760 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0671; FRL–8802–4] 

Choline chloride; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of choline 

chloride (CAS Reg. No. 67–48–1) 

applied pre-harvest on all raw 

agricultural commodities when applied/ 

used as a solvent. Loveland Products, 

Inc., submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), requesting an exemption 

from the requirement of a tolerance. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of choline chloride. 

DATES: This regulation is effective 

January 6, 2010. Objections and requests 

for hearings must be received on or 

before March 8, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0671. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Deirdre Sunderland, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0851; e-mail address: 

sunderland.deirdre@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0671 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before March 8, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0671, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of December 3, 

2008 (73 FR 73648) (FRL–8391–3), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, as amended 

by FQPA (Public Law 104–170), 

announcing the filing of a pesticide 

petition (PP 8E7387 ) by Loveland 

Products, Inc., P.O. Box 1286, Greeley, 

CO 80632–1286. The petition requested 

that 40 CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of choline chloride when used as an 

inert ingredient in pesticide 

formulations applied pre-harvest. That 

notice included a summary of the 

petition prepared by the petitioner. 

There were no comments received in 

response to the notice of filing. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 


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all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene ploymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. The 

nature of the toxic effects caused by 

choline chloride are discussed in this 

unit. The following provides a brief 

summary of the risk assessment and 

conclusions from the Agency’s review of 

choline chloride. The Agency’s full 

decision document for this action is 

available in the Agency’s electronic 

docket (regulations.gov) under the 

docket number EPA–HQ–OPP–2008– 

0671. 

Choline chloride is a quaternary 

ammonium salt which dissociates in 

water resulting in a positively charged 

quaternary hydroxyl alkylammonium 

ion and a negatively charged chloride 

ion. Choline is an essential component 

of the human diet and acts as a 

precursor to acetylcholine, 

phospholipids, and the methyl donor 

betaine. It is important for the structural 

integrity of cell membranes, cholinergic 

neurotransmission, transmembrane 

signaling, methyl metabolism, and lipid 

and cholesterol transport and 

metabolism. 

Choline was officially made an 

‘‘essential nutrient’’ in 1998 and 

adequate intake (AI) levels were 

established (women-425 milligram/day 

(mg/day), pregnant women-450 mg/day, 

men and lactating women-550 mg/day). 

The Daily Upper Intake Level for 

choline is 3.5 grams for adults. Research 

indicates that many individuals are not 

getting enough choline, with daily 

intake levels far below the AI. 

Chloride is a binary compound of 

chlorine; a salt of hydrochloric acid. 

Chloride is the major extracellular anion 

and contributes to many body functions 

including the maintenance of osmotic 

pressure, acid-base balance, muscular 

activity, and the movement of water 

between fluid compartments. The World 

Health Organization has performed two 

assessments which determined that 

from a toxicological point of view, there 

were no concerns for the chloride ion. 

It was considered to be naturallyoccurring and a normal participant of 

animal and human metabolism. 

Choline chloride has demonstrated a 

low acute oral toxicity with LD50 values 

for rats ranging from 3,150 to ≥ 6,000 

milligram/kilogram (mg/kg) and LD50 for 

mice in the range of 3,900 to 6,000 mg/ 

kg. Although appropriate animal studies 

are lacking for acute dermal toxicity, an 

in vitro percutaneous absorption study 

performed under occluded and 

unoccluded conditions showed that 

choline chloride is expected to have a 

low potential for percutaneous 

absorption. Acceptable acute inhalation 

studies are not available. Studies 

conducted in the early 1960’s showed 

only slight transient irritation of the 

skin and eye. 

Repeat dose animal studies on choline 

chloride are limited. One study in mice 

evaluated the impact of 200 mg/kg/day 

choline chloride given orally or 

intranasally for 28 days. No adverse 

effects were observed with regards to 

body weight, food and water 

consumption, hematology, clinical 

biochemistry, or histopathology of 

various organs (lung, heart, liver, 

spleen, and kidney). Results from 

intranasal exposure to choline chloride 

were comparable with their respective 

controls and to other treatment groups. 

The no adverse effects are observed 

(NOAEL) for oral and intranasally 

administered choline chloride is ≥ 200 

mg/kg/day. 

A 72–week feeding study in rats 

administered 500 mg/kg/day of choline 

chloride and observed the animals for 

30 weeks post exposure. There were no 

significant difference between the 

control and treated group in relation to 

body weights, relative liver weight, 

survival rates, and the number of 

neoplastic liver nodules, hepatocellular 

carcinomas, lung tumors, leukemia, or 

other tumors. This study resulted in a 

NOAEL of 500 mg/kg/day (the highest 

dose tested). 

Choline is a precursor to the vital 

neurotransmitter acetylcholine. Studies 

show that choline has beneficial effects 

on the nervous system and memory. 

Choline is necessary to promote proper 

development in the fetus and infant and 

prevent cognitive problems. Choline 

chloride is not expected to cause 

neurotoxicity and it is not a known 

endocrine disruptor nor are its 

metabolites related to any class of 

known endocrine disruptors. Based on 

the results of the in vitro and in vivo 

studies the Agency concluded that 

choline chloride is not expected to be 

carcinogenic or mutagenic. 

Since the 1930’s choline chloride has 

been used as a widespread nutrient in 

animal feed without adverse effects 

reported on fertility or teratogenicity. 

The Food and Drug Administration 

(FDA) requires choline be added to nonmilk based infant formulas at a 

minimum concentration of 7 mg for 

every 100 kilocalories (21 CFR 107.100). 

