[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Rules and Regulations]
[Pages 30996-31002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14721]
[[Page 30996]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300495; FRL-5719-3]
RIN 2070-AB78
Bifenthrin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of the pesticide bifenthrin in or on the raw agricultural
commodity crop group, cucurbits (Crop Group 9 - cucumbers, melons, and
squash), and in or on the raw agricultural commodity raspberries, in
connection with EPA's granting of emergency exemptions under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of bifenthrin on cucurbits in California, Arizona, and Texas; and
use of bifenthrin on raspberries in Oregon and Washington. This
regulation establishes maximum permissible levels for residues of
bifenthrin on these commodities pursuant to section 408(l)(6) of the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. These tolerances will expire and are revoked on
April 30, 1998 (cucurbits) and September 30, 1997 (raspberries).
DATES: This regulation becomes effective June 6, 1997. Objections and
requests for hearings must be received by EPA on August 5, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300495], 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
document control number, [OPP ], should be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), 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. 1132, 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 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-300495]. 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 (7505W), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail:
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA 22202. (703) 308-8791, 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 tolerances for
residues of the pesticide ((2-methyl [1,1'-biphenyl]-3-yl) methyl-3-
(2-chloro-3,3,3,-trifluoro-1-propenyl) -2,2-
dimethylcyclopropanecarboxylate), also referred to in this document as
bifenthrin, in or on cucurbits at 1.0 ppm, and in or on raspberries at
3.0 ppm. These tolerances will expire and be revoked on April 30, 1998
(cucurbits) and September 30, 1997 (raspberries). EPA will publish
documents in the Federal Register to remove the revoked tolerances from
the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. 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) allows EPA to establish a tolerance
(the legal limit for a pesticide chemical residue in or on a food) only
if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption''. This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA
requires EPA to establish a time-limited tolerance or exemption from
the requirement for a tolerance for pesticide chemical residues in food
that will result from the use of a pesticide under an emergency
exemption granted by EPA under section 18 of FIFRA. Such tolerances can
be established without providing notice or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemptions for Bifenthrin and FFDCA Tolerances
Bifenthrin on cucurbits. From November 1996 - January 1997,
requests were received from the California Department of Pesticide
Regulation, and the Arizona and Texas Departments of Agriculture,
(hereafter referred to as the Applicants) for specific exemptions under
FIFRA section 18 for the use of
[[Page 30997]]
bifenthrin to control whiteflies in cucurbits. The Applicants state
that an emergency situation is present due to this recently introduced
pest, its devastating effects on the cucurbit crop, and its resistance
to registered alternatives. The Applicants state that this pest can
have devastating effects on growers' production and revenue. After
having reviewed their submission, EPA concurs that an emergency
condition exists. EPA has authorized under FIFRA section 18, the use of
bifenthrin on cucurbits for control of whiteflies.
Bifenthrin on raspberries. In February 1997, requests were received
from the Oregon and Washington Departments of Agriculture (hereafter
referred to as the Applicants) for specific exemptions under FIFRA
section 18 for the use of bifenthrin to control weevils in raspberries.
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. After having reviewed their submission, EPA
concurs that an emergency condition exists. EPA has authorized under
FIFRA section 18, the use of bifenthrin on raspberries for control of
weevils.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of bifenthrin in or
on cucurbits and raspberries. In doing so, EPA considered the new
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the new safety standard and with FIFRA section 18. These
tolerances for bifenthrin will permit the marketing of cucurbits and
raspberries treated in accordance with the provisions of the section 18
emergency exemptions. Consistent with the need to move quickly on the
emergency exemptions, in order to address urgent non-routine
situations, and to ensure that the resulting food is safe and lawful,
EPA is issuing these tolerances without notice and opportunity for
public comment under section 408(e) as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on April 30, 1998
(cucurbits) and September 30, 1997 (raspberries), under FFDCA section
408(l)(5), residues of bifenthrin not in excess of the amount specified
in the tolerances remaining in or on cucurbits or raspberries after the
dates specified above will not be unlawful, provided the pesticide is
applied during the term of, and in accordance with all the conditions
of, the emergency exemptions. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
EPA has not made any decisions about whether bifenthrin meets the
requirements for registration under FIFRA section 3 for use on
cucurbits and raspberries, or whether permanent tolerances for these
uses would be appropriate. This action by EPA does not serve as a basis
for registration of bifenthrin by a State for special local needs under
FIFRA section 24(c). Nor does this action serve as the basis for any
State other than those specified in this document to use this product
on cucurbits or raspberries under section 18 of FIFRA without following
all provisions of section 18 as identified in 40 CFR 180.166. For
additional information regarding the emergency exemptions, 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. For many
of these 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
hundredfold MOE is based on the same rationale as the hundredfold
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.
