[Federal Register Volume 62, Number 93 (Wednesday, May 14, 1997)]
[Rules and Regulations]
[Pages 26412-26416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12474]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300483; FRL-5715-5]
RIN 2070-AB78


Dimethomorph; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of the fungicide dimethomorph in or on the food commodity 
potatoes in connection with EPA's granting of emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of dimethomorph on potatoes in the states of 
Alabama, California, Colorado, Delaware, Florida, Idaho, Indiana, 
Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska, 
Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, 
Oregon, Pennsylvania, Virginia, Washington, and Wisconsin. The 
tolerance will expire and is revoked on March 15, 1999.
DATES: This regulation is effective May 14, 1997. Objections and 
requests for hearings must be received by EPA on or before July 14, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
doument control number,[OPP-300483], 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 document control number, [OPP-300483], 
must also 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, Crystal Mall #2, 1921 Jefferson Davis Highway, 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 document control 
number [OPP-300483]. 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: Libby Pemberton, 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, 703-308-8326, 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 dimethomorph on potatoes at 0.05 parts per 
million (ppm). This tolerance will expire and is revoked by EPA on 
March 15, 1999. After March 15, 1999, 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 FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under a new FFDCA 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 CFR 58135, November 13, 1996)(FRL-5572-9).
    New Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food commodity) only if EPA determines that the tolerance is ``safe.'' 
Section 408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that 
``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' This includes exposure through drinking 
water and in residential settings, but does not include occupational 
exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
commodities that will result from the use of a pesticide under an 
emergency exemption granted by EPA under section 18 of FIFRA. Such 
tolerances can be established without providing notice or a period for 
public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerance to set binding precedents for the 
application of FFDCA section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemptions for Dimethomorph on Potatoes and FFDCA 
Tolerances

    EPA has authorized under FIFRA section 18 the use of dimethomorph 
on potatoes for control of late blight, as requested by the states 
previously listed. Recent failures to control late blight in potatoes 
as well as tomatoes with the registered fungicides, have been caused 
almost exclusively by immigrant strains

[[Page 26413]]

of late blight (phytophthora infestans), which are resistant to the 
control of choice, metalaxyl. Before the immigrant strains of late 
blight arrived, all of the strains in the United States were previously 
controlled by treatment with metalaxyl. Presently, there are no 
fungicides registered in the U.S. that will provide adequate control of 
the immigrant strains of late blight. After having reviewed their 
submissions, EPA concurs that emergency conditions exist.
    As part of its assessment of these specific exemptions, EPA 
assessed the potential risks presented by residues of dimethomorph on 
potatoes. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided 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 residues of 
dimethomorph will permit the marketing of potatoes treated in 
accordance with the provisions of the section 18 emergency exemptions. 
Consistent with the need to move quickly on these emergency exemptions 
in order to address an urgent non-routine situation and to ensure that 
the resulting food commodity is safe and lawful, EPA is issuing this 
tolerance without notice and opportunity for public comment under FFDCA 
section 408(e) as provided in FFDCA section 408(l)(6). Although this 
tolerance will expire and is revoked on March 15, 1999, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amount specified in the tolerance remaining in or on potatoes after 
that date will not be unlawful, provided the pesticide is applied 
during the term of, and in accordance with all the conditions of, 
section 18 of FIFRA. 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 dimethomorph meets 
EPA's registration requirements for use on potatoes or whether a 
permanent tolerance for this use would be appropriate. This tolerance 
does not serve as a basis for registration of dimethomorph by a State 
for special local needs under FIFRA section 24(c). Nor does this action 
serve as the basis for any States other than previously listed and 
States which are subsequently granted specific exemptions for this use 
to use this pesticide on this crop under section 18 of FIFRA without 
following all provisions of section 18 of FIFRA as identified in 40 CFR 
part 166. For additional information regarding the emergency exemptions 
for dimethomorph, contact the Agency's Registration Division at the 
address provided above in ``ADDRESSES''.

