75066 Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0378; FRL–7688–2]

2,4-D; Notice of Filing a Pesticide 

Petition to Establish a Permanent 

Tolerance for a Certain Pesticide 

Chemical in or on Food

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the 

filing of a pesticide petition proposing 

the establishment of regulations for 

residues of a certain pesticide chemical 

in or on various food commodities.

DATES: Comments, identified by docket 

identification (ID) number OPP–2004–

0378, must be received on or before 

January 14, 2005.

ADDRESSES: Comments may be 

submitted electronically, by mail, or 

through hand delivery/courier. Follow 

the detailed instructions as provided in 

Unit I. of the SUPPLEMENTARY

INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Joanne I. Miller, Registration Division 

(7505C), Office of Pesticide Programs, 

EnvironmentalProtection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6224; e-mail 

address:miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

32532)

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Get Copies of this 

Document and Other Related 

Information?

1. Docket. EPA has established an 

official public docket for this action 

under docket ID number OPP–2004–

0378. The official public docket consists 

of the documents specifically referenced 

in this action, any public comments 

received, and other information related 

to this action. Although a part of the 

official docket, the public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The official public docket is the 

collection of materials that is available 

for public viewing 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.

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search’’ then key in 

the appropriate docket ID number.

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket.

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing in EPA’s electronic public 

docket as EPA receives them and 

without change, unless the comment 

contains copyrighted material, CBI, or 

other information whose disclosure is 

restricted by statute. When EPA 

identifies a comment containing 

copyrighted material, EPA will provide 

a reference to that material in the 

version of the comment that is placed in 

EPA’s electronic public docket. The 

entire printed comment, including the 

copyrighted material, will be available 

in the public docket.

Public comments submitted on 

computer disks that are mailed or 

delivered to the docket will be 

transferred to EPA’s electronic public 

docket. Public comments that are 

mailed or delivered to the docket will be 

scanned and placed in EPA’s electronic 

public docket. Where practical, physical 

objects will be photographed, and the 

photograph will be placed in EPA’s 

electronic public docket along with a 

brief description written by the docket 

staff.

C. How and to Whom Do I Submit 

Comments?

You may submit comments 

electronically, by mail, or through hand 

delivery/courier. To ensure proper 

receipt by EPA, identify the appropriate 

docket ID number in the subject line on 

the first page of your comment. Please 

ensure that your comments are 

submitted within the specified comment 

period. Comments received after the 

close of the comment period will be 

marked ‘‘late.’’ EPA is not required to 

consider these late comments. If you 

wish to submit CBI or information that 

is otherwise protected by statute, please 

follow the instructions in Unit I.D. Do 

not use EPA Dockets or e-mail to submit 

CBI or information protected by statute.

1. Electronically. If you submit an 

electronic comment as prescribed in this 

unit, EPA recommends that you include 

your name, mailing address, and an email address or other contact 

information in the body of your 

comment. Also, include this contact 

information on the outside of any disk 

or CD ROM you submit, and in any 

Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 75067

cover letter accompanying the disk or 

CD ROM. This ensures that you can be 

identified as the submitter of the 

comment, and allows EPA to contact 

you in case EPA cannot read your 

comment due totechnical difficulties or 

needs further information on the 

substance of your comment. EPA’s 

policy is that EPA will not edit your 

comment, and any identifying or contact 

information provided in the body of a 

comment will be included as part of the 

comment that is placed in the official 

public docket, and made available in 

EPA’s electronic public docket. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment.

i. EPA Dockets. Your use of EPA’s 

electronic public docket to submit 

comments to EPA electronically is 

EPA’s preferred method for receiving 

comments. Go directly to EPA Dockets 

at http://www.epa.gov/edocket/, and 

follow the online instructions for 

submitting comments. Once in the 

system, select ‘‘search,’’ and then key in 

docket ID number OPP–2004–0378. The 

system is an ‘‘anonymous access’’

system, which means EPA will not 

know your identity, e-mail address, or 

other contact information unless you 

provide it in the body of your comment.

