[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Rules and Regulations]
[Pages 65073-65078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31546]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300751; FRL 6040-7]
RIN 2070-AB78


Carfentrazone-ethyl; 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 
combined residues of carfentrazone-ethyl and its chloropropionic acid 
metabolite in or on rice, grain and rice, straw. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on rice. This regulation establishes maximum 
permissible levels for residues of carfentrazone-ethyl in this food 
commodity pursuant to section 408(l)(6) of the Federal Food, Drug, and 
Cosmetic Act, as amended by the Food Quality Protection Act of 1996. 
The tolerances will expire and are revoked on October 31, 1999.

DATES: This regulation is effective November 25, 1998. Objections and 
requests for hearings must be received by EPA on or before January 25, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, (OPP-300751), 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-300751, must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), 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. 119, Crystal 
Mall #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 5.1/6.1 
or ASCII file format. All copies of objections and hearing requests in 
electronic form must be identified by the docket control number (OPP-
300751). 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: Stephen Schaible, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9362; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 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 
combined residues of the herbicide carfentrazone-ethyl and its 
chloropropionic acid metabolite, in or on rice, grain at 0.1 part per 
million (ppm) and rice, straw at 1.0 ppm. These tolerances will expire 
and are revoked on October 31, 1999. EPA will publish a document in the 
Federal Register to remove the revoked tolerances 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) of the FFDCA 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 and in residential settings, 
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

[[Page 65074]]

FQPA. EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA 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. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Carfentrazone-ethyl on Rice and FFDCA 
Tolerances

    According to the Applicant, California arrowhead Sagittaria 
montevidensis spp. Calcycina and ricefield bulrush Scirpus mucronatus 
cause economic damage by competing with rice plants for soil, nutrients 
and sunlight, and by interfering with harvesting equipment to reduce 
yields. Resistance to the registered alternative herbicide of choice, 
bensulfuron methyl, has been observed in populations of these weeds. 
Resistance was first reported in 1992, and a survey conducted in 1995 
estimated that 60% of rice fields in California have resistant 
California arrowhead and 15% have resistant ricefield bulrush. Phenoxy 
herbicides such as MCPA or 2,4-D may be used on bensulfuron methyl 
resistant weeds, but are phytotoxic to rice plants. Additionally, 
manufacturers have announced that they will not supply these products 
in the Sacramento Valley, due to persistent concerns about off-target 
applications, drift and damage symptoms on non-target crops, especially 
cotton. Propanil and triclopyr may offer partial control of these 
weeds, but neither is labeled for this use. EPA has authorized under 
FIFRA section 18 the use of carfentrazone-ethyl on rice for control of 
California arrowhead and ricefield bulrush in California. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of carfentrazone-ethyl in or 
on rice, grain and rice, straw. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerances under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although these tolerances will expire and are revoked on 
October 31, 1999, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerances 
remaining in or on rice, grain and rice, straw after that date will not 
be unlawful, provided the pesticide is applied in a manner that was 
lawful under FIFRA, and the residues do not exceed the levels that were 
authorized by these tolerances at the time of that application. EPA 
will take action to revoke these tolerances earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions EPA has not made any decisions about whether carfentrazone-
ethyl meets EPA's registration requirements for use on rice or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of carfentrazone-ethyl by a State for special 
local needs under FIFRA section 24(c). Nor do these tolerances serve as 
the basis for any State other than California to use this pesticide on 
this crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
carfentrazone-ethyl, contact the Agency's Registration Division at the 
address provided above.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the Final Rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action EPA has sufficient data to assess the hazards of 
carfentrazone-ethyl and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
combined residues of carfentrazone-ethyl and its chloropropionic acid 
metabolite on rice, grain and rice, straw at 0.1 ppm and 1.0 ppm, 
respectively. EPA's assessment of the dietary exposures and risks 
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by carfentrazone-ethyl 
are discussed below.
    1. Acute toxicity. For the acute dietary exposure and risk 
assessment, the acute RfD was established at 5 milligrams/kilogram/day 
(mg/kg/day). The no observed adverse effect level (NOAEL) of 500 mg/kg/
day, taken from the acute neurotoxicity study in rats, was based on 
clinical observations (i.e., excessive salivation) and motor activity 
testing at the lowest adverse effect level (LOAEL) of 1,000 mg/kg/day. 
The acute RfD reflects an uncertainty factor of 100, based on 
interspecies extrapolation 10x, intraspecies variability 10x, and the 
Agency determination that the FQPA 10x factor was not required.
    2. Short - and intermediate - term toxicity. The Agency determined 
that short- and intermediate-term dermal risk assessments are not 
required because no systemic toxicity was seen at the limit-dose (1,000 
mg/kg/day) in a 21-day dermal toxicity study in rats. In addition, 
based on the use pattern, long-term dermal exposure is not anticipated, 
therefore the chronic dermal risk assessment is not required.
     Based on the low toxicity and the use pattern (one application at 
0.008-0.031 lbs. a.i./acre/season), the Agency also concluded that a 
risk assessment for inhalation exposure (any time period) is not 
required.
    3. Chronic toxicity. EPA has established the RfD for carfentrazone-
ethyl at 0.03 (mg/kg/day). This RfD is based on a NOAEL of 3 mg/kg/day 
taken from the 2-year chronic toxicity study in rats. Effects observed 
at the LOAEL

