62602 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

scientists critically appraised all the 

data at that time and came to the 

conclusion that Mr. Samuels’ objection 

was unwarranted (Ref. 2). However, 

EPA wishes to make sure all possible 

areas of disagreement are covered and 

has reviewed the latest information 

submitted by the objectors and believes 

nothing substantive has been added to 

the body of data known on these 

chemicals, and no change in the 

previous exemption is necessary.

VI. Regulatory Assessment 

Requirements

As indicated previously, this action 

announces the Agency’s final decision 

regarding an objection filed under 

section 408 of FFDCA. As such, this 

action is an adjudication and not a rule. 

The regulatory assessment requirements 

imposed on rulemakings do not, 

therefore, apply to this action.

VII. 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, does not apply 

because this action is not a rule for 

purposes of 5 U.S.C. 804(3). 

VIII. References

1. Letter from Jack L. Samuels to Sue 

Smith, The White House, Aug. 20, 1998.

2. Letter from J. Andersen to J. 

Samuels, Oct. 13, 1998.

3. Raiten, D.J. et al., Analysis of 

Adverse Reactions to Monosodium 

Glutamate (MSG), American Institute of 

Nutrition, MD, 1995.

4. e-Mail from J. Samuels to J. 

Andersen, 7/28/98.

5. Kuznesof, P.M., Expert Report, 

undated.

6. Stevenson, D.S. Expert Report, 

undated.

7. Hattan, D.G. Expert Report, 

undated.

8. Auer, R.N., Expert Report, undated. 

9. Olney, J. W. Excitotoxins in Foods. 

Neurotoxicology 15(3) 535–544, 1994.

10. Olney, J.W., et al., Cytotoxic 

effects of acidic and sulphur containing 

amino acids on the infant mouse central 

nervous system. Exp. Brain Res. 14:61–

76, 1971.

11. Martinez, F., et al. Neuroexcitatory 

amino acid levels in plasma and 

cerebrospinal fluid during migraine 

attacks. Cephalalgia. 13:89–93, 1993.

12. Strong, F.C., Why do some dietary 

migraine patients claim they get 

headaches from placebos? Clin. 

Experimental Allergy. 30:739–743, 

2000.

13. Geha R. S. et al., Multicenter, 

double-blind, placebo-controlled, 

multiple challenge evaluation of 

reported reactions to monosodium 

glutamate. J. Allergy Clin. Immunol. 

106:973–980, 2000.

14. Anantharaman, K., In utero and 

dietary administration of monosodium 

L-glutamate to mice: reproductive 

performance and development in a 

multigeneration study. In ‘‘Glutamic 

Acid: Advances in Biochemistry.’’ L. J. 

Filer, et al., eds. Raven Press, N.Y., 

1979.

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative procedure, pesticides 

and pests.

Dated: October 18, 2004.

James Jones,

Director, Office of Pesticide Programs.

[FR Doc. 04–24041 Filed 10–26–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0331; FRL–7683–5]

Deltamethrin; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

deltamethrin, isomers transdeltamethrin and a-R-deltamethrin in or 

on almond hulls; apples, wet pomace; 

artichoke, globe; barley, bran; cattle, fat; 

cattle, meat; cattle, meat byproducts; 

corn, field, forage; corn, field, refined 

oil; corn, field, stover; corn, pop, stover; 

corn, sweet, forage; corn, sweet, kernel 

+ cob with husks removed; corn, sweet, 

stover; egg; fruit, pome, group 11; goat, 

fat; goat, meat; goat, meat byproducts; 

grain, aspirated fractions; grain, cereal, 

group 15, except sweet corn; hog, fat; 

horse, fat; horse, meat; horse, meat 

byproducts; lychee (import tolerance); 

milk, fat (reflecting 0.02 ppm in whole 

milk); nut, tree, group 14; onion, dry 

bulb; onion, green; poultry, fat; poultry, 

meat; poultry, meat byproducts; radish 

tops; rapeseed; rice, hulls; rye, bran; 

sheep, fat; sheep, meat; sheep, meat 

byproducts; sorghum, grain forage; 

sorghum, grain stover; soybean, seed; 

soybean, hulls; starfruit (import 

tolerance); sunflower seeds; vegetable, 

cucurbit, group 9; vegetable, fruiting, 

group 8; vegetable, root, except sugar 

beet, subgroup IB; vegetable, tuberous 

and corm, subgroup; IC; wheat, bran. 

Bayer Crop Science LP, formerly 

Aventis CropScience, requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA).

DATES: This regulation is effective 

October 27, 2004. Objections and 

requests for hearings must be received 

on or before December 27, 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–

0331. 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:

George LaRocca, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–6100; e-mail address: 

larocca.george@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; 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62603

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET

(http://www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

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

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

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

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of November 

7, 2001 (66 FR 56298) (FRL–6808–5), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 1E6232) (PP 

0F6080) by Bayer Crop Science LP, 

formerly Aventis CropScience, P.O. Box 

12014, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.435 

be amended by establishing a tolerance 

for residues of the insecticide 

deltamethrin, in or on almond hulls; 

apples, wet pomace; artichokes; 

brassica, head and stem crop subgroup 

5A, excluding cabbage; bulb vegetables 

; cabbage (w/wrapper leaves); cabbage 

(w/o wrapper leaves); carambola (star 

fruit); corn, field grain; corn, forage 

(field); corn, fodder/stover (field); corn, 

refined oil; corn, flour; corn, meal; corn, 

milled by products; cucurbit vegetables; 

eggs; fruiting vegetables; leafy 

vegetables; lichi fruit; milk, fat 

(reflecting 0.02 ppm in whole milk); 

mustard greens; pome fruit; poultry, fat; 

poultry, mbyp; poultry, meat; prunes; 

rapeseed (including canola and crambe); 

root vegetable, except sugarbeet 

(subgroup 1B): roots; ruminant fat; 

ruminant mbyp; ruminant meat; 

sorghum, forage; sorghum, fodder/

stover; sorghum, grain; soybeans; stone 

fruit; sunflower seeds; tree nuts; 

tuberous and corm vegetables subgroup 

1C, excluding artichokes; wheat gluten 

(post harvest); wheat, grain (post 

harvest); wheat, grain dust (post harvest) 

