Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57197

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 17, 2004.

James Jones,

Director, Office of Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

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

■ 2. Section 180.605 is added to read as 

follows:

§ 180.605 Penoxsulam; tolerances for 

residues.

(a) General. Tolerances are 

established for the herbicide, 

penoxsulam (2-(2,2-difluoroethoxy)-N-

(5,8-dimethoxy[1,2,4] triazolo[1,5-

c]pyrimidin-2-yl)-6-

(trifluoromethyl)benzenesulfonamide) 

in/on the following raw agricultural 

commodities:

Commodity Parts per million 

Rice, grain ...................... 0.02

Rice, straw ...................... 0.50

(b) Section 18 emergency exemptions. 

[Reserved]

(c) Tolerances with regional 

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 04–21502 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0315; FRL–7680–1]

Dimethenamid; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of dimethenamid 

in or on onions (dry bulb), garlic, 

shallots (dry bulb), tuberous and corm 

vegetables, sugar beets, garden beets, 

and horseradish. Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). In addition, this 

regulatory action is part of the tolerance 

reassessment requirements of section 

408(q) of the FFDCA 21 U.S.C. 346a(q), 

as amended by the FQPA of 1996. By 

law, EPA is required to reassess all 

tolerances in existence on August 2, 

1996 by August 2006. This regulatory 

action will count for thirteen 

reassessments towards this August 2006 

deadline.

DATES: This regulation is effective 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0315. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 South Bell 

St., Arlington, VA. This docket facility 

is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT: Jim 

Tompkins, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail address: 

tompkins.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

57198 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

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

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

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

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

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

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of March 12, 

2003 (68 FR11850) (FRL–7295–9), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 0E6196) by 

Interregional Research Project No. 4 (IR–

4), Technology Centre of New Jersey, 

Rutgers, the State University of New 

Jersey, 681 U.S. Highway #1 South, 

North Brunswick, NJ 08902–3390. The 

petition requested that 40 CFR 180.464 

be amended by establishing a tolerance 

for residues of the herbicide 

dimethenamid, (R,S)-2-chloro-N-[(1-

methyl-2-methoxy) ethyl]-N-(2,4-

dimethyl-thien-3-yl)-acetamide, in or on 

onions (dry bulb), garlic, shallots (dry 

bulb), tuberous and corm vegetables, 

sugar beets, garden beets, and 

horseradish at 0.01 parts per million 

(ppm). That notice included a summary 

of the petition prepared by IR–4, the 

registrant. There were no comments 

received in response to the notice of 

filing.

Dimethenamid was originally 

registered as a mixture of R and Sisomers (50:50, S:R), and tolerances for 

the 50:50 mixture were established for 

dry beans, field corn, sweet corn, 

peanuts, sorghum, and soybean. 

Manufacture of the 50:50 mixture has 

ceased and has been replaced by a 

mixture (dimethenamid-P) that is 

enriched in the biologically active Sisomer (90:10, S:R). Registration of the 

original 50:50 mixture will be cancelled 

when existing stock is depleted. 

Currently, both dimethenamid (50:50, 

S:R) and dimethenamid-P (90:10, S:R) 

are used. The petition sought to have 

tolerances established on a non-isomer 

specific bases. The existing toxicological 

and residue chemistry databases are 

established primarily on studies 

conducted with the 50:50 mixture. To 

address the uncertainty concerning 

qualitative or quantitative toxicological 

difference(s) between the original 50:50 

mixture and the enriched 90:10 mixture, 

EPA reviewed several toxicological 

studies conducted using both products. 

EPA concluded that the dimethenamid 

toxicology database is adequate for the 

risk assessment of both dimethenamid 

and dimethenamid-P. Therefore, 40 CFR 

180.464 is being revised to include 

tolerances for residues resulting from 

application of both dimethenamid 

(50:50, S:R) and dimethenamid-P (90:10, 

S:R).

In addition, existing tolerances for 

dimethenamid were reassessed as part 

of the tolerance reassessment 

requirements of section 408(q) of the 

FFDCA 21 U.S.C. 346a(q), as amended 

by the FQPA of 1996. By law, EPA is 

required to reassess all tolerances in 

existence on August 2, 1996 by August 

2006.