[[Page 65075]]

of 12 mg/kg/day include histopathology (increases in microscopic red 
fluorescence of the liver, liver pigment) and total mean urinary 
porphyrin.
    4. Carcinogenicity. Carfentrazone-ethyl has been classified by the 
Agency as a ``not likely'' human carcinogen; there is no evidence of 
carcinogenicity in reviewed studies.

B. Exposures and Risks

    1. From food and feed uses. Permanent tolerances for field corn, 
soybean and wheat commodities were published in the Federal Register on 
September 30, 1998. An amendment to add the remaining commodities in 
the cereal grain crop group is pending with the Agency. Secondary 
residues in animal commodities resulting from this section 18 use are 
expected to be negligible. Risk assessments were conducted by EPA to 
assess dietary exposures and risks from carfentrazone-ethyl as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. Tolerance level residues and 100% crop 
treated were assumed to derive TMRC exposure values; these values 
should be viewed as conservative risk estimates; further refinement 
using anticipated residue values and percent crop-treated data in 
conjunction with Monte Carlo analysis would result in a lower acute 
dietary exposure estimate.
    The existing and proposed food uses of carfentrazone-ethyl result 
in an acute dietary exposure of 0.002 mg/kg/day for the U.S. population 
(0.04% of the acute RfD), 0.003 mg/kg/day for non-nursing infants (< 1 
year) (0.06% of the acute RfD), and 0.001 mg/kg/day for females 13+ 
years ( 0.02% of the acute RfD).
    ii. Chronic exposure and risk. In estimating chronic dietary 
exposure from food uses of carfentrazone-ethyl, it was assumed that 
100% of rice and all other commodities having carfentrazone-ethyl 
tolerances will contain residues and those residues would be at the 
level of the tolerance; these assumptions lead to overestimation of 
human dietary exposure. Thus, in making a safety determination for this 
tolerance, the Agency is taking into account this conservative exposure 
assessment.
     Existing and proposed carfentrazone-ethyl food uses result in a 
TMRC of 0.0003 mg/kg/day (1% of the RfD) for the U.S. population, and 
0.0007 mg/kg/day (2% of the RfD) for both non-nursing infants (< 1 year 
old) and children (1-6 years old), the two subgroups having the highest 
exposure.
    2. From drinking water. The Agency has calculated drinking water 
levels of concern (DWLOCs) for acute and chronic exposure to 
carfentrazone-ethyl in surface and groundwater. The DWLOCs are 
calculated by subtracting from the RfD (acute or chronic) the 
respective acute or chronic dietary exposure attributable to food to 
obtain the acceptable exposure to carfentrazone in drinking water; as 
there are no residential uses of carfentrazone-ethyl at this time, this 
component is not reflected in the calculation. Default body weights (70 
kg for males, 60 kg for females, and 10 kg for non-nursing infants < 1 
year old) and default drinking water consumption estimates (2 L/day for 
adults, 1 L/day for non-nursing infants) are then used to calculate the 
actual DWLOCs. The DWLOC represents the concentration level in surface 
water or groundwater at which aggregate exposure to the chemical is not 
of concern.
    Using generic expected environmental concentration (GENEEC) 
(surface water) and SCI-GROW (groundwater) models, the Agency has 
calculated acute and chronic Tier I estimated environmental 
concentrations (EECs) for carfentrazone-ethyl for use in human health 
risk assessments. These values represent the upper bound estimates of 
the concentrations of carfentrazone-ethyl that might be found in 
surface and ground water assuming the maximum application rate allowed 
on the label. The EECs from these models are compared to the DWLOCs to 
make the safety determination.
    i. Acute exposure and risk. Acute DWLOCs were calculated to be 175 
ppm for the U.S. population, 150 ppm for females 13+ years, and 50 ppm 
for non-nursing infants less than 1 year old. Using the GENEEC model, 
the calculated acute EECs in surface water for carfentrazone-ethyl and 
its chloropropionic acid degradate were 1.2 parts per billion (ppb) and 
2.88 ppb, respectively. Using the SCI-GROW model, the acute EECs in 
groundwater were calculated to be 0.000181 ppb for carfentrazone-ethyl 
and 0.016065 ppb for chloropropionic acid.
    ii. Chronic exposure and risk. Chronic DWLOCs were calculated by 
the Agency to be 1040 ppb for the U.S. population, 891 ppb for females 
13+ years, and 293 ppb for non-nursing infants less than 1 year old. 
Using the GENEEC model, the calculated chronic EECs in surface water 
for carfentrazone-ethyl and its chloropropionic acid degradate were 
0.02 ppb and 2.46 ppb, respectively. Using the SCI-GROW model, the 
chronic EECs in groundwater were calculated to be 0.000181 ppb for 
carfentrazone-ethyl and 0.016065 for chloropropionic acid.
    3. From non-dietary exposure. Carfentrazone-ethyl is a new chemical 
with no registered residential uses. There is no concern for non-
dietary exposure via the dermal or inhalation routes.
    4. 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.''
    EPA does not have, at this time, available data to determine 
whether carfentrazone-ethyl 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, 
carfentrazone-ethyl 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 carfentrazone-ethyl has a 
common mechanism of toxicity with other substances. For more 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the Final Rule for Bifenthrin Pesticide Tolerances 
(62 FR 62961, November 26, 1997)(FRL-5754-7).

C. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Using the TMRC assumptions described above, acute 
dietary exposure from existing and proposed uses of carfentrazone-ethyl 
was calculated to represent 0.4% of the acute RfD for the U.S. 
population and 0.02% of the RfD for females 13+ years. Estimated acute 
or peak EECs in surface water and groundwater of both carfentrazone-
ethyl and its chloropropionic acid degradate are well below the acute 
DWLOCs calculated by the Agency for all population subgroups of 
concern.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to carfentrazone-ethyl 
from food will utilize 1% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate

[[Page 65076]]

exposure is non-nursing infants less than 1 year old (discussed below). 
EPA generally has no concern for exposures below 100% 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. Estimated chronic EECs in surface water and groundwater 
of both carfentrazone-ethyl and its chloropropionic acid degradate are 
well below the chronic DWLOCs calculated by the Agency for all 
population subgroups of concern.
    3. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl 
has been classified by the Agency as a ``not likely'' human carcinogen; 
there is no evidence of carcinogenicity in reviewed studies. This risk 
assessment was not required.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to carfentrazone-ethyl residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of carfentrazone-ethyl, 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 maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    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 database 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 margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard MOE and uncertainty factor (usually 100 for combined 
inter- and intra-species variability)) and not the additional tenfold 
MOE/uncertainty 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 MOE/safety factor.
     ii. Developmental toxicity studies. In the rat study, the maternal 
(systemic) NOAEL was 100 mg/kg/day based on abdominogenital and cage 
liner staining at the LOAEL of 600 mg/kg/day. The developmental (fetal) 
NOAEL was 600 mg/kg/day based on wavy or thickened ribs at the LOAEL of 
1,250 mg/kg/day. In the rabbit developmental toxicity study, the 
maternal (systemic) NOAEL was 150 mg/kg/day based on 
unthriftiness and emaciation in two doses in the current study at the 
LOAEL of 300 mg/kg/day, as well as, dyspnea, decreased locomotion, 
lacrimation, abdominogenital staining, loss of righting reflex, nasal 
discharge, unthriftiness, and dehydration reported in pilot studies at 
350 and 700 mg/kg/day. The developmental (fetal) NOAEL was 
300 mg/kg/day, the highest dose tested.
    iii. Reproductive toxicity study. In the 2-generation rat 
reproduction study, the maternal (systemic) NOAEL was 127 mg/kg/day in 
males and 142 mg/kg/day in females based on decreased body weight 
gains, increased liver weights, liver and bile duct histopathology, and 
reductions in the mean cell volume, hematocrit, and hemoglobin at the 
LOAEL of 343 mg/kg/day in males and 387 mg/kg/day in females.
    iv. Pre- and post-natal sensitivity. Based on the developmental and 
reproductive toxicity studies for carfentrazone-ethyl there does not 
appear to be an extra sensitivity for pre- or post-natal effects. 
Therefore, the Agency has concluded that the 10x safety factor to 
account for potential sensitivity by infants and children to 
carfentrazone-ethyl should be removed.
    v. Conclusion. There is a complete toxicity database for 
carfentrazone-ethyl and exposure data is complete or is estimated based 
on data that reasonably accounts for potential exposures.
    2. Acute risk. Using the TMRC assumptions described above, acute 
dietary exposure from existing and proposed uses of carfentrazone-ethyl 
was calculated to represent 0.06% of the RfD for non-nursing infants 
less than 1 year old, the infant and children subgroup most highly 
exposed. Estimated acute or peak EECs in surface water and groundwater 
of both carfentrazone-ethyl and its chloropropionic acid degradate are 
well below the acute DWLOCs calculated by the Agency for all population 
subgroups of concern.
    3. Chronic risk. Using the exposure assumptions described above, 
EPA has concluded that aggregate exposure to carfentrazone-ethyl from 
food will utilize 2% of the RfD for infants and children. EPA generally 
has no concern for exposures below 100% 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. 
Estimated chronic EECs in surface water and groundwater of both 
carfentrazone-ethyl and its chloropropionic acid degradate are well 
below the chronic DWLOCs calculated by the Agency for all population 
subgroups of concern.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to carfentrazone-ethyl 
residues.

