Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65073

August 10, 1999). This action merely 

approves a state rule implementing a 

federal standard, and does not alter the 

relationship or the distribution of power 

and responsibilities established in the 

Clean Air Act. 

Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

This rule also is not subject to 

Executive Order 13045 ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant. 

National Technology Transfer 

Advancement Act 

In reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Clean Air Act. In this context, in the 

absence of a prior existing requirement 

for the state to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a SIP submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a SIP submission, 

to use VCS in place of a SIP submission 

that otherwise satisfies the provisions of 

the Clean Air Act. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. 

Paperwork Reduction Act 

This rule does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by January 10, 2005. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this rule for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).)

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen oxide, Ozone.

Dated: October 8, 2004. 

Norman Niedergang, 

Acting Regional Administrator, Region 5.

■ Part 52, chapter I, title 40 of the Code 

of Federal Regulations 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 YY—Wisconsin

■ 2. Section 52.2570 is amended by 

adding paragraph (c)(111)to read as 

follows:

§ 52.2570 Identification of plan.

* * * * *

(c) * * *

(111) On May 25, 2004, Lloyd L. 

Eagan, Director, Wisconsin Department 

of Natural Resources, submitted a 

revision to its rule for control of 

nitrogen oxide emissions as a requested 

revision to the Wisconsin State 

Implementation Plan. The revision 

modifies language to clarify which 

sources are eligible to participate in the 

NOX emission averaging program to 

demonstrate compliance as part of the 

one-hour ozone attainment plan 

approved by EPA for the MilwaukeeRacine ozone nonattainment area 

(Kenosha, Manitowoc, Milwaukee, 

Ozaukee, Racine, Sheboygan, 

Washington, and Waukesha counties). 

The rule revision also creates a separate 

categorical emission limit for new 

combustion turbines burning 

biologically derived gaseous fuels. The 

new NOX categorical limit for newly 

installed combustion turbines burning 

biologically derived fuel applies only to 

new sources located in Kenosha, 

Milwaukee, Ozaukee, Racine, 

Washington, and Waukesha counties in 

southeastern Wisconsin. 

(i) Incorporation by reference. 

(A) NR 428.02(1)and (1m); NR 

428.04(2)(g)(1); NR 428.04(2)(g)(4); and 

NR 428.06(2)(a) as published in the 

(Wisconsin) Register, December 2003, 

No.576 and effective January 1, 2004.

[FR Doc. 04–24914 Filed 11–9–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0329; FRL–7684–2]

Hexythiazox; Pesticide Tolerances for 

Emergency Exemptions

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

time-limited tolerances for combined 

residues of hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its 

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety in or on field corn 

grain, stover, and fodder. This action is 

in response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on field 

corn. This regulation establishes 

maximum permissible levels for 

residues of hexythiazox in these food 

commodities. The tolerances will expire 

and are revoked on December 31, 2007.

DATES: This regulation is effective 

November 10, 2004. Objections and 

requests for hearings must be received 

on or before January 10, 2005.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2004–

0329. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

65074 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Andrew Ertman, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: sec-18-

mailbox@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 111) 

• Animal production (NAICS 112) 

• Food manufacturing (NAICS 311) 

• Pesticide manufacturing (NAICS 

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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(1)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a, 

is establishing tolerances for combined 

residues of hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its 

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety in or on corn, field, 

grain at 0.05 ppm; corn, field, forage at 

2.0 ppm; and corn, field, stover at 2.0 

ppm. These tolerances will expire and 

are revoked on December 31, 2007. EPA 

will publish a document in the Federal 

Register to remove the revoked 

tolerances from the Code of Federal 

Regulations.

Section 408(l)(6) of the 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 under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related tolerances 

to set binding precedents for the 

application of section 408 of the FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of the FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party.

Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .’’

Section 18 of the FIFRA authorizes 

EPA to exempt any Federal or State 

agency from any provision of FIFRA, if 

EPA determines that ‘‘emergency 

conditions exist which require such 

exemption.’’ This provision was not 

amended by the Food Quality Protection 

Act of 1996 (FQPA). EPA has 

established regulations governing such 

emergency exemptions in 40 CFR part 

166.

