Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68287

88.502 be removed from the approved 

program. In the December 23, 2003, 

letter, Pennsylvania revised the 1998 

amendment as submitted to retain, as 

part of its approved program, the above 

referenced regulations which provide 

effluent limits and the definitions of 

‘‘dry weather flow’’ and ‘‘best 

professional judgment.’’ Therefore, we 

consider those portions of the 1998 

amendment submission as withdrawn 

and they will not be considered further 

in this rulemaking. No comments will 

be accepted with regard to these areas.

Also in the December 23, 2003, letter 

Pennsylvania indicated that the 1998 

program amendment had included 

Sections 4(g.1), 4(g.2), and 4(g.3) of 

PASMCRA relating to minimal impact 

postmining discharges and the release of 

bonds on mine sites with discharges. 

Pennsylvania noted in that letter that 

since the definition of minimal impact 

postmining discharges and the 

regulations for postmining discharges 

were not included in the program 

amendment, it was requesting that these 

sections of PASMCRA be removed from 

the proposed amendment. Pennsylvania 

noted in the letter that it was intending 

to submit these sections along with the 

associated regulations as a separate 

program amendment. Therefore, these 

sections are also withdrawn and will 

not be considered further in this 

rulemaking. No comments will be 

accepted with regard to these areas. 

In the April 13, 2004, letter, 

Pennsylvania notified us that it wished 

to withdraw Section 18(a.4) of 

PASMCRA from consideration under 

the 1998 program amendment because 

the areas suitable for reclamation by 

remining program has not yet been 

developed. Therefore, this section will 

not be considered further in this 

rulemaking. No comments will be 

accepted with regard to these areas. 

Also in its April 13, 2004, letter 

Pennsylvania requested that we 

consider for approval Sections 4.10 and 

4.11 of PASMCRA and the 

corresponding regulations at 25 Pa. 

Code Sections 86.251 through 86.270. 

These sections of the statute and 

regulations provide for Pennsylvania’s 

Remining Operators Assistance 

Program. This program provides 

incentives to operators to undertake 

reclamation and remining of abandoned 

mine lands and bond forfeiture sites. 

These provisions are now included in 

this rulemaking action and we are 

seeking comment with regard to these 

sections of PASMCRA and 25 Pa. Code 

Chapter 86. 

In the April 13, 2004, letter, and its 

attachment, Pennsylvania also notified 

us that it intends to address outstanding 

issues in this amendment relating to: De 

minimis cost increases for a replacement 

water supply; temporary replacement of 

water supply; waivers for water supply 

replacement; adequate versus equivalent 

water supply; operation and 

maintenance costs for replaced water 

supplies; financial guarantees to 

operators to reclaim abandoned mine 

lands through remining; and, operator 

cost recovery, through additional 

regulation changes. While Pennsylvania 

has indicated that it intends to further 

revise those portions of the pending 

package, it has not withdrawn those 

portions and has asked that we proceed 

with a decision. Since we received no 

changes or clarifications from the 

original amendment with regard to these 

areas, we are not reopening the 

comment period for them. 

III. Public Comment Procedures 

Under the provisions of 30 CFR 

732.17(h), we are seeking your 

comments on whether the information 

described above satisfies the applicable 

program approval criteria of 30 CFR 

732.15. If we approve the amendment, 

it will become part of the State program. 

Written Comments 

Send your written or electronic 

comments to OSM at the address given 

above. Your written comments should 

be specific, pertain only to the issues 

proposed in this rulemaking, and 

include explanations in support of your 

recommendations. We will not 

necessarily consider or respond to your 

comments when developing the final 

rule if they are received after the close 

of the comment period (see DATES). We 

will make every attempt to log all 

comments into the administrative 

record, but comments delivered to an 

address other than the Harrisburg Office 

may not be logged in. 

Electronic Comments 

Please submit Internet comments as 

an ASCII or Word file avoiding the use 

of special characters and any form of 

encryption. Please also include ‘‘Attn: 

SATS No. PA–124–FOR’’ and your 

name and return address in your 

Internet message. If you do not receive 

a confirmation that we have received 

your Internet message, contact the 

Harrisburg Office at (717) 782–4036. 

Availability of Comments 

We will make comments, including 

names and addresses of respondents, 

available for public review during 

normal business hours. We will not 

consider anonymous comments. If 

individual respondents request 

confidentiality, we will honor their 

request to the extent allowable by law. 

Individual respondents who wish to 

withhold their name or address from 

public review, except for the city or 

town, must state this prominently at the 

beginning of their comments. We will 

make all submissions from 

organizations or businesses, and from 

individuals identifying themselves as 

representatives or officials of 

organizations or businesses, available 

for public review in their entirety.

List of Subjects in 30 CFR Part 938 

Intergovernmental relations, Surface 

mining, Underground mining.

Dated: September 9, 2004. 

Brent Wahlquist, 

Regional Director, Appalachian Regional 

Coordinating Center.

[FR Doc. 04–25971 Filed 11–23–04; 8:45 am] 

BILLING CODE 4310–05–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0142; FRL–7686–4]

Trifluralin; Proposed Pesticide 

Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to 

establish a tolerance for residues of 

trifluralin in mint oil under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality 

Protection Act of 1996 (FQPA). The 

amendment substantially rewrote 

section 408 of FFDCA. As a result, the 

revisions made it necessary, once again, 

to establish tolerances on certain 

commodities, such as mint oils, that had 

previously been deemed unnecessary.

DATES: Comments must be received on 

or before January 24, 2005.

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number OPP–2004–0142, by one of the 

following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov/. Follow the online instructions for submitting 

comments.

• Agency Website: http://

www.epa.gov/edocket/. EDOCKET, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments.

• E-mail: Comments may be sent by 

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

68288 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

Attention: Docket ID Number OPP–

2004–0142.

• Mail: 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–2004–0142.

• Hand Delivery: 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–2004–0142. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information.

Instructions: Direct your comments to 

docket ID number OPP–2004–0142. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.epa.gov/edocket/, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through EDOCKET, 

regulations.gov, or e-mail. The EPA 

EDOCKET and the regulations.gov 

websites are ‘‘anonymous access’’

systems, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through EDOCKET or 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD ROM you submit. 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. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket visit 

EDOCKET on-line or see the Federal 

Register of May 31, 2002 (67 FR 38102) 

(FRL–7181–7).

Docket: 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: John 

W. Pates, Jr., Reregistration Division 

(7508C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8195; e-mail address: 

pates.john@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 a professional 

applicator, commercial applicator, 

residential applicator, agricultural 

worker, and/or a non-residential user. 