at 1.2, 1.2, 0.5, 0.50, 1.5, 1.5, 0.15, 0.2, 

0.06, 0.7, 7.0, 0.6, 0.18, 0.12, 0.18, 0.06, 

0.02, 0.25, 4.5, 0.2, 0.1, 4.5, 0.2, 0.05, 

0.02, 0.02, 2.4, 0.12, 0.15, 0.04, 0.02, 

0.02, 0.5, 2.0, 0.5, 0.05, 0.6, 0.05, 4.0, 

0.1, 0.04, 1.4, 2.0, and 2.7 parts per 

million (ppm) respectively . The 

registrant originally filed petition PP 

1E6232 with the Agency, proposing the 

establishment of regulations for residues 

of deltamethrin, an insecticide, in or on 

various food commodities. The petition 

(PP 1E6232) requested the establishment 

of proposed tolerances for deltamethrin 

in/on almond hull, three crop subgroups 

and rapeseed, and import tolerances for 

two tropical fruits, as petitioned through 

the Minor Crop Pest Management 

program (IR-4). Petition (PP 1E6232) 

was superceded, at the request of the 

registrant, by petition (PP 0F6080), 

including additional tolerances for the 

above listed crops, and the proposed 

commodities described in the previous 

petition (PP 1E6232). The Notice of 

Filing of November 7, 2001 (66 FR 

56298) (FRL–6808–5) identified an 

inclusive summary of both petitions 

prepared by Bayer Crop Science LP 

formerly Aventis CropScience, the 

registrant. There were no comments 

received in response to the notice of 

filing.

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 combined 

residues of deltamethrin, isomers transdeltamethrin and a-R-deltamethrin in or 

on the commodities listed in Unit II. 

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 deltamethrin is 

discussed in Tables 1 and 2 of this unit 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies reviewed.

62604 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90-day oral toxicity—rodentsNOAEL = 1.0 and 10 milligrams/kilogram/day (mg/kg/day) for males and females respectively 

LOAEL = 2.5 mg/kg/day for males based on decreased body weight for males, females was not established.

870.3150 90-Day oral toxicity—nonrodentsNOAEL = 1.0 mg/kg/day males and females 

LOAEL = 2.5 mg/kg/day based on central nervous system effects diarrhea, vomiting 

and decreased body weight gain for males and females.

870.3200 21/28-Day dermal toxicity 

rat

NOAEL > 1,000 mg/kg/day for males and females (limit dose) 

Dermal NOAEL was not established.

Signs of local irritation seen at all doses.

870.3250 90-Day dermal toxicity NA

870.3465 21-Day inhalation toxicity 

rat

NOAEL = 3.0 mg/kg/day males and females. 

LOAEL = 9.6 mg/kg/day based on decreased weight gain, nervous system stimulation and skin irritation for males and females

870.3700 Prenatal developmental—

rodents

Maternal NOAEL = 3.3 mg/kg/day 

Maternal LOAEL = 7.0 mg/kg/day based on decreased body weights and body 

weight gains and clinical signs of toxicity

Developmental NOAEL = greater than 11.0 mg/kg/day

Developmental LOAEL = none observed

870.3700 Prenatal developmental—

mouse

Maternal NOAEL ≥ 10 mg/kg/day 

Maternal LOAEL = not observed

Developmental NOAEL = 0.1 mg/kg/day

Developmental LOAEL = 1.0 mg/kg/day based on decreased fetal weight, and delayed ossification of the sternebrae and paws

870.3800 Reproduction and fertility 

effects

Parental/Systemic NOAEL = 5.4 and 6.1 mg/kg/day for males and females respectively. 

Parental/Systemic LOAEL = 21.2 and 23.5 mg/kg/day for males and females respectively. Based on increased mortality and clinical signs, decreased body weights, 

body weight gains, and absolute food consumption, and gross pathological findings in both sexes.

Reproductive NOAEL = 21.2 mg/kg/day for males and females.

Reproductive LOAEL = [not established]

Offspring NOAEL = 5.8 and 6.7 mg/kg/day for males and females respectively.

Offspring LOAEL = 24.9 and 27.2 mg/kg/day for males and females respectiveley. 

Based on increased mortality and clinical signs, decreased body weights, body 

weight gains, and absolute food consumption, and gross pathological findings in 

both sexes.

870.4100 Chronic toxicity—rodents Same as Chronic Toxicity/Carcinogenicity-rat see below (870.4300)

870.4100 Chronic toxicity—dogs NOAEL = 1.0 mg/kg/day males and females. 

LOAEL = 10.0 mg/kg/day males and females. Based on reduced body weight gain, 

chewing and scratching of extremities, and liquid feces.

870.4200 Carcinogenicity—rats No evidence of carcinogenicity 

Same as chronic toxicity/carcinogenicity-rat see below (870.4300).

870.4300 Carcinogenicity—mice NOAEL = 2,000 mg/kg/day (HDT) 

LOAEL = not established

No evidence of carcinogenicity, HDT assumed to be adequate to characterize the 

carcinogenic potential based on a 12-week toxicity study in mice showing death 

and body weight differences (13% decrease) at 3,000 ppm.

870.4300 Chronic/CarcinogenicityratNOAEL = >50 ppm (HDT) for males and females. 

LOAEL was not determined

No evidence of carcinogenicity

870.5100 Bacterial reverse mutation 

test-S. typhimurium

There was no evidence of an induced mutagenic effect up to cytotoxic concentrations ≥38 micro grams/mL -S9; 150 μg/mL +S9). Levels ≥75 micrograms/mL were 

insoluble.

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62605

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

Guideline No. Study Type Results 

870.5375 In vitro mammalian chromosome aberration 

test- Chinese hamster 

ovary (CHO) cells

There was no evidence of an induced mutagenic effect up to cytotoxic concentrations (≥38 micrograms/mL -S9; 150 micrograms/mL +S9). Levels ≥75 micrograms/

mL were insoluble.

870.5550 Other Genotoxicity 

Bacterial DNA damage/repair-E. coli

There was no evidence of DNA repair/damage up to the limit dose ((5,000 

micrograms/well +/-S9). Compound precipitation seen at ≥200 micrograms/well.

870.5550 Other Genotoxicity 

Unscheduled DNA synthesis in primary rat 

hepatocytes

There was no evidence that unscheduled DNA synthesis was induced up to insoluble concentrations (≥130 micrograms/mL).

870.6200 Acute neurotoxicity 

screening battery rats

NOAEL = 5 mg/kg/day 

LOAEL = 15 mg/kg/day based on salivation, soiled fur, impaired motility, no reaction 

to approach or touch response in the functional observation battery (FOB)

870.6200 Subchronic neurotoxicity 

screening battery

NOAEL = 14 and 16 mg/kg/day for males and females respectively. 

LOAEL = 54 and 58 mg/kg/day for males and females respectivley.. Based on mortality, clinical signs, FOB findings, and decreased body weights, body weight 

gains, and food consumption.

