[Federal Register Volume 62, Number 131 (Wednesday, July 9, 1997)]
[Rules and Regulations]
[Pages 36671-36678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17589]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300510; FRL-5729-3]
RIN 2070-AB78
Myclobutanil; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of myclobutanil in or on peppers (bell and non-bell),
peppermint and spearmint. This action is in response to EPA's granting
of an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
peppers (bell and non-bell) in California and peppermint and spearmint
in Idaho and Washington. This regulation establishes a maximum
permissible level for residues of myclobutanil 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. These tolerances will expire and are revoked on July 1, 1998.
[[Page 36672]]
DATES: This regulation is effective July 9, 1997. Objections and
requests for hearings must be received by EPA on or before September 8,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300510], 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-300510], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: 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-300510]. 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 atmany Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, 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) 308-9367, e-mail:
ertman.andrew@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 a tolerance for
combined residues of the fungicide myclobutanil, in or on peppers (bell
and non-bell) at 1.0 ppm, peppermint at 2.5 ppm and spearmint at 2.5
ppm. These tolerances will expire and are revoked on July 1, 1998. EPA
will publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(I) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Myclobutanil on Peppers (bell and non-
bell), Peppermint and Spearmint and FFDCA Tolerances
The state of California requested a specific exemption for the use
of myclobutanil on bell and non-bell peppers to control a species of
powdery mildew new to the crop as of the early 1990's. Powdery mildew
is a pathogen that can cause substantial losses in peppers.
The states of Idaho and Washington have requested exemptions for
the use of myclobutanil on mint to control powdery mildew. Significant
economic losses are expected to occur without the use of myclobutanil
as both yields and prices of mint oil may be reduced.
EPA has authorized under FIFRA section 18 the use of myclobutanil
on peppers (bell and non-bell) for control of powdery mildew (Oidiopsis
taurica) in California and peppermint and spearmint for control of
powdery mildew (Erysiphe cichoracearum) in Idaho and Washington. After
having reviewed these submissions, EPA concurs that emergency
conditions exist for these states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of myclobutanil in or on bell
and non-bell peppers, peppermint and spearmint. In doing so, EPA
considered the new safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the new safety standard and with FIFRA section
18. Consistent with the need to move quickly on the emergency exemption
in order to address an urgent non-routine situation and to ensure that
the resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are
[[Page 36673]]
revoked on July 1, 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 peppers (bell and non-bell), peppermint and
spearmint 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 myclobutanil
meets EPA's registration requirements for use on bell and non-bell
peppers, peppermint and spearmint 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
myclobutanil by a State for special local needs under FIFRA section
24(c). Nor do these tolerances serve as the basis for any States other
than California (bell and non-bell peppers) and Idaho and Washington
(peppermint and spearmint) to use this pesticide on these crops under
section 18 of FIFRA without following all provisions of section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for myclobutanil, contact the Agency's Registration
Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High-end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population
[[Page 36674]]
