Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 763 

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 


cprice-sewell on DSK2BSOYB1PROD with RULES
764 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@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 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–2009–0610 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–2009–0610, 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 September 

4, 2009 (71 FR 45848) (FRL–8434–4), 

EPA issued a notice pursuant to section 

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

announcing the filing of a pesticide 

petition (PP 9E7581) by Dow 

Agrosciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268–1054. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of dibenzylidene 

sorbitol. That notice included a 

summary of the petition prepared by the 

petitioner. No substantive comments 

were 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 

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 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. 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 


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Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 765 

nature of the toxic effects caused by 

dibenzylidene sorbitol (DBS) are 

discussed in this unit. 

Some of the toxicological studies 

available in the database were 

conducted with Millad® 3905. Millad® 

3905 is a tradename for the inert 

ingredient DBS and contains a 

minimum of 96% DBS. 

DBS is not expected to pose a hazard 

when used for its proposed use pattern. 

A skin sensitization study in guinea pigs 

determined that DBS is not a sensitizer. 

A primary dermal irritation study in rats 

determined that DBS is not irritating. 

The combined LD50 of DBS in an acute 

oral toxicity study in mice was 12,800 

mg/kg/day. The dermal LD50 in mice 

(males only) was 6400 mg/kg/day. 

In a 90–day subchronic oral toxicity 

study in mice and rats, the no-observedadverse-effect-level (NOAEL) was 

determined to be 3200 mg/kg/day for 

mice and 2000 mg/kg/day for rats. No 

treatment-related clinical signs of 

toxicity or systemic toxicity were noted 

during the 90–day test period at the 

highest dose tested. In a separate 13– 

week oral toxicity with recovery phase 

assessment study in rats there were no 

significant treatment-related effects 

noted and the NOAEL was determined 

to be 20,000 parts per million (ppm) 

(1261.3 mg/kg/day for males and 1479.2 

mg/kg/day for females). In a 90–day 

subchronic oral toxicity study in dogs 

the NOAEL was determined to be 92.1 

mg/kg/day for males and 91.5 mg/kg/ 

day for females. No evidence of 

systemic toxicity was observed at doses 

as high as 2500 ppm (92.1 and 91.5 mg/ 

kg/day in males and females, 

respectively; the highest dose tested). 

In a mammalian cell gene mutation 

assay at the TK locus, mouse lymphoma 

L5178Y cells cultured in vitro were 

exposed to Millad® 3905. The study 

concluded that Millad® 3905 was 

negative in the in vitro mammalian cells 

in culture gene mutation assay in mouse 

lymphoma L5178Y cells, both with and 

without S9-mix under the conditions of 

testing. 

In a mouse bone marrow 

micronucleus assay mice were treated 

orally by gavage with Millad® 3905. 

There were no signs of toxicity during 

the study and the test substance is 

considered negative in the mouse bone 

marrow micronucleus test. 

In a reverse gene mutation assay in 

bacteria of S. typhimurium were 

exposed to Millad® 3905. It was 

negative for mutagenicity both in the 

presence and absence of metabolic 

activations. 

Based on the results from these 

studies, EPA concluded that DBS is not 

likely to be genotoxic. No 

carcinogenicity studies are available on 

DBS. Based on the lack of any systemic 

toxicity at high doses in rats and mice 

in a 90–day study and the lack of 

mutagenicity, EPA concluded that DBS 

is not likely to be carcinogenic. It is also 

likely that DBS will metabolized into 

sorbitol and benzaldehyde in the body. 

Sorbitol is a natural constituent and is 

considered non-carcinogenic and 

benzaldehyde has been shown to be 

non-carcinogenic in rats at doses up to 

400 mg/kg/day. (Bishop, 1990) 

No neurotoxicity studies are available 

on DBS, however, there were no clinical 

signs of neurotoxicity were observed in 

the database. 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

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. 

The primary route of exposure to DBS 

from its use as an inert ingredient in 

pesticide products would most likely be 

through consumption of food to which 

pesticide products containing it have 

been applied, and possibly through 

drinking water (from runoff). 

In addition to pesticide use, DBS has 

reported uses in personal care products, 

such as antiperspirants, shampoos, 

conditioners, and moisturizers. There is 

a potential exposure via dermal and 

inhalation routes based on its use 

pattern in personal care products. 

No hazard was identified for the acute 

and chronic dietary assessment (food 

and drinking water), or for the short, 

intermediate, and long term residential 

assessments, and therefore no aggregate 

risk assessments were performed. 

VI. Cumulative Effects 

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

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 pesticide ingredients for 

which EPA has followed as cumulative 

risk approach based on a common 

mechanism of toxicity, EPA has not 

made a common mechanism of toxicity 

finding as to DBS and any other 

substances and, DBS does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that DBS has 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 the FFDCA provides 

that EPA shall apply an additional 

tenfold (10X) 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. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X or uses a different 

additional safety factor when reliable 

data to EPA supports the choice of a 

different factor. The toxicity database is 

sufficient for DBS and potential 

exposure is adequately characterized 

given the low toxicity of the chemical. 

