[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [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-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: 
[email protected].
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:
    [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. 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