ii. E-mail. Comments may be sent by 

e-mail to opp-docket@epa.gov, 

Attention: Docket ID Number OPP–

2004–0378. In contrast to EPA’s 

electronic public docket, EPA’s e-mail 

system is not an ‘‘anonymous access’’

system. If you send an e-mail comment 

directly to the docket without going 

through EPA’s electronic public docket, 

EPA’s e-mail system automatically 

captures your e-mail address. E-mail 

addresses that are automatically 

captured by EPA’s e-mail system are 

included as part of the comment that is 

placed in the official public docket, and 

made available in EPA’s electronic 

public docket.

iii. Disk or CD ROM. You may submit 

comments on a disk or CD ROM that 

you mail to the mailing address 

identified in Unit I.C.2. These electronic 

submissions will be accepted in 

WordPerfect or ASCII file format. Avoid 

the use of special characters and any 

form of encryption.

2. By mail. Send your comments to: 

Public Information and Records 

Integrity Branch (PIRIB) (7502C), Office 

of Pesticide Programs (OPP), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001, Attention: Docket ID 

Number OPP–2004–0378.

3. By hand delivery or courier. Deliver 

your comments to: Public Information 

and Records Integrity Branch (PIRIB), 

Office of Pesticide Programs (OPP), 

Environmental Protection Agency, Rm. 

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

Arlington, VA, Attention: Docket ID 

Number OPP–2004–0378. Such 

deliveries are only accepted during the 

docket’s normal hours of operation as 

identified in Unit I.B.1.

D. How Should I Submit CBI to the 

Agency?

Do not submit information that you 

consider to be CBI electronically 

through EPA’s electronic public docket 

or by e-mail. You may claim 

information that you submit to EPA as 

CBI by marking any part or all of that 

information as CBI (if you submit CBI 

on disk or CD ROM, mark the outside 

of the disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

CBI). Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2.

In addition to one complete version of 

the comment that includes any 

information claimed as CBI, a copy of 

the comment that does not contain the 

information claimed as CBI must be 

submitted for inclusion in the public 

docket and EPA’s electronic public 

docket. If you submit the copy that does 

not contain CBI on disk or CD ROM, 

mark the outside of the disk or CD ROM 

clearly that it does not contain CBI. 

Information not marked as CBI will be 

included in the public docket and EPA’s 

electronic public docket without prior 

notice. If you have any questions about 

CBI or the procedures for claiming CBI, 

please consult the person listed under 

FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare 

My Comments for EPA?

You may find the following 

suggestions helpful for preparing your 

comments:

1. Explain your views as clearly as 

possible.

2. Describe any assumptions that you 

used.

3. Provide copies of any technical 

information and/or data you used that 

support your views.

4. If you estimate potential burden or 

costs, explain how you arrived at the 

estimate that you provide.

5. Provide specific examples to 

illustrate your concerns.

6. Make sure to submit your 

comments by the deadline in this 

notice.

7. To ensure proper receipt by EPA, 

be sure to identify the docket ID number 

assigned to this action in the subject 

line on the first page of your response. 

You may also provide the name, date, 

and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition 

as follows proposing the establishment 

and/or amendment of regulations for 

residues of a certain pesticide chemical 

in or on various food commodities 

under section 408 of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a. EPA has determined that 

this petition contains data or 

information regarding the elements set 

forth in FFDCA section 408(d)(2); 

however, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the petition. Additional data 

may be needed before EPA rules on the 

petition.

List of Subjects

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: November 30, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

Summary of Petition

The petitioner summary of the 

pesticide petition is printed below as 

required by FFDCA section 408(d)(3). 

The summary of the petition was 

prepared by the petitioner and 

represents the view of the petitioner. 

