[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Rules and Regulations]
[Pages 33557-33563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16214]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300348; FRL-5718-7]
RIN 2070-AC78
Terbacil; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of the herbicide, terbacil in or on the raw agricultural
commodities watermelons in connection with EPA's granting of emergency
exemptions under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act authorizing use of terbacil on watermelons in Delaware,
Maryland, and Virginia. This regulation establishes maximum permissible
levels for residues of terbacil on watermelons pursuant to section
408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996. This tolerance will expire and
is revoked on May 31, 1998.
DATES: This regulation becomes effective June 20, 1997. Objections and
requests for hearings must be received by EPA on August 19, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, ``OPP-300348,'' 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-300348,'' should be submitted to: Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring a copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: 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 control
number ``OPP-300348.'' No Confidential Business Information (CBI)
should be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Virginia Dietrich,
Registration Division (7505C), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location,
[[Page 33558]]
telephone number, and e-mail address: Document Processing Desk,
(7505C), Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA
22202, (703) 308-9359, e-mail: dietrich.virginia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, pursuant to section 408(e) and (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
and (l)(6), is establishing tolerances for residues of the herbicide
terbacil (3-tert-Butyl-5-chloro-6-methyluracil and its three
metabolites 3-tert-butyl-5-chloro-6-hydroxymethyluracil, 6-chloro-2,3-
dihydro-7-hydroxymethyl-3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin-5-
one, and 6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a)
pyrimidin-5-one) which are calculated as terbacil in or on watermelons
at 0.4 parts per million (ppm). This tolerance will expire and is
revoked on May 31, 1998. After May 31, 1998, EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(I) allows EPA to establish a tolerance
(the legal limit for a pesticide chemical residue in or on a food) only
if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Terbacil on Watermelons and FFDCA
Tolerances
Between November 4 and December 3, 1996, Departments of Agriculture
from three states, Delaware, Maryland, and Virginia, each requested a
specific exemption under FIFRA section 18 for the use of terbacil to
control weeds in watermelons. They asserted that no efficacious
pesticide is registered under section 3 of FIFRA for control of weeds
in watermelons. This situation was caused by the suspension of dinoseb
in 1987. They also said that growers will experience significant
economic loss if the weeds are not controlled. After having reviewed
their submission, EPA concurs that an emergency condition exists.
As part of its assessment of these applications for emergency
exemption, EPA assessed the potential risks presented by residues of
terbacil on watermelons. In doing so, EPA considered the new safety
standard in FFDCA section 408(b)(2), and EPA decided to grant the
section 18 exemptions only after concluding that the necessary
tolerance under FFDCA section 408(l)(6) would clearly be consistent
with the new safety standard and with FIFRA section 18. This tolerance
for terbacil will permit the marketing of watermelons treated in
accordance with the provisions of the section 18 emergency exemptions.
Consistent with the need to move quickly on the emergency exemptions
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment under section 408(e) as provided in section 408(l)(6). 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 terbacil meets the
requirements for registration under FIFRA section 3 for use on
watermelons or whether permanent tolerances for terbacil for
watermelons would be appropriate. This action by EPA does not serve as
a basis for registration of terbacil by a State for special local needs
under FIFRA section 24(c). Nor does this action serve as the basis for
any State other than Delaware, Maryland, and Virginia to use this
product on watermelons under section 18 of FIFRA without following all
provisions of section 18 as identified in 40 CFR 180.166. For
additional information regarding the emergency exemptions for terbacil,
contact the Agency's
[[Page 33559]]
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 watermelons is treated by pesticides that have established
tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk
that is greater than approximately one in a million, EPA attempts to
derive a more accurate exposure estimate for the pesticide by
evaluating additional types of information (anticipated residue data
and/or percent of watermelons treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Terbacil is not registered by EPA for indoor or outdoor
residential use. Existing food and feed use tolerances for terbacil are
listed in 40 CFR 180.209. EPA has sufficient data to assess the hazards
of terbacil and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for the time-limited tolerances for
residues of terbacil in or on watermelons at 0.4 ppm. EPA's assessment
of the dietary exposures and risks associated with establishing these
tolerances follows.