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, and other non-
occupational exposures, such as where residues leach into 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. 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
[[Page 30998]]
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.
IV. Aggregate Risk Assessment and Determination of Safety
A. Toxicological Profile
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
these actions. EPA has evaluated the available toxicology data and
considered its validity, completeness, and reliability as well as the
relationship of the result 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 risk. The maternal NOEL of 1 mg/kg/day from the oral
developmental toxicity study in rats is used for acute dietary risk
estimates. The maternal LEL 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
determine acute dietary risks to all population subgroups.
2. Short- and intermediate-term risk. 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). The maternal LEL of this study of 2 mg/kg/day
was based on tremors from day 7-17 of dosing.
3. Chronic risk. Based on available chronic toxicity data, the OPP
has established the RfD for bifenthrin at 0.015 mg/kg/day. The RfD is
based on a 1-year oral feeding study in dogs with a NOEL of 1.5 mg/kg/
day and an uncertainty factor of 100, based on intermittent tremors
observed at the LEL of 3 mg/kg/day.
4. Cancer risk. OPP 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. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses). In
evaluating food exposures, EPA takes into account varying consumption
patterns of major identifiable subgroups of consumers, including
infants and children.
Tolerances for residues of bifenthrin are currently expressed as 2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl) -2,2-dimethylcyclopropanecarboxylate. Tolerances currently
exist for residues on hops; strawberries; corn grain, forage and
fodder; cotton seed; and livestock commodities of cattle, goats, hogs,
horses, sheep, and poultry (see 40 CFR 180.442).
1. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. Drinking water is also considered a component of
the acute dietary exposure; however, EPA generally will not include
residential or other non-dietary exposure as a component of the acute
exposure assessment. Theoretically, it is also possible that a
residential, or other non-dietary exposure could be combined with the
acute total dietary exposure form food and water. However, the Agency
does not believe that aggregating multiple exposure to large amounts of
pesticide residues in the residential environment via multiple products
and routes for a one day exposure is a reasonably probable event. It is
highly unlikely that, in one day, an individual would have multiple
high-end exposures to the same pesticide by treating their lawn and
garden, treating their house via crack and crevice application,
swimming in a pool, and be maximally exposed in the food and water
consumed. Additionally, the concept of an acute exposure as a single
exposure does not allow for including post-application exposures, in
which residues decline over a period of days after application.
Therefore, the Agency believes that residential exposures are more
appropriately included in the short-term exposure scenario. Thus, the
Agency estimates acute risk from dietary exposure only. EPA concluded
that aggregate dietary risk (food plus drinking water) would not exceed
levels of concern.
2. Short- and intermediate-term exposure. Short- and intermediate-
term aggregate exposure takes into account chronic dietary food and
water (considered to be a background exposure) plus indoor and outdoor
residential exposure. The only use that could result in a residential
exposure is the one registered use for bifenthrin as a termiticide. EPA
evaluated information contained in a risk characterization document
produced by the California Environmental Protection Agency, concerning
the use of bifenthrin as a subterranean termiticide. This document
characterized the risks to residents of houses treated with bifenthrin,
from aggregate residential and acute dietary exposure. Exposure was
calculated based on exposure data collected from indoor air monitoring
data, with the absorbed dose from residential exposure converted to an
oral equivalent, for comparison with the NOEL derived from an oral
dosing study. Dietary exposure assessment assumed maximum anticipated
residue levels resulting from the registration on cotton, and secondary
meat/milk/poultry expected residue levels were extrapolated based on
feeding studies. Although the California risk assessment document did
not include dietary exposure resulting from bifenthrin use oin corn and
hops, because of the low tolerance for corn grain (0.05 ppm) and low
consumption for hops and strawberries, it is the best scientific
judgment of EPA scientiest that addition of these commodities would not
sufficiently lower the MOEs to levels of concern. Based on this risk
characterization document produced by the California Environmental
Protection Agency, aggregate short- and intermediate-term risks do not
exceed EPA's level of concern.
