[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: 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 5.1/6.1
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:
schaible.stephen@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov.
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
