[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