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 <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="" myclobutanil="" and="" to="" make="" a="" determination="" on="" aggregate="" exposure,="" consistent="" with="" section="" 408(b)(2),="" for="" time-limited="" tolerances="" for="" the="" combined="" residues="" of="" myclobutanil="" on="" peppers="" (bell="" and="" non-bell)="" at="" 1.0="" ppm,="" peppermint="" and="" 2.5="" ppm="" and="" spearmint="" at="" 2.5="" ppm.="" epa's="" assessment="" of="" the="" dietary="" exposures="" and="" risks="" associated="" with="" establishing="" the="" tolerance="" 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="" myclobutanil="" are="" discussed="" below.="" 1.="" short="" -="" and="" intermediate="" -="" term="" toxicity.="" for="" short-term="" dermal="" moe="" calculations,="" the="" agency="" used="" the="" systemic="" noel="" of="" 100="" mg/kg/day="" from="" a="" 21-day="" dermal="" toxicity="" study="" in="" rats.="" this="" dose="" was="" the="" highest="" tested="" in="" the="" study.="" the="" agency="" did="" not="" identify="" an="" inhalation="" endpoint.="" for="" intermediate-term="" moe="" calculations,="" the="" agency="" used="" the="" noel="" of="" 10="" mg/kg/day="" from="" a="" 2-generation="" reproductive="" toxicity="" study="" in="" rats.="" at="" the="" lowest="" effect="" level="" (lel)="" of="" 50="" mg/kg/day,="" there="" were="" decreases="" in="" pup="" body="" weight,="" an="" increased="" incidence="" in="" the="" number="" of="" stillborns,="" and="" atrophy="" of="" the="" prostate="" and="" testes.="" 2.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" myclobutanil="" at="" 0.025="" milligrams/kilogram/day="" (mg/kg/day).="" this="" rfd="" is="" based="" on="" a="" chronic="" feeding="" study="" in="" rats="" using="" a="" noel="" of="" 2.5="" mg/kg/day="" and="" an="" uncertainty="" factor="" of="" 100.="" at="" the="" lowest="" observed="" effect="" level="" (loel)="" of="" 9.9="" mg/kg/day="" there="" was="" testicular="" atrophy.="" 3.="" carcinogenicity.="" myclobutanil="" has="" been="" classified="" as="" a="" group="" e="" chemical="" (no="" evidence="" of="" carcinogenicity="" for="" humans)="" by="" the="" agency.="" b.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.="" tolerances="" have="" been="" established="" (40="" cfr="" 180.443)="" for="" the="" combined="" residues="" of="" myclobutanil="" [alpha-butyl-="" alpha-(4-chlorophenyl)-1h-1,2,4-triazole-1-propanenitrile]="" plus="" its="" alcohol="" metabolite="" [alpha-(3-hydroxybutyl)-alpha-(4-chlorophenyl)-1h-="" 1,2,4-triazole-1-propanenitrile]="" (free="" and="" bound),="" in="" or="" on="" a="" variety="" of="" raw="" agricultural="" commodities="" at="" levels="" ranging="" from="" 5.0="" ppm="" in="" cherries="" to="" 0.02="" ppm="" in="" eggs.="" a="" tolerance="" has="" also="" been="" established="" (40="" cfr="" 180.443(b))="" for="" the="" combined="" residues="" of="" myclobutanil="" plus="" its="" alcohol="" metabolite="" (free="" and="" bound)="" and="" diol="" metabolite="" [alpha-(4-="" chlorophenyl)-alpha-(3,4-dihydroxybutyl)-1h-1,2,4-triazole-1-="" propanenitrile],="" in="" milk="" at="" 0.05="" ppm.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" assess="" dietary="" exposures="" and="" risks="" from="" myclobutanil="" as="" follows:="" chronic="" exposure="" and="" risk.="" in="" conducting="" this="" chronic="" dietary="" risk="" assessment,="" epa="" has="" made="" somewhat="" conservative="" assumptions="" --="" with="" the="" exception="" of="" bananas,="" all="" commodities="" having="" myclobutanil="" tolerances="" will="" contain="" myclobutanil="" and="" metabolite="" residues="" and="" those="" residues="" will="" be="" at="" the="" level="" of="" the="" established="" tolerance="" --="" which="" results="" in="" an="" overestimate="" of="" human="" dietary="" exposure.="" for="" bananas="" an="" anticipated="" residue="" estimate="" was="" used.="" percent="" crop-treated="" estimates="" were="" utilized="" for="" selected="" commodities="" included="" in="" the="" assessment.="" thus,="" in="" making="" a="" safety="" determination="" for="" this="" tolerance,="" epa="" is="" taking="" into="" account="" this="" partially="" refined="" exposure="" assessment.="" the="" existing="" myclobutanil="" tolerances="" (published,="" pending,="" and="" including="" the="" necessary="" section="" 18="" tolerances)="" result="" in="" an="" anticipated="" residue="" contribution="" (arc)="" that="" is="" equivalent="" to="" the="" following="" percentages="" of="" the="" rfd:="" ------------------------------------------------------------------------="" arc="" food="" (mg/kg/="" population="" subgroup="" day)="" %rfd="" ------------------------------------------------------------------------="" u.s.="" population="" (48="" states).....="" 0.003427="" 14%="" nursing="" infants=""><1 year="" old)...="" 0.006242="" 25%="" non-nursing="" infants=""><1 year="" 0.018291="" 73%="" old).="" children="" (1-6="" years="" old)........="" 0.009747="" 39%="" [[page="" 36675]]="" children="" (7-12="" years="" old).......="" 0.005505="" 22%="" northeast="" region................="" 0.003678="" 15%="" western="" region..................="" 0.003999="" 16%="" hispanics.......................="" 0.004125="" 17%="" non-hispanic="" others.............="" 0.003728="" 15%="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" myclobutanil="" is="" persistent="" and="" not="" considered="" mobile="" in="" soils="" with="" the="" exception="" of="" sandy="" soils.