In terms of hazard, there are low 

concerns and no residual uncertainties 

regarding prenatal and/or postnatal 

toxicity. DBS has low subchronic 


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

toxicity. Although no developmental or 

reproductive studies, per se, were 

identified, subchronic 90–day studies in 

dogs, rats and mice have not 

demonstrated any systemic toxicity or 

effects on the reproductive organs. No 

acute or subchronic neurotoxicity 

studies are available, but there were no 

signs of neurological effects observed in 

the database at high doses. Therefore, 

the Agency concluded that the 

developmental neurotoxicity study is 

not required. No immunotoxicity study 

is available, however, no systemic 

toxicity was observed in mice, rats and 

dogs at high doses. In addition, no 

hazard has been identified following 

exposure to DBS. Based on this 

information, there is no concern at this 

time for increased sensitivity to infants 

and children to DBS when used as an 

inert ingredient in pesticide 

formulations and a safety factor analysis 

has not been used to assess risk. For the 

same reason, EPA has determined that 

an additional safety factor is not needed 

to protect the safety of infants and 

children. 

VIII. Determination of Safety 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be 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. 

Residues of concern are not 

anticipated for dietary exposure (food 

and drinking water) or for residential 

exposure from the use of DBS for the 

proposed use pattern as an inert 

ingredient in pesticide products. As 

discussed elsewhere, EPA expects 

aggregate exposure to DBS to pose no 

appreciable dietary risk given that the 

data on DBS show a lack of any 

systemic toxicity at high doses in mice 

and rats. 

Taking into consideration all available 

information on DBS, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to DBS. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.920 for residues of DBS when used 

as an inert ingredient in pesticide 

formulations applied pre-harvest can be 

considered safe under section 408 of the 

FFDCA. Dow Agrosciences submitted a 

petition (#9E7581) proposing to 

establish an exemption from the 

requirement of a tolerance under 40 CFR 

180.920 (pre-harvest only) for residues 

of DBS when used as a pesticide inert 

ingredient, limited to herbicide use only 

with a 3% formulation cap. Based upon 

review of the data supporting the 

petition, EPA has modified the 

requested exemption. No limitations are 

necessary because no hazard was 

identified. 

IX. Other Considerations 

A. Endocrine Disruptors 

EPA is required under the Federal 

Food, Drug and Cosmetic Act (FFDCA), 

as amended by FQPA, to develop a 

screening program to determine whether 

certain substances (including all 

pesticide active and other ingredients) 

‘‘may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen, or other 

such endocrine effects as the 

Administrator may designate.’’ 

Following recommendations of its 

Endocrine Disruptor and Testing 

Advisory Committee (EDSTAC), EPA 

determined that there was a scientific 

basis for including, as part of the 

program, the androgen and thyroid 

hormone systems, in addition to the 

estrogen hormone system. EPA also 

adopted EDSTAC’s recommendation 

that the Program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority to require the 

wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). 

When additional appropriate 

screening and/or testing protocols being 

considered under the Agency’s EDSP 

have been developed, DBS may be 

subjected to further screening and/or 

testing to better characterize effects 

related to endocrine disruption. 

B. 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. 

X. Conclusions 

Based on the information in this 

preamble, EPA concludes that there is a 

reasonable certainty of no harm from 

aggregate exposure to residues of 

dibenzylidene sorbitol. Accordingly, 

EPA finds that exempting dibenzylidene 

sorbitol from the requirement of a 

tolerance will be safe. 

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 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 


cprice-sewell on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 767 

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 ingredient to read as follows: 

§ 180.920 Inert Ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

dibenzylidene sorbitol 

(32647-67-9) 

Thinning 

agent 

* * * * * 

[FR Doc. E9–31281 Filed 1–5–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0824; FRL–8801–9] 

Extension of Tolerances for 

Emergency Exemptions (Multiple 

Chemicals) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation extends timelimited tolerances for the pesticides 

listed in Unit II. of the SUPPLEMENTARY

INFORMATION. These actions are in 

response to EPA’s granting of emergency 

exemptions under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of these pesticides. Section 408(l)(6) 

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA) requires EPA to establish 

a time-limited tolerance or exemption 

from the requirement for a tolerance for 

pesticide chemical residues in food that 

will result from the use of a pesticide 

under an emergency exemption granted 

by EPA. 

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–2009–0824. 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: See 

the table in this unit for the name of a 

specific contact person. The following 

information applies to all contact 

persons: Emergency Response Team, 

Registration Division (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

Pesticide/CFR Citation Contact Person 

Bifenthrin — § 180.442 Andrea Conrath 

conrath.andrea@epa.gov 

(703) 308–9356 

Avermectin — § 180.449 Andrew Ertman 

ertman.andrew@epa.gov 

(703) 308–9367 


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