[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Rules and Regulations]
[Pages 6486-6491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3380]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300452; FRL-5585-1]
RIN 2070-AB78
Bifenthrin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of the insecticide bifenthrin in or on the raw
agricultural commodities broccoli and cauliflower 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 broccoli and cauliflower in California. This regulation
establishes a maximum permissible level for residues of bifenthrin in
these foods 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 be revoked automatically without
further action by EPA on January 31, 1998.
DATES: This regulation becomes effective February 12, 1997. This
regulation expires and is revoked automatically without further action
by EPA on January 31, 1998. Objections and requests for hearings must
be received by EPA on April 14, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300452], 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-300452], should be submitted to: Public
Response and Program Resources Branch, Field Operations 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: [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 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300452]. 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: Margarita Collantes,
Registration Division (7505W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis
Highway, Arlington, VA 22202, (703) 308-8347, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA 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, (2-methyl[1,1'-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3,-
trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate in or on
broccoli at 0.1 parts per million (ppm) and cauliflower at 0.05 ppm.
These tolerances will expire and be revoked automatically without
further action by EPA on January 31, 1998.
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
[[Page 6487]]
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 were discussed
in detail in the final rule establishing a tolerance for an 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, 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Bifenthrin on Broccoli and Cauliflower
and FFDCA Tolerances
The California Department of Pesticide Regulations requested a
specific exemption for use of bifenthrin on broccoli, cabbage,
cauliflower, rapini, leaf lettuce and head lettuce to control the
silverleaf whitefly. California indicates that it still does not have
material that will provide them with satisfactory late season control
of the silverleaf whitefly. The registrant (Bayer Inc.) for the
registered alternative product imidacloprid Admire/Provado does not
want growers to use imidacloprid throughout the growing season in order
to eliminate any potential that the silverleaf whitefly may develop a
resistant gene to imidacloprid. When used as a combination,
Imidacloprid and bifenthrin allowed the growers to maintain the ability
to grow a marketable crop in 1993 and 1994. Without the use of
bifenthrin, the Applicant claims that growers will suffer significant
economic loss this growing season.
Upon review of the economic data submitted for this application,
the expected net revenue for cabbage, head and leaf lettuce, each fall
inside the range of the respective historical variations, implying that
no significant economic loss would occur. However, the net revenue for
cauliflower and broccoli fall outside of the historical range of
variations of net revenue and are therefore expected to result in
significant economic losses and an urgent non-routine situation.
As part of its assessment of these applications for emergency
exemptions, EPA assessed the potential risks presented by residues of
bifenthrin on broccoli and cauliflower. In doing so, EPA considered the
new safety standard in FFDCA section 408(b)(2), and EPA decided to
grant the section 18 exemptions only after concluding 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 broccoli and
cauliflower, treated in accordance with the provisions of the section
18 emergency exemptions. Consistent with the need to move quickly on
the emergency exemptions 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 be revoked
automatically without further action by EPA on January 31, 1998, under
FFDCA section 408(l)(5), residues of bifenthrin not in excess of the
amount specified in the tolerances remaining in or on broccoli and
cauliflower after that date 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 broccoli
or cauliflower or whether a permanent tolerance for bifenthrin for
these crops 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 States other than those listed above to use this product
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 exemptions 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
[[Page 6488]]
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 percent or less of the
RfD) is generally considered by EPA to pose no appreciable risk.
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 Margin of Exposure (MOE) calculation based on the
appropriate NOEL) may 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. 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 percent
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.
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. Bifenthrin is already registered by EPA for numerous food
and feed uses, as well as residential use (ornamentals, houseplants,
turf, pets and inside domestic dwellings). At this time, EPA is not in
possession of a registration application for bifenthrin on broccoli or
cauliflower. However, a petition tolerance for these uses is expected
in 1997. Based on information submitted to the Agency thus far, 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 the time-limited tolerances for residues of bifenthrin on broccoli
at 0.1 ppm and cauliflower at 0.05 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing these tolerances
follows.
A. Toxicological Profile
1. Chronic toxicity. Based on the available chronic toxicity data,
EPA's Office of Pesticide Programs (OPP) has established the RfD for
bifenthrin at 0.015 milligrams(mg)/kilogram(kg)/day. The RfD for
bifenthrin is based on a 1-year feeding study in dogs with a NOEL of
1.5 mg/kg/day and an uncertainty factor of 100. Intermittent tremors
was the effect observed at the Lowest Effect Level (LEL) of 3 mg/kg/
day.
