60820 Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 

than established during the initial or 

subsequent performance test or the daily 

average fan RPM at or above the 

minimum level established during the 

initial or subsequent performance test; 

and 

(ii) Checking the static pressure or fan 

RPM at least every 8 hours to verify the 

daily average static pressure at the inlet 

to the control device is at an equal or 

greater vacuum than established during 

the initial or subsequent performance 

test or the daily average fan RPM is at 

or above the minimum level established 

during the initial or subsequent 

performance test and recording the 

results of each check. 

(e) * * * 

(2) Operating and maintaining a 

COMS and collecting and reducing the 

COMS data according to § 63.7331(j).

* * * * *

(h) For each multicyclone applied to 

pushing emissions and subject to the 

operating limit in § 63.7290(b)(4), you 

must demonstrate compliance by 

meeting the requirements in paragraphs 

(h)(1) through (3) of this section. 

(1) Maintaining the daily average 

pressure drop at a level at or below the 

level established during the initial or 

subsequent performance test. 

(2) Operating and maintaining each 

CPMS according to § 63.7331(k) and 

recording all information needed to 

document conformance with these 

requirements. 

(3) Collecting and reducing 

monitoring data for pressure drop 

according to § 63.7331(e)(1) through (3).

[FR Doc. 04–22871 Filed 10–12–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0299; FRL–7681–8]

Mepanipyrim; Pesticide Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

mepanipyrim, 4-methyl-N-phenyl-6-(1-

propynyl)-2-pyrimidinamine, and its 

metabolite, 4-methyl-N-phenyl-6-(2-

hydroxypropyl)-2-pyrimidinamine, both 

free and conjugated in or on grape; 

grape, raisin; strawberry; and tomato. KI Chemical U.S.A., Inc., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA).

DATES: This regulation is effective 

October 13, 2004. Objections and 

requests for hearings must be received 

on or before December 13, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0299. 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:

Mary L. Waller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

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

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

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

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of May 26, 

2004 (69 FR 29940) (FRL–7357–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E5017) by K-I 

Chemical U.S.A., Inc., 11 Martine Ave., 

9th Floor, White Plains, NY 10606. That 

notice included a summary of the 

petition prepared by K-I Chemical 

U.S.A., the petitioner. One comment 

from a private citizen was received in 

response to the notice of filing. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for combined residues of the fungicide 

mepanipyrim in or on grape at 2.0 parts 

per million (ppm); grape, raisin at 4.0 

ppm; strawberry at 1.5 ppm; and tomato 

at 0.5 ppm.

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

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

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section

Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 60821

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of 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).

III. Aggregate Risk Assessment and 

Determination of Safety

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for combined 

residues of mepanipyrim and its 

metabolite in or on grape at 1.5 ppm; 

grape, raisin at 3.0 ppm; strawberry at 

1.5 ppm; and tomato at 0.5 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. The nature of the 

toxic effects caused by mepanipyrim are 

discussed in Table 1 of this unit as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90-Day oral toxicity rodents (rat)NOAEL = ≥ 55.9/61.3 milligrams/kilogram/day 

LOAEL = Not established 

870.3100 90-Day oral toxicity rodents (rat)NOAEL = Not established

LOAEL = 109/120 mg/kg/day, based on increased total bilirubin, alkaline phosphatase, phospholipids, non-esterified fatty acids in males; increased fatty liver 

changes in both sexes; decreased food efficiency, triglycerides, and phospholipids 

and increased incidence of hepatic abnormalities (yellowish, malformative nodules, 

granulation, hepatodiaphragmatic nodule, and fatty change) in females. 

870.3100 90-Day oral toxicity rodents (mouse)NOAEL = 182/224/mg/kg/day 

LOAEL = 603/675 mg/kg/day (male/female (M/F)), based on increased absolute and 

relative (to body) liver weights in both sexes, increased severity of anisonucleosis 

in male liver, and increased food consumption in males.

870.3150 90-Day oral toxicity in nonrodents (dog) NOAEL = Not established 

LOAEL = 15 mg/kg/day (M/F), based on increased incidences of minimal pigment 

deposition in the Kupffer cells and hepatocytes and increased alanine 

aminotransferase in both sexes.

