29958 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn Boyle, Field and External 

Affairs Division, (7506P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington DC 20460–0001; 

telephone number: (703) 305–6304; email address: boyle.kathryn @epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. If you have 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under the FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

II. What Does this Technical 

Amendment Do? 

In the Federal Register of October 24, 

2007 (72 FR 60251) (FRL–8116–2), EPA 

issued a Final Rule which, among other 

things, redesignated 40 CFR part 158 as 

40 CFR part 161. The regulations in 

redesignated part 161 were intended to 

apply to, and are applicable only to 

antimicrobial pesticides as was shown 

in the redesignation table. This 

technical amendment is issued to clarify 

the applicability of part 161, clear up 

any confusion among the users of the 

regulations in 40 CFR parts 158 and 161, 

and to correct the part heading for part 

161 to show applicability to 

antimicrobial pesticides. The data 

requirements for conventional, 

biochemical, and microbial pesticides 

are set forth in 40 CFR part 158. 

III. Why is this Tehnical Amendment 

Issued as a Final Rule? 

Section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 

553(b)(B), provides that, when an 

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the Agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making today’s technical 

amendment final without prior proposal 

and opportunity for comment, because 

EPA is not making any substantive 

changes to the regulations and is merely 

clarifying the applicability of existing 

regulations to avoid confusion. EPA 

finds that this constitutes good cause 

under 5 U.S.C. 553(b)(B). 

IV. Do Any of the Statutory and 

Executive Order Reviews Apply to this 

Action? 

The appropriate statutory and 

Executive Order reviews were included 

in the October 24, 2007 Final Rule. 

V. 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 161 

Environmental protection, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 12, 2009. 

Debra Edwards, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR part 161 is 

amended as follows: 

PART 161—[AMENDED] 

■ 1. The authority citation for part 161 

continues to read as follows: 

Authority: 7 U.S.C. 136—136y. 

■ 2. Revise the heading for part 161 to 

read as follows: 

PART 161—DATA REQUIREMENTS 

FOR REGISTRATION OF 

ANTIMICROBIAL PESTICIDES 

[FR Doc. E9–14620 Filed 6–23–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0386; FRL–8421–2] 

Triallate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triallate and 

its metabolite TCPSA in or on 

bermudagrass, hay under 40 CFR 

180.314(a). Gowan Company requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

24, 2009. Objections and requests for 

hearings must be received on or before 

August 24, 2009, 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–2008–0386. 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: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5704; e-mail address: 

walters.vickie@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 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29959 

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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 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. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0386 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 

as required by 40 CFR part 178 on or 

before August 24, 2009. 

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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0386 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. Petition for Tolerance 

In the Federal Register of June 13, 

2008 (73 FR 33817) (FRL–8367–3), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8F7334) by the 

Gowan Company, 370 South Main St., 

Yuma, AZ 85364. The petition 

requested that 40 CFR 180.314 be 

amended by establishing tolerances for 

residues of the herbicide triallate, (S2,3,4-trichloroallyl 

diisopropylthiocarbamate), in or on 

Bermudagrass hay at 0.2 parts per 

million (ppm). That notice referenced a 

summary of the petition prepared by 

Gowan Company, the registrant, which 

is available to the public in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

The Gowan Company has requested 

an amendment to a Section 3 

registration under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) to register a new use on 

Bermuda grass for grass grown for seed 

or hay. The petitioner has requested a 

tolerance for Bermuda grass, hay to 

support registration of the new use. This 

petition was filed in conjunction with 

Gowan’s requested amendment to its 

FIFRA registration. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the correct commodity 

name and numerical value for the 

tolerance proposed in this petition is 

Bermudagrass, hay at 0.3 ppm. EPA has 

also assigned the proposed tolerance in 

this petition to paragraph 40 CFR 

180.314(a), is correcting the tolerance 

expression to read: ‘‘Tolerances are 

established for residues of the herbicide 

(S-2,3,4-trichloroallyl 

diisopropylthiocarbamate) and its 

metabolite 2,3,3-trichloroprop-2- 

enesulfonic acid (TCPSA) in or on the 

following food commodity 

Bermudagrass, hay at 0.3 ppm.’’ The 

reasons for these changes are explained 

in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish 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....’’ 

