Pyriproxyfen; Pesticide Tolerances for Emergency Exemptions
[Federal Register: May 13, 1998 (Volume 63, Number 92)]
[Rules and Regulations]
[Page 26466-26472]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my98-36]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300651; FRL-5788-2]
RIN 2070-AB78
Pyriproxyfen; 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
residues of pyriproxyfen in or on citrus fruit, juice, dried pulp, and
oil; pears; and tomatoes. This action is in response to EPA's granting
of emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on citrus, pears, and tomatoes. This regulation establishes maximum
permissible levels for residues of pyriproxyfen in these food and feed
commodities pursuant to section 408(l)(6) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
of 1996 (FQPA). The tolerances will expire and are revoked on July 31,
1999.
DATES: This regulation is effective May 13, 1998. Objections and
requests for hearings must be received by EPA on or before July 13,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300651], 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-300651], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: 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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300651]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: Telephone numbers and e-mail
addresses: For pyriproxyfen on citrus: Andrea Beard (703) 308-9356, e-
mail: beard.andrea@epamail.epa.gov; For pyriproxyfen on pears or
tomatoes: Virginia Dietrich (703) 308-9359, e-mail:
dietrich.virginia@epamail.epa.gov. Office location (both): Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA. By mail (both):
Registration Division 7505C, Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6),
is establishing tolerances for residues of the pesticide pyriproxyfen,
in or on citrus fruit at 0.3 parts per million (ppm), citrus juice and
dried citrus pulp at 1.0 ppm, and citrus oil at 300 ppm; pears at 0.2
ppm; and tomatoes at 0.1 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 FQPA (Pub. L. 104-170) was signed into law August 3, 1996. FQPA
amends both the FFDCA, 21 U.S.C. 301 et seq., and the 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
[[Page 26467]]
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 Pyriproxyfen on Citrus and FFDCA
Tolerances
Pyriproxyfen on Citrus: A request was received from California for
use of pyriproxyfen on citrus to control red scale, which has developed
resistance to available controls, in some localized citrus-producing
areas of California, causing significant losses to the affected citrus
producers.
Pyriproxyfen on Pears: A request was received from Oregon for the
use of pyriproxyfen on pears for control of pear psylla, which has
developed resistance to currently available controls, and is expected
to cause significant economic loss if not adequately controlled.
Pyriproxyfen on Tomatoes: A request was received from Florida for
the use of pyriproxyfen on tomatoes for control of whiteflies. A
recently introduced strain or species of whitefly has caused extensive
damage over the past several years to various vegetable crops in
southern areas of the U.S., including tomatoes. This pest has
demonstrated resistance to available materials and is expected to cause
significant economic losses if not adequately controlled.
EPA has authorized under FIFRA section 18 the use of pyriproxyfen
on citrus for control of red scale in California; on pears for control
of pear psylla in Oregon; and, on tomatoes for control of whiteflies in
Florida. After having reviewed the submissions, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of pyriproxyfen in or on
citrus, pears, and tomatoes. 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 tolerances
remaining in or on citrus commodities, pears and tomatoes after that
date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these tolerances at the time of that
application. 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 pyriproxyfen
meets EPA's registration requirements for use on citrus, pears, or
tomatoes, 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 pyriproxyfen by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than California,
Oregon, and Florida to use this pesticide on these crops 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 pyriproxyfen, contact the Agency's Registration
Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor
[[Page 26468]]
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, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (Children 1 - 6
Years 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
pyriproxyfen and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of pyriproxyfen on citrus fruit at 0.3 ppm, citrus juice and
dried citrus pulp at 1.0 ppm, and citrus oil at 300 ppm; pears at 0.2
ppm; and tomatoes at 0.1 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as
[[Page 26469]]
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
pyriproxyfen are discussed below.
1. Acute toxicity. There are no acute dietary endpoints of concern
for pyriproxyfen. No concern exists for acute dietary exposure to
pyriproxyfen residues.
2. Short - and intermediate - term toxicity. There are no
endpoints and no concern exists for short- or intermediate-term
toxicity from pyriproxyfen.
3. Chronic toxicity. EPA has established the RfD for pyriproxyfen
at 0.35 milligrams/kilogram/day (mg/kg/day). This RfD is based on 2-
year and 90-day feeding studies in rats with a NOEL of 35.1 mg/kg/day
and an uncertainty factor of 100, based on intra-and interspecies
differences. At the LOEL of 141.28 mg/kg/day, there was a decrease in
body weight gain in females.
4. Carcinogenicity. Pyriproxyfen has been classified in Group E of
EPA's cancer classification system, indicating there is evidence of
non-carcinogenicity for humans. Therefore, there is no concern for
cancer risk from exposure to pyriproxyfen.