870.3150 90-Day oral toxicity in nonrodents (dog) NOAEL = 7.5 mg/kg/day 

LOAEL = Not established

870.3700 Prenatal developmental in 

rodents (rat)

Maternal NOAEL = 750/mg/kg/day 

LOAEL was not established. 

Developmental NOAEL = 750 mg/kg/day 

LOAEL was not established. 

870.3700 Prenatal developmental in 

nonrodents (rabbit)

Maternal NOAEL = 90/mg/kg/day 

LOAEL was not established. 

Developmental NOAEL = 90 mg/kg/day 

LOAEL was not established. 

870.3800 Reproduction and fertility 

effects (rats)

Parental/Systemic NOAEL = 3.7/mg/kg/day 

LOAEL = 11.2/12.7 mg/kg/day, based on increased incidence of periacinar 

hepatocytic fatty vacuolation in the P and F1 generation males.

Reproductive NOAEL = 11.2/12.7 mg/kg/day

LOAEL was not established.

Offspring NOAEL = 3.7/4.2/mg/kg/day

LOAEL = 11.2/12.7 mg/kg/day, based on focal inflammation with associated 

hepatocytic vacuolation in the males, periacinar/panacinar hepatocytic fatty 

vacuolation and increased absolute liver eights in the females, and increased relative (to body) liver weights in both sexes.

60822 Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results 

870.3800 Reproduction and fertility 

effects (rats)

Parental/Systemic NOAEL was not established. 

LOAEL = 10.5/12.0 mg/kg/day (M/F), based on increased incidence of periacinar 

hepatocytic fatty vacuolation in the F1 males. 

Reproductive NOAEL = 141.9/165.7/mg/kg/day (M/F) 

LOAEL was not established. 

Offspring NOAEL = 3.7/4.2 mg/kg/day (M/F) 

LOAEL = 10.5/12.0 mg/kg/day (M/F), based on increased liver weights, macroscopic 

hepatic findings (accentuated lobular pattern and pale liver), and hepatocytic fatty 

vacuolation.

870.4300 Combined chronic toxicity/

carcinogenicity rodents 

(rat)

NOAEL = 7.34/9.29/mg/kg/day 

LOAEL = 100/125 mg/kg/day based on increased incidence of clinical signs of toxicity 

in males, decreased body weight, body weight gain and food efficiency in both 

sexes, and evidence of hepatotoxicity, nephrotoxicity, and fatty acid/lipid metabolism disruption in both sexes.

Evidence of carcinogenicity, based on hepatocellular adenomas in females.

870.4100 Chronic toxicity dogs NOAEL = 7.5 mg/kg/day 

LOAEL = 50 mg/kg/day (M/F), based on decreased body weights, body weight gains, 

and food consumption in females; increased leukocytes (neutrophils and 

lymphocytes), decreased erythroid series, and increased myeloid to erythroid ratio 

in both sexes; and indications of liver toxicity, including increased ALT, alkaline 

phosphatase, and ornithine carbamyl transferase, and lipofuscin, enlargement, and 

inflammatory infiltrate in the hepatocytes of both sexes.

870.4300 Carcinogenicity mice NOAEL = 56/68 (M/F) mg/kg/day

LOAEL = 578/681 mg/kg/day (M/F), based on decreased body weights, body weight 

gains, and food efficiency in males, absolute and relative to body liver weights in 

both sexes, and gross and microscopic hepatic lesions in both sexes. 

Evidence of carcinogenicity, based on hepatocellular adenomas and carcinomas in 

male and female mice.

870.5100 Reverse gene mutation 

assay in bacteria 

There was no evidence of induced mutant colonies over background.

870.5300 Forward gene mutation 

assay in mammalian 

cells

There was no evidence that KIF 3535 induced mutant colonies over background in 

the ± S9 activation.

870.5375 In vitro mammalian cytogenetic assayNot clastogenic with or without S9 activation, at any dose tested.

870.5385 In vivo mammalian cytogenetic assayNo increase in aberrant cells were seen in the bone marrow chromosomal aberration 

assay.

