[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: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
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:
[email protected].
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:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
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