The petition summary announces the 

availability of a description of the 

analytical methods available to EPA for 

the detection and measurement of the 

pesticide chemical residues or an 

explanation of why no such method is 

needed.

Interregional Research Project Number 

4

PP 4E3060

EPA has received a pesticide petition 

(4E3060) from the Industry Task Force 

II on 2,4-D Research Data (Task Force) 

and its registrant members and affiliates, 

1900 K St., NW., Washington, DC 20006 

on behalf of The Interregional Research 

Project Number 4 (IR-4) proposing, 

pursuant to section 408(d) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a(d), to amend 40 CFR part 

180 to remove the expiration date of 

December 31, 2004 for 2,4-D in or on the 

raw agricultural commodity soybean 

seed at 0.02 parts per million (ppm) (40 

CFR 180.142(a)(11)) (March 8, 2002, 67 

FR 10622). EPA has determined that the 

petition contains data or information 

75068 Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 

regarding the elements set forth in 

section 408(d)(2) of the FFDCA; 

however, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the petition. Additional data 

may be needed before EPA rules on the 

petition.

A. Residue Chemistry

1. Plant and animal metabolism. The 

nature of the residue in plants is 

adequately understood. Acceptable 

wheat, lemon, and potato metabolism 

studies have been submitted. The nature 

of the residue in animals is adequately 

understood based upon acceptable 

ruminant and poultry metabolism 

studies submitted.

2. Analytical method. The residue 

field tests on soybeans used a gas 

chromatography (GC) method with 

electron capture detection (ECD), ENCAS method ENC-2/93. This GC/ECD 

method is adequate for determining 

residues in or on soybeans with a limit 

of quantitation (LOQ) of 0.01 part per 

million (ppm).

3. Magnitude of residues. In 27 tests 

on soybeans conducted in Arkansas, 

Illinois, Louisiana, Missouri, and 

Tennessee, residues of 2,4-D were 

nondetectable (<0.01 ppm) in/on all 

samples of forage, and seeds from 

soybeans treated with a preplant 

application of 2,4-D (acid, ester, or 

amine) at 0.5, 1.25, and 2.75 lbs active 

ingredient per acre at lX, 2.5X, and 5.5X 

rates. Residues of 2,4-D were also 

nondetectable (<0.01 ppm) in/on 21 of 

27 hay samples from the same tests. Hay 

samples with detectable residues of 

0.01–0.04 ppm only came from 2.5X and 

5.5X applications of the 2,4-D 2-

ethylhexyl ester (2-EHE). Since data 

from the 5.5X application demonstrate 

that 2,4-D residues on soybean seeds are 

nondetectable or <0.05 ppm, a soybean 

processing study is not required. Based 

on the residue data for soybeans, 

tolerances of 0.02, 2.0, and 0.02 ppm in 

or on the raw agricultural commodities 

soybean seed, hay, and forage are 

appropriate.

B. Toxicological Profile

1. Acute toxicity. The oral lethal dose 

(LD)50 of 2,4-D acid is 699 milligrams/

kilogram (mg/kg) in the rat. The dermal 

LD50 in the rabbit is >2,000 mg/kg. The 

acute inhalation lethal concentration 

(LC)50 in the rat is >1.8 milligrams/liter 

(mg/l). A primary eye irritation study in 

the rabbit showed severe irritation. A 

dermal irritation study in the rabbit 

showed moderate irritation. A dermal 

sensitization study in the guinea pig 

showed no skin sensitization. An acute 

neurotoxicity study in the rat produced 

a no observed adverse effect level 

(NOAEL) of 227 mg/kg for systemic 

toxicity and a neurobehavioral NOAEL 

of 67 mg/kgwith a lowest observed 

adverse effect level (LOAEL) of 227 mg/

kg.

2. Genotoxicty. Mutagenicity studies 

including gene mutation, chromosomal 

aberrations, and direct DNA damage 

tests were negative for mutagenic 

effects. 2,4-D acid has been evaluated 

extensively in open literature in a range 

of in vivo and in vitro assays that have 

included tests with human cells. 

