[Federal Register Volume 62, Number 6 (Thursday, January 9, 1997)]
[Rules and Regulations]
[Pages 1284-1288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-514]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300447; FRL-5579-7]
RIN 2070-AB78
Myclobutanil; Pesticide Tolerances for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of the fungicide myclobutanil in or on the crop group cucurbit
vegetables in connection with EPA's granting of an emergency exemption
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizing use of myclobutanil on cucurbit vegetables in
California. This regulation establishes a maximum permissible level for
residues of myclobutanil in these foods pursuant to section 408(l)(6)
of the Federal Food, Drug and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. The tolerance will expire and be
revoked automatically without further action by EPA on November 30,
1997.
DATES: This regulation becomes effective January 9, 1997. This
regulation expires and is revoked automatically without further action
by EPA on November 30, 1997. Objections and requests for hearings must
be received by EPA on March 10, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300447], 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
number, [OPP-300447], 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-300447]. 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: Stephen Schaible,
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 22202, (703) 308-8337, e-mail:
schaible.stephen@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
residues of the fungicide myclobutanil [alpha-butyl-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile] and its metabolite
alpha-(3-hydroxybutyl)-alpha-(4-chlorophenol)-1H-1,2,4-triazole-1-
propanenitrile (free and bound), hereafter referred to as myclobutanil,
in or on cucurbit vegetables at 0.3 part per million (ppm). This
tolerance will expire and be revoked automatically without further
action by EPA on November 30, 1997.
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).
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
[[Page 1285]]
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 Exemption for Myclobutanil on Cucurbits and FFDCA
Tolerances
On July 29, 1996, the State of California availed itself of the
authority to declare the existence of a crisis situation within the
State, thereby authorizing use under FIFRA section 18 of myclobutanil
on watermelons to control powdery mildew (Sphaerotheca fuliginea). This
crisis exemption was amended August 7, 1996 to cover all cucurbit
vegetables. California stated that emergency conditions developed due
to the outbreak of this particular strain of powdery mildew which is
resistant to the registered product Bayleton. Though considered a minor
pest in the past, environmental conditions in the last 2 years have
contributed to this disease outbreak. Without the use of myclobutanil,
it is claimed that watermelon growers specifically, and growers of
cucurbits in general, will suffer severe economic losses.
As part of its assessment of this crisis declaration, EPA assessed
the potential risks presented by residues of myclobutanil in or on
cucurbits. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided to grant the section 18 exemption
only after concluding that the necessary tolerance under FFDCA section
408(l)(6) would be consistent with the new safety standard and with
FIFRA section 18. This tolerance for myclobutanil will permit the
marketing of cucurbits treated in accordance with the provisions of the
section 18 emergency exemption. Consistent with the need to move
quickly on the emergency exemption and to ensure that the resulting
food is safe and lawful, EPA is issuing this tolerance without notice
and opportunity for public comment under section 408(e) as provided in
section 408(l)(6). Although this tolerance will expire and be revoked
automatically without further action by EPA on November 30, 1997, under
FFDCA section 408(l)(5), residues of myclobutanil not in excess of the
amounts specified in the tolerance remaining in or on cucurbits 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 exemption. 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 myclobutanil meets the
requirements for registration under FIFRA section 3 for use on
cucurbits, or whether a permanent tolerance for myclobutanil for
cucurbit vegetables would be appropriate. This action by EPA does not
serve as a basis for registration of myclobutanil 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 California to use this
product on this crop under section 18 of FIFRA without following all
provisions of section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for
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. 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 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 acceptable by EPA.
[[Page 1286]]
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 (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.
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 every crop considered in the analysis is treated with the pesticide
being evaluated. 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 and that the market for pest control on any
given crop seldom belongs to a single pesticide.
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Myclobutanil is already registered by EPA for numerous
food and feed uses, as well as residential use on annuals and
perennials, turf, shrubs and trees, and African violets (indoor). EPA
has received a petition requesting establishment of a tolerance for
myclobutanil on cucurbits. The time-limited tolerance associated with
the current emergency exemption does not constitute a decision
regarding the pending petition for tolerance on cucurbit vegetables.
For the purposes of this emergency exemption, 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 a time-
limited tolerance for residues of myclobutanil on cucurbit vegetables
at 0.3 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing this tolerance follows.
