[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Rules and Regulations]
[Pages 44565-44572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22396]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300529; FRL-5737-7]
RIN 2070-AB78


Chlorfenapyr; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes time-limited tolerances for 
chlorfenapyr in or on cottonseed; cotton gin byproducts; milk; milk 
fat; meat of cattle, goats, hogs, horses, and sheep; fat of cattle, 
goats, hogs, horses, and sheep; and meat byproducts of cattle, goats, 
hogs, horses and sheep. This action is in response to EPA's granting of 
emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of the pesticide on 
cotton. This regulation establishes maximum permissible level for 
residues of chlorfenapyr in/on these food commodities pursuant to 
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996. These tolerances 
will expire and are revoked on July 31, 1999.

DATES: This regulation is effective August 22, 1997. Objections and 
requests for hearings must be received by EPA on or before October 21, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300529], 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-300529], must also be submitted 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-300529]. No Confidential Business

[[Page 44566]]

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: Daniel Rosenblatt, 
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) 308-9375, 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 tolerances for 
the insecticide chlorfenapyr in or on cottonseed at 0.5 parts per 
million (ppm); cotton gin byproducts at 2.0 ppm; milk at 0.01 ppm; milk 
fat at 0.15 ppm; meat of cattle, goats, hogs, horses, and sheep at 0.01 
ppm; fat of cattle, goats, hogs, horses, and sheep at 0.10 ppm; and 
meat byproducts of cattle, goats, hogs, horses, and sheep at 0.3 ppm. 
These tolerances will expire and are revoked on July 31, 1999. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerances 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 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 Chlorfenapyr on Cotton and FFDCA 
Tolerances

    Beet armyworm has infested cotton fields to a high degree in recent 
growing seasons. EPA received submissions from Texas, Mississippi, 
Alabama, Arkansas, Florida, Georgia, Louisiana, South Carolina, and 
California for a section 18 exemption for the use of the unregistered 
pesticide chlorfenapyr to address the problem. The resistant tobacco 
budworm is also negatively affecting yields in these states. EPA has 
reviewed the submissions and has concluded that these pest situations 
represent urgent and non-routine problems. Therefore, EPA has 
authorized under FIFRA section 18 the use of the new pesticide 
chlorfenapyr on cotton for control of beet armyworm and resistant 
tobacco budworm in the listed states.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of chlorfenapyr in 
or on cottonseed; cotton gin byproducts; milk; milk fat; meat of 
cattle, goats, hogs, horses, and sheep; fat of cattle, goats, hogs, 
horses, and sheep; and meat byproducts of cattle, goats, hogs, horses, 
and sheep. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerances 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 these tolerances without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although these tolerances will expire and are revoked on 
July 31, 1999, under FFDCA section 408(l)(5), residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on cottonseed; cotton gin byproducts; milk; milk fat; meat of cattle, 
goats, hogs, horses, and sheep; fat of cattle, goats, hogs, horses, and 
sheep; and meat byproducts of cattle, goats, hogs, horses, and sheep 
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 
these tolerances earlier if any experience with, scientific data on, or 
other relevant information on this pesticide indicate that the residues 
are not safe.
    Because these tolerances are being approved under emergency 
conditions EPA has not made any decisions about whether chlorfenapyr 
meets EPA's registration requirements for use on cotton or whether 
permanent tolerances for these uses would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of chlorfenapyr by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for any States other than previously listed 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 chlorfenapyr, contact 
the Agency's Registration Division at the address provided above.

[[Page 44567]]

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% 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 
100-fold MOE is based on the same 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 only are 
applicable since there are no residential uses of chlorfenapyr. 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

[[Page 44568]]

