58304 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 FFDCA section 408(n)(4). 

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.

XI. 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: September 23, 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. In § 180.910, the table is amended by 

adding alphabetically the following inert 

ingredient to read as follows:

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance.

* * * * *

Inert Ingredients Limits Uses 

*****

1-Octanal 

(CAS Reg. 

No. 124–

13–0) 

Not more 

than 0.2% 

of the pesticide formulation

Odor masking 

agent

*****

■ 3. In § 180.930, the table is amended by 

adding alphabetically the following inert 

ingredient to read as follows:

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance.

* * * * *

Inert Ingredients Limits Uses 

*****

1-Octanal 

(CAS Reg. 

No. 124–

13–0)

Not more 

than 0.2% 

of the pesticide formulation

Odor masking 

agent

Inert Ingredients Limits Uses 

*****

[FR Doc. 04–21937 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0313; FRL–7678–8]

Mesotrione; Pesticide Tolerances for 

Emergency Exemptions

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

mesotrione, 2-[4-(methylsulfonyl)-2-

nitrobenzoyl]-1,3-cyclohexanedione, in 

or on cranberry. 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 

cranberry. This regulation establishes a 

maximum permissible level for residues 

of mesotrione in this food commodity. 

The tolerance will expire and is revoked 

on December 31, 2007.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

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–

0313. 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 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58305

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Libby Pemberton, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; 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 code 111)

• Animal production (NAICS code 

112)

• Food manufacturing (NAICS code 

311)

• Pesticide manufacturing (NAICS 

code 32532).

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Access Electronic Copies 

of this Document 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(l)(6) of the Federal Food, Drug, and 

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

is establishing a tolerance for residues of 

the herbicide mesotrione, 2-[4-

(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on cranberry at 

0.01 parts per million (ppm). This 

tolerance will expire and is revoked on 

December 31, 2007. EPA will publish a 

document in the Federal Register to 

remove the revoked tolerance 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 

Mesotrione on Cranberry and FFDCA 

Tolerances

The States claim that emergency 

situations have occurred due to new 

pests that have been introduced into 

cranberry producing areas. Oregon and 

Washington have both declared crisis 

exemptions under FIFRA section 18 for 

the use of mesotrione on cranberry for 

control of several broadleaf weeds. EPA 

concurs that emergency conditions exist 

for these States.

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

mesotrione in or on cranberry. 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 

this tolerance without notice and 

opportunity for public comment as 

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

FFDCA. Although this tolerance will 

expire and is 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 

tolerance remaining in or on cranberry 

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 a level 

that was authorized by this tolerance at 

the time of that application. EPA will 

take action to revoke this tolerance 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe.

Because this tolerance is being 

approved under emergency conditions, 

EPA has not made any decisions about 

whether mesotrione meets EPA’s 

registration requirements for use on 

cranberry or whether a permanent 

tolerance for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this tolerance 

serves as a basis for registration of 

mesotrione by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance serve as the basis for 

any State other than Oregon and 

Washington to use this pesticide on this 

crop under section 18 of FIFRA without 

following all provisions of EPA’s 

regulations implementing FIFRA section 

18 as identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for mesotrione, 

contact the Agency’s Registration 

Division at the address provided 

underFOR FURTHER INFORMATION

CONTACT.

58306 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 mesotrione and to make 

a determination on aggregate exposure, 

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

FFDCA, for a time-limited tolerance for 

residues of mesotrione in or on 

cranberry at 0.01 ppm. EPA’s 

assessment of the dietary exposures and 

risks associated with establishing the 

tolerance follows.

A. Toxicological Endpoints

The dose at which no adverse effects 

are observed (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 LOAEL) is sometimes 

used for risk assessment if no 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 (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor 

(SF) 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 x 10-6 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. A 

summary of the toxicological endpoints 

for mesotrione used for human risk 

assessment is shown in the following 

Table 1:

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

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF 

FQPA SF and LOC for 

Risk Assessment Study and Toxicological Effects 

Acute dietary 

all populations 

Not applicable Not applicable No appropriate study available.

Chronic dietary 

all populations

LOAEL = 2.1 milligrams/

kilograms/day (mg/kg/

day) 

UF = 3 

Chronic RfD = 0.007 mg/

kg/day

FQPA SF = 10X 

cPAD = chronic RfD ÷

FQPA SF = 0.0007 mg/

kg/day

Reproduction study - mouse 

Offspring LOAEL = 2.1 mg/kg/day based upon 

tyrosinemia in F1 and F2a offspring and ocular discharge in F1 pups.

Short-term dermal (1–7 days) 

(Occupational/Residential)

Oral study 

LOAEL = 100 mg/kg/day 

(dermal-absorption rate = 

25%)

LOC for MOE = 300 (Occupational) 

LOC for MOE = 3,000 

(Residential)

Developmental toxicity study - rat 

Developmental LOAEL = 100 mg/kg/day based 

upon delays in skeletal ossification and 

changes in manus/pes ossification assessments.

Short-term inhalation (1–7 days) 

(Occupational/Residential)

Oral study LOAEL = 100 

mg/kg/day 

(inhalation-absorption rate 

= 100%)

LOC for MOE = 300 (Occupational) 

LOC for MOE = 3,000 

(Residential).

Developmental toxicity study - rat 

Developmental LOAEL = 100 mg/kg/day based 

upon delays in skeletal ossification and 

changes in manus/pes ossification assessments.

Cancer (oral, dermal, inhalation) ‘‘Not likely’’ Not applicable Acceptable oral rat and mouse carcinogenicity 

studies; no evidence of carcinogenic or mutagenic potential.

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58307

B. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.571) for the 

residues of mesotrione, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

mesotrione 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 one 

day or single exposure. No appropriate 

study available show any acute dietary 

effects of concern.

