[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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