III. Emergency Exemption for 

Hexythiazox on Corn and FFDCA 

Tolerances

The applicant stated that the 

development of resistance in spider 

mite populations to the standard 

acaricide used to control mites has 

created an urgent and non-routine 

situation. EPA has authorized under 

FIFRA section 18 the use of hexythiazox 

on corn for control of Banks grass mite 

and two-spotted spider mite in Texas. 

After having reviewed the submission, 

EPA concurs that emergency conditions 

exist for this State.

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

hexythiazox in or on field corn grain, 

stover, and fodder. In doing so, EPA 

considered the safety standard in 

section 408(b)(2) of the FFDCA, and 

EPA decided that the necessary 

tolerance under section 408(l)(6) of the 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

these tolerances without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of the 

FFDCA. Although these tolerances will 

expire and are revoked on December 31, 

2007, under section 408(l)(5) of the 

FFDCA, residues of the pesticide not in 

excess of the amounts specified in the 

tolerances remaining in or on field corn 

grain, stover, and fodder after that date 

will not be unlawful, provided the 

pesticide is applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed levels that were 

authorized by these tolerances at the 

time of that application. EPA will take 

action to revoke these tolerances earlier 

if any experience with, scientific data 

on, or other relevant information on this 

pesticide indicate that the residues are 

not safe.

Because these tolerances are being 

approved under emergency conditions, 

EPA has not made any decisions about 

whether hexythiazox meets EPA’s 

registration requirements for use on 

corn or whether permanent tolerances 

for this use would be appropriate. 

Under these circumstances, EPA does 

not believe that these tolerances serve as 

a basis for registration of hexythiazox by 

a State for special local needs under 

FIFRA section 24(c). Nor do these 

tolerances serve as the basis for any 

State other than Texas to use this 

pesticide on this crop under section 18 

of FIFRA without following all 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65075

provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for hexythiazox, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and 

Determination of Safety

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see the final 

rule on Bifenthrin Pesticide Tolerances 

(62 FR 62961, November 26, 1997) 

(FRL–5754–7).

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

of the 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 hexythiazox and to make 

a determination on aggregate exposure, 

consistent with section 408(b)(2) of the 

FFDCA, for time-limited tolerances for 

combined residues of hexythiazox 

(trans-5-(4-chlorophenyl)-N-cyclohexyl4-methyl-2-oxothiazolidine-3-

carboxamide) and its metabolites 

containing the (4-chlorophenyl)-4-

methyl-2-oxo-3-thiazolidine moiety in 

or on corn, field, grain at 0.05 ppm; 

corn, field, forage at 2.0 ppm; and corn, 

field, stover at 2.0 ppm. EPA’s 

assessment of the dietary exposures and 

risks associated with establishing the 

tolerance follows.

A. Toxicological Endpoints

The dose at which no observed 

adverse effect level (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological 

endpoint. However, the lowest dose at 

which adverse effects of concern are 

identified (the lowest observed adverse 

effect level (LOAEL)) is sometimes used 

for risk assessment if NOAEL was 

achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (aRfD or cRfD) where the RfD is 

equal to the NOAEL divided by the 

appropriate UF (RfD = NOAEL/UF). 

Where an additional safety factor is 

retained due to concerns unique to the 

FQPA, this additional factor is applied 

to the RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of FQPA SF.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (LOC). 

For example, when 100 is the 

appropriate UF (10X to account for 

interspecies differences and 10X for 

intraspecies differences) the LOC is 100. 

To estimate risk, a ratio of the NOAEL 

to exposures (margin of exposure (MOE) 

= NOAEL/exposure) is calculated and 

compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk is expressed as 1 x10-6 or one 

in a million). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

derived from the dose response curve. 

To estimate risk, a ratio of the point of 

departure to exposure (MOEcancer = point 

of departure/exposures) is calculated.