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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit II. 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/.

C. What Should I Consider as I Prepare 

My Comments for EPA?

1. Submitting CBI. Do not submit this 

information to EPA through EDOCKET, 

regulations.gov, or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD ROM that 

you mail to EPA, 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 

claimed as CBI. In addition to one 

complete version of the comment that 

includes 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. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2.

2. Tips for preparing your comments. 

When submitting comments, remember 

to:

i. Identify the rulemaking by docket 

ID number and other identifying 

information (subject heading, Federal 

Register date, and page number).

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number.

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes.

iv. Describe any assumptions and 

provide any technical information and/

or data that you used.

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced.

vi. Provide specific examples to 

illustrate your concerns, and suggest 

alternatives.

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats.

viii. Make sure to submit your 

comments by the comment period 

deadline identified.

II. Background and Statutory Findings

EPA on its own initiative, under 

section 408(e) of FFDCA, 21 U.S.C. 

346a(e), is proposing to establish a 

permanent tolerance for residues of the 

herbicide trifluralin in mint oil at 2.0 

parts per million (ppm).

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68289

Tolerances under section 408 of 

FFDCA for trifluralin in or on 

peppermint tops and spearmint tops are 

established in 40 CFR 180.207 at 0.05 

ppm. Previously, under section 409 of 

FFDCA, tolerances were established for 

trifluralin in peppermint oil and 

spearmint oil at 2.0 ppm. In 1996, these 

section 409 of FFDCA tolerance 

regulations were revoked as 

unnecessary. Shortly thereafter, the 

FFDCA was amended by FQPA. This 

amendment substantially rewrote 

section 408 of FFDCA and consolidated, 

for the most part, the authority 

addressing pesticide residues in food 

under section 408 of FFDCA. The 

revisions to section 408 of FFDCA also 

made it necessary, once again, to 

establish tolerances on certain 

commodities, such as mint oils, that had 

previously been deemed unnecessary.

The Agency has completed the human 

health risk assessment for trifluralin and 

is now proposing to establish a 

permanent tolerance at 2.0 ppm for mint 

oil. Also, all existing tolerances are 

being maintained at current levels and 

are considered to be reassessed by the 

Trifluralin Tolerance Reassessment 

Eligibility Decision (TRED) signed on 

August 31, 2004.

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 

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 a tolerance for residues of 

trifluralin in mint oil at 2.0 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 trifluralin 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 TABLES

Guideline No./Study 

Type 

MRID No. (year)/Classification/

Doses Results/Comments 

870.3100

2-Week R-F Feeding—

Rats (male)

00157154 (1983) 

0; 6,500 ppm range-finding 

study for 00157156 (1985), 

41038301 (1986)

Acceptable/Nonguideline

NOAEL = Not achieved 

LOAEL = 6,500 ppm based on renal epithelial damage, urine triple phosphates 

crystals and urinary sediment

870.3100

90-Day Oral toxicity—

Rat

00151906 (1980) 

0; 800; 2,000; or 5,000 ppm

M: 0, 59, 154, and 392 milligram/kilogram/day (mg/kg/

day)

F: 0, 69, 168, and 421 mg/kg/

day

Acceptable/Guideline

NOAEL = 2,000 ppm (154/168 mg/kg/day, Male/Female (M/F)) 

LOAEL = 5,000 (392/421(mg/kg/day), M/F)

Based on minor decreases in overall body weight gains and food consumption in 

males and females, decreased hemoglobin, alkaline phosphatase, and alanine 

aminotransferase in the males, and increased absolute and relative (to body) 

liver weights in males and females

870.3200

21/28-Day dermal toxicity—Rabbit

41993810 (1991) 

0, 100, 500, or 1,000 mg/kg/

day (formulation containing 

35.8% trifluralin and 2.6% 

XRD-498)

Acceptable/Guideline

Systemic NOAEL =1,000 mg/kg/day 

Systemic LOAEL = Not achieved

Dermal NOAEL = Not achieved

Dermal LOAEL = 100 mg/kg/day, edema, and/or scaling and fissuring 100 mg/kg/

day based skin irritation

870.3200

31-Day dermal toxicity—

Rat

00153171 (1982) 

0; 40; 200; or 1,000 mg/kg/day

Acceptable/Guideline

Systemic NOAEL = 1,000 mg/kg/day (limit dose) 

Systemic LOAEL = Not achieved

Dermal NOAEL = 40 mg/kg/day

Dermal LOAEL = 200 mg/kg/day based on sub-epidermal inflamation and ulcerations inmales and females

68290 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

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

Guideline No./Study 

Type 

MRID No. (year)/Classification/

Doses Results/Comments 

870.3200

21/28-Day dermal toxicity—Rat

00152888 (1985) 

0; 1,000 mg/kg/day (limit dose)

Acceptable/Guideline

Systemic NOAEL = 1,000 mg/kg/day 

Systemic LOAEL = Not achieved

Dermal NOAEL= Not achieved

Dermal LOAEL = 1,000 mg/kg/day (limit dose) based on erythema, edema, and 

desquamination of the treated skin

870.3465

30-Day inhalation toxicity

40392312 (1987) reformat of 

00151904 (1982) 

0; 100; 301; 1,006 mg/m3(6 

hours/day 5 days/week for 

up to 30 days)

Acceptable/Nonguideline

NOAEL = 301 mg/m3

LOAEL = 1,006 mg/m3 based on increased bilirubin in females and incidences of 

dyspnea and ruffled fur in males and females

870.3700

Developmental Toxicity 

Study—Rat

00151899 (1983), 159620 

(1986), 40392310 (1987) 

0, 20, 100, 500 mg/kg/day

Systemic Maternal NOAEL = 100 mg/kg/day 

Systemic Maternal LOAEL = 500 mg/kg/day based on mortality, clinical signs, decreased body weight gains, decreased food consumption, and increased liver 

and spleen weights

Developmental NOAEL =100 mg/kg/day

Developmental LOAEL = 500 mg/kg/day based on reduced ossification of the 

vertebrae and ribs and thickened, wavy or bent ribs and increased incidences 

of resorptions

870.3700

Developmental Toxicity 

Study—Rat

00152419 (1984) 

0; 100; 225; 470; or 1,000 mg/

kg/day

Acceptable/Guideline

Maternal NOAEL = 475 mg/kg/day 

Maternal LOAEL = 1,000 mg/kg/day based on decreased body weights and decreased food consumption

