Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49499

FR 38025) is withdrawn as of August 24, 

2005.

[FR Doc. 05–16810 Filed 8–23–05; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2005–0225; FRL–7731–2]

Myclobutanil; Pesticide Tolerances for 

Emergency Exemptions

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

myclobutanil in or on soybeans. 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 

soybeans. This regulation establishes a 

maximum permissible level for residues 

of myclobutanil in this food commodity. 

The tolerance will expire and is revoked 

on December 31, 2009.

DATES: This regulation is effective 

August 24, 2005. Objections and 

requests for hearings must be received 

on or before October 24, 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–2005–

0225. 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., 

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 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 on 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 combined 

residues of the fungicide myclobutanil 

alpha-butyl-alpha-(4-chlorophenyl)-1H1,2,4-triazole-1-propanenitrile and its 

alcohol metabolite (alpha-(3-

hydroxybutyl)-alpha-(4-chlorophenyl)-

1H-1,2,4-triazole-1-propanenitrile (free 

and bound), in or on soybean at 0.05 

parts per million (ppm). 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 

Myclobutanil on Soybeans and FFDCA 

Tolerances

The States of Minnesota and South 

Dakota, as lead state agencies in what is 

essentially a ‘‘national’’ section 18 

request for all soybean growing states, 

have petitioned the Agency requesting 

an emergency exemption for 

myclobutanil to control soybean rust 

49500 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). On November 10, 2004, the 

U.S. Department of Agriculture’s 

Animal and Plant Health Inspection 

Service (USDA/APHIS) confirmed the 

presence of Phakopsora pachyrhizi, the 

pathogen that causes soybean rust, on 

soybean leaf samples taken from two 

plots associated with a Louisiana State 

University research farm. Soybean rust 

has been designated as a biosecurity 

threat and therefore it is important that 

control measures be available for the 

disease. EPA has authorized under 

FIFRA section 18 the use of 

myclobutanil on soybeans for control of 

soybean rust in Minnesota, South 

Dakota, and all the other states that have 

requested an exemption for this use. 

After having reviewed the submission, 

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 

myclobutanil in or on soybeans. 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, 

2009, 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 soybeans 

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 myclobutanil meets EPA’s 

registration requirements for use on 

soybeans 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 

myclobutanil 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 those which have 

been granted exemptions as part of the 

soybean rust section 18 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 myclobutanil, 

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 myclobutanil and to 

make a determination on aggregate 

exposure, consistent with section 

408(b)(2) of the FFDCA, for a timelimited tolerance for residues of 

myclobutanil in or on soybeans at 0.05 

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 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 myclobutanil used for human risk 

assessment is shown in the following 

table:

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49501

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

ASSESSMENT

Exposure/Scenario Dose Used in Risk/Assessment, UF 

Hazard and Exposure 

Based Special FQPA Safety Factor*Study and Toxicological Effects 

Acute dietary 

(Females 13–50)

NOAEL = 60 milligrams/

kilogram/day (mg/kg/day) 

UF =100

Acute RfD = 0.6 mg/kg/day

FQPA SF = 1X 

aPAD = acute RfD

= 0.6 mg/kg/day

Developmental toxicity study - Rats 

LOAEL = 200 mg/kg/day based on increased 

resorptions, decreased litter size

Chronic dietary 

(All populations)

NOAEL= 2.49 mg/kg/day 

UF = 100

Chronic RfD = 0.025 mg/

kg/day

FQPA SF = 1X 

cPAD = chronic RfD

= 0.025 mg/kg/day

Chronic toxicity/Oncogenicity study - Rats 

LOAEL = 10 mg/kg/day based on decreased 

testicular weights and increased testicular atrophy

Short-term (1–30 days) 

Dermal

NOAEL = 100 mg ai/kg/day Residential MOE = 100 28–day Dermal toxicity - Rats 

There were no signs of toxicity at the high 

dose of 100 mg/kg a.i.

Intermediate-term 

(1–6 months) Dermal

Oral NOAEL = 10 mg ai/kg/

day

Residential MOE = 100 2–Generation reproduction toxicity - Rats 

LOAEL = 50 mg/kg bw/day based on atrophy 

of the testes and prostate as well as an increase in the number of stillborn pups and a 

decrease in pup weight gain during lactation

Long-term 

Dermal (> 6 months)

Oral NOAEL = 2.49 mg/kg/

day

Residential MOE = 100 Chronic toxicity/Carcinogenicity - Rats 

LOAEL = 10 mg/kg/day based on decreased 

testicular weights and increased testicular atrophy

Short-term (1–30 Days) 