Overall, the pattern of responses 

observed in both in vivo and in vitro

tests indicates that 2,4-D acid was not 

mutagenic, although some cytogenetic 

effects were observed.

3. Reproductive and developmental 

toxicity. A two-generation reproduction 

study was conducted in rats with 

NOAELs for parental and offspring 

toxicity of 5 milligrams/kilograms/day 

(mg/kg/day). The LOAELs for this study 

are established at 20 mg/kg/day based 

on decreased female body weight/body 

weight gain (F1), male renal tubule 

alteration (F0 and F1), and decreased 

pup body weight (F1b). A teratology 

study in rabbits given gavage doses at 0, 

10, 30, and 90 mg/kg on days 6 through 

18 of gestation was negative for 

developmental toxicity at alldoses 

tested. A teratology study in rats given 

gavage doses at 0, 8, 25, and 75 mg/kg 

on days 6 through 15 of gestation 

showed maternal toxicity only at 75 mg/

kg, which is above the renal clearance 

threshold for 2,4-D. A NOAEL for 

fetotoxicity was established at 25 mg/

kg/day based on skeletal abnormalities 

and variations at the 75 mg/kg dose 

level. The effects on pups occurred in 

the presence of parental toxicity.

4. Subchronic toxicity. A subchronic 

dietary study was conducted with mice 

fed diets containing 0, 1, 15, 100, and 

300 mg/kg/day with a NOAEL of 15 mg/

kg/day. The LOAEL was established at 

100 mg/kg/day based on decreased 

glucose and thyroxine levels, increases 

in absolute and relative kidney weights, 

and histopathological lesions in the 

liver and kidneys. A 90–day dietary 

study in rats fed diets containing 0, 1, 

15, 100, or 300 mg/ kg/day resulted in 

a NOAEL of 15 mg/kg/day, and an 

LOAEL of 100 mg/kg/day. The LOAEL 

was based on decreases in body weight 

and food consumption, alteration in 

clinical pathology, changes in organ 

weights, and histopathological lesions 

in the kidney, liver, and adrenal glands 

of both sexes of rats. A 90–day feeding 

study was conducted in dogs fed diets 

containing 0, 0.3, 1, 3, and 10 mg/kg/

day with a NOAEL of 1 mg/kg/day. The 

LOAEL was established at 3 mg/kg/day 

based on decreased body weight/body 

weight gain and food consumption 

(males), alterations in clinical chemistry 

parameters increased blood urea 

nitrogren (both sexes), creatinine (both 

sexes), and decreased testis weight 

(males).

5. Chronic toxicity. Previously, the 

2,4-D chronic reference dose was based 

on the chronic dog study. More recently, 

the Hazard Identification Assessment 

Review Committee (HIARC) chose to 

use the rat as the more relevant species 

for risk assessment. Use of the dog as 

the basis for regulation exaggerates the 

apparent severity of effects anticipated 

because of the limited renal capacity of 

dogs to excrete organic acids. Points of 

consideration included: The dog has a 

decreased clearance relative to humans, 

rats, mice, and other species. The 

decreased clearance results in higher 

blood levels in the dog relative to those 

found in the rat and consequently, 

effects are seen at lower dose levels in 

the dog than in the rat. The half-life of 

elimination for dogs is significantly 

longer than for all other species 

considered. Dogs exhibited half-lives of 

31 to 106 hours for doses of 1 to 5 mg/

kg. In other species (mice, rats, pigs, 

cats, and humans), elimination halflives ranged from 0.75 to 11.6 hours for 

similar doses. The difference in the 

elimination pattern among dogs and 

other mammalian species persuaded 

HIARC that the rat was a better 

predictor than the dog of the potential 

toxicity of 2,4-D to human.