A. Toxicological Profile
1. Dietary endpoint selection--i. Acute risk. For acute dietary
risk assessment, the Agency selected the NOEL of 12.5 milligrams/
kilograms/day (mg/kg/day) from the developmental study in rats. This
was based on a decrease in the number of implants and a decrease in the
number of live fetuses at the LEL of 62.5 mg/kg/day. This risk
assessment will evaluate acute dietary risk to females age 13+.
ii. Chronic risk. The RfD of 0.013 mg/kg/day was established based
on a chronic dog study with a NOEL of 1.25 mg/kg/day and an uncertainty
factor of 100 based on increased thyroid:body weight ratio, slight
increase in liver weight and elevated alkaline phosphatase at the LEL
of 6.25 mg/kg/day.
iii. Cancer risk. Terbacil has been classified as a Group E
chemical (evidence of noncarcinogenicity for humans) by the RfD
Committee.
iv. Infants and children--a. Developmental studies--(1) Rat. From
the rat developmental study, the maternal (systemic) NOEL was 12.5 mg/
kg/day, based on decreased body weight at the lowest observed effect
level (LOEL) of 62.5 mg/kg/day. The developmental (pup) NOEL was 12.5
mg/kg/day, based on decreased number of implantations and live fetuses
at the LOEL of 62.5 mg/kg/day.
(2) Rabbit. From the rabbit developmental study, the maternal
(systemic) NOEL was 200 mg/kg/day, based on decreased weight gain at
the LOEL of 600 mg/kg/day. The developmental (pup) NOEL was 600 mg/kg/
day (highest dose tested).
b. Reproduction studies. Rat - From the rat reproduction study, the
parental (systemic) LOEL was 2.5 mg/kg/day [lowest dose tested], based
on decreased body weight. The reproductive/developmental (pup) NOEL was
12.5 mg/kg/day [highest dose tested].
B. Aggregate Exposure and Risk
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses).
The nature of the residue in plants is adequately understood for
the purposes of this section 18 request. The residues of concern are
terbacil and its three metabolites (all calculated as terbacil).
Tolerances currently exist for residues on more than a dozen
commodities (see 40 CFR 180.209). Residues of terbacil and its
regulated metabolites are not
[[Page 33560]]
expected to exceed 0.4 ppm in watermelons as a result of this use.
For purposes of assessing the potential dietary exposure under this
tolerance, EPA assumed tolerance level residues and 100 percent of crop
treated to estimate the TMRC from all established food uses for
terbacil (for more than a dozen commodities) and the proposed use on
watermelons. There are no watermelon animal feed items so no residue
levels in animal commodities potentially resulting from feeding of
these commodities were considered.
Because terbacil is very persistent and very mobile, there is
potential for terbacil to leach to ground water and to subsequently be
ingested in drinking water. In fact, terbacil has been found in
groundwater. The document ``Pesticides in Groundwater Database'' EPA
734-12-92-001, September 1992 cites data that 6 wells out of 288 tested
positive for terbacil at levels up to 0.009 ppm. However detections
were at levels well below the Health Advisory Levels (1-day, 0.3 ppm,
10-day, 0.3 ppm, and lifetime, 0.09 ppm).
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk assessment for many
pesticides, EPA has commenced and nearly completed a process to
identify a reasonable yet conservative bounding figure for the
potential contribution of water-related exposure to the aggregate risk
posed by a pesticide. In developing the bounding figure, EPA estimated
residue levels in water for a number of specific pesticides using
various data sources. The Agency then applied the estimated residue
levels, in conjunction with appropriate toxicological endpoints (RfD's
or acute dietary NOEL's) and assumptions about body weight and
consumption, to calculate, for each pesticide, the increment of
aggregate risk contributed by consumption of contaminated water. While
EPA has not yet pinpointed the appropriate bounding figure for
consumption of contaminated water, the ranges the Agency is continuing
to examine are all well below the level that would cause terbacil to
exceed the RfD if the tolerances being considered in this document were
granted. The Agency has therefore concluded that the potential
exposures associated with terbacil in water, even at the higher levels
the Agency is considering as a conservative upper bound, would not
prevent the Agency from determining that there is a reasonable
certainty of no harm if the tolerances are granted.
