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triadimefon (Bayleton) Pesticide Tolerance

[Federal Register: December 2, 1996 (Volume 61, Number 232)]
[Rules and Regulations]
[Page 63721-63726]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]


[[Page 63721]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180
[OPP-300444; FRL-5574-8]
RIN 2070-AB78


Triadimefon; 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
combined residues of the fungicide triadimefon in or on the raw
agricultural commodity chili peppers in connection with EPA's granting
of an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of triadimefon on chili
peppers in New Mexico. This regulation establishes a maximum
permissible level for residues of triadimefon in this food 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 be revoked automatically without further action by EPA on
November 8, 1998.

DATES: This regulation becomes effective December 2, 1996. This
regulation expires and is revoked automatically without further action
by EPA on November 8, 1998. Objections and requests for hearings must
be received by EPA on or before January 31, 1997.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300444], 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-300444], 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, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300444]. 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: David Deegan, 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) 308-8327, e-mail:
deegan.dave@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the fungicide triadimefon, 1-(4-chlorophenoxy)-3,3-
dimethyl-1-(1-H-1,2,4-triazol-1-yl)-2-butanone, in or on chili peppers
at 0.5 part per million (ppm). This tolerance will expire and be
revoked automatically without further action by EPA on November 8,
1998.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104170) 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 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

[[Page 63722]]

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 Triadimefon on Chili Peppers and FFDCA
Tolerances

    On September 10, 1996, the New Mexico Department of Agriculture
availed of itself the authority to declare the existence of a crisis
situation within the state, thereby authorizing use under FIFRA section
18 of triadimefon on chili peppers to control powdery mildew (Oidiopsis
taurica). New Mexico stated that emergency conditions developed due to
unusually wet conditions in the chili pepper growing regions of the
state, which resulted in an outbreak of powdery mildew. This pest, New
Mexico asserts, can have devastating effects on growers' production and
revenue.
    As part of its assessment of this crisis declaration, EPA assessed
the potential risks presented by residues of triadimefon in or on chili
peppers. 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 triadimefon will permit the
marketing of chili peppers 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 8, 1998, under
FFDCA section 408(l)(5), residues of triadimefon not in excess of the
amount specified in the tolerance remaining in or on chili peppers
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 triadimefon meets the
requirements for registration under FIFRA section 3 for use on chili
peppers, or whether a permanent tolerance for triadimefon for chili
peppers would be appropriate. This action by EPA does not serve as a
basis for registration of triadimefon 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 New Mexico 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 triadimefon, 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 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 crop 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

[[Page 63723]]

information in support of this action. Triadimefon is already
registered by EPA for use on almonds, apples, apricots, barley, chick
pea seed, cucurbits, grapes, grass, nectarines, peaches, pears,
pineapples, plums, raspberries, sugar beets, and wheat (see 40 CFR
180.410 for specific tolerances). At this time, EPA is not in
possession of a registration application for triadimefon on chili
peppers. However, based on information submitted to the Agency, EPA has
sufficient data to assess the hazards of triadimefon and to make a
determination on aggregate exposure, consistent with section 408(b)(2),
for a time-limited tolerance for residues of triadimefon on chili
peppers at 0.5 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Profile

    1. Chronic toxicity. Based on the available chronic toxicity data,
EPA has established the RfD for triadimefon at 0.04 milligrams(mg)/
kilogram(kg)/day. This RfD is based on a 2-year dog feeding study with
a NOEL of 11.4 mg/kg/day and an uncertainty factor of 300. An
uncertainty factor of 300 was applied to account for inter-species
extrapolation (10), intra-species variability (10), and the lack of an
adequate reproduction study (3). Decreased food intake, depression in
weight gain, and significantly (p <0.05) increased alkaline phosphatase
activity in both sexes were the effects observed at the lowest effect
level (LEL).
    2. Acute toxicity. Agency toxicologists recommended that the
developmental NOEL from the rabbit developmental toxicity study (20 mg/
kg/day) be used for acute dietary risk calculations. The rabbit
developmental study is discussed below under Unit IV.D. of this
preamble. The population of concern for this risk assessment is females
13+ years old.
    3. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified triadimefon as Group ``C'' for carcinogenicity (possible
human carcinogen) based on the results of carcinogenicity studies in
two species. The classification as Group C was based on borderline
statistically significant increases in thyroid adenomas in male rats,
and increases in liver adenomas in both sexes of mice. Because the
tumors were benign, and there were no apparent genotoxicity concerns,
the Cancer Peer Review Committee recommended the RfD approach for
quantitation of human risk.

