[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Rules and Regulations]
[Pages 37280-37286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18279]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300677; FRL-5797-7]
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 a time-limited tolerance for
residues of bifenthrin in or on raspberries. 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 raspberries. This regulation establishes maximum
permissible levels 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, 1999.
DATES: This regulation is effective July 10, 1998. Objections and
requests for hearings must be received by EPA on or before September 8,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300677], 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-300677], 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, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
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-300677]. 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: Andrea Beard, 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) 308-9356, e-mail:
beard.andrea@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the insecticide bifenthrin, in or on raspberries at 3.0
parts per million (ppm). This tolerance will expire and is revoked on
December 31, 1999. 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 tolerance 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 Raspberries and FFDCA
Tolerances
The Applicants state that an emergency situation is present due to
these pests developing resistance to available alternatives, and the
low tolerance for weevil contamination in raspberries. Rejection by the
processors of contaminated raspberries can lead to significant losses
in revenue for the growers. EPA has authorized under FIFRA section 18
the use of bifenthrin on raspberries for control of weevils in
Washington and Oregon. After having reviewed the submission, EPA
concurs
[[Page 37281]]
that emergency conditions exist for these states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of bifenthrin in or on
raspberries. In doing so, EPA considered the new 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 new 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, 1999, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on raspberries after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA. 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 raspberries 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 Washington and Oregon to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
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. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use inresidential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure,
[[Page 37282]]
and the toxicological endpoint/NOEL is selected to be adequate for at
least 7 days of exposure. (Toxicity results at lower levels when the
dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants, less than 1 year old) was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, 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 a time-limited tolerance for
residues of bifenthrin on raspberries at 3.0 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 maternal NOEL of 1 milligram/kilogram/day
(mg/kg/day) from the oral developmental toxicity study in rats is used
for acute dietary risk assessments. The maternal lowest observable
effect level (LOEL) of this study of 2 mg/kg/day was based on tremors
from day 7-17 of dosing. This acute dietary endpoint is used to
estimate dietary risks to all population subgroups.
2. Short - and intermediate - term toxicity. The maternal NOEL of
1 mg/kg/day from the oral developmental toxicity study in rats is also
used for short- and intermediate-term MOE calculations (as well as
acute, discussed in (1) above).
3. Chronic toxicity. EPA has established the RfD for bifenthrin at
0.015 mg/kg/day. This RfD is based on a 1-year oral feeding study in
dogs with a NOEL of 1.5 mg/kg/day, based on intermittent tremors at the
LOEL of 3 mg/kg/day; an uncertainty factor of 100 is used.
4. Carcinogenicity. OPP has classified bifenthrin as a Group C
chemical (possible human carcinogen) based upon urinary bladder tumors
in mice, but did not recommend assignment of a Q*.
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, raspberries, 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 study has
indicated the possibility of an effect of concern occurring as a result
of a 1 day or single exposure. The acute risk assessment used Monte
Carlo methodology. This methodology incorporates distributions of
residues and refined percent of crop treated estimates, and thus
results in highly refined risk estimates. 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)
MOE of 193; at the 99th percentile the MOE is 1018. For non-nursing
infants <1 year="" old,="" the="" high-end="" exposure="" (at="" the="" 99.9th="" percentile)="" moe="" is="" 590;="" at="" the="" 99th="" percentile="" it="" is="" 880.="" for="" the="" overall="" u.s.="" population,="" the="" high-end="" exposure="" (99.9th="" percentile)="" moe="" is="" 466;="" at="" the="" 99th="" percentile="" it="" is="" 1768.="" the="" moe="" estimates="" are="" all="" well="" within="" acceptable="" limits="" (="">100) for all population subgroups.
ii. Short- and intermediate-term risk. The short- and
intermediate-term risk assessment used maximum anticipated residue
levels for cotton, extrapolated residue levels for meat/milk/poultry/
eggs, and air monitoring data collected from 15 homes in four states.
Based on this data, the MOEs for children are calculated to be 280 for
the average consumer and 250 for the high-end consumer. The MOEs for
adults are
[[Page 37283]]
calculated to be 450 for the average consumer and 390 for the high-end
consumer. EPA generally has no concern for MOEs greater than 100, and
thus these do not exceed EPA's level of concern.
