[Federal Register Volume 62, Number 146 (Wednesday, July 30, 1997)]
[Rules and Regulations]
[Pages 40735-40742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20061]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300519; FRL-5732-1]
RIN 2070-AB78


Buprofezin; 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 
combined residues of buprofezin and its metabolite BF 12 in or on 
citrus; dried citrus pulp; cotton seed; cotton gin byproducts; milk; 
and cattle, sheep, hogs, goats, and horse meat, fat, and meat by-
products . This action is in response to EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of the pesticide on cotton in Arizona 
and California, and on citrus in California. This regulation 
establishes maximum permissible levels for residues of buprofezin in 
these food commodities pursuant to section 408(l)(6) of the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996. The tolerances will expire and are revoked on July 31, 
1998.

DATES: This regulation is effective July 30, 1997. Objections and 
requests for hearings must be received by EPA on or before September 
29, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300519], 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-300519], must also be submitted to:

[[Page 40736]]

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: <a href="/cdn-cgi/l/email-protection#5d322d2d7039323e3638291d382d3c303c343173382d3c733a322b"><span class="__cf_email__" data-cfemail="0d627d7d2069626e6668794d687d6c606c646123687d6c236a627b">[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 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-300519]. 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: 
<a href="/cdn-cgi/l/email-protection#accec9cddec882cdc2c8dec9cdecc9dccdc1cdc5c082c9dccd82cbc3da"><span class="__cf_email__" data-cfemail="f19394908395df909f95839490b19481909c90989ddf948190df969e87">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for 
combined residues of the insecticide buprofezin, in or on citrus fruit 
at 2.0 part per million (ppm); dried citrus pulp at 10 ppm; cotton seed 
at 1.0 ppm; cotton gin byproducts at 20 ppm; milk at 0.03 ppm; and 
cattle, sheep, hogs, goats, and horse meat and fat at 0.02 ppm, and 
meat by-products at 0.5 ppm. 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 Exemptions for Buprofezin on Citrus and 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 pyriproxyfen are addressed in a separate 
Federal Register document. See July 25, 1997 issue of the Federal 
Register) for control of a recently introduced strain or species of 
sweetpotato whitefly, which has had devestating 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 buprofezin on cotton for control of whiteflies in 
Arizona and California. After having reviewed the submission, EPA 
concurs that emergency conditions exist.
    A request was recieved from California for use of buprofezin and 
imidacloprid on citrus to control red scale, which has developed 
resistance in some localized citrus-producing areas of California, 
causing significant losses to the affected citrus producers. Over the 
past several years, control of scale in citrus has required increasing 
amounts of pesticide applications due to the resistance development. A 
pesticide with a different mode of action is required, and California 
has requested the use of two materials based on the ability of this 
pest to quickly develop resistance. After having reviewed the 
submission, EPA concurs that an emergency condition exist, and has 
authorized the use of buprofezin on citrus for control of red scale in 
California under FIFRA section 18.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of buprofezin in or 
on citrus and cotton commodities, milk, and meat. 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

[[Page 40737]]

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 these tolerances will expire and are 
revoked on July 31, 1998, 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 fruit and dried pulp, cotton seed, cotton gin 
byproducts, meat, and milk after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA. EPA will take action to revoke these tolerances earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions EPA has not made any decisions about whether buprofezin 
meets EPA's registration requirements for use on citrus and cotton or 
whether permanent tolerances for these uses would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of buprofezin 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 Arizona and California 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 exemptions for 
buprofezin, 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 
hundredfold MOE is based on the same rationale as the hundredfold 
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. 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

[[Page 40738]]

