[Federal Register Volume 63, Number 165 (Wednesday, August 26, 1998)]
[Rules and Regulations]
[Pages 45406-45414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22529]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300669; FRL-5795-2]
RIN 2070-AB78


Deltamethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
deltamethrin in or on food and feed items as a result of use in food 
and feed handling establishments at 0.05 parts per million (ppm). 
AgrEvo Environmental Health requested this tolerance under the Federal 
Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (Pub. L. 104-170). This tolerance was requested 
under petition number PP 7F4820 (formerly 4H5710).

DATES: This regulation is effective August 26, 1998. Objections and 
requests for hearings must be received by EPA on or before October 26, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300669], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300669], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300669]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: George LaRocca, Registration 
Division 7505C, Office of Pesticide Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location, 
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 305-6100, e-mail: larocca.george 
@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of April 30, 1997 (62 FR 23455)(FRL-5600-8), which 
announced that AgrEvo Environmental Health, 95 Chestnut Ridge Road, 
P.O. Box 30, Montvale, NJ 07645 had submitted pursuant to section 408 
of the FFDCA 21 U.S.C. 346a(d)8, a petition, PP 7F4820, that proposed 
amending 40 CFR part 180 by establishing a tolerance to permit residues 
of the insecticide deltamethrin [(1R, 3R)-3-(2,2,-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester] in or on food and feed items as a result of use in food and feed 
handling establishments at 0.05 ppm. This petition was initially 
announced in the Federal Register of February 8, 1995 [60 FR 7539](FRL-
4926-4). A proposed rule proposing a tolerance of 0.02 ppm was 
published for comment in the Federal Register dated November 30, 1995 
[60 FR 61504](FRL-4983-5). On February 14, 1996, the German Ministry of 
Health commented that the proposed tolerance level of 0.02 ppm is not 
justified because in the European Community the tolerance for 
deltamethrin on food and feed items is 0.05 ppm. They indicated that 
the import of products to the United States from the European Community 
could have deltamethrin residues greater than 0.02 ppm and as a result 
may be rejected.
    AgrEvo Environmental Health initially objected to any increase of 
the tolerance based on concerns that establishing the tolerance level 
at 0.05 ppm could result in an unnecessary increase in the percent of 
the Reference Dose (RfD) used by this use pattern and could create 
difficulties in obtaining future use/tolerances for deltamethrin due to 
dietary risk.
    In response, EPA assessed the incremental effect of this tolerance

[[Page 45407]]

increase (0.02 to 0.05 ppm) on dietary exposure and concluded that 
there would be no significant change on the percentage of the RfD 
utilized for the food/feed handling establishment use when the Agency 
uses anticipated residues rather than tolerance levels in its dietary 
exposure analysis. The 0.02 ppm tolerance was based on the limit of 
quantitation (LOQ) of the enforcement method since the residue field 
study showed that residues found in food and feed items were below 0.02 
ppm when the food/feed was uncovered (label directions require food/
feed to be covered during application) and thus quantifiable residues 
of deltamethrin in food/feed were not expected. When using anticipated 
residues for these food/feed handling establishment uses, EPA uses a 
value of one-half the LOQ, i.e., 0.001 ppm in its dietary exposure 
assessment regardless of whether the tolerance is set at 0.02 or 0.05 
ppm. Thus increasing the tolerance to 0.05 ppm will not affect the 
dietary risk of future crop uses of deltamethrin and is in keeping with 
the Agency's initiative to align U.S. tolerances with Codex tolerances 
when feasible.
    In a letter dated March 26, 1996, AgrEvo Environmental Health 
requested that the proposed food/feed additive tolerances be increased 
from 0.02 ppm to 0.05 ppm.
    On November 26, 1997, EPA published in the Federal Register (62 FR 
62993)(FRL-5756-2), a final rule establishing tolerances for residues 
of deltamethrin and tralomethrin on various crops. Both chemicals were 
combined for risk assessment analysis under FQPA because tralomethrin 
is rapidly metabolized by animals to deltamethrin as a result of 
debromination. Results of the rat metabolism study supports this 
combined analysis. The same FQPA analysis was used for setting this 
tolerance in or on food and feed items since the exposure information 
from this use pattern was included in the original analysis.

I. Risk Assessment and Statutory Findings

    New section 408(b)(2)(A)(i) of the 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) 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) 
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. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100 percent or less of the 
RfD) is generally considered acceptable by EPA. EPA generally uses the 
RfD to evaluate the chronic risks posed by pesticide exposure. For 
shorter term risks, EPA calculates a margin of exposure (MOE) by 
dividing the estimated human exposure into the NOEL from the 
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be 
unacceptable. This hundredfold MOE is based on the same rationale as 
the hundredfold uncertainty factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end

[[Page 45408]]

residential exposure, are aggregated. High-end exposures from all three 
sources are not typically added because of the very low probability of 
this occurring in most cases, and because the other conservative 
assumptions built into the assessment assure adequate protection of 
public health. However, for cases in which high-end exposure can 
reasonably be expected from multiple sources (e.g. frequent and 
widespread homeowner use in a specific geographical area), multiple 
high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
The TMRC is a ``worst case'' estimate since it is based on the 
assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from Federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (non-nursing 
infants <1 year old) was not regionally based.