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 

dimethenamid on onions (dry bulb), 

garlic, shallots (dry bulb), tuberous and 

corm vegetables, sugar beets, garden 

beets, and horseradish at 0.01 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 dimethenamid 

are discussed in Table 1. of this unit as 

well as the no observed adverse effect 

level (NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.1100 Acute oral/rats [Sprague 

Dawley] dimethenamidP (90:10 S:R isomers)

LD50 = 429 mg/kg for males LD50 = 531 mg/kg for females 

LD50 = 480 mg/kg for both sexes

Toxicity category II

870.1100 Acute oral/rats [Sprague 

Dawley] dimethenamid 

(50:50 S:R isomers)

LD50 = 500 mg/kg. The mean for both sexes 

Toxicity category II

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57199

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

Guideline No. Study Type Results 

870.1200 Acute dermal/rabbits 

dimethenamid-P (90:10 

S:R isomers)

LD50 = > 2,000 mg/kg 

Toxicity category III

870.1200 Acute dermal/rabbits 

dimethenamid (50:50 

S:R isomers)

LD50 = > 2,000 mg/kg 

Toxicity category III

870.1300 Acute inhalation [Sprague 

Dawley] dimethenamidP (90:10 S:R isomers)

LC50 = 2.2 mg/L 

Toxicity category III

870.1300 Acute inhalation/rats 

[Wistar] dimethenamid 

(50:50 S:R isomers)

LC50 = 4.99 mg/L 

Toxicity category III

870.2400 Acute eye irritation rabbits 

dimethenamid-P (90:10 

S:R isomers)

Minimally irritating 

Toxicity category III

870.2400 Acute eye irritation/rabbits 

dimethenamid (50:50 

S:R isomers)

Minimally irritating 

Toxicity category III

870.2500 Acute dermal irritation 

rabbits dimethenamid-P 

(90:10 S:R isomers)

Minimally irritating 

Toxicity category IV

870.2500 Acute dermal irritation/rabbits dimethenamid 

(50:50 S:R isomers)

Minimally irritating 

Toxicity category IV

870.2600 Skin sensitization [Guinea 

Pigs] dimethenamid-P 

(90:10 S:R isomers)

Mild skin senstizer

870.2600 Skin sensitization [Guinea 

Pigs] dimethenamid 

(50:50 S:R isomers)

Mild skin senstizer

870.3100 Subchronic Feeding/

Sprague Dawley Rat 

dimethenamid-P (90:10 

S:R isomers)

NOAEL= 37/40(M/F) mg/kg/day [500 ppm] 

LOAEL= 110/125 (M/F) mg/kg/day [1,500 ppm] based on decreased body weight 

(bwt) and bwt gain in males and females, increased gamma-glutamyl transferase 

in both sexes, increased cholesterol in males, increased absolute and relative liver 

weight and periportal hepatocytic hypertrophy and periportal eosinophilic inclusions in males, centrilobular hypertrophy in females and liver necrosis in females

870.3100 Subchronic Feeding/

Sprague Dawley rat 

dimethenamid (50:50 

S:R isomers)

NOAEL= 33.5/40.1 (M/F) mg/kg/day [500 ppm] 

LOAEL= 98/119 (m/f) mg/kg/day [1,500 ppm] based on decreased bwt and bwt gain, 

increased total protein in males; in females, increased cholesterol, increased liver 

weight and centrilobular hepatocytic enlargement

870.3150 Subchronic oral toxicity 

(dog) dimethenamid 

(50:50 S:R isomers)

NOAEL = 4.72/4.98 (M/F) mg/kg/day [100 ppm ] 

LOAEL = 33.6/39.7 (M/F) mg/kg/day [750 ppm] based on decreased bwt and bwt 

gain in females, increased relative liver weight in both sexes, increased periportal 

vacuolation in both sexes and dilation of liver sinusoids in females

870.3200 21/28-Day dermal toxicity 

(rabbit) dimethenamid 

(50:50 S:R isomers)

