[Federal Register Volume 63, Number 92 (Wednesday, May 13, 1998)]
[Rules and Regulations]
[Pages 26466-26472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12426]


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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: <a href="/cdn-cgi/l/email-protection#8be4fbfba6efe4e8e0eeffcbeefbeae6eae2e7a5eefbeaa5ece4fd"><span class="__cf_email__" data-cfemail="80eff0f0ade4efe3ebe5f4c0e5f0e1ede1e9ecaee5f0e1aee7eff6">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#c8aaada9baace6a9a6acbaada988adb8a9a5a9a1a4e6adb8a9e6afa7be"><span class="__cf_email__" data-cfemail="83e1e6e2f1e7ade2ede7f1e6e2c3e6f3e2eee2eaefade6f3e2ade4ecf5">[email protected]</span></a>; For pyriproxyfen on pears or 
tomatoes: Virginia Dietrich (703) 308-9359, e-mail: 
<a href="/cdn-cgi/l/email-protection#4e2a272b3a3c272d266038273c292720272f0e2b3e2f232f2722602b3e2f60292138"><span class="__cf_email__" data-cfemail="c0a4a9a5b4b2a9a3a8eeb6a9b2a7a9aea9a180a5b0a1ada1a9aceea5b0a1eea7afb6">[email protected]</span></a>. 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:
    <a href="/cdn-cgi/l/email-protection#513e21217c353e323a3425113421303c30383d7f3421307f363e27"><span class="__cf_email__" data-cfemail="99f6e9e9b4fdf6faf2fcedd9fce9f8f4f8f0f5b7fce9f8b7fef6ef">[email protected]</span></a>.


    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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