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), 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 
deltamethrin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a tolerance for residues of 
deltamethrin in or on food and feed items as a result of use in food 
and feed handling establishments at 0.05 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing the tolerance 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data for both deltamethrin 
and tralomethrin 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 and tralomethrin are discussed below.
    1. Deltamethrin-- i. A battery of acute toxicity studies places 
technical deltamethrin in Toxicity Category III for acute dermal 
(LD50 > 2,000 milligrams/kilogram (mg/kg)), acute inhalation 
(LC50 = 2.2 mg/l), and primary eye irritation; Category IV 
for acute oral (LD50 > 5,000 mg/kg) and primary dermal 
irritation. Deltamethrin is a non-sensitizer. The NOEL for acute 
delayed neurotoxicity is greater than 5,000 mg/kg.
    ii. In a subchronic oral toxicity study, deltamethrin was 
administered to 20 Sprague-Dawley rats/sex/dose in polyethylene glycol 
200 by gavage at dose levels of 0, 0.1, 1.0, 2.5, or 10.0 mg/kg/day for 
13 weeks. The lowest observed effect level (LOEL) for males is 2.5 mg/
kg/day, based on depressed body weights and body weight gains. The LOEL 
for females is 10 mg/kg/day, based on some hypersensitivity observed 
during neurotoxicity testing. The NOEL for males and females is 1.0 and 
2.5 mg/kg/day, respectively. This subchronic oral toxicity study in 
rats is classified as core minimum.
    iii. In a subchronic oral toxicity study, deltamethrin was 
administered to 3-5 beagle dogs/sex/dose in polyethylene glycol in 
gelatine capsules at dose levels of 0, 0.1, 1.0, 2.5 or 10.0 mg/kg/day 
for 13 weeks. The LOEL is 2.5 mg/kg/day, based on gastro-intestinal 
disturbance and stimulation of the nervous system as noted in the 
clinical signs of toxicity for both sexes. The NOEL is 1.0 mg/kg/day. 
This subchronic oral toxicity study in dogs is classified as core 
minimum. A NOEL of 1.0 mg/kg/day is supported. At higher levels, 
stimulation of the nervous system is noted (the LOEL is set at 2.5 mg/
kg/day, but effects were more definite at 10 mg/kg/day).
    iv. In a 21-day subchronic dermal toxicity study, five Sprague-
Dawley rats/sex/dose were dermally exposed to 6 ml/kg of deltamethrin 
for 6 hours/day at dose levels of 0, 100, 300, or 1,000 mg/kg/day 
(limit test). The LOEL for males is 300 mg/kg/day, based on slightly 
decreased body weight gain supported by marginally decreased food 
consumption. The NOEL for males is 100 mg/kg/day. The LOEL for females 
was not observed. The NOEL for females is > 1,000 mg/kg/day (limit 
dose).
    v. In a 3-week inhalation toxicity study, deltamethrin was 
administered to 8 CD rats/sex/dose at concentrations of 0.003, 0.0096, 
or 0.0563 mg/l for 6 hours/day for 5 days/week (14 exposures total). 
The LOEL is 0.0096 mg/l, based on signs of irritation (nerve 
stimulation) and reduced body weight gains in males and elevated Na+ 
levels

[[Page 45409]]