Although one study did show 

developmental effects, they were only 

seen at very high doses (≥4,160 mg/kg/ 

day) and only in the presence of 

maternal toxicity. There were no 

observed adverse effects for both 

mothers and pups exposed to 1,250 mg/ 

kg/day. Based on this information the 

Agency concluded that choline 

chloride, when used as an inert 

ingredient, will not cause reproductive 

or developmental toxicity and therefore, 

does not anticipate an increased risk to 

infants and children. 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 


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concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Exposure from the use of choline 

chloride is expected through the oral 

route via food and drinking water. 

Exposure via the dermal route may 

occur for those individuals applying the 

product both occupationally and 

residentially. Due to the rapid 

degradation of the chemical and the 

natural presence of choline and chloride 

in the environment, exposure from the 

use of choline chloride as an inert 

ingredient in pesticide products is not 

expected to increase the aggregate 

exposure to all subpopulation including 

infants and children and therefore a 

quantitative exposure assessment has 

not been performed. 

VI. Cumulative Effects 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

choline chloride and any other 

substances, and these chemicals do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

these chemicals have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative/. 

VII. Additional Safety Factor for the 

Protection of Infants and Children. 

Section 408 of FFDCA provides that 

EPA shall apply an additional tenfold 

margin of safety for infants and children 

in the case of threshold effects to 

account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure 

unless EPA determines that a different 

margin of safety will be safe for infants 

and children. EPA concluded that the 

FQPA safety factor for choline chloride 

should be reduced to 1X. 

The database for choline chloride is 

adequate to make a determination of 

safety for infants and children. Choline 

is a natural component of a variety of 

commonly consumed foods. It has been 

added as a supplement to infant formula 

in the United States for decades. In 

addition to dietary consumption of 

choline and chloride, choline is made 

endogenously in the human body. 

Choline is a precursor to the vital 

neurotransmitter acetylcholine. Studies 

show that choline has beneficial effects 

on the nervous system and memory. 

Choline is necessary to promote proper 

development in the fetus and infant and 

prevent cognitive problems. Choline 

chloride is not expected to cause 

neurotoxicity. 

Chloride is also important for many 

biological functions. It helps to maintain 

the fluid balance of cells, proper blood 

volume, blood pressure, and the pH of 

body fluids. The World Health 

Organization has performed two 

assessments which determined that 

from a toxicological point of view, there 

were no concerns for the chloride ion. 

It was considered to be naturallyoccurring and a normal participant of 

animal and human metabolism. 

Choline chloride has been used as a 

widespread nutrient in animal feed 

since the 1930’s without adverse effects 

reported on fertility or teratogenicity. 

Although one study in mice did show 

developmental effects, they were only 

seen at very high doses (≥4,160 mg/kg/ 

day) and only in the presence of 

maternal toxicity. There were no 

observed adverse effects for both 

mothers and pups exposed to 1,250 mg/ 

kg/day. 

Exposure to choline chloride is not 

expected to significantly increase the 

pre-existing levels found in commonly 

eaten foods. Due to the negligible 

anticipated crop residues and 

subsequent exposure, the low toxicity of 

the chemical and its metabolites, the 

bodies need for choline from a dietary 

source, and the beneficial role choline 

plays in fetal development and memory; 

the safety factor has been reduced to 1 

X. 

VIII. Determination of Safety for U.S. 

Population 

In addition to its low toxicity, 

exposure to choline chloride will be 

limited. The expected exposure 

pathway is via the oral and the dermal 

routes. Humans are currently exposed to 

choline and chloride on a daily basis 

through commonly eaten foods (both 

naturally occurring and when added as 

a nutrient) and through the bodies 

natural ability to synthesize the 

nutrient. It is unlikely that the exposure 

from choline chloride, when used as an 

inert ingredient applied pre-harvest to 

food commodities, will significantly 

increase the natural concentration of 

choline and chloride in foods. Choline 

and chloride are also found naturally in 

the environment. Choline chloride is 

readily biodegradable and because of its 

high water solubility it is expected that 

most of the inert will be washed from 

the plant prior to consumption. Once in 

water, its preferred media, it will be 

broken into a quaternary hydroxyl 

alkylammonium ion and a chloride ion. 

Taking into consideration all available 

information on choline chloride, it has 

been determined that there is a 

reasonable certainty that no harm to any 

population subgroup, including infants 

and children, will result from aggregate 

exposure to this chemical. Therefore, 

the exemption from the requirement of 

a tolerance for residues of choline 

chloride (CAS Reg. No. 67–48–1), when 

used as an inert ingredient in preharvest applications, under 40 CFR 

180.920 can be considered safe under 

section 408(q) of the FFDCA. 

IX. Other Considerations 

A. Analytical Method(s) 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 


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B. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for choline 

chloride nor have any CODEX 

Maximum Residue Levels (MRLs) been 

established for any food crops at this 

time. 

X. Conclusions 

Therefore, a tolerance exemption is 

established for choline chloride (CAS 

Reg. No. 67–48–1) when used as inert 

ingredient in pesticide formulations 

applied to growing crops only. 

XI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

XII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 24, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In §180.920, the table is amended 

by adding alphabetically the following 

inert ingredients: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

Inert ingredients Limits Uses 

* * * * * 

Choline chloride (CAS 

Reg. No. 67–48–1) 

------------ 

------ 

As a solvent 

* * * * * 

[FR Doc. E9–31280 Filed 1–5–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0610; FRL–8802–5] 

Dibenzylidene Sorbitol; Exemption 

from the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of dibenzylidene 

sorbitol (CAS Reg. No. 32647–67–9) 

under 40 CFR 180.920 when used as the 

inert ingredient in pesticdes 

formulations applied in or on growing 

crops. Dow Agrosciences LLC submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of dibenzylidene sorbitol. 

DATES: This regulation is effective 

January 6, 2010. Objections and requests 

for hearings must be received on or 

before March 8, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0610. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 


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