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, 

UF 

FQPA SF and Endpoint for Risk 

Assessment Study and Toxicological Effects 

Acute dietary females (13-50 

years of age)

Developmental NOAEL = 240 

mg/kg/day 

UF = 100

Acute RfD = 2.4 mg/kg/day

FQPA SF = 1X 

aPAD= acute RfD/FQPA SF 

= 2.4 mg/kg/day

Developmental toxicity study 

- rat 

Developmental LOAEL = 720 

mg/kg/day based on delayed ossification

Acute dietary (general population including infants and 

children)

A dose and endpoint attributable to a single exposure were not identified from the available 

oral toxicity studies, including maternal toxicity in the developmental toxicity studies.

Chronic dietary (all populations)NOAEL= 2.5 mg/kg/day 

UF = 100 chronic

RfD= 0.025 mg/kg/day

FQPA SF = 1X 

cPAD= chronic RfD/FQPA 

SF = 0.025 mg/kg/day 

One–Year toxicity feeding 

study - dog 

LOAEL = 12.5 mg/kg/day 

based on increased absolute and relative adrenal 

weights and associated adrenal histopathology

Cancer (oral, dermal, inhalation)Category C (possible human 

carcinogen)

Q1* = 2.22 x 10-2 Increases in incidence of malignant and combined benign/malignant liver tumors 

in mice

65076 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

B. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.448) for the 

combined of hexythiazox, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

hexythiazox in food as follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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. The Dietary 

Exposure Evaluation Model (DEEMTM) 

analysis evaluated the individual food 

consumption as reported by 

respondents in the United States 

Department of Agriculture (USDA) 

1994–1996, and 1998 nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

commodity. Published and proposed 

tolerance level residues were used. 

Default and specially assigned 

processing factors were assumed for all 

commodities.

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment, the 

DEEMTM analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996, and 1998 nationwide CSFII 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Partially refined, deterministic 

assessment using tolerance-level residue 

or anticipated residues, average 

weighted percent crop treated (% CT) 

information and modified DEEMTM

(version 2.0) processing factors for some 

commodities based on guideline 

processing studies.

iii. Cancer. The Agency believes that 

pesticidal use of hexythiazox is likely to 

pose a carcinogenic hazard to humans. 

Thus, a cancer dietary risk assessment is 

required. Hexythiazox was classified by 

the Agency as a ‘‘Group C’’ - possible 

human carcinogen-chemical. It has been 

assigned a Q1* = 2.22 x 10-2 milligrams/

kilogram/day (mg/kg/day) for purposes 

of risk assessment. The estimated 

exposure of the U.S. population (total) 

to hexythiazox is 3.0 x 10–5 mg/kg/day.

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of the 

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 

chemicals that have been measured in 

food. If EPA relies on such information, 

EPA must require 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 

levels anticipated. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. As required by 

section 408(b)(2)(E) of the FFDCA, EPA 

will issue a Data Call-In for information 

relating to anticipated residues to be 

submitted no later than 5 years from the 

date of issuance of this tolerance.

Section 408(b)(2)(F) of the FFDCA 

states that the Agency may use data on 

the actual percent of food treated for 

assessing chronic dietary risk only if the 

Agency can make the following 

findings: Condition 1, that the data used 

are reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain such pesticide residue; 

Condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

Condition 3, if data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

section 408(b)(2)(F) of the FFDCA, EPA 

may require registrants to submit data 

on PCT.

The Agency used PCT information as 

follows:

Almond nutmeat, 2%; pecans, <1%; 

other nutmeat, <1%; almond hulls, 2%; 

apricots, 2%; cherries, <1%; peaches, 

1%; nectarines, 2%; plum, 1%; plum, 

prune, fresh, <1%; plum, prune, dried, 

<1%; caneberry crop subgroup, 15%; 

spearmint tops, 5%; peppermint, tops, 

5%; undelinted cottonseed, 1%; 

cottonseed meal, 1%; refined cottonseed 

oil, 1%; apples, 4%; apple juice, 4%; 

wet apple pomace, 4%; pears, 3%; hops, 

45%; dates, 45%; strawberries, 14%.