2. Acute toxicity. Based on available acute toxicity data, OPP has
determined that the NOEL of 1 mg/kg/day from the oral developmental
toxicity study in rats should be used to assess risk. The maternal
effects observed at the LEL of 2 mg/kg/day was based on tremors from
day 7 to 17 of dosing. This acute dietary endpoint will determine acute
dietary risks to all subgroups of the population.
3. Short-term toxicity. OPP has determined that a short- and
intermediate-term risk assessment is appropriate for occupational and
residential routes of exposure. OPP recommends that the same NOEL of 1
mg/kg/day, taken from the above acute rat developmental oral toxicity
study be used for these MOE residential calculations. A dermal
penetration of 20 percent (similar to other pyrethroids) should be
employed for worker MOE calculations. OPP did not identify an
inhalation exposure intermediate-term hazard.
4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), the
Carcinogenicity Peer Review Committee (CPRC) has classified bifenthrin
as a Group C chemical, possible human carcinogen, based on urinary
bladder tumors in mice, but did not recommended assignment of a
Q1*, instead recommended the RfD approach. Based on CPRC's
recommendation that the RfD approach be used to assess dietary cancer
risk, a quantitative dietary risk assessment was not performed. Human
health risk concerns due to long-term consumption of bifenthrin
residues are adequately addressed by DRES chronic exposure analysis
using the RfD.
B. Aggregate Exposure
Tolerances for residues of bifenthrin in or on food/feed
commodities are currently expressed in terms of the combined 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 (40 CFR 180.442(b)) expressed in or on
certain raw agricultural commodities ranging from 0.05 ppm in eggs to
10.0 ppm in dried hops.
For the purpose of assessing chronic dietary exposure from
bifenthrin, EPA assumed tolerance level residues and 100 percent of
crop treated refinements to estimate the TMRC from all the established
existing food uses of bifenthrin. There are no livestock feed items
associated with this section 18
[[Page 6489]]
request, so no additional livestock dietary burden will result from
this section 18 registration. Therefore, no secondary residues in meat,
milk, poultry, and eggs are expected as a result of this use and
existing meat, milk and poultry tolerances are adequate.
For the purpose of assessing acute dietary exposure from
bifenthrin, EPA assumed anticipated residue data for most of the
established existing food uses of bifenthrin. Although no livestock
feed items are associated with this section 18 use, additional
refinement of the acute milk residue values were performed for this
section 18 in order to further define the acute risk estimate.
Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational (non-dietary) sources. Based on the available studies
used in EPA's assessment of environmental risk, bifenthrin appears to
be moderately persistent and not mobile. There are 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, Sept. 1992), indicates that bifenthrin has not been
monitored. Based on the available data and percentage of the RfD which
is occupied (maximum of 55 percent for non-nursing infants with no
anticipated residue or percent crop treated refinement), OPP does not
anticipate that addition of risk from drinking water to the dietary
burden would result in a TMRC that exceeds 100 percent of the RfD.
Therefore, OPP concludes that potential bifenthrin residues in drinking
water are not likely to pose a human health concern.
There are residential uses of bifenthrin and EPA acknowledges that
there may be short- and intermediate-term non-occupational exposure
scenarios. OPP has identified a toxicity endpoint for an intermediate-
term residential risk assessment. However, no acceptable reliable
exposure data to assess these potential risks are available at this
time. Given the time-limited nature of this request, the need to make
emergency exemption decisions quickly, and the significant scientific
uncertainty at this time about how to aggregate non-occupational
exposure with dietary exposure, the Agency will make its safety
determination for this tolerance based on those factors which it can
reasonably integrate into a risk assessment.
At this time, the Agency has not made a determination that
bifenthrin and other substances that may have a common mode of toxicity
would have cumulative effects. Given the time-limited nature of this
request, the need to make emergency exemption decisions quickly, and
the significant scientific uncertainty at this time about how to define
common mode of toxicity, the Agency will make its safety determination
for this tolerance based on those factors which it can reasonably
integrate into a risk assessment. For purposes of this tolerance only,
the Agency is considering only the potential risks of bifenthrin in its
aggregate exposure.
C. Safety Determinations for U.S. Population
EPA has concluded that chronic dietary exposure to bifenthrin will
utilize 23 percent of the RfD for the U.S. population. As mentioned
before, EPA does not expect that chronic exposure from drinking water
would result in an aggregate exposure which would exceed 100 percent of
the RfD. EPA concludes that there is a reasonable certainty that no
harm will result from aggregate exposure to bifenthrin residues. For
the acute population subgroup of concern, children (1 to 6 years old),
the calculated MOE value is 50. MOE values under 100 exceed the
Agency's level of concern for acute dietary exposure. Though the acute
dietary risk assessment assumes anticipated residues for most
commodities and is a relatively refined estimate of exposure, OPP
expects that further refinement of the acute dietary risk assessment
for children (1 to 6 years old) using the Monte Carlo model would
result in an acceptable MOE. Use of the Monte Carlo methodology would
allow incorporation of the range of expected residues for each
commodity being evaluated, instead of point estimates, as well as
consideration of percent crop treated refinements in the acute exposure
analysis. Currently, 100 percent crop treated is assumed for every
commodity evaluated in the analysis; this results in over estimation of
acute dietary exposure from bifenthrin.