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% or less of the RfD) is 
generally considered acceptable by EPA.
    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 commodity in question, 
residues in other food commodities 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 commodity contained pesticide residues equal to the tolerance. The 
TMRC is a ``worst case'' estimate since it is based on the assumptions 
that food commodity contains pesticide residues at the tolerance level 
and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most food commodities when they are eaten are 
well below established tolerances.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. Dimethomorph is not registered by EPA for use in the 
United States. Nevertheless, EPA believes it has sufficient data to 
assess the hazards of dimethomorph and to make a determination on 
aggregate exposure, consistent with FFDCA section 408(b)(2), for the 
time-limited tolerances for residues of dimethomorph on potatoes at 
0.05 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing these tolerances follows.

[[Page 26414]]

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by dimethomorph are 
discussed below.
    1. Chronic toxicity. Based on the available chronic toxicity data, 
the Office of Pesticide Programs (OPP) has selected an RfD for 
dimethomorph of 0.01 milligrams(mg)/kilogram(kg)/day. This RfD is based 
on a NOEL of 10 mg/kg/day in a 2-year chronic rat study, using an 
uncertainty factor of 1,000. The lowest-observed-effect level (LOEL) of 
57.7 mg/kg/day was based on decreased body weight and increased 
incidence of liver ``ground glass'' foci in females. The additional 10-
fold uncertainty factor was used to protect infants and children, since 
data gaps consisted of rat and rabbit developmental studies and the rat 
reproduction study.
    2. Acute toxicity. An acute dietary risk endpoint was not 
identified by OPP.
    3. Short-term, non-dietary inhalation and dermal toxicity. OPP 
recommends use of the developmental toxicity study in rats for short-
term, non-dietary risk calculations. The maternal NOEL was 60.0 mg/kg/
day. At the LOEL of 160 mg/kg/day there was reduced food commodity 
consumption, body weights, and weight gain. Intermediate-term risk 
endpoints have also been identified. The NOEL of 15 mg/kg/day in the 
90-day dog feeding study has been chosen as the intermediate-term 
toxicity endpoint. At the LOEL of 43 mg/kg/day, there were decreases in 
the absolute and relative weights of the prostrate and possible 
threshold liver effects.
    4. Carcinogenicity. Dimethomorph has not been classified as to 
carcinogenic potential. No cancer risks have been identified in the 
available dimethomorph data evaluation records.

B. Aggregate Exposure

    There are no established U.S. tolerances for dimethomorph, and 
there are no registered uses for dimethomorph in the United States.
    For the purpose of assessing chronic dietary exposure from 
dimethomorph, EPA assumed tolerance level residues and 100% of crop 
treated for the proposed use of dimethomorph. These conservative 
assumptions result in overestimation of human dietary exposures. 
Secondary residues of dimethomorph are not expected to transfer to 
animal commodities as a result of the proposed use.
    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food commodities 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).
    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 below the level that would cause dimethomorph 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 dimethomorph in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerances are granted.
    There is no entry for dimethomorph in the ``Pesticides in 
Groundwater Data Base'' (EPA 734-12-92-001, September 1992). There is 
no established Maximum Concentration Level (MCL) for residues of 
dimethomorph in drinking water. No drinking water health advisory 
levels have been established for dimethomorph. Dimethomorph is not 
registered for any residential uses so no exposure from this route is 
expected. Because there are no short- or intermediate-term, non-
dietary, non-occupational exposure scenarios associated with 
dimethomorph, a short- or intermediate-term, aggregate-risk assessment 
is not required.

C. Cumulative Exposure to Substances With Common Mechanism of Toxicity

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' The Agency believes that 
``available information'' in this context might include not only 
toxicity, chemistry, and exposure data, but also scientific policies 
and methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed). EPA does not have, at this 
time, available data to determine whether dimethomorph has a common

[[Page 26415]]

mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, dimethomorph does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that dimethomorph has 
a common mechanism of toxicity with other substances.

D. Safety Determinations for U.S. Population

    Based on the completeness and reliability of the toxicity data, EPA 
has concluded that dietary exposure to dimethomorph in food commodities 
from published tolerances will utilize less than 1% of the RfD for the 
U.S. population. An acute-dietary-risk endpoint was not identified. 
Therefore, an acute-aggregate- risk assessment is not required. 
Whatever reasonable bounding figure the Agency eventually decides upon 
for the contribution from water, exposure to dimethomorph is not 
expected to exceed the RfD. EPA concludes that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
dimethomorph residues.