NOAEL = 50 mg/kg/day 

LOAEL = 150 mg/kg/day based on decreased blood phosphate in both sexes [15% 

at 150mg/kg/day and 15% at 500 mg/kg/day] [p < 0.05]

870.3250 Subchronic dermal toxicity 

dimethenamid (50:50 

S:R isomers)

Not required

870.3465 Subchronic inhalation toxicity es) dimethenamid 

(50:50 S:R isomers)

Not required

57200 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

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

Guideline No. Study Type Results 

870.3700 Prenatal developmental in 

(Sprague Dawley rats) 

dimethenamid-P (90:10 

S:R isomers)

Maternal NOAEL = None 

LOAEL = 25 mg/kg/day based on bwt decrement on Gestation Day 13–19(Gday) 

(no single dose effect) and body weight gain decrease and food consumption decrease GDay 6–16 and 6–9, respectively

Developmental NOAEL = 25 mg/kg/day

LOAEL=150 mg/kg/day based on ossification delays in the pubis and at 300 mg/kg/

day ossification delays in the pubis, sternal centra, incidences of microphthalmia, 

umbilical hernia and at 400 mg/kg/day increased post implantation loss in a rangefinding study

870.3700 Prenatal developmental in 

(Sprague Dawley rats) 

dimethenamid (50:50 

S:R isomers)

Maternal NOAEL = 50 mg/kg/day 

LOAEL = 215 mg/kg/day based on bwt decrement on GDay 12 (but not a single 

dose effect) and bwt decrement and food consumption decrease, both GDay 6–9 

and 6–16

Developmental NOAEL = 215 mg/kg/day

LOAEL= 425 mg/kg/day based on increased post implantation loss

870.3700 Prenatal Developmental 

(NZW/Rabbit) 

dimethenamid (50:50 

S:R isomers)

Maternal NOAEL = 75 mg/kg/day 

LOAEL = 150 mg/kg/day based on slight bwt decrement (80g, GDay 12–15), bwt 

loss (75g GDay 15–19) and 2 abortions and in a 20 litter/group range-finding 

study, death (13/20) and abortions (7/20) at 250 mg/kg/day

Developmental NOAEL = 75 mg/kg/day

LOAEL = 150 mg/kg/day based on SS fetal incidence of irregular parietals and hyoid 

angulated. Litter incidence was nominally elevated by 50% and 100%, respectively, and nominally increase post implantation loss (double control)

870.3800 Reproduction and fertility 

effects (Wistar 

rats)dimethenamid 

(50:50 S:R isomers)

Parental/Systemic NOAEL = M/F 36/40 mg/kg/day [500 ppm] 

LOAEL =M/F 150/160 mg/kg/day [2,000 ppm] based on decrease bwt, bwt gain, 

food consumption and absolute and relative liver weight increase

Reproductive NOAEL = M/F 150/160 mg/kg/day [2,000 ppm]

LOAEL = None

Offspring NOAEL = 40 mg/kg/day [500 ppm]

LOAEL = 160 mg/kg/day [2,000 ppm] based on f1 pup weight decrement at LDay 21 

and f2 pup weight decrease at LDay day 7 and 2

870.4100 Chronic toxicity (Rat) 

dimethenamid (50:50 

S:R isomers)

Satisfied by data for 870.4300

870.4100 Chronic toxicity (dog) 

dimethenamid (50:50 

S:R isomers)

NOAEL = M/F 10.1/9.1 mg/kg/day [250 ppm] 

LOAEL = M/F 48.7/49.3 mg/kg/day [1,250 ppm] based on decreased bwt and bwt 

gains [43% to 60%, 0–26 wk] both sexes 100% in males wk 26–52] alkaline phosphatase increased in females 109–2185 through out study and 80% in males. Portal vacuolation in males; vacuoles not lipid or glycogen

870.4200 Carcinogenicity (rat 

dimethenamid (50:50 

S:R isomers)

Satisfied by data for 870.4300

870.4200 Carcinogenicity (mouse) 

dimethenamid (50:50 

S:R isomers)