A 2–year oncogenicity study was 

conducted in mice fed diets containing 

0, 1, 15, and 45 mg/kg/day with a 

NOAEL of 1 mg/kg/day. The systemic 

LOAEL was established at 15 mg/kg/day 

based on treatment-related increase in 

kidney weights in both sexes and 

microscopic renal lesions in males. 

There was no treatment-related increase 

in the incidence of any tumor type. A 

subsequent 2–year oncogenicity study 

in mice with a NOAEL of 5 mg/kg/day 

demonstrated that the NOAEL of 1 mg/

kg/day in this earlier study was an 

artifact of dose selection.

A second 2–year oncogenicity study 

was conducted in mice fed diets 

containing 0, 5, 62.5, and 125 mg/kg/

day (males) and 0, 5, 150, and 300 mg/

kg/day (females). The NOAEL was 5 mg/

kg/day and LOAEL was 62.5 (males) and 

150 (females) mg/kg/day based on an 

increased absolute and/or relative 

kidney weights and an increased 

incidence of renal microscopic lesions. 

There was no treatment-related increase 

in the incidence of any tumor type.

A 2–year feeding/oncogenicity study 

was conducted in rats fed diets 

containing 0, 5, 75, and 150 mg/kg/day. 

Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 75069

The NOAEL was 5 mg/kg/day and the 

LOAEL was 75 mg/kg/day based on 

decreased body weight gain (females) 

and food consumption (females), 

alterations in hematology decreased red 

blood cells (females), hemoglobin 

(females), platelets (both sexes) and 

clinical chemistry parameters increased 

creatinine (both sexes), alanine and 

aspartate aminotransferase (males), 

alkaline phosphatase (both sexes), 

decreased T4 (both sexes), glucose 

(females), cholesterol (both sexes), and 

triglycerides (females), increased 

thyroid weights (both sexes at study 

termination), decreased testes and 

ovarian weights, and microscopic 

lesions in the lungs (females). At the 

high-dose level, there were microscopic 

lesions in the eyes, liver, adipose tissue, 

and lungs. There was no treatmentrelated increase in the incidence of any 

tumor.

6. Animal metabolism. The 

metabolism of phenyl ring labeled 14C2,4-D was studied in the rat following a 

single intravenous or oral dose of 

approximately 1 mg/kg/day. At 48 hours 

after treatment, recovery of radioactivity 

in urine was in excess of 94%. Parent 

2,4-D was the major metabolite (72.9% 

to 90.5%) found in the urine.

7. Metabolite toxicology. Because 2,4-

D is rapidly excreted without significant 

metabolism, the toxicology data on the 

parent compound adequately represents 

metabolite toxicology.

8. Endocrine disruption. Although 

tests explicitly designed to evaluate the 

potential endocrine effects of 2,4-D have 

not been conducted, large and diverse 

batteries of toxicology studies are 

available including acute, subchronic, 

chronic, reproductive, and 

developmental toxicity tests. The 

thyroid effects seen in the subchronic 

(decreases in T4, follicular cell 

hypertrophy) and chronic (decreases in 

T4, increase in thyroid weights) toxicity 

study in rats occurred only at high 

doses, which were at or above the 

threshold of renal clearance. These 

effects were seen in the presence of 

other systemic (liver or kidney) toxicity, 

and there was no evidence of thyroid 

toxicity in dogs. No evidence of 

endocrine disruptions were seen in the 

appropriate parameters that evaluated 

this effect in the two-generation 

reproduction study.

