Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53577 

VHF–FM marine band radio channels 

13 and 16. 

(4) The operator of any vessel within 

or in the immediate vicinity of this 

safety zone shall: 

(i) Stop the vessel immediately upon 

being directed to do so by any 

commissioned, warrant or petty officer 

on board a vessel displaying a Coast 

Guard Ensign, and 

(ii) Proceed as directed by any 

commissioned, warrant or petty officer 

on board a vessel displaying a Coast 

Guard Ensign. 

(c) Definitions. Captain of the Port 

Baltimore means the Commander, Coast 

Guard Sector Baltimore or any Coast 

Guard commissioned, warrant or petty 

officer who has been authorized by the 

Captain of the Port to act on his behalf. 

Designated representative means any 

Coast Guard commissioned, warrant, or 

petty officer who has been authorized 

by the Captain of the Port Baltimore to 

assist in enforcing the safety zone 

described in paragraph (a) of this 

section. 

(d) Enforcement. The U.S. Coast 

Guard may be assisted by Federal, State 

and local agencies in the patrol and 

enforcement of the zone. 

(e) Enforcement periods. This section 

will be enforced from 6 p.m. through 

11 p.m. on September 1, 2010, 

September 21, 2010, October 1, 2010, 

October 9, 2010 and November 18, 2010, 

and if necessary due to inclement 

weather, from 6 p.m. through 11 p.m. on 

November 19, 2010. 

Dated: August 16, 2010. 

Mark P. O’Malley, 

Captain, U.S. Coast Guard, Captain of the 

Port Baltimore. 

[FR Doc. 2010–21781 Filed 8–31–10; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0233; FRL–8841–6] 

Choline hydroxide; 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 

hydroxide (CAS Reg. No. 123–41–1) 

when used as an inert ingredient that 

acts as a neutralizer in food use, acidic, 

preharvest herbicide products. The Dow 

AgroSciences, LLC, has submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of choline 

hydroxide. 

DATES: This regulation is effective 

September 1, 2010. Objections and 

requests for hearings must be received 

on or before November 1, 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–2010–0233. 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: 

Mark Dow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5533; e-mail address: 

dow.mark@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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 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. 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–2010–0233 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 1, 2010. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0233, 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 

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53578 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 

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. Petition for Exemption 

In the Federal Register of May 19, 

2010 (75 FR 28009)(FRL–9153–1), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

0E7686)(75 FR 28012) by Dow 

AgroSciences, LLC, 9330 Zionsville 

Road, Indianapolis, IN, 46268. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of choline 

hydroxide (CAS Reg. No. 123–41–1) 

when used as an inert ingredient (a 

neutralizer) in acidic herbicide 

formulations applied preharvest. That 

notice referenced a summary of the 

petition prepared by Dow AgroSciences, 

the petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the exemption requested to 

pesticide formulations rather than 

herbicide formulations. 

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 polymers 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. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(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 

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 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. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for choline 

hydroxide including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with choline 

hydroxide follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by choline hydroxide as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

No toxicity data are available for 

choline hydroxide. Upon contact with 

water, choline hydroxide is expected to 

dissociate into the cationic form 

(choline) and the anionic form 

(hydroxide ions). Choline hydroxide 

added to an acidic herbicide, forms an 

herbicide-choline salt product which 

will be sold in concentrate form. When 

the concentrate is mixed with water 

prior to application, the salt dissociates 

to the cationic form (choline). Choline 

cation therefore, is the moiety of 

interest. Since no toxicological studies 

are available in the literature, studies on 

choline chloride and other salts were 

used for evaluating the risk from 

exposure to choline hydroxide. 

According to the Organisation for 

Economic Co-operation and 

Development (OECD) due to its caustic 

nature (pH 14), acute toxicity testing of 

choline hydroxide would not be 

appropriate (OECD Guidelines for the 

Testing of Chemicals, Procedure 404 

(2002); OECD Guideline for testing of 

Chemicals, Procedure, 405, 2002). 

Choline hydroxide is known as a skin, 

eye and respiratory irritant. It should be 

noted here that there will be essentially 

no contact with choline hydroxide in an 

end-use product. 

As was discussed above, the hydroxy 

moiety dissociates and essentially 

ceases to exist upon mixing with water 

in preparation for application and in the 

body. The choline cation is what is left 

to be considered. The Agency has 

extensively assessed the effects of 

choline upon human systems and the 

environment. A summary of the 

Agency’s findings are recorded in: Final 

Rule, Choline Chloride; Exemption from 

the Requirement of a Tolerance, EPA– 

HQ–OPP–2008–0671; FRL–8802–4 (75 

FR 760, January 6, 2010). Details of the 

Agency’s assessment are found in: 

Decision Document for Petition Number 

8E7387; Choline Chloride, CAS Reg. No 

67–48–1; Memorandum, D. Sunderland, 

RD/OPP, 16 OCT 2009. 

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 

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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 milligrams/ 

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 (g) for adults. 

Research indicates that many 

individuals are not getting enough 

choline, with daily intake levels far 

below the AI. 