The Agency believes that the three 

conditions listed above have been met. 

With respect to Condition 1, PCT 

estimates are derived from Federal and 

private market survey data, which are 

reliable and have a valid basis. EPA uses 

a weighted average PCT for chronic 

dietary exposure estimates. This 

weighted average PCT figure is derived 

by averaging State-level data for a 

period of up to 10 years, and weighting 

for the more robust and recent data. A 

weighted average of the PCT reasonably 

represents a person’s dietary exposure 

over a lifetime, and is unlikely to 

underestimate exposure to an individual 

because of the fact that pesticide use 

patterns (both regionally and nationally) 

tend to change continuously over time, 

such that an individual is unlikely to be 

exposed to more than the average PCT 

over a lifetime. For acute dietary 

exposure estimates, EPA uses an 

estimated maximum PCT. The exposure 

estimates resulting from this approach 

reasonably represent the highest levels 

to which an individual could be 

exposed, and are unlikely to 

underestimate an individual’s acute 

dietary exposure. The Agency is 

reasonably certain that the percentage of 

the food treated is not likely to be an 

underestimation. As to Conditions 2 and 

3, regional consumption information 

and consumption information for 

significant subpopulations is taken into 

account through EPA’s computer-based 

model for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available information on the 

regional consumption of food to which 

hexythiazox may be applied in a 

particular area.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

hexythiazox in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

hexythiazox.

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System 

(PRZM/EXAMS) to estimate pesticide 

concentrations in surface water and SCIGROW, which predicts pesticide 

concentrations in ground water. In 

general, EPA will use GENEEC (a Tier 

1 model) before using PRZM/EXAMS (a 

Tier 2 model) for a screening-level 

assessment for surface water. The 

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides. 

GENEEC incorporates a farm pond 

scenario, while PRZM/EXAMS 

incorporate an index reservoir 

environment in place of the previous 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65077

pond scenario. The PRZM/EXAMS 

model includes a percent crop (PC) area 

factor as an adjustment to account for 

the maximum PC coverage within a 

watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever exceed human health levels of 

concern.

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs) from these 

models to quantify drinking water 

exposure and risk as a %RfD or %PAD. 

Instead drinking water levels of 

comparison (DWLOCs) are calculated 

and used as a point of comparison 

against the model estimates of a 

pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to hexythiazox, 

they are further discussed in the 

aggregate risk sections below.

Based on the GENEEC and SCI-GROW 

models, the EECs of hexythiazox for 

acute exposures are estimated to be 1.81 

parts per billion (ppb) for surface water 

and 0.009 ppb for ground water. The 

EECs for chronic exposures are 

estimated to be 0.91 ppb for surface 

water and 0.009 ppb for ground 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).

Hexythiazox is not registered for use 

on any sites that would result in 

residential exposure.

4. Cumulative exposure to substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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 does not have, at this time, 

available data to determine whether 

hexythiazox has a common mechanism 

of toxicity with other substances or how 

to include this pesticide in a cumulative 

risk assessment. Unlike other pesticides 

for which EPA has followed a 

cumulative risk approach based on a 

common mechanism of toxicity, 

hexythiazox 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 hexythiazox 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 final rule for 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. In general. Section 408 of the 

FFDCA provides that EPA shall apply 

an additional tenfold margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines that a different margin of 

safety will be safe for infants and 

children. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans.

2. Developmental toxicity studies—a. 

rats. In the rat developmental study, the 

maternal (systemic) NOEL was 240 mg/

kg/day. The maternal LOEL of 720 mg/

kg/day was based on decreased food 

consumption and decreased body 

weight. The developmental (fetal) NOEL 

was 240 mg/kg/day. The developmental 

LOEL was based on slight delayed 

ossification.

b. Rabbits. In the rabbit 

developmental toxicity study, the 

maternal (systemic) NOEL was 1,080 

mg/kg/day at the highest dose tested 

(HDT). The developmental (fetal) NOEL 

was 1,080 mg/kg/day at the HDT.

