[Federal Register Volume 62, Number 143 (Friday, July 25, 1997)]
[Rules and Regulations]
[Pages 39962-39967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19671]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300518; FRL-5731-9]
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 cotton seed and cotton gin byproducts 
. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of the pesticide on cotton in Arizona 
and California. This regulation establishes a maximum permissible level 
for residues of pyriproxyfen in these food/feed 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. The tolerance will 
expire and is revoked on July 31, 1998.

DATES: This regulation is effective July 25, 1997. Objections and 
requests for hearings must be received by EPA on or before September 
23, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300518], 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-300518], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300518]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Andrea Beard, 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) 308-9356, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the pesticide pyriproxyfen, in or on cotton seed and cotton 
gin byproducts at 0.05 and 2.0 part per million (ppm), respectively. 
These tolerances will expire and are revoked on July 31, 1998. 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 Pyriproxyfen on Cotton and FFDCA 
Tolerances

     Requests were received from Arizona and California for use of two 
insect growth regulators, buprofezin and pyriproxyfen (residues and 
associated risk assessments of buprofezin are addressed in a separate 
Federal Register document), for control of a recently introduced strain 
or species of

[[Page 39963]]

sweetpotato whitefly, which has had devastating effects on cotton and 
various vegetable crops in the southwest for the past several years. 
This newer strain of whitefly, often referred to as the silverleaf 
whitefly, appears to be capable of quickly developing resistance, and 
is resistant to available alternative controls. Use of two chemicals 
was approved because the use patterns of each only allow one 
application, which will not be sufficient to control whitefly 
populations throughout the season. EPA has authorized under FIFRA 
section 18 the use of pyriproxyfen on cotton for control of whiteflies 
in Arizona and California. After having reviewed the submission, 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 
cotton seed and cotton gin byproducts. In doing so, EPA considered the 
new safety standard in FFDCA section 408(b)(2), and EPA decided that 
the necessary tolerance under FFDCA section 408(l)(6) would be 
consistent with the new safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment under section 408(e), 
as provided in section 408(l)(6). Although this tolerance will expire 
and is revoked on July 31, 1998, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on cotton seed and cotton gin byproducts 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA. EPA will take action to revoke 
this tolerance earlier if any experience with, scientific data on, or 
other relevant information on this pesticide indicate that the residues 
are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whetherpyriproxyfen meets EPA's 
registration requirements for use on cotton or whether permanent 
tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of pyriproxyfen by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Arizona and California 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 
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 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 enactment 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.

[[Page 39964]]

 High-end exposures from all 3 sources are not typically added because 
of the very low probability of this occurring in most cases, and 
because the other conservative assumptions built into the assessment 
assure adequate protection of public health. However, for cases in 
which high-end exposure can reasonably be expected from multiple 
sources (e.g. frequent and widespread homeowner use in a specific 
geographical area), multiple high-end risks will be aggregated and 
presented as part of the comprehensive risk assessment/
characterization. Since the toxicological endpoint considered in this 
assessment reflects exposure over a period of at least 7 days, an 
additional degree of conservatism is built into the assessment; i.e., 
the risk assessment nominally covers 1-7 days exposure, and the 
toxicological endpoint/NOEL is selected to be adequate for at least 7 
days of exposure. (Toxicity results at lower levels when the dosing 
duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
The TMRC is a ``worst case'' estimate since it is based on the 
assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (children 1 to 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 a time-limited tolerance for 
residues of pyriproxyfen on cotton seed and cotton gin byproducts at 
0.05 and 2.0 ppm, respectively. 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 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 a 
chronic feeding/carcinogenicity study 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 lowest observed effect level (LOEL) of 
150 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. There are currently no registered food 
uses for pyriproxyfen, and thus no established tolerances. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from pyriproxyfen as follows:
    Chronic exposure and risk. 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, all 
population subgroups had less than 1% of the RfD utilized .
    2. From drinking water. Because the Agency lacks sufficient water-
related exposure data to complete a comprehensive drinking water risk 
assessment for many pesticides, EPA has commenced and nearly completed 
a process to identify a reasonable yet conservative bounding figure for 
the potential contribution of water-related exposure to the aggregate 
risk posed by a pesticide. In developing the bounding figure, EPA 
estimated residue levels in water for a number of specific pesticides 
using various data sources. The Agency then applied the estimated 
residue levels, in conjunction with appropriate toxicological endpoints 
(RfD's or acute dietary NOEL's) and assumptions about body weight and 
consumption, to

[[Page 39965]]

calculate, for each pesticide, the increment of aggregate risk 
contributed by consumption of contaminated water. While EPA has not yet 
pinpointed the appropriate bounding figure for exposure from 
contaminated water, the ranges the Agency is continuing to examine are 
all below the level that would cause pyriproxyfen to exceed the RfD if 
the tolerance being considered in this document were granted. The 
Agency has therefore concluded that the potential exposures associated 
with pyriproxyfen in water, even at the higher levels the Agency is 
considering as a conservative upper bound, would not prevent the Agency 
from determining that there is a reasonable certainty of no harm if the 
tolerance is granted.
    3. From non-dietary exposure. Pyriproxyfen is currently registered 
for use on the following residential non-food sites: storage areas; 
farm animals; pets; household or domestic dwellings; spot treatments; 
food processing, handling, and storage areas; commercial storage 
warehouses; hospitals and related institutions; eating establishments; 
and canneries and frozen food plants.
     Chronic exposure and risk. EPA scientists have determined that the 
residential uses ofpyriproxyfen would not constitute a chronic 
scenario. Therefore, a chronic risk assessment from non-dietary 
residential exposures 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 pyriproxyfen 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, 
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

