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Chlorfenapyr. August 22, 1997.
Pesticide Tolerances for Emergency Exemptions.
Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/August/Day-22/p22396.htm
[Federal Register: August 22, 1997 (Volume 62, Number 163)]
[Rules and Regulations]
[Page 44565-44572]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au97-10]
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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.
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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: opp-docket@epamail.epa.gov. 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:
rosenblatt.dan@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov.
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