3. Chronic exposure. The Agency identified chronic exposure as
appropriate for aggregate risk assessment. The aggregate chronic risk
is equal to the sum of the chronic risk from exposure from food + water
+ residential (indoor + outdoor) uses.
i. Dietary food exposure. For purposes of assessing the potential
dietary exposure under this tolerance, EPA used tolerance level
residues and 100% of crop treated to estimate the TMRC from all
established food uses for bifenthrin and the proposed uses on cucurbits
and raspberries. There are no cucurbit or raspberry animal feed items
so no additional dietary livestock dietary burden will result from
these section 18
[[Page 30999]]
uses. Therefore, existing meat/milk/poultry tolerances are adequate.
ii. Drinking water exposure. Based on the available studies used in
EPA's assessment of environmental risk, bifenthrin is moderately
persistent and not mobile. There is no established Maximum
Concentration Level for residues of bifenthrin in drinking water. No
health advisory levels for bifenthrin in drinking water have been
established. The ``Pesticides in Groundwater Database'' (EPA 734-12-92-
001, September 1992) does not contain any information for bifenthrin.
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk assessment for many
pesticides, EPA has commenced and nearly completed a process to
identify a reasonable yet conservative bounding figure for the
potential contribution of water-related exposure to the aggregate risk
posed by a pesticide. In developing the bounding figure, EPA estimated
residue levels in water for a number of specific pesticides using
various data sources. The Agency then applied the estimated residue
levels, in conjunction with appropriate toxicological endpoints (RfD's,
cancer potency factors (Q*s), acute dietary NOEL's) and assumptions
about body weight and consumption, to calculate, for each pesticide,
the increment of aggregate risk contributed by consumption of
contaminated water. While EPA has not yet pinpointed the appropriate
bounding figure for consumption of contaminated water, the ranges the
Agency is continuing to examine are all well below the level that would
cause bifenthrin to exceed the RfD if the tolerances being considered
in this document were granted. The Agency has therefore concluded that
the potential exposures associated with bifenthrin in water, even at
the higher levels the Agency is considering as a conservative upper
bound, would not prevent the Agency from determining that there is a
reasonable certainty of no harm if the tolerances are granted.
iii. Non-dietary, non-occupational exposure. Bifenthrin is not
registered for any residential outdoor uses so no exposure from this
route is expected. However, bifenthrin is registered for residential
use as a termiticide, and the Agency has concluded that a chronic
exposure scenario may exist with respect to this use. The Agency
estimates that aggregate risk (food plus drinking water plus
residential) would not exceed the RfD for bifenthrin.
C. 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, EPA has
considered only risks from bifenthrin. Therefore, EPA has not assumed
that bifenthrin has a common mechanism of toxicity with other
substances.
D. Safety Determinations for U.S. Population
1. Acute risk. The acute risk assessment used anticipated residues
for all commodities having bifenthrin tolerances, except for cucurbits
and raspberries, for which proposed tolerance level residues were used.
Additionally, the assessment assumed that 100% of the commodities for
which there are tolerances, would contain residues of bifenthrin at
these levels. For the most highly exposed population subgroup, children
1 - 6 years old, the high-end exposure results in a dietary (food only)
MOE of 40; at the 97th percentile the MOE is 111. For infants <1 year="" old,="" the="" high-end="" exposure="" moe="" is="" 50;="" at="" the="" 98th="" percentile="" it="" is="" 111.="" for="" the="" u.s.="" population,="" the="" high-end="" exposure="" moe="" is="" 67;="" at="" the="" 99th="" percentile="" it="" is="" 111.="" the="" major="" portion="" of="" the="" estimated="" dietary="" exposure="" from="" bifenthrin="" is="" contributed="" through="" the="" tolerances="" for="" field="" corn="" and="" secondary="" residues="" in="" animal="" commodities="" resulting="" from="" feeding="" of="" the="" treated="" field="" corn.="" this="" assessment="" used="" the="" extremely="" conservative="" assumptin="" that="" 100%="" of="" the="" field="" corn="" and="" livestock="" commodities="" would="" contain="" residues="" of="" bifenthrin.="" however,="" available="" data="" show="" that="" of="" the="" total="" field="" corn="" crop="" grown="" in="" the="" u.s.,="" only="" about="" 0.45="" percent="" was="" actually="" treated="" with="" bifenthrin="" in="" 1994-96="" (3-="" year="" average);="" it="" is="" expected="" that="" a="" similar="" percentage="" will="" be="" treated="" for="" the="" current="" year="" (1997),="" since="" this="" figure="" has="" generally="" remained="" consistent="" for="" the="" past="" three="" years.="" therefore,="" it="" is="" unlikely="" that="" the="" actual="" exposure="" is="" considerably="" less="" than="" the="" conservative="" estimates="" given="" here;="" if="" these="" estimates="" were="" refined="" using="" actual="" percent="" of="" crop="" treated="" figures,="" epa="" scientists="" believe="" that="" the="" moes="" would="" be="" increased="" to="" acceptable="" levels="" for="" the="" high-end="" consumer.