[Federal Register Volume 63, Number 241 (Wednesday, December 16, 1998)]
[Rules and Regulations]
[Pages 69200-69205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33120]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300762; FRL-6048-1]
RIN 2070-AB78
Bifenthrin; 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 bifenthrin in or on citrus, whole fruit; citrus oil; and
citrus dried pulp. 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
bifenthrin on citrus. This regulation establishes a maximum permissible
level for residues of bifenthrin 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 tolerance will
expire and is revoked on December 31, 2000.
DATES: This regulation is effective December 16, 1998. Objections and
requests for hearings must be received by EPA on or before February 16,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300762], 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-300762], 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
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-300762]. 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: Barbara Madden, 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) 305-6463, e-mail:
madden.barbara@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 a tolerance for
residues of the insecticide bifenthrin in or on citrus, whole fruit at
0.03 parts per million (ppm); 0.3 ppm for citrus oil; and 0.3 ppm for
citrus dried pulp. This tolerance will expire and is revoked on
December 31, 2000. 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) 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 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 Bifenthrin on Citrus and FFDCA
Tolerances
Recently Diaprepes root weevil has spread into citrus areas in
Florida. Much of the infested citrus acreage is exhibiting severe
decline or is out of production. Registered controls only provide 75%
control of Diaprepes root
[[Page 69201]]
weevil. That level of control is inadequate to prevent tree or grove
losses, and contain the spread of the pest. EPA has authorized under
FIFRA section 18 the use of bifenthrin on citrus for control of
Diaprepes root weevils. After having reviewed the submission, EPA
concurs that emergency conditions exist.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of bifenthrin in or on
citrus. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance 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 this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on December 31,
2000, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
citrus 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 a level that was authorized by this tolerance at the time of
that application. 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.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether bifenthrin meets EPA's
registration requirements for use on citrus or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of bifenthrin by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than Florida 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
bifenthrin, 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 bifenthrin
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for time-limited tolerances for residues of
bifenthrin on citrus, whole fruit at 0.03 ppm; citrus oil at 0.3 ppm;
and citrus dried pulp at 0.3 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance 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 bifenthrin are
discussed below.
1. Acute toxicity. The acute reference dose (RfD) of 0.01
milligram/kilogram/day (mg/kg/day) was established based on a maternal
no observable adverse effect level (NOAEL) of 1 mg/kg/day from a
developmental toxicity study in rats. At the lowest observable adverse
effect level (LOAEL) of 2 mg/kg/day, tremors from day 7-17 of dosing
were observed. An uncertainty factor of 100 (10X for inter-species
extrapolation and 10X for intra-species variability) was applied to the
NOAEL of 1 mg/kg/day to calculate the acute RfD of 0.01 mg/kg/day. EPA
has determined that the 10X factor to account for enhanced
susceptibility of infants and children (as required by FQPA) can be
removed. This determination is based on the results of reproductive and
developmental toxicity studies. No evidence of additional sensitivity
to young rats or rabbits was observed following pre- or post-natal
exposure to bifenthrin.
2. Short - and intermediate - term toxicity. The maternal NOAEL of
1 mg/kg/day from the oral developmental toxicity study in rats
(discussed in Unit A. 1. of this preamble) was also identified as the
toxicological endpoints for short- or intermediate-term dermal and
inhalation toxicity. A dermal absorption rate of 25%, based on the
weight-of-the-evidence available for structurally-related pyrethroids,
is appropriate for dermal risk assessments. One-hundred percent
absorption is assumed for inhalation risk assessments. Margin of
exposures (MOEs) of 100 or greater to account for inter-species
extrapolation (10X) and for intra-species variability (10X) are
acceptable.
3. Chronic toxicity. EPA has established the chronic RfD for
bifenthrin at 0.015 mg/kg/day. This RfD is based on the NOAEL of 1.5
mg/kg/day from a chronic toxicity study in dogs. Tremors in both sexes
of dogs were observed at the LOAEL of 3.0 mg/kg/day. An uncertainty
factor of 100 to account for inter-species extrapolation and intra-
species variability was applied to the NOAEL. As discussed in Unit A.