B. Exposures and Risks
1. From food and feed uses. Time-limited tolerances have been
established (40 CFR 180.510) for the residues of pyriproxyfen, in or on
cotton commodities, in association with the use under emergency
exemptions. There are currently no registered food uses for
pyriproxyfen, and thus no permanent tolerances established. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from pyriproxyfen as follows:
Chronic exposure and risk. As stated above, there are time-limited
tolerances for cotton commodities established in connection with use
under emergency exemptions. This risk assessment took these into
account, as well as these tolerances being established for citrus
commodities, pears, and tomatoes. The chronic dietary (food only) risk
assessment used tolerance level residues and assumed 100% crop treated.
Therefore, the resulting exposure estimates should be viewed as
conservative; further refinement using anticipated residues and/or
percent of crop treated would result in lower dietary exposure
estimates. For chronic dietary (food only) risk estimates, the two most
highly exposed subgroups, Non-Nursing Infants (<1 Year Old) and
Children (1-6 Years Old) had 1.54 and 1.84% of the RfD utilized,
respectively. All other population subgroups had less than 1% of the
RfD utilized.
2. From drinking water. A Tier II drinking water assessment of
pyriproxyfen was conducted, using computer models which simulate the
fate in a surface water body. The estimated environmental
concentrations (EECs) are generated for high exposure agricultural
scenarios and represent one in ten years EECs in a stagnant pond with
no outlet that receives pesticide loading from an adjacent 100%
cropped, 100% treated field. As such, these computer generated EECs
represent conservative screening levels for ponds and lakes and are
used only for screening. The EECs for surface water ranged from a peak
of 0.677 ppb, to a 60-days average of 0.142 ppb, to a 1-year average of
0.103 ppb. These estimates are based on 2 applications at a rate of
0.11 lb. active ingredient per acre. For ground water, a computer model
was used which resulted in estimated 60-day average concentrations of
pyriproxyfen of 0.006 ppb.
Chronic exposure and risk. A human health drinking water level of
concern (DWLOC) is the concentration in drinking water that would be
acceptable as an upper limit in light of total aggregate exposure to
that chemical from food, water and non-occupational (residential)
sources. The DWLOC for chronic risk is the concentration in drinking
water as a part of the aggregate chronic exposure, that occupies no
more than 100% of the RfD. In conducting these calculations, default
body weights are used of 70 kg (adult male), 60 kg (adult female) and
10 kg (child); default consumption values of water are used of 2 liters
per day for adults and 1 liter per day for children. Using these
assumptions and the levels provided by the computer models, given
above, the resultant percentage of the RfD utilized for both children
and adults was calculated to be 0.35%. Therefore, taking into account
present uses, including this use on citrus under section 18, EPA
concludes that there is reasonable certainty of no harm if these
tolerances are established.
3. From non-dietary exposure. Pyriproxyfen is currently registered
for use on the following residential non-food sites: Products for flea
and tick control, including foggers, aerosol sprays, emulsifiable
concentrates, and impregnated material (pet collars).
Chronic exposure and risk. Long-term exposure to pyriproxyfen in
residential use products is not expected. Consumer use of these
products typically results in short-term intermittent exposures. Hence,
a chronic residential exposure assessment is not required.
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 pyriproxyfen has a common mechanism
[[Page 26470]]
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, pyriproxyfen 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 pyriproxyfen has a common
mechanism of toxicity with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. There are no acute dietary endpoints of concern for
pyriproxyfen. No concern exists for acute dietary exposure to
pyriproxyfen residues.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to pyriproxyfen from
food and drinking water will utilize 0.67 and 0.35% of the RfD,
respectively, for the U.S. population (total of 1.02% RfD utilized).
The major identifiable subgroup with the highest aggregate exposure is
Children (1-6 Years Old), with 1.84 and 0.35% of the RfD utilized by
food and drinking water, respectively, for a total of 2.19% of the RfD
utilized. This is discussed further below. EPA generally has no concern
for exposures below 100% of the RfD because the RfD represents the
level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. EPA concludes
that there is a reasonable certainty that no harm will result from
aggregate exposure to pyriproxyfen residues.
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. There are no endpoints and no concern exists for
short- or intermediate-term toxicity from pyriproxyfen.
D. Aggregate Cancer Risk for U.S. Population
Pyriproxyfen has been classified in Group E of EPA's cancer
classification system, indicating there is evidence of non-
carcinogenicity for humans. Therefore, there is no concern for cancer
risk from exposure to pyriproxyfen.