Inhalation

Oral NOAEL = 10 mg/kg/

day

Residential MOE = 100 2–Generation reproduction toxicity study - Rats 

LOAEL = 50 mg/kg bw/day based on atrophy 

of the testes and prostate as well as an increase in the number of stillborn pups and a 

decrease in pup weight gain during lactation

Intermediate-term (1–6 months) 

Inhalation

Oral NOAEL = 10 mg/kg/

day

Residential MOE = 100 2–Generation reproduction toxicity study - Rats 

LOAEL = 50 mg/kg bw/day based on atrophy 

of the testes and prostate as well as an increase in the number of stillborn pups and a 

decrease in pup weight gain during lactation

Long-term 

Inhalation (> 6 months)

Oral NOAEL = 2.49 mg/kg/

day

Residential MOE = 100 Chronic toxicity/Carcinogenicity - Rats 

LOAEL = 10 mg/kg/day based on decreased 

testicular weights and increased testicular atrophy

Cancer Group E- likely not a human carcinogen

* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and 

drinking water. Tolerances are 

established for combined residues of the 

fungicide myclobutanil alpha-butyl–

alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile and its alcohol 

metabolite alpha-(3-hydroxybutyl)-

alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile (free and 

bound), ranging from 0.02 ppm on 

cotton seed and eggs to 25 ppm on grape 

raisin waste. Time-limited tolerances 

and tolerances for inadvertent residues 

have also been established.

In conducting the acute and chronic 

dietary risk assessments, EPA used the 

Dietary Exposure Evaluation Model 

(DEEMTM) software. Modeled estimates 

of drinking water concentrations were 

directly entered into the exposure 

model to assess the contribution from 

drinking water. Risk assessments were 

conducted by EPA to assess dietary 

exposures from myclobutanil 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 DEEMTM

analysis evaluated the individual food 

consumption as reported by 

respondents in the USDA 1994–1996 

and 1998 nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

acute analysis is a conservative Tier 1 

assessment based on tolerance-level 

residues and the assumption of 100% 

crop treated (PCT) for established and 

proposed myclobutanil tolerances. 

DEEMTM default processing factors from 

DEEMTM (Version 7.76) were used for 

all processed commodities that do not 

have individual tolerances. Aggregate 

acute food and water exposure was 

determined by including modeled 

estimates of drinking water 

concentrations in the dietary model. 

The highest estimate for acute water 

exposure, 333 parts per billion (ppb), 

was used in the analysis.

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 

49502 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

1994–1996 and 1998 nationwide CSFII 

and accumulated exposure to the 

chemical for each commodity. The 

chronic analysis is based on partially 

refined Tier 3 assumptions in that it 

incorporates estimates of average PCT 

for some crops, as well as Pesticide Data 

Program (PDP) monitoring data from 

apple juice, bananas (not plantains) and 

milk. The following average PCT 

information was used: Apples, 40%; 

apricots, 15%; cherries, 40%; grapes, 

45%; nectarines, 20%; peaches, 10%; 

plums, 15%; and cotton, 1%. One 

hundred PCT was assumed for all other 

commodities. DEEMTM default 

processing factors from DEEMTM

(Version 7.76) were used for all 

processed commodities that do not have 

individual tolerances. Aggregate chronic 

food and water exposure was 

determined by including modeled 

estimates of drinking water 

concentrations in the dietary model. 

The highest estimate for chronic water 

exposure, 86 ppb, was used in the 

analysis.

iii. Cancer. The Agency has classified 

myclobutanil as a ‘‘Group E - not likely 

human carcinogen’’ and, therefore, 

quantification of human cancer risk is 

not required.

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 pursuant to section 408(f)(1) 

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. For the present 

action, EPA will issue such Data CallIns for information relating to 

anticipated residues as are required by 

FFDCA section 408(b)(2)(E) and 

authorized under FFDCA section 

408(f)(1). Such Data Call-Ins will be 

required 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: Apples, 40%; apricots, 15%; 

cherries, 40%; grapes, 45%; nectarines, 

20%; peaches, 10%; plums, 15%; and 

cotton, 1%.

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 

myclobutanil 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 

myclobutanil 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 

myclobutanil.

The Agency uses the First Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone/Exposure Analysis 

Modeling System (PRZM/EXAMS) to 

produce estimates of pesticide 

concentrations in an index reservoir. 

The screening concentration in ground 

water (SCI-GROW) model is used to 

predict pesticide concentrations in 

shallow ground water. For a screeninglevel assessment for surface water EPA 

will generally use FIRST (a Tier 1 

model) before using PRZM/EXAMS (a 

Tier 2 model). The FIRST model is a 

subset of the PRZM/EXAMS model that 

uses a specific high-end runoff scenario 

for pesticides. While both FIRST and 

PRZM/EXAMS incorporate an index 

reservoir environment, 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.