iii. Chronic exposure and risk. The chronic dietary (food only)
risk assessment for bifenthrin was conducted using Monte Carlo
methodology, and thus these risk estimates are highly refined. This
risk assessment estimated that dietary exposure to bifenthrin will
utilize 0.1% of the RfD for the overall U.S. population. The major
identifiable subgroup with the highest exposure is non-nursing infants
<1 year="" old,="" at="" 0.3%="" of="" the="" rfd.="" this="" is="" further="" discussed="" below="" in="" the="" section="" on="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposure="" below="" 100="" percent="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" 2.="" from="" drinking="" water.="" a="" tier="" ii="" drinking="" water="" assessment="" of="" bifenthrin="" was="" conducted,="" using="" computer="" models="" which="" simulate="" the="" fate="" in="" a="" surface="" water="" body.="" the="" estimated="" environmental="" concentrations="" (eecs)="" are="" generated="" for="" high="" exposure="" agricultural="" scenarios="" and="" represent="" one="" in="" ten="" years="" eecs="" in="" a="" stagnant="" pond="" with="" no="" outlet="" that="" receives="" pesticide="" loading="" from="" an="" adjacent="" 100%="" cropped,="" 100%="" treated="" field.="" as="" such,="" these="" computer="" generated="" eecs="" represent="" conservative="" screening="" levels="" for="" ponds="" and="" lakes="" and="" are="" used="" only="" for="" screening.="" the="" eecs="" for="" surface="" water="" ranged="" from="" a="" peak="" of="" 0.260="" part="" per="" billion="" (ppb),="" to="" a="" 90-days="" average="" of="" 0.018="" ppb.="" in="" conducting="" both="" the="" acute="" and="" chronic="" risk="" assessments,="" monte="" carlo="" methodology="" was="" again="" used,="" and="" thus="" these="" risk="" estimates="" are="" considered="" to="" be="" highly="" refined.="" i.="" acute="" exposure="" and="" risk.="" the="" moes="" for="" the="" acute="" risk="" estimate="" from="" drinking="" water="" for="" bifenthrin="" ranged="" from="" 29,035="" for="" the="" most="" highly="" exposed="" population="" subgroup,="" non-nursing="" infants=""><1 yr="" old),="" to="" 131,980="" for="" the="" overall="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" moes="" greater="" than="" 100,="" and="" thus="" these="" risk="" estimates="" are="" well="" within="" acceptable="" limits.="" ii.="" chronic="" exposure="" and="" risk.="" for="" the="" chronic="" risk="" estimates,="" the="" percentage="" of="" rfd="" utilized="" by="" contribution="" through="" drinking="" water="" was="" estimated="" to="" be="" well="" below="" 0.0%="" for="" all="" population="" subgroups.="" 3.="" from="" non-dietary="" exposure.="" bifenthrin="" is="" currently="" only="" registered="" for="" residential="" non-food="" use="" as="" a="" termiticide.="" based="" on="" information="" referred="" to="" above="" regarding="" short-="" and="" intermediate-term="" exposure,="" this="" use="" is="" not="" expected="" to="" result="" in="" risks="" that="" exceed="" levels="" of="" concern.="" therefore,="" reasonable="" certainty="" of="" no="" harm="" is="" expected="" from="" exposure="" through="" non-dietary,="" non-occupational="" 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.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" 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.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" for="" the="" overall="" u.s.="" population,="" the="" calculated="" moe="" value="" (for="" food="" only)="" is="" 466;="" for="" food="" plus="" drinking="" water,="" this="" estimate="" is="" 464.="" for="" the="" most="" highly="" exposed="" subgroup,="" children="" 1="" -="" 6="" years="" old,="" the="" moe="" for="" food="" is="" 193;="" from="" food="" plus="" drinking="" water,="" this="" estimate="" is="" 192.="" as="" stated="" above,="" epa="" generally="" has="" no="" concern="" for="" moes="" greater="" than="" 100,="" and="" thus="" these="" are="" within="" acceptable="" limits.="" therefore,="" epa="" concludes="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" acute="" exposure="" to="" bifenthrin.="" 2.="" chronic="" risk.="" using="" the="" monte="" carlo="" methodology="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bifenthrin="" from="" food="" will="" utilize="" 0.1%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants=""><1 year="" old,="" with="" 0.3%="" of="" the="" rfd="" utilized,="" further="" 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.="" the="" risk="" estimates="" from="" drinking="" water="" exposure="" are="" calculated="" to="" be="" well="" below="" 0.0%="" of="" the="" rfd="" for="" all="" population="" subgroups,="" and="" thus="" do="" not="" add="" appreciably="" to="" the="" estimates="" for="" food="" alone.="" therefore,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" bifenthrin="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" based="" on="" bifenthrin="" not="" being="" registered="" for="" indoor="" residential="" or="" pet="" uses,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" [[page="" 37284]]="" not="" exceed="" levels="" of="" concern,="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result.