Offspring NOAEL = 475 mg/kg/day

Offspring LOAEL = 1,000 mg/kg/day based on decreased fetal body weights

Developmental NOAEL = 1,000 mg/kg/day

Developmental LOAEL was not established

870.3700

Developmental Toxicity—Rabbit

00152421 (1984) 

0, 100, 225, 500 mg/kg/day

Acceptable/Guideline

Maternal NOAEL = 100 mg/kg/day 

Maternal LOAEL = 225 mg/kg/day based on abortions, macroscopic changes in 

the liver and lungs, and decreased food consumption

Developmental NOAEL = 100 mg/kg/day

Developmental LOAEL = 225 mg/kg based on abortions

870.3800

2-Generation reproduction—Rat

00151901 (1984) 

00151902 (1984) Feed analysis

00151903 (1984) Path

0; 200; 650; 2,000 ppm 

0, 20, 32.5, 200 mg/kg/day (1 

ppm = 0.5 mg/kg/day)

Acceptable/Guideline

Parental NOAEL = 200 ppm (10 mg/kg/day) 

Parental LOAEL = 650 ppm (32.5 mg/kg/day) based on mortality due to acute 

renal failure and increased lesions of the renal proximal tubules in the F1 females; increased relative (to body) weights of the liver, kidney (males), and testes in both generations 

Offspring NOAEL = 200 ppm (10 mg/kg/day) 

Offspring LOAEL = 650 ppm (32.5 mg/kg/day) based on decreased pup weights 

in both generations and increased relative to body liver weights in the F2b females 

Repro NOAEL = 2,000 ppm (100 mg/kg/day) 

Repro LOAEL = Not established

870.3800

2-Generation reproduction—Rat

00162543 (1986), 44135107 

(1996) 

0; 200; 630; 2,000 ppm

0, 15, 47, 148 mg/kg/day

Acceptable/Guideline

Parental NOAEL = 200 ppn (15 mg/kg/day) 

Parental LOAEL = 630 ppm (47 mg/kg/day) based on decreased body weight 

gains (BWG) and food consumption 

Offspring NOAEL = 200 ppm (15 mg/kg/day) 

Offspring LOAEL = 630 ppm (47 mg/kg/day) based on small pup size in 3 litters 

Reproductive NOAEL = 2,000 ppm (148 mg/kg/day) 

Reproductive LOAEL = Not established

870.3800

2-Generation reproduction—Rat

40405007 (1987) 

0; 50; 450; 4,000 ppm

M: 0, 3.9, 35, 295 mg/kg/day

F: 0, 4.7, 42, 337 mg/kg/day

Acceptable/Guideline

Parental NOAEL = 450 ppm (35/42 mg/kg/day M/F) 

Parental LOAEL = 4,000 ppm (295/337 mg/kg/day M/F) based on decreased body 

weights, body weight gains, food consumption, and food efficiency in males and 

females of both generations; decreased ovary weights in both generations; 

colon distension in the F1 males; and uterine atrophy in the females of both 

generations 

Offspring NOAEL = 450 ppm (35/42 mg/kg/day M/F) 

Offspring LOAEL = 4,000 ppm (295/337mg/kg/day, M/F) based on decreased pup 

weight in F1a litters 

Reproductive NOAEL = 450 ppm (35/42 mg/kg/day) 

Reproductive LOAEL = 4,000 ppm(295/337 mg/kg/day M/F) based on decreased 

fetal, neonatal, and litter viability and decreased lactation index in the F1a pups; 

and decreased number of implantation sites, newborn pups, litter size, and pup 

weights in both generations

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68291

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

Guideline No./Study 

Type 

MRID No. (year)/Classification/

Doses Results/Comments 

870.4100

1-Year Oral (capsule) 

Study—Dog

00151908 (1984), 00159618 

(1985) 

0, 30, 150, or 750 ppm

0.0, 0.8, 3.8, 18.8 mg/kg /day

Acceptable/Guideline

NOAEL = 30 ppm (0.8 mg/kg/day) 

LOAEL = 150 ppm (3.8 mg/kg/day) based on increased absolute liver weights in 

males

870.4100

1-Year Oral (capsule) 

Study—Dog

42447001 (1992) 

0, 0.75, 2.4, 40 mg/kg/day

Acceptable/Guideline

Systemic NOAEL = 2.4 mg/kg/day 

Systemic LOAEL = 40 mg/kg/day, based on increased frequency of abnormal 

stool and pigment deposition in the kidney and liver in males and females, decreased body weights and body weight gains, and on decreased erythrocytes 

and hemoglobin and increased thrombocytes in males

870.4300

24-Month Chronic Toxicity/Carcinogenicity 

Study—Rat

00162457 (1985), 00162458 

(1985) 

0; 200; 800; or 3,200 ppm

M: 0, 10, 40, and 169 mg/kg/

day

F: 0, 13, 53, and 219 mg/kg/

day

Acceptable/Guideline

NOAEL = 800 ppm (40/53 mg/kg/day M/F) 

LOAEL = 3,200 ppm (169/219 mg/kg/day M/F) based on decreases in body 

weight and body weight gains 

At the doses tested, the carcinogenic potential of trifluralin was negative. Dosing 

was considered adequate based on differences in body weight and body weight 

gains.

870.4300

24- Month Carcinogenicity Study—

Mouse

00158935 (1986), 40392313 

(1987) 

0, 50, 200, or 800 ppm

M: 0, 7.5, 29, and 118 mg/kg/

day

F: 0, 10.5, 41, and 165 mg/kg/

day

Unacceptable/Guideline

Sys NOAEL = 800 ppm (118/165 mg/kg/day in males/females); highest dose tested 

System LOAEL = Not achieved 

NOAEL for the range finder was 2500 ppm (375 mg/kg/day), the highest dose 

tested

870.5100

Bacterial Reverse Gene 

Mutation Assay

MRID 00148345 (1984) 

Acceptable/Guideline

There was no evidence of induced mutant colonies over background.

870.5100

Bacterial Reverse Gene 

Mutation Assay

MRID 40334707 (1987) 

Acceptable/Guideline

There was no evidence of induced mutant colonies over background.

870.5100

Bacterial Reverse Gene 

Mutation Assay

MRID 00153173 (1979) 

Acceptable/Guideline

There was no evidence of induced mutant colonies over background.

870.5250

Gene Mutation Assay—

Yeast

MRID 00151898 (1982) 

Acceptable/Guideline

There was no concentration-related positive response of induced mutant colonies 

over background.

870.5300

In vitro Mammalian Cell 

Gene Mutation Assay

MRID 00126661

Acceptable/Guideline

There was no concentration-related positive response of induced mutant colonies 

over background.

