modify 

the regulations published in the final 

rule and would provide small entities 

with more tools to use in day-to-day 

operations. 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, 

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 NOP’s Accreditation and 

International Activities Division, the 

number of certified U.S. organic crop 

and livestock operations totaled over 

17,000 in 2010. According to USDA, 

Economic Research Service (ERS) data 

based on information from USDAaccredited certifying agents, certified 

organic acreage exceeded 4.8 million 

acres in 2008.5 In 2009, U.S. certified 

organic apple acreage exceeded 21,000 

acres, primarily concentrated in 

Washington and California.6 ERS, based 

upon the list of certified operations 

maintained by the NOP, estimated the 

number of certified handling operations 

was 3,225 in 2007.7 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 

beverages have grown from $1 billion in 

1990 to $26.7 billion in 2010. Sales in 

2010 represented 7.7 percent growth 

over 2009 sales.8 The USDA has 93 

accredited certifying agents who 

provide certification services to 

producers and handlers under the NOP. 

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 proposed 

rule. Accordingly, OMB clearance is not 

required by the Paperwork Reduction 

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

E. Executive Order 13175 

This final rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this regulation will not have substantial 

and direct effects on Tribal governments 

and will not have significant Tribal 

implications. 

F. Comments Received on Proposed 

Rule NOP–11–09 

AMS received 25 comments on 

proposed rule AMS–11–0058; NOP–11– 

09PR. Comments were received from 

organic crop producers, crop 

distributors, consumers, accredited 

certifying agents, trade associations, 

non-profit organizations, growers 

associations, advocacy groups and an 

industry working group. 

Twenty one of the comments 

submitted addressed tetracycline. 

Seventeen comments supported a 

continued allowance for tetracycline in 

organic crop production after its current 

expiration date of October 21, 2012. 

Two commenters opposed any use of 

tetracycline in organic crop production, 

and asserted that antibiotic use is 

contrary to organic principles. These 

two comments concurred with the 

NOSB’s concerns over engendering 

antibiotic resistance and supported the 

eventual prohibition of all antibiotic 

use, including that for tetracycline, in 

organic crop production. One 

commenter specifically supported the 

2014 expiration date on the grounds that 

current research efforts are too heavily 

focused on antibiotic product 

replacement instead of on the NOSB’s 

principle of achieving agro-ecosystems 

that are ecologically, socially, and 

economically sustainable.9 The same 


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

getfile?dDocName=STELDEV3013893. 

10Streptomycin is currently listed at § 205.601 of 

the National List for fire blight control in organic 

apple and pear production. This allowance on the 

National List expires on October 21, 2014. 

11May 2011 Letters submitted by NOP to USDA 

ARS and NIFA on fire blight research. Available at 

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

AMSv1.0/getfile?dDocName=STELPRDC5091325. 12 January 2012 OREI Request for Proposals. 

National Institute of Food and Agriculture. 

commenter stated that, in the absence of 

alternative materials that could meet 

organic standards, organic consumers 

would support the planting of existing 

varieties that are more resistant to fire 

blight than those varieties favored by 

the conventional market. 

One commenter expressed support for 

the use of formic acid as a pesticide in 

bee hives, stating that the substance is 

a safe and effective treatment that is 

easy to apply. The commenter also 

conveyed that an allowance for this use 

of formic acid under the NOP 

regulations would be consistent with 

other international organic standards. In 

the proposed rule on November 8, 2011 

(76 FR 61941), AMS specifically sought 

comments on the appropriate placement 

of formic acid on § 205.603 of the 

National List. No comments were 

received addressing this topic, therefore 

the proposal to list formic acid at 

§ 205.603(b) of the National List is 

retained in this final rule. No comments 

were received regarding attapulgite. 

Two comments stated their general 

opposition to the allowance of 

synthetics in organic production and 

handling, and two comments submitted 

statements unrelated to the proposed 

rulemaking action. 

Changes Requested But Not Made 

Many comments supportive of 

continuing the allowance for 

tetracycline recommended that the 

substance be listed without an 

expiration date. Such an action would, 

in effect, extend the allowance for the 

substance until October 2017 under the 

five year sunset review process for the 

National List. These commenters believe 

that more alternatives to tetracycline 

could be available to organic producers 

by 2017. These comments further stated 

that an October 21, 2014 expiration date 

for tetracycline will not provide a 

sufficient timeframe for development 

and implementation of suitable 

alternatives. These commenters 

described the following as specific 

concerns with the expiration of 

tetracycline from the National List: (1) 

An increase in streptomycin resistance 

by the pathogen, which will further 

limit the ability of producers to control 

fire blight;10 (2) consumer preference for 

apple and pear varieties which are more 

susceptible to fire blight; and (3) the 

lack of fire blight resistant root stocks 

and effective biological controls. Many 

of these comments stated that the 

expiration of tetracycline in 2014 could 

result in a reduced volume of U.S. 

organic apples and pears. Some 

commenters cited the potential costs to 

organic apple and pear growers (e.g. cost 

to replant trees, reduced productivity in 

existing trees) and organic handlers (e.g. 

constrained domestic supply of organic 

apples and pears) following the 

expiration of tetracycline from the 

National List in 2014. The commenters 

suggested that the slow development 

and limited availability of alternatives 

to control fire blight control in organic 

orchards could also trigger conversion 

to conventional production. 