in both males and females. The NOEL is 0.003 mg/l.
    vi. In a chronic toxicity study, deltamethrin was administered to 8 
beagle dogs/sex/dose in the diet at dose levels of 0, 0.026, 0.261, or 
1.134 mg/kg/day for males and 0, 0.024, 0.271, or 1.061 mg/kg/day for 
females for 24 months. The NOEL is  40 ppm (equivalent to 
1.134 mg/kg/day for males and 1.061 mg/kg/day for females). A LOEL was 
not observed. Sufficient data to support a NOEL of > 40 ppm have been 
generated.
    vii. In a chronic toxicity study, deltamethrin was administered to 
80 Charles River CD-1 mice/sex/dose in the diet at dose levels of 0, 
0.12, 0.61, 3.1, or 12 mg/kg/day for males and 0, 0.15, 0.76, 3.8, or 
15 mg/kg/day for females. The NOEL is  12 mg/kg/day for 
males or  15 mg/kg/day for females. A LOEL was not observed.
    viii. In a chronic toxicity study, deltamethrin was administered to 
90 Charles River CD rats/sex/dose in the diet at dose levels of 0, 0.1, 
1.0, or 2.5 mg/kg/day. The LOEL is 2.5 mg/kg/day based on decreased 
body weight gains noted in both sexes. The NOEL is 1.0 mg/kg/day. Under 
the conditions of this study, there was no evidence of carcinogenic 
potential.
    ix. In a developmental toxicity study, deltamethrin was 
administered to 16 New Zealand White rabbits/dose in 0.5% carboxymethyl 
cellulose by gavage at dose levels of 0, 10, 25, or 100 mg/kg/day from 
days 7 through 19 of gestation. The maternal LOEL is 25 mg/kg/day, 
based on treatment-related clinical findings (decreased defecation). 
The maternal NOEL is 10 mg/kg/day. The developmental LOEL is 100 mg/kg/
day, based on treatment-related increases in the fetal incidence of 
several skeletal variations and a positive trend for litter incidence 
of two of these variations (unossified pubic and tail bones). The 
developmental NOEL is 25 mg/kg/day. The developmental toxicity study in 
the rabbit is classified core minimum.
    x. In a developmental toxicity study, deltamethrin was administered 
to 25 Charles River Crl:CD VAF/Plus rats/dose in corn oil by gavage at 
dose levels of 0, 1.0, 3.3, or 11 mg/kg/day from days 6 through 15 of 
gestation. Because of excessive toxicity at 11 mg/kg/day, an additional 
group of 25 rats dosed at 7 mg/kg/day was added. The maternal LOEL is 7 
mg/kg/day, based on treatment-related increases in mortality, clinical 
findings (increased salivation), and decreased body weight gains during 
dosing. The maternal NOEL is 3.3 mg/kg/day. There were no treatment-
related effects on fetal deaths or resorptions, altered growth, or 
developmental malformations or variations (external, visceral, and 
skeletal) noted at any dose level. The developmental NOEL is 
 11 mg/kg/day. A developmental LOEL was not observed.
    xi. In three different developmental toxicity studies, deltamethrin 
was administered to mice, rats, and rabbits. Mice: Mice were dosed at 
0, 0.1, 1.0, or 10 mg/kg/day on gestational days 6-17 and were 
sacrificed on day 18. The maternal NOEL is  10 mg/kg/day. 
There was no maternal LOEL observed. The developmental LOEL is 1.0 mg/
kg/day based on increased incidence (fetal and/or litter) of delayed 
ossification of the sternebrae and paws together with decreased fetal 
body weights. The developmental NOEL is 0.1 mg/kg/day. Rats: Rats were 
dosed at 0, 0.1, 1.0, or 10 mg/kg/day on days 6-18 of gestation and 
were sacrificed on day 21. The maternal LOEL is 10 mg/kg/day based on 
slightly reduced body weights. The maternal NOEL is 1.0 mg/kg/day. The 
developmental LOEL is equivocally set at 10 mg/kg/day, based only on a 
statistically significant increased incidence (fetal and/or litter) or 
delayed ossification of the sternebrae. The developmental NOEL is 1.0 
mg/kg/day. Rabbits: Rabbits were dosed at 0, 1, 4, or 16 mg/kg/day on 
days 6-19 of gestation and were sacrificed on day 28; two separate 
groups of rabbits received 16 mg/kg/day. The maternal NOEL is 
 16 mg/kg/day. There was no maternal LOEL observed. The 
developmental LOEL is 16 mg/kg/day based on increased fetal losses and 
decreased fetal weights. The developmental NOEL is 4 mg/kg/day.
    In mice, although the developmental effects appear to occur in the 
absence of maternal toxicity (indicating possible increased 
susceptibility), low confidence was assigned to these study results due 
to: The age of the study (conducted in 1976); the lack of adequate 
description of the experimental methods used; and the lack of adequate 
criteria (e.g., fetal/litter incidences were not adequately 
differentiated).
    xii. In a three-generation reproduction study, deltamethrin was 
administered to 10 male and 20 female Charles River CD rats/dose in the 
diet at doses of 0, 0.1, 1.0, or 2.5 mg/kg/day. Parental toxicity was 
not demonstrated at any dose level. The NOEL for systemic toxicity is 
 2.5 mg/kg/day. The LOEL for systemic toxicity was not 
observed. Reproductive toxicity was not demonstrated at any dose level. 
The NOEL for reproductive toxicity is  2.5 mg/kg/day. The 
reproductive LOEL was not observed.
    xiii. There is no mutagenicity concern. There are three acceptable 
studies: One reverse mutation assay; one in vitro chromosome aberration 
study; one UDS assay in primary rat hepatocytes. All these studies were 
negative. A dominant lethal study is also available but has not been 
officially reviewed. A quick assessment indicated that it is also 
negative.
    xiv. Studies on metabolism. Deltamethrin 14C-labeled at 
either the benzyl (BD) or the dimethyl (DMD) portion of the molecule 
was relatively well absorbed. Urine and fecal excretions were almost 
complete at 48 hours post-dosing. Seven days after dosing, 31-56% of 
the radioactivity administered was recovered in the urine, 36-59% 
recovered in the feces, < 0.2% recovered in tissues (fat was highest) 
and < 1.2% recovered in carcass. Fecal extracts contained mostly 
unabsorbed, unchanged deltamethrin (17-46% of BD dose and 21-35% of DMD 
dose).
    xv. Studies on neurotoxicity. With the exception of the acute 
delayed neurotoxicity study, no neurotoxicity studies are available.
    xvi. The following studies are considered data gaps in the 
toxicology data base: Acute and subchronic neurotoxicity. These studies 
will be required under a special Data Call-In letter pursuant to 
section 3(c)(2)(B) of FIFRA. Although these data are lacking, EPA has 
sufficient toxicity data to support these tolerances and these 
additional studies are not expected to significantly change its risk 
assessment.
    2. Tralomethrin-- i. A battery of acute toxicity studies places 
technical tralomethrin in Toxicity Category II for acute oral 
LD50, acute inhalation LC50, primary eye 
irritation; Category III for acute dermal LD50; Category IV 
for primary dermal irritation. Tralomethrin is not a sensitizer. The 
NOEL for acute delayed neurotoxicity is greater than 6,000 mg/kg.
    ii. In a rat oral toxicity study, tralomethrin was administered to 
20 CD rats/sex/dose via gavage at dose levels of 0, 1, 6, or 18 mg/kg/
day for 13 weeks (91 days). The LOEL for this 13-week rat oral toxicity 
study is 6 mg/kg/day based on decreased liver weights. The NOEL is 1 
mg/kg/day.
    iii. In a 13-week dog feeding study, tralomethrin in polyethylene 
glycol was administered to 5 beagle dogs/sex/group via capsule at dose 
levels of 0, 0.1, 1.0, or 10 mg/kg/day. The LOEL for this 13-week dog 
feeding study is 10 mg/kg/day based on neurological and hematological 
effects. The NOEL is 1 mg/kg/day.