870.5395 In vivo mammalian cytogenetic assayDid not induce micronucleated polychromatic erythrocytes (PMCEs) in bone marrow 

at any dose.

870.5500 Bacterial DNA damage 

and repair test

No evidence that DNA damage was induced.

870.5550 UDS synthesis in mammalian cell cultureDid not induce UDS at any dose.

870.7485 Metabolism and pharmacokinetics (rat)In an unacceptable rat metabolism study mepanipyrim was readily absorbed from the 

gastrointestinal tract and about 96% of the administered dose was eliminated in 

feces and urine. Bile was the major route of excretion (72%); and less than 0.1% 

of the dose was eliminated in expired air. There was no sex difference in absorption and elimination of mepanipyrim. Parent and up to 16 metabolites were purported to be identified; however, > 5% of the administered dose was not accounted 

or analyzed in the excreta.

Non-guideline Mechanism of fatty liver 

(rats)

Dietary administration of 4,000 ppm KIF 3535 to male rats may cause fatty liver by a 

mechanism inhibiting the synthesis and/or transport and release of VLDL from the 

liver, as demonstrated by decreased acetate incorporation, decreased serum lipid 

concentrations, increased liver lipid concentrations, decreased VLDL, LDL, and 

HDL-triglycerides and HDL-cholesterol levels in serum, and decreased adipose tissue weight.

Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 60823

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results 

Non-guideline Oxidative damage to hepatic DNA (females rats 

and mice)

Measurement of liver 8-hydroxyguanine were inconsistent and not accompanied by 

vehicle control data, therefore, interpretation of the results were inconclusive.

Non-guideline Induction of lipid 

peroxidation (female 

rats and mice)

Oral or dietary administration of the test compound did not induce hepatic lipid 

peroxidation as measured by thiobarbituric acid-reactive compounds in either female rats or mice in this study.

Non-guideline Induction of mixed function 

oxidase (female rats 

and mice)

Dietary administration of mepanipyrim induced cytochrome P-450 and aminopyrine Ndemthylase activities in the female rat and aminopyrine N-demthylase activity in female mice.

Non-guideline Promotion of liver carcinogenesis (rats)Liver is the target organ, consistent with other studies. The test compound may/or 

may not act as a tumor promoting agent in the two-stage model of hepatic carcinogenesis utilized in the current study.

Non-guideline Liver enzyme induction 

(mice)

Single oral administration of 5000 mg/kg or multiple administrations of 3000 mg/kg/

day KIF-3535 to male mice causes hepatotoxicity (increased liver weights, cellular 

hypertrophy, and increase in cell proliferation) and increase in liver metabolic enzymes (cytochrome P-450).

Non-guideline Liver enzyme induction 

(rat)

Single administration of 5,000 mg/kg or multiple administrations of 2,000 mg/kg KIF3535 to rats caused decrease in body weights, hepatotoxicity (increased liver 

weights, discoloration, cellular hypertrophy, fatty changes, elevated GPT and GOT, 

and increase in cell proliferation) and increase in mild increase in liver metabolic 

enzymes (cytochrome P-450).

B. 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 level 

of concern (LOC). 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.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

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 an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

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 safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the 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). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

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 mepanipyrim used for 

human risk assessment is shown in 

Table 2 of this unit:

60824 Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR MEPANIPYRIM HUMAN HEALTH RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF 

FQPA SF* and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute Dietary Not available None An endpoint of concern attributable to a single 

dose was not identified. An acute RfD was 

not established.

Chronic Dietary all populations NOAEL= 7.3 mg/kg/day 

UF = 100

Chronic RfD = 0.073 mg/

kg/day 

FQPA SF = 1X 

cPAD = chronic RfD 

FQPA SF = 0.073 mg/kg/

day 

Chronic Toxicity - Rat 

Systemic Toxicity LOAEL = 100 mg/kg/day, 

based on increased incidence of clinical 

signs of toxicity in males, decreased body 

weight, body weight gain and food efficiency 

in both sexes, and evidence of 

hepatotoxicity, nephrotoxicity, and fatty acid/

lipid metabolism disruption in both sexes. 