1. of this preamble, EPA has determined that the 10X factor to account
for enhanced susceptibility of infants and children can be removed.
4. Carcinogenicity. Bifenthrin has been classified as a Group C
chemical (possible human carcinogen) based upon urinary bladder tumors
in mice. No Q* was assigned because the RfD approach was recommended
for cancer risk assessment. Based on this recommendation, a
quantitative dietary cancer risk assessment was not performed since,
dietary risk concerns due to long-term consumption of bifenthrin are
adequately addressed by the chronic exposure analysis using the RfD.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.442) for the residues of bifenthrin, in or on a variety of raw
agricultural commodities. Tolerances, in support of registrations,
currently exist for residues of bifenthrin on hops; strawberries; corn
grain, forage, and fodder; cotton seed; and livestock commodities of
cattle, goats, hogs, horses, sheep, and poultry. Additionally, time-
limited tolerances associated with emergency exemptions have been
established for broccoli, cauliflower, cucurbits, and canola. Risk
assessments were conducted by Novigen Sciences, Inc., and reviewed by
EPA, to assess dietary exposures and risks from bifenthrin as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological
[[Page 69202]]
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. An acute dietary (food) risk
assessment was submitted by the petitioner where the Novigen DEEM
(Dietary Exposure Evaluation Model) system Tier 3 (Monte Carlo)
approach was used. This methodology incorporates distributions of
residues and refined percent of crop treated estimates for some crops,
and thus results in refined risk estimates. For citrus, it was assumed
100% crop treated and half of the limit of detection (LOD) value, (0.01
ppm) was used in this Monte Carlo analysis. This acute dietary exposure
analysis from food sources was conducted using the acute RfD of 0.01
mg/kg/day. The analysis evaluated individual food consumption as
reported by respondents in the USDA Continuing Surveys of Food Intake
by Individuals conducted in 1989 through 1992. The model accumulated
exposure to bifenthrin for each commodity and expresses risk as a
function of dietary exposure. For the most highly exposed population
subgroup, Children 1-6 years old, the resulting high-end exposure (at
the 99.9th percentile) results in a dietary (food only) percentage of
the acute RfD at 80%. For the overall U.S. Population, the high-end
exposure (99.9th percentile) percentage of the acute RfD is 50%.
ii. Chronic exposure and risk. This chronic dietary exposure
analysis from food sources was conducted using the chronic RfD of 0.015
mg/kg bwt/day. In conducting this chronic dietary (food only) risk
assessment, the petitioner used anticipated residue field trial values
and percent crop treated information. A mean field trial residue value
for citrus of 0.005 ppm was used. The analysis evaluates individual
food consumption as reported by respondents in the USDA Continuing
Surveys of Food Intake by Individuals conducted in 1989 through 1992.
The model accumulates exposure to bifenthrin for each commodity and
expresses risk as a function of dietary exposure. The existing
bifenthrin tolerances published, pending, and including the necessary
section 18 tolerances result in chronic dietary risk estimates (food
only) for the U.S. population of 3% of the RfD and the most highly
exposed population subgroup, children, (1-6 years) 9% of the RfD.
2. From drinking water. The Agency lacks sufficient water-related
exposure data to complete a comprehensive drinking water exposure
analysis and risk assessment for bifenthrin. Because the Agency does
not have comprehensive and reliable monitoring data, drinking water
concentration estimates must be made by reliance on some sort of
simulation or modeling. To date, there are no validated modeling
approaches for reliably predicting pesticide levels in drinking water.
The Agency is currently relying on GENEEC and PRZM/EXAMS for surface
water, which are used to produce estimates of pesticide concentrations
in a farm pond and SCI-GROW, which predicts pesticide concentrations in
groundwater. None of these models include consideration of the impact
processing of raw water for distribution as drinking water would likely
have on the removal of pesticides from the source water. The primary
use of these models by the Agency at this stage is to provide a coarse
screen for sorting out pesticides for which it is highly unlikely that
drinking water concentrations would ever exceed human health levels of
concern.
Drinking water levels of comparison (DWLOCs) are calculated and
compared to the models' estimates for both surface and ground water.