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 (non-nursing 
infants, less than 1 year old) was not regionally based.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action, EPA has sufficient data to assess the hazards of 
buprofezin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
combined residues of buprofezin and its metabolite BF 12 on citrus 
fruit at 2.0 ppm; dried citrus pulp at 10 ppm; cotton seed at 1.0 ppm; 
cotton gin byproducts at 20 ppm; milk at 0.03 ppm; and cattle, sheep, 
hogs, goats, and horse meat and fat at 0.02 ppm, and meat by-products 
at 0.5 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 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 buprofezin are 
discussed below.
    1. Acute toxicity. EPA has selected the developmental NOEL of 200 
mg/kg/day from a rat developmental study, for the acute dietary 
endpoint; at the LOEL of 800 mg/kg/day, decreased fetal body weight and 
delayed ossification was observed. The population subgroup of concern 
is females 13+ years of age.
    2. Chronic toxicity. EPA has calculated a temporary RfD for 
buprofezin at 0.002 milligrams/kilogram/day (mg/kg/day). This RfD is 
based on the systemic lowest effect level (LEL) of 2.0 mg/kg/day 
(lowest dose tested) from a 2-year dog study (an NOEL was not 
established), and uses a thousandfold uncertainty factor); an extra 
factor of 10 was added to the standard hundredfold uncertainty factor 
since the RfD was based on an LEL (rather than an NOEL) and the 
database is lacking an adequate reproductive study). At the LEL, slight 
liver effects were observed.
    3. Carcinogenicity. There is no concern for cancer risks identified 
by the EPA; data from available studies do not indicate a treatment-
related tumor problem, and cancer risk endpoints have not been 
identified.

B. Exposures and Risks

    1. From food and feed uses. Risk assessments were conducted by EPA 
to assess dietary exposures and risks from these section 18 uses of 
buprofezin as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. The acute dietary risk assessment 
(only contribution is tolerances in connection with this use on cotton) 
used tolerance-level residue values and assumed 100% of crop treated. 
The resulting high-end exposure estimate of 0.04 mg/kg/day results in a 
dietary MOE of 5,000 for the population subgroup of concern, females 
13+ years old. This MOE is a conservative risk assessment; refinement 
using anticipated residue values and percent crop treated data in 
conjunction with Monte Carlo analysis would result in a lower acute 
dietary exposure estimate.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, the only refinement to the data estimates used was 
calculating anticipated residue levels for citrus commodities. For the 
other commodities, EPA used the very conservative assumptions that 
residues would occur in 100% of the U.S. cotton and livestock 
commodities at tolerance levels; and that the anticiated residues 
calculated would occur in 100% of the U.S. citrus crop. In actuality, 
under these exemptions, only a portion of the cotton crop in Arizona 
and California may potentially be treated; and a very small portion of 
the citrus crop in California (portions of Kerns and Tulare Counties 
only) may potentially be treated. Under these very conservative 
assumptions, these time-limited tolerances on citrus, cotton, and 
livestock commodites result in an ARC that is equivalent to the 
following percentages of the RfD: U.S. Population, 23%; Non-Nursing 
Infants (<1 year old), 104%; Nursing Infants, 23%; Children (1-6 years 
old), 63%; Children (7-12 years old), 40%. Additional refinement using 
anticipated residue values for cotton and livestock commodities, and 
percent of crop treated would result in much lower dietary exposure 
estiomates, especially considering that this use is only for a small 
portion of the cotton grown in California and Arizona, and an extremely 
limited area of citrus in California only.

[[Page 40739]]

    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 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 buprofezin 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 buprofezin 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. Buprofezin is not registered for any 
residential uses at this time. Therefore, no non-dietary, non-
occupational exposure is antipated..
    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 buprofezin 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, 
buprofezin 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 buprofezin has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk. For the population of concern (females 13 years and 
older), the calculated MOE value (for food only) is 5,000. Although 
theoretically there is the potential for exposure to buprofezin in 
dringking water, EPA does not expect that exposure would result in an 
aggregate MOE (food blus water) that would exceed the levels of concern 
for acute dietary exposure.
    2. Chronic risk. Using the ARC exposure assumptions described 
above, EPA has concluded that aggregate exposure to buprofezin from 
food will utilize 23 percent of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is Non-
nursing infants, < 1 year 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. Despite the 
potential for exposure to buprofezin 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 buprofezin residues.
    Therefore, EPA concludes that there is reasonable certainty that no 
harm will result from exposure to buprofezin through these uses.