870.5450

Dominant Lethal—Rat

MRID 00148319 (1984) 

Acceptable/Guideline

There was no time-related positive response of increased pre- or post-implantation loss compared to controls.

870.5300

Forward Gene Mutation 

Assay

MRID 40765601 (1988) 

Acceptable/Guideline

There was no evidence of induced mutant colonies over background in the presence or absence of S9-activation.

870.5300

Forward Gene Mutation 

Assay

MRID 00148318 (1984) 

Acceptable/Guideline

There was no evidence of induced mutant colonies over background in the presence or absence of S9-activation.

870.5385

In Vivo Mammalian Cytogenetics (Bone Marrow/Spermatogonial 

Aberration Test)

MRID 40765603 (1988) 

Acceptable/Guideline

There was no evidence of chromosome aberration induced over background.

68292 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

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

Guideline No./Study 

Type 

MRID No. (year)/Classification/

Doses Results/Comments 

870.5385

In Vivo Mammalian Cytogenetics (Bone Marrow Chromosome Aberration Test)

MRID 00148320

Acceptable/Guideline

There was no evidence of chromosome aberration induced over background.

870.5395

In Vivo Mouse Erythrocyte Micronucleus 

Assay

MRID 00151895 (1981) 

Acceptable/Guideline

There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow compared to controls.

870.5450

Dominant Lethal—

Mouse

MRID 00151896 (1984) 

Acceptable/Guideline

There was no time-related positive response of increased pre- or post-implantation loss compared to controls.

870.5550

Unscheduled DNA synthesis in mammalian 

cell culture

MRID 40765602 (1988) 

Acceptable/Guideline

There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures (nuclear silver grain counts), was induced.

870.5550

Unscheduled DNA synthesis in mammalian 

cell culture

MRID 00151894 (1982) 

Acceptable/Guideline

There was no evidence that unscheduled DNA synthesis, as determined by liquid 

scintillation counting procedures, was induced.

870.5900

In Vivo Sister Chromatid 

Exchange Assay

MRID 00133426 (1983) 

Acceptable/Guideline

There was no evidence of SCE induced over background.

870.7845

Metabolism—Rat

Urinary metabolites

41218901 (1989) 

Acceptable/Guideline

The objective of this study was to identify the urinary metabolites of trifluralin. 

There was no sex-dependent effect on metabolic profiles. A minimum of 20–30 

non-conjugated metabolites and an additional 10–20 conjugated metabolites 

were present in the urine, but no parent compound was detected. Information 

on the percentage of the administered dose excreted in the urine was not provided. However, no single metabolite accounted for more than 8–10% of the 

total urinary radioactivity, and the majority of the metabolites were present at 1–

2% of the total urinary radioactivity. Thus, almost all of the metabolites were 

minor (<5% of the total radioactive dose). Metabolite F1B was found at 8.2–

8.9% of the total urinary radioactivity in both sexes, and Metabolite F2, N-[(3-

(acetylamino)-2-amino-5-(trifluoromethyl)phenyl] acetamide, was found at 4.0–

5.2%. Metabolite F1B was partially characterized as retaining the trifluoromethyl 

groups, the two equivalent aromatic protons, and the two nitro groups, but the 

propyl groups were lost. Ten other metabolites were identified (<0.1–3.7% of 

total urinary radioactivity, each compound in each sex). Two additional metabolites were partially characterized (0.–2.6% of total urinary radioactivity, each 

compound in each sex). 

Four metabolic pathways were identified as follows: 

i. Oxidative N-dealkylation of one or both propyl groups and metabolites which 

were hydroxylated on the propyl side chain. 

ii. Reduction of one or both nitro groups to the corresponding amine. 

iii. Cyclization reactions to give a variety of substituted and unsubstituted benzimidazole metabolites. 

iv. Conjugation reactions, including acetylation of the reduced nitro groups, sulfate, and glucuronic acid conjugates. 

Special study 

3-Month Feeding—Rat 

with Urinalysis Study 

00157156 (1985), 

40138301(1986), 41086101 

(1989) 

0; 50; 200; 800; 3,200; and 

6,400 ppm 

0, 2.6, 10.7, 42.2, 170.2, and 

342.1 mg/kg/day 

Acceptable/Nonguideline. 

NOAEL = 200 ppm (10.7 mg/kg/day) 

LOAEL for nephrotoxicity = 800 ppm (42.2mg/kg/day), based on the presence of 

cortical tubular cytoplasmic hyaline droplets; increased total protein, aspartate 

aminotransferase (AST), and lactate dehydrogenase (LDH) in the urine; and increased urinary volume upon protein electrophoresis and urinalysis.

This study was to provide additional information to establish a NOAEL for 

nephrotoxicity, which was observed in a chronic feeding study in rats at the lowest dose tested.

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 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68293

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. A 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 

an additional factor. The acute or 

chronic Population Adjusted Dose 

(aPAD or cPAD) is a modification of the 

RfD to accommodate this type of FQPA 

Safety Factor (SF).

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 is a 

conservative method which 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). Even though the Agency 

does not have a mouse study, the 

database is considered to be complete 

with the rat data. A summary of the 

toxicological endpoints for trifluralin 

used for human risk assessment is 

shown in Table 2 of this unit:

TABLE 2.—TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIFLURALIN

Exposure scenario Dose used in risk assessment, 

UF Special FQPA SF* target MOE Study and toxicological effects 

Acute Dietary 

(Females 13–50 years 

of age)

NOAEL = 100 mg/kg/day 

UF = 100

Acute RfD = 1.0 mg/kg/day

Special FQPA SF = 1

aPAD = 1.0 mg/kg/day

Developmental Toxicity Study—Rat 

LOAEL = 500 mg/kg/day based on increased 

total litter resorptions

Acute Dietary 

(General population, including infants and 

children)

No appropriate single dose endpoint was selected.

Chronic Dietary 

All population

NOAEL = 2.4 mg/kg/day 

UF = 100

Chronic RfD = 0.024 mg/kg/

day

Special FQPA SF = 1

cPAD = 0.024 mg/kg/day

Chronic Toxicity (capsule)—Dog 

LOAEL = 40 mg/kg/day based on based on 

increased frequency of abnormal stool, decreased body weights and body weight 

gains, and on decreased erythrocytes and 

hemoglobin and increased thrombocytes in 

males

Short-Term Incidental 

Oral 

(1–30 days)

NOAEL = 10 mg/kg/day MOE = 100 2-Generation Reproduction Study—Rat 

LOAEL = 32.5 mg/kg/day based on decreased pup weights in both generations 

Intermediate-Term Incidental Oral 

(1–6 months)

NOAEL = 10 mg/kg/day MOE = 100 Special Urinalysis Study—Rat 

LOAEL = 40 mg/kg/day based on based on 

the presence of tubular cytoplasmic hyaline 

droplets; increased total protein, AST, and 

LDH in the urine; albumin a1-globulin and 

a2-globulin observed by urine electrophoresis; and increased urinary volume 

Short-Term Dermal 

(1 to 30 days)

No quantification required since there was no systemic toxicity at the limit dose in the dermal toxicity study. There 

are no developmental toxicity concerns. The HIARC also recommends that the products containing trifluralin 

should be labeled as SENSITIZER.

