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

69141 

Vol. 76, No. 216 

Tuesday, November 8, 2011 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–11–0058; 

NOP–11–09PR] 

RIN 0581–AD15 

National Organic Program; Proposed 

Amendments to the National List of 

Allowed and Prohibited Substances 

(Crops, Livestock and Processing) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

amend the U.S. Department of 

Agriculture’s (USDA’s) National List of 

Allowed and Prohibited Substances 

(National List) to reflect 

recommendations submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB) on October 28, 2010, and April 

29, 2011. The recommendations 

addressed in this proposed rule pertain 

to changing the annotation for one 

substance, tetracycline, currently 

allowed for use in organic crop 

production, and adding two substances, 

formic acid and attapulgite, along with 

any restrictive annotations, for use in 

organic livestock production and 

organic processing, respectively. 

DATES: Comments must be received by 

January 9, 2012. 

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–11–0058; NOP–11–09PR, and/or 

Regulatory Information Number (RIN) 

0581–AD15 for this rulemaking. You 

should clearly indicate the topic and 

section number of this proposed rule to 

which your comment refers. You should 

clearly indicate whether you support 

the action being proposed for the 

substances in this proposed rule. You 

should clearly indicate the reason(s) for 

your position. You should also supply 

information on alternative management 

practices, where applicable, that 

support alternatives to the proposed 

action. You should also offer any 

recommended language change(s) that 

would be appropriate to your position. 

Please include relevant information and 

data to support your position (e.g., 

scientific, environmental, 

manufacturing, industry, impact 

information, etc.). Only relevant 

material supporting your position 

should be submitted. All comments 

received will be posted without change 

to http://www.regulations.gov. 

Document: For access to the 

document 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 

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 the synthetic substances that 

may be used and the nonsynthetic 

(natural) substances that may not be 

used in organic production. The 

National List also identifies synthetic, 

nonsynthetic nonagricultural and 

nonorganic agricultural substances that 

may be used in organic handling. The 

Organic Foods Production Act of 1990, 

as amended (7 U.S.C. 6501 et seq.) 

(OFPA), and 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 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); and March 14, 2011 (76 FR 

13501). Additionally, proposed 

amendments to the National List were 

published on November 8, 2010 (75 FR 

68505) and on May 5, 2011 (76 FR 

25612). 

This proposed rule would amend the 

National List to reflect three 

recommendations submitted to the 

Secretary by the NOSB on October 28, 

2010, and April 29, 2011. Based upon 

their evaluation of petitions submitted 

by industry participants and review of 

technical reports, the NOSB 

recommended that the Secretary revise 

the annotation for one substance 

(tetracycline) for organic crop 

production on § 205.601, add one 

substance (formic acid) to § 205.603(b) 

for organic livestock production, and 

add one substance (attapulgite) to 

§ 205.605(a) for organic processing. The 

exemptions for use of each substance in 

organic production were evaluated by 

the NOSB using the criteria specified in 

OFPA (7 U.S.C. 6517–6518). 

II. Overview of Proposed Amendments 

The following provides an overview 

of the proposed amendments to 

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69142 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

1Technical Report on Tetracycline 

(oxytetracycline). April 1, 2011. Available in 

petitioned substances database, under ‘‘T,’’ at the 

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

2NOSB Crops Committee Recommendation on 

Tetracycline. April 2011. Available at the NOP Web 

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

getfile?dDocName=STELPRDC5089511&acct=nosb. 

3Transcript from the April 26–29, 2011 NOSB 

meeting is available under the NOSB section of the 

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

4U.S. Department of Agriculture, National 

Agricultural Statistics Service. 2007 Census of 

Agriculture: Organic Production Survey: Organic 

Fruit and Tree Nuts Harvested from Certified 

Organic Farms, Table 24, 2008. Available at: 

http://www.agcensus.usda.gov/Publications/2007/ 

Online_highlights/Organics/ORGANICS.pdf. 

5The petition was submitted by the Washington 

State Horticultural Association, and is available 

from the NOP Web site in the Petitioned Substances 

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

NOPPetitionedSubstancesDatabase. 