C. Aggregate Exposure

1. Dietary exposure. Residues are 

below the limit of quantification (LOQ 

= 0.01 ppm) in soybeans. Tolerances 

have been established (40 CFR 180.142) 

for residues of 2,4-D as the acid or 

various of its salts and esters, in or on 

a variety of raw agricultural 

commodities. In addition, there are also 

tolerances for 2,4-D for meat, milk, and 

eggs. 

i. Food. The Agency has conducted an 

extensive assessment of the aggregate 

exposure. Results are reported in the 

Federal Register of March 8, 2002 (FR 

67 10622) (FRL–6827–1). The Agency 

found that acute dietary exposure from 

food to 2,4-D will occupy 7.3% of the 

acute population adjusted dose (aPAD) 

for the U.S. population, 12% of the 

aPAD for females 13 years and older, 

9.4% of the aPAD for infants less than 

1 year old, 12% of the aPAD for 

children 1–6 years old, and 8.8% of the 

aPAD for children 7–12 years old. The 

Agency found that chronic dietary 

exposure to 2,4-D from food will 

utilize24% of the chronic population 

adjusted dose (cPAD) for the U.S. 

population, 20% for females 13 years 

and older, 19% of the cPAD for infants 

less than 1 year old, 46% of the cPAD 

for children 1–6 years old, and 36% of 

the cPAD for children 7–12 years old. 

ii. Drinking water. 2,4-D is soluble in 

water. The average field half-life is 10 

days. The chemical is potentially 

mobile, but rapid degradation in soil 

and removal by plant uptake minimizes 

leaching. A Maximum Contaminant 

Level (MCL) of 0.07 mg/L has been 

established. In addition, the following 

health advisories have been established: 

For a 10-kg child, a range of 1 mg/L 

from 1–day exposure to 0.1 mg/L for 

longer-term exposure up to 7 years; for 

a 70 kg adult, a range of 0.4 mg/L for 

longer-term exposure to 0.07 mg/L for 

lifetime exposure.

2. Non-dietary exposure. 2,4-D is 

currently registered for use on the 

following residential non-food sites: 

Ornamental turf, lawns, and grasses, 

golf course turf, recreational areas, and 

several other indoor, and outdoor uses. 

2,4-D is a commonly-used pesticide in 

non-agricultural settings. There are 

chemical-specific and site-specific data 

available to determine the potential 

risks associated with residential 

exposures from the registered uses of 

2,4-D. Dislodgeable residues taken from 

10 2,4-D turf transferable residue studies 

showed low dislodgeable percent of 

application, 0.9% at 1 hour, 0.8% at 8 

hours, and 0.7% at 24 hours following 

applications. No detectable residues 

were found in urine samples supplied 

by volunteers exposed to sprayed turf 24 

hours following application. 

Intermediate-term post-application 

exposure is thus not expected.

D. Cumulative Effects

A cumulative risk assessment cannot 

be performed as part of a human health 

risk assessment because EPA has not yet 

made a determination as to which 

compounds to which humans may be 

exposed, if any, have a common 

mechanism of toxicity. There are no 

available data to determine whether 2,4-

D has a common mechanism of toxicity 

with other substances or how to include 

this pesticide in a cumulative risk 

assessment. Unlike other pesticides for 

which EPA has followed a cumulative 

risk approach based on a common 

mechanism of toxicity, 2,4-D does not 

appear to produce a toxic metabolite 

produced by other substances.

E. Safety Determination

1. U.S. population. For chronic 

dietary exposure, EPA has established 

the RfD for 2,4-D at 0.005 mg/kg/day. 

This RfD is based on a 2–year dietary 

toxicity study in rats with a NOAEL of 

5 mg/kg/day and an uncertainty factor 

of 1,000. In the most recent revised HED 

human health risk assessment, EPA 

used tolerance-level exposure values for 

most commodities, and averages of field 

trial data, and processing study factors 

for small grains, citrus, and sugarcane 

sugar, and molasses. EPA concluded 

that for food consumption only, chronic 

dietary (food only) risks calculated 

using the Dietary Exposure Evaluation 

Model (DEEMTM) software consumed 

2.5–6.9% of the cPAD (2.5–6.7% cPAD 

using Lifeline). Risk to the general U.S. 

population was 3.4% of the cPAD (3.2% 

cPAD using Lifeline). Despite the 

potential for exposure to 2,4-D in 

drinking water and from non-dietary, 

non-occupational exposure, EPA did not 

expect the aggregate exposure to exceed 

100% of the cPAD.