The Agency identified both acute and chronic duration of exposure
as appropriate for aggregate risk assessment. For acute exposure, this
estimate does not exceed the Agency's level of concern (MOE <100). for="" females="" 13+="" years="" (the="" population="" subgroup="" of="" concern),="" the="" resulting="" high-end="" exposure="" estimate="" is="" 0.005="" mg/kg/day.="" this="" results="" in="" a="" dietary="" (food="" only)="" moe="" of="" 2,500.="" this="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" dietary="" food="" and="" water="" only.="" the="" acute="" dietary="" (food="" only)="" risk="" assessment="" used="" tolerance="" level="" residues="" and="" assumed="" 100%="" crop="" treated.="" therefore="" this="" estimate="" should="" be="" viewed="" as="" a="" conservative="" risk="" estimate.="" for="" aggregate="" chronic="" risk="" (food="" plus="" drinking="" water),="" the="" agency="" estimates="" do="" not="" exceed="" the="" rfd="" for="" terbacil.="" for="" example,="" for="" non-="" nursing="" infants=""><1 year="" old),="" the="" population="" subgroup="" most="" highly="" exposed,="" the="" agency="" estimated="" that="" up="" to="" 72%="" of="" the="" rfd="" may="" be="" occupied="" by="" exposure="" to="" terbacil="" with="" risk="" from="" residues="" potentially="" present="" in="" water="" assumed="" to="" account="" for="" 10%="" of="" the="" total="" allowable="" chronic="" and="" acute="" risk="" until="" further="" data="" are="" provided.="" estimates="" for="" other="" population="" subgroups="" were="" much="" less.="" the="" agency="" used="" the="" following="" formula="" to="" estimate="" risk.="" the="" aggregate="" chronic="" risk="" is="" equal="" to="" the="" sum="" of="" the="" chronic="" risk="" from="" exposure="" from="" food="" +="" water="" +="" residential="" (indoor="" and="" outdoor)="" uses.="" since="" terbacil="" is="" not="" registered="" for="" any="" residential="" uses,="" no="" exposure="" from="" this="" route="" is="" expected="" and="" thus="" not="" considered="" this="" estimate.="" c.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" pesticide's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" terbacil="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" terbacil="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" terbacil="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" subtances.="" d.="" safety="" determinations="" for="" u.s.="" population="" based="" on="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" tmrc="" dietary="" exposure="" assumptions,="" epa="" has="" concluded="" that="" dietary="" exposure="" from="" food="" to="" terbacil="" will="" utilize="" 23="" percent="" of="" the="" rfd="" for="" the="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" whatever="" reasonable="" bounding="" figure="" the="" agency="" eventually="" decides="" upon="" for="" the="" contribution="" from="" water,="" that="" number="" is="" expected="" to="" be="" well="" below="" 99%="" of="" the="" rfd.="" epa="" [[page="" 33561]]="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" terbacil="" residues.="" e.="" determination="" of="" safety="" for="" infants="" and="" children="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" in="" either="" case,="" epa="" generally="" defines="" the="" level="" of="" appreciable="" risk="" as="" exposure="" that="" is="" greater="" than="" 1/100="" of="" the="" noel="" in="" the="" animal="" study="" appropriate="" to="" the="" particular="" risk="" assessment.="" this="" 100-fold="" uncertainty="" (safety)="" factor/margin="" of="" exposure="" (safety)="" is="" designed="" to="" account="" for="" combined="" inter-="" and="" intra-species="" variability.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" 100-fold="" margin/factor="" not="" the="" additional="" tenfold="" margin/factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" margin/factor.="" based="" on="" current="" toxicological="" data="" requirements,="" the="" data="" base="" for="" terbacil="" relative="" to="" pre-="" (provided="" by="" rat="" and="" rabbit="" developmental="" studies)="" and="" post-natal="" (provided="" by="" the="" rat="" reproduction="" study)="" toxicity="" is="" complete.="" in="" assessing="" the="" adequacy="" of="" the="" standard="" uncertainty="" factor="" for="" terbacil,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" in="" the="" rat="" developmental="" study,="" the="" noel="" and="" loel="" for="" developmental="" and="" maternal="" effects="" occurred="" at="" the="" same="" levels="" (12.5="" and="" 62.5="" mg/kg/="" day,="" respectively).