="" 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="" 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="" 100-="" fold="" safety="" factor="" (usually="" 100="" for="" combined="" inter-and="" intra-species="" variability))="" and="" not="" the="" additional="" tenfold="" safety="" 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="" rabbit="" developmental="" study,="" there="" were="" no="" developmental="" effects="" observed="" in="" the="" fetuses="" exposed="" to="" bifenthrin.="" the="" maternal="" noel="" was="" 2.67="" mg/kg/day="" based="" on="" head="" and="" forelimb="" twitching="" at="" the="" loel="" of="" 4="" mg/kg/day.="" in="" the="" rat="" developmental="" study,="" the="" maternal="" noel="" was="" 1="" mg/kg/day,="" based="" on="" tremors="" at="" the="" loel="" of="" 2="" mg/kg/day.="" the="" developmental="" (pup)="" noel="" was="" also="" 1="" mg/kg/day,="" based="" upon="" increased="" incidence="" of="" hydroureter="" at="" the="" loel="" 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.="" 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.="" epa="" believes="" that="" residential="" exposures="" are="" more="" appropriately="" included="" in="" the="" short-term="" exposure="" scenario,="" and="" thus="" estimates="" acute="" risk="" from="" dietary="" exposure="" only.="" epa="" concluded="" that="" aggregate="" dietary="" acute="" risk="" (food="" plus="" water)="" would="" not="" exceed="" levels="" of="" concern.="" this="" is="" discussed="" in="" greater="" detail="" above.="" 3.="" chronic="" risk.="" using="" the="" monte="" carlo="" methodology="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" estimates="" to="" bifenthrin="" from="" food="" will="" utilize="" from="" 0.1="" to="" 0.3%="" 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.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" bifenthrin="" residues.="" 4.="" short-="" or="" intermediate-term="" risk.="" the="" estimated="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" epa's="" levels="" of="" concern="" for="" children.="" moes="" for="" children="" are="" calculated="" to="" be="" 280="" for="" the="" average="" consumer="" and="" 250="" for="" the="" high-end="" consumer,="" discussed="" in="" greater="" detail="" above.="" there="" is="" generally="" no="" concern="" for="" moes="" which="" are="" greater="" than="" 100.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" bifenthrin="" in="" raspberries="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" the="" residue="" of="" concern="" is="" the="" parent="" compound="" only.="" b.="" analytical="" enforcement="" methodology="" there="" is="" a="" practical="" analytical="" method="" for="" detecting="" and="" measuring="" levels="" of="" bifenthrin="" in="" or="" on="" food="" with="" a="" limit="" of="" detection="" that="" allows="" monitoring="" of="" food="" with="" residues="" at="" or="" above="" the="" levels="" set="" in="" this="" tolerance="" document="" (gas="" chromatography="" with="" electron="" capture="" detection,="" analytical="" method="" p-2132m,="" pp#="" 0e3921;="" mrid#41658601).="" epa="" has="" provided="" information="" on="" this="" method="" to="" fda.="" the="" method="" is="" available="" to="" anyone="" who="" is="" interested="" from="" opp's="" health="" effects="" division="" (7509c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" c.="" magnitude="" of="" residues="" residues="" of="" bifenthrin="" are="" not="" likely="" to="" exceed="" 3.0="" ppm="" in="" or="" on="" raspberries="" as="" a="" result="" of="" the="" proposed="" use.="" secondary="" residues="" are="" not="" expected="" to="" occur="" in="" animal="" commodities.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" residue="" limits="" for="" residues="" of="" bifenthrin="" in="" or="" on="" raspberries.="" e.="" rotational="" crop="" restrictions="" the="" confined="" rotational="" crop="" data="" requirements="" for="" bifenthrin="" have="" been="" satisfied.="" the="" following="" rotation="" instructions="" are="" required:="" (1)="" leafy="" vegetables="" and="" root="" crops="" may="" be="" rotated="" 30="" days="" following="" the="" final="" application="" of="" bifenthrin;="" (2)="" crops="" for="" which="" bifenthrin="" tolerances="" exist="" may="" be="" rotated="" at="" any="" time;="" and="" (3)="" all="" other="" crops="" may="" be="" rotated="" seven="" months="" following="" the="" final="" application="" of="" bifenthrin.="" there="" are="" no="" rotational="" crop="" considerations="" associated="" with="" raspberries.="" vi.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" bifenthrin="" in="" or="" on="" raspberries="" at="" 3.0="" ppm.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" [[page="" 37285]]="" 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="" september="" 8,="" 1998,="" 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="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300677]="" (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.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited 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 these 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.
X. 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: June 24, 1998.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
[[Page 37286]]
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 the table under paragraph (b) by
revising the entry for ``Raspberries'' to read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * * * *
Raspberries..................... 3.0 12/31/99
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-18279 Filed 7-9-98; 8:45 am]
BILLING CODE 6560-50-F
