[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Rules and Regulations]
[Pages 63721-63726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30552]



[[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: [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-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: 
[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 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