6Summarized from 2010 survey of organic apple 

and pear growers in Washington State: Organic 

Orchards: Needs and Priorities, conducted by David 

Granatstein (WSU–CSANR), Mark LaPierre, WilburEllis Co., and Nadine Lehrer, WSU–TFRC. 

designated sections of the National List 

regulations: 

Section 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

This proposed rule would amend 

§ 205.601 by changing the annotation at 

paragraph (i)(12) to add an expiration 

date and specify the permitted use for 

the following substance: 

Tetracycline. Tetracycline, in the form 

of oxytetracycline calcium complex, 

was included in the National List as 

originally published on December 21, 

2000 (FR 65 80548), for use for fire 

blight control only. 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, the 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. 

Oxytetracyclines are derived from the 

soil bacteria, Streptomyces, by a 

fermentation process. Technical grade 

tetracycline is a pale yellow to tan 

crystalline powder, is freely soluble in 

water, and decomposes above 180 

degrees Celsius. Formulated products 

containing the technical grade 

oxytetracycline calcium complex and 

oxytetracyline hydrochloride for fire 

blight are wettable powders which are 

spray-applied using ground or aircraft 

equipment on foliage at early bloom 

stage, when fire blight infection usually 

occurs. Application may also occur by 

injection into the tree trunks using an 

injection device and an aqueous 

solution of oxytetracycline calcium and/ 

or oxytetracycline hydrochloride. In 

addition to agronomic uses, 

oxytetracyclines are also antibiotics 

used in human and animal drugs to treat 

bacterial diseases.1

On July 6, 2010, AMS published a 

final rule (75 FR 38693), amending the 

listing for tetracycline to allow the use 

of another form of tetracycline, 

oxytetracycline hydrochloride, and 

adding an expiration date of October 21, 

2012, in accordance with the NOSB 

November 2008 recommendation. In 

October 2010, a petition was submitted 

requesting the removal of the October 

21, 2012 expiration date. In effect, the 

petitioner requested an allowance for 

the use of tetracycline to control fire 

blight in apples and pears beyond the 

substance’s current expiration date. 

The NOSB Crops Committee reviewed 

the October 2010 petition to remove the 

expiration date from the current 

tetracycline annotation and initially 

issued a Committee proposal against the 

petitioner’s request. The Committee 

referenced their concerns over antibiotic 

resistance and availability of fire blight 

resistant varieties as alternatives to 

tetracycline use as the basis for their 

proposal.2 This proposal would have, in 

effect, retained the October 21, 2012 

expiration date for tetracycline, after 

which the substance could no longer be 

used in organic crop production. 

At its April 26–29, 2011, meeting in 

Seattle, WA, the NOSB received public 

comment on the Crops Committee’s 

proposal to reject the petitioner’s 

request. During the meeting, the NOSB 

discussed and received comments on 

potential alternatives to tetracycline, the 

challenges with the efficacy and 

adoption of those alternative strategies, 

and the potential impact of not allowing 

tetracycline for fire blight control after 

October 2012. Many commenters 

discussed the scope and availability of 

alternative methods for fire blight 

control including the use of fire blight 

resistant root stocks, biological controls, 

streptomycin, and apple and pear 

varieties that are less susceptible to fire 

blight. Comments from producers and 

researchers informed the NOSB that fire 

blight resistant root stocks and some 

biological controls are not yet 

commercially available.3 These 

commenters also stated that the efficacy 

of commercially available biological 

control products is inconsistent in 

reducing disease incidence, thus 

discouraging producers from using these 

products instead of tetracycline. 

Comments further described widespread 

pathogen resistance to streptomycin in 

certain areas of the country, such as the 

Pacific Northwest, which has decreased 

its effectiveness against fire blight. 

Commenters stated that this resistance 

to streptomycin has prompted some 

producers to use tetracycline as an 

alternative. In addition, the NOSB was 

informed that consumer demand is 

linked to apple and pear varieties which 

are more susceptible to fire blight. 

