[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: [email protected]. 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: 
[email protected].

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:
[email protected].
    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.            
------------------------------------------------------------------------

[FR Doc. 97-514 Filed 1-8-97; 8:45 am]
BILLING CODE 6560-50-F