="" 2.="" 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="" [[page="" 31000]]="" calculated="" to="" be="" 280="" for="" the="" average="" consumer="" and="" 250="" for="" the="" high-end="" consumer.="" the="" moes="" for="" adults="" are="" 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.="" 3.="" chronic="" risk.="" using="" the="" conservative="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" dietary="" exposure="" to="" bifenthrin="" will="" utilize="" 25%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-="" nursing="" infants=""><1 year="" old),="" at="" 58%="" of="" the="" rfd.="" this="" is="" further="" discussed="" below="" in="" the="" section="" on="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposure="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" bifenthrin="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" bifenthrin="" residues.="" e.="" determination="" of="" safety="" for="" infants="" and="" children="" in="" assessing="" the="" adequacy="" of="" the="" standard="" uncertainty="" factor="" for="" bifenthrin,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit,="" and="" a="" two-generation="" reproductive="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" 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="" moe="" (usually="" 100x="" for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" 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.="" 1.="" developmental="" toxicity="" studies--a.="" rabbit="" study.="" 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.="" b.="" rat="" study.="" 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="" 2="" mg/kg/day.="" there="" were="" 5/23="" (22%)="" 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,="" incidence="" of="" distended="" ureter="" averaged="" 11%="" with="" a="" maximum="" incidence="" of="" 90%.="" c.="" pre-natal="" sensitivity.="" 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.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" hundredfold="" moe/uncertainty="" factor,="" and="" that="" an="" additional="" moe/="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" reproductive="" toxicity="" study--a.="" rat="" study.="" in="" the="" rat="" reproduction="" study,="" parental="" toxicity="" occurred="" as="" decreased="" body="" weight="" 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).="" b.="" post-natal="" sensitivity.="" 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.="" 3.="" acute="" risk.="" the="" 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="" drinking="" water)="" would="" not="" exceed="" levels="" of="" concern.="" acute="" risk="" is="" discussed="" in="" detail="" in="" units="" iv.b.1="" and="" iv.d.1="" of="" this="" document.="" 4.="" short-="" and="" intermediate-term="" risk.="" the="" estimated="" short-="" and="" intermediate-term="" risk="" 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.="" this="" is="" discussed="" in="" greater="" detail="" in="" units="" iv.b.2.="" and="" iv.d.2.="" of="" this="" document.="" 5.="" chronic="" risk.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" of="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" hyuman="" health.="" despite="" the="" potential="" for="" exposure="" in="" drinking="" water,="" epa="" has="" concluded="" that="" the="" percentage="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" dietary="" exposure="" (including="" drinking="" water="" exposure)="" to="" residues="" of="" bifenthrin="" does="" not="" exceed="" 100%="" for="" any="" of="" the="" population="" subgroups.="" using="" the="" conservative="" exposure="" assmuptions="" descibed="" agove,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bifenthrin="" from="" food="" will="" utilize="" 58%="" of="" the="" rfd="" for="" non-nursing="" infants,="" the="" population="" subgroup="" with="" the="" largest="" percentage="" of="" the="" rfd="" occupied.="" therefore,="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" bifenthrin="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" bifenthrin="" in="" cucurbits,="" raspberries,="" and="" animal="" commodities="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" tolerances.="" 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="" (gas="" chromatography="" with="" electron="" capture="" detection="" (gc/="" ecd)="" analytical="" method="" p-2132m,="">0E3921,
MRID41658601). EPA has provided information on this method to
[[Page 31001]]
FDA. The method is available to anyone who is interested in pesticide
residue enforcement from: By mail, Calvin Furlow, Public Inormation and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St. SW., Washington, DC 20460. Office location and telephone
number: Crystal Mall #2, Rm. 1128, 1921 Jefferson Davis Hwy.,
Arlington, VA, 703-305-5805.
C. Magnitude of Residues
Residues of bifenthrin are not likely to exceed 1.0 ppm in or on
cucurbits, or 3.0 ppm in or on raspberries, as a result of the proposed
uses. No animal feed items are associated with either use; therefore,
no secondary residues in meat, milk, poultry, and eggs are expected to
result.