NOAEL = 300 ppm (M/F: 40.8/40.1 mg/kg/day) 

LOAEL = 1,500 ppm (M/F: 205/200 mg/kg/day) based on decreased bwt gain in 

both sexes

No treatment related tumors were seen at adequate doses

870.4300 Chronic/carc-inogenicity 

(Sprague Dawley rat) 

dimethenamid (50:50 

S:R isomers)

NOAEL = 100 ppm [M/F: 5.1/6.8 mg/kg/day] 

LOAEL = 7,000 ppm [M/F: 36/49 mg/kg/day] based on decreased bwt and bwt gain 

in both sexes and microscopic hepatic lesions in both sexes. A dose related increased incidence of liver tumors in males (benign and malignant combined) were 

seen at the 1,500 ppm dose both exceeding slightly historical controls. 

Dimethenamid (50:50 S:R isomers) characterized as a Group C - possible human 

carcinogen. For the purpose of risk assessment, the MOE approach will be used 

for human risk assessment)

870.5100 Bacterial Reverse mutation dimethenamid-P 

(90:10 S:R isomers)

S. typhimurium exposed to 500–4,000 μg/plate +/¥ S9

E. coli exposed to 20–5,000 μg/plate +/¥ S9 using the standard plate incorporation 

method or 4–2,500 μg/plate +/¥ S9 using the pre-incubation modification to the 

standard test. Highest doses were cytotoxic

All assays were negative

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57201

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

Guideline No. Study Type Results 

870.5100 Bacterial Reverse mutation dimethenamid-P 

(90:10 S:R isomers)

Exposed to 20–5,000 μg/plate in a plate incorporation assay. Marginal cytotoxicity at 

limit dose of 5,000 μg/plate +/¥ S9

Assays were negative with both bacteria +/¥ S9

870.5100 Bacterial Reverse mutation dimethenamid-P 

(90:10 S:R isomers)

Repeat of MRID # 44123502. S. typhimurium TA100 was exposed to 100–5,000 μg/

plate +/¥ S9

Assay was negative

870.5100 Bacterial Reverse mutation dimethenamid-P 

(90:10 S:R isomers)

Exposed to 100–5,000 μg/plate, +/¥ S9, in a plate incorporation assay. Insolubility 

seen at 333 and 5,000 μg/plate, but no toxicity at any dose +/¥ S9

Assays were negative with both bacteria + S9, however, ¥ S9 induced 1.5 fold increases at 333 μg/plate and 4.1 fold increases in reverents in TA100 strain at 

5000 μg/plate. This mutagenic response was reproducible at 100 to 5,000 μg/plate

870.5100 Bacterial Reverse mutation dimethenamid-P 

(90:10 S:R isomers)

Strains tested at 1000–10,000 μg/plate, ¥ S9 and 1,000–6,500 μg/plate, + S9. 

Cytotoxicity and precipitation were noted at higher doses 

Test was negative, +/¥ S9

870.5300 Mammalian cell mutation 

dimethenamid-P (90:10 

S:R isomers)

Chinese hamster ovary (CHO) cells were exposed to 100–400 μg/mL, ¥ S9, and 

100–450 μg/mL, + S9. Slight cytotoxicity was seen at the highest dose and severe 

toxicity was seen at ≥ 500 μg/mL 

Test was negative for mutagenic effects, +/¥ S9

870.5395 Mouse erythrocyte micronucleus test 

dimethenamid (50:50 

S:R isomers)

CD–1 mice dosed at 710 mg/kg in two daily doses. LD50 = 1,417 mg/kg. Bone marrow erythrocytes harvested 24 and 48 hours later 

Test negative

870.5395 Mouse erythrocyte micronucleus test 

dimethenamid (50:50 

S:R isomers)

Mice dosed 0–1,000 mg/kg in single doses. Mice showed no toxicity; only one 

mouse died 

Test negative

870.5375 Chromosomal aberration 

test dimethenamid 

(50:50 S:R isomers)

Cells in 125–150 μg/mL, ¥ S9 and 400 to 500 μg/mL, + S9; all doses were 

cytotoxic. Study needs repeating at none cytotoxic doses. 