="" data="" are="" not="" available="" for="" its="" diol="" metabolite.="" there="" is="" no="" established="" maximum="" contaminant="" level="" for="" residues="" of="" myclobutanil="" in="" drinking="" water.="" no="" health="" advisory="" levels="" for="" myclobutanil="" in="" drinking="" water="" have="" been="" established.="" chronic="" exposure="" and="" risk.="" 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="" myclobutanil="" 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="" myclobutanil="" 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.="" myclobutanil="" is="" currently="" registered="" for="" use="" on="" the="" following="" residential="" non-food="" sites:="" outdoor="" residential="" and="" greenhouse="" use="" on="" annuals="" and="" perennials,="" turf,="" shrubs,="" trees,="" flowers.="" these="" uses="" do="" not="" constitute="" a="" chronic="" exposure="" scenario,="" but="" may="" constitute="" a="" short-="" to="" intermediate-term="" exposure="" scenario.="" however,="" epa="" lacks="" sufficient="" residential-related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" for="" many="" pesticides,="" including="" myclobutanil.="" 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="" myclobutanil="" 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,="" myclobutanil="" 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="" myclobutanil="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" chronic="" risk.="" using="" the="" partially="" refined="" exposure="" assumptions="" described="" under="" unit="" iv.b.1.="" ``chronic="" exposure="" and="" risk''="" and="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data,="" epa="" has="" concluded="" that="" aggregate="" dietary="" exposure="" (food="" only)="" to="" myclobutanil="" will="" utilize="" 14%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" epa="" has="" determined="" that="" the="" outdoor="" registered="" uses="" of="" myclobutanil="" would="" not="" fall="" under="" a="" chronic="" exposure="" scenario.="" despite="" the="" potential="" for="" exposure="" to="" myclobutanil="" in="" drinking="" water,="" using="" best="" scientific="" judgement="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" of="" food="" and="" water="" to="" [[page="" 36676]]="" exceed="" 100%="" of="" the="" rfd.="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" chronic="" exposure="" to="" myclobutanil="" residues.="" 2.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" although="" short-term="" exposure="" scenarios="" may="" be="" present,="" based="" on="" the="" lack="" of="" acute="" toxicological="" endpoints="" and="" the="" low="" percent="" of="" rfd="" occupied,="" in="" the="" best="" scientific="" judgement="" of="" the="" agency,="" aggregate="" short-="" and="" intermediate-term="" risk="" will="" not="" exceed="" epa's="" level="" of="" concern.="" additionally,="" the="" agency="" notes="" that="" there="" are="" no="" indoor="" residential="" uses="" of="" myclobutanil,="" thus="" indoor="" residential="" exposure="" is="" expected="" to="" be="" minimal.="" d.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" myclobutanil="" was="" classified="" by="" the="" agency="" as="" a="" group="" e="" chemical="" (no="" evidence="" of="" carcinogenicity="" for="" humans).="" thus,="" a="" cancer="" risk="" assessment="" was="" not="" conducted.="" 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="" myclobutanil,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-="" species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" b.="" developmental="" toxicity="" studies.="" in="" the="" developmental="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 93.8="" mg/kg/day,="" based="" on="" rough="" hair="" coat,="" and="" salivation="" at="" the="" loel="" of="" 312.6="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 93.8="" mg/kg/day="" based="" on="" incidences="" of="" 14th="" rudimentary="" and="" 7th="" cervical="" ribs="" at="" the="" loel="" of="" 312.6="" mg/kg/day.="" in="" the="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" (systemic)="" noel="" was="" 60="" mg/kg/day,="" based="" on="" reduced="" weight="" gain,="" clinical="" signs="" of="" toxicity="" and="" abortions="" at="" the="" loel="" of="" 200="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 60="" mg/kg/day,="" based="" on="" increases="" in="" number="" of="" resorptions,="" decreases="" in="" litter="" size,="" and="" a="" decrease="" in="" the="" viability="" index="" at="" the="" loel="" of="" 200="" mg/kg/day.="" c.="" reproductive="" toxicity="" study.="" in="" the="" 2-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" parental="" (systemic)="" noel="" was="" 2.5="" mg/kg/day,="" based="" on="" increased="" liver="" weights="" and="" liver="" cell="" hypertrophy="" at="" the="" loel="" of="" 10="" mg/kg/day.