[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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="">