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

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 

tolerances for residues of triallate and 

its metabolite TCPSA in/on 

bermudagrass, hay at 0.3 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its 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. 

Triallate has a low order of acute 

toxicity via oral, dermal, and inhalation 

routes. Triallate is neurotoxic in rats 

29960 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

based on the acute neurotoxicity study, 

the subchronic neurotoxicity study, the 

rat multi-generation reproduction study, 

and the developmental neurotoxicity 

study. In subchronic studies in rats, the 

major target organ appears to be the 

kidney. Following chronic exposure, 

systemic toxicity in dogs is limited to an 

increase in liver weight in both sexes, 

increases in serum alkaline phosphatase 

in both sexes, and increases in 

hemosiderm in the spleen. Toxicity in 

mice included increased absolute liver 

weight, increased incidence of altered 

foci of the liver and hematopoiesis in 

the spleen. In rats, systemic toxicity was 

manifested as decreased survival in both 

sexes, decreased body weight and 

increased adrenal weight in males. In 

high dose males from the chronic 

toxicity/carcinogenicity study, the only 

treatment-related finding at interim 

sacrifice was linear papillary 

mineralization. The only treatmentrelated effect noted in male Syrian 

hamsters was decreased serum 

triglycerides. 

There was no increased susceptibility 

to the offspring of rats following in utero 

exposure in the prenatal developmental 

toxicity study in rats, the 2-generation 

reproduction study in rats, or the 

developmental neurotoxicity study in 

rats. However, there is evidence of 

increased susceptibility in the prenatal 

developmental toxicity study in rabbits. 

Triallate has been classified as a 

possible human carcinogen based on 

hepatocelluar carcinomas in male mice, 

with a positive trend and borderline 

significance in female mice and 

increased incidence of renal tubular cell 

adenomas in rats. A linear low-dose 

approach is used to quantify cancer risk 

to humans. The existing toxicological 

data for triallate do not show any 

significant effects on immunological 

organs or functions. 

The Agency has determined that only 

triallate and its metabolite TCPSA 

should be regulated and assessed for 

dietary exposure in plant commodities. 

The Agency decided to regulate on the 

TCPSA metabolite because it is present 

at more than 10% of the total 

radioactive residue (TRR) in the plant 

metabolism studies, and in the absence 

of toxicological data for this metabolite, 

the same toxicity as the parent 

compound, triallate is assumed. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triallate and its 

metabolite TCPSA as well as the noobserved-adverse-effect-level (NOAEL) 

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

can be found at http:// 

www.regulations.gov in document 

Triallate: Risk Assessment for Proposed 

New Use of Triallate as Pre-Emergence 

Herbicide for Bermuda grass, Case # 

824883, pages 32–42 in docket ID 

number EPA–HQ–OPP–2008–0386 

identified as document EPA–HQ–OPP– 

2008–0386–0003. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold 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 greater than that 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. 

A summary of the toxicological 

endpoints for triallate and TCPSA used 

for human risk assessment can be found 

at http://www.regulations.gov in 

document Triallate: Risk Assessment for 

Proposed New Use of Triallate as PreEmergence Herbicide for Bermuda grass, 

Case # 824883, pages 32–42 in docket ID 

number EPA–HQ–OPP–2008–0386 

identified as document EPA–HQ–OPP– 

2008–0386–0003. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to triallate and its metabolite 

TCPSA, EPA considered exposure under 

the petitioned-for tolerances as well as 

all existing triallate tolerances in 40 CFR 

180.314. EPA assessed dietary 

exposures from triallate and TCPSA in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

insert 1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used field trial data, 

empirical processing factors and 100 

percent crop treated (PCT) for all 

commodities. Anticipated residues (AR) 

were used. All commodities with the 

exception of succulent peas were 

blended commodities; therefore, average 

field trial values were used for these 

commodities. The acute AR for 

succulent peas is the highest field trial 

residue. PCT data were not used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA insert 1994–1996 and 

1998 CSFII. As to residue levels in food, 

EPA used field trial data, empirical 

processing factors and 100 PCT for all 

commodities. AR were used. All 

commodities with the exception of 

succulent peas were blended 

commodities; therefore, average field 

trial values were used for these 

commodities. The chronic AR for 

succulent peas is the average field trial 

residue. PCT data were not used. 

iii. Cancer. To assess cancer risk, EPA 

used the same assessment as for chronic 

exposure. 

iv. Anticipated residue information. 