870.6300 Developmental 

neurotoxicity

NA

870.7485 Metabolism and pharmacokinetics - ratsThe test material was relatively well absorbed. Excretion was almost complete within 

48 hours. Approximately 36-59% of the dose was found in feces and an approximately equal amount in urine. Absorbed deltamethrin was cleaved by hydrolysis at 

the ester site followed by rapid sulfate and glucuronide conjugation.

870.7600 Dermal penetration NA

Special studies There were no special studies

TABLE 2.—NON-GUIDELINE TOXICITY STUDIES AND LITERATURE.

Study Type Results Citation 

Acute Motor Function Oralmale ratVehicle: Corn oil 

ED50 5.1 mg/kg

LOAEL 3.0 mg/kg (based on reduced motor function)

NOAEL 1.0 mg/kg

Vehicle: Methylcellulose

ED50 >1,000 mg/kg

LOAEL 300 mg/kg (based on reduced motor function)

NOAEL 100 mg/kg

Crofton et al., 

(1995)

Acute Motor Function Oralmale ratVehicle: Corn oil 

LOAEL 2.0 mg/kg (based on reduced motor function)

NOAEL Not established

Crofton and 

Reiter, (1984)

Acute Locomotor Activity 

Oral- male rat

Vehicle: Corn oil 

LOAEL 3.0 mg/kg (based on reduced locomotor activity)

NOAEL 1.0 mg/kg

Gilbert et al., 

(1990)

Acute Acoustic Startle Response (ASR) Oral-ratsVehicle: Corn oil 

21-day old rats:

LOAEL 1 mg/kg

NOAEL Not established

Adults:

LOAEL 2 mg/kg

NOAEL Not established

At the ED50 (4 mg/kg), the brain concentration of deltamethrin was ≈2-fold higher in 

weanlings than in adults

Sheets et al., 

(1994)

62606 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

TABLE 2.—NON-GUIDELINE TOXICITY STUDIES AND LITERATURE.—Continued

Study Type Results Citation 

Acute Behavioral Tests Oral 

- Mice

Vehicle: 20% Fat Emulsion at 0.7 mg/kg (only dose tested) 

17- day old mice

No significant changes

4-month old mice

Significant changes in locomotion, rearing and activity and a significant decrease in 3HQNB 

binding sites in the cerebral cortex.

Eriksson and 

Fredriksson, 

(1991)

Prenatal developmental—rodentsMaternal NOAEL = 1.0 mg/kg/day 

Maternal LOAEL = 7.0 mg/kg/day based on slightly reduced body weights

Developmental NOAEL = 1.0 mg/kg/day

Developmental LOAEL = 10 mg/kg/day based on delayed ossification of the sternebrae

Non-guideline

Prenatal developmental—

nonrodents

Maternal NOAEL = 100 mg/kg/day 

Maternal LOAEL = not established 

Developmental NOAEL = 25 mg/kg/day 

Developmental LOAEL = 100 mg/kg/day based on increases in the incidences of delayed 

ossification and skeletal variations

Non-guideline

Prenatal developmental—

nonrodents

Maternal NOAEL = 10 mg/kg/day 

Maternal LOAEL = 32 mg/kg/day based on decreased bodyweight gain between GD 6 and 

21. 

Developmental NOAEL = >32 mg/kg/day 

Developmental LOAEL = not established 

Non-guideline

B. Toxicological Endpoints

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

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

probability risk is expressed would be to 

describe the risk as one in one hundred 

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

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

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for deltamethrin used for 

human risk assessment is shown in 

Table 3 of this unit:

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62607

TABLE 3.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DELTAMETHRIN 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 (General Population and 

Females 13-49 years of age) NOAEL = 1.0 mg/kg/day 

UF = 100

Acute RfD = 0.01 mg/kg/day

Special FQPA SF = 3X 

aPAD = acute RfD/ Special 

FQPA SF = 0.0033 mg/kg/day

Neurotoxicity-Motor Activity 

(Crofton et al., 1995) 

LOAEL = 3.0 mg/kg/day based 

on reduced motor activity

Chronic Dietary (All populations) NOAEL= 1.0 mg/kg/day 

UF = 100

Chronic RfD = 0.01 mg/kg/day

Special FQPA SF = 3X 

cPAD = chronic RfD/Special 

FQPA SF = 0.0033 mg/kg/day

Chronic Dog Study 

LOAEL = 10 mg/kg/day based 

on clinical signs and reduced 

body weight gain

Incidental Oral Short and Intermediate 

Term NOAEL = 1.0 mg/kg/day 

UF = 100

LOC for MOE = 300 Same as chronic dietary

Dermal All Durations Not required: No systemic 

toxicity via the dermal route 

was seen at the limit dose; 

there was no evidence of 

cumulative toxicity; and 

physical and dermal properties 

indicate low dermal absorption.

Inhalation All Durations (Residential) NOAEL = 1.0 mg/kg/day 

UF = 100= 100%)

LOC for MOE = 300 

(Residential)

Same as chronic dietary.

Cancer (oral, dermal, inhalation) Classification: Not likely to be 

a human carcinogen.

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.435) for the 

combined residues of deltamethrin, 

isomers trans-deltamethrin and a-Rdeltamethrin, in or on a variety of raw 

agricultural commodities, including 

additional meat, milk, poultry and egg 

tolerances. Risk assessments were 

conducted by EPA to assess dietary 

exposures from combined residues of 

deltamethrin, isomers transdeltamethrin and a-R-deltamethrin, and 

tralomethrin 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 (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: The acute dietary exposure 

analysis was a refined probabilistic one. 

The analysis was refined through the 

use of projected market share estimates 

from Agency analysis and anticipated 

residues (ARs) based on field trial 

values. At the 99.9th percentile of 

exposure, the risk estimate for the 

general U.S. population is 39% of the 

acute population adjusted dose (aPAD). 

The most highly exposed population 

subgroup is All Infants, which utilizes 

65% of the aPAD.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEMFCIDTM), which incorporates food 

consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Chronic exposure analysis was refined 

through the use of projected market 

share estimates from Agency analysis 

and the anticipated residues (ARs) are 

based on field trial values. The U.S. 

population and all population 

subgroups have exposure and risk 

estimates that are below the Agency’s 

level of concern. The general U.S. 

population utilizes 3.0% of the chronic 

PAD (cPAD). The most highly exposed 

subgroup, Children 1-2 years, utilizes 

7.6% of the cPAD. 

iii. Cancer. Deltamethrin is classified 

by the Agency as not likely to be 

carcinogenic in humans.

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

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

EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide chemicals 

that have been measured in food. If EPA 

relies on such information, EPA must 

require that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate.