B. Aggregate Exposure

    Tolerances have been established (40 CFR 180.410) for the combined
residues of triadimefon and its metabolites containing chlorophenoxy
and triazole moieties (expressed as the fungicide) in or on various raw
agricultural commodities ranging from 0.04 ppm in milk, eggs, and fat,
meat and meat by-products in hogs and poultry to 145.0 ppm in grass
seed cleanings (including hulls). There are no animal feed items
associated with chili peppers, therefore the livestock dietary burden
will not be increased by this section 18 exemption.
    In conducting this exposure assessment, EPA has made very
conservative assumptions--that 100% of chili peppers and all other
commodities having triadimefon tolerances will contain triadimefon
residues and those residues would be at the level of the tolerance--
which result in an overestimate of human dietary exposure. Thus, in
making a safety determination for this tolerance, EPA is taking into
account this conservative exposure assessment.
    1. Chronic exposure. Given the emergency nature of this request for
the use of triadimefon and the resulting need for a timely analysis and
risk assessment, EPA has utilized the TMRC to estimate chronic dietary
exposure from the tolerance for triadimefon on chili peppers at 0.5
ppm. The TMRC is obtained by multiplying the tolerance level residue
for chili peppers by average consumption data, which estimate the
amount of chili peppers and chili peppers products eaten by various
population subgroups. This calculation is performed as well for every
food having existing triadimefon tolerances. The risk assessment is
therefore considered to be overestimated. The Agency has extensive
experience refining chronic dietary risk assessments for a broad range
of pesticide chemicals. It is the Agency's experience that when the
chronic dietary risk assessment is refined using ARC (anticipated
residue contribution) estimates derived from anticipated residue levels
and percent of crop treated data, the percent of the RfD occupied by
the ARC is generally in the range of an order of magnitude lower than
the percent of the RfD occupied by the unrefined TMRC.
    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, triadimefon and its metabolites are mobile and
persistent and have the potential to leach into groundwater. There is
no established Maximum Concentration Level for residues of triadimefon
in drinking water. No drinking water health advisory levels have been
issued for triadimefon or its metabolite triadimenol. The ``Pesticides
in Groundwater Database (EPA 734-12-92-001, September 1992) indicated
that triadimefon was monitored for in 14 wells in California from 1984
to 1989. There were no detectable residues (limit of detection was not
stated). The Agency does not have available data to perform a
quantitative drinking water risk assessment for triadimefon at this
time.
    Previous experience with more persistent and mobile pesticides for
which there have been available data to perform quantitative risk
assessments have demonstrated that drinking water exposure is typically
a small percentage of the total exposure when compared to the total
dietary exposure. This observation holds even for pesticides detected
in wells and drinking water at levels nearing or exceeding established
MCLs. Based on this experience and the Agency's best scientific
judgement, EPA concludes that it is not likely that the potential
exposure from residues of triadimefon in drinking water added to the
current dietary exposure will result in an exposure which exceeds the
RfD.
    Triadimefon is currently registered for residential use as a
preservative treatment for wood and for lawn and ornamental uses. At
this time, the Agency does not have reliable data which would allow
quantitative incorporation of risk from these uses into a human health
risk assessment.
    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-dietary, 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.
    2. Acute exposure. EPA has not estimated non-occupational exposures
other than dietary for triadimefon. Acceptable, reliable data are not
currently available with which to assess acute risk. Triadimefon is
registered for outdoor residential use (lawn use). While dietary and
residential scenarios could possibly occur in a single day, triadimefon
would rarely be present on both the food eaten and the lawn on that
single day. Even assuming this were the case, it is yet more unlikely
that residues would be present at tolerance level on all food eaten
that day for

[[Page 63724]]

which triadimefon tolerances exist, as is assumed in the acute dietary
risk analysis, and on the lawn that same day.
    Because the acute dietary exposure estimate assumes tolerance level
residues and 100% crop treated for all crops evaluated it is a large
over-estimate of exposure and it is considered to be protective of any
acute exposure scenario.
    At this time, the Agency has not made a determination that
triadimefon and other substances that may have a common mode of
toxicity would have cumulative effects. For purposes of this tolerance
only, the Agency is considering only the potential risks of triadimefon
in its aggregate exposure.

C. Determination of Safety for U.S. Population

    1. Chronic risk. Using the conservative exposure assumptions
described above and taking into account the completeness and
reliability of the toxicity data, EPA has concluded that dietary
exposure to triadimefon will utilize 7.8 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. Acceptable, reliable data are not
available to quantitatively assess risk from drinking water or from
residential uses. However, EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to
triadimefon residues.
    2. Acute risk. For the population subgroup of concern, females 13+
years old, the calculated Margin Of Exposure (MOE) value is 555. This
MOE does not exceed the Agency's level of concern for acute dietary
exposure.

D. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants
and children to residues of triadimefon, EPA considered data from
developmental toxicity studies in the rat and rabbit. The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from pesticide exposure during prenatal
development.
    In the developmental toxicity study in rats, the maternal systemic
NOEL was 30 mg/kg/day and the LOEL 90 mg/kg/day. The NOEL for
developmental toxicity was 30 mg/kg/day and the LOEL was 90 mg/kg/day.
In the developmental toxicity study in rabbits, the maternal systemic
NOEL was 50 mg/kg/day and the LOEL 120 mg/kg/day. The NOEL for
developmental toxicity was 20 mg/kg/day and the LOEL was 50 mg/kg/day.
Effects seen at the developmental LEL in the rabbit study were
irregular spinous process and ossification of various bones.
    An acceptable 2-generation reproduction study in rats is not
available.
    1. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that the percentage of the RfD that
will be utilized by aggregate exposure to residues of triadimefon
ranges from 25.6 percent for children 7-12 years old, up to 74.8
percent for non-nursing infants.
    FFDCA section 408 provides that EPA shall 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 unless EPA concludes that a different margin of safety is
appropriate. Based on current toxicological data requirements, the data
base for triadimefon relative to pre- and post-natal toxicity is not
complete. An additional 3-fold uncertainty factor has already been
incorporated into the calculation of the RfD because of the absence of
an acceptable reproduction study. The reproduction study would provide
additional information regarding post-natal toxicity to infants and
children.
    The Agency notes that there is approximately a two-fold difference
between the developmental NOEL of 20 mg/kg/day from the rabbit
developmental toxicity study and the NOEL of 11.4 mg/kg/day from the 2-
year dog feeding study which was the basis of the RfD. It is further
noted that in the rabbit developmental toxicity study, the
developmental NOEL of 20 mg/kg/day is lower than the maternal systemic
NOEL of 50 mg/kg/day, suggesting the possibility of increased
sensitivity for the pre-natal child.
    The TMRC value for the most highly exposed infant and children
subgroup (non-nursing infants <1 year old) occupies 74.8% of the RfD.
However, this calculation also assumes 100% crop treated and uses
tolerance level residues for all commodities. As mentioned previously,
refinement of the dietary risk assessment by using percent of crop
treated and anticipated residue data would likely greatly reduce the
dietary exposure estimate and result in an anticipated residue
contribution (ARC) which would occupy a percent of the RfD that is
substantially lower than the currently calculated TMRC value.
    Should an additional uncertainty factor be deemed appropriate, when
considered in conjunction with a refined exposure estimate, it is
unlikely that the dietary risk will exceed 100 percent of the RfD.
Therefore, taking into account the completeness and reliability of the
toxicity data and the conservative exposure assessment, EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to triadimefon residues.
    2. Acute risk. At present, the acute dietary MOE for females 13+
years old is 555. This MOE calculation was based on the developmental
NOEL of 20 mg/kg/day, compared to the less sensitive maternal NOEL of
50 mg/kg day from the same rabbit developmental study. This risk
assessment also assumed 100% crop treated with tolerance level residues
on all treated crops consumed, resulting in a significant over estimate
of dietary exposure. The large acute dietary MOE calculated for females
13+ years old provides assurance that there is a reasonable certainty
of no harm for both females 13+ years and the pre-natal development of
infants.

V. Other Considerations

    The metabolism of triadimefon in plants and animals is adequately
understood for the purposes of this tolerance. There are no Codex
maximum residue levels established for residues of triadimefon on chili
peppers. There is a practical analytical method for detecting and
measuring levels of triadimefon 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. Enforcement methods are published in PAM Vol. II
Pesticide Reg. Sec. 180.410 as Methods I and II.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18
emergency exemptions is established for residues of triadimefon in
chili peppers at 0.5 ppm. This tolerance will expire and be
automatically revoked without further action by EPA on November 8,
1998.

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

[[Page 63725]]

can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
    Any person may, by January 31, 1996, 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

    A record has been established for this rulemaking under docket
number [OPP-300444]. A public version of this record, which does not
include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 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 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: November 20, 1996.
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 180.410, by adding a new paragraph (c) to read as follows:


Sec. 180.410   1-(4-chlorophenoxy)-3,3-dimethyl-1-(1-H-1,2,4-triazol-1-
yl)-2-butanone; tolerances for residues.

    *    *    *    *    *
    (c) A time-limited tolerance is established for residues of the
fungicide triadimefon 1-(4-chlorophenoxy)-3,3-dimethyl-1-(1-H-1,2,4-
triazol-1-yl)-2-butanone in connection with use of the pesticide under
the section 18 emergency exemption granted by EPA. The tolerance is
specified in the following table. The tolerance expires and is
automatically revoked on the date specified in the table without
further action by EPA.


------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Chili peppers...................  0.5                 November 8, 1997
------------------------------------------------------------------------



[[Page 63726]]

[FR Doc. 96-30552 Filed 11-29-96; 8:45 am]
BILLING CODE 6560-50-F