Section 08(b)(2)(E) of FFDCA authorizes 

EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29961 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for triallate and TCPSA in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of triallate and TCSPA. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model /Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

triallate and TCPSA for acute exposures 

are estimated to be 9.45 parts per billion 

(ppb) for surface water and 0.21 ppb for 

ground water. 

The estimated EDWCs of triallate and 

TCPSA for chronic exposures for noncancer assessments are estimated to be 

1.26 ppb for surface water and 0.21 ppb 

for ground water. 

The estimated EDWCs of triallate and 

TCPSA for chronic exposures for cancer 

assessments are estimated to be 1.26 

ppb for surface water and 0.21 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

water concentration value of 9.45 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 1.26 

ppb was used to assess the contribution 

to drinking water. 

For cancer dietary risk assessment, 

the water concentration of value 1.26 

ppb was used to assess the contribution 

to 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., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Triallate and its metabolite TCPSA are 

not registered for any specific use 

patterns that would result in residential 

exposure. 

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 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA found in 2001 that although 

studies suggest that the thiocarbamate 

pesticides (including triallate) share a 

common metabolic profile and a 

common toxic effect (neuropathology of 

the sciatic nerve), insufficient 

information exists to establish a 

common mechanism of toxicity for this 

effect. For the purposes of this tolerance 

action, therefore, EPA has assumed that 

triallate does not have a common 

mechanism of toxicity with other 

substances. For more information 

regarding the common mechanism 

determination for triallate and the other 

thiocarbamate pesticides see http:// 

www.epa.gov/oppsrrd/cumulative/ 

thiocarbamate.pdf. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

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 

based on reliable data 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 available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

A Degree of Concern analysis was 

performed for triallate and TCPSA 

because the rabbit developmental study 

provided evidence of increased 

susceptibility in the fetus. The purpose 

of the Degree of Concern analysis was: 

i. To determine the level of concern 

for the effects observed when 

considered in the context of all available 

toxicity data; and 

ii. Identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment. 

In the case of triallate and TCPSA, 

there was no increased susceptibility to 

the offspring of rats following in utero 

exposure in the prenatal developmental 

toxicity study in rats, in the 2– 

generation reproduction study in rats, or 

in the developmental neurotoxicity 

study in rats. However there was 

evidence of increased susceptibility in 

the prenatal developmental toxicity 

study in rabbits. Fetal effects include 

decreased body weight and increased 

skeletal variations at 15 mg/kg/day. 

However, the rabbit developmental 

study identified a NOAEL of 5 mg/kg/ 

day for fetal effects, and this NOAEL 

was selected as the point of departure 

for the acute dietary risk assessment. 

The point of departure for chronic 

dietary exposure (2.5 mg/kg/day) is 

lower than the NOAEL for fetal effects 

(observed at 15 mg/kg/day) and is 

protective of this endpoint, thus there 

are no residual concerns. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for triallate 

and its metabolite is adequate for 

addressing the sensitivity of infant and 

children to triallate exposure. The 

toxicity database for triallate is complete 

with the exception of an 

immunotoxicity study. The existing 

subchronic and chronic studies did not 

indicate that the immune system will be 

affected by triallate based on 

hematology, lymphoid organ weights, 

and histopathology measurements. The 

effects seen in the chronic study in dogs 

and the chronic toxicity study in mice 

in the spleen are related to hematology, 

but not related to immunotoxicity— 

they’re just manifested in the spleen as 

well as in other organs. They do not 

increase concern for immunotoxicity in 

any way. Thus, the residual concerns for 

immunotoxicity are low. 

ii. No quantitative or qualitative 

increased susceptibility was 

demonstrated in the fetuses in the 

prenatal developmental study in rats 

following in utero exposure, in the 

offspring in the developmental 

neurotoxicity study in rats, as well as in 

the offspring in the 2–generational 

reproduction study in rats following in 

utero and/or postnatal exposure to 

triallate. 