Intermediate-Term Dermal 

(1 to 6 months)

Oral study 

NOAEL = 10 mg/kg/day

(dermal absorption rate = 3%)

Residential MOE = 100

Occupational MOE = 100

Special Urinalysis Study—Rat 

LOAEL = 40mg/kg/day based on based on 

the presence of tubular cytoplasmic hyaline 

droplets; increased total protein, AST, and 

LDH in the urine; albumin a1-globulin and 

a2-globulin observed by urine electrophoresis; and increased urinary volume

Long-Term Dermal 

(>6 months)

Oral study 

NOAEL = 2.4 mg/kg/day

(dermal absorption rate = 3% 

when appropriate)

Residential MOE = 100

Occupational MOE = 100

Chronic Toxicity (capsule)—Dog 

LOAEL = 40mg/kg/day based on based on increased frequency of abnormal stool, decreased body weights and body weight 

gains, and on decreased erythrocytes and 

hemoglobin and increased thrombocytes in 

males

68294 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

TABLE 2.—TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIFLURALIN—Continued

Exposure scenario Dose used in risk assessment, 

UF Special FQPA SF* target MOE Study and toxicological effects 

Short-Term Inhalation 

(1 to 30 days)

Inhalation study NOAEL= 81 

mg/kg/day 

Residential MOE = 100

Occupational MOE = 100

30-Day Inhalation Study—Rat 

LOAEL = 270 mg/kg/day based on increased 

methemoglobin and bilirubin in females and 

incidences of dyspnea and ruffled fur in 

males and females 

Intermediate-Term Inhalation 

(1 to 6 months)

Oral study NOAEL = 10 mg/

kg/day 

(inhalation absorption rate = 

100%)

Residential MOE = 100

Occupational MOE = 100

Special Urinalysis Study—Rat 

LOAEL = 40 mg/kg/day based on based on 

the presence of tubular cytoplasmic hyaline 

droplets; increased total protein, AST, and 

LDH in the urine; albumin a1-globulin and 

a2-globulin observed by urine electrophoresis; and increased urinary volume 

Long-Term Inhalation 

(>6 months)

Oral studyNOAEL= 2.4 mg/kg/

day 

(inhalation absorption rate = 

100%)

Residential MOE = 100

Occupational MOE = 100

Chronic Toxicity (capsule)—Dog 

LOAEL = 40 mg/kg/day based on based on 

increased frequency of abnormal stool, decreased body weights and body weight 

gains, and on decreased erythrocytes and 

hemoglobin and increased thrombocytes in 

males 

Cancer 

(Oral, dermal, inhalation)

Q1* = 5.8 X 10-3 (mg/kg/day)-1. The Agency concluded that trifluralin is a ‘‘Group C’’ (limited evidence of carcinogenicity) carcinogen with a Q1* of 0.0077 (mg/kg/day)-1; (Based on male rat thyroid follicular cell tumors combined). 

Recalculation of the Q1* with ds interspecies scaling factor resulted in a Q1* of 0.00579 (mg/kg/day)-1. (No additional 

data needed).

UF = uncertainty factor, Special FQPA SF = Special FQPA safety factor - a FQPA safety factor based on concerns unique to the FQPA, NOAL 

= no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD 

= reference dose, MOE = margin of exposure, NA = Not Applicable

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.207) for the 

residues of trifluralin, in or on a variety 

of raw agricultural commodities. Dietary 

exposure estimates are also factored by 

the estimated weighted average usage, 

or percent crop treated (PCT) data. Risk 

assessments were conducted by EPA to 

assess dietary exposures from trifluralin 

in food as follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a one 

day or single exposure. The Dietary 

Exposure Evaluation Model (DEEMTM) 

analysis evaluated the individual food 

consumption as reported by 

respondents in the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

commodity. Additionally, acute risks 

were also estimated using the Lifeline 

model (version 2.0). Lifeline converts 

the raw agricultural commodity (RAC) 

residues into food residues by randomly 

selecting a RAC residue value from the 

user defined residue distribution 

(created from the residue, PCT, and 

processing factors data), and calculating 

a net residue for that food based on the 

ingredient’s mass contribution to that 

food item. The Lifeline model estimated 

acute exposure based on the acute 1-day 

dietary dose drawn randomly from an 

age-specific seasonal exposure profile of 

1,000 individuals.

In the course of conducting a Tier 3 

dietary exposure analysis, decisions are 

made regarding the following: The 

residue data used in the analysis (field 

trials, monitoring data, etc.) refinements 

incorporated in such as PCT and 

processing factors. Monitoring data were 

used for the majority of crops whereby 

field trial data was used for the 

remainder of the commodities. 

Monitoring data were translated to 

similar crops when possible, generally 

according to the Agency’s Standard 

Operating Procedure (SOP) 99.3 

‘‘Translation of Monitoring Data.’’ The 

following commodities used USDA 

Pesticide Data Program (PDP) 

monitoring data: Carrots, celery, orange, 

peach, squash, sweet pepper, and 

wheat. For PCT, the following 

commodities noted 100 PCT: Apricot, 

apricot juice, apricots-dried, brussel 

sprouts, cherries, cherries-dried, 

cherries-juice, chicory, eggplant, endive 

(escarole), flax seed, horseradish, 

kohlrabi, mustard seeds, mung beans, 

oats, oats-bran, parsnip, rapeseed 

(canola oil), and salsify. However, the 

majority of PCT for all other 

commodities is well below 100% (e.g, 

mint = 3%). For a more comprehensive 

listing of all commodities regarding PCT 

see the Residue Chemistry Chapter for 

Trifluralin, which is provided as 

background in EPA’s public docket at 

http://www.epa.gov/edocket/ under 

docket ID number OPP–2004–0142.