Growers in Washington State produced 

88% of organic apples and 79% of 

organic pears harvested in the U.S. in 

2008, and cultivars accounting for the 

highest proportion of this production 

are highly or moderately susceptible to 

fire blight.4 5 The petitioner also 

commented that at least 38 of 50 organic 

apple and pear producers surveyed in 

Washington State felt that if the 

exemption for the use of tetracycline 

was allowed to expire on October 21, 

2012, then they would be forced to 

reduce their acreage of susceptible 

varieties or exit the organic apple and 

pear production industry.6

Based upon the public comments, the 

NOSB Crops Committee revised their 

proposal at the April 2011 NOSB 

meeting and recommended extending 

the allowance for the use of tetracycline 

to control fire blight in apples and pears 

until October 21, 2014. The NOSB voted 

on and issued a final recommendation 

in support of this proposal. The NOSB 

concluded that use of tetracycline 

should be permitted to continue through 

October 21, 2014, as options for 

biological controls and resistant 

varieties and rootstocks are further 

developed for commercial use. In their 

recommendation, the NOSB specified 

that the annotation include language to 

convey that the use of tetracycline is 

limited to apples and pears. The 

addition of ‘‘apples and pears’’ in the 

annotation accurately identifies the 

allowed use of this substance in organic 

production and would not change 

current use patterns. 

The NOSB recommendation also 

stated that the Board expects the 

industry to make progress in the 

development of alternatives for fire 

blight control. The NOSB 

recommendation conveyed this 

expectation in stating that, ‘‘members of 

the industry will collaborate and 

coordinate efforts in preparing for the 

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Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 69143 

7NOSB Formal Recommendation on 

Tetracycline. April 29, 2011. Available at the NOP 

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

getfile?dDocName=STELPRDC5091701. 

8May 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. 

9The 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. 

10Hazardous Substances Data Bank (HSDB). 

2010. Formic Acid, CASRN: 64–18–6. Last revised 

4–27–2010. Retrieved February 15, 2011, from 

http://toxnet.nlm.nih.gov. 

11NOAA (CAMEO Chemical), 2011. Formic Acid, 

Retrieved February 15, 2011 from http:// 

cameochemicals.noaa.gov/chemical/3513. 

12Technical Report on Formic acid. June 1, 2011. 

Available in petitioned substances database, under 

‘‘F,’’ at the NOP Web site: www.ams.usda.gov/nop. 

13Tracheal mites lay eggs inside bees’ tracheal 

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

hatch. 

14EPA, 2010. Formic Acid (214900) Fact Sheet, 

Retrieved February 15, 2011, from http:// 

www.epa.gov/oppbppd1/biopesticides/ingredients/ 

factsheets/factsheet_214900.htm. 

15The record contains acknowledgement that the 

Board had requested a Technical Report for formic 

acid. However, this report was not available for 

review by the October 2010 meeting. The NOSB 

stated that, based on the information contained in 

the petition, they concluded that the substance is 

consistent with the OFPA evaluation criteria. 

16Transcripts from the April 26–29, 2011 meeting 

can be retrieved from the NOSB section of the NOP 

Web page. 

eventual removal of this material from 

the National List, specifically 

optimizing the use of resistant 

rootstocks and cultivars, preventive 

management methods, and the use of 

alternative, allowed biological and 

chemical controls whenever 

warranted.’’ 7

In response to the requests by the 

NOSB and the industry for additional 

resources to support research on 

alternatives to tetracycline in organic 

production, the NOP issued requests to 

the USDA Agricultural Research Service 

and the National Institute of Food and 

Agriculture in May of 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.8

The Secretary has reviewed and 

proposes to accept the NOSB’s 

recommendation. This proposed rule 

would amend § 205.601(i)(12) of the 

National List 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 apple and pear crop 

production for fire blight control. 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

This proposed rule would amend 

§ 205.603 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). Formic 

acid was petitioned for use in May 2010, 

as a pesticide for suppression of Varroa 

mites.9 Varroa mites attach themselves 

to the abdomens of bees and extract 

fluids from the circulatory system, 

causing the bees to weaken and die. 

Infestations can quickly destroy a hive 

and spread easily to nearby hives. 

Formic acid is a colorless liquid with a 

pungent odor which is miscible in 

water. This substance is the simplest 

carboxylic acid and is naturally 

occurring in small amounts in some 

insects and plants and is a natural 

component of honey. The 

manufacturing process for formic acid 

begins with the hydrolysis of methyl 

formate. Methanol and carbon 

monoxide are combined along with a 

strong base to produce methyl formate, 

which is then hydrolyzed to produce 

formic acid.10 Formic acid is considered 

corrosive to metals and biological tissue, 

and occupational exposure to these 

fumigant products can cause eye, skin, 

and mucosal irritation.11 This can be 

mitigated by the use of personal 

protective equipment. Fumigant mite 

control products for beehives generally 

consist of a gel pad impregnated with 

formic acid which is contained in a 

sealed plastic pouch. Application 

consists of cutting vents in the pouch 

and setting it in the hive, where it 

releases vapors that diffuse throughout 

the hive. The volatilization of formic 

acid causes mite deaths by asphyxiation 

generally without harm to exposed bees. 

