[Federal Register Volume 62, Number 85 (Friday, May 2, 1997)]
[Rules and Regulations]
[Pages 24040-24045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11505]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300481; FRL-5713-6]
RIN 2070-AB78
Clomazone; 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
residues of the herbicide clomazone in or on the food commodity
watermelons in connection with EPA's granting of emergency exemptions
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizing use of clomazone on watermelons in Delaware, Virginia,
and Maryland. This regulation establishes maximum permissible levels
for residues of clomazone on watermelons pursuant to section 408(l)(6)
of the Federal Food, Drug and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. This tolerance will expire and is
revoked on May 30, 1998.
DATES: This regulation becomes effective May 2, 1997. Objections and
requests for hearings must be received by July 1, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300481], 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-300481], should be submitted to: Public Response
and Program Resources Branch, Field Operations 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 number
[OPP-300481]. 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: Virginia Dietrich,
Registration Division (7505W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA (703) 308-8347, e-mail:
dietrich.virginia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, 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 residues of the herbicide
clomazone (2-(2-Chlorophenyl) methyl-4,4-dimethyl-3-isoxazolidinone) in
or on watermelons at 0.1 ppm. This tolerance will expire and be revoked
by EPA on May 30, 1998. After May 30, 1998, EPA will publish a document
in the Federal Register to remove the revoked tolerance 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
[[Page 24041]]
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 CFR 58135, November 13, 1996) (FRL-5572-
9).
New section 408(b)(2)(A)(i) 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, 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Clomazone on Watermelons and FFDCA
Tolerances
Between December 30, 1996 and January 24, 1997, Departments of
Agriculture from three states (Delaware, Maryland and Virginia) each
requested a specific exemption under FIFRA section 18 for the use of
clomazone to control weeds in watermelons. These exemptions stated that
no herbicides with efficacy similar to clomazone are currently
registered for use on watermelons and that without its use, significant
economic loss will be expected. After having reviewed their submission,
EPA concurs that an emergency condition exists.
As part of its assessment of these applications for emergency
exemption, EPA assessed the potential risks presented by residues of
clomazone on watermelons. In doing so, EPA considered the new safety
standard in FFDCA section 408(b)(2), and EPA decided to grant the
section 18 exemptions only after concluding that the necessary
tolerance under FFDCA section 408(l)(6) would clearly be consistent
with the new safety standard and with FIFRA section 18. This tolerance
for clomazone will permit the marketing of watermelons treated in
accordance with the provisions of the section 18 emergency exemptions.
Consistent with the need to move quickly on the emergency exemptions
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment under section 408(e) as provided in section 408(l)(6). Although
these tolerances will expire and are revoked on May 30, 1998, under
FFDCA section 408(l)(5), residues of clomazone not in excess of the
amount specified in the tolerance remaining in or on watermelons after
that date will not be unlawful, provided the pesticide is applied
during the term of, and in accordance with all the conditions of the
emergency exemptions. EPA will take action to revoke this tolerance
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
EPA has not made any decisions about whether clomazone meets the
requirements for registration under FIFRA section 3 for use on
watermelons or whether permanent tolerance for clomazone for
watermelons would be appropriate. This action by EPA does not serve as
a basis for registration of clomazone by a State for special local
needs under FIFRA section 24(c). Nor does this action serve as the
basis for any State other than Delaware, Virginia, and Maryland to use
this product on watermelons under section 18 of FIFRA without following
all provisions of section 18 as identified in 40 CFR 180.166. For
additional information regarding the emergency exemptions for
clomazone, 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. For many
of these 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
[[Page 24042]]
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 percent or less
of the RfD) is generally considered by EPA to pose a reasonable
certainty of no harm.
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 margin of exposure 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.
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, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. 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. 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 percent
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 watermelons treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
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. Clomazone is not registered by EPA for indoor or outdoor
residential use. Existing food and feed use tolerances for clomazone
are listed in 40 CFR 180.425. EPA has sufficient data to assess the
hazards of clomazone and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for the time-limited tolerance for
residues of clomazone in or on watermelons at 0.1 ppm. EPA's assessment
of the dietary exposures and risks associated with establishing these
tolerances follows.
A. Toxicological Profile
1. Acute risk. No appropriate acute dietary endpoint was identified
by the Office of Pesticide Programs (OPP).
2. Chronic risk. Based on available chronic toxicity data, the OPP
has established the RfD for clomazone at 0.043 mg/kg/day. The RfD is
based on a 2-year feeding study in rats with a no observed effect level
(NOEL) of 4.3 mg/kg/day and an uncertainty factor of 100, based on
increased liver weights and serum cholesterol at the Lowest observed
effect level (LOEL) of 21.5 mg/kg/day.
