[Federal Register Volume 62, Number 134 (Monday, July 14, 1997)]
[Rules and Regulations]
[Pages 37516-37522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18560]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300515; FRL-5731-3]
RIN 2070-AB78


Fenpropathrin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of fenpropathrin in or on currants . This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on currants in Washington. This regulation 
establishes a maximum permissible level for residues of fenpropathrin 
in this food commodity pursuant to section 408(l)(6) of the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996. The tolerance will expire and is revoked on December 31, 
1998.

DATES: This regulation is effective July 14, 1997. Objections and 
requests for hearings must be received by EPA on or before September 
12, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300515], 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-300515], must also besubmitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), 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. 1132, 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 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-300515]. 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: Olga Odiott, 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) 308-9363, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the insecticide fenpropathrin, in or on currants at 15 part 
per million (ppm). This tolerance will expire and is revoked on 
December 31, 1998. EPA will publish a document in the Federal Register 
to remove the revoked tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq . The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described below and discussed in 
greater detail in the final rule establishing the time-limited 
tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
    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

[[Page 37517]]

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. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Fenpropathrin on Currants and FFDCA 
Tolerances

    The Washington Department of Agriculture availed itself of the 
authority to declare the existence of a crisis situation within the 
state on May 21, 1997, thereby authorizing use under FIFRA Section 18 
of fenpropathrin to control the currant borer (Synanthedon 
tipuliformes) . Washington has also requested a specific exemption for 
this use of fenpropathrin. The applicant stated that the currant borer 
is a serious pest of currants in Washington. The currant borer adults 
emerge during mid May in central Washington and lay their eggs on the 
currant canes over a period of 4 to 5 weeks. Newly hatched larvae bore 
into the center of the cane and feed in the pith creating a tunnel. 
Borer damage increases each year when no control measures are taken. 
With the cancellation of parathion there are no registered pesticides 
that will provide adequate control. The applicant stated that 
presently, cane stands have dead canes ranging from 10 to 30% and if 
left uncontrolled, the perennial plantings will be lost. EPA has 
authorized under FIFRA section 18 the use of fenpropathrin on currants 
for control of the currant borer in Washington. After having reviewed 
the submission, EPA concurs that emergency conditions exist for this 
state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fenpropathrin in or on 
currants. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on 
December 31, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on currants after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA. EPA will take action to revoke this tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether fenpropathrin meets EPA's 
registration requirements for use on currants or whether a permanent 
tolerance for this use would be appropriate. Under these circumstances, 
EPA does not believe that this tolerance serves as a basis for 
registration of fenpropathrin by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than Washington to use this pesticide on this crop under 
section 18 of FIFRA without following all provisions of section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for fenpropathrin, contact the Agency's 
Registration Division at the address provided above.

III. Risk Assessment and Statutory Findings

    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% r 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 
100-fold MOE is based on the same

[[Page 37518]]

rationale as the 100-fold 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 residential exposure, are aggregated. High-end exposures from all 3 
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.

IV. 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 
fenpropathrin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of fenpropathrin on currants at 15 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 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 fenpropathrin are 
discussed below.
    1. Acute toxicity. An acute dietary endpoint was not identified 
from the toxicity studies available to the Agency; therefore this risk 
assessment was not required.
     2. Short - and intermediate - term toxicity. For short- and 
intermediate-term toxicity endpoints were not

[[Page 37519]]

identified from the available data; therefore this risk assessment was 
not required.
    3. Chronic toxicity. EPA has established the RfD for fenpropathrin 
at 0.025 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 1-
year feeding study in dogs with a NOEL of 2.5 mg/kg/day and an 
uncertainty factor of 100. The lowest observed effect level (LOEL) of 
6.25 mg/kg/day was based on tremors.
    4. Carcinogenicity. Fenpropathrin has not been classified as to its 
carcinogenicity by the EPA. However, studies in two species show no 
evidence of oncogenicity.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.466) for the residues of fenpropathrin, in or on a variety of 
raw agricultural commodities at levels ranging from 0.01 ppm in peanuts 
to 20 ppm in peanut hay. Animal commodity tolerances have been 
established for meat, fat, meat by-products, eggs, and milk. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from fenpropathrin as follows:
    Chronic exposure and risk. The chronic dietary risk assessment 
assumed 100% of currants will contain tolerance level residues and 100% 
of the crop will be treated. All other commodities having fenpropathrin 
tolerances were assumed to be 100% crop-treated, but most have received 
anticipated residue refinement. Thus, in making a safety determination 
for this tolerance, the EPA is taking into account this conservative 
exposure assessment. The population subgroup with the largest 
percentage of the RfD occupied is non-nursing infants <1 year old, at 
26% of the RfD.
    2. From drinking water. Based on available data used in EPA's 
assessment of environmental risk, fenpropathrin is persistent and not 
mobile. There are no established Maximum Contaminant Level for residues 
of fenpropathrin in drinking water. No health advisory levels for 
fenpropathrin in drinking water have been established.
    Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water-related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfD's or acute dietary NOEL's) and assumptions about body 
weight and consumption, to calculate, for each pesticide, the increment 
of aggregate risk contributed by consumption of contaminated water. 
While EPA has not yet pinpointed the appropriate bounding figure for 
exposure from contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause fenpropathrin to 
exceed the RfD if the tolerance being considered in this document were 
granted. The Agency has therefore concluded that the potential 
exposures associated with fenpropathrin in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    3. From non-dietary exposure. Fenpropathrin is currently registered 
for use on ornamental plants. EPA believes that this use would not fall 
under a chronic exposure scenario, but may constitute a short- and/or 
intermediate-term exposure scenario. However, no toxicological 
endpoints for non-dietary exposure have been identified.
    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 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).
    Fenpropathrin is a member of the synthetic pyrethroids class of 
pesticides. Other members of this class include allethrin, 
tetramethrin, resmethrin, bioresmethrin, phenothrin, fenvalerate, 
permethrin, cyfluthrin, cypermethrin, flucythrinate, fluvalinate, 
tralomethrin, bifenthrin, tefluthrin, and lambda-cyhalothrin.
    EPA does not have, at this time, available data to determine 
whether fenpropathrin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. For the purposes of this tolerance action, therefore, EPA 
has not assumed that fenpropathrin has a common mechanism of toxicity 
with other substances.