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 (infants less 
than a 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 
chlorfenapyr and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of chlorfenapyr in or on cottonseed at 0.5 ppm; cotton gin 
byproducts at 2.0 ppm; milk at 0.01 ppm; milk fat at 0.15 ppm; meat of 
cattle, goats, hogs, horses, and sheep at 0.01 ppm; fat of cattle, 
goats, hogs, horses, and sheep at 0.10 ppm; and meat byproducts of 
cattle, goats, hogs, horses, and sheep at 0.3 ppm. EPA's assessment of 
the dietary exposures and risks associated with establishing these 
tolerances 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 chlorfenapyr are 
discussed below.
    1. Acute toxicity. For acute dietary risk assessment, EPA 
recommends use of a NOEL for chlorfenapyr of 45 mg/kg/day from the rat 
acute neurotoxicity study. The Lowest Exposure Level (LEL) of 90 mg/kg/
day was based on lethargy of the rats on the day of treatment. An MOE 
of 1,000 is required for all subgroups. An additional modifying factor 
of 10 was applied because the neurotoxicity study was classified as 
supplemental.
     2. Short - and intermediate - term toxicity. For short- and 
intermediate-term MOE calculations, EPA recommends the use of a NOEL of 
100 mg/kg/day from the 28-day dermal toxicity study in rabbits. The LEL 
of 400 mg/kg/day was based on increased serum cholesterol, increased 
relative liver weights, and unspecified histological lesions. EPA 
concludes that an MOE of 1,000 is required.
    3. Chronic toxicity. EPA has established the RfD for chlorfenapyr 
at 0.003 milligrams/kilogram/day (mg/kg/day). This RfD is based on an 
80-week feeding study in mice with a NOEL of 2.8 mg/kg/day and an LEL 
of 16.0 mg/kg/day based on brain lesions (both sexes) and scabbing of 
skin (males) An uncertainty factor of 1,000 was used with an additional 
modifying factor of 10 due to uncertainties regarding neurological 
risks in infants and children.
    4. Carcinogenicity. EPA has classified chlorfenapyr as a Group D 
(not classifiable as to human carcinogenicity) chemical.

B. Exposures and Risks

    1. From food and feed uses. Chlorfenapyr is an unregistered 
pesticide. The manufacturer has submitted registration applications for 
approval for chlorfenapyr products, however, none have been approved to 
date. This is the first tolerance-related action associated with this 
chemical. Risk assessments were conducted by EPA to assess dietary 
exposures and risks from chlorfenapyr 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 one day or single exposure. The acute dietary exposure endpoint of 
concern for chlorfenapyr is lethargy the day of dosing, which would 
affect all population subgroups. The acute analysis assumed tolerance 
level residues for all commodities. For all the population subgroups, 
the calculated MOE values are greater than 1,125. These MOEs do not 
represent a level of concern to EPA. Further, it should be noted that 
if the analysis were to incorporate anticipated residue levels and 
percent crop-treated, the MOEs would be even larger.
    ii. Chronic exposure and risk. For the purposes of chronic dietary 
risk analysis, EPA assumed tolerance level residues and 100% crop 
treated for all commodities. The Theoretical Residue Contributions 
(TMRC) attributable to the use of this pesticide in accordance with the 
section 18 authorizations referenced in this notice are equivalent to 
RfD contributions that range from 23% for the U.S. population (48 
states) to 76% for non-nursing infants less than a year old.
    2. From drinking water. In examining aggregate exposure, FQPA 
directs EPA to consider available information concerning exposures from 
the pesticide residues in food and all other non-occupational 
exposures. The primary non-food sources of exposure the Agency looks at 
include drinking water (whether from ground or surface water), and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses). Based on data available to EPA, 
chlorfenapyr is considered immobile and has a relatively high affinity 
for soil. The mobility characteristics exhibited by this compound are 
not those generally associated with compounds found in groundwater. 
However, the chemical behavior of chlorfenapyr does present surface 
water concerns. Special models were used by EPA to calculate Tier II 
Estimated Environmental Concentrations (EECs) to estimate the exposure 
of chlorfenapyr from surface water. The values represent an upper bound 
estimate of the concentration in an edge-of-the-field pond with no 
outlet. The recommended values for drinking water exposure for use in 
human health risk assessment for surface water are 11 micrograms/L for 
acute drinking water exposure and 9 micrograms/L for chronic drinking 
water exposure .
    i. Acute exposure and risk. EPA developed acute exposure levels for 
adults and children. For children, the acute exposure from drinking 
water is calculated to be 0.0011 mg/kg/day (11 micrograms/L x 
10-3 mg/ug x L/day divided by 10 kg). For adults, the acute 
exposure is calculated to be 0.0003 mg/kg/day.
    ii. Chronic exposure and risk. The chronic exposure form drinking 
water to children is calculated to be 30% of the RfD (9 micrograms/L x 
10-3 mg/ug x 1 L/day divided by 10 kg divided by 0.003 mg/
kg/day x 100 = 30%). The exposure for the general U.S. population would 
be 10% of the RfD.
    iii. Short- and intermediate-term exposure and 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. However, since there is no 
potential residential indoor/outdoor non-dietary non-occupational 
exposure scenarios for

[[Page 44569]]

chlorfenapyr, an aggregate short- and intermediate-term risk assessment 
is not necessary.
    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).
    EPA does not have, at this time, available data to determine 
whether chlorfenapyr has 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, 
chlorfenapyr does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that chlorfenapyr has a common mechanism of 
toxicity with other substances.