Based on the FIRST and SCI-GROW 

models, the estimated environmental 

concentrations (EECs) of myclobutanil 

for acute exposures are estimated to be 

333 ppb for surface water and 3.2 ppb 

for ground water. The EECs for chronic 

exposures are estimated to be 86 ppb for 

surface water and 3.2 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).

Myclobutanil is present in numerous 

end-use products, including those 

registered for use on turf, roses, flowers, 

shrubs and trees. Soluble concentrate 

may be applied with hose-end or trigger 

bottle sprayers. Small scale lawn 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49503

application has the greatest potential for 

homeowner exposures. Short- and 

intermediate-term exposures are 

expected for residential handlers. The 

Agency has determined that a 50% 

dermal absorption factor should be 

applied for intermediate-term 

assessments. A dermal absorption factor 

is not required for short-term 

assessments because the NOAEL used is 

based upon a 28–day dermal study.

4. Cumulative effects from 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

myclobutanil and any other substances 

and myclobutanil 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 myclobutanil has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http://

www.epa.gov/pesticides/cumulative/.

However, the Agency does have 

concern about potential toxicity to 1,2,4-

triazole and two conjugates, 

triazolylalanine and triazolyl acetic 

acid, metabolites common to most of the 

triazole fungicides. To support the 

extension of existing parent triazolederivative fungicide tolerances, EPA 

conducted an interim human health 

assessment for aggregate exposure to 

1,2,4-triazole. The exposure and risk 

estimates presented in this assessment 

are overestimates of actual likely 

exposures and therefore, should be 

considered to be highly conservative. 

Based on this assessment EPA 

concluded that for all exposure 

durations and population subgroups, 

aggregate exposures to 1,2,4-triazole are 

not expected to exceed EPA’s LOC. This 

assessment is presented in the April 22, 

2005 Federal Register (70 FR 20821) 

(FRL–7702–4) notice for another triazole 

fungicide, tetraconazole. This 

assessment should be considered 

interim due to the ongoing series of 

studies being conducted by the U.S. 

Triazole Task Force (USTTF). Those 

studies are designed to provide the 

Agency with more complete 

toxicological and residue information 

for free triazole. Upon completion of the 

review of these data, EPA will prepare 

a more sophisticated assessment based 

on the revised toxicological and 

exposure data bases.

C. Safety Factor for Infants and Children

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.

As outlined in Table 1 (above), there 

is a complete toxicity data base for 

myclobutanil and exposure data are 

complete or are estimated based on data 

that reasonably accounts for potential 

exposures. In a range of laboratory 

studies to indicate concerns regarding 

developmental toxicity, reproductive 

toxicity and prenatal and postnatal 

sensitivity, EPA’s analysis reconfirmed 

previous findings, that an additional 

FQPA safety factor is not necessary for 

myclobutanil. Existing default safety 

factors provide adequate protection for 

public health, including for infants and 

children.

D. Aggregate Risks and Determination of 

Safety

The Agency currently has two ways to 

estimate total aggregate exposure to a 

pesticide from food, drinking water, and 

residential uses. First, a screening 

assessment can be used, in which the 

Agency calculates drinking water levels 

of comparison (DWLOCs) which are 

used as a point of comparison against 

EECs. The DWLOC values are not 

regulatory standards for drinking water, 

but 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 + residential 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 the chemical 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 myclobutanil on drinking 

water as a part of the aggregate risk 

assessment process.

More recently the Agency has begun 

using another approach to estimate 

aggregate exposure through food, 

residential and drinking water 

pathways. In this approach, modeled 

surface water and ground water EECs 

are directly incorporated into the 

dietary exposure analysis, along with 

food. This can provide a more realistic 

estimate of exposure because actual 

body weights and water consumption 

from the CSFII can often be used. The 

combined food and water exposures are 

then added to estimated exposure from 

residential sources to calculate aggregate 

risks. Combining screening level 

estimates of pesticide residues in 

drinking water from drinking water 

models with what may be more realistic 

values for residues in food is not ideal. 

Once screening level values are 

combined with more realistic values it 

is easy to lose sight of the fact that 

aggregate exposure estimate is based on 

a mixture of very conservative and more 

realistic estimates. Nonetheless, this 

49504 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

concern with mixing screening level 

and more realistic values is outweighed 

where the Agency is able to incorporate 

information on actual body weights and 

water consumption into the aggregate 

exposure calculation. This risk 

assessment for myclobutanil was 

conducted using this approach.