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

    Chronic risk. Using the partially refined ARC exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
fenpropathrin from food will utilize 8% of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is non-nursing infants < 1year old at 26% of the RfD 
(discussed below). 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. Despite the potential for exposure 
to fenpropathrin in drinking water and

[[Page 37520]]

from non-dietary, non-occupational exposure, EPA does not expect the 
aggregate exposure to exceed 100% of the RfD. EPA concludes that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to fenpropathrin residues.

D. Aggregate Cancer Risk for U.S. Population

    Fenpropathrin has not been classified as to its carcinogenicity by 
the EPA. However, studies in two species show no evidence of 
oncogenicity.

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

    1. Safety factor for infants and children-- a. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of fenpropathrin, 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 maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to pre- and post-
natal effects from exposure to the pesticide, information 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 database 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.
    b. Developmental toxicity studies-- Rats: The maternal (systemic) 
NOEL was 6 mg/kg/day. The maternal LOEL of 10 mg/kg/day was based on 
death, moribundity, ataxia, hypersensitivity, spastic jumping, tremors, 
convulsions, hunched posture, and squinting eyes. The developmental 
(fetal) NOEL was 10 mg/kg/day at the highest dose tested 
[HDT]. Rabbits: The maternal (systemic) NOEL was 4 mg/kg/day. The 
maternal LOEL of 12 mg/kg/day was based on anorexia, grooming, and 
flicking of the forepaws. The developmental (fetal) NOEL was 
36 mg/kg/day at the HDT.
    c. Reproductive toxicity study-- Rats: In the 3-generation 
reproductive toxicity study in rats, the parental (systemic) NOEL was 3 
mg/kg/day. The parental (systemic) LOEL of 8.9 mg/kg/day was based on 
body tremors with spasmodic muscle twitches, increased sensitivity and 
maternal lethality. The developmental NOEL was 3.0 mg/kg/day. The 
developmental LOEL of 8.9 mg/kg/day was based on body tremors and 
increased mortality. The reproductive (pup) NOEL was 8.9 mg/kg/day. The 
reproductive LOEL of 8.9 mg/kg/day was based on increased pup loss in 
the F2 generation.
    d. Pre- and post-natal sensitivity. The toxicological data base for 
evaluating pre- and post-natal toxicity for fenpropathrin is complete 
with respect to current data requirements. There are no pre- or post-
natal toxicity concerns for infants and children, based on the results 
of the rat and rabbit developmental toxicity studies or the 3-
generation reproductive toxicity study in rats.
    e. Conclusion. EPA concludes that reliable data support use of the 
standard 100-fold uncertainty factor and that an additional uncertainty 
factor is not needed to protect infants and children.
    2. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that the percentage of the RfD that 
will be utilized by dietary (food only) exposure to residues of 
fenpropathrin ranges from 13 % for children (7-12 years old), up to 26% 
for non-nursing infants (< 1 year old). 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. Despite the 
potential for exposure to fenpropathrin in drinking water, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to fenpropathrin residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in/on tree fruits is adequately 
understood. The residue of concern is fenpropathrin, per se, as 
specified in 40 CFR 180.466 .

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. Method RM-22-4 was successfully validated by EPA 
on apples. The method has been submitted for inclusion in PAM II.

C. Magnitude of Residues

    Residues of fenpropathrin per se are not expected to exceed 15 ppm 
in/on currants as a result of this Section 18 use. Secondary residues 
are not expected in animal commodities as no feed items are associated 
with this Section 18 use.

D. International Residue Limits

    No CODEX MRL has been established for residues of fenpropathrin in/
on currants. A CODEX MRL has been established for residues of 
fenpropathrin in/on the pome fruit crop group at 5.0 ppm and grapes at 
5.0 ppm.

E. Rotational Crop Restrictions.

    The results from field rotational crop studies indicate that no 
rotational crop restrictions or tolerances are required.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
fenpropathrin in currants at 15 ppm.

VII. 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 September 12, 1997, 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

[[Page 37521]]

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.

VIII. Public Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300515] (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 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., 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.

IX. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408(l)(6). 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 tolerances and exemptions that are established 
under FFDCA section 408 (l)(6), 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 acations published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: July 9, 1997.
James 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. Section 180.466 is amended by designating the existing text as 
paragraph (a) and adding a heading, by adding paragraph (b) and by 
adding and reserving paragraphs (c) and (d) to read as follows:


Sec.  180.466 Fenpropathrin.

    (a) General   .  *  *  *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide fenpropathrin in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. The tolerance will expire and is revoked on the date specified 
in the following table.

[[Page 37522]]



                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Currants........................  15                   December 31, 1998
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 97-18560 Filed 7-11-97; 8:45 am]
BILLING CODE 6560-50-F