IV. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants and animals is adequately 
understood. The residue of concern is the parent compound 
carfentrazone-ethyl and its chloropropionic acid metabolite.

B. Analytical Enforcement Methodology

     Adequate enforcement methodology is available from the Agency, 
(associated with PP#7F4795) to enforce the proposed tolerance on rice. 
This enforcement method is a GC method that uses ECD (electron capture 
detection), MSD (mass selective detection), ELCD (electrolytic 
conductivity detection), or MS/NCI (negative ion chemical ionization 
mass spectrometry). The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 101FF, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703-305-5229).
     Data on multi-residue methods has been submitted pertaining multi-
residue methods testing for carfentrazone-ethyl. Carfentrazone-ethyl 
was detected under Protocol C using either an ECD or NPD detector. 
Better sensitivity was achieved with ECD detection. Carfentrazone-ethyl 
metabolites were tested using Protocols B and C with ECD detection. 
These data have been forwarded to FDA to be included in PAM I, Appendix 
I.

C. Magnitude of Residues

    Residues of carfentrazone-ethyl and its chloropropionic acid 
metabolite are not expected to exceed 0.10 ppm in/on

[[Page 65077]]

rice, grain and 1.0 ppm in/on rice, straw as a result of this section 
18 use.

D. International Residue Limits

    No Codex, Canadian, and Mexican tolerances are established for 
carfentrazone-ethyl. Therefore, no compatibility problems exist between 
the proposed U.S. and Codex tolerances.

E. Rotational Crop Restrictions

    A 30-day plant-back interval is to be required on the label. The 
recommended time-limited tolerances reflect this restriction.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
carfentrazone-ethyl and its chloropropionic acid metabolite in rice, 
grain at 0.1 ppm and rice, straw at 1.0 ppm.

VI. 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 January 25, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number (OPP-300751) (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, 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 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C) 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
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 which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under FFDCA section 408 
(l)(6). The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerances and exemptions that are established 
under FFDCA section 408 (l)(6), such as the tolerance in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply. Nevertheless, the Agency has previously assessed whether 
establishing tolerances, exemptions from tolerances, raising tolerance 
levels or expanding exemptions might adversely impact small entities 
and concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is

[[Page 65078]]

unfunded, EPA must provide to OMB a description of the extent of EPA's 
prior consultation with representatives of affected State, local, and 
tribal governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide to OMB, in a separately 
identified section of the preamble to the rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the 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: October 21, 1998.

James Jones,
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. In Sec. 180.515 is amended by revising paragraph (b) to read as 
follows:


Sec.  180.515  Carfentrazone-ethyl; tolerances for residues

*    *    *    *    *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for combined residues of the herbicide carfentrazone-ethyl 
and its chloropropionic acid metabolite in connection with use of the 
pesticide under section 18 emergency exemptions granted by EPA. These 
tolerances will expire and are revoked on the dates specified in the 
following table.

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Rice, grain.....................  0.1                 10/31/99
 
Rice, straw.....................  1.0                 10/31/99
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 98-31546 Filed 11-24-98; 8:45 am]
BILLING CODE 6560-50-F