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

states that the Agency may use data on 

the actual percent of food treated for 

assessing chronic dietary risk only if the 

Agency can make the following 

findings: Condition 1, that the data used 

are reliable and provide a valid basis to 

62608 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

show what percentage of the food 

derived from such crop is likely to 

contain such pesticide residue; 

Condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

Condition 3, if data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of %CT as required by 

section 408(b)(2)(F) of the FFDCA, EPA 

may require registrants to submit data 

on %CT. 

The Agency used PCT information as 

follows:

For existing uses of deltamethrin and 

tralomethrin, the Agency used estimates 

of PCT for the acute and chronic 

exposure assessments which were 

determined using Doanes Market Survey 

Data (1996–2001). The following 

deltamethrin PCT data estimates were 

used for both the acute and chronic 

dietary exposure assessments: Cotton 

(14), tomato (19). The following 

tralomethrin PCT data estimates were 

used for both the acute and chronic 

dietary exposure assessments: Broccoli 

(6.0), lettuce, head (15), lettuce, leaf 

(22), and soybean (1.0). Tralomethrin is 

also registered for use on cotton and 

sunflower. For cotton, the deltamethrin 

PCT value is higher; therefore, the 

deltamethrin value was used in the 

assessment. There is a proposed use for 

deltamethrin on sunflower, and the 

projected market share value is higher 

than the PCT value for tralomethrin. As 

a result, the projected market share 

value for deltamethrin was used in the 

assessment. Since deltamethrin and 

tralomethrin are essentially the same 

chemical, it was assumed that both 

pesticides would not be used on the 

same crop.

The Agency believes that the three 

conditions listed in Unit III.C.1.iv. have 

been met. With respect to Condition 1, 

PCT estimates are derived from market 

survey data, which are reliable and have 

a valid basis.

The Agency used maximum PCT for 

both acute and chronic dietary exposure 

estimates. A maximum PCT is unlikely 

to underestimate exposure to an 

individual because of the fact that an 

individual is unlikely to be exposed to 

more than the maximum PCT either on 

an acute basis or over a lifetime. For 

acute assessments, the Agency 

incorporates PCT information by 

creating a residue distribution file 

which includes the measured residue 

values from field trials, and zero residue 

values added to account for the percent 

of crop not treated. This approach is 

used only for non-blended or partially 

blended commodities as defined under 

EPA SOP99.6. For blended 

commodities, a single-point estimate is 

created from the residue value 

multiplied by the upper bound PCT. 

The Agency is reasonably certain that 

the percentage of the food treated is not 

likely to be an underestimation.

For the new uses, the Agency used 

PCT estimates for both the acute and 

chronic exposure assessments based on 

market share projections as follows: 

Almond (28 %); apple (38 %); canola 

(1.0 %); cantaloupe (11 %); carrot (22 

%); corn (5.0 %); cucumber (10 %); 

garlic (1.0 %); onion (2.0 %); pear (23 

%); pepper (12 %); potato (7.0 %); 

soybean (1.0 %); squash (2.0 %); 

sunflower (9.0 %); and walnut (5.0%). 

The following methods were used to 

estimate market share for the new uses: 

The Agency reviewed the proposed new 

uses for deltamethrin, identified 

practicable alternatives based on the 

primary target pest for each use site, and 

estimated a likely upper-bound for the 

percent crop treated. The Agency has 

determined that the alternatives are 

viable based on the best available EPA 

data, and assumes they will control the 

insect pests identified on the proposed 

label. The Agency believes that the 

projected market share estimates are 

upper-bound estimates because it 

summed the current market share of all 

chemicals that are currently being used 

to control the target pest on a particular 

crop. By doing so, the Agency has made 

the assumption that deltamethrin will 

replace all other insecticides that are 

currently being used on that crop to 

control the primary target pest that 

deltamethrin will be used to control. 

Furthermore, the Agency has made the 

assumption that deltamethrin will 

replace all competing insecticides on all 

of the crops for which projected market 

share data were used. In addition, the 

Agency has made the assumption that 

for many of the crops in the dietary 

analysis, 100% of the crop would be 

treated. For the stored grains, the PCT 

estimates are derived from usage data 

for chlorpyriphos-methyl, historically 

the most widely used insecticide for 

control of insect pests in stored grains. 

The estimates are as follows: Wheat, 

oats, and barley (avg: 8.0 %, max: 9.0 

%); field corn and pop corn (avg: 3.0 %, 

max: 6.0 %); sweet corn (avg: 2.1 %, 

max: 3.5 %); sorghum (avg: 3.2 %, max: 

3.7 %); and rice (avg: 2.9 %, max: 3.1 

%). For all other new uses, it was 

assumed that 100% of the crop would 

be treated.

The Agency believes that the three 

conditions previously discussed have 

been met regarding PCT estimates for 

the new deltamethrin registrations. With 

respect to Condition 1, EPA finds that 

the PCT information described in Unit 

II.C.1.iv. for deltamethrin on almonds, 

apples, canola, cantaloupe, carrots, 

corn, cucumbers, garlic, onions, pears, 

peppers, potatoes, soybeans, squash, 

sunflowers, walnuts, and stored cereal 

grains is derived from market survey 

data, which are reliable and have a valid 

basis. For almonds, apples, canola, 

cantaloupe, carrots, corn, cucumbers, 

garlic, onions, pears, peppers, potatoes, 

soybeans, squash, sunflowers, and 

walnuts, the PCT estimates are based on 

current market share data for all 

alternative insecticides used to control 

the primary target pest, and the 

generous assumption that deltamethrin 

will replace all of the competing 

insecticides used to control that target 

pest. For stored grains, the estimate is 

derived from usage data for 

chlorpyrifos-methyl, historically the 

most widely used insecticide for control 

of insect pests in stored grains. These 

estimates should not underestimate 

actual usage of deltamethrin on the new 

crops/sites.

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 

deltamethrin may be applied in a 

particular area.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

deltamethrin 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 

deltamethrin.

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62609

The Agency uses the FQPA Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone/Exposure Analysis 

Modeling System (PRZM/EXAMS), to 

produce estimates of pesticide 

concentrations in an index reservoir. 

The SCI-GROW model is used to predict 

pesticide concentrations in shallow 

groundwater. For a screening-level 

assessment for surface water EPA will 

use FIRST, a tier 1 model, before using 

PRZM/EXAMS, a tier 2 model. The 

FIRST model is a subset of the PRZM/

EXAMS model that uses a specific high 

end runoff scenario for pesticides. 

While both FIRST and PRZM/EXAMS 

incorporate an index reservoir 

environment, the PRZM/EXAMS model 

includes a percent crop area factor as an 

adjustment to account for the maximum 

percent crop coverage within a 

watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. 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 deltamethrin 

they are further discussed in the 

aggregate risk sections in Unit III.E.