Test considered equivocally positive

870.5550 Unscheduled DNA 

(deoxyribonucleic acid) 

Synthesis (UDS) in rat 

hepatocytes 

dimethenamid (50:50 

S:R isomers)

Cell in 1.0–100 nl/mL. No cytotoxicity was seen 

Test was negative

870.5550 UDS in rat hepatocytes 

dimethenamid (50:50 

S:R isomers)

Fisher 344 rat administered SAN 582H doses of 158 or 500 mg/kg. Sampled 2–4 

and 12–14 hours after dosing. Only 0.2–3.6% cells in repair, but negative control 

was less than zero 

Test was negative for UDS at 158 and 500 mg/kg

870.5550 UDS in rat hepatocytes 

dimethenamid (50:50 

S:R isomers)

SAN 582H administered at 0.01 to 50 μg/mL. Unscheduled DNA synthesis was seen 

well below cytotoxic doses. Unequivocally positive for UDS 

Test positive

870.5550 UDS in rat hepatocytes 

dimethenamid (50:50 

S:R isomers)

SAN 582H administered at 0.0128 to 1,000 μg/mL to rat primary cultures of 

hepatocytes. Doses at 1,000 μg/mL were cytotoxic. No UDS was noted 

Test negative for UDS

870.5450 Dominant Lethal 

dimethenamid (50:50 

S:R isomers)

Male Charles River (CR) rats (40–55) administered SAN 582H in single oral doses 

of 275, 550, or 1,100 mg/kg were mated starting at 10 weeks to 40–55 female 

undosed CR rats. Increased dead implants at week 1 and week 2 may suggest a 

dominant lethal effect. These were mostly late implant deaths, which some consultants claim are not characteristic of a dominant lethal effect

870.5450 Dominant Lethal 

dimethenamid (50:50 

S:R isomers)

Male Sprague Dawley rats (40–60) administered SAN 582H in single oral doses of 

275, 550, or 1,100 mg/kg were mated starting the day after dosing in Trial 1 and 2 

days after dosing in Trial 2 to 80–120 female undosed Sprague Dawley rats . 

Each male was mated to 2 females over a five day sequence. Results equivocal 

Note: Both the high dose rabbit and rat developmental studies showed increased 

late and early resorptions

57202 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

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

Guideline No. Study Type Results 

870.5375 Cytogenetics in CHO cells 

dimethenamid-P(90:10 

S:R isomers)

CHO cells were exposed to 2–120 μg/mL ¥ S9; cytotoxic at ≥ 120 μg/mL. CHO 

cells were exposed to 15–120 μg/mL + S9; cytotoxic at ≥ 500 μg/mL 

Assay was negative +/¥ S9

870.5395 Cytogenetics; mouse 

erythrocyte microncleus 

test dimethenamid-P 

(90:10 S:R isomers)

Mice (5/sex) were exposed to i.p. injections of 103, 205, 410 mg/kg 

Assay was negative, indicating no clastogenic or aneugenic response

870.5550 UDS in mammalian cell 

culture dimethenamid-P 

(90:10 S:R isomers)

Cells tested at 7.8–125 μg/mL. Cytotoxicity and insolubility were seen at ≥ 250 μg/

mL 

Test was negative for UDS

870.6200 Acute neurotoxicity 

screening battery 

dimethenamid-P (90:10 

S:R isomers)

Not required

870.6200 Acute neurotoxicity 

screening battery 

dimethenamid (50:50 

S:R isomers)

Not required

870.6200 Subchronic neurotoxicity 

screening battery 

dimethenamid-P (90:10 

S:R isomers)

Not required

870.6300 Developmental 

neurotoxicity 

dimethenamid-P (90:10 

S:R isomers)

Not required

870.7485 Metabolism and pharmacokinetics (species) 

dimethenamid-P (90:10 

S:R isomers)

Not required

870.7600 Dermal penetration (species) dimethenamid-P 

(90:10 S:R isomers)

Not required

870.7600 Dermal penetration (species) dimethenamid 

(50:50 S:R isomers)

Not required

B. Toxicological Endpoint

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57203

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

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

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

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for dimethenamid used for 

human risk assessment is shown in 

Table 2. of this unit:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DIMETHENAMID FOR USE IN HUMAN RISK

ASSESSMENT.