[[Page 45410]]

    iv. In a 1-year dog feeding study, tralomethrin in corn oil was 
administered to eight beagle dogs/sex/group by capsule at dose levels 
of 0.75, 3.0, and 10.0 mg/kg/day. The high dose level was excessively 
toxic and was reduced to 8.0 mg/kg/day at 4 weeks and to 6.0 mg/kg/day 
on week 14. The low dose level was increased from 0.75 to 1.0 mg/kg/day 
during week 14. The LOEL in this 1-year dog feeding study is 3.0 mg/kg/
day, based on reduced body weight gain, tremors, and ptyalism. The NOEL 
is 0.75/1.0 mg/kg/day.
    v. In a mouse carcinogenicity study, tralomethrin in corn oil was 
administered to 80 CD-1 mice/sex/dose by gavage at dose levels of 0.75, 
3.0, or 10.0 mg/kg/day for up to 2 years. The systemic LOEL in this 
mouse carcinogenicity study is 3 mg/kg/day, based on skin lesions in 
male and female mice. The systemic NOEL is 0.75 mg/kg/day. Under the 
conditions of this study, there was no evidence of carcinogenic 
potential.
    vi. In rat chronic toxicity/carcinogenicity study, tralomethrin in 
corn oil was administered to 80 CD rats/sex/dose by gavage at dose 
levels of 0.75, 3.0, or 12.0 mg/kg/day for up to 2 years. The LOEL is 3 
mg/kg/day in male and female rats based on decreased body weight gain 
in males and decreased food and water consumption in males and females 
at 3.0 mg/kg/day. The NOEL is 0.75 mg/kg/day. Under the conditions of 
this study, there was no evidence of carcinogenic potential.
    vii. In a rat developmental study, tralomethrin in corn oil was 
administered to 25 female Sprague-Dawley CD rats per group at 0, 2, 6, 
or 18 mg/kg/day via gavage on days 6-17 of gestation. On day 21 the 
rats were sacrificed and pups delivered by cesarean section. The 
maternal LOEL is 18 mg/kg/day based on one treatment-related death at 
this dose level. The maternal NOEL is 6 mg/kg/day. There was no 
developmental toxicity noted at any dose level. There were no 
treatment-related increases in malformations or variations found upon 
external, internal, and skeletal examination of the fetuses. A 
developmental LOEL was not observed. The developmental NOEL is 
 18 mg/kg/day.
    viii. In a developmental study, tralomethrin corn oil was 
administered to 15 female New Zealand white rabbits per group at 0, 2, 
8, or 32 mg/kg/day via gavage on days 6-18 of gestation. There was no 
maternal toxicity noted at any dose level. In a developmental study, 
tralomethrin (purity not indicated) in corn oil was administered to 15 
female New Zealand white rabbits per group at 0, 2, 8, or 32 mg/kg/day 
via gavage on days 6-18 of gestation. On Day 28 the dams were 
sacrificed and pups delivered. A maternal LOEL was not observed. The 
maternal NOEL is  32 mg/kg/day. There was no developmental 
toxicity noted at any dose level. A developmental LOEL was not 
observed. The developmental NOEL is  32 mg/kg/day.
    ix. In a two-generation rat reproductive toxicity study, 
tralomethrin in corn oil was administered to COBS CD rats by gavage at 
dose levels of 0, 0.75, 3.0, or 12.0 mg/kg/day. The LOEL for parental 
toxicity is 3.0 mg/kg/day, based on decreased body weight gains. The 
NOEL for parental toxicity is 0.75 mg/kg/day. Reproductive toxicity was 
demonstrated at the mid- and high-doses. The LOEL for reproductive 
toxicity is 0.75 mg/kg/day, based on litters with smaller than normal 
pups. A reproductive NOEL was not observed.
    x. There does not appear to be a concern for mutagenicity, however, 
all studies should be revisited, particularly, the mouse lymphoma. 
There are three reviewed studies that are not classified for 
acceptability: one mouse lymphoma assay; one in vitro chromosome 
aberration study in CHO cells and one UDS assay in primary rat 
hepatocytes. The mouse lymphoma assay tested negatively without 
activation and was moderately positive with activation. The other two 
assays tested negatively.
    xi. The metabolism studies indicate that tralomethrin is rapidly 
debrominated to deltamethrin. It is then further metabolized to 
alcohols, carboxylic acids, glucuronides, glycine and sulfate 
conjugates.
    xii. No mammalian neurotoxicity studies are available. The acute 
delayed neurotoxicity study in the hen is summarized in section one.