D. Rotational Crop Restrictions
The confined rotational crop data requirements for bifenthrin have
been satisfied. The following rotation instructions are required:
a. Leafy vegetables and root crops may be rotated 30 days following
the final application of bifenthrin.
b. Crops for which bifenthrin tolerances exist may be rotated at
any time.
c. All other crops may be rotated seven months following the final
application of bifenthrin. There are no rotational crop considerations
associated with raspberries.
E. International Residue Limits
There are no Codex, Canadian, or Mexican residue limits for
residues of bifenthrin in or on cucurbits or raspberries.
VI. Conclusion
Therefore, tolerances in connection with the FIFRA section 18
emergency exemptions are established for residues of bifenthrin in or
on cucurbits at 1.0 ppm, and 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 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 August 5, 1997, file written objections to any
aspect of this regulation (including the automatic revocation
provision) 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 Docket
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number [OPP-300495] (including comments and data submitted
electronically as described below). 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 official rulemaking record is located at the Virginia
address in ADDRESSES at the beginning of this document.
Electronic comments can 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. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number [OPP-300495]. Electronic comments on
this rule may be filed online at many Federal Depository Libraries.
IX. Regulatory Assessment Requirements
Under Executive Order 12566 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty, or contain
any unfunded mandates as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with state
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), entitled Enhancing the Intergovernmental Partnership, or
special considerations as required by Executive Order 12898 (59 FR
7629, February 16, 1994).
Because FFDCA section 408(l)(6) permits establishment of this
regulation without a notice of proposed rulemaking, the regulatory
flexibility analysis requirements of the Regulatory Flexibility Act, 5
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously
assessed whether establishing tolerances or exemptions from tolerance,
raising tolerance levels, or expanding exemptions adversely impact
small entities and concluded, as a generic matter, that there is no
adverse impact. (46 FR 24950, May 4, 1981).
Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110
Stat. 847), EPA submitted 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 General Accounting
Office prior to publication of the rule in today's Federal Register.
[[Page 31002]]
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 record
keeping requirements.
Dated: May 22, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By revising Sec. 180.442 to read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
(a) General. Tolerances are established for residues of the
pyrethroid bifenthrin, (2-methyl (1,1-biphenyl)-3-yl) methyl-3-(2-
chloro-3,3,3-trifluoro-1-propenyl) -2,2-
dimethylcyclopropanecarboxylate, in or on the following commodities:
------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
------------------------------------------------------------------------
Cattle, fat................. 1.0 11/15/97
Cattle, mbyp................ 0.10 11/15/97
Cattle, meat................ 0.5 11/15/97
Corn, fodder................ 5.0 11/15/97
Corn, forage................ 2.0 11/15/97
Corn, grain (field, seed,
and pop)................... 0.05 11/15/97
Cottonseed.................. 0.5 11/15/97
Eggs........................ 0.05 11/15/97
Goats, fat.................. 1.0 11/15/97
Goats, mbyp................. 0.10 11/15/97
Goats, meat................. 0.5 11/15/97
Hogs, fat................... 1.0 11/15/97
Hogs, mbyp.................. 0.10 11/15/97
Hogs, meat.................. 0.5 11/15/97
Hops, dried................. 10.0 11/15/97
Horses, fat................. 1.0 11/15/97
Horses, mbyp................ 0.10 11/15/97
Horses, meat................ 0.5 11/15/97
Milk, fat (reflecting 0.1
ppm in whole milk)......... 1.0 11/15/97
Poultry, fat................ 0.05 11/15/97
Poultry, mbyp............... 0.05 11/15/97
Poultry, meat............... 0.05 11/15/97
Sheep, fat.................. 1.0 11/15/97
Sheep, mbyp................. 0.10 11/15/97
Sheep, meat................. 0.5 11/15/97
Strawberries................ 3.00 None
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time limited tolerances are
established for residues of the insecticide bifenthrin ((2-methyl
[1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)
-2,2-dimethylcyclopropanecarboxylate), in connection with use of the
pesticide under section 18 emergency exemptions granted by EPA. The
tolerances will expire and are revoked on the dates specified in the
following table.
------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
------------------------------------------------------------------------
Broccoli.................... 0.1 1/31/98
Cauliflower................. 0.05 1/31/98
Raspberries................. 3.0 9/30/97
Vegetables, cucurbits....... 1.0 4/30/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-14721 Filed 6-5-97; 8:45 am]
BILLING CODE 6560-50-F