Several commenters expressed their 

preference that tetracycline be allowed 

beyond 2014 (e.g. until 2015, 2016, or 

2017) to allow the industry time to 

develop more alternatives to this 

substance. Listing tetracycline with a 

later date or without an expiration date 

would not meet the intent of the NOSB 

to phase out the use of this substance in 

organic apple and pear production over 

time. Therefore, consistent with the 

NOSB recommendation, AMS is 

codifying the October 21, 2014 

expiration date to the listing for 

tetracycline through this final rule. AMS 

notes that extending the allowance for 

the use of tetracycline after the October 

21, 2014, expiration date would require 

a petition to the NOSB. This process can 

be initiated in accordance with the 

Notice of Guidelines on Procedures for 

Submitting National List Petitions (72 

FR 2167). 

Some commenters also stated that 

allowing the substance to expire on 

October 21, 2014 would have a negative 

economic impact on small businesses 

and that this rulemaking action should 

therefore be classified as ‘‘significant’’. 

AMS disagrees. This action does not 

further restrict the use of this substance. 

This action extends the allowance for 

the substance in organic crop 

production for an additional two years 

after its current expiration date of 

October 21, 2012. Parties interested in 

requesting an extension for the 

authorized use of tetracycline in organic 

crop production after October 21, 2014 

may submit a petition to the NOSB. The 

petition process is outlined in 72 FR 

2167 (January 18, 2007). 

Based on the public comments 

received, commenters remain concerned 

regarding the availability and efficacy of 

alternatives to tetracycline for fire blight 

control. Several commenters specifically 

requested that the NOSB reconsider the 

October 21, 2014 expiration date for 

tetracycline. Further, commenters asked 

that the NOP and the NOSB develop a 

phase-out plan for the use of antibiotics 

in fruit trees that has benchmarks and 

timelines based on consultations with 

appropriate stakeholders to ensure that 

the methods proposed to reach them are 

feasible. The NOSB recommended that 

tetracycline is allowed for fire blight 

control in apples and pears through 

October 21, 2014. Parties interested in 

requesting an extension for the 

authorized use of tetracycline in organic 

crop production after October 21, 2014 

may submit a petition to the NOSB. 

Parties interested in having the NOSB 

develop a phase-out plan for the use of 

antibiotics in tree fruit production may 

submit public comments to the NOSB at 

any of their public meetings. The public 

comment process is outlined on the 

NOP Web site. 

Commenters also requested that the 

NOP establish a Fire Blight Task Force 

to assist in development of alternatives. 

After the NOSB issued their 

recommendation on tetracycline in 

April 2011, stakeholders from the 

research community and organic tree 

fruit industry established a working 

group to consolidate efforts and develop 

alternatives to tetracycline for fire blight 

control. This working group is expected 

to provide updates to the public on their 

progress at future NOSB meetings. 

Furthermore, in response to the requests 

by the NOSB and to comments from the 

public for additional resources to 

support research on alternatives to 

tetracycline in organic production, AMS 

submitted requests to the USDA 

Agricultural Research Service (ARS) and 

the National Institute of Food and 

Agriculture (NIFA) in May 2011 for 

assistance in prioritizing research in the 

following areas: (1) The efficacy of 

combinations of substances for fire 

blight management; (2) breeding, 

production, and propagation of resistant 

cultivars and rootstocks that are 

commercially viable; and (3) cultural 

practices, crop management, disease 

forecasting and other production 

practices that can optimize control of 

this disease.11 In fiscal year 2011, NIFA 

funded a project through the Organic 

Agriculture Research and Extension 

Initiative (OREI) for research on the 

development of non-antibiotic 

treatments for the control of fire blight 

in organic apple and pear crops. In 

January 2012, NIFA included a targeted 

request for additional research 

proposals on alternatives to the use of 

tetracycline for fire blight control in 

organic production as part of their 

solicitation for proposals under OREI.12


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Available online at: http://www.nifa.usda.gov/ 

funding/rfas/pdfs/12_orei.pdf. 

1The Dodd-Frank Act, Public Law 111–203, 124 

Stat. 1376, was signed into law on July 21, 2010. 

AMS will continue to seek assistance 

across USDA as appropriate on this 

issue. 

A few commenters requested that the 

NOP address concerns with the current 

use of antibiotics in organic tree fruit 

production through ensuring 

compliance with § 205.206(a)(3). 