    Chronic risk.. Using the TMRC exposure assumptions described above, 
EPA has concluded that aggregate exposure to pyriproxyfen from food 
will utilize <1% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is children 1 
- 6 years old, discussed below. EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health. Use the following sentence 
if applicable, or delete and insert applicable text. 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 from aggregate exposure 
to pyriproxyfen residues.

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

    1. Safety factor for infants and children--a. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of 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 100-
fold safety factor (usually 100 for combined inter- and intra-species 
variability)) and not the additional tenfold safety 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.
    b. Developmental toxicity studies. In both rats and rabbits, 
developmental studies demonstrated that the developmental findings 
occurred at dose levels at which maternal toxicity was also present. 
The maternal NOEL and LOEL for both studies were 100 and 300 mg/kg/day, 
respectively; the developmental NOEL and LOEL for both studies were 300 
and 1,000 mg/kg/day, respectively. Therefore, there was no 
developmental toxicity at 300 mg/kg/day in both species, although 
maternal effects were present at this dose level. These data 
demonstrate no special pre-natal sensitivity for developing fetuses.

[[Page 39966]]

    c. Reproductive toxicity study. In the post-natal evaluation to 
infants and children, as shown in the results of the rat reproduction 
study, the NOEL and LOEL (87 and 453 mg/kg/day, respectively) for both 
parental systemic toxicity effect of decreased weight gain and pup 
toxicity occurred at the same dose levels. There were slight 
differences in the mg/kg/day levels in parental and pup values, which 
reflect the fact that the maternal and paternal animals have slightly 
different rates of food utilization. The results of the rat 
reproduction study demonstrate no special post-natal sensitivity for 
infants and children.
    d. Pre- and post-natal sensitivity. As stated above, the results of 
the developmental and reproduction study indicated no special pre- or 
post- natal sensitivity for infants and children.
    e. 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. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
pyriproxyfen from food will utilize <1% of the RfD for 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. 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.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants is adequately understood, and 
the residue to be regulated is parent pyriproxyfen [4-phenoxyphenyl 
(RS)-2-(2-pyridyloxy)propyl ether]. Although no formal decision has 
been made on the residue to be regulated in animal commodities, EPA 
concludes that for the purposes if this section 18 use, it is 
appropriate to regulate based on residues of the parent pyriproxyfen .

B. Analytical Enforcement Methodology

    Adequate analytical methodology is available to enforce the 
tolerance expression. The methodology for pyriproxyfen and its 
metabolites in cottonseed and gin byproducts are summarized in the 
following reports: ``Determination of Pyriproxyfen and PYPAC Residues 
in Cottonseed'', Method RM-33P-2-2; ``Determination of Pyriproxyfen in 
Cotton Gin Trash'', Method RM-33P-4-1; and, ``Determination of DPH-PYR 
and DPH-PYR Conjugates in Cotton Gin Trash'', Method RM-33P-5, all by 
Valent U.S.A. Corporation, Dublin, California.

C. Magnitude of Residues

    Residues of pyriproxyfen are not expected to exceed 0.05 ppm in 
cottonseed, and 2.0 ppm in cotton gin byproducts, as a result of this 
emergency exemption use.

D. International Residue Limits

    There are no Canadian, Mexican, or Codex maximum residue limits 
(MRLs) for residues of pyriproxyfen on cotton.

VI. Conclusion

    Therefore, tolerances are established for residues of pyriproxyfen 
in cotton seed at 0.05 ppm, and cotton gin byproducts at 2.0 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by September 23, 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 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-300518] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will

[[Page 39967]]

transfer any copies of objections and hearing requests received 
electronically into printed, paper form as they are received and will 
place the paper copies in the official rulemaking record which will 
also include all comments submitted directly in writing. The official 
rulemaking record is the paper record maintained at the Virginia 
address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408(l)(6). The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any 
prior consultation as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993), or special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since these tolerances and exemptions that are 
established under FFDCA section 408 (l)(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: July 16, 1997.

James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority : 21 U.S.C. 346a and 371.

    2. By adding Sec. 180.510 to read as follows:


Sec. 180.510 Pyriproxyfen; tolerances for residues.

    (a) General . [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the residues of the insect growth regulator 
pyriproxyfen, in connection with the use of the pesticide under section 
18 emergency exemptions granted by EPA. The tolerances will expire on 
the dates specified in the following table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Cotton seed.....................  0.05                7/31/98           
Cotton, gin byproducts..........  2.0                 7/31/98           
------------------------------------------------------------------------

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

[FR Doc. 97-19671 Filed 7-24-97; 8:45 am]
BILLING CODE 6560-50-F