3. Reproductive toxicity study—rats. 

In the 2-generation reproductive toxicity 

study in rats, the parental (systemic) 

NOEL was 20 mg/kg/day. The LOEL of 

120 mg/kg/day was based on decreased 

body weight and decreased food 

consumption. The developmental NOEL 

was 20 mg/kg/day. The developmental 

LOEL of 120 mg/kg/day was based on 

decreased body weight and delayed 

maturation. The reproductive NOEL was 

120 mg/kg/day at the HDT.

4. Prenatal and postnatal sensitivity.

The prenatal and postnatal toxicology 

data base for hexythiazox is complete 

with respect to current toxicological 

data requirements. There are no prenatal 

or postnatal toxicity concerns for infants 

and children, based on the results of the 

rat and rabbit developmental toxicity 

studies and the 2-generation rat 

reproductive toxicity study. In the 

developmental study in rats, the 

developmental NOEL and LOEL is the 

same as the maternal NOEL and LOEL 

demonstrating that no extra-sensitivity 

for infants and children is present. In 

rabbits, there are no maternal or 

developmental effects up to the limit 

dose of 1,080 mg/kg/day HDT. In the 2-

generation reproductive toxicity study 

in rats, there are no pup effects at doses 

below maternal effects and the common 

effects in both pups and parental 

animals decreased body weight also 

demonstrates that there is no extrasensitivity for infants and children.

5. Conclusion. Based on the above, 

EPA concludes that reliable data 

support use of the standard 100-fold 

uncertainty factor and that the 10x 

FQPA safety factor be removed since the 

hazard and exposure assessments do not 

indicate a concern for potential risk to 

infants and children.

D. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against the model 

estimates of a pesticide’s concentration 

in water (EECs). DWLOC values are not 

regulatory standards for drinking water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + chronic non-dietary, nonoccupational exposure). This allowable 

exposure through drinking water is used 

to calculate a DWLOC.

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the USEPA Office of Water 

are used to calculate DWLOCs: 2 liter 

(L)/70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

65078 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, EPA concludes 

with reasonable certainty that exposures 

to hexythiazox in drinking water (when 

considered along with other sources of 

exposure for which EPA has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because EPA considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, EPA will reassess the potential 

impacts of hexythiazox on drinking 

water as a part of the aggregate risk 

assessment process.

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to hexythiazox will 

occupy 0.12 of the aPAD for females 13–

49 years old, the population sub-group 

of concern. In addition, despite the 

potential for acute dietary exposure to 

hexythiazox in drinking water, after 

calculating DWLOCs and comparing 

them to conservative model EECs of 

hexythiazox in surfacewater and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the aPAD, as shown in the following 

Table 2:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO HEXYTHIAZOX

Population Subgroup aPAD (mg/

kg) 

% aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

Females (13-49 years old) 2.4 0.12 1.81 0.009 72,000

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to hexythiazox from food 

will utilize 0.1% of the cPAD for the 

U.S. population, 0.2% of the cPAD for 

all infants, and 0.4% of the cPAD for 

children 1–5 years old. There are no 

residential uses for hexythiazox that 

result in chronic residential exposure to 

hexythiazox. In addition, despite the 

potential for chronic dietary exposure to 

hexythiazox in drinking water, after 

calculating DWLOCs and comparing 

them to conservative model EECs of 

hexythiazox in surface water and 

ground water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in the following 

Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO HEXYTHIAZOX

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

General U.S. population 0.025 0.1 0.910 0.009 870

All Infants (< 1 year old) 0.025 0.2 0.910 0.009 250

Children (1-2 years old) 0.025 0.4 0.910 0.009 250

Females (13-49 years old) 0.025 0.1 0.910 0.009 750

Youth (13-19 years old) 0.025 0.1 0.910 0.009 750

Adults (20-49 years old) 0.025 0.1 0.910 0.009 870

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Hexythiazox is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which were previously 

addressed.

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account non-dietary, nonoccupational exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Hexythiazox is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which were previously 

addressed.