DWLOCs are theoretical upper limits on a pesticide's concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, drinking water, and through residential uses. A DWLOC will vary
depending on the toxic endpoint, with drinking water consumption, and
body weights. Different populations will have different DWLOCs. Since
DWLOCs address total aggregate exposure to bifenthrin they are further
discussed in the aggregate risk sections below.
3. From non-dietary exposure. Bifenthrin is currently registered
for use on the following residential non-food sites: turf, home gardens
and pets. Exposure estimates were calculated for the turf use, which is
considered the use pattern with the highest exposure potential for
adults, children (1-6 years) and infants (<1 year).="" moes="" were="" then="" calculated="" for="" each="" exposure="" scenario="" using="" the="" following="" equation:="" moe="NOAEL/Exposure." moes="" for="" short-="" and="" intermediate-term="" oral,="" dermal="" and="" inhalation="" non-dietary="" exposure="" for="" the="" u.s.="" population,="" infants="">< 1="" year)="" and="" children="" (1-6="" years)="" were="" all="" greater="" than="" 100.="" as="" discussed="" in="" unit="" a.="" 2.="" of="" this="" preamble,="" moes="" of="" 100="" or="" greater="" are="" considered="" acceptable.="" 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="" bifenthrin="" 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,="" bifenthrin="" 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="" bifenthrin="" 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).="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" as="" discussed="" earlier,="" no="" monitoring="" data="" are="" available="" for="" drinking="" water.="" therefore,="" for="" acute="" aggregate="" risk,="" a="" dwloc="" was="" calculated="" for="" the="" u.s.="" population.="" dwlocs="" are="" theoretical="" upper="" limits="" on="" a="" pesticide's="" concentration="" in="" drinking="" water="" in="" light="" of="" total="" aggregate="" exposure="" to="" a="" pesticide="" in="" food,="" drinking="" water,="" and="" through="" residential="" uses.="" the="" dwlocs="" was="" calculated="" for="" bifenthrin="" taking="" into="" account="" acute="" exposure="" assumptions="" from="" food.="" exposure="" from="" residential="" uses="" are="" not="" included="" in="" acute="" aggregate="" risk="" estimates.="" for="" purposes="" of="" risk="" assessment,="" the="" estimated="" maximum="" concentration="" of="" bifenthrin="" in="" surface="" water="" (0.26="" parts="" per="" billion="" (ppb))="" was="" used="" for="" comparison="" to="" the="" back-calculated="" human="" health="" dwloc="" for="" the="" acute="" endpoint.="" for="" bifenthrin,="" it="" was="" determined="" that="" an="" acute="" dietary="" exposure="" (food="" plus="" water)="" of="" 100%="" or="" less="" of="" the="" acute="" rfd="" is="" acceptable="" to="" protect="" the="" safety="" of="" all="" population="" subgroups.="" the="" back-="" calculated="" dwloc="" for="" the="" u.s.="" population="" is="" 180="" ppb="" for="" acute="" dietary="" risk.="" based="" on="" a="" comparison="" of="" the="" calculated="" dwloc="" and="" the="" estimated="" exposure="" to="" bifenthrin="" in="" drinking="" water="" (0.26="" ppb),="" the="" agency="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" acute="" rfd="" for="" adults.="" 2.="" chronic="" risk.="" using="" the="" arc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bifenthrin="" from="" food="" will="" utilize="" 3%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" (1-6="" years),="" discussed="" below.="" epa="" generally="" has="" no="" [[page="" 69203]]="" 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.="" despite="" the="" potential="" for="" exposure="" to="" bifenthrin="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" risk="" takes="" into="" account="" chronic="" dietary="" exposure="" from="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" the="" short-="" and="" intermediate-term="" aggregate="" risks="" are="" estimated="" by="" combining="" exposure="" from="" food,="" water="" and="" residential="" uses="" (in="" this="" case,="" turf="" use).="" for="" adults,="" the="" routes="" of="" exposure="" from="" turf="" use="" include="" dermal="" and="" inhalation.