Based on FIRST and SCI-GROW 

models, the EECs of deltamethrin for 

acute exposures are estimated to be 0.20 

parts per billion (ppb) for surface water 

and 0.006 ppb for ground water. The 

EECs for chronic exposures are 

estimated to be 0.067 ppb for surface 

water and 0.006 ppb for ground water.

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets).

Deltamethrin is currently registered 

for use on lawns, turf, golf courses, sod 

farms, ornamental gardens, perimeter 

treatment, indoor broadcast, spot, and 

crack and crevice surface treatment, and 

pet collars. The end use products are 

formulated as ready-to-use sprays, 

granular, dust, wettable powders and 

liquids to be applied by commercial 

applicators and/or homeowners 

depending on the product. These uses 

include a wide range of application 

methods including hose-end sprayers, 

push-type spreader, shaker can, aerosol 

can, low/high pressure hand wands, 

injection, airless sprayers, injection 

syringe, and paint brush/roller used to 

treat indoors and outdoors.

No dermal endpoint was selected 

because no systemic toxicity via the 

dermal route was seen at the limit dose 

and therefore a dermal risk assessment 

for handlers was not required. All 

inhalation MOEs for residential 

handlers exposure ranged from 3,300 to 

1,800,000 and therefore did not exceed 

the Agency’s level of concern.

Based on the use pattern of residential 

products, duration of postapplication 

exposure is expected to be short term. 

As indicated previously no dermal 

endpoint was selected and therefore no 

risk from dermal exposure is expected. 

The Agency concluded that use of an 

indoor fogger would result in the worst 

case scenario for assessing 

postapplication inhalation exposure. 

The postapplication inhalation MOEs 

following use of a fogger were greater 

than the targeted MOE and therefore the 

risks were not of concern. Fogger 

postapplication risks are protective of 

inhalation risks from other indoor 

products. Furthermore the vapor 

pressure of deltamethrin is very low (1.5 

x 10-8 mm Hg at 25≥) and therefore 

postapplication inhalation exposure is 

expected to be minimal for indoor uses.

The following postapplication 

incidental oral scenarios following 

application to lawns and indoor 

surfaces (carpet versus hardwood or 

vinyl floors) were assessed:

i. Short-term oral hand-to-mouth 

exposure to toddlers and children from 

indoor use ;

ii. Short-term oral object to mouth 

exposure to toddlers and children from 

ingestion of pesticide treated turf; and

iii. Short-term oral exposure to 

toddlers and children following soil 

ingestion.

Since the FQPA safety factor for the 

protection of children and infants was 

reduced to 3X, a target MOE value of 

300 has been identified for residential 

assessments. MOE values greater than 

300 are not considered to be of concern 

to the Agency. MOE estimates are based 

on the NOAEL dose level of 1 mg/kg/

day established for short-term oral risk 

assessment.

TABLE 4.—SUMMARY OF SHORT-TERM RESIDENTIAL POSTAPPLICATION MOES.

Exposure Scenario Oral Dose (mg/kg/day Oral MOE 

Hand-to-Mouth (Indoor Use) 0.0028 340

Object-to-Mouth (Turf) 0.00049 2,000

Soil Ingestion (Turf) 0.0000065 150,000

Note: Episodic incidental ingestion of granules and paint chips was also assessed and was not considered to be of concern to the Agency.

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 

deltamethrin and any other substances 

and deltamethrin 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 deltamethrin has a 

common mechanism of toxicity with 

other substances. For information 

62610 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

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

cumulative/.

D. Safety Factor for Infants and 

Children

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the 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. 

The toxicology data base for 

deltamethrin for an FQPA assessment 

includes developmental toxicity studies 

in rats, rabbits and mice, a twogeneration reproduction toxicity study 

in rats, acute and subchronic 

neurotoxicity studies in rats, and 

studies from the open literature 

indicating increased susceptibility and 

neurotoxicity.

Signs of neurotoxicity were seen in 

guideline acute and subchronic 

neurotoxicity studies in rats, including 

salivation, soiled fur, impaired mobility, 

no reaction to approach and no reaction 

to touch response observed in the 

functional observation battery (FOB) in 

the acute study, and mortality, clinical 

signs of toxicity, FOB findings, and 

decreased body weights, body weight 

gains, and food consumption in the 

subchronic study. In addition, similar 

signs of neurotoxicity were observed in 

several literature studies conducted in 

rats and mice.

Acceptable developmental toxicity 

studies in rats and rabbits indicated no 

evidence of developmental toxicity. In 3 

non-guideline multi-species 

developmental toxicity studies, there is 

concern for developmental effects that 

occurred in either the absence of or in 

the presence of mild maternal toxicity 

in three species (mice, rats and rabbits). 

In mice, an increase in delayed 

ossification in the fetuses was seen in 

the absence of maternal toxicity at the 

highest dose tested. In rats, increased 

delayed ossification was seen in the 

presence of decreased body weight in 

the dams. In rabbits, increased fetal 

death and decreased fetal body weight 

were seen in the absenceof maternal 

toxicity at the highest dose tested.

There is qualitative evidence of 

increased susceptibility only at the 

highest dose tested in the twogeneration toxicity study in rats. Effects 

were seen in the adults of the F1 

generation. These effects were not seen 

in the P generation or in the F1 rats 

when they were pups. These effects 

included increased death, clinical 

findings (i.e. impaired righting reflexes, 

hyperactivity, splayed limbs, 

vocalization, and excessive salivation) 

and cerebral congestion and/or blood 

clots at the highest dose tested. 

Evidence for age-related sensitivity was 

seen in a published literature study in 

which the brain concentration of 

deltamethrin in weanling rats was 

higher than in adult rats.

Based on clinical signs indicative of 

neurotoxicity observed in adult animals, 

concern for the effects seen in the twogeneration reproduction study and 

structural-activity relationship 

concerns, a developmental 

neurotoxicity study (DNT) has been 

required for deltamethrin. The study 

protocol indicates that the proposed 

lowest dose in the study is 1 mg/kg/day, 

which is equivalent to the NOAELs 

currently selected for dietary and nondietary risk assessment.

3. Conclusion. The hazard-based 

FQPA Safety Factor has been reduced to 

3x for all population subgroups 

including those comprised of infants 

and children.

Previously, the Agency determined 

that the overall FQPA Safety Factor 

should be retained at 10x due to the lack 

of an acceptable pre-natal toxicity study 

in rabbits; the lack of the required 

developmental neurotoxicity (DNT) 

study; an overall degree of concern for 

the qualitative and quantitative 

evidence of increased susceptibility 

observed in mice; and residual 

uncertainties for pre/post-natal toxicity. 