Cancer (oral, dermal, inhalation) EPA concluded that mepanipyrim is ‘‘likely to 

be carcinogenic to humans.’’ For risk assessment purposes EPA derived a Q1*= 1.35 x 

10-2, based on mouse liver combined adenomas and carcinomas.

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Mepanipyrim is a new 

chemical and these are the first 

tolerances to be proposed for this 

chemical. Risk assessments were 

conducted by EPA to assess dietary 

exposures from mepanipyrim 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 oneday or single exposure. There were no 

toxic effects attributable to a single dose. 

An endpoint of concern was not 

identified to quantitate acute dietary 

risk to the general population, including 

infants and children, or to the 

subpopulation females 13–50 years old. 

Therefore, a quantitative acute exposure 

assessment was not performed.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEMFCIDTM), which incorporates food 

consumption data 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 

following assumptions were made for 

the chronic exposure assessments: It 

was assumed that 100% of the crop 

imported from Western Europe was 

treated and that anticipated residues 

based on average field trial data 

occurred on all commodities. Since the 

petitioner provided pesticide product 

labels limited to use in Western Europe 

only, it was assumed that use of 

mepanipyrim would be limited to 

Western Europe. 

iii. Cancer. For the cancer exposure 

assessment, the same assumptions as 

identified in the chronic exposure unit, 

Unit III.C.1.ii., were used. Applying the 

Q1* of 0.0135 (mg/kg/day)-1 to the 

exposure value results in a cancer risk 

estimate of 2.6 x 10-7.

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide chemicals that have 

been measured in food. If EPA relies on 

such information, EPA must pursuant to 

section 408(f)(1) of FFDCA 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.

Section 408(b)(2)(F) of 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 FFDCA, EPA may 

require registrants to submit data on 

PCT.

The Agency used PCT information as 

follows: The percentage of imported 

crops from Western Europe which are 

consumed by the United States are as 

follows: Grapes, fresh - 1%; grape, juice 

- 1%; grape, raisin - 3.3%; strawberry, 

fresh - 1%; strawberry, juice - 31.5%; 

tomatoes, fresh - 1.3% and tomatoes, 

processed - 4%.

The Agency believes that the three 

conditions listed in Unit III. have been 

met. With respect to Condition 1, the 

PCT estimates were derived from the 

U.S. Department of Agriculture’s 

Economic Service and the U.S. Census 

Bureau for the period of 1981–2000 to 

determine the imported share of U.S. 

consumed food. Additionally, import 

data from the Foreign Agricultural 

Trade of the United States (FATUS) 

database which is used as the official 

United States source of import and 

export data served as the source to 

determine the percentage of imported 

grapes, strawberries, and tomatoes 

imported from Western Europe. Import 

data from the years 2000 to 2003 was 

analyzed and averaged in order to 

estimate the percentage of imports. The 

Agency believes this data is reliable as 

the import data was stable over a 3 year 

period, and the United States has other 

major sources favored for import of 

these commodities. As to Conditions 2 

and 3, regional consumption 

information and consumption 

Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 60825

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 

mepanipyrim may be applied in a 

particular area.

2. Dietary exposure from drinking 

water. The proposed tolerances are for 

imported commodities only, and there 

are no current or proposed U.S. 

registrations for this chemical. 

Therefore, there is no potential for 

exposure to mepanipyrim through 

drinking water, and a drinking water 

assessment was not performed.

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). There are 

no products containing mepanipyrim 

proposed or registered for residential 

use or that may be applied by 

commercial applicators to residential 

sites. Therefore, a residential exposure 

assessment was not performed.

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

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 

mepanipyrim and any other substances 

and mepanipyrim 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 mepanipyrim 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 OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

at http://www.epa.gov/pesticides/

cumulative/.

D. Safety Factor for Infants and 

Children

1. In general. Section 408 of 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 database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. 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. In applying this provision, 

EPA either retains the default value of 

10X when reliable data do not support 

the choice of a different factor, or, if 

reliable data are available, EPA uses a 

different additional safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate.