An acute dietary assessment was not 

conducted for the general U.S. 

population or infants and children 

because there was no appropriate single 

dose endpoint for this population 

subgroup. Trifluralin is not acutely toxic 

and there is no expectation that single, 

or single-day high-end exposure, 

including aggregate exposure, will have 

an adverse effect.

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

Dietary Exposure Evaluation Model 

(DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996 and 1998 CSFII and 

accumulated exposure to the chemical 

for each commodity. The following 

summarizes the Agency’s current 

method for determining exposure due to 

use on food commodities. Chronic 

dietary exposure is estimated for the 

general U.S. population and population 

subgroups defined by sex, age, region, 

and ethnicity. Durations of chronic 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68295

exposure vary from 1-year as 

represented by ‘‘all infants,’’ to lifetime 

exposure as represented by the general 

U.S. population, which combines all 

population subgroups to form a mean 

exposure value. It should be noted that 

all parameters of chronic dietary 

exposure estimates are averaged values 

(i.e., average food consumption, average 

residue, etc.). The assessment is based 

on PDP, field trial (provides an upper 

bound estimate of dietary exposure) and 

processing data. Dietary exposure 

estimates are also factored by the 

estimated weighted average usage, or 

‘‘percent crop treated’’ data.

iii. Cancer. The estimated exposure of 

the general U.S. population (only) to 

trifluralin is 0.000028 mg/kg/day. 

Carcinogenic dietary risk is based on the 

chronic exposure estimate for the 

general U.S. population derived from 

the same residue, percent use, and 

averaged consumption data. Note that 

the consumption data for the general 

U.S. population represents all age 

groups, all geographic areas, all ethnic 

groups, and incorporates reports of no 

consumption (non-user). The final risk 

estimate is calculated by multiplying 

the average U.S. exposure estimate by 

the trifluralin upper-bound potency 

factor, or Q1*.

iv. Anticipated residue and percent 

crop treated (PCT) information. The 

dietary assessment relies on field trial, 

monitoring (PDP), and usage data (PCT). 

Trifluralin residues were LOQ in/on all 

commodities except alfalfa, collards, 

flax seeds, and mint field trials.

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 

require that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. As required by 

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

issue a data call-in for information 

relating to anticipated residues to be 

submitted no later than 5 years from the 

date of issuance of this tolerance.

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

that the Agency may use data on the 

actual PCT 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.

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:

Crops with less than 2.5 PCT: Alfalfa, 

almonds, apples, corn, grapes, lettuce, 

mint, onions, oranges, peaches, pears, 

pecans, prunes and plums, sorghum, 

and walnuts.

Crops with 5–20 PCT: Barley (5), 

broccoli (10), cantaloupes (15), 

cauliflower (10), celery (10), cucumbers 

(5), dry peas (15), honeydew (5), hops 

(5), lemons (5), okra (20), spring wheat 

(5), peanuts (10), potatoes (5), pumpkins 

(5), radishes (10), soybeans (15), spinach 

(10), squash (5), sugar beets (5), 

sugarcane (10), and watermelons (15).

Crops with 25 or more PCT: 

Asparagus (25), beans, green (35), 

cabbage (45), carrots (55), collards (35), 

cotton (45), dry beans (30), durum 

wheat (35), kale (25), greens, mustard 

(25), peas, green (30), peppers (25), 

safflower (60), sunflowers (30), tomatoes 

(50), and turnip (30).

Modeling was performed by using the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCID) and 

Lifeline. Using the DEEM-FCID method, 

an estimate of the residue level in each 

food or food-form on the food 

commodity residue list is multiplied by 

the average daily consumption estimate 

for that food/food form. The resulting 

residue consumption estimate for each 

food/food form is summed with the 

residue consumption estimates for all 

other food/food forms on the 

commodity residue list to arrive at the 

total average estimated exposure. 

Exposure is expressed in mg/kg body 

weight/day and as a percent of the 

cPAD. This procedure is performed for 

each population subgroup. Using the 

same consumption data, Lifeline 

converts the Raw Agricultural 

Commodity an average daily exposure 

from a profile of 1,000 individuals over 

a 1-year period. In conjunction, a 

Screening Level Estimates of 

Agricultural Uses (SLUA) for trifluralin 

was used to estimate PCT. The SLUA 

provides a quick snap shot of pesticide 

use, by crop. For mint, the PCT of 3% 

was based on the SLUA report, which 

averages the total pounds applied to 

trifluralin and PCT from 1997–2001.

The Agency believes that the three 

conditions listed in this unit 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 

trifluralin may be applied in a particular 

area.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient data 

to accurately determine dietary 

exposure from drinking water. 

Therefore, contamination estimates for 

drinking water are refined by PRZMEXAMS modeling, incorporating 

percent cropped area (PCA) data.

68296 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

Since trifluralin is registered on 

several crops, Tier II modeling crop 

scenarios were selected to reflect crops 

with the highest uses of trifluralin 

(soybeans and cotton), the maximum 

application rate (sugarcane), and 

availability of scenarios. The maximum 

daily peak concentration of trifluralin 

from PRZM/EXAMS simulation (38.1 

parts per billion (ppb)) is greater than 

the highest concentration in the United 

States Geological Survey (USGS) 

National Water Quality Assessment 

(NAWQA) monitoring database (1.74 

ppb) for surface water. However, the 

maximum annual average trifluralin 

concentration in surface water (1.9 ppb) 

is comparable to time weighted annual 

means (TWAM) concentrations in USGS 

monitoring studies (0.618 ppb). The 

minimum criteria for calculating TWAM 

concentration at a sampling station in a 

given year was a single detection of 

trifluralin. As to groundwater, the 

maximum trifluralin concentration 

predicted by SCI-GROW is 0.035 ppb 

and the maximum single value from 

NAWQA monitoring of ground water is 

0.150 ppb. The 99.8 percentile NAWQA 

value is 0.012 ppb. Because these values 

are well below predicted and actual 

surface water values, no further analysis 

of the reliability of the maximum 

NAWQA groundwater value was 

conducted. Modeling was conducted 

using the maximum application rate for 

specific crops. Modeling estimates from 

typical application rates on specific 

crops will predict lower concentrations. 

For further information on trifluralin 

modeling and monitoring, see docket ID 

number OPP–2004–0142 at http://

www.epa.gov/edocket/ for the following 

documents: Trifluralin—Drinking Water 

Assessment for Tolerance Reassessment 

Eligibility Decision and a memorandum 

entitled Clarification of the Trifluralin 

Drinking Water Assessment for the 

Health Effects Division (HED) Tolerance 

Reassessment (PC Code: 036101) and 

characterization on relative differences 

of USGS NAWQA ground water 

monitoring data and its comparison to 

SCI-GROW model predictions as 

presented in the NRDC objection (see 

Imidacloprid in the Federal Register of 

May 26, 2004 (69 FR 30042) (FRL–7355–

7)) and the trifluralin TRED.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever exceed human health levels of 

concern.