It can also penetrate capped cells and 

sealed brood cells where mites are 

feeding.12

The use of synthetic formic acid is 

regulated by other Federal agencies. 

Formic acid has antibacterial properties 

that make it effective as a preservative, 

and the Food and Drug Administration 

(FDA) permits its use as a food additive 

in the feed and drinking water of 

animals (21 CFR 573.480). FDA also 

permits the use of formic acid as 

flavoring agent in processed foods (21 

CFR 172.515). 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).13 The 

EPA has examined the potential for 

formic acid residues to appear in 

beeswax and honey and concluded that 

residues above those found naturally are 

not expected when a formic acid 

pesticide product is used as directed.14

Synthetic formic acid is currently 

permitted in Canada and the European 

Union for use in organic apiculture to 

control parasitic mites. 

At its October 25–28, 2010, meeting in 

Madison, WI, the NOSB recommended 

adding formic acid to the National List 

for use in organic livestock production 

solely as a pesticide within honeybee 

hives. The NOSB evaluated formic acid 

against the evaluation criteria of 7 

U.S.C. 6517 and 6510 of the OFPA and 

received public comment at this 

meeting.15 During the NOSB 

deliberations, the Board noted that they 

had not received any public comments 

against the addition of formic acid to the 

National List. The NOSB deliberations 

over the petition for this substance 

heavily relied upon the information 

provided by the petitioner. According to 

the formic acid petition, there are 

several methods for controlling mite 

populations in honeybee hives. These 

methods include those that are 

mechanical (e.g. trapping) and 

biochemical such as the use of synthetic 

sucrose octanoate esters (currently listed 

on § 205.603) for control for Varroa 

mites. However, data was provided by 

the petitioner illustrating that the 

allowed biochemical and mechanical 

control methods do not have the same 

efficacy as formic acid in the climatic 

conditions in Hawaii, one of the U.S.’s 

highest-producing organic honey 

regions.16 The information presented by 

the petitioner and considered by the 

NOSB is generally supported by a June 

2011 technical report for formic acid 

that the NOSB Livestock Committee 

accepted as sufficient. 

During their deliberations, the NOSB 

also considered formic acid in the 

context of their final recommendations 

for apiculture standards from 2001 and 

2010 and feedback from the Apiculture 

Working Group. Based upon their 

review of this information, the NOSB 

issued a final recommendation to add 

formic acid to the National List at 

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69144 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

17 Due to the nonsynthetic classification of this 

substance, a petition for use as an additive for 

organic livestock feed is not required. 18The petition was submitted by the Oil-Dri 

Corporation of America, and is retrievable from the 

NOP Web site in the Petitioned Substances 

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

NOPPetitionedSubstancesDatabase. 

19Technical Report on Attapulgite. February 1, 

2010. A copy of this report is available in the 

petitioned substances database, http:// 

www.ams.usda.gov/ 

NOPPetitionedSubstancesDatabase. 

§ 205.603(b) with an annotation that 

would limit the substance’s use to a 

pesticide solely within honeybee hives. 

In their recommendation, the NOSB did 

not limit the use of formic acid only for 

treatment of Varroa mites, which was 

the use specified by the petitioner. 

Since EPA registers formic acid as a 

pesticide to control Varroa and tracheal 

mites, their recommendation and this 

proposed rule would, in effect, allow 

the use of formic acid to control both 

Varroa and tracheal mites in organic 

apiculture. 

At the October 2010 NOSB meeting, 

the NOP and NOSB discussed the 

placement of formic acid on the 

National List. The NOP raised the 

question of whether listing formic acid, 

a miticide, under § 205.603(b) is 

appropriate given that § 205.603(b) 

specifies that substances under this 

section be limited to use as ‘‘a topical 

treatment, external parasiticide 

(emphasis added) or local anesthetic as 

applicable’’. The NOSB explained that 

their research indicated that mites can 

be considered a parasite. The NOSB also 

stated that listing formic acid at 

§ 205.603(b) would be consistent with 

the listing for sucrose octanoate esters, 

another substance in this National List 

section which is approved for use in 

apiculture to control Varroa mites. 