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

    1. Acute risk. In order to assess aggregate risks, EPA combines the 
acute MOE calculations for food and water. EPA's processes for 
determining acute dietary (food only) and surface water exposures are 
described elsewhere in this notice. The most highly exposed subgroup 
for chlorfenapyr is infants less than a year old, with a combined 
dietary and drinking water exposure at 0.0153 mg/kg/day. Using the NOEL 
of 45 mg/kg/day, produces an aggregate acute risk assessment MOE of 
2,900. Therefore, in EPA's judgement, aggregate acute risk to 
chlorfenapyr does not exceed levels of concern.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to chlorfenapyr from 
food and water will utilize 33% of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is 
infants and children. See below for a discussion of the analysis of the 
risks for that subgroup. 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. However, since there is no potential residential 
indoor/outdoor non-dietary non-occupational exposure scenarios for 
chlorfenapyr, an aggregate short- and intermediate-term risk assessment 
is not necessary.

D. Aggregate Cancer Risk for U.S. Population

    Chlorfenapyr has been classified as a Group D chemical signifying 
that it is ``not classifiable as to human carcinogenicity.

E. 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 chlorfenapyr, 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 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 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 100-
fold safety factor (usually 100 for combined inter- and intra-species 
variability)) and not the additional tenfold 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 safety factor.
    ii. Developmental toxicity studies. In the rat developmental 
toxicity study, the maternal (systemic) NOEL was 25 mg/kg/day. The LEL 
of 75 mg/kg/day was based on decreased body weight gain, decreased 
relative feed intake, and decreased water consumption. The 
developmental (pup) NOEL was greater than 225 mg/kg/day (HDT). In the 
rabbit developmental toxicity study, the maternal (systemic) NOEL was 5 
mg/kg/day. The LEL of 15 mg/kg/day was based on decreased body weight 
gain. The reproductive developmental NOEL was greater than 30 mg/kg/day 
(HDT).
    iii. Reproductive toxicity study. From the multigeneration 
reproductive toxicity study in the rat, the maternal (systemic) NOEL 
was 5 mg/kg/day. The LEL of 22 mg/kg/day was based on decreased body 
weight gain (pre-mating). The reproductive developmental NOEL was 5 mg/
kg/day.

[[Page 44570]]

 The LEL of 22 mg/kg/day was based on decreased weight gain during 
lactation.
    iv. Pre- and post-natal sensitivity. The pre- and post-natal 
toxicity data base for chlorfenapyr is complete. EPA notes that the 
developmental toxicity NOELs of greater than 225 mg/kg/day (HDT in 
rats) and greater than 30 mg/kg/day (HDT in rabbits) demonstrate that 
there is no developmental (prenatal) toxicity present at levels which 
produce maternal effects. Additionally, these developmental NOELs are 
75- and 10-fold higher in the rats and rabbits, respectively, than the 
NOEL of 1.8 mg/kg/day from the 1-year feeding study in dogs (the basis 
of the RfD).
    In the reproductive toxicity study in the rat, the reproductive 
developmental NOEL (5 mg/kg/day) is equal to the parental NOEL (5 mg/
kg/day). Both the pup LEL and the parental LEL of 22 mg/kg/day were 
based on decreased body weight. This finding suggests that there is no 
special post-natal sensitivity present in the reproductive study and 
that young rats have the same sensitivity to chlorfenapyr as adult 
animals.
    v. Conclusion. The developmental and reproductive toxicity studies 
indicate that infants and children have no special sensitivity to 
chlorfenapyr relative to other population subgroups. An additional 
safety factor for infants and children is not necessary for the use 
authorized in association with this tolerance.
    2. Acute risk. To determine acute dietary and drinking water risks 
to children, an MOE approach is used where the total acute exposure 
from the diet and drinking water is compared to the acute dietary 
endpoint of concern, the NOEL of 45 mg/kg/day. Infants less than a year 
old are the most highly exposed subgroup and have a combined dietary 
and drinking water exposure at 0.0153 mg/kg/day which yields an MOE of 
2,900. Therefore, in EPA's judgement, the aggregate acute risks to 
children and infants to chlorfenapyr does not exceed levels of concern.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
chlorfenapyr from food will utilize 45% of the RfD for nursing infants, 
106% for non-nursing infants, 91% for children 1-6 years old, and 69% 
for children 7-12 years old. These figures are quite conservative since 
TMRC's and 100% crop treated assumptions were used in the assessment. 
If anticipated residue and refined percent crop-treated data were used, 
the calculated risk would be much lower. In addition, the RfD of 0.003 
mg/kg/day was established using an uncertainty factor (UF) of 1,000. 
The UF contains an additional modifying factor of 10 due to 
uncertainties regarding neurological risks in infants and children. It 
is EPA's best scientific judgment that the aggregate chronic risks 
posed by chlorfenapyr do not exceed our level of concern.
    4. Short- or intermediate-term risk. Since there is no potential 
residential indoor/outdoor non-dietary non-occupational exposure 
scenarios for chlorfenapyr, an aggregate short- and intermediate-term 
risk assessment is not necessary.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue of chlorfenapyr in plants and ruminants 
is adequately understood. The residue of concern is the parent 
compound. For chlorfenapyr dietary risk assessments on ruminant 
commodities (excluding meat byproducts), residues of parent only will 
be used. However, chlorfenapyr dietary risk assessments on ruminant 
meat byproducts should include the two metabolites CL 303,268, and CL 
325,195 as well as the parent (CL 303,630). The ruminant meat byproduct 
risk assessment will use a factor (i.e. ratio parent plus metabolites/
parent) multiplied by the parent-based tolerance determined from the 
residue levels of the three moieties in the ruminant metabolism 
studies.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. American Cyanamid has prepared a method for 
cottonseed, meat, and milk.