="" the="" agency="" notes="" that="" the="" effects="" seen="" at="" the="" loel="" were="" more="" severe="" in="" the="" pups="" than="" the="" maternal="" effects.="" this="" indicates="" a="" potential="" special,="" pre-natal="" sensitivity.="" the="" results="" of="" the="" rabbit="" developmental="" study="" demonstrated="" that="" there="" were="" no="" developmental="" effects="" up="" to="" 600="" mg/kg/day="" (highest="" dose="" tested).="" there="" was="" no="" evidence="" of="" post-natal="" toxicity="" to="" infants="" and="" children,="" since="" the="" pup="" noel="" was="" 12.5="" mg/kg/day="" [highest="" dose="" tested]="" in="" the="" 2-generation="" rat="" reproduction="" study.="" the="" acute="" dietary="" moe="" for="" females="" 13+="" years="" was="" 2,500.="" this="" moe="" is="" considered="" sufficient="" to="" protect="" infants="" and="" children="" against="" a="" pre-="" and="" post-natal="" toxicity="" from="" aggregate="" exposure="" to="" terbacil.="" opp="" believes="" that="" reliable="" data="" show="" that="" the="" standard="" uncertainty="" factor="" will="" be="" protective="" of="" the="" safety="" of="" infants="" and="" children="" and="" an="" additional="" uncertainty="" factor="" is="" not="" needed.="" based="" on="" tmrc="" exposure="" estimates="" for="" food,="" as="" described="" above,="" epa="" has="" concluded="" that="" the="" percentage="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" dietary="" exposure="" to="" residues="" of="" terbacil="" does="" not="" exceed="" 100%="" of="" the="" rfd="" for="" any="" of="" the="" population="" subgroups.="" estimates="" range="" from="" 20="" percent="" for="" nursing="" infants="" up="" to="" 62="" percent="" for="" non-nursing="" infants="" (the="" most="" highly="" exposed="" population="" subgroup).="" 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="" terbacil="" residues.="" v.="" other="" considerations="" the="" metabolism="" of="" terbacil="" in="" plants="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" there="" is="" no="" codex="" maximum="" residue="" level="" established="" for="" residues="" of="" terbacil="" on="" watermelons.="" there="" is="" a="" practical="" analytical="" method="" (gc/elcd)="" for="" detecting="" and="" measuring="" levels="" of="" terbacil="" in="" or="" on="" food="" with="" a="" limit="" of="" detection="" that="" allows="" monitoring="" of="" food="" with="" residues="" at="" or="" above="" the="" level="" set="" by="" the="" terbacil="" tolerance="" (method="" ii="" of="" pam="" vol.="" ii).="" epa="" has="" provided="" information="" on="" this="" method="" to="" fda.="" the="" method="" is="" available="" to="" anyone="" who="" is="" interested="" in="" pesticide="" residue="" enforcement="" from:="" by="" mail,="" calvin="" furlow,="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" crystal="" mall="" #2,="" rm.="" 1128,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 22202,="" 703-="" 305-5805.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" terbacil="" in="" or="" on="" watermelons="" at="" 0.4="" ppm.="" these="" tolerances="" will="" expire="" and="" be="" revoked="" by="" epa="" on="" may="" 30,="" 1998.="" no="" further="" action="" will="" be="" taken="" by="" epa="" to="" revoke="" these="" tolerances="" after="" the="" expiration="" of="" their="" term="" other="" than="" publishing="" a="" notification="" that="" the="" revocation="" has="" occurred.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" august="" 19,="" 1997,="" 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="" [[page="" 33562]]="" 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="" control="" number="" opp-300348.="" a="" public="" version="" of="" this="" record,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" 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),="" the="" agency="" must="" determine="" whether="" the="" regulatory="" action="" is="" ``significant''="" and="" therefore="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget="" (omb)="" and="" the="" requirements="" of="" the="" executive="" order.