Through this proposed rule, the NOP is 

seeking comments on the placement of 

formic acid on the National List. 

Furthermore, the NOP may reconsider 

the placement of formic acid on the 

National List as part of any future 

rulemaking on organic apiculture 

standards. In the NOP’s consideration of 

the addition of formic acid to the 

National List, the NOP would also like 

to reiterate that registered pesticide 

products intended for use in organic 

production and handling must also be 

evaluated for compliance with EPA’s 

August 2004 list of inert ingredients, 

minus any revoked inert ingredients. 

The Secretary has reviewed and 

proposes to accept the NOSB’s 

recommendation. Consistent with the 

NOSB recommendation, this proposed 

rule would amend § 205.603 of the 

National List by adding formic acid 

(CAS #64–18–6) at paragraph (b)(2) as a 

synthetic substance allowed for use as 

follows: 

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 proposed rule would amend 

§ 205.605(a) of the National List 

regulations by adding the following 

substance: 

Attapulgite. Attapulgite was 

petitioned 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.17 Attapulgite is the product of 

naturally occurring attapulgus clay that 

is mined and subsequently dried and 

pulverized into a fine bluish gray 

powder. Fine particle size and high 

porosity and surface area give 

attapulgite the capacity to absorb and 

adsorb various materials such as 

chlorophyll, metals and other impurities 

to improve the appearance, flavor and 

stability of plant and animal oils. The 

clay is added to heated liquid oil, 

stirred, and filtered out of the oil. 

According to the petitioner, adverse 

effects to human health would not be 

expected from occupational exposure to 

this product through inhalation or 

ingestion when proper protective 

equipment is utilized.18 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 180.910.19

At its April 26–29, 2011, meeting in 

Seattle, WA, the NOSB recommended 

adding attapulgite to the National List 

for use as a processing aid in organic 

handling of plant and animal oils. The 

NOSB did not receive public comments 

against this recommendation. During 

their deliberations, the NOSB noted that 

bentonite, a material already on the 

National List which can serve a similar 

bleaching function as attapulgite, 

requires acid activation. The NOSB 

explained that, though acid activation 

can be used to enhance bleaching 

properties of attapulgite, acid activation 

is not required for the substance to 

function as a processing aid and, 

therefore, may be preferable to the use 

of bentonite. The NOSB did not, 

however, recommend restricting the use 

of attapulgite to non-acid activated 

forms. During this public meeting, the 

NOSB evaluated attapulgite against the 

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

6510 of the OFPA, received public 

comment, and concluded the substance 

is consistent with the OFPA evaluation 

criteria. Based upon the evaluation 

criteria, public comment, and the 

petitioner’s request, the NOSB issued a 

final recommendation to add attapulgite 

to the National List. 

The Secretary has reviewed and 

proposes to accept the NOSB 

recommendation. Consistent with the 

NOSB recommendation, this proposed 

rule would amend § 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. Related Documents 

Two notices were published regarding 

the meetings of the NOSB and 

deliberations on recommendations and 

substances petitioned for amending the 

National List. Substances and 

recommendations included in this 

proposed rule were announced for 

NOSB deliberation in the following 

Federal Register notices: (1) 76 FR 

12013, March 4, 2011, (Attapulgite and 

Tetracycline); (2) 75 FR 57194, 

September 20, 2010, (Formic acid). 

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) 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 

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Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 69145 

20U.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/. 

21 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. 

22Organic Trade Association’s 2011 Organic 

Industry Survey. Available at: http://www.ota.com. 

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/nop. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in 

§ 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 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 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 et seq.) 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 proposed rule 

would not be significant. The effect of 

this proposed rule would be to allow the 

use of additional substances in 

agricultural production and handling. 

This action would relax the regulations 

published in the final rule and would 

provide small entities with more tools to 

use in day-to-day operations. 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. 

Based on USDA data from the 

Economic Research Service (ERS), the 

U.S. organic sector included nearly 

13,000 certified organic crop and 

livestock operations at the end of 2008. 