The default 10x factor encompassed the 

database uncertainty factor and the 

Special FQPA Safety Factor.

The Agency has since received and 

reviewed an acceptable pre-natal 

developmental toxicity study in rabbits 

which does not show evidence 

(quantitative or qualitative) of increased 

susceptibility. A dose analysis indicated 

no need for a database uncertainty factor 

for the lack of a DNT since this study 

is not expected to lower the doses 

currently used for the overall risk 

assessment. Therefore, there is no need 

for a database uncertainty factor. 

However, the Special FQPA Safety 

Factor is needed since there is still a 

concern for the qualitative evidence of 

increased susceptibility observed in 

mice. A Special FQPA Safety Factor of 

3X (as opposed to a 10X) was 

determined to be adequate based on the 

following weight-of-evidence 

considerations.

i. The endpoint of concern for risk 

assessment is already based on the most 

sensitive endpoint (i.e., clinical signs 

indicative of neurotoxicity),

ii. In the acute and subchronic 

neurotoxicity studies, no damage to the 

neurological system (e.g., 

neuropathology or alterations in brain 

weight) was seen, and there was no 

evidence of malformations or variations 

of the central nervous system of the 

fetuses in the pre-natal studies or to 

offspring in the post-natal study,

iii. The generally accepted 

mechanism of action for pyrethroids, 

sodium channel disruption, has not 

been traditionally associated with 

developmental neuropathology, and

iv. A dose that was four-fold higher 

than the dose used for risk assessment 

was required to cause the two-fold 

difference in brain concentration of 

deltamethrin in weanling rats.

The NOAEL of 1.0 mg/kg/day 

currently used for overall risk 

assessment is protected by a safety 

factor of 3X which yields an 

extrapolated dose of 0.3 mg/kg/day. 

This dose is an order of magnitude 

lower than the dose that caused the twofold decrease in brain concentrations of 

deltamethrin in the weanling rats. 

Therefore, a half-log reduction (3X) in 

the Special FQPA Safety Factor is 

considered to be sufficiently protective 

of the concerns for the qualitative 

susceptibility seen in mice.

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 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62611

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 youth 13-19), and 1L/10 kg 

(child). Default body weights and 

drinking water consumption values vary 

on an individual basis. This variation 

will be taken into account in more 

refined screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to deltamethrin will 

occupy 39% of the aPAD for the U.S. 

population, 28% of the aPAD for 

females 13 to 49, 65% of the aPAD for 

All Infants (< 1 year old), and 60% of 

the aPAD for Children 1-2 years old. In 

addition, there is potential for acute 

dietary exposure to deltamethrin in 

drinking water. After calculating 

DWLOCs and comparing them to the 

EECs for surface and ground water, EPA 

does not expect the aggregate exposure 

to exceed 100% of the aPAD, as shown 

in Table 5 of this unit:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO DELTAMETHRIN

Population Subgroup Exposure 

(mg/kg) 

% aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

General U.S. Population 0.001305 39 0.20 0.006 71

All Infants (< 1 year old) 0.002175 65 0.20 0.006 12

Children 1-2 years old 0.001992 60 0.20 0.006 13

Children 3-5 years old 0.002135 64 0.20 0.006 12

Children 6-12 years old 0.001555 47 0.20 0.006 18

Youth 13-19 years old 0.001010 30 0.20 0.006 70

Adults 20-49 years old 0.000830 25 0.20 0.006 88

Adults 50+ years old 0.000836 25 0.20 0.006 87

Females 13-49 years old 0.000937 28 0.20 0.006 72

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to deltamethrin from food 

will utilize 3 % of the cPAD for the U.S. 

population, 7.6 % of the cPAD for 

Children 1-2 years old. Based on the use 

pattern, chronic residential exposure to 

residues of deltamethrin is not 

expected. In addition, there is potential 

for chronic dietary exposure to 

deltamethrin in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 6 of this 

unit:

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO DELTAMETHRIN

Population Subgroup Exposure 

mg/kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. Population 0.000099 3.0 0.067 0.006 110

All Infants (< 1 year old) 0.000157 4.7 0.067 0.006 32

Children 1-2 years old 0.000252 7.6 0.067 0.006 31

Children 3-5 years old 0.000238 7.1 0.067 0.006 31

Children 6-12 Years 0.000149 4.5 0.067 0.006 32

62612 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO DELTAMETHRIN—Continued

Population Subgroup Exposure 

mg/kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

Youth 13-19 Years 0.000086 2.6 0.067 0.006 97

Adults 20-49 Years 0.000076 2.3 0.067 0.006 110

Adults 50+ Years 0.000078 2.3 0.067 0.006 110

Females 13-49 0.000077 2.3 0.067 0.006 98

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).

Deltamethrin is currently registered 

for use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for deltamethrin.

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that food 

and residential exposures aggregated 

result in aggregate MOEs of 2600 for the 

U.S. Population, 2700 for Females 13-

49, 338 for all infants <1 year old, 328 

for Children 1-2 years old, and 329 for 

Children 3-5 years old. These aggregated 

MOEs include average exposure from 

deltamethrin residues in food as well as 

inhalation exposure of adults; oral 

(hand-to-mouth) exposure of infants and 

children from the residential uses of 

deltamethrin resulting from spot, and 

crack and crevice use and surface 

treatments to carpet and vinyl surfaces. 

These aggregate MOEs do not exceed the 

Agency’s level of concern for aggregate 

exposure to food and residential uses. In 

addition, short-term DWLOCs were 

calculated and compared to the EECs for 

chronic exposure of deltamethrin in 

ground and surface water. After 

calculating DWLOCs and comparing 

them to- the EECs for surface and 

ground water, EPA does not expect 

short-term aggregate exposure to exceed 

the Agency’s level of concern, as shown 

in Table 7 of this unit:

TABLE 7.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO DELTAMETHRIN

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Short-Term 

DWLOC 

(ppb) 

U.S. Population 2,600 300 0.067 0.006 100

Females 13-49 2,700 300 0.067 0.006 89

All infants (<1 year) 338 300 0.067 0.006 3.8

Children 1-2 328 300 0.067 0.006 2.8

Children 3-5 329 300 0.067 0.006 3.0

4. Intermediate-term risk. 

Intermediate term residential exposures 

are not anticipated from the registered 

and proposed uses of deltamethrin, 

therefore, an intermediate term risks are 

not expected.

5. Aggregate cancer risk for U.S. 

population. Deltamethrin is classified 

by the Agency as not likely to be 

carcinogenic in humans, therefore, 

deltamethrin is not expected to pose a 

cancer risk.