5. Aggregate cancer risk for U.S. 

population. Chronic (cancer) aggregate 

risk estimates are below the Agency’s 

level of concern. A partially refined 

analysis was performed using 

anticipated residue levels for most 

crops, processing factors where 

applicable, and PCT or anticipated 

market share information for all crops. 

The chronic cancer analysis applied to 

the U.S. population only. The 

carcinogenic risk estimate (food only) 

for the general U.S. population was 6.6 

x 10-7. The Agency’s level of concern is 

for risks that exceed 1 x 10-6. Thus, the 

estimated dietary cancer risk to the U.S. 

population associated with the existing 

and pending uses is below the level the 

Agency generally considers negligible 

for excess lifetime cancer risk.

The surface water and ground water 

EECs were used to compare against 

back-calculated DWLOCs for aggregate 

risk assessments. For the carcinogenic 

risk scenario, the DWLOC is 3.675 ppb 

for the U.S population. For ground 

water and surface water, the EECs for 

hexythiazox are less than EPA’s 

DWLOCs for hexythiazox in drinking 

water as a contribution to carcinogenic 

aggregate exposure. Therefore, EPA 

concludes with reasonable certainty that 

residues of hexythiazox in drinking 

water do not contribute significantly to 

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65079

the carcinogenic aggregate humanhealth risk at the present time.

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, and to infants and children 

from aggregate exposure to hexythiazox 

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

(example—gas chromatography) is 

available to enforce the tolerance 

expression. The method 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 international residues 

limits for hexythiazox on field corn, and 

therefore, this is not an issue.

VI. Conclusion

Therefore, the tolerances are 

established for combined residues of 

hexythiazox (trans-5-(4-chlorophenyl)-

N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its 

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety in or on corn, field, 

grain at 0.05 ppm; corn, field, forage at 

2.0 ppm; and corn, field, stover at 2.0 

ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as 

amended by the FQPA, 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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 

for filing objections is now 60 days, 

rather than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket identification 

(ID) number OPP–2004–0329 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 January 10, 2005.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Tolerance fee payment. If you file 

an objection or request a hearing, you 

must also pay the fee prescribed by 40 

CFR 180.33(i) or request a waiver of that 

fee pursuant to 40 CFR 180.33(m). You 

must mail the fee to: EPA Headquarters 

Accounting Operations Branch, Office 

of Pesticide Programs, P.O. Box 

360277M, Pittsburgh, PA 15251. Please 

identify the fee submission by labeling 

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee 

requirement ‘‘when in the judgement of 

the Administrator such a waiver or 

refund is equitable and not contrary to 

the purpose of this subsection.’’ For 

additional information regarding the 

waiver of these fees, you may contact 

James Tompkins by phone at (703) 305–

5697, by e-mail at 

tompkins.jim@epa.gov, or by mailing a 

request for information to Mr. Tompkins 

at Registration Division (7505C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001.

If you would like to request a waiver 

of the tolerance objection fees, you must 

mail your request for such a waiver to: 

James Hollins, Information Resources 

and Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001.

3.Copies for the Docket. In addition to 

filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VII.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by the docket ID 

number OPP–2004–0329, to: Public 

Information and Records Integrity 

Branch, Information Resources and 

Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. In person or by courier, bring a 

copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

via e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

65080 Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 

VIII. Statutory and Executive Order 

Reviews

This final rule establishes timelimited tolerances under section 408 of 

the FFDCA. 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 

rule has been exempted from review 

under Executive Order 12866 due to its 

lack of significance, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a FIFRA 

section 18 exemption under section 408 

of the FFDCA, such as the tolerances 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

IX. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: October 27, 2004.

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. Section 180.448 is amended by 

adding text to paragraph (b) to read as 

follows:

§ 180.448 Hexythiazox; tolerances for 

residues.

* * * * *

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for the combined residues of the 

insecticide hexythiazox and its 

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety in connection with 

use of the pesticide under section 18 

emergency exemptions granted by EPA. 

These tolerances will expire and are 

revoked on the dates specified in the 

following table.