iii. Although there was some 

increased susceptibility in the rabbit 

developmental toxicity study (where the 

developmental NOAEL of 5 mg/kg/day 

was lower than the maternal NOAEL of 

15 mg/kg/day), the dose response for 

this effect has been adequately 

characterized (see discussion in Unit 

III.D.2) and the fetal NOAEL was 

selected as a point of departure for the 

acute dietary risk assessment. The point 

29962 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

of departure for the chronic dietary 

assessment (2.5 mg/kg/day) is lower 

than the NOAEL for fetal effects 

(observed at 15 mg/kg/day). Thus, these 

assessments are protective of potential 

adverse effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT, and 

reliable data from field trial studies and 

food processing studies. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to triallate and 

TCPSA in drinking water. There are no 

residential uses for triallate, therefore no 

residential exposure is expected from 

the use of triallate. These assessments 

will not underestimate the exposure and 

risks posed by triallate and its 

metabolite TCPSA. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to triallate and 

TCPSA will occupy <1% of the aPAD 

for (all infants <1 year old), the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to triallate and 

TCPSA from food and water will utilize 

<1% of the cPAD for (all infants <1 year 

old) the population group receiving the 

greatest exposure. There are no 

residential uses for triallate and TCPSA. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

average exposure to food and water 

(considered to be a background 

exposure level). 

Triallate and its metabolite TCPSA are 

not registered for any use patterns that 

would result in residential exposure. 

Therefore, the short-term aggregate risk 

is the sum of the risk from exposure to 

triallate and TCPSA through food and 

water and will not be greater than the 

chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus average 

exposure to food and water (considered 

to be a background exposure level). 

Triallate and its metabolite TCPSA are 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Therefore, the 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

triallate and TCPSA through food and 

water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in this unit for 

cancer exposure, EPA has determined 

that the estimated dietary exposure for 

the general U.S. population 

corresponded to a cancer risk of 3 X 10-7

for food and drinking water, which is 

less than the range of 1 in 1 million (1 

X 10-6), the EPA level of concern. 

6. Determination of safety. Based on 

these risk assessments, 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 residues of 

triallate and its metabolite TCPSA. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Two analytical methods are available 

for enforcement of tolerances. They 

include the current PAM VOL. II 

method (gas chromatography with 

electron capture detection (GC/ECD) 

designated as method A and another 

GC/ECD method (designated as Method 

RES-099-96, Version 2) which may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Canadian, Mexican or 

Codex MRLs established for triallate and 

its metabolite TCPSA for Bermudagrass, 

hay, the tolerance established by this 

rule. Therefore, there are no issues 

regarding compatibility with respect to 

the tolerance established for 

bermudagrass, hay in this rule. 

C. Revisions to Petitioned-For 

Tolerances 

Based on residue trial data submitted 

to the Agency, EPA determined that the 

proposed tolerance of 0.2 ppm for 

Bermudagrass, hay was to low. The 

residue trail data support the 

establishment of a tolerance of 0.3 ppm 

on Bermudagrass, hay expressed in the 

terms of triallate and its metabolite 

TCPSA. 

V. Conclusion 

Therefore, tolerances are established 

for residues of triallate, S-2,3,4- 

trichloroallyl diisopropylthiocarbamate 

and its metabolite 2,3,3-trichloroprop-2- 

enesulfonic acid (TCPSA), in or on the 

following food commodity: 

Bermudagrass, hay at 0.3 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29963 

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). 

VII. 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: June 12, 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. Paragraph (a) of §180.314 is revised 

to read as follows: 

§180.314 Triallate; tolerances for residues. 

(a) General. Tolerances are 

established for residues of triallate, S2,3,4-trichloroallyl 

diisopropylthiocarbamate and its 

metabolite 2,3,3-trichloroprop-2- 

enesulfonic acid (TCPSA) in or on the 

following food commodity: 

Commodity Parts per million 

Bermudagrass, hay ........ 0.3 

* * * * * 

[FR Doc. E9–14869 Filed 6–23–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0007; FRL–8417–5] 

Glyphosate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases the 

tolerance for residues of glyphosate in 

or on cotton, gin byproducts. 

Cheminova, Inc requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

24, 2009. Objections and requests for 

hearings must be received on or before 

August 24, 2009, 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–2009–0007. 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: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5704; e-mail address: 

walters.vickie@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 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