These operations contained more than 

4.8 million certified acres consisting of 

2,665,382 acres of cropland and 

2,160,577 acres of pasture and 

rangeland. The total acreage under 

organic management represents a twelve 

percent increase from 2007.20 AMS 

believes that most of the certified 

production and handling operations 

would be classified as 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 

2008.21 Between 1990 and 2008, organic 

food sales have historically 

demonstrated a growth rate between 15 

to 24 percent each year. In 2010, organic 

food sales grew 7.7%.22

In addition, USDA has accredited 93 

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 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 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 

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69146 Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Proposed Rules 

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 by the 

NOSB to the Secretary to amend the 

annotation for one substance and to add 

two substances on the National List. A 

60-day period for interested persons to 

comment on this rule is provided and is 

deemed appropriate. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205, Subpart G is 

proposed to be amended as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

2. Section 205.601 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 new 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: November 1, 2011. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2011–28800 Filed 11–7–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Office of Advocacy and Outreach 

7 CFR Part 2502 

RIN 0503–AA49 

Agricultural Career and Employment 

Grants Program; Withdrawal 

AGENCY: Office of Advocacy and 

Outreach, Departmental Management, 

USDA. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: On October 27, 2011, USDA 

submitted a proposed rule concerning 

grants to assist agricultural employers 

and farm workers by improving the 

supply, stability, safety, and training of 

the agricultural labor force. The 

Department intended this document to 

be submitted as an interim rule. 

Therefore, the proposed rule is 

withdrawn. In the Rules and 

Regulations section of this issue of the 

Federal Register, USDA is publishing 

the interim rule. 

DATES: As of November 8, 2011, the 

proposed rule published October 27, 

2011, at 76 FR 66656, is withdrawn. 

FOR FURTHER INFORMATION CONTACT: 

Christine Chavez, Program Leader, 

Farmworker Coordination, Office of 

Advocacy and Outreach, U.S. 

Department of Agriculture, 1400 

Independence Avenue SW., Stop 9801, 

Washington, DC 20250, Voice: (202) 

205–4215, Fax: (202) 720–7136, Email: 

christine.chavez@osec.usda.gov. 

SUPPLEMENTARY INFORMATION: USDA is 

withdrawing its proposed rule of 

October 27, 2011, entitled ‘‘Agricultural 

Career and Employment Grants 

Program,’’ because it was intended to 

publish in the Federal Register as an 

interim rule. This document officially 

withdraws the proposed rule. The 

interim rule can be found in the Rules 

and Regulation section of this issue of 

the Federal Register. 

Signed in Washington, DC, on November 3, 

2011. 

Pearlie Reed, 

Assistant Secretary for Administration for the 

Office of the Secretary. 

[FR Doc. 2011–29033 Filed 11–7–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 319 and 381 

[Docket No. FSIS–2010–0012] 

RIN 0583–AD41 

Common or Usual Name for Raw Meat 

and Poultry Products Containing 

Added Solutions—Reopening of 

Comment Period 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is reopening 

for 60 days the comment period for the 

proposed rule, ‘‘Common or Usual 

Name for Raw Meat and Poultry 

Products Containing Added Solutions.’’ 

It is also providing information 

concerning data used to develop the 

proposed rule and providing examples 

of labels about which FSIS has 

concerns. 

DATES: The comment period for the 

proposed rule published July 27, 2011, 

at 76 FR 44855, is reopened. Submit 

comments by January 9, 2012. 

ADDRESSES: FSIS invites interested 

persons to submit relevant comments on 

the implementation of this proposed 

rule. Comments may be submitted by 

either of the following methods: 

• Federal eRulemaking Portal: This 

Web site provides the ability to type 

short comments directly into the 

comment field on this Web page or 

attach a file for lengthier comments. Go 

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

the online instructions at that site for 

submitting comments. 

• Mail, including floppy disks or CD– 

ROMs, and hand- or courier-delivered 

items: Send to U.S. Department of 

Agriculture (USDA), FSIS, Docket Clerk, 

Patriots Plaza 3, 1400 Independence 

Avenue SW., Room 8–163A, Mailstop 

3782, Washington, DC 20250–3700. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2010–0012. Comments received in 

response to this docket will be made 

available for public inspection and 

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