8500 Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: January 21, 2010. 

Walter W. Kovalick Jr., 

Acting Regional Administrator, Region 5. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart K—Ohio 

■ 2. Section 52.1870 is amended by 

adding paragraph (c)(145) to read as 

follows: 

§ 52.1870 Identification of plan. 

* * * * * 

(c) * * * 

(145) On September 14, 2004, Ohio 

submitted modifications to its 

Prevention of Significant Deterioration 

and nonattainment New Source Review 

rules as a revision to the State 

implementation plan. 

(i) Incorporation by reference. 

(A) Ohio Administrative Code Rule 

3745–31–01, Definitions: (C), (D), (E), 

(J), (M), (N), (O), (P), (Q), (S), (T), (U), 

(V), (W), (X), (DD), (EE), (FF), (GG), (JJ), 

(MM), (NN), (QQ), (DDD), (EEE), (FFF), 

(JJJ), (KKK), (NNN), (UUU), (VVV), 

(WWW), (XXX), (YYY), (ZZZ), (CCCC), 

(DDDD), (EEEE), (FFFF), (GGGG), 

(HHHH), (IIII), (JJJJ), (KKKK), (LLLL), 

(MMMM), (OOOO), (PPPP), (QQQQ), 

(SSSS), (VVVV), (WWWW), (XXXX), 

(ZZZZ), (DDDDD), (EEEEE), (HHHHH), 

(KKKKK), (LLLLL), (PPPPP), (QQQQQ), 

(UUUUU), and (XXXXX), adopted on 

October 18, 2004, effective October 28, 

2004. 

(B) Ohio Administrative Code Rules 

3745–31–01, Definitions: (III) and (SSS), 

3745–31–10 ‘‘Air Stationary Source 

Obligations.’’, and 3745–31–22 

‘‘Nonattainment Provisions—Conditions 

for Approval’’, adopted on October 18, 

2004, effective October 28, 2004 and 

revised by the November 15, 2005 letter 

from Joseph P. Koncelik to Thomas 

Skinner. This letter, included as 

Additional material in paragraph 

(145)(ii)(B) below, removes references to 

the Pollution Control Project (PCP) and 

Clean Unit provisions vacated by a June 

24, 2005 DC Circuit Court of Appeals 

decision. 

(C) Ohio Administrative Code Rules 

3745–31–09 ‘‘Air permit to install 

completeness determinations, public 

participation and public notice.’’, 3745– 

31–13 ‘‘Attainment provisions—review 

of major stationary sources and major 

modifications, stationary source 

applicability and exemptions.’’, 3745– 

31–15 ‘‘Attainment provisions—Control 

Technology Review.’’, 3745–31–21 

‘‘Nonattainment provisions—review of 

major stationary sources and major 

modifications—stationary source 

applicability and exemptions.’’, 3745– 

31–24 ‘‘Non-attainment Provisions— 

Baseline for Determining Credit for 

Emission and Air Quality Offsets.’’, 

3745–31–26 ‘‘Nonattainment 

Provisions—Offset Ratio 

Requirements.’’, and 3745–31–32 

‘‘Plantwide applicability limit (PAL).’’, 

adopted on October 18, 2004, effective 

October 28, 2004. 

(D) October 18, 2004, ‘‘Director’s Final 

Findings and Orders’’, signed by 

Christopher Jones, Director, Ohio 

Environmental Protection Agency, 

adopting rules 3745–31–01, 3745–31– 

09, 3745–31–10, 3745–31–13, 3745–31– 

15, 3745–31–21, 3745–31–22, 3745–31– 

24, 3745–31–26, 3745–31–30, 3745–31– 

31, and 3745–31–32. 

(ii) Additional material. 

(A) Ohio Administrative Code Rule 

3745–31–01, Definitions: (ZZZZZ) 

adopted on October 18, 2004, effective 

October 28, 2004. 

(B) Letter dated November 15, 2005, 

from Ohio EPA Director Joseph P. 