One study in mice evaluated the 

impact of 200 milligram/kilogram/day 

(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-observed-adverse-effect-level 

(NOAEL) for oral and intranasally 

administered choline chloride is ≥ 200 

mg/kg/day. 

A 72–week feeding study was 

conducted in rats administered 500 mg/ 

kg/day of choline chloride; the animals 

were observed for 30 weeks post 

exposure. There were no significant 

differences 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. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL of concern are identified. 

Uncertainty/safety factors are used in 

conjunction with the POD to calculate a 

safe exposure level – generally referred 

to as a population-adjusted dose (PAD) 

or a reference dose (RfD) – and a safe 

margin of exposure (MOE). For nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

No toxicological endpoints have been 

identified in the available toxicological 

database. Considering the low toxicity 

of choline chloride, its natural 

occurrence, the body’s ability to 

synthesize the nutrient, and the 

relatively small amount in the 

formulation, it is not necessary to 

conduct a quantitative risk assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to choline hydroxide, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from choline 

hydroxide in food as follows: 

Choline is a natural component of a 

variety of commonly consumed foods 

(e.g. (per 100 g food) - eggs (251 mg), 

wheat germ (152 mg), bacon (125 mg), 

dried soybeans (116 mg), pork (103 mg), 

cod (83 mg), beef (80 mg), chicken (70 

mg), and salmon (65 mg)) United States 

Department of Agriculture (USDA, 

2004). It has been added as a 

supplement to infant formula in the 

United States for decades (Politizer 

Shronts, 1997). In addition to dietary 

consumption, choline is made 

endogenously in the human body. 

Humans are currently exposed to 

choline 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 preharvest to food commodities, 

will significantly increase the natural 

concentration of choline present in 

foods. 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, it 

will be broken into in a quaternary 

hydroxyl alkylammonium ion and a 

chloride ion. 

2. Dietary exposure from drinking 

water. A quantitative drinking water 

assessment was not performed because 

it is expected that upon contact with 

water choline chloride will be broken 

into a quaternary hydroxyl 

alkylammonium ion and a chloride ion. 

Therefore, direct contact with choline 

hydroxide is not expected through 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Occupational exposure to choline 

chloride is expected via dermal and 

inhalation routes of exposure. Since an 

endpoint for risk assessment was not 

identified, a quantitative occupational 

and residential exposure assessment for 

choline hydroxide was not conducted. 

Residential (dermal and inhalation) 

exposures from home garden uses are 

possible. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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 

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cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found choline hydroxide 

to share a common mechanism of 

toxicity with any other substances, and 

choline hydroxide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that choline hydroxide does 

not 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 EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

There is no evidence of increased 

susceptibility in the available 

developmental toxicity study in mice. 

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, 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 

hydroxide is not expected to cause 

neurotoxicity. Exposure to choline 

hydroxide 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, and the body’s need for 

choline from a dietary source, EPA has 

determined that a quantitative risk 

assessment using safety factors is 

unnecessary. For the same reason, no 

additional safety factor for the 

protection of infants and children is 

needed. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on choline hydroxide, EPA 

has determined that there is a 

reasonable certainty that no harm to any 

population subgroup will result from 

aggregate exposure to choline hydroxide 

under reasonably foreseeable 

circumstances. 

In addition to its low toxicity, 

exposure to choline hydroxide will be 

limited. The expected exposure 

pathway is via the oral and the dermal 

routes. Humans are currently exposed to 

choline 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 

hydroxide, when used as an inert 

ingredient applied preharvest to food 

commodities, will significantly increase 

the natural concentration of choline and 

chloride in foods. Choline is also found 

naturally in the environment. 

Taking into consideration all available 

information on choline hydroxide, 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 establishment of an exemption from 

tolerance under 40 CFR 180.920 for 

residues of choline hydroxide when 

used as an inert ingredient in pesticide 

formulations applied to preharvest 

applications of pesticides, is safe under 

FFDCA section 408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

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. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for choline hydroxide. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for choline 

hydroxide (CAS Reg. No. 123–41–1) 

when used as an inert ingredient (in 

acidic herbicides to act as a neutralizer]) 

in pesticide formulations applied to 

preharvest applications. 

VII. 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 tolerance 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 

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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53581 

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). 

VIII. 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: August 20, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR part 180 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 add alphabetically the 

following inert ingredient to the table to 

read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

Inert ingredients Limits Uses 

* * * * * * * 

Choline hydroxide (CAS Reg No. 123–41–1) Without limitation Neutralizer 

* * * * * * * 

[FR Doc. 2010–21544 Filed 8–31–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0682; FRL–8841–9] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spiromesifen 

in or on leaf petioles subgroup 4B, dry 

pea seed, spearmint tops, and 

peppermint tops. The Interregional 

Research Project Number 4 (IR-4) and 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 1, 2010. Objections and 

requests for hearings must be received 

on or before November 1, 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–2009–0682. 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: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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 those engaged in the 

following activities: 

• 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 to provide 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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 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. 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 

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