For acute dietary exposure, the 

NOAEL of 67 mg/kg/day from the rat 

acute neurotoxicity study should be 

used for risk assessment. As 

neurotoxicity is the effect of concern, 

the acute dietary risk assessment should 

evaluate acute dietary risk to all 

population subgroups. Again, relying 

upon the June 2, 2004, revised HED 

human health risk assessment, EPA 

concluded that risk to the general U.S. 

population was 17% of the aPAD using 

both DEEMTM and Lifeline.

Regarding dietary cancer risk 

assessment, EPA’s Cancer Peer Review 

Committee has classified 2,4-D as a 

Group D chemical (not classifiable as to 

human carcinogenicity) on the basis 

that, the evidence is inadequate and 

cannot be interpreted as showing either 

the presence or absence of a 

carcinogenic effect.

2. Infants and children. The database 

on 2,4-D relative to prenatal and 

postnatal toxicity is complete with 

respect to current data requirements. In 

its most recent evaluations, EPA has 

75070 Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 

determined that, based on the 2,4-D 

database summarized above, no special 

FQPA safety factor is needed (1X) since 

there are no residual uncertainties for 

prenatal and/or postnatal toxicity. 

Chronic dietary risk to children 1–2 

years of age, the most highly exposed 

population subgroup, was 6.9% of the 

cPAD (6.7% cPAD using Lifeline). For 

acute dietary risk, the most highly 

exposed population subgroup using 

both DEEMTM and Lifeline was children 

1–2 years of age; risks were 33% and 

30% of the aPAD, respectively.

F. International Tolerances

There are no Codex, Canadian, or 

Mexican maximum residue 

limitsestablished for 2,4-D on soybeans.

[FR Doc. 04–27173 Filed 12–14–04; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information 

Collection(s) Being Submitted to OMB 

for Review and Approval 

December 8, 2004.

SUMMARY: The Federal Communications 

Commissions, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection, as 

required by the Paperwork Reduction 

Act of 1995, Public Law 104–13. An 

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control 

number. No person shall be subject to 

any penalty for failing to comply with 

a collection of information subject to the 

Paperwork Reduction Act (PRA) that 

does not display a valid control number. 

Comments are requested concerning (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information shall have practical utility; 

(b) the accuracy of the Commission’s 

burden estimate; (c) ways to enhance 

the quality, utility, and clarity of the 

information collected; and (d) ways to 

minimize the burden of the collection of 

information on the respondents, 

including the use of automated 

collection techniques or other forms of 

information technology.

DATES: Written comments should be 

submitted on or before January 14, 2005. 

If you anticipate that you will be 

submitting comments, but find it 

difficult to do so within the period of 

time allowed by this notice, you should 

advise the contact listed below as soon 

as possible.

ADDRESSES: Direct all comments to 

Cathy Williams, Federal 

Communications Commission, Room 1–

C823, 445 12th Street, SW., Washington, 

DC 20554 or via the Internet to 

Cathy.Williams@fcc.gov or Kristy L. 

LaLonde, Office of Management and 

Budget (OMB), Room 10236 NEOB, 

Washington, DC 20503, (202) 395–3087 

or via the Internet at 

Kristy_L._LaLonde@omb.eop.gov.

FOR FURTHER INFORMATION CONTACT: For 

additional information or copy of the 

information collection(s) contact Cathy 

Williams at (202) 418–2918 or via the 

Internet at Cathy.Williams@fcc.gov.

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–0095. 

Title: Multi-Channel Video 

Programming Distributors Annual 

Employment Report, FCC Form 395–A. 

Form Number: FCC Form 395–A. 

Type of Review: Extension of a 

currently approved collection. 

