[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: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket 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: [email protected].

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