2. Prenatal and postnatal sensitivity. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rat and rabbit fetuses to in utero

exposure to mepanipyrim in 

developmental studies. There is no 

quantitative or qualitative evidence of 

increased susceptibility to mepanipyrim 

following pre-/postnatal exposure in a 

2-generation reproduction study. There 

is no concern for developmental 

neurotoxicity resulting from exposure to 

mepanipyrim. Since there was no 

observed evidence of developmental 

neurotoxicity in short and long-term 

toxicity studies in rats, mice, and dogs, 

a developmental neurotoxicity (DNT) 

study is not required.

3. Conclusion. There is a complete 

toxicity database for mepanipyrim and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. There 

is no evidence of susceptibility 

following in utero exposure in the 

developmental toxicity studies in rats or 

rabbits, and in the 2-generation rat 

reproduction study. There are no 

residual uncertainties concerning preand postnatal toxicity and no 

neurotoxicity concerns. The chronic and 

cancer dietary food exposure 

assessments utilizes ARs calculated 

from field trial data and percent crop 

imported from Western Europe data for 

all commodities. Although refined, the 

assessments are based on reliable data 

and will not underestimate exposure/

risk. There is no potential for drinking 

water exposure. There is no potential for 

residential exposure. Based on these 

data and conclusions, EPA reduced the 

FQPA Safety Factor to 1X and a 

developmental neurotoxicity study will 

not be required.

E. Aggregate Risks and Determination of 

Safety

1. Acute risk. An acute endpoint was 

not identified in any of the toxicity 

studies. Therefore, no acute risk is 

expected from exposure to 

mepanipyrim.

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to mepanipyrim from food 

will utilize < 1% of the cPAD for the 

U.S. population, < 1% of the cPAD for 

all infants < 1 year old, and < 1 % of 

the cPAD for children 1–2 years old. 

There are no residential uses for 

mepanipyrim that result in chronic 

residential exposure to mepanipyrim. 

There are no current or proposed U.S. 

registrations of mepanipyrim for the 

United States and, as a result, there is 

no expectation of exposure through 

drinking water. Therefore, EPA does not 

expect the aggregate exposure (dietary) 

to exceed 100% of the cPAD, as shown 

in Table 3 of this unit:

TABLE 3.—SUMMARY OF CHRONIC DIETARY EXPOSURE AND RISK FOR MEPANIPYRIM

Population Subgroup cPAD (mg/kg/day) 

Exposure (mg/kg/day) % cPAD 

DEEM-FCID DEEM-FCID 

General U.S. Population 0.73 19 <1

60826 Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 

TABLE 3.—SUMMARY OF CHRONIC DIETARY EXPOSURE AND RISK FOR MEPANIPYRIM—Continued

Population Subgroup cPAD (mg/kg/day) 

Exposure (mg/kg/day) % cPAD 

DEEM-FCID DEEM-FCID 

All Infants <1 year old) 0.73 0.000006 <1

Children 1–2 years old 0.73 0.000051 <1

Children 3–5 years old 0.73 0.000053 <1

Children 6–12 years old 0.73 0.000028 <1

Youth 13–19 years old 0.73 0.000013 <1

Adults 20–49 years old 0.73 0.000015 <1

Adults 50+ years old 0.73 0.000017 <1

Females 13–49 years old 0.73 0.000015 <1

3. Aggregate cancer risk for U.S. 

population. Applying the Q1* of 0.0135 

(mg/kg/day)-1 to the exposure value 

results in a cancer risk estimate of 2.6 

x 10-7. Therefore, estimated cancer risk 

is below the Agency’s level of concern 

of risk in the range of 1 x 10-6.

4. 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 toinfants and children 

from aggregate exposure to 

mepanipyrim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

(gas chromotography/nitrogenphosphorus detector (GC/NPD) method 

and multi-residue method (MRM)) 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 currently no established 

Codex, Canadian or Mexican maximum 

residue limits (MRLs) for mepanipyrim.