Exposure Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (Females 13–49 

years of age) Based on [RS] 

data

NOAEL = 75 mg/kg/day 

UF = 100

Acute RfD = 0.75 mg/kg/day

FQPA SF = 1X 

aPAD = acute RfD ÷ FQPA 

SF = 0.75 mg/kg/day

Developmental Toxicity in rabbits 

Maternal; LOAEL = 150 mg/kg/day based on 

abortions and decreased body weight gain 

and food consumption

Developmental; LOAEL = 150 mg/kg/day 

based on post-implantation loss

Chronic Dietary (All populations) Based on [RS] dataNOAEL= 5 mg/kg/day 

UF = 100

Chronic RfD = 0.05 mg/kg/

day

FQPA SF = 1X 

cPAD = chronic RfD ÷

FQPA SF = 0.05 mg/kg/

day

Chronic/rats 

LOAEL = M/F; 36/49 mg/kg/day based on decreased body weight and body weight gain 

in both sexes, increased food conversion ratios in females, and increased microscopic 

hepatic lesions in both sexes

Carcinogenicity Based on [RS] 

data

Classified as a Group C 

(possible human carcinogen)

N/A Chronic risk assessment protective of any potential carcinogenic risk

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.464) for the 

residues of dimethenamid, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

dimethenamid in food as follows:

i. Acute exposure. Acute dietary risk 

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

has indicated the possibility of an effect 

of concern occurring as a result of a oneday or single exposure. In conducting 

the acute dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEMFCIDTM), which incorporates food 

consumption data as reported by 

respondents in the 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. The following assumptions 

were made for the acute exposure 

assessments: The residue estimate for 

each food commodity was the tolerance 

for that crop (0.01 ppm) and each crop 

was assessed as if 100% of the crop has 

been treated with dimethenamid.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the DEEM-FCIDTM, which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 CSFII, and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: The residue 

estimate for each food commodity was 

the tolerance for that crop (0.01 ppm) 

and each crop was assessed as if 100% 

of the crop has been treated with 

dimethenamid.

iii. Cancer. Dimethenamid (50:50 S:R 

isomers) was classified as a group ‘‘C’’

(possible human carcinogen). The 

Agency concluded that the chronic risk 

assessment, making use of the cPAD, to 

be protective of any potential 

carcinogenic risk. Dimethenamid is at 

best a weak carcinogen. An intermediate 

dose showed marginally significant 

results (p = 0.056) with liver adenomas 

one species (rat) and one sex (males). 

The incidence of liver tumors was just 

slightly increased from the level in the 

historical control data. Higher doses did 

not demonstrate the occurrence of liver 

adenomas significantly different from 

the controls. No dose-related tumors 

were seen in the mouse carcinogenicity 

study, and a battery of mutagenicity 

studies with dimethenamid-P (90:10 S:R 

isomers) were negative or equivocal for 

genetic mutations including 

unscheduled DNA synthesis.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

dimethenamid in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

dimethenamid.

57204 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to estimate 

pesticide concentrations in surface 

water and SCI-GROW, which predicts 

pesticide concentrations in 

groundwater. In general, EPA will use 

GENEEC (a tier 1 model) before using 

PRZM/EXAMS (a tier 2 model) for a 

screening-level assessment for surface 

water. The GENEEC model is a subset of 

the PRZM/EXAMS model that uses a 

specific high-end runoff scenario for 

pesticides. GENEEC incorporates a farm 

pond scenario, while PRZM/EXAMS 

incorporate an index reservoir 

environment in place of the previous 

pond scenario. The PRZM/EXAMS 

model includes a percent crop area 

factor as an adjustment to account for 

the maximum percent crop coverage 

within a watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern.