Respondents: Business or other forprofit entities. 

Number of Respondents: 2,500. 

Estimated Time Per Response: 53 

minutes (0.88 hours). 

Frequency of Response:

Recordkeeping requirement; Annual 

reporting requirement; Once every five 

years. 

Total Annual Burden: 2,200 hours. 

Total Annual Cost: None. 

Privacy Impact Assessment: No 

impact(s). 

Needs and Uses: FCC Form 395–A, 

‘‘The Multi-Channel Video 

Programming Distributor Annual 

Employment Report,’’ is a data 

collection device used to assess industry 

employment trends and provide reports 

to Congress. The report identifies 

employees by gender and race/ethnicity 

in fifteen job categories. FCC Form 395–

A contains a grid which collects data on 

full and part-time employees and 

requests a list of employees by job title, 

indicating the job category and full or 

part-time status of the position. Every 

cable entity with 6 or more full-time 

employees and all Satellite Master 

Antenna Television Systems (SMATV) 

serving 50 or more subscribers and 

having 6 or more full-time employees 

must complete FCC Form 395–A in its 

entirety and file it by September 30 each 

year. However, cable entities with 5 or 

fewer full-time employees are not 

required to file but if they do, they need 

to complete and file only Sections I, II 

and VIII of the FCC Form 395–A, and 

thereafter need not file again unless 

their employment increases. In addition, 

cable entities with 6 or more full-time 

employees will file a Supplemental 

Investigation Sheet once every 5 years.

On June 4, 2004, the FCC released the 

Third Report and Order and Fourth 

Notice of Proposed Rulemaking (3rd 

R&O), In the Matter of Review of 

Commission’s Broadcast and Cable 

Equal Employment Opportunity Rules 

and Policies, MM Docket No. 98–204, 

FCC 04–103, in which it considers 

issues relating to the Annual 

Employment Report forms, including 

FCC Form 395–A, ‘‘The Multi-Channel 

Video Programming Distributor Annual 

Employment Report.’’ In the 3rd R&O, 

the Commission is adopting revised 

rules for MVPDs to file FCC Form 395–

A, which cable and other MVPDs will 

use to file annual employment reports. 

The intent of this 3rd R&O is to update 

rules for MVPDs to file Form 395–A 

consistent with new rules adopted in 

the 2nd R&O. The intent of the Fourth 

Notice of Proposed Rulemaking is to 

provide time for cable and other MVPDs 

and the public to address the issue of 

whether the Commission should keep 

these forms confidential after they are 

filed. With the effective date of the rule 

revisions adopted in the 3rd R&O, 

MVPDs and broadcasters must start 

keeping records of their employees so 

they can prepare their annual 

employment reports that were due to be 

filed on September 30, 2004. 

OMB Control Number: 3060–0171. 

Title: Section 73.1125, Station Main 

Studio Location. 

Form Number: Not applicable. 

Type of Review: Revision of a 

currently approved collection. 

Respondents: Business or other forprofit entities. 

Number of Respondents: 72. 

Estimated Time Per Response: 0.5–2 

hours. 

Frequency of Response: On occasion 

reporting requirement. 

Total Annual Burden: 135 hours. 

Total Annual Cost: $87,780.00. 

Privacy Impact Assessment: No 

impact(s). 

Needs and Uses: On March 14, 2002, 

the Commission released an Order, 

Establishment of the Media Bureau and 

Other Organizational Changes, DA No. 

02–577, the Commission amended 47 

CFR 73.1125(d) to reflect the 

reorganization of the existing Cable 

Services and Mass Media Bureaus into 

a new Media Bureau. Section 73.1125(d) 

requires licensees to receive written 

authority to locate a main studio outside 

the locations specified in paragraph (a) 

or (c) of this rule section for the first 

time must be obtained from the Audio 

Division, Media Bureau for AM and FM 

stations, or the Video Division for TV