="" under="" section="" 3(f),="" the="" order="" defines="" ``a="" significant="" regulatory="" action''="" as="" an="" action="" that="" is="" likely="" to="" result="" in="" a="" rule:="" (1)="" having="" an="" annual="" effect="" on="" the="" economy="" of="" $100="" million="" or="" more,="" or="" adversely="" and="" materially="" affecting="" a="" sector="" of="" the="" economy,="" productivity,="" competition,="" jobs,="" the="" environment,="" public="" health="" or="" safety,="" or="" state,="" local="" or="" tribal="" governments="" or="" communities="" (also="" referred="" to="" as="" ``economically="" significant'');="" (2)="" creating="" serious="" inconsistency="" or="" otherwise="" interfering="" with="" an="" action="" taken="" or="" planned="" by="" another="" agency;="" (3)="" materially="" altering="" the="" budgetary="" impacts="" of="" entitlement,="" grants,="" user="" fees,="" or="" loan="" programs="" or="" the="" rights="" and="" obligations="" thereof;="" or="" (4)="" raising="" novel="" legal="" or="" policy="" issues="" arising="" out="" of="" legal="" mandates,="" the="" president's="" priorities,="" or="" the="" principles="" set="" forth="" in="" this="" executive="" order.="" pursuant="" to="" the="" terms="" of="" this="" executive="" order,="" epa="" has="" determined="" that="" this="" rule="" is="" not="" ``significant''="" and="" is="" therefore="" not="" subject="" to="" omb="" review.="" this="" action="" does="" not="" impose="" any="" enforceable="" duty,="" or="" contain="" any="" ``unfunded="" mandates''="" as="" described="" in="" title="" ii="" of="" the="" unfunded="" mandates="" reform="" act="" of="" 1995="" (pub.="" l.="" 104-4),="" or="" require="" prior="" consultation="" as="" specified="" by="" executive="" order="" 12875="" (58="" fr="" 58093,="" october="" 28,="" 1993),="" entitled="" ``enhancing="" the="" intergovernmental="" partnership,''="" or="" special="" consideration="" as="" required="" by="" executive="" order="" 12898="" (59="" fr="" 7629,="" february="" 16,="" 1994).="" because="" ffdca="" section="" 408(l)(6)="" permits="" establishment="" of="" this="" regulation="" without="" a="" notice="" of="" proposed="" rulemaking,="" the="" regulatory="" flexibility="" analysis="" requirements="" of="" the="" regulatory="" flexibility="" act,="" 5="" u.s.c.="" 604(a),="" do="" not="" apply.="" nonetheless,="" the="" agency="" has="" previously="" assessed="" whether="" establishing="" tolerances="" or="" exemptions="" from="" tolerance,="" raising="" tolerance="" levels,="" or="" expanding="" exemptions="" adversely="" impact="" small="" entities="" and="" concluded,="" as="" a="" generic="" matter,="" that="" there="" is="" no="" adverse="" impact.="" (46="" fr="" 24950)="" (may="" 4,="" 1981).="" under="" 5="" u.s.c.="" 801(a)(1)(a)="" of="" the="" small="" business="" regulatory="" enforcement="" fairness="" act="" of="" 1996="" (title="" ii="" of="" pub.="" l.="" 104-121,="" 110="" stat.="" 847),="" epa="" submitted="" a="" report="" containing="" this="" rule="" and="" other="" required="" information="" to="" the="" u.s.="" senate,="" the="" u.s.="" house="" of="" representatives="" and="" the="" comptroller="" general="" of="" the="" general="" accounting="" office="" prior="" to="" publication="" of="" the="" rule="" in="" today's="" federal="" register.="" this="" rule="" is="" not="" a="" ``major="" rule''="" as="" defined="" by="" 5="" u.s.c.="" 804(2).="" list="" of="" subjects="" in="" 40="" cfr="" part="" 180="" environmental="" protection,="" administrative="" practice="" and="" procedure,="" agricultural="" commodities,="" pesticides="" and="" pests,="" reporting="" and="" recordkeeping="" requirements.="" dated:="" june="" 9,="" 1997.="" james="" jones,="" acting="" director,="" registration="" division,="" office="" of="" pesticide="" programs.="" therefore,="" 40="" cfr="" chapter="" i="" is="" amended="" as="" follows:="" part="" 180="" [amended]="" 1.="" the="" authority="" citation="" for="" part="" 180="" continues="" to="" read="" as="" follows:="" authority:="" 21="" u.s.c.="" 346a="" and="" 371.="" 2.="" by="" revising="" 180.209="" to="" read="" as="" follows:="" sec.="" 180.209="" terbacil;="" tolerances="" for="" residues.="" (a)="" general.="" (1)="" tolerances="" are="" established="" for="" residues="" of="" the="" herbicide="" terbacil="" (3-tert-butyl-5-chloro-6-methyluracil)="" in="" or="" on="" the="" following="" raw="" agricultural="" commodities:="" ------------------------------------------------------------------------="" commodity="" parts="" per="" million="" ------------------------------------------------------------------------="" apples...............................................