3. Cancer risk. Clomazone has not been classified by the Office of
Pesticide programs. However, there have been no cancer concerns
reported at this time.
B. Aggregate Exposure
Tolerances for residues of clomazone are currently expressed as 2-
(2-Chlorophenyl)methyl-4,4-dimethyl-3-isoxa-zolidinone. Tolerances
currently exist for residues on more than a dozen commodities (see 40
CFR 180.425).
The Agency identified chronic exposure as appropriate for aggregate
risk assessment. The aggregate chronic risk is equal to the sum of the
chronic risk from exposure from food + water + residential (indoor and
outdoor) uses. Clomazone is not registered for any residential uses so
no exposure from this route is expected. The Agency estimates that
aggregate risk (food plus drinking water) would not exceed the RfD for
clomazone.
No short- or intermediate-term non-dietary, non-occupational
exposure scenario exists for clomazone, therefore, a short- or
intermediate-term aggregate risk assessment is not required. No
appropriate acute dietary risk endpoint was identified, thus no acute
aggregate risk assessment is required. A cancer aggregate risk
assessment is not required because there are no reported cancer
concerns at this time.
For purposes of assessing the potential dietary exposure under this
tolerance, EPA assumed tolerance level residues and 100 percent of crop
treated to estimate the TMRC from all established food uses for
clomazone (for more than a dozen commodities) and the proposed use on
watermelons. There are no watermelon animal feed items so no residue
levels in animal commodities potentially resulting from feeding of
these commodities were considered.
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses).
There is potential for clomazone to leach to ground water because
based on the available studies used in EPA's assessment of
environmental risk, clomazone is moderately persistent and potentially
mobile. For this reason, exposure to clomazone through drinking water
was considered during the risk assessment.
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
consumption of contaminated water, the ranges the Agency is continuing
to examine are all well below the level that would cause clomazone to
exceed the RfD if the tolerances being considered in this document were
granted. The Agency has therefore concluded that the potential
exposures associated with clomazone in water, even at the higher levels
the Agency is considering as a conservative upper bound, would not
[[Page 24043]]
prevent the Agency from determining that there is a reasonable
certainty of no harm if the tolerances are granted.
C. 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 has not made a
determination whether clomazone and any other pesticide have a common
mode of toxicity and require cumulative risk assessment. For purposes
of these section 18 exemptions, the Agency has considered only risks
from clomazone.
D. Safety Determination for U.S. Population
Based on the completeness and reliability of the toxicity data and
the conservative TMRC dietary exposure assumptions, EPA has concluded
that dietary exposure from food to clomazone will utilize <1 percent="" of="" the="" rfd="" for="" the="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" 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.="" whatever="" reasonable="" bounding="" figure="" the="" agency="" eventually="" decides="" upon="" for="" the="" contribution="" from="" water,="" that="" number="" is="" expected="" to="" be="" well="" below="" 99%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" clomazone="" residues.="" e.="" safety="" determation="" for="" infants="" and="" children="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" exposure="" (safety="" factor)="" 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="" exposure="" (safety)="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" exposure="" (safety)="" are="" often="" referred="" to="" as="" uncertainty="" (safety)="" factors.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" margin="" of="" exposure="" (usually="" 100x="" for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" margin="" of="" exposure="" 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="" margin="" of="" exposure.="" based="" on="" current="" toxicological="" data="" requirements,="" the="" database="" for="" clomazone="" relative="" to="" pre-="" (provided="" by="" rat="" and="" rabbit="" developmental="" studies)="" and="" post-natal="" (provided="" by="" the="" rat="" reproduction="" study)="" toxicity="" is="" complete.="" in="" assessing="" the="" adequacy="" of="" the="" standard="" uncertainty="" factor="" for="" clomazone,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-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.="" developmental="" toxicity="" was="" not="" observed="" in="" developmental="" studies="" using="" rats="" and="" rabbits.="" in="" the="" rat="" developmental="" toxicity="" study,="" the="" maternal="" and="" developmental="" noels="" and="" lels="" occurred="" at="" the="" same="" dose="" levels="" of="" 100="" and="" 300="" mg/kg/day,="" respectively,="" and="" the="" developmental="" findings="" did="" not="" indicate="" a="" need="" for="" an="" acute="" dietary="" risk="" assessment.="" the="" rabbit="" developmental="" study="" had="" no="" developmental="" findings="" up="" to="" 700="" mg/kg/day="" (highest="" dose="" tested).="" the="" agency's="" review,="" completed="" in="" 1986,="" of="" the="" rat="" reproductive="" toxicity="" study="" indicates="" that="" there="" may="" be="" a="" special="" post-natal="" sensitivity="" for="" infants="" and="" children.