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs), which are the 

model estimates of a pesticide’s 

concentration in water. EECs derived 

from these models are used to quantify 

drinking water exposure and risk as a 

%RfD or %PAD. Instead drinking water 

levels of comparison (DWLOCs) are 

calculated and used as a point of 

comparison against the model estimates 

of a pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to 

dimethenamid they are further 

discussed in the aggregate risk sections 

in Unit III.E.

Based on the PRZM/EXAMS and SCIGROW models, the EECs of 

dimethenamid for acute exposures are 

estimated to be 49 parts per billion 

(ppb) for surface water and 0.42 ppb for 

groundwater. The EECs for chronic 

exposures are estimated to be 7.9 ppb 

(non-cancer exposure) and 5.1 ppb 

(cancer exposure) for surface water and 

0.42 ppb for groundwater.

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets).

Dimethenamid is not registered for 

use on any sites that would result in 

residential exposure.

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

dimethenamid and any other 

substances. Dimethenamid 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 

dimethenamid 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 

(OPP) concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s web site at http://www.epa.gov/

pesticides/cumulative/.

D. Safety Factor for Infants and 

Children

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate.

2. Prenatal and postnatal sensitivity. 

No offspring pre- or postnatal 

susceptibility to either dimethenamid 

(50:50 S:R isomers) or dimethenamid-P 

(90:10 S:R isomers) was seen in a rabbit 

or two rat developmental studies and 

reproduction study. There is low 

concern for pre- or postnatal toxicity 

since the developmental effects from the 

[S] and [RS] mixture are similar and 

occur at similar doses.

3. Conclusion. There is a complete 

toxicity data base for dimethenamid and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. EPA 

determined that the safety factor for 

dimethenamid should be 100 (10X 

safety factor for interspecies 

extrapolation and 10X for intraspecies 

variation). The additional FQPA SF was 

removed taking into account the low 

concerns and lack residual uncertainties 

with regard to prenatal and postnatal 

toxicity and the completeness of the 

toxicity and exposure data base.

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 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 EPA’s 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 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57205

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, 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.

1. Acute risk. The dimethenamid 

aPAD is 0.75 mg/kg/day (applicable to 

child bearing females only (females 13–

49 years old) (Table 3.). The estimated 

acute (one day) aggregate exposure of 

females 13–49 years of age (0.006857 

mg/kg/day) utilizes less than 1% of the 

dimethenamid aPAD. For the other 

population subgroups, an appropriate 

acute endpoint attributed to a single 

dose was not available in the toxicity 

data base including the developmental 

toxicity studies.

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO DIMETHENAMID

Population Subgroup aPAD (mg/

kg) 

% aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

Females 13–49 yrs 0.75 < 1% 49 0.42 22,294

2. Chronic risk. The dimethenamid 

cPAD is 0.05 mg/kg/day. The estimated 

chronic aggregate exposure is the same 

as the chronic dietary exposure because 

dimethenamid has no residential uses. 

The chronic dietary exposure utilizes 

less than 1% of the cPAD for all 

population subgroups except infants 

less than 1 year old, which utilizes less 

than 2% of the dimethenamid cPAD. 

The chronic DWLOC was acceptable for 

chronic exposure to surface and 

groundwater (Table 4.).

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO DIMETHENAMID

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.05 < 1 7.9 0.42 1,494

All infants (< 1 yr.) 0.05 < 2 7.9 0.42 494

Children 1–2 yrs. 0.05 < 1 7.9 0.42 497

Children 3–5 yrs. 0.05 < 1 7.9 0.42 248

Children 6–12 yrs. 0.05 < 1 7.9 0.42 249

Youth 13–19 yrs. 0.05 < 1 7.9 0.42 249

Adults 20–49 yrs. 0.05 < 1 7.9 0.42 1,494

Adults 50+ yrs. 0.024 < 1 7.9 0.42 719

Females 13–49 yrs. 0.024 < 1 7.9 0.42 719

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).

Dimethenamid is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Dimethenamid is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

5. Aggregate cancer risk for U.S. 

population. The Agency considers the 

chronic aggregate risk assessment, 

making use of the cPAD, to be protective 

of any aggregate cancer risk. See Table 

4., Unit III.E.2.