B. Toxicological Endpoints

    The synthetic pyrethroid, tralomethrin is rapidly metabolized to 
deltamethrin. The toxicology data bases for deltamethrin and 
tralomethrin were combined in order to determine appropriate endpoints 
for risk assessment as discussed above. Results of the rat metabolism 
study support this action.
    1. Acute toxicity. EPA has established a NOEL of 1.0 mg/kg/day 
based on combined acute dietary dog studies with a combined 
deltamethrin/tralomethrin data base. This NOEL is based on an 
uncertainty factor of 100 to account for both interspecies 
extrapolation and intraspecies variability.
     2. Short- and intermediate-term toxicity. There is no concern for 
short and intermediate term toxicity. There is no dermal or systemic 
toxicity at 1,000 mg/kg/day in 21 day dermal study in rats.
     3. Chronic toxicity. EPA has established the RfD for deltamethrin 
at 0.01 mg/kg/day. This RfD is based on a NOEL of 1.0 mg/kg/day from 
subchronic dog and rat toxicity studies. The NOEL is based on decreased 
body weight gain in rats. This RfD is based on an uncertainty factor of 
100 to account for both interspecies extrapolation and intraspecies 
variability.
    4. Carcinogenicity. There is no evidence of carcinogenicity in 
either rats or mice.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.435 and 180.422) for the residues of deltamethrin and 
tralomethrin, in or on a variety of raw agricultural commodities. For 
the purposes of the risk assessment, the data bases for deltamethrin 
and tralomethrin have been combined. EPA notes that the acute dietary 
risk assessments used Monte Carlo modeling (in accordance with Tier 3 
of EPA's June 1996 ``Acute Dietary Exposure Assessment'' guidance 
document) incorporating anticipated residues and percent crop treated 
refinements. Field trial data and FDA monitoring data were used to 
generate anticipated residues of residue distribution for Monte Carlo 
analyses. Chronic dietary risk assessments used anticipated residues 
and percent crop treated refinements. Risk assessments were conducted 
by EPA to assess dietary exposures and risks from deltamethrin and 
tralomethrin as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1 day or single exposure. The NOEL used for the acute dietary 
exposure was 1.0 mg/kg/day. Potential acute exposures from food 
commodities were estimated using a Tier 3 acute dietary risk assessment 
(Monte Carlo Analysis). The MOE (99.9th percentile) for the U.S. 
population based on an acute dietary exposure of 0.000728 mg/kg/day is 
1,373. For children 1-6 years old (most highly exposed population) the 
MOE based on an acute dietary exposure of 0.001855 mg/kg/day is 539. 
The Agency has no cause for concern if total exposure calculated for 
the 99.9th percentile yields an MOE of 100 or larger.