Koncelik to Regional Administrator 

Thomas Skinner, titled Request for 

Approval of Ohio Administrative Code 

(‘‘OAC’’) Chapter 3745–31 NSR Reform 

Rule Changes into the State 

Implementation Plan (‘‘SIP’’). 

* * * * * 

[FR Doc. 2010–3831 Filed 2–24–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0213; FRL–8813–8] 

1,2,3-Propanetriol, Homopolymer 

Diisooctadecanoate; 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 1,2,3- 

propanetriol, homopolymer 

diisooctadecanoate, herein referred to as 

triglycerol diisostearate, when used as 

an inert ingredient (emulsifier) when 

applied to animals. Valent Biosciences 

Corporation 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 

triglycerol diisostearate. 

DATES: This regulation is effective 

February 25, 2010. Objections and 

requests for hearings must be received 

on or before April 26, 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–2009–0213. 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: 

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 


jlentini on DSKJ8SOYB1PROD with RULES
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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–2009–0213 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 April 26, 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–2009–0213, 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 May 6, 2009 

(74 FR 20947) (FRL–8412–7), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

8E7354) by Valent Biosciences 

Corporation, 870 Technology Way, 

Libertyville, IL 60048. The petition 

requested that 40 CFR 180.930 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of 1,2,3-propanetriol, 

homopolymer diisooctadecanoate, 

herein referred to as triglycerol 

diisostearate. 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 

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 

nature of the toxic effects caused by 

triglycerol diisostearate are discussed in 

this unit. 

The Agency has determined that 

triglycerol diisostearate is represented 

by the group of chemicals known as 

polyglycerol esters of fatty acids. Where 

specific information on triglycerol 

diisostearate is not available, 

information on polyglycerol esters of 

fatty acids is used to assess toxicity. 

The polyglycerol esters of fatty acids 

represent a large group of closely related 

compounds with complex 

compositions. The individual 

components are found as normal 

constituents of the human diet, i.e. 

glycerol, glycerol mono-, di- and tri-fatty 

acid esters and individual fatty acids. 

Hydrolysis by enzymes or gastric juices 

to form esters and carbon dioxide is the 

main pathway for metabolic degradation 

for polyglycerol esters of fatty acids. 

Acute toxicity studies conducted with 

polyglycerol esters of fatty acids in rats 

and rabbits show no adverse effects at 

doses up to 29 grams/kilogram (g/kg) 

body weight. Repeated dose testing in 

rats over 5 days did not result in any 

deaths at doses up to 10 g/kg body 

weight.. 

In a short-term study, rats were 

maintained on 9% polyglycerol ester 

(equivalent to 4,500 milligrams/ 

kilogram/day (mg/kg/day)) and 1% 

ground-nut oil for 17 weeks. No 


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systemic toxicity was observed in the 

study. There were also no adverse 

effects noted in a study where rats were 

maintained on a diet of 10% 

polyglycerol ester (equivalent to 5,000 

mg/kg/day) for 90 days. In a third study, 

rats were fed a diet containing 15% 

polyglycerol ester (equivalent to 7,500 

mg/kg/day) of fatty acids for 5 weeks. 

No adverse effects were reported during 

this study. 

In a long-term study, mice were fed a 

diet of either 5% polyglycerol ester 

(equivalent to 2,500 mg/kg/day) or 

ground-nut oil for 80 weeks. All animals 

survived the study and no adverse 

effects were reported on body weight, 

food consumption or peripheral blood 

picture. Microscopic examination of all 

major organs showed nothing 

remarkable. Similar results were 

exhibited in a study with rats fed the 

same diet for 2 years. In a third study, 

mice were maintained on a diet of 1% 

polyglycerol ester (equivalent to 500 

mg/kg/day) for 15.5 months. There were 

no adverse effects noted in this study. 

In a reproductive study, rats were fed 

a diet containing 1.5% polyglycerol 

ester (equivalent to 750 mg/kg/day) for 

three generations. There were no 

significant effects on fertility or 

reproductive performance during the 

first year. There were also no consistent, 

compound-related abnormalities noted 

after gross and histological examination 

of the third generation. 