1. Acute risk. The acute dietary 

endpoint for females in the 13 to 50 year 

age group is based on the NOAEL for a 

developmental toxicity in rabbits which 

manifested as increases in resorptions, 

decreases in litter size. This endpoint is 

considered appropriate for females of 

childbearing age (13–50 years old) since 

the effects could occur due to a single 

in utero exposure. There were no 

appropriate toxicological effects for the 

general population attributable to a 

single exposure (dose) observed in oral 

toxicity studies including the maternal 

effects in the developmental toxicity 

studies in rats and rabbits. Therefore, an 

acute dose and an endpoint were not 

selected for the general population for 

this risk assessment.

Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to myclobutanil 

will occupy 4% of the aPAD for the 

population subgroup of interest, females 

13–49 years old.

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO

MYCLOBUTANIL

Population 

Subgroup 

aPAD (mg/

kg) 

% aPAD/

(Food + 

Water) 

Females (13–

49 years 

old) 0.6 4%

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to myclobutanil from food 

and water will utilize 21% of the cPAD 

for the U.S. population, 41% of the 

cPAD for all infants < 1 year old, and 

45% of the cPAD for children 1–2 years 

old. Based the use pattern, chronic 

residential exposure to residues of 

myclobutanil is not expected.

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

EXPOSURE TO MYCLOBUTANIL

Population 

Subgroup 

cPAD/(mg/

kg/day) % cPAD 

General U.S. 

population 0.025 21%

All Infants (<

1 year old) 0.025 41%

Children (1–2 

years old) 0.025 45%

Children (3–5 

years old) 0.025 38%

Children (6–

12 years 

old) 0.025 25%

Youth (13–19 

years old) 0.025 16%

Adults (20–49 

years old) 0.025 18%

Adults (50+ 

years old) 0.025 19%

Females (13–

49 years 

old) 0.025 18%

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).

Myclobutanil is currently registered 

for uses that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for myclobutanil. 

For short-term aggregate exposure risk 

assessment, even though there was no 

systemic toxicity in a dermal study, by 

combining dermal with oral and 

inhalation exposures would provide the 

most conservative risk assessment 

approach. Since all the acceptable shortterm MOEs are 100 but the NOAELs 

vary (short-term dermal NOAEL is 100 

mg/kg/day, all others are 10 mg/kg/day), 

the reciprocal equation approach will be 

used to calculate aggregate short-term 

risk estimates. The aggregate short-term 

exposure estimates are below the 

Agency’s LOC (MOEs < 100).

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO MYCLOBUTANIL

Population Subgroup Target MOE 

Food + Water 

Dermal 

MOE Oral MOE Aggregate 

NOAEL1 MOE3

(mg/kg/day) 

Average 

Food + 

Water Exposure (mg/kg/

day) 

MOE2

Children (1–2 years old) 100 10 0.011230 890 830 140 110

U.S. population 100 10 0.005234 1,900 1,400 N/A 800

1 Short-term Oral NOAEL

2 MOE = NOAEL/Exposure

3 Aggregate MOE = [1÷ ((1/MOE Food + Water) + (1/MOE Dermal) + (1/MOE Oral))]

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).

Myclobutanil is currently registered 

for use(s) that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for myclobutanil. For 

myclobutanil intermediate-term 

aggregate exposure risk assessment, oral, 

dermal and inhalation exposures can be 

combined because dermal and 

inhalation exposures can be expressed 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49505

as oral equivalent doses. The aggregate 

intermediate-term exposure estimates 

for myclobutanil do not include 

inhalation exposure, as there is no 

associated scenario.

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

330 for children 1–2 years old and 620 

for the general U.S. population. These 

aggregate MOEs do not exceed the 

Agency’s LOC for aggregate exposure to 

food, water and residential uses.

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO MYCLOBUTANIL

Population Subgroup NOAEL 

(mg/kg/day) 

Max allowable exposure1 (mg/

kg/day) 

Average 

Food + 

Water Exposure (mg/kg/

day) 

Dermal Exposure (mg/

kg/day) 

Oral Exposure (mg/kg/

day) 

Residential 

Exposure 

(mg/kg/

day)2

Aggregate 

MOE3

Children (1–2 years old) 10 0.1 0.011230 0.018 0.0013 0.0193 330

U.S. population 10 0.1 0.005234 0.011 N/A 0.011 620

1 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE of 100.

2 Residential Exposure = The combined dermal and incidental oral ingestion for infants and dermal only for adults.

3 Aggregate MOE = [NOAEL ÷ (Avg Food & Water Exposure + Residential Exposure)]

5. Aggregate cancer risk for U.S. 

population. The Agency has classified 

myclobutanil as a ‘‘Group E - not likely 

human carcinogen’’ and, therefore, 

quantification of human cancer risk is 

not required.