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 deltamethrin 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate analytical methods based 

on gas chromatography (GC) with 

electron capture detection (ECD) are 

available for enforcing tolerances for 

residues of deltamethrin. These 

methods are used for the determination 

of cis-deltamethrin, trans-deltamethrin, 

and alpha-R-deltamethrin in various 

raw agricultural, animal-derived, and 

processed commodities. In addition, cisdeltamethrin is completely recovered 

and its trans isomer is partially 

recovered by one of the multiresidue 

methods utilized by the Food and Drug 

Administration for monitoring of 

pesticide residues. 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

Codex Maximum Residue Limits 

(MRL’s) are established on a variety of 

commodities for residues of 

deltamethrin in terms of the cis-isomer 

only. This definition is not compatible 

with the U.S. tolerances, which also 

include the trans and alpha-R isomers. 

However, the cis-isomer is consistently 

present at much higher levels than the 

other two isomers in crop field trials. 

Thus, in numerical terms there is not a 

significant difference in the tolerance 

definitions. Therefore, the Agency 

concludes that it is reasonable to 

harmonize U.S. tolerance levels 

numerically with Codex MRL’s where 

feasible. The commodities for which the 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62613

U.S. tolerances have been raised for 

harmonization purposes are meat 

byproducts of cattle, goats, horses, and 

sheep (to match the 0.05 ppm Codex 

MRL for edible mammalian offal); cereal 

grains; soybean seed (0.1 ppm Codex 

MRL for legume vegetables); sunflower 

seed (0.1 ppm Codex MRL on oilseeds); 

cucurbit vegetables; and wheat bran. 

The U.S. tolerances on barley bran and 

rye bran have also been increased since 

they are based on the data for wheat 

bran. The data for dry bulb onions in the 

U.S. support setting the tolerance at the 

same level as the Codex bulb vegetable 

tolerance. The following U.S. tolerances 

can not be harmonized numerically 

with Codex MRL’s due to residues being 

higher from the requested uses in the 

U.S. or the tolerances being based on the 

sum of the analytical method limits of 

quantitation for the three deltamethrin 

isomers (versus only the cis-isomer 

included in Codex MRL’s): globe 

artichoke; meat of cattle, goats, horses, 

and sheep; stover of field corn, pop 

corn, sweet corn, and grain sorghum; 

eggs; pome fruit; green onion; poultry 

meat and meat byproducts; rapeseed; 

fruiting vegetables; root vegetables; and 

tuberous and corm vegetables.

V. Conclusion

Therefore, the tolerance is established 

for combined residues of deltamethrin, 

isomers trans-deltamethrin and a-Rdeltamethrin, in or on almond hulls; 

apples, wet pomace; artichoke, globe; 

barley, bran; cattle, fat; cattle, meat; 

cattle, meat byproducts; corn, field, 

forage; corn, field, refined oil; corn, 

field, stover; corn, pop, stover; corn, 

sweet, forage; corn, sweet, kernel + cob 

with husks removed; corn, sweet, 

stover; egg; fruit, pome, group 11; goat, 

fat; goat, meat; goat, meat byproducts; 

grain, aspirated fractions; grain, cereal, 

group 15, except sweet corn; hog, fat; 

horse, fat; horse, meat; horse, meat 

byproducts; lychee (import tolerance); 

milk, fat (reflecting 0.02 ppm in whole 

milk); nut, tree, group 14; onion, dry 

bulb; onion, green; poultry, fat; poultry, 

meat; poultry, meat byproducts; radish 

tops; rapeseed; rice, hulls; rye, bran; 

sheep, fat; sheep, meat; sheep, meat 

byproducts; sorghum, grain forage; 

sorghum, grain stover; soybean, seed; 

soybean, hulls; starfruit (import 

tolerance); sunflower seeds; vegetable, 

cucurbit, group 9; vegetable, fruiting, 

group 8; vegetable, root, except sugar 

beet, subgroup IB; vegetable, tuberous 

and corm, subgroup; IC; wheat, bran at 

2.5, 1.0, 0.5, 5.0, 0.05, 0.02, 0.05, 0.7, 

2.5, 5.0, 5.0, 10, 0.03, 15, 0.02, 0.2, 0.05, 

0.02, 0.05, 65, 1.0, 0.05, 0.05, 0.02, 0.05, 

0.2, 0.1, 0.1, 0.1, 1.5, 0.05, 0.02, 0.02, 

4.0, 0.2, 2.5, 5.0, 0.05, 0.02, 0.05, 0.5, 

1.0, 0.1, 0.2, 0.2, 0.1, 0.2, 0.3, 0.2, 0.04, 

5.0 parts per million (ppm) respectively 

. 

At the request of the registrant (Bayer 

Crop Science LP, formerly Aventis 

CropScience, P.O. Box 12014, 2 T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709]) the following crop 

tolerances were voluntarily withdrawn 

from the original petition: head & stem 

brassica vegetables, leafy vegetables and 

stone fruits.

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–2004–0331 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before December 27, 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. Tolerance fee payment. If you file 

an objection or request a hearing, you 

must also pay the fee prescribed by 40 

CFR 180.33(i) or request a waiver of that 

fee pursuant to 40 CFR 180.33(m). You 

must mail the fee to: EPA Headquarters 

Accounting Operations Branch, Office 

of Pesticide Programs, P.O. Box 

360277M, Pittsburgh, PA 15251. Please 

identify the fee submission by labeling 

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee 

requirement ‘‘when in the judgement of 

the Administrator such a waiver or 

refund is equitable and not contrary to 

the purpose of this subsection.’’ For 

additional information regarding the 

waiver of these fees, you may contact 

James Tompkins by phone at (703) 305–

5697, by e-mail at 

tompkins.jim@epa.gov, or by mailing a 

request for information to Mr. Tompkins 

at Registration Division (7505C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001.

If you would like to request a waiver 

of the tolerance objection fees, you must 

mail your request for such a waiver to: 

James Hollins, Information Resources 

and Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001.

3. 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–2004–0331, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

62614 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 

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 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

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

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

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 30, 2004.

Lois Rossi,

Director, Registration Division, 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 180.435 is amended by 

alphabetically adding commodities to 

the table in paragraph (a)(1) to read as 

follows:

§ 180.435 Deltamethrin; tolerances for 

residues.