No carcinogenicity studies are 

available on triglycerol diisostearate, 

however, there was no systemic toxicity 

observed in mice and rats at doses up 

to 2,500 mg/kg/day for 80 weeks and 2 

years, respectively. 

No neurotoxicity studies are available 

in the database; however, there was no 

systemic toxicity in mice and rats at 

doses up to 2,500 mg/kg/day during 

prolonged exposure. 

No mutagenicity studies are available, 

however, polyglycerol esters of fatty 

acids are normal constituents in the 

diet. Therefore, there is no concern for 

mutagenic effects. 

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 

triglycerol diisostearate 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, 

triglycerol diisostearate has reported 

uses in personal care products, such as 

lipstick, lip gloss, sunscreen, makeup, 

skin cream and cleanser. 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 triglycerol diisostearate 

and any other substances and, 

triglycerol diisostearate 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 triglycerol 

diisostearate 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. Safety Factor for 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 Agency has determined that 

triglycerol diisostearate is represented 

by the group of chemicals known as 

polyglycerol esters of fatty acids. Where 

specific information on triglycerol 

diisostearate is not available, 

information on polyglycerol esters of 

fatty acids is used to assess toxicity. The 

toxicity database is sufficient for 

polyglycerol esters of fatty acids 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. Polyglycerol esters of 

fatty acids have low subchronic and 

chronic toxicity. There was no systemic 

toxicity in mice and rats at very high 

doses for 80 weeks and 2 years 

respectively. In a reproductive study 

with rats, there were no significant 

effects on fertility or reproductive 

performance for three generations. 

There were also no consistent, 

compound-related abnormalities noted 

after gross and histological examination 

of the third generation. No 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 and rats 

at high doses. In addition, no hazard has 

been identified following exposure to 


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Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 8503 

triglycerol diisostearate. Based on this 

information, there is no concern at this 

time for increased sensitivity to infants 

and children to triglycerol diisostearate 

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 from dietary exposure (food 

and drinking water) or for residential 

exposure from the use of triglycerol 

diisostearate for the proposed use 

pattern as an inert ingredient 

(emulsifier) in pesticide formulations 

applied to animals. A quantitative 

dietary risk or residential risk 

assessment was not performed since no 

endpoint of concern was identified in 

the database. 

Taking into consideration all available 

information on triglycerol diisostearate, 

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 

triglycerol diisostearate. Therefore, the 

establishment of an exemption from the 

requirement of a tolerance under 40 CFR 

180.930 for residues of triglycerol 

diisostearate when used as an inert 

ingredient (emulsifier) in pesticide 

formulations applied to animals can be 

considered safe under section 408 of the 

FFDCA. 

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, triglycerol 

diisostearate may be subjected to further 

screening and/or testing to better 

characterize effects related to endocrine 

disruption. 

B. Analytical Method 

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. 

C. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for 

triglycerol diisostearate nor have any 

CODEX Maximum Residue Levels 

(MRLs) been established for any food 

crops at this time. 

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 

triglycerol diisostearate. Accordingly, 

EPA finds that exempting triglycerol 

diisostearate 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 

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 


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8504 Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 

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: February 19, 2010. 

Meredith F. Laws, 

Acting 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 §180.930, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

1,2,3-Propanetriol, homopolymer diisooctadecanoate (CAS Reg. 

No. 63705–03–3) 

Emulsifier 

* * * * * 

[FR Doc. 2010–3859 Filed 2–24–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0749; FRL–8799–4] 

Trichoderma gamsii strain ICC 080; 

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 the 

Trichoderma gamsii strain ICC 080 on 

all food/feed commodities when applied 

preharvest in accordance with good 

agricultural practices. Isagro, S.p.A. 

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 Trichoderma gamsii 

strain ICC 080. 

DATES: This regulation is effective 

February 25, 2010. Objections and 

requests for hearings must be received 

on or before April 26, 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–2008–0749. 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: 

Susanne Cerrelli, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8077; e-mail address: 

cerrelli.susanne@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? 

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. 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 


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