="" as="" with="" the="" acute="" dietary="" aggregate="" risk="" estimate,="" for="" the="" short-="" and="" intermediate-="" term="" aggregate="" risk,="" dwlocs="" were="" calculated.="" for="" purposes="" of="" risk="" assessment,="" the="" estimated="" chronic="" concentration="" of="" bifenthrin="" in="" surface="" water="" (0.018="" ppb)="" were="" used="" for="" comparison="" to="" the="" back-="" calculated="" human="" health="" dwlocs="" for="" both="" the="" short-and="" intermediate-term="" endpoints.="" the="" back-calculated="" dwloc="" for="" the="" u.s.="" population="" is="" 310="" ppb="" for="" short-="" and="" intermediate-term="" risk.="" based="" on="" a="" comparison="" of="" the="" calculated="" dwloc="" and="" the="" estimated="" exposure="" to="" bifenthrin="" in="" drinking="" water="" (0.018="" ppb),="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" adults="" from="" short-="" or="" intermediate-term="" aggregate="" exposure="" to="" bifenthrin.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" as="" discussed="" earlier,="" cancer="" risk="" concerns="" due="" to="" exposure="" of="" bifenthrin="" are="" adequately="" addressed="" by="" the="" chronic="" aggregate="" risk="" analysis.="" 5.="" 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="" bifenthrin="" residues.="" d.="" 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="" bifenthrin,="" 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="" a="" rabbit="" developmental="" toxicity="" study,="" there="" were="" no="" developmental="" effects="" observed="" in="" the="" fetuses="" exposed="" to="" bifenthrin.="" the="" maternal="" noael="" was="" 2.67="" mg/kg/day="" based="" on="" head="" and="" forelimb="" twitching="" at="" the="" loael="" of="" 4="" mg/kg/day.="" in="" the="" rat="" developmental="" study,="" the="" maternal="" noael="" was="" 1="" mg/kg/day,="" based="" on="" tremors="" at="" the="" loael="" of="" 2="" mg/kg/day.="" the="" developmental="" (pup)="" noael="" was="" also="" 1="" mg/kg/day,="" based="" upon="" increased="" incidence="" of="" hydroureter="" at="" the="" loael="" of="" 2="" mg/kg/day.="" there="" were="" 5/23="" (22%)="" of="" the="" litters="" affected="" (5/141="" fetuses="" since="" each="" litter="" only="" had="" one="" affected="" fetus)="" in="" the="" 2="" mg/kg/day="" group,="" compared="" with="" zero="" in="" the="" control,="" 1,="" and="" 0.5="" mg/kg/day="" groups.="" according="" to="" recent="" historical="" data="" (1992-="" 1994)="" for="" this="" strain="" of="" rat,="" background="" incidence="" of="" distended="" ureter="" averaged="" 11%="" with="" a="" maximum="" incidence="" of="" 90%.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" rat="" reproduction="" study,="" parental="" toxicity="" occurred="" as="" decreased="" body="" weight="" and="" tremors="" at="" 5.0="" mg/kg/day="" with="" a="" noel="" of="" 3.0="" mg/kg/day.="" there="" were="" no="" developmental="" (pup)="" or="" reproductive="" effects="" up="" to="" 5.0="" mg/kg/day="" (highest="" dose="" tested).="" iv.="" pre-="" and="" post-natal="" sensitivity--="" a.="" pre-natal.="" since="" there="" was="" not="" a="" dose-related="" finding="" of="" hydroureter="" in="" the="" rat="" developmental="" study="" and="" in="" the="" presence="" of="" similar="" incidences="" in="" the="" recent="" historical="" control="" data,="" the="" marginal="" finding="" of="" hydroureter="" in="" rat="" fetuses="" at="" 2="" mg/kg/day="" (in="" the="" presence="" of="" maternal="" toxicity)="" is="" not="" considered="" a="" significant="" developmental="" finding.="" nor="" does="" it="" provide="" sufficient="" evidence="" of="" a="" special="" dietary="" risk="" (either="" acute="" or="" chronic)="" for="" infants="" and="" children="" which="" would="" require="" an="" additional="" safety="" factor.="" b.="" post-natal.="" based="" on="" the="" absence="" of="" pup="" toxicity="" up="" to="" dose="" levels="" which="" produced="" toxicity="" in="" the="" parental="" animals,="" there="" is="" no="" evidence="" of="" special="" post-natal="" sensitivity="" to="" infants="" and="" children="" in="" the="" rat="" reproduction="" study.="" v.="" conclusion.="" there="" is="" a="" complete="" toxicity="" database="" for="" bifenthrin="" and="" exposure="" data="" is="" complete="" or="" is="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" uncertainty="" factor,="" and="" that="" an="" additional="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" acute="" risk.