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 

dimethenamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

(AM–0884–0193–1) is available to 

enforce the tolerance expression. AM–

0884–0193–1 is a GC method using an 

HP–1 or HP–5 column and mass 

selective detection (MSD). 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; email address: residuemethods@epa.gov.

57206 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

B. International Residue Limits

There are no Codex maximum residue 

levels (MRL’s) for dimethenamid.

C. Conditions

There are no conditions of registration 

for establishment of tolerances on: 

onions (dry bulb), garlic, shallots (dry 

bulb), tuberous and corm vegetables, 

sugar beets, garden beets, and 

horseradish.

V. Conclusion

Therefore, the tolerance is established 

for residues of dimethenamid, (R,S)-2-

chloro-N-[(1-methyl-2-methoxy) ethyl]-

N-(2,4-dimethyl-thien-3-yl)-acetamide, 

in or on onions (dry bulb), garlic, 

shallots (dry bulb), tuberous and corm 

vegetables, sugar beets, garden beets, 

and horseradish at 0.01 ppm. This 

action results in the reassessment of 

thirteen tolerances as follows: bean, dry, 

seed at 0.01 ppm; corn, forage at 0.01 

ppm; corn, grain at 0.01 ppm; corn, 

stover at 0.01 ppm; corn, sweet, fodder 

(stover) at 0.01 ppm; corn, sweet, forage 

at 0.01 ppm; corn, sweet, kernel plus 

cob with husks removed at 0.01 ppm; 

peanut at 0.01 ppm; peanut, hay at 0.01 

ppm; sorghum, grain, fodder at 0.01 

ppm; sorghum, grain, forage at 0.01 

ppm; sorghum, grain at 0.01 ppm; and 

soybeans at 0.01 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0315 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 23, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0315, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

VII. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57207

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 14, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

■ Therefore, 40 CFR part 180 is amended 

as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

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

■ 2. Section 180.464 is amended as 

follows:

a. By revising paragraph (a). 

b. By removing and reserving 

paragraph (b).

§ 180.464 Dimethenamid, 2-chloro-N-[(1-

methyl-2-methoxy)ethyl]-N-(2,4-

dimethylthien-3-yl)-acetamide.

(a) General. Tolerances are 

established for residues of the herbicide 

dimethenamid, 1(R,S)-2-chloro-N-[(1-

methyl-2-methoxy)ethyl]-N-(2,4-

dimethylthien-3-yl)-acetamide, applied 

as either the 90:10 or 50:50 S:R isomers, 

in or on the following food 

commodities:

Commodity Parts per 

million 

Bean, dry, seed ........................ 0.01

Beet, garden, roots ................... 0.01

Beet, garden, tops .................... 0.01

Beet, sugar, dried pulp ............. 0.01

Beet, sugar, molasses .............. 0.01

Beet, sugar, roots ..................... 0.01

Beet, sugar, tops ...................... 0.01

Commodity Parts per 

million 

Corn, field, forage ..................... 0.01

Corn, field, grain ....................... 0.01

Corn, field, stover ..................... 0.01

Corn, pop, forage ..................... 0.01

Corn, pop, grain ........................ 0.01

Corn, pop, stover ...................... 0.01

Corn, sweet, forage .................. 0.01

Corn, sweet, kernal plus cob 

with husks removed .............. 0.01

Corn, sweet, stover .................. 0.01

Garlic ........................................ 0.01

Onion, dry bulb ......................... 0.01

Peanut, hay .............................. 0.01

Peanut, nutmeat ....................... 0.01

Shallot, bulb .............................. 0.01

Sorghum, grain ......................... 0.01

Sorghum, grain, forage ............. 0.01

Sorghum, grain, stover ............. 0.01

Soybean, seed .......................... 0.01

Tuberous and corm vegetables 0.01

(b) Section 18 emergency exemptions.

[Reserved]

[FR Doc. 04–21501 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0293; FRL–7680–2]

Lactofen; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of lactofen in or 

on cotton undelinted seed, cotton gin 

byproducts, and peanut. Valent U.S.A. 

Corporation requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA).

DATES: This regulation is effective 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0293. 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,