="" 0.1="" citrus="" fruits........................................="" 0.1="" peaches..............................................="" 0.1="" pears................................................="" 0.1="" sugarcane............................................="" 0.1="" ------------------------------------------------------------------------="" (2)="" tolerances="" are="" established="" for="" combined="" residues="" of="" the="" herbicide="" terbacil="" (3-tert-butyl-5-chloro-6-methyluracil)="" and="" its="" metabolites="" 3-tert-butyl-5-chloro-6-hydroxymethyluracil,="" 6-chloro-2,="" 3-="" dihydro-7-hydroxymethyl-3,3-dimethyl-5h-oxazolo="" (3,2-a)="" pyrimidin-5-="" one,="" and="" 6-chloro-2,3-dihydro-3,3,="" 7-trimethyl-5h-oxazolo="" (3,2-a)="" pyrimidin-5-one="" (calculated="" as="" terbacil)="" in="" or="" on="" raw="" agricultural="" commodities="" as="" follows:="" ------------------------------------------------------------------------="" commodity="" parts="" per="" million="" ------------------------------------------------------------------------="" alfalfa,="" forage......................................="" 5.0="" alfalfa,="" hay.........................................="" 5.0="" asparagus............................................="" 0.2="" blueberries..........................................="" 0.1="" caneberries="" (blackberries,="" boysenberries,="" dewberries,="" loganberries,="" raspberries,="" and="" youngberries)........="" 0.1="" cattle,="" fat..........................................="" 0.1="" cattle,="" mbyp.........................................="" 0.1="" cattle,="" meat.........................................="" 0.1="" goats,="" fat...........................................="" 0.1="" goats,="" mbyp..........................................="" 0.1="" goats,="" meat..........................................="" 0.1="" hogs,="" fat............................................="" 0.1="" hogs,="" mbyp...........................................="" 0.1="" hogs,="" meat...........................................="" 0.1="" horses,="" fat..........................................="" 0.1="" horses,="" mbyp.........................................="" 0.1="" horses,="" meat.........................................="" 0.1="" milk,="" fat="" (="0.1" in="" whole="" milk).......................="" 0.5="" mint="" hay="" (peppermint="" and="" spearmint)..................="" 2.0="" pecans...............................................="" 0.1="" sainfoin,="" forage.....................................="" 5.0="" sainfoin="" hay.........................................="" 5.0="" sheep,="" fat...........................................="" 0.1="" sheep,="" mbyp..........................................="" 0.1="" [[page="" 33563]]="" sheep,="" meat..........................................="" 0.1="" strawberries.........................................="" 0.1="" ------------------------------------------------------------------------="" (b)="" section="" 18="" emergency="" exemptions.="" time="" limited="" tolerances="" are="" established="" for="" residues="" of="" the="" herbicide="" terbacil="" (3-tert-butyl-5-="" chloro="" -6-methyluracil="" and="" its="" three="" metabolites="" 3-tert-butyl-5-chloro-="" 6-hydroxymethyluracil,="" 6-chloro-2,="" 3-dihydro-7-hydroxymethyl="" 3,3-="" dimethyl-5h-oxazolo="" (3,2-a)="" pyrimidin-5-one,="" and="" 6-chloro-2,3-dihydro-="" 3,3,7-trimethyl-5h-oxazolo="" (3,2-a)="" pyrimidin-5-one),="" calculated="" as="" terbacil,="" in="" connection="" with="" use="" of="" the="" pesticide="" under="" section="" 18="" emergency="" exemptions="" granted="" by="" epa.="" the="" tolerance="" is="" specified="" in="" the="" following="" table.="" the="" tolerance="" expires="" and="" will="" be="" revoked="" by="" epa="" on="" the="" date="" specified="" in="" the="" table.="" ------------------------------------------------------------------------="" expiration/="" commodity="" parts="" per="" revocation="" million="" date="" ------------------------------------------------------------------------="" watermelon....................................="" 0.4="" 5/30/98="" ------------------------------------------------------------------------="" (c)="" tolerances="" with="" regional="" registration.="" [reserved]="" (d)="" indirect="" or="" inadvertent="" residues.="" [reserved]="" [fr="" doc.="" 97-16214="" filed="" 6-19-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">