[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: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-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:
beard.andrea@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
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:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes 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