3. Non-dietary exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., for lawn and 

garden pest control, indoor pest control, 

termiticides, and flea and tick control 

on pets).

Trifluralin is currently registered for 

use on the following residential nondietary sites: Home lawns, vegetable 

gardens, ornamental gardens (including 

planting beds, flowers, shrubs, and 

trees), including other residential sites 

such as golf courses, recreational parks, 

bike/golf cart paths, and cemeteries. The 

risk assessment was conducted using 

the following residential exposure 

assumptions: 

• For residential scenarios, 

homeowner handlers are expected to 

complete all tasks associated with the 

use of a pesticide product, including 

mixing/loading as well as application.

• Residential handler exposure 

scenarios are only considered to be 

short-term in nature due to the episodic 

uses associated with homeowner 

products.

• Label use rates and use information 

specific to residential products serve as 

the basis for the risk calculations.

• Area/volumes of spray or chemical 

used in the risk assessment are based on 

Agency guidance specific to residential 

use patterns.

The Agency has determined that there 

are potential exposures to residential 

handlers (i.e., mixer, loader, applicators) 

during the usual use-patterns associated 

with trifluralin. Likewise, the Agency 

has determined that there are potential 

post-application exposures to adults and 

children in residential settings during 

the usual use-patterns associated with 

trifluralin. For non-cancer postapplication risks, since there is no shortterm dermal toxicological endpoint of 

concern for trifluralin and no 

intermediate-term dermal exposure is 

anticipated, the only assessment is for 

incidental ingestion by toddlers.

The Agency has also determined that 

there are potential post-application 

cancer risks for adults in residential 

areas treated with trifluralin. The 

following scenarios were assessed:

• Dermal exposure to residue on 

lawns.

• Dermal exposure to golf course 

turfgrass.

• Dermal exposure to residue on 

home gardens.

For the residential turfgrass scenario, 

the cancer risks were combined for 

residential handlers applying granular 

formulation to lawns with postapplication cancer risks to adults from 

exercising on just-treated lawns. This 

combined two screening-level 

calculations.

4. Cumulative exposure to 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 

trifluralin and any other substances and 

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 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/.

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 

that a different margin of safety will be 

safe for infants and children. Margins of 

safety are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans.

2. Prenatal and postnatal sensitivity. 

There are no residual uncertainties for 

pre- and/or postnatal toxicity.

3. Conclusion. There is a complete 

toxicity database for trifluralin and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. Based 

on this information and the lack of any 

residual concerns for pre- and/or 

postnatal toxicity, EPA concludes it has 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68297

reliable data to remove the additional 

10X FQPA safety factor.

E. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against the model 

estimates of a pesticide’s concentration 

in water (EECs). DWLOC values are not 

regulatory standards for drinking water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

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

available for exposure through drinking 

water [e.g., allowable chronic water 

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

food + 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 

groundwater are less than the calculated 

DWLOCs, OPP concludes with 

reasonable certainty that exposures to 

the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP 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, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

Aggregate exposure assessment is 

based, in part, on the assumption that 

there is a predictable level of chronic 

pesticide exposure, attributable to food 

and drinking water, and this level is 

estimated on a per day basis (mg/kg/

day) by using averaged estimates of 

residue, use, and consumption. This 

average, or ‘‘background’’ level of 

exposure is assumed to be constant, not 

seasonal, and residential or other 

exposures are additive to this 

background.

For trifluralin, homeowner use is 

highly seasonal (mostly early Spring) 

and this exposure will likely be acute 

(one day of golf) or short-term (multiple 

residential applications). The route of 

exposure may be oral (children on turf), 

dermal (at application or postapplication), or by inhalation (at 

application).

1. Acute risk. A quantitative acute 

dietary assessment was not conducted 

for the general U.S. population or 

population subgroups other than 

females 13–49 because there was no 

appropriate single dose endpoint. 

Exposure to trifluralin is not expected to 

pose an acute risk to these population 

groups. The upper-bound acute risk 

estimate for females 13–49 years of age 

is less than 1% of the aPAD at the 99.9th

exposure percentile. Results of the 

Lifeline analysis (see Table 3 of this 

unit) are fully consistent with DEEMFCID results (<1% aPAD).

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO TRIFLURALIN (FOOD/ WATER COMBINED) 

Acute Dietary Estimates (99.9th Percentile of Exposure) 

Population subgroup 

PAD,

mg/kg/day

DEEM-FCID Lifeline 

Exposure,

mg/kg/day % PAD 

Exposure,

mg/kg/day %PAD 

Females 13–49 years 1 0.000262 0.03 0.000311 <1

2. Chronic risk. Dietary risk for 

trifluralin is assessed by comparing 

chronic dietary exposure estimates (in 

mg/kg/day) to the trifluralin cPAD, with 

dietary risk expressed as a percent of the 

cPAD. The cPAD is the chronic 

population adjusted dose; the chronic 

reference dose (0.024 mg/kg/day) 

modified by the FQPA safety factor. The 

trifluralin cPAD is 0.024 mg/kg/day 

based on a RfD of 0.024 mg/kg/day (see 

section 3.3.1, Endpoint Selection 

Discussion in the Trifluralin: Human 

Risk Assessment document), and 

incorporating the FQPA safety factor of 

1X (no additional factor) for the overall 

U.S. population or any population 

subgroups.

The cPAD method of risk assessment 

is applicable to the oral exposure route 

and is used to assess both food and 

drinking water exposure. Exposure 

estimates that are less than 100% of the 

cPAD indicate a determination of safety 

can be concluded (see Table 4 of this 

unit).

TABLE 4.—CHRONIC DIETARY EXPOSURE AND RISK ESTIMATES

Chronic PAD Dietary Estimates 

Population subgroup 

PAD,

mg/kg/day

DEEM-FCID Lifeline 

Exposure,

mg/kg/day %PAD 

Exposure,

mg/kg/day %PAD 

U.S. Population 0.024 0.000030 <1 0.000019 <1

All infants (< 1 year) 0.024 0.000062 <1 0.000033 <1

68298 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

TABLE 4.—CHRONIC DIETARY EXPOSURE AND RISK ESTIMATES—Continued

Chronic PAD Dietary Estimates 

Population subgroup 

PAD,

mg/kg/day

DEEM-FCID Lifeline 

Exposure,

mg/kg/day %PAD 

Exposure,

mg/kg/day %PAD 

Children 1–2 years 0.024 0.000073 <1 0.000051 <1

Children 3–5 years 0.024 0.000062 <1 0.000039 <1

Children 6–12 years 0.024 0.000041 <1 0.000024 <1

Youth 13–19 years and All Adults 0.024 0.000025 <1 0.000016 <1

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). 