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 pyriproxyfen, 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 MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) NOEL was 100 mg/kg/day, based on
decreased bodyweight, body weight gain, food consumption, and increased
water consumption at the LOEL of 300 mg/kg/day. The developmental
(fetal) NOEL was 300 mg/kg/day, based on increased skeletal variations
and unspecified visceral variations at the LOEL of 1,000 mg/kg/day
In the developmental toxicity study in rabbits, the maternal
(systemic) NOEL was 100 mg/kg/day, based on abortions, soft stools,
emaciation, decreased activity, and bradypnea at the LOEL of 300 mg/kg/
day. The developmental (pup) NOEL was 300 mg/kg/day, based on decreased
viable litters available for examination at the LOEL of 1,000 mg/kg/
day.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the maternal (systemic) NOEL was 87/96 mg/kg/
day for Males/Females, based on decreased body weights, body weight
gains, and increased liver weight associated with histopathological
findings in the liver at the LOEL of 453/498 mg/kg/day for M/F. The
developmental (pup) NOEL was 87/96 mg/kg/day, based on decreased body
weight on lactation days 14 and 21 at the LOEL of 453/498 mg/kg/day.
The reproductive NOEL was 453/498 mg/kg/day for M/F (the highest dose
tested).
iv. Pre- and post-natal sensitivity. In both rats and rabbits,
developmental studies demonstrated that the developmental findings
occurred at dose levels at which maternal toxicity was also present,
demonstrating no special pre-natal sensitivity for developing fetuses.
In the post-natal evaluation to infants and children, as shown in the
results of the rat reproduction study, the NOEL and LOEL for both
parental systemic toxicity and pup toxicity occurred at the same dose
levels, demonstrating no special post-natal sensitivity for infants and
children.
v. Conclusion. Given the fact that there is a complete toxicity
data base for pyriproxyfen, and no special pre- or post- natal
sensitivities are indicated for infants and children, an additional 10-
fold safety factor is not warranted. EPA concludes that there is
reasonable certainty of safety for infants and children exposed to
dietary residues of pyriproxyfen.
2. Acute risk. There are no acute dietary endpoints of concern for
pyriproxyfen. No concern exists for acute dietary exposure to
pyriproxyfen residues.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
pyriproxyfen from food will utilize 1.84% of the RfD for Children 1-6
years old, the most highly exposed subgroup of infants and children.
EPA generally has no concern for exposures below 100% of the RfD
because the RfD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. The risk from drinking water is conservatively estimated
to utilize 0.35% of the RfD for infants and children, as discussed
above. Despite the potential for exposure to pyriproxyfen in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to pyriproxyfen residues.
[[Page 26471]]
4. Short- or intermediate-term risk. There are no endpoints and no
concern exists for short- or intermediate-term toxicity from
pyriproxyfen.
V. Other Considerations
A. Metabolism In Plants and Animals
For the purposes of these uses under section 18, the nature of the
residue in plants is adequately understood, and the residue to be
regulated is parent pyriproxyfen per se [4-phenoxyphenyl (RS)-2-(2-
pyridyloxy)propyl ether]. There are no detectable residues expected in
animal commodities as a result of these uses.
B. Analytical Enforcement Methodology
Adequate analytical methodology is available to enforce the
tolerance expression, in residue analytical method RM-33P-2 using gas
chromatography with a nitrogen-phosphorus detector. This has been
validated by EPA and is available from the Registrant of pyriproxyfen,
Valent U.S.A. Corporation, Dublin, California.
C. Magnitude of Residues
Residues of pyriproxyfen are not expected to exceed 0.3 ppm in/on
citrus fruit, 1.0 ppm in citrus juice and dried citrus pulp, and 300
ppm in citrus oil; 0.2 ppm in/on pears; and 0.1 ppm in/on tomatoes; no
detectable residues are expected to occur in animal commodities, as a
result of these emergency exemption uses.
D. International Residue Limits
There are no Canadian, Mexican, or Codex maximum residue limits
(MRLs) for residues of pyriproxyfen in/on citrus, pears, or tomatoes.
E. Rotational Crop Restrictions
There are no applicable rotational crop restrictions for these
emergency exemption uses.
VI. Conclusion
Therefore, the tolerances are established for residues of
pyriproxyfen in/on citrus fruit at 0.3 ppm, citrus juice and dried
citrus pulp at 1.0 ppm, and citrus oil at 300 ppm; 0.2 ppm in/on pears;
and 0.1 ppm in/on tomatoes.
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 July 13, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as 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-300651] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 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 time-limited tolerances under FFDCA
section 408(d) in response to petitions submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). This final rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
[[Page 26472]]
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the time-limited
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: April 27, 1998.
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. In Sec. 180.510, in paragraph (b) by alphabetically adding the
following commodities to the table to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Citrus fruit.................... 0.3 7/31/99
Citrus juice.................... 1.0 7/31/99
Citrus oil...................... 300 7/31/99
Citrus pulp, dried.............. 1.0 7/31/99
* * * * *
* *
Pears........................... 0.2 7/31/99
Tomatoes........................ 0.1 7/31/99
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-12426 Filed 5-12-98; 8:45 am]
BILLING CODE 6560-50-F
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