Commodity Parts per million Expiration/revocation date 

Corn, field, grain .......................................................................................................................................... 0.05 ppm 12/31/07

Corn, field, forage ........................................................................................................................................ 2.0 ppm 12/31/07

Corn, field, stover ........................................................................................................................................ 2.0 ppm 12/31/07

Federal Register / Vol. 69, No. 217 / Wednesday, November 10, 2004 / Rules and Regulations 65081

* * * * *

[FR Doc. 04–24926 Filed 11–9–04; 8:45 am] 

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0323; FRL–7683–9]

Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of glyphosate, N-

(phosphonomethyl)glycine, resulting 

from the application of glyphosate, the 

isopropylamine salt of glyphosate, the 

ethanolamine salt of glyphosate, the 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate in or on 

cotton, gin byproducts and cotton, 

undelinted seed. Monsanto Company 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective 

November 10, 2004. Objections and 

requests for hearings must be received 

on or before January 10, 2005.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0323. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket/. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 South Bell 

St., Arlington, VA. This docket facility 

is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

James A.Tompkins, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., 

NW.,Washington, DC 20460–0001; 

telephone number: (703) 305–5697; email address: tompkins.jim@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 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of August 18, 

2004 (69 FR 51301) (FRL–7364–5), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 0F6195, 1F6274, 

2F6487, and 3F6570) by Monsanto 

Company, 600 13th St., NW., Suite 660, 

Washington, DC 20005. The petition 

requested that 40 CFR 180.364 be 

amended by establishing a tolerance for 

residues of the herbicide glyphosate, N-

(phosphonomethyl)glycine, in or on 

alfalfa seed at 0.5 parts per million 

(ppm) (PP 2F6487); increasing the 

current tolerance for cotton, gin 

byproducts from 100 ppm to 150 ppm 

(PP 3F6570); rice, bran at 30 ppm; rice, 

grain at 15 ppm; and rice, hulls at 25 

ppm (PP 1F6274); wheat, forage at 10.0 

ppm; wheat, hay at 10.0 ppm (PP 

0F6195). Monsanto Company also 

proposed to revise the entry for grain, 

cereal group tolerance ‘‘except rice’’ to 

read as grain, cereal group 15 except 

barley, field corn, grain sorghum, oats, 

rice, and wheat at 0.1 ppm (PP 1F6274). 

Monsanto Company also amended PP 

0F6195 to delete the proposal for wheat 

grain at 6 ppm that was announced in 

the Federal Register of April 17, 2002 

(67 FR 18894) (FRL–6830–5). The notice 

stated that tolerances for alfalfa, rice, 

wheat, and cotton gin byproducts 

include both conventional and 

genetically altered crops.

The notice also proposed that the 

tolerances for alfalfa, forage at 175 ppm 

and alfalfa, hay at 400 ppm be deleted 

from § 180.364. Also proposed was to 

amend § 180.364 by replacing the 

current listing vegetable, legume, group 

6 except soybean at 5.0 ppm with the 

current crop group pea and bean, dried 

and shelled, subgroup 6C at 5.0 ppm. 

That notice included a summary of the 

petition prepared by Monsanto 

Company, the registrant. One comment 

was received in response to the notice 

of filing from B. Sachau, 15 Elm St., 

Florham Park, NJ 07932. The 

commenter objected to allowing any 

tolerance, wavier, or exemption for 

glyphosate. The commenter also 

objected to animal testing and stated 

that a more reliable method of testing 

should be developed. This comment is 

discussed further in Unit V.

During the course of the review the 

Agency decided to correct the company 

address to read Monsanto Company, 

1300 I St., NW., Suite 450 East, 

Washington, DC 20005. The Agency also 

determined the tolerance proposed for 

cotton, gin byproducts should be raised 

to 175 ppm and that the current 

tolerance for cotton, undelinted seed be 

increased to 35 ppm.

The Agency has determined that 

based on available data, the current 

tolerances for alfalfa, forage and alfalfa, 

hay are to be maintained and that the 

current listing for vegetable, legume,