[[Page 45411]]

    ii. Chronic exposure and risk. Potential chronic exposures were 
estimated using NOVIGEN's DEEM (Dietary Exposure Evaluation Model). The 
RfD used for the chronic dietary analysis is 0.01 mg/kg/day. Using 
tolerance values and anticipated residues discussed above, the risk 
assessment resulted in use of 0.2% of the RfD for the general U.S. 
population and 0.5% of the RfD for children 1-6 years old.
    Section 408(b)(2)(E) authorizes EPA to consider 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 the time frame 
it deems appropriate. Section 408(b)(2)(F) allows the Agency to use 
data on the actual percent of crop treated when establishing a 
tolerance only where the Agency can make the following findings: (a) 
That the data used are reliable and provide a valid basis for showing 
the percentage of food derived from a crop that is likely to contain 
residues; (b) that the exposure estimate does not underestimate the 
exposure for any significant subpopulation and; (c) where data on 
regional pesticide use and food consumption are available, that the 
exposure estimate does not understate exposure for any regional 
population. In addition, the Agency must provide for periodic 
evaluation of any estimates used.
    The percent of crop treated estimates for deltamethrin were derived 
from Federal and market survey data. EPA considers these data reliable. 
A range of estimates are supplied by this data and the upper end of 
this range was used for the exposure assessment. By using this upper 
end estimate of percent crop treated, the Agency is reasonably certain 
that exposure is not underestimated for any significant subpopulation. 
Further, regional consumption information is taken into account through 
EPA's computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Review of this 
regional data allows the Agency to be reasonably certain that no 
regional population is exposed to residue levels higher than those 
estimated by the Agency. To meet the requirement for data on 
anticipated residues, EPA will issue a Data Call-In (DCI) notice 
pursuant to FFDCA section 408(f) requiring submission of data on 
anticipated residues in conjunction with approval of the registration 
under FIFRA.
    2. From drinking water. Deltamethrin and tralomethrin are immobile 
in soil and will not leach into groundwater. Additionally, due to their 
insolubility and lipophilic nature, any residues in surface water will 
rapidly and tightly bind to soil particles and remain with sediment. A 
screening evaluation of leaching potential of a typical pyrethroid was 
conducted using EPA's Pesticide Root Zone Model (PRZM3). Based on this 
screening assessment, the potential concentrations of a pyrethroid in 
ground water at depths of 1 and 2 meters are essentially zero (much 
less than 0.001 ppb). Therefore, EPA concludes that residues are not 
expected to occur in drinking water.
    i. Acute exposure and risk. Acute drinking water exposure is 
estimated for the U.S. population to be 0.000014 mg/kg/day with an MOE 
of 69,093. For non-nursing infants less than 1 year old the exposure is 
0.000028 with an MOE of 35,895.
    ii. Chronic exposure and risk. Chronic drinking water exposure is 
estimated for the U.S. population to be zero and for the non-nursing 
infants 0.000001 mg/kg/day. Zero percent of the RfD is occupied by both 
population groups.
    3. From non-dietary exposure. Deltamethrin and tralomethrin are 
broad spectrum insecticides registered for use on a variety of food and 
non-food agricultural commodities. Non-agricultural registered uses 
include turf and lawn care treatments, broadcast carpet treatments, 
spot, crack and crevice treatment, lawn and garden sprays and indoor 
and outdoor residential and industrial establishments.
    To evaluate non-dietary exposure, the ``flea infestation control'' 
scenario was chosen to represent a plausible but worst case non-dietary 
(indoor and outdoor) non-occupational exposure. This scenario provides 
a situation where deltamethrin and/or tralomethrin is commonly used and 
they can be used concurrently for a multitude of uses, e.g., spot and/
or broadcast treatment of infested indoor surfaces such as carpets and 
rugs, treatment of pets and treatment of the lawn. This hypothetical 
situation provides a very conservative, upper bound estimate of 
potential non-dietary exposures. Consequently, if health risks are 
acceptable under these conditions, the potential risks associated with 
other more likely scenarios would also be acceptable.
    Because tralomethrin is rapidly metabolized to deltamethrin, and 
the toxicology profiles of deltamethrin and tralomethrin are virtually 
identical, a non-dietary and aggregate (non-dietary + chronic dietary) 
exposure/risk assessment has been conducted for the combination of both 
active ingredients. The total exposure to both materials was expressed 
as ``deltamethrin equivalents'' and these were compared to the 
toxicology endpoints identified.
    The total aggregate non-dietary exposure including lawn, carpet, 
and pet uses (in mg/kg/day) are: 0.00002 for adults; 0.000503 for 
children aged 1-6 years; and 0.000543 for infants less than 1 year old.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to