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 myclobutanil 

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 CODEX, Canadian, or 

Mexican Maximum Residue Limits 

(MRLs) for myclobutanil on soybeans. 

Therefore, there are no international 

harmonization issues associated with 

this action.

VI. Conclusion

Therefore, the tolerance is established 

for combined residues of the fungicide 

myclobutanil alpha-butyl-alpha-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile and its alcohol 

metabolite (alpha-(3-hydroxybutyl)-

alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile (free and 

bound), in or on soybeans at 0.05 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–2005–0225 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 October 24, 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 issue(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–2005–0225, 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. 

49506 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

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 

issue(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 

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: August 12, 2005.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

n Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

n 1. The authority citation for part 180 

continues to read as follows:

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

n 2. Section 180.443 is amended by 

alphabetically adding a commodity to 

the table in paragraph (b) to read as 

follows:

§ 180.443 Myclobutanil; tolerances for 

residues.

* * * * *

(b) * * *

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49507

Commodity Parts per million Expiration/Revocation Date 

*****

Soybean ....................................................................................................................................................... 0.05 12/31/09

* * * * *

[FR Doc. 05–16805 Filed 8–23–05; 8:45 am]

BILLING CODE 6560–50–S

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric 

Administration

50 CFR Part 679

[Docket No. 041126333–5040–02; I.D. 

081805B]

Fisheries of the Economic Exclusive 

Zone Off Alaska; Shallow-Water 

Species Fishery by Vessels Using 

Trawl Gear in the Gulf of Alaska

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce.

ACTION: Temporary rule; closure.

SUMMARY: NMFS is prohibiting directed 

fishing for species that comprise the 

shallow-water species fishery by vessels 

using trawl gear in the Gulf of Alaska 

(GOA). This action is necessary because 

the third seasonal apportionment of the 

2005 Pacific halibut bycatch allowance 

specified for the shallow-water species 

fishery in the GOA has been reached.

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), August 19, 2005, through 

1200 hrs, A.l.t., September 1, 2005.

FOR FURTHER INFORMATION CONTACT: Josh 

Keaton, 907–586–7228.

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

GOA exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Gulf of 

Alaska (FMP) prepared by the North 

Pacific Fishery Management Council 

under authority of the MagnusonStevens Fishery Conservation and 

Management Act. Regulations governing 

fishing by U.S. vessels in accordance 

with the FMP appear at subpart H of 50 

CFR part 600 and 50 CFR part 679.

The third seasonal apportionment of 

the 2005 Pacific halibut bycatch 

allowance specified for the shallowwater species fishery in the GOA is 200 

metric tons as established by the 2005 

and 2006 harvest specifications for 

groundfish of the GOA (70 FR 8958, 

February 24, 2005), for the period 1200 

hrs, A.l.t., July 5, 2005, through 1200 

hrs, A.l.t., September 1, 2005.

In accordance with § 679.21(d)(7)(i), 

the Administrator, Alaska Region, 

NMFS, has determined that the third 

seasonal apportionment of the 2005 

Pacific halibut bycatch allowance 

specified for the trawl shallow-water 

species fishery in the GOA has been 

reached. Consequently, NMFS is 

prohibiting directed fishing for the 

shallow-water species fishery by vessels 

using trawl gear in the GOA. The 

species and species groups that 

comprise the shallow-water species 

fishery are pollock, Pacific cod, shallowwater flatfish, flathead sole, Atka 

mackerel, skates and ‘‘other species.’’

This closure does not apply to fishing 

for pollock by vessels using pelagic 

trawl gear in those portions of the GOA 

open to directed fishing for pollock.

After the effective date of this closure 

the maximum retainable amounts at 

§§ 679.20(e) and (f) apply at any time 

during a trip.

Classification

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such requirement is 

impracticable and contrary to the public 

interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay the closure of the shallow-water 

species fishery by vessels using trawl 

gear in the GOA.

The AA also finds good cause to 

waive the 30-day delay in the effective 

date of this action under 5 U.S.C. 

553(d)(3). This finding is based upon 

the reasons provided above for waiver of 

prior notice and opportunity for public 

comment.

This action is required by § 679.21 

and is exempt from review under 

Executive Order 12866.

Authority: 16 U.S.C. 1801 et seq.

Dated: August 18, 2005.

Alan D. Risenhoover,

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service.

[FR Doc. 05–16839 Filed 8–19–05; 2:24 pm]

BILLING CODE 3510–22–S