IV. Aggregate Risk Assessment and Determination of Safety
A. Toxicological Profile
1. Chronic toxicity. The RfD of 0.025 milligram(mg)/kilogram(kg)/
day was established by the Agency based on the chronic feeding study in
rats with a NOEL of 2.5 mg/kg/day and an uncertainty factor of 100.
There was testicular atrophy at the lowest effect level (LEL) of 9.9
mg/kg/day.
2. Acute toxicity. OPP has determined that data do not indicate the
potential for adverse effects after a single dietary exposure.
3. Short-term toxicity. OPP has determined that short- and
intermediate-term risk assessments are appropriate for occupational and
residential routes of exposure. OPP recommends that the NOEL of 100 mg/
kg/day, taken from the 21-day dermal toxicity study in rats, be used
for the short term dermal MOE calculations. This dose level was the
highest tested in the study. For intermediate term MOE calculations,
OPP recommended using the NOEL of 10 mg/kg/day from the 2-generation
rat study. Effects seen at the LEL in this study (50 mg/kg/day) were
decreases in pup body weight, an increased incidence in number of
stillborns, and atrophy of the prostate and testes. Though these
endpoints have been identified, no acceptable reliable exposure data to
assess these potential risks are available at this time.
4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified myclobutanil as Group E chemical--``no evidence of
carcinogenicity for humans''--based on the results of carcinogenicity
studies in two species. The doses tested are adequate for identifying a
cancer risk.
B. Aggregate Exposure
Established U.S. tolerances for myclobutanil and its alcohol
metabolites (free and bound) are found in 40 CFR 180.443, and range
from 0.05 ppm for milk to 5 ppm for cherries (sweet and sour). The
proposed time-limited tolerance of 0.3 ppm is based on residue field
trial data on cantaloupes submitted in support of PP 9G3765 and PP
2F4155. There are no livestock feed items associated with the proposed
use on cucurbits, so no additional livestock dietary burden will result
from this Section 18 registration. Therefore, existing meat, milk, and
poultry tolerances are adequate.
For the purpose of assessing potential chronic dietary exposure
from myclobutanil, EPA assumed tolerance level residues and percent of
crop treated refinements to estimate the Anticipated Residue
Contribution (ARC) from the proposed and existing food uses of
metolachlor. The use of percent of crop treated data for most of the
existing food uses in this analysis results in a more refined estimate
of exposure than the TMRC. In conducting this exposure assessment, EPA
has made conservative assumptions--all foods considered in the analysis
were assumed to have myclobutanil residues present at the level of the
tolerance. Percent crop treated data were used for many commodities
with existing myclobutanil tolerances (stone fruits, pome fruits,
grapes, and cottonseed) in the chronic exposure assessment, but were
not considered when calculating the dietary burden from which secondary
residue tolerances in meat, milk and poultry were derived or for the
proposed use on cucurbit vegetables. Thus, in making a safety
determination for the subject Section 18 tolerances, EPA is taking into
account this conservative exposure assessment.
Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational sources. Based on the available studies used in EPA's
assessment of environmental risk, EPA does not anticipate exposure to
residues of myclobutanil in drinking water. Review of terrestrial field
dissipation data by the Agency indicates that myclobutanil did not
leach into groundwater in either sandy loam or coastal soil. There is
no established Maximum Concentration Level for residues of myclobutanil
in drinking water. No drinking water health advisories have been issued
for myclobutanil. The ``Pesticides in Groundwater Database (EPA 734-12-
92-001, September 1992) has no
[[Page 1287]]
information concerning myclobutanil. Based on the available data, the
Agency does not anticipate that there will be significant exposure to
the general population from myclobutanil residues in drinking water.
There are residential uses of myclobutanil and EPA acknowledges
that there may be short-, intermediate- and long-term non-occupational
exposure scenarios. OPP has identified toxicity endpoints for short-
and intermediate-term residential risk assessment. However, no
acceptable reliable exposure data to assess these potential risks are
available at this time. Given the time-limited nature of this request,
the need to make emergency exemption decisions quickly, and the
significant scientific uncertainty at this time about how to aggregate
non-occupational exposure with dietary exposure, the Agency will make
its safety determination for this tolerance based on those factors
which it can reasonably integrate into a risk assessment.