="" the="" parental="" noel="" and="" loel="" were="" 50="" and="" 100="" mg/kg/day,="" respectively,="" based="" on="" decreased="" body="" weight,="" decreased="" food="" consumption,="" increased="" clinical="" signs="" and="" increased="" organ="" weights.="" the="" pup="" noel="" and="" loel="" were="" 5="" and="" 50="" mg/kg/day,="" respectively,="" based="" on="" decreased="" survival,="" decreased="" viability,="" and="" decreased="" body="" weight.="" however,="" upon="" rereview="" of="" this="" study="" for="" this="" section="" 18="" exemption,="" the="" agency="" has="" discovered="" discrepancies="" between="" the="" conclusions="" presented="" in="" the="" review="" and="" the="" data="" provided="" in="" its="" summary="" tables.="" however,="" based="" on="" our="" review,="" the="" office="" of="" pesticide="" programs="" believes="" that="" the="" standard="" uncertainty="" factor="" is="" adequate="" to="" protect="" infants="" and="" children="" and="" that="" an="" additional="" uncertainty="" factor="" is="" not="" necessary.="" in="" any="" event,="" given="" the="" low="" percentage="">< 1%)="" of="" the="" rfd="" occupied="" for="" infants="" and="" children,="" which="" was="" calculated="" using="" very="" conservative="" aggregate="" risk="" estimates,="" aggregate="" exposure="" estimates="" for="" infants="" and="" children="" would="" not="" exceed="" the="" agency's="" level="" of="" concern="" even="" if="" an="" additional="" uncertainty="" factor="" were="" to="" be="" added.="" despite="" the="" potential="" for="" exposure="" through="" drinking="" water,="" epa="" has="" concluded="" that="" the="" percentage="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" dietary="" exposure="" (including="" drinking="" water="" exposure)="" to="" residues="" of="" clomazone="" does="" not="" exceed="" 100%="" for="" any="" of="" the="" population="" subgroups.="" considering="" food="" only,="" the="" population="" subgroup="" with="" the="" largest="" percentage="" of="" the="" rfd="" occupied="" is="" the="" non-nursing="" infants="">< 1="" year="" old)="" at="">< 1%="" of="" the="" rfd.="" therefore,="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" epa="" [[page="" 24044]]="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" clomazone="" residues.="" v.="" other="" considerations="" the="" metabolism="" of="" clomazone="" in="" plants="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" international="" maximum="" residue="" levels="" established="" for="" residues="" of="" clomazone="" on="" watermelons.="" there="" is="" a="" practical="" analytical="" method="" (method="" i,="" pesticide="" analytical="" manual,="" volume="" ii)="" for="" detecting="" and="" measuring="" levels="" of="" clomazone="" in="" or="" on="" food="" with="" a="" limit="" of="" detection="" that="" allows="" monitoring="" of="" food="" with="" residues="" at="" or="" above="" the="" level="" set="" by="" the="" clomazone="" tolerance.="" epa="" has="" provided="" information="" on="" this="" method="" to="" fda.="" the="" method="" is="" available="" to="" anyone="" who="" is="" interested="" in="" pesticide="" residue="" enforcement="" from:="" by="" mail,="" calvin="" furlow,="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" crystal="" mall="" #2,="" rm="" 1128,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 703-305-5805.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" clomazone="" in="" or="" on="" watermelons="" at="" 0.1="" p.m.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" july="" 1,="" 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="" number="" [opp-300481]="" (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="" response="" and="" program="" resources="" branch,="" field="" operations="" 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
address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Because FFDCA section 408(l)(6) permits establishment of this
regulation without a notice of proposed rulemaking, the regulatory
flexibility analysis requirements of the Regulatory Flexibility Act, 5
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously
assessed whether establishing tolerances or exemptions from tolerance,
raising tolerance levels, or expanding exemptions adversely impact
small entities and concluded, as a generic matter, that there is no
adverse impact. (46 FR 24950, May 4, 1981).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA 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 the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
[[Page 24045]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 18, 1997.
Peter Caulkins,
Director, 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. Section 180.425 is amended as follows
i. By designating the existing text as paragraph (a) ``General''.
ii. By adding paragraph (b).
iii. By adding and reserving paragraphs (c) and (d).
Sec. 180.425 Clomazone; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time limited tolerances are
established for residues of the herbicide clomazone (2-(2-Chlorophenyl)
methyl-4,4-dimethyl-3-isoxazolidinone) in connection with use of the
pesticide under section 18 emergency exemptions granted by EPA. The
tolerance is specified in the following table. The tolerance expires
and will be revoked by EPA on the date specified in the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Watermelons................................... 0.1 5/30/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-11505 Filed 5-01-97; 8:45 am]
BILLING CODE 6560-50-F