Section 205.206(a) requires producers to 

use management practices to prevent 

disease through crop rotation, sanitation 

measures and cultural practices. Section 

205.206(a)(3) lists specific cultural 

practices that enhance crop health, 

including selection of plant species and 

varieties with regard to suitability to 

site-specific conditions and resistance to 

prevalent pests, weeds, and diseases. 

Certifying agents are responsible for 

ensuring that all organic producers use 

management practices to prevent 

disease. Certifying agents verify that 

organic producers are meeting all USDA 

organic requirements including utilizing 

preventative management practices to 

prevent disease. 

These same commenters also stated 

that, as part of a strategy for addressing 

fire blight in organic apple and pear 

production, the NOP should consider 

variances under § 205.290 to allow 

antibiotic use in instances when fire 

blight disease puts orchards at risk. 

Temporary variances for the use of a 

synthetic substance that is not on the 

National List (i.e. use of tetracycline 

after October 21, 2014) cannot be 

granted per the current requirements at 

§ 205.290(e). 

F. Effective Date 

This final rule reflects 

recommendations submitted to the 

Secretary by the NOSB. The amendment 

to the listing of one exempted substance 

and the addition of two substances to 

the National List were based on 

petitions from the industry and 

evaluated by the NOSB using criteria in 

OFPA and the NOP regulations. Because 

the amendments have been subject to 

extensive discussion and public 

comment and are considered vital to 

organic crops, processing and livestock 

production, AMS believes that 

producers and handlers should be able 

to use them on their operations as soon 

as possible. Furthermore, tetracycline is 

due to expire from the National List on 

October 21, 2012; this action must be 

finalized by October 21, 2012, to ensure 

that organic apple and pear producers 

have access to this substance for two 

additional years beyond its current 

expiration date. Accordingly, AMS finds 

that good cause exists under 5 U.S.C. 

553(d)(3) for not postponing the 

effective date of this rule until 30 days 

after publication in the Federal 

Register. 

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. 

■ 2. Section 205.601 paragraph (i)(12) is 

revised to read as follows: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

* * * * * 

(i) * * * 

(12) Tetracycline, for fire blight 

control in apples and pears only until 

October 21, 2014. 

* * * * * 

■ 3. Section 205.603 is amended by: 

■ A. Redesignating paragraphs (b)(2) 

through (b)(7) as paragraphs (b)(3) 

through (b)(8); and 

■ B. Adding paragraph (b)(2) to read as 

follows: 

§ 205.603 Synthetic substances allowed 

for use in organic livestock production. 

* * * * * 

(b) * * * 

(2) Formic acid (CAS # 64–18–6)—for 

use as a pesticide solely within 

honeybee hives. 

* * * * * 

■ 4. In § 205.605(a), the substance 

‘‘Attapulgite’’ is added in alphabetical 

order 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 groups(s)).’’ 

* * * * * 

(a) * * * 

Attapulgite—as a processing aid in 

the handling of plant and animal oils. 

* * * * * 

Dated: July 27, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–18819 Filed 8–1–12; 8:45 am] 

BILLING CODE 3410–02–P 

FEDERAL RESERVE SYSTEM 

12 CFR Part 234 

[Regulation HH; Docket No. R–1412] 

RIN 7100–AD 71 

Financial Market Utilities 

AGENCY: Board of Governors of the 

Federal Reserve System. 

ACTION: Final rule. 

SUMMARY: The Board is publishing a 

final rule, Regulation HH, Designated 

Financial Market Utilities. This rule 

implements provisions of sections 

805(a) and 806(e) of the Dodd-Frank 

Wall Street Reform and Consumer 

Protection Act (‘‘Dodd-Frank Act’’ or 

‘‘Act’’), including risk-management 

standards for financial market utilities 

(‘‘FMUs’’) that are designated as 

systemically important by the Financial 

Stability Oversight Council (the 

‘‘Council’’) and standards for 

determining when a designated FMU is 

required to provide advance notice of 

proposed changes to its rules, 

procedures, or operations that could 

materially affect the nature or level of 

risks presented by the designated FMU. 

DATES: This final rule is effective 

September 14, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer A. Lucier, Assistant Director 

(202) 872–7581 or Kathy C. Wang, 

Senior Financial Services Analyst (202) 

872–4991, Division of Reserve Bank 

Operations and Payment Systems; 

Christopher W. Clubb, Senior Counsel 

(202) 452–3904 or Kara L. Handzlik, 

Senior Attorney (202) 452–3852, Legal 

Division; for users of 

Telecommunications Device for the Deaf 

(TDD) only, contact (202) 263–4869. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Title VIII of the Dodd-Frank Act, 

titled the ‘‘Payment, Clearing, and 

Settlement Supervision Act of 2010,’’ 

was enacted to mitigate systemic risk in 

the financial system and to promote 

financial stability, in part, through 

enhanced supervision of designated 

FMUs.1 Section 803 of the Dodd-Frank 


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