="" the="" back-calculated="" dwlocs="" for="" children="" (1-6="" years)="" and="" infants=""><1 year)="" are="" 20="" parts="" per="" billion="" (ppb)="" and="" 32="" ppb,="" respectively.="" based="" on="" a="" comparison="" of="" the="" calculated="" dwloc="" and="" the="" estimated="" exposure="" to="" bifenthrin="" in="" drinking="" water="" (0.26="" ppb),="" the="" agency="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" acute="" rfd="" for="" children="" and="" infants.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bifenthrin="" from="" food="" will="" utilize="" 9%="" 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.="" despite="" the="" potential="" for="" exposure="" to="" bifenthrin="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" the="" short-="" and="" intermediate-="" term="" aggregate="" risks="" are="" estimated="" by="" combining="" exposure="" from="" food,="" water="" and="" residential="" uses="" (in="" this="" case,="" turf="" use).="" for="" infants="" and="" children,="" the="" routes="" of="" exposure="" from="" turf="" use="" include="" oral="" (nondietary),="" dermal="" and="" inhalation.="" the="" back-calculated="" dwlocs="" for="" infants="" and="" children="" are="" 77="" ppb="" and="" 70="" ppb,="" respectively.="" based="" on="" a="" comparison="" of="" the="" calculated="" dwlocs="" and="" the="" estimated="" exposure="" to="" bifenthrin="" in="" drinking="" water="" (0.018="" ppb),="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" [[page="" 69204]]="" result="" to="" infants="" and="" children="" from="" short-="" or="" intermediate-term="" aggregate="" exposure="" to="" bifenthrin.="" 5.="" 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="" bifenthrin="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" residue="" of="" concern="" in="" citrus="" is="" the="" parent="" compound="" only.="" therefore,="" the="" agency="" has="" determined="" that="" only="" the="" parent="" compound,="" bifenthrin,="" should="" appear="" in="" the="" tolerance="" expression.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" 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).="" c.="" magnitude="" of="" residues="" residues="" of="" bifenthrin="" per="" se="" are="" not="" expected="" to="" exceed="" 0.05="" ppm="" for="" citrus="" whole="" fruit;="" 0.3="" ppm="" for="" citrus="" oil;="" and="" 0.3="" ppm="" for="" citrus="" dried="" pulp="" as="" a="" result="" of="" the="" section="" 18="" use.="" d.="" international="" residue="" limits="" codex="" has="" established="" mrl's="" for="" bifenthrin="" on="" grapefruit,="" lemon="" and="" sweet="" orange="" at="" 0.05="" ppm.="" no="" canadian="" or="" mexican="" mrl's="" have="" been="" established="" for="" bifenthrin="" on="" citrus.="" the="" recommended="" tolerance="" levels="" for="" bifenthrin="" in/on="" citrus="" are="" harmonized="" with="" codex.="" e.="" rotational="" crop="" restrictions="" rotational="" crop="" restrictions="" are="" not="" applicable="" for="" citrus.="" v.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" residues="" of="" bifenthrin="" in="" citrus,="" whole="" fruit="" at="" 0.05="" ppm;="" 0.3="" ppm="" for="" citrus="" oil;="" and="" 0.3="" ppm="" for="" citrus="" dried="" pulp.="" 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="" february="" 16,="" 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-300762]="" (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 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
[[Page 69205]]
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 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: December 7, 1998.
Arnold E. Layne,
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. In Sec. 180.442, by amending paragraph (b), by alphabetically
adding the following commodities in the table to read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million Revocation Date
------------------------------------------------------------------------
* * * * *
Citrus, dried pulp...................... 0.3 12/31/00
Citrus oil.............................. 0.3 12/31/00
Citrus, whole fruit..................... 0.05 12/31/00
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-33120 Filed 12-15-98; 8:45 am]
BILLING CODE 6560-50-F