D. Aggregate Cancer Risk for U.S. Population

    There is no concern for cancer risks identified by the EPA; data 
from available studies do not indicate a treatment-related tumor 
problem, and cancer risk endpoints have not been identified.

E. 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 buprofezin, EPA considered data from 
developmental toxicity studies in the rat and rabbit. EPA currently has 
an incomplete database (no adequate reproduction study) and no NOEL for 
the chronic study which was used to determine the temporary RfD. 
Therefore, a thousandfold margin/factor was applied to the chronic 
study which provides a reasonable certainty of safety for infants and 
children exposed to residues of buprofezin. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from maternal pesticide xeposure 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

[[Page 40740]]

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 hundredfold 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. As 
stated above, EPA currently has an incomplete database for buprofezin, 
and therefore an additional tenfold safety factor was added onto the 
standard hundredfold safety factor, providing a reasonable certainty of 
no harm to infants and children exposed to buprofezin through these 
uses.
    b. Developmental toxicity studies. In the rat developmental 
toxicity study, the maternal (systemic) NOEL was 200 mg/kg/day, based 
on mortality, decreased pregnancy, and increased resorption rates, at 
the LOEL of 800 mg/kg/day. The developmental (fetal) NOEL was 200 mg/
kg/day, based on the increased incidence of delayed ossifications and 
decreased pup weight at the LOEL of 800 mg/kg/day.
    In the rabbit developmental study, the maternal (systemic) NOEL was 
50 mg/kg/day, based on decreased body weight and food consumption and 
possibly increased fetal loss at the LOEL of 250 mg/kg/day. The 
developmental (fetal) NOEL was 250 mg/kg/day highest dose tested.
    c. Reproductive toxicity study. While a 2-generation rat 
reproductive study was submitted, it does not satisfy guideline 
requirements for a reproductive study, and is considered a data gap in 
the buprofezin database.
    d. Pre- and post-natal sensitivity. The toxicology database is 
currently incomplete for evaluating post-natal, but not pre-natal, 
risks to infants and children. Based on the results of the rat 
developmental toxicity study, an acute dietary risk assessment was 
conduected for females 13+ years of age. The MOE of 5,000 obtained for 
this risk assessment demonstrates that acute developmental (pre-natal) 
risks are low.
    e. Conclusion. The rat reproductive study is a data gap and a 
tenfold modifying factor has been added to the usual hundredfold 
uncertainty factor for a total uncertainty factor of 1,000 in 
calculation of the RfD. This additional uncertainty factor provides a 
reasonable certainty of safety for infants and children exposed to 
dietary residues of buprofezin.
    2. Acute risk. The acute, aggregate dietary MOE of 5,000 which was 
calculated for females 13+ years old, accounts for both maternal and 
fetal exposure. The large aggregate MOE calculated provides assurance 
that there is a reasonable certainty of no harm to infants and 
children.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
buprofezin from food will utilize from 23% of the RfD for the subgroup 
nursing infants, to 104% of the RfD for the subgroup, non-nursing 
infants (< 1 year old). 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. Although the percentage of the RfD 
utilized is 104% for Non-nursing infants, this estimate was arrived at 
using extremely conservative assumptions, and is an overestimate of the 
actual risk. If further refinement of the estimates, as described 
above, were used, the dietary exposure estimates would be considerably 
lower. EPA does not expect that aggregate exposure will exceed 100% of 
the RfD for any of the infant and children population subgroups. Taking 
into account the completeness and reliability of the toxicity data and 
this conservative exposure assessment, EPA concludes that there is 
reasonable certainty that no harm will result to infants and children 
from chronic aggregate exposure to buprofezin residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    For the puposes of these uses under section 18, the nature of the 
residues in plants and animals is adequately undersotood. The residue 
of concern is the parent buprofezin BF 01, 2-tert-butylimino-3-
isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one] only.