C. Magnitude of Residues

    Residues of chlorfenapyr are not expected to exceed 0.5 ppm in/on 
cottonseed as a result of this use. No concentration of parent residues 
(average level of 0.30 ppm in ginned cottonseed) occurred in crude/
refined cottonseed oil or hulls. Therefore, separate tolerances for 
cottonseed processed commodities are not required. Cotton gin byproduct 
field trial data have not been submitted. In the absence of these 
required data, EPA recommends a tolerance of 2.0 ppm of chlorfenapyr 
residues in/on cotton gin byproducts.
    Residues of chlorfenapyr in animal commodities are not expected to 
exceed: 0.01 ppm in milk; 0.15 ppm in milk fat; 0.01 ppm in meat of 
cattle, goats, hogs, horses, and sheep; 0.10 ppm in fat of cattle, 
goats, hogs, horses, and sheep; and 0.3 ppm in meat byproducts of 
cattle, goats, hogs, horses, and sheep.

D. International Residue Limits

    No Codex, Canadian, or Mexican Maximum Residue Limits (MRLs) exist. 
Therefore, there are no compatibility issues with respect to this 
action.

VI. Conclusion

    Therefore, tolerances are established for chlorfenapyr in or on 
cottonseed at 0.5 ppm; cotton gin byproducts at 2.0 ppm; milk at 0.01 
ppm; milk fat at 0.15 ppm; meat of cattle, goats, hogs, horses, and 
sheep at 0.01 ppm; fat of cattle, goats, hogs, horses, and sheep at 
0.10 ppm; and meat byproducts of cattle, goats, hogs, horses, and sheep 
at 0.3 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 October 21, 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 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

[[Page 44571]]

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-300529] (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 tolerances under FFDCA section 
408(1)(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 these tolerances and exemptions that are 
established under FFDCA section 408(1)(6), such as the tolerances 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.

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: August 12, 1997.

James Jones,
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 180.513 is added to read as follows:


Sec. 180.513  Chlorfenapyr; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the insecticide chlorfenapyr in connection with use of 
the pesticide under section 18 emergency exemption granted by EPA. 
These tolerances will expire and are revoked on the date specified in 
the following table:

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    revocation date 
------------------------------------------------------------------------
Cattle, fat.....................  0.10                7/31/99           
Cattle, mbyp....................  0.3                 7/31/99           
Cattle, meat....................  0.01                7/31/99           
Cottonseed......................  0.5                 7/31/99           
Cotton gin byproducts...........  2.0                 7/31/99           
Goats, fat......................  0.10                7/31/99           
Goats, mbyp.....................  0.3                 7/31/99           
Goats, meat.....................  0.01                7/31/99           

[[Page 44572]]

                                                                        
Hogs, fat.......................  0.10                7/31/99           
Hogs, mbyp......................  0.3                 7/31/99           
Hogs, meat......................  0.01                7/31/99           
Horses, fat.....................  0.10                7/31/99           
Horses, mbyp....................  0.3                 7/31/99           
Horses, meat....................  0.01                7/31/99           
Milk............................  0.01                7/31/99           
Milk fat........................  0.15                7/31/99           
Sheep, fat......................  0.10                7/31/99           
Sheep, mbyp.....................  0.3                 7/31/99           
Sheep, meat.....................  0.01                7/31/99           
------------------------------------------------------------------------

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

[FR Doc. 97-22396 Filed 8-21-97; 8:45 am]
BILLING CODE 6560-50-F