[[Page 45412]]

which the common mechanism issues can be resolved. These pesticides 
include pesticides that are toxicologically dissimilar to existing 
chemical substances (in which case the Agency can conclude that it is 
unlikely that a pesticide shares a common mechanism of activity with 
other substances) and pesticides that produce a common toxic metabolite 
(in which case common mechanism of activity will be assumed).
    Although deltamethrin and tralomethrin are similar to other members 
of the synthetic pyrethroid class of insecticides, EPA does not have, 
at this time, available data to determine whether deltamethrin and 
tralomethrin have a common mechanism of toxicity with other substances 
or how to include this pesticide in a cumulative risk assessment. 
Unlike other pesticides for which EPA has followed a cumulative risk 
approach based on a common mechanism of toxicity, deltamethrin and 
tralomethrin do 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 and tralomethrin have a common 
mechanism of toxicity with other substances.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. The acute aggregate risk assessment takes into 
account exposure from food and drinking water. The potential acute 
exposure from food and water to the U.S. population for deltamethrin 
and tralomethrin is 0.000742 mg/kg/day with an MOE of 1,348. This acute 
dietary exposure estimate is considered conservative, using anticipated 
residue values and percent crop-treated data in conjunction with Monte 
Carlo analysis.
    2. Chronic risk. Using the ARC exposure assumptions described 
above, EPA has concluded that aggregate exposure to deltamethrin and 
tralomethrin from food will utilize 0.2% of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is children 1-6 years old discussed in Unit II.F of this 
preamble. EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. The potential short- and intermediate-term 
aggregate risk for the U.S. population is an exposure 0.000042 mg/kg/
day with an MOE of 49,000. EPA concludes that there is reasonable 
certainty that no harm will result from aggregate exposure to 
deltamethrin and tralomethrin residues.

E. Aggregate Cancer Risk for U.S. Population

    Deltamethrin and tralomethrin do not yet have carcinogenicity 
classification; however, there is no evidence of carcinogenicity in any 
of the chronic studies. Therefore, a carcinogenicity risk analysis is 
not required.

F. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of deltamethrin and tralomethrin, EPA considered 
data from developmental toxicity studies in the rat and rabbit and a 
two-generation reproduction study in the rat. The developmental 
toxicity studies are designed to evaluate adverse effects on the 
developing organism resulting from pesticide exposure during prenatal 
development to one or both parents. Reproduction studies provide 
information relating to effects from exposure to the pesticide on the 
reproductive capability of mating animals and data on systemic 
toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the data base unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard MOE 
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty 
factor when EPA has a complete data base under existing guidelines and 
when the severity of the effect in infants or children or the potency 
or unusual toxic properties of a compound do not raise concerns 
regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. See toxicological profile in 
Unit II.A of this preamble.
    iii. Reproductive toxicity study. See toxicological profile in Unit 
II.A of this preamble.
    iv. Pre- and post-natal sensitivity. There is no evidence of 
additional sensitivity to young rats or rabbits following prenatal 
exposure to deltamethrin or tralomethrin.
    v. Conclusion. Based on the above, EPA concludes that reliable data 
support use of the standard hundredfold uncertainty factor, and that an 
additional uncertainty factor is not needed to protect the safety of 
infants and children.
    2. Acute risk. The potential acute exposure from food and drinking 
water to the most sensitive population subgroup, children 1-6 years old 
is 0.001867 mg/kg/day with an MOE of 535. The Agency has no cause for 
concern if total acute exposure calculated for the 99.9th percentile 
yields an MOE of 100 or larger.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
deltamethrin and tralomethrin from food will utilize 0.5% of the RfD 
for infants and children. EPA generally has no concern for exposures 
below 100% of the RfD because the RfD represents the level at or below 
which daily aggregate dietary exposure over a lifetime will not pose 
appreciable risks to human health.
    4. Short- or intermediate-term risk. EPA has concluded that 
potential short- or intermediate-term aggregate exposure of 
deltamethrin and tralomethrin from chronic dietary food and drinking 
water (considered to be a background exposure level) plus indoor and 
outdoor residential exposure to infants (less than 1 year old) is 
0.000057 mg/kg/day with an MOE of 1,800. For children (1-6 years old) 
the exposure is 0.000055 mg/kg/day with an MOE of 2,700.
    5.  Special docket. The complete acute and chronic exposure 
analyses (including dietary, non-dietary, drinking water, and 
residential exposure, and analysis of exposure to infants and children) 
used for risk assessment purposes can be found in the Special Docket 
for the FQPA under the title ``Risk Assessment for Extension of 
Tolerances for Synthetic Pyrethroids.'' Further explanation regarding 
EPA's decision regarding the additional safety factor can also be found 
in the Special Docket.
    EPA concludes that there is reasonable certainty that no harm will 
result to infants and children from aggregate exposure to deltamethrin 
and tralomethrin.