B. Analytical Enforcement Methodology

    Adequate methodology is available to enforce these tolerances. The 
methodology for buprofezin and its mtebolites is summarized in the 
following reports: ``Determination of Buprofezin and BF 12 Residues in 
Cottonseed and Gin Trash,'' method BF-01-96; ``Determination of 
Residues of Buprofezin and the Metabolite BF 12 in Beef Tissues via 
Solid Phase Extraction and Gas Chromatography With MS Detection,'' 
method BF-05-97; ``Determination of BF 02 Residues in Beef Tissues by 
Gas Chromatography Using Nitrogen Phosphorus Detection,'' method BF-06-
97; ``An Analytic Method for the Determination of Residues of 
Buprofezin at Estimated Tolerance Levels in Almonds, Cotton Seed, 
Citrus (lemons), and Grapes by Gas Chromatography Using Nitrogen 
Phosphorous Detection,'' method BF-09-97; AgrEvo Corporation, 
Wilmington, Delaware.

C. Magnitude of Residues

    Residues of buprofezin are not expected to exceed the following, as 
a result of these emergency exemption uses: 2.0 ppm in citrus fruit; 10 
ppm in dried citrus pulp; 1.0 ppm in cotton seed; 20 ppm in cotton gin 
byproducts; 0.03 ppm in milk; 0.02 ppm in meat and fat, and 0.5 ppm in 
meat byproducts, of cattle, sheep, hogs, goats, and horses.

D. International Residue Limits

    There are no maximum residue levels (MRLs) established for 
buprofezin on any cotton or livestock commodities, and Canadian or 
Mexican MRLs established for buprofezin in/on citrus. A temporary Codex 
MRL of 0.3 mg/kg has been established for buprofezin on oranges.

VI. Conclusion

    Therefore, the tolerances are established for residues of 
buprofezin in the various commodities at the levels given as follows: 
2.0 ppm in citrus fruit; 10 ppm in dried citrus pulp; 1.0 ppm in cotton 
seed; 20 ppm in cotton gin byproducts; 0.03 ppm in milk; 0.02 ppm in 
meat and fat, and 0.5 ppm in meat byproducts, of cattle, sheep, hogs, 
goats, and horses.

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 29, 1997, file written objections to 
any aspect of this regulation and may also request a hearing on those 
objections.

[[Page 40741]]

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-300519] (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:
    <a href="/cdn-cgi/l/email-protection#cda2bdbde0a9a2aea6a8b98da8bdaca0aca4a1e3a8bdace3aaa2bb"><span class="__cf_email__" data-cfemail="18776868357c777b737d6c587d687975797174367d6879367f776e">[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 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 tolerance 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 acations 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,

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. 180.511, to read as follows:


Sec. 180.511  Buprofezin; Tolerances for Residues.

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

[[Page 40742]]



                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Cattle, fat.....................  0.02                July 31, 1998     
Cattle, MBYP....................  0.5                 July 31, 1998     
Cattle, meat....................  0.02                July 31, 1998     
Citrus fruit....................  2.0                 July 31, 1998     
Citrus, pulp, dried.............  10                  July 31, 1998     
Cotton seed.....................  1.0                 July 31, 1998     
Cotton, gin byproducts..........  20                  July 31, 1998     
Goats, fat......................  0.02                July 31, 1998     
Goats, MBYP.....................  0.5                 July 31, 1998     
Goats, meat.....................  0.02                July 31, 1998     
Hogs, fat.......................  0.02                July 31, 1998     
Hogs, MBYP......................  0.5                 July 31, 1998     
Hogs, meat......................  0.02                July 31, 1998     
Horses, fat.....................  0.02                July 31, 1998     
Horses, MBYP....................  0.5                 July 31, 1998     
Horses, meat....................  0.02                July 31, 1998     
Milk............................  0.03                July 31, 1998     
Sheep, fat......................  0.02                July 31, 1998     
Sheep, MBYP.....................  0.5                 July 31, 1998     
Sheep, meat.....................  0.02                July 31, 1998     
------------------------------------------------------------------------

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

[FR Doc. 97-20061 Filed 7-29-97; 8:45 am]
BILLING CODE 6560-50-F


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