="" the="" developmental="" (pup)="" noel="" was="" 10="" mg/kg/day,="" based="" on="" decreased="" pup="" body="" weight="" during="" lactation="" at="" the="" loel="" of="" 50="" mg/kg/="" day.="" the="" reproductive="" (pup)="" noel="" was="" 10="" mg/kg/day,="" based="" on="" the="" increased="" incidence="" of="" stillborns,="" and="" atrophy="" of="" the="" testes,="" epididymides,="" and="" prostate="" at="" the="" lel="" of="" 50="" mg/kg/day.="" d.="" pre-="" and="" post-natal="" sensitivity.="" the="" pre-="" and="" post-natal="" toxicology="" data="" base="" for="" myclobutanil="" is="" complete="" with="" respect="" to="" current="" toxicological="" data="" requirements.="" based="" on="" the="" developmental="" and="" reproductive="" toxicity="" studies="" discussed="" above,="" for="" myclobutanil="" there="" does="" not="" appear="" to="" be="" an="" extra="" sensitivity="" for="" pre-="" or="" post-natal="" effects.="" e.="" conclusion.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" uncertainty="" factor="" and="" that="" a="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" myclobutanil="" from="" food="" ranges="" from="" 22%="" of="" the="" rfd="" for="" children="" (7="" to="" 12="" years="" old),="" up="" to="" 73%="" for="" 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.="" despite="" the="" potential="" for="" exposure="" to="" myclobutanil="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" myclobutanil="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood.="" the="" residue="" of="" concern="" is="" myclobutanil="" plus="" its="" alcohol="" metabolite="" (free="" and="" bound),="" as="" specified="" in="" 40="" cfr="" 180.443(a).="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" enforcement="" method="" is="" available="" to="" enforce="" the="" established="" tolerances.="" quantitation="" is="" by="" glc="" using="" a="" nitrogen/="" phosphorus="" detector="" for="" myclobutanil="" and="" an="" electron="" capture="" detector="">63) for residues measured as the alcohol metabolite.
C. Magnitude of Residues
Residues of myclobutanil and its alcohol metabolite are not
expected to exceed 1.0 ppm in/on peppers (bell and non-bell), 2.5 ppm
in/on peppermint or 2.5 ppm in/on spearmint as a result of this section
18 use. Secondary residues are not expected in animal commodities as no
feedstuffs are associated with these Section 18 uses. Meat/milk/
poultry/egg tolerances have been established as a result of other
myclobutanil uses.
D. International Residue Limits
There are no Codex, Canadian or Mexican residue limits established
for myclobutanil and its metabolites on the commodities included in
these Section 18 requests. Thus, harmonization is not an issue for
these Section 18 actions.
E. Rotational Crop Restrictions
Information concerning the likelihood of residues in rotational
crops is not available for myclobutanil. As mint and pepper (bell and
non-bell) fields are normally rotated, the Agency concludes the
following restriction should be added to the label for the requested
Section 18: Rally treated fields can be rotated at any time to crops
which are included on the Rally label. All other crops may be planted 1
year following applications of Rally Agricultural Fungicide.
[[Page 36677]]
VI. Conclusion
Therefore, the tolerance is established for combined residues of
myclobutanil in bell and non-bell peppers at 1.0 ppm, peppermint at 2.5
ppm and spearmint at 2.5 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by September 8, 1997 file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300510] (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 Highway, 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 tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (d),
such as the tolerances in this final rule, do not require the issuance
of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 26, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
[[Page 36678]]
PART 180 [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority : 21 U.S.C. 346a and 371.
2. In Sec. 180.443, in paragraph (b), by revising the introductory
text and alphabetically adding the following commodities to the table
to read as follows:
Sec. 180.443 Myclobutanil; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide myclobutanil in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. These tolerances will expire and are revoked on the dates
specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * *
* * *
Peppermint...................... 2.5 July 1, 1998
Peppers (bell and non-bell)..... 1.0 July 1, 1998
Spearmint....................... 2.5 July 1, 1998
------------------------------------------------------------------------
* * * * *
[FR Doc. 97-17589 Filed 7-8-97; 8:45 am]
BILLING CODE 6560-50-F