Dietary exposure is assumed to be 

constant, not seasonal and residential or 

other exposures are additive to this 

background. Homeowner use for 

trifluralin is highly seasonal and this 

exposure will likely be acute or shortterm. Thus, the route of exposure may 

be oral (children on turf), dermal, or 

inhalation where residential exposure 

could occur with the use of trifluralin. 

However, no toxicological effects have 

been identified for short-term toxicity. 

Therefore, the aggregate risk does not 

exceed the Agency’s level of concern.

The chronic dietary exposure and risk 

estimates for the general United States 

and population subgroups, are aggregate 

estimates based on both food and 

drinking water sources. The aggregate (3 

specific exposure scenarios) incidentaloral exposure estimate for children on 

turf is 0.00009 mg/kg/day. When 

combined with the estimated chronic 

dietary exposure (0.000051 mg/kg/day) 

for children 1–2 years old, the sum is 

0.00014 mg/kg/day. Compared to the 

appropriate dose (10 mg/kg/day) for 

short-term incidental-oral risk 

assessment, this aggregate exposure 

estimate is much greater than the target 

MOE of 100, and a conclusion of safety 

can be made.

4. Intermediate-term risk. 

Intermediate and long-term residential 

exposure is not expected for trifluralin 

and thus no such risk is expected from 

the use of trifluralin.

5. Cancer risk. When using the Q1* 

approach to assess a pesticide, the 

Agency considers all exposure to be 

additive to aggregate carcinogenic risk, 

regardless of exposure route or exposure 

duration (per season). For trifluralin, 

this means that the chronic exposure 

from foods (0.000022 mg/kg/day) is 

added to chronic exposure due to 

drinking water (0.000008 mg/kg/day) 

and this in turn is added to exposure 

estimated for residential use. Based on 

this assumption, carcinogenic risk 

estimates are made for those applying 

trifluralin themselves, each season, 

throughout adulthood (50 years).

The exposure and carcinogenic risk 

estimates for residential applicators vary 

significantly depending on the 

application method, even if other inputs 

(rate and area treated) remain the same. 

Since the carcinogenic risk assessment 

attempts to reflect long-term exposure, 

the most appropriate exposure estimate 

would be based on the most common 

application method; the push-type 

spreader (for homeowners).

The risk estimate represents the 

probability of ‘‘excess’’ cancers 

attributable to trifluralin. In general, the 

Agency considers carcinogenic risk 

estimates in the range of 10-6, or less, to 

be negligible. Applying the Q1* of 5.8 x 

10-3 (mg/kg/day)-1 to the exposure 

value, results in a cancer risk estimate 

of 1.64 x 10-7 (DEEM-FCID) and 1.13 x 

10-7 (Lifeline). Therefore, estimated 

cancer risk is below the Agency’s level 

of concern.

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 trifluralin 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

(GC method; TFN0291) using an 

electron capture detector (ECD), Eli Lilly 

Method AM-AA-CA-R023-AA-755, and 

GRM 92.11) 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

Canada, Codex, and Mexico do not 

have maximum residue limits (MRLs) 

for residues of trifluralin in mint oil or 

in/on spearmint and peppermint tops. 

Furthermore, no maximum MRLs for 

trifluralin have been established or 

proposed by Codex for any agricultural 

commodity. Therefore, no compatibility 

questions exist with respect to U.S. 

tolerances.

C. Conditions

Currently, there are no additional 

requirements. Also, all existing 

tolerances are being maintained at 

current levels and are considered to be 

reassessed by the Trifluralin Tolerance 

Reassessment Eligibility Decision signed 

on August 31, 2004.

V. Conclusion

A tolerance is proposed for residues 

of trifluralin in mint oil at 2.0 ppm.

VI. Statutory and Executive Order 

Reviews

This proposed 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 proposed rule has been 

exempted from review under Executive 

Order 12866 due to its lack of 

significance, this proposed 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 proposed 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 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68299

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). Because this 

action will not have an adverse impact 

on small business, I certify, under the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.), that this action will not have 

a significant economic impact on a 

substantial number of small entities. 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 proposed 

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 

proposed 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 

proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: November 16, 2004.

Debra Edwards,

Director, Special Review and Reregistration 

Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180 

would continue to read as follows:

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

2. Section 180.207 would be amended 

by revising the table in paragraph (a) to 

read as follows:

§ 180.207 Trifluralin; tolerances for 

residues.

(a) * * *

Commodity Parts per 

million 

Alfalfa, hay ................................ 0.2

Asparagus ................................. 0.05

Barley, hay ................................ 0.05

Barley, straw ............................. 0.05

Bean, mung, sprouts ................ 2.0

Carrot, roots .............................. 1.0

Corn, field, forage ..................... 0.05

Corn, field, grain ....................... 0.05

Corn, field, stover ..................... 0.05

Cotton, undelinted seed ........... 0.05

Cress, upland ........................... 0.05

Flax, seed ................................. 0.05

Friut, citrus, group 10 ............... 0.05

Fruit, stone, group 12 ............... 0.05

Grain, crop, except corn, sweet 

and rice grain ........................ 0.05

Grape ........................................ 0.05

Hop ........................................... 0.05

Legume, forage ........................ 0.05

Nut, tree, group 14 ................... 0.05

Peanut ...................................... 0.05

Peppermint oil ........................... 2.0

Peppermint, tops ...................... 0.05

Rapeseed, seed ....................... 0.05

Safflower, seed ......................... 0.05

Sorghum, forage ....................... 0.05

Sorghum, grain, stover ............. 0.05

Spearmint oil ............................. 2.0

Spearmint, tops ........................ 0.05

Sugarcane, cane ...................... 0.05

Sunflower, seed ........................ 0.05

Vegetable, cucurbit, group 9 .... 0.05

Vegetable, fruiting, group 8 ...... 0.05

Vegetables, leafy ...................... 0.05

Vegetables, root (exc. carrots) 0.05

Vegetables, seed and pod ....... 0.05

Wheat, grain ............................. 0.05

Wheat, straw ............................. 0.05

* * * * *

[FR Doc. 04–25941 Filed 11–23–04; 8:45 am]

BILLING CODE 6560–50–S