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Bifenthrin - Pesticide Tolerances for Emergency Exemptions 2/97

[Federal Register: February 12, 1997 (Volume 62, Number 29)] [Rules and Regulations]
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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: 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 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: collantes.margarita@epamail.epa.gov.
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 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 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
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 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.
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]