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

Dietary Exposure Evaluation Model 

(DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1989–1992 nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Residue levels are at the recommended 

tolerances for cranberry, field and sweet 

corn, and 100% of the crop is treated 

with mesotrione. The % cPAD for the 

general U.S. population is 2.3% and for 

the most sensitive population 

subgroups, Children (1–6 years old), is 

5.4%

iii. Cancer. Acceptable oral rat and 

mouse carcinogenicity studies showed 

no evidence of carcinogenic or 

mutagenic potential.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

mesotrione 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 

mesotrione.

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 

screening concentration in ground water 

(SCI-GROW), 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 

pond scenario. The PRZM/EXAMS 

model includes a percent crop area 

factor as an adjustment to account for 

the maximum percent crop 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 LOC.

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 mesotrione 

they are further discussed in the 

aggregate risk sections below.

Based on the GENEEC (Version 1.2) 

and SCI-GROW models the EECs of 

mesotrione for acute exposures are 

estimated to be 20 parts per billion 

(ppb) for surface water and 0.15 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 4.3 ppb 

for surface water and 0.15 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). 

Mesotrione 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 

mesotrione 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, 

mesotrione 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 mesotrione 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. Prenatal and postnatal sensitivity.

There is quantitative evidence of 

increased susceptibility of the young 

exposed to mesotrione in the prenatal 

developmental toxicity studies in rats, 

mice, and rabbits. Delayed ossification 

was seen in the fetuses at doses below 

those at which maternal toxic effects 

were noted. Maternal toxic effects in the 

rat were decreased body weight gain 

during treatment and decreased food 

consumption and in the rabbit, 

abortions and GI effects.

3. Conclusion. The FQPA safety factor 

(10x) is retained in assessing the risk 

posed because there is quantitative 

evidence of increased susceptibility of 

the young exposed to mesotrione in the 

prenatal developmental toxicity studies 

in mice, rats, and rabbits and in the 

multi-generation reproduction study in 

mice, there is qualitative evidence of 

increased susceptibility of the young 

58308 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

exposed to mesotrione in the multigeneration reproduction study in rats; 

and a Developmental Neurotoxicity 

Study is required to assess the effects of 

tyrosinemia on the developing nervous 

system exposed to mesotrione.

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 

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 mesotrione 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 mesotrione on drinking water 

as a part of the aggregate risk assessment 

process.

1. Acute risk. Acute doses and 

endpoints were not selected for the 

general U.S. population (including 

infants and children) or the females 13–

50 years old population subgroup for 

mesotrione; therefore, an acute dietary 

exposure analysis was not performed. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to mesotrione from food 

will utilize 2.3% of the cPAD for the 

U.S. population, 2.9% of the cPAD for 

all infants <1 year old and 5.4% of the 

cPAD for children (3–5 years old). There 

are no residential uses for mesotrione 

that result in chronic residential 

exposure to mesotrione. In addition, 

despite the potential for chronic dietary 

exposure to mesotrione in drinking 

water, after calculating DWLOCs and 

comparing them to conservative model 

EECs of mesotrione 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 2:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO MESOTRIONE

Population Subgroup cPAD (mg/

kg/day) 

% cPAD 

(food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.0007 2.3 4.3 0.15 23.8

All infants 0.0007 2.9 4.3 0.15 6.8

Children (1–6) years old) 0.0007 5.4 4.3 0.15 6.7

Females (13–49 years old) 0.0007 1.58 4.3 0.15 20.7

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).

Mesotrione 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).

Mesotrione 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. Based on the lack of 

carcinogenic response in rats and mice 

and the lack of mutagenic effects, and 

that there are no data in the literature or 

SAR information to indicate 

carcinogenic potential, no cancer risk is 

posed. 

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 mesotrione 

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

(high pressure liquid 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 CODEX, Canadian, or 

Mexican tolerances/Maximum Residue 

Levels for mesotrione residues. Thus, 

harmonization is not an issue at this 

time.

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58309

C. Conditions

Data deficiencies include the 

following:

1. Storage stability data in the plant 

and livestock metabolism studies.

2. Revised interference study.

3. Developmental neurotoxicity (DNT) 

study in the mouse. (A DNT study is 

required in the mouse in order to better 

characterize the effects of tyrosinemia 

on the developing nervous system and 

to correlate plasma tyrosine levels to 

neurotoxic effects.)

4. A 28-day inhalation toxicity study.

VI. Conclusion

Therefore, the tolerance is established 

for residues of mesotrione, 2-[4-

(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on cranberry at 

0.01 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 ID number 

OPP–2004–0313 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 November 29, 2004.

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.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–2004–0313, 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).

VIII. Statutory and Executive Order 

Reviews

This final rule establishes a timelimited tolerance 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 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. 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 

58310 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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: September 24, 2004.

Donald R. Stubbs,

Acting Director, Registration Division, Office 

of Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

■ 2. Section 180.571 is amended by 

alphabetically adding an entry for 

‘‘Cranberry’’ to the table in paragraph (b) 

to read as follows:

§ 180.571 Mesotrione; tolerances for 

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date 

** * **

Cranberry ..................................................................................................................................................... 0.01 12/31/07

* * * * *

[FR Doc. 04–21934 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0289; FRL–7677–1]

Sodium Thiosulfate; Exemption from 

the Requirement of a Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation amends an 

existing exemption from the 

requirement of a tolerance for residues 

of sodium thiosulfate on raw 

agricultural commodities when used in 

pesticide formulations as an inert 

ingredient on raw agricultural 

commodities after harvest. Eden 

Bioscience Corporation submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA), requesting an 

unlimited exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of sodium thiosulfate.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit IX. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0289. 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:

Princess Campbell, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8033; e-mail address: 

campbell.princess@epa.gov.