E. Determination of Safety for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 10-
fold margin of safety for infants and children in the case of threshold 
effects to account for pre-and post-natal toxicity and the completeness 
of the database unless EPA determines that a different margin of safety 
will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
either case, EPA generally defines the level of appreciable risk as 
exposure that is greater than 1/100 of the NOEL in the animal study 
appropriate to the particular risk assessment. This 100-fold 
uncertainty (safety) factor/MOE (safety) is designed to account for 
combined inter- and intra-species variability. EPA believes that 
reliable data support using the standard 100-fold margin/factor not the 
additional 10-fold margin/factor when EPA has a complete data base 
under existing guidelines and when the severity of the effect in 
infants or children or the potency or unusual toxic properties of a 
compound do not raise concerns regarding the adequacy of the standard 
margin/factor. Based on current toxicological data requirements, the 
data base for dimethomorph relative to pre- and post-natal toxicity is 
not complete.
    It can not be established whether dimethomorph does or does not 
demonstrate extra pre- or post-natal sensitivity for infants and 
children based on the results of the rat and rabbit developmental 
studies and the rat reproduction study. These studies were rated 
supplementary (not acceptable). To compensate for the lack of 
acceptable studies, the RfD (0.01 mg/kg/day) was calculated using an 
uncertainty factor of 1,000. The additional 10-fold uncertainty factor 
was added because of the data gaps and in order to protect infants and 
children from possible pre-and post-natal, toxic risks from dietary 
exposure to dimethomorph.
    EPA has concluded that the percent of the RfD that will be utilized 
by chronic dietary (food commodity) exposure to residues of 
dimethomorph is less than or equal to 1% for all population subgroups 
which includes nursing and non-nursing infants (<1 year old), and 
children (1-6 yrs.) and (7-12 yrs.). This calculation assumes tolerance 
level residues and is therefore an over-estimate of dietary risk. 
Refinement of the dietary risk assessment by using anticipated residue 
data would reduce dietary exposure. The addition of potential exposure 
from dimethomorph residues in drinking water is not expected to result 
in an exposure which would exceed the RfD. Therefore, EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to dimethomorph residues.

V. Other Considerations

    The metabolism of dimethomorph in potatoes is adequately understood 
only for the purposes of this tolerance. There are no Codex maximum 
residue levels established for residues of dimethomorph. The residue of 
concern, for the purposes of this tolerance, is dimethomorph. An 
adequate method is available for detection of the residues of concern 
for the purpose of this FIFRA section 18 request. High Performance 
Liquid Chromotography/Ultra Violet (HPLC/UV) analytical method FAMS 
002-02 is adequate for detecting residues of dimethomorph in/on 
potatoes. This method has undergone a successful Agency validation. The 
methods are 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 Highway, Arlington, VA, 703-305-
5805.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of dimethomorph in or 
on potatoes at 0.05 ppm. This tolerance will expire and is revoked by 
EPA on March 15, 1999. After that date, EPA will publish a document in 
the Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.

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 FFDCA section 408(e) and (l)(6) as was provided in the old FFDCA 
section 408 and in FFDCA 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 14, 1997, 
file written objections on 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 in 
``ADDRESSES'' (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

[[Page 26416]]

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 
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 Record

    A record has been established for this rulemaking under document 
control number [OPP-300483]. A public version of this record, 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. The 
official record for this rulemaking, as well as the public version, as 
described above, is kept in paper form. Accordingly, in the event there 
are objections and hearing requests, 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. 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 mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation 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 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 1, 1997.

James J. Jones,

Acting Director, Registration Division, 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. By adding Sec. 180.493 to subpart C to read as follows:


Sec. 180.493  Dimethomorph; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the fungicide dimethomorph in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. The tolerance is specified in the following table. This 
tolerance will expire and is revoked by EPA on March 15, 1999. After 
March 15, 1999, EPA will publish a document in the Federal Register to 
remove the revoked tolerance from the Code of Federal Regulations.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        date   
------------------------------------------------------------------------
Potatoes......................................         0.05      3/15/99
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    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertent residues. [Reserved]
[FR Doc. 97-12474 Filed 5-13-97; 8:45 am]
BILLING CODE 6560-50-F