V. Conclusion

Therefore, the tolerances are 

established for combined residues of 

mepanipyrim, 4-methyl-N-phenyl-6-(1-

propynyl)-2-pyrimidinamine, and its 

metabolite, 4-methyl-N-phenyl-6-(2-

hydroxypropyl)-2-pyrimidinamine, both 

free and conjugated in or on grape at 1.5 

ppm; grape, raisin at 3.0 ppm; 

strawberry at 1.5 ppm; and tomato at 0.5 

ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by 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 FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of 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 FFDCA, as was 

provided in the old sections 408 and 

409 of 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–2004–0299 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 December 13, 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 VI.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 docket ID number 

OPP–2004–0299, 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 eVerDate jul<14>2003 10:50 Oct 12, 2004 Jkt 205001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\13OCR1.SGM 13OCR1
Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 60827

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).

VII. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this 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 petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 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 

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.

VIII. 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 30, 2004.

James Jones,

Director, 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 180.604 is added to subpart 

C to read as follows:

§ 180.604 Mepanipyrim; tolerances for 

residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions. 

[Reserved]

(c) Tolerances with regional 

registrations. [Reserved]

(d) Indirect of inadvertent residues. 

[Reserved]

(e) Revoked tolerances subject to the 

channel of trade provisions. [Reserved] 

(f) Import tolerances. Tolerances are 

established for the combined residues of 

mepanipyrim, 4-methyl-N-phenyl-6-(1-

propynyl)-2-pyrimidinamine, and its 

metabolite, 4-methyl-N-phenyl-6-(2-

hydroxypropylk)-2-pyrimidinamine, 

60828 Federal Register / Vol. 69, No. 197 / Wednesday, October 13, 2004 / Rules and Regulations 

both free and conjugated in or on the 

following commodities:

Commodity Parts per 

million 

Grape ........................................ 1.5

Grape, raisin ............................. 3.0

Strawberry ................................ 1.5

Tomato ...................................... 0.5

[FR Doc. 04–22963 Filed 10–12–04; 8:45 am]

BILLING CODE 6560–50–S

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric 

Administration

50 CFR Part 679

[Docket No. 031126297–3297–01; I.D. 

100604A]

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pollock in Statistical 

Area 630 of the Gulf of Alaska

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce.

ACTION: Modification of a closure.

SUMMARY: NMFS is opening directed 

fishing for pollock in Statistical Area 

630 of the Gulf of Alaska (GOA) for 48 

hours. This action is necessary to fully 

use the 2004 total allowable catch (TAC) 

of pollock specified for Statistical Area 

630.

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), October 7, 2004, through 

1200 hrs, A.l.t., October 9, 2004.

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.

NMFS closed the directed fishery for 

pollock in Statistical Area 630 of the 

GOA under § 679.20(d)(1)(iii) on 

October 2, 2004 (69 FR 59834, October 

6, 2004).

NMFS has determined that, 

approximately 2,767 mt of pollock 

remain in the 2004 directed fishing 

allowance. This amount is large enough 

to provide for a manageable directed 

pollock fishery in Statistical Area 630. 

Therefore, in accordance with 

679.25(a)(2)(i)(C) and (a)(2)(iii)(D), and 

to fully utilize the 2004 TAC of pollock 

specified for Statistical Area 630, NMFS 

is terminating the previous closure and 

is reopening directed fishing for pollock 

in Statistical Area 630 of the GOA. In 

accordance with § 679.20(d)(1)(iii), the 

Regional Administrator finds that this 

directed fishing allowance will be 

reached after 48 hours. Consequently, 

NMFS is prohibiting directed fishing for 

pollock in Statistical Area 630 of the 

GOA effective 1200 hrs, A.l.t., October 

9, 2004.

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 opening of pollock in 

Statistical Area 630.

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 § 679.20 

and is exempt from review under 

Executive Order 12866.

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

Dated: October 6, 2004.

Alan D. Risenhoover,

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service.

[FR Doc. 04–22938 Filed 10–7–04; 1:46 pm]

BILLING CODE 3510–22–S