[[Page 45413]]

G. Endocrine Disrupter Effects

     EPA is required to develop a screening program to determine 
whether certain substances (including all pesticides and inerts) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally occurring estrogen, or such other endocrine effect...'' The 
Agency is currently working with interested stakeholders, including 
other government agencies, public interest groups, industry and 
research scientists in developing a screening and testing program and a 
priority setting scheme to implement this program. Congress has allowed 
3 years from the passage of FQPA (August 3, 1999) to implement this 
program. At that time, EPA may require further testing of this active 
ingredient and end use products for endocrine disrupter effects.

III. Other Considerations

A. Metabolism in Plants and Animals

    EPA has reviewed the results of animal metabolism studies and has 
concluded that the metabolism of deltamethrin in animals is adequately 
understood for the purposes of these tolerances. The absorption of 
deltamethrin appears to be highly dependent upon the route and vehicle 
of administration. Once absorbed, deltamethrin is rapidly and 
extensively metabolized and excreted through urine and feces, almost 
completed within the first 48 hours. The residue of concern is 
deltamethrin.

B. Analytical Enforcement Methodology

    The analytical method designated HRAV-7B is adequate for 
enforcement purposes. Multiresidue methods data for tralomethrin, 
deltamethrin, and trans-deltamethrin have been sent to the Food and 
Drug Administration.

C. Magnitude of Residues

    Adequate residue data were provided to support tolerances of 0.05 
ppm. Residue levels of deltamethrin in food and/or feed items after 
applications to food and feed handling establishments were below the 
level of quantitation (LOQ) i.e., below 0.02 ppm. There is no 
reasonable expectation of secondary residues in eggs, meat, milk or 
poultry from the proposed use as delineated in 40 CFR 180.6(a)(3).

D. International Residue Limits

    Deltamethrin is a broad spectrum insecticide used throughout the 
world to control pests of livestock, crops, ornamental plants and turf, 
and household, commercial and industrial food use areas. A reevaluation 
of the maximum residue limits (MRLs) was conducted in 1994, in 
accordance with the EC Directive (91/414/EEC) Registration Requirements 
for Plant Protection Products. A comparison of the proposed CODEX MRL's 
and tolerances for deltamethrin in or on food and feed items is 
presented below:

----------------------------------------------------------------------------------------------------------------
                                                      Proposed/Current MRL (CODEX)       Proposed/Established   
                      Commodity                                  in ppm               Tolerance (US EPA) in ppm 
----------------------------------------------------------------------------------------------------------------
Food/Feed Items.....................................              0.05                           0.05           
----------------------------------------------------------------------------------------------------------------

    Since the CODEX MRL's are the same as the proposed U.S. EPA 
tolerance, there is no concern for international harmonization.

IV. Conclusion

    Therefore, a tolerance is established for residues of deltamethrin 
in or on food and feed items as a result of use in food and feed 
handling establishments at 0.05 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by October 26, 1998, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is 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 in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as 
Confidential Business Information (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.

VI. Public Docket and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300669] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency,

[[Page 45414]]

Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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). 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) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency has 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

VIII. Submission to Congress and the Comptroller General

    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 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 the rule in the Federal Register. This 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: June 10, 1998.

James J. Jones,

Acting 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. 346a and 371.


    2. In Sec. 180.435, paragraph (a) by designating the text following 
the paragraph heading as paragraph (a)(1) and by adding paragraph 
(a)(2) to read as follows:


Sec. 180.435  Deltamethrin; tolerances for residues.

    (a) General. *    *    *
    (2) A tolerance of 0.05 ppm is established for residues of the 
insecticide deltamethrin (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester and its major metabolites, trans deltamethrin (S)-alpha-cyano-m-
phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate and alpha-R-deltamethrin[(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] as follows:
    (i) In or on all food/feed items (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments.
    (ii) The insecticide may be present as a residue from application 
of deltamethrin in food handling establishments, including food 
service, manufacturing and processing establishments, such as 
restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, 
meat slaughtering and packing plants, and canneries, feed handling 
establishments including feed manufacturing and processing 
establishments, in accordance with the following prescribed conditions:
    (A) Application shall be limited to general surface and spot and/or 
crack and crevice treatment in food/feed handling establishments where 
food/feed and food/feed products are held, processed, prepared and 
served. General surface application may be used only when the facility 
is not in operation provided exposed food/feed has been covered or 
removed from the area being treated. Spot and/or crack and crevice 
application may be used while the facility is in operation provided 
exposed food/feed is covered or removed from the area being treated 
prior to application. Spray concentration shall be limited to a maximum 
of 0.06 percent active ingredient. Contamination of food/feed or food/
feed contact surfaces shall be avoided.
    (B) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency and shall be used in accordance with such label and labeling.
*        *        *        *        *
[FR Doc. 98-22529 Filed 8-25-98; 8:45 am]
BILLING CODE 6560-50-F