At this time, the Agency has not made a determination that
myclobutanil and other substances that may have a common mode of
toxicity would have cumulative effects. Given the time limited nature
of this request, the need to make emergency exemption decisions
quickly, and the significant scientific uncertainty at this time about
how to define common mode of toxicity, the Agency will make its safety
determination for this tolerance based on those factors which it can
reasonably integrate into a risk assessment. For purposes of this
tolerance only, the Agency is considering only the potential risks of
myclobutanil in its aggregate exposure.
C. Determination of Safety for U.S. Population
EPA has calculated that chronic dietary exposure to myclobutanil
will utilize 13.5 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. EPA concludes that there is a reasonable certainty that
no harm will result from aggregate exposure to myclobutanil residues.
D. Determination of Safety for Infants and Children
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 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.
From the rat developmental study, 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 (pup) NOEL was 93.8 mg/kg/day, based
on increased incidences of 14th rudimentary and 7th cervical ribs at
the LOEL of 312.6 mg/kg/day. From the rabbit developmental study, 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 (pup) 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 LEL of 200 mg/kg/day.
From the rat reproduction study, the maternal (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 LEL of 50 mg/kg/day. The reproductive (parental) NOEL was 10 mg/
kg/day, based on increased incidence of stillborns, and atrophy of the
testes, epididymides, and prostate at the LEL of 50 mg/kg/day.
FFDCA section 408 provides that EPA may apply an additional 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
data base. Based on current toxicological data requirements, the data
base for myclobutanil relative to pre- and post-natal toxicity is
complete. The Agency notes that there is approximately a 25-fold
difference between the developmental NOEL of 60 mg/kg/day from the
rabbit developmental toxicity study and the NOEL of 2.5 mg/kg/day from
the chronic rat feeding study which was the basis of the RfD. It is
further noted that in both the rabbit and rat developmental toxicity
studies, the developmental NOEL and maternal NOEL are the same (60 mg/
kg/day for the rabbit and 93.8 mg/kg/day for the rat). In the rat
reproduction study, the maternal NOEL (2.5 mg/kg/day) was four times
lower than the developmental (pup) and reproductive NOELs (10 mg/kg/
day). These studies indicate that there does not appear to be
additional sensitivity for infants and children in the absence of
maternal toxicity.
EPA has calculated that the percent of the RfD that will be
utilized by chronic dietary exposure to residues of myclobutanil ranges
from 21.8 percent for children 7 to 12 years old, up to 73.1 percent
for non-nursing infants. Given the conservative assumptions used in the
calculation of dietary risk, it is felt that even a conservative
assumption of transfer of residues to drinking water would result in an
aggregate exposure below the Agency's level of concern. 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
The metabolism of myclobutanil in plants and animals is adequately
understood for the purposes of this tolerance. There is no Codex
maximum residue level established for residues of myclobutanil on
cucurbits. There is a practical analytical method for detecting and
measuring levels of myclobutanil in or on food with a limit of
detection that allows monitoring of food with residues at or above the
levels set in this 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 22202, (703) 305-5805.
VI. Conclusion
Therefore, a tolerance in connection with the FIFRA section 18
emergency exemption is established for residues of myclobutanil in
cucurbits at 0.3 ppm. This tolerance will expire and be automatically
revoked without further action by EPA on November 30, 1997.
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 sections 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
[[Page 1288]]
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 March 10, 1997, file written objections to any
aspect of this regulation (including the automatic revocation
provision) 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-300447] (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 4:00 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.
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.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 2, 1997.
Daniel M. Barolo,
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. In Sec. 180.443, by adding a new paragraph (d) to read as
follows:
Sec. 180.443 Myclobutanil; tolerances for residues.
* * * * *
(d) A time-limited tolerance is established for residues of the
fungicide myclobutanil, in connection with use of the pesticide under
section 18 emergency exemption granted by EPA. The tolerance is
specified in the following table. This tolerance expires and is
automatically revoked on the date specified in the table without
further action by EPA.
------------------------------------------------------------------------
Parts
Commodity per Expiration/revocation date
million
------------------------------------------------------------------------
Cucurbit vegetables................ 0.3 Nov. 30, 1997.
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[FR Doc. 97-514 Filed 1-8-97; 8:45 am]
BILLING CODE 6560-50-F