D. Determination of Safety for Infants and Children.
In assessing the potential for additional sensitivity of infants
and children to residues of bifenthrin, EPA considered pre- and post-
natal toxicity data in rabbits and rats. EPA notes that the
developmental toxicity NOEL of 8.0 mg/kg/day highest dose tesed (HDT)
demonstrates that there is no developmental (prenatal) effects in
fetuses exposed to bifenthrin in rabbits. The developmental toxicity
NOEL of 2.0 mg/kg/day HDT in rats indicated a slight increase in
litters with hydroureter (distended ureter). In the absence of 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 findings of hydroureter in rat fetuses at 2.0 mg/kg/
day [in the presence of maternal toxicity] is not considered a
significant developmental finding nor is it considered to provide
sufficient evidence of a special dietary risk (either acute or chronic)
for infants and children which would require an additional safety
factor.
In the 2-generation reproductive toxicity study in the rat,
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 HDT. Therefore, there is no
evidence of special post-natal sensitivity to infants and children in
the rat reproduction study. This finding suggests that post-natal
development in pups is not more sensitive and that infants and children
may not have a greater sensitivity to bifenthrin than adult animals.
EPA has concluded that the percent of the RfD that will be utilized
by chronic dietary exposure to residues of bifenthrin ranges from 14
percent for nursing infants to 55 percent for non-nursing infants (<1
year old). However, this calculation assumes tolerance level residues
for all commodities and is therefore an over-estimate of dietary risk.
Refinement of the dietary risk assessment by using anticipated residue
data would reduce dietary exposure. As mentioned before, the addition
of potential exposure from bifenthrin residues in drinking water is not
expected to result in an exposure which would exceed the RfD. EPA
therefore concludes that there is a reasonable certainty that no harm
will result to infants and children from aggregate exposure to
bifenthrin.
As mentioned above, dietary cancer concerns for infants and
children are adequately addressed by the chronic exposure analysis
using the RfD.
FFDCA section 408 provides that EPA shall apply an additional
safety factor for infants and children in the case of threshold effects
to account for pre- and post-natal toxicity and the completeness of the
data base unless EPA concludes based on reliable data that said
additional safety factor is unnecessary. Should an additional
uncertainty factor be deemed appropriate, when
[[Page 6490]]
considered in conjunction with a refined exposure estimate, it is
unlikely that the dietary risk will exceed 100 percent of the RfD.
Therefore, 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
The metabolism of bifenthrin in plants and animals is adequately
understood for the purposes of this tolerance. There are no Codex
maximum residue levels established for residues of bifenthrin on
brassica vegetables and lettuce. Adequate methods for purposes of data
collection and enforcement of tolerance for bifenthrin residues are
available. Method P-2132M (MRID# 416585-01), which was validated on
celery, should be adequate for analysis of brassica vegetables and
lettuce.
VI. Conclusion
Therefore, a tolerance in connection with the FIFRA section 18
emergency exemptions is established for residues of bifenthrin on
broccoli at 0.1 ppm and cauliflower at 0.05 ppm. These tolerances will
expire and be automatically revoked without further action by EPA on
January 31, 1998.
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 April 14, 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 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
A record has been established for this rulemaking under docket
control number [OPP-300452]. A public version of this record, 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 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, 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. 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
Under Executive Order 12866 (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 mandate 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), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement to this effect was published in the Federal
Register of May 4, 1981 (46 FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by 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. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 30, 1997.
Penelope A. Fenner-Crisp,
Acting Director, 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.
[[Page 6491]]
2. In 180.442, by adding a new paragraph (c) to read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
* * * * *
(c) A time-limited tolerance is established for residues of the
combined 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. These tolerances
are specified in the following table. These tolerances will expire and
be automatically revoked on the date specified in the table without
further action by EPA.
------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
------------------------------------------------------------------------
Broccoli.................... 0.1 January 31, 1998
Cauliflower................. 0.05 January 31, 1998
------------------------------------------------------------------------
[FR Doc. 97-3380 Filed 2-11-97; 8:45 am]
BILLING CODE 6560-50-F