(a) * * *

Commodity Parts per million 

Almond hulls ................... 2.5

Apples, wet pomace ....... 1.0

Artichoke, globe .............. 0.5

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Rules and Regulations 62615

Commodity Parts per million 

Barley, bran .................... 5.0

Cattle, fat ........................ 0.05

Cattle, meat .................... 0.02

Cattle, meat byproducts 0.05

Corn, field, forage ........... 0.7

Corn, field, refined oil ..... 2.5

Corn, field, stover ........... 5.0

Corn, pop, stover ............ 5.0

Corn, sweet, forage ........ 10

Corn, sweet, kernel + 

cob with husks removed ......................... 0.03

Corn, sweet, stover ........ 15

*** * *

Egg ................................. 0.02

Fruit, pome, Group 11 .... 0.2

Goat, fat .......................... 0.05

Goat, meat ...................... 0.02

Goat, meat byproducts ... 0.05

Grain, aspirated fractions 65

Grain, cereal, Group 15, 

except sweet corn ....... 1.0

Hog, fat ........................... 0.05

Horse, fat ........................ 0.05

Horse, meat .................... 0.02

Horse, meat byproducts 0.05

Lychee* ........................... 0.2

Milk, fat (reflecting 0.02 

ppm in whole milk) ...... 0.1

Nut, tree, Group 14 ........ 0.1

Onion, dry bulb ............... 0.1

Onion, green ................... 1.5

Poultry, fat ...................... 0.05

Poultry, meat .................. 0.02

Poultry, meat byproducts 0.02

Radish tops ..................... 4.0

Rapeseed ....................... 0.2

Rice, hulls ....................... 2.5

Rye, bran ........................ 5.0

Sheep, fat ....................... 0.05

Sheep, meat ................... 0.02

Sheep, meat byproducts 0.05

Sorghum, grain forage .... 0.5

Sorghum, grain stover .... 1.0

Soybean, seed ................ 0.1

Soybean, hulls ................ 0.2

Starfruit* .......................... 0.2

Sunflower seed ............... 0.1

*** * *

Vegetable, cucurbit, 

Group 9 ....................... 0.2

Vegetable, fruiting, Group 

8 .................................. 0.3

Vegetable, root, except 

sugar beet, Subgroup 

IB ................................. 0.2

Vegetable, tuberous and 

corm, Subgroup IC ...... 0.04

Wheat, bran .................... 5.0

*There are no U.S. registrations for use of 

deltamethrin on starfruit and lychee.

* * * * *

[FR Doc. 04–24040 Filed 10–26–04; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 15, 74, 78, and 101 

[ET Docket Nos. 00–258, 95–18; FCC 04–

219] 

Advanced Wireless Services

AGENCY: Federal Communications 

Commission.

ACTION: Final rule.

SUMMARY: In this document, the 

Commission found that the bands 1915–

1920 MHz paired with 1995–2000 MHz 

and 2020–2025 MHz paired with 2175–

2180 MHz were well suited to provide 

additional spectrum for AWS use and 

designated these paired bands for such 

use. The Commission also modified the 

rules pertaining to unlicensed PCS 

service in the 1920–1930 MHz band in 

order to provide additional flexibility to 

users of the band to offer both voice and 

data services using a variety of 

technologies. The Third Memorandum 

Opinion and Order denies petitions for 

rulemaking related to the reallocation to 

AWS in previous rulemakings and the 

Fifth Memorandum Opinion and Order

clarifies rules governing relocation of FS 

licensees.

DATES: Effective November 26, 2004.

FOR FURTHER INFORMATION CONTACT:

Shameeka Hunt or Priya Shrinivasan, 

Office of Engineering and Technology, 

(202) 418–2472.

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Sixth 

Report and Order, Third Memorandum 

Opinion and Order, and Fifth 

Memorandum Opinion and Order, ET 

Docket Nos. 00–258 and 95–18, FCC 04–

219, adopted September 9, 2004, and 

released September 22, 2004. The full 

text of this Commission decision is 

available on the Commission’s Internet 

site at http://www.fcc.gov. It is available 

for inspection and copying during 

normal business hours in the FCC 

Reference Information Center, Room 

CY–A257, 445 12th Street, SW., 

Washington, DC 20554. The complete 

text of this document also may be 

purchased from the Commission’s copy 

contractor, Best Copy and Printing, Inc., 

Room CY-B402, 445 12th Street, SW., 

Washington, DC 20554. Alternate 

formats are available to persons with 

disabilities by contacting Brian Millin at 

(202) 418–7426 or TTY (202) 418–7365. 

Summary of the Report and Order 

1. In the Sixth Report and Order 

(Sixth R&O and Third MO&O) in ET 

Docket No. 00–258, the Commission 

continues its ongoing efforts to promote 

spectrum utilization and efficiency by 

evaluating spectrum that may be 

suitable for the provision of new 

services, including Advanced Wireless 

Services (AWS). In the Sixth R&O, we 

find that the bands 1915–1920 MHz 

paired with 1995–2000 MHz and 2020–

2025 MHz paired with 2175–2180 

MHz—which were all previously 

reallocated for Fixed and Mobile 

services—are well suited to provide 

additional spectrum for AWS use and 

we designate these paired bands for 

such use. This action will provide an 

additional twenty megahertz of 

spectrum for the introduction of new 

services and technology. We also 

modified the rules pertaining to 

unlicensed PCS services in the 1920–

1930 MHz band in order to provide 

additional flexibility to users of the 

band to offer both voice and data 

services using a variety of technologies. 

2. The Sixth R&O identifies two five 

+ five megahertz spectrum blocks that 

are especially well suited for AWS use, 

and find that such a designation will 

maximize the potential use of the 

spectrum and promote the deployment 

of high value service offerings. 

Specifically, we redesignate the 1915–

1920 MHz and 1995–2000 MHz, as well 

as the 2020–2025 MHz and 2175–2180 

MHz spectrum blocks as paired bands 

suitable for the introduction of new 

technologies. 

A. 1915–1920 MHz and 1995–2000 MHz 

Bands 

3. The Commission concludes that 

AWS operations in the 1915–1920 MHz 

band are technically feasible with a ten 

megahertz frequency separation 

between Broadband PCS mobile and 

base operations. We recognize, that 

additional technical constraints may 

need to be placed on AWS to avoid 

impairing incumbent PCS operations. 

Although we conclude here that this 

band will be designated for AWS, one 

goal of the AWS 2 GHZ Service Rules 

NPRM is to adopt technical rules that 

will protect existing PCS operations 

from interference. 

4. The Commission also concluded 

that AWS operations can be deployed in 

the 1995–2000 MHz band. Several 

parties contend that technical 

constraints will need to be placed on 

new AWS operations in the 1995–2000 

MHz band in order to avoid interference 

to adjacent MSS operations in the 2020–

2025 MHz band. However, we note that 

prior to the reallocation of MSS 

spectrum in the 1990–2000 MHz band 

to fixed and mobile services, existing 

Broadband PCS was immediately 

adjacent to the MSS. Thus, by 

redesignating the 1995–2000 MHz band