[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Rules and Regulations]
[Pages 60628-60632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30475]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300446; FRL-5574-9]

RIN 2070-AC78


Tebufenozide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of the insecticide tebufenozide in or on the raw agricultural 
commodity peppers in connection with EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of tebufenozide on peppers in Georgia 
and New Mexico. This regulation establishes maximum permissible levels 
for residues of tebufenozide on peppers pursuant to section 408(l)(6) 
of the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. This tolerance will expire and be 
revoked automatically without further action by EPA on November 30, 
1997.
DATES: This regulation becomes effective November 29, 1996. This 
regulation expires and is revoked automatically without further action 
by EPA on November 30, 1997. Objections and requests for hearings must 
be received by EPA on January 28, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300446], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251.
    A copy of any objections and hearing requests filed with the 
Hearing Clerk identified by the docket control number, [OPP-300446], 
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-
[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-300446]. 
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: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
Arlington, VA 22202. (703) 308-8347, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the insecticide tebufenozide (benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2(4-ethylbenzoyl)hydrazide) in or on peppers at 0.5 
part per million (ppm). This tolerance will expire and be revoked 
automatically without further action by EPA on November 30, 1997.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104170) 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.
    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

[[Page 60629]]

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 Tebufenozide on Peppers and FFDCA 
Tolerances

    On September 4, 1996, the Georgia Department of Agriculture availed 
of itself the authority to declare the existence of a crisis situation 
within the state, thereby authorizing use under FIFRA section 18 of 
tebufenozide on peppers to control the beet armyworm (BAW). The state 
of New Mexico has also requested a specific exemption for use of this 
chemical to control beet armyworm. Emergency conditions are determined 
to exist due to the BAW populations demonstrating resistance to 
registered insecticides. The available data indicate that tebufenozide 
effectively controls BAW larvae, small and large, and will be used only 
after the registered alternatives, methomyl and chlorpyrifos, have 
failed.
    As part of its assessment of these applications for emergency 
exemption, EPA assessed the potential risks presented by residues of 
tebufenozide on peppers. 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 
tolerance under FFDCA section 408(l)(6) would clearly be consistent 
with the new safety standard and with FIFRA section 18. This tolerance 
for tebufenozide will permit the marketing of peppers 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 this tolerance without notice and opportunity for public 
comment under section 408(e) as provided in section 408(l)(6). Although 
this tolerance will expire and be revoked automatically without further 
action by EPA on November 30, 1997, under FFDCA section 408(l)(5), 
residues of tebufenozide not in excess of the amount specified in the 
tolerance remaining in or on peppers 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 this tolerance 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 tebufenozide meets the 
requirements for registration under FIFRA section 3 for use on peppers 
or whether a permanent tolerance for tebufenozide for peppers would be 
appropriate. This action by EPA does not serve as a basis for 
registration of tebufenozide by a State for special local needs under 
FIFRA section 24(c). Nor does this action serve as the basis for any 
State other than Georgia or New Mexico 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 180.166. For additional information 
regarding the emergency exemptions for tebufenozide, 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 acceptable by EPA.
    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 calculation based on the 
appropriate NOEL) will be carried out based on the nature of the 
carcinogenic response and the Agency's knowledge of its mode of action.
    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, and other non-
occupational exposures, such as where residues leach into groundwater 
or surface water that is consumed as drinking water. 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. Tebufenozide is not registered by EPA

[[Page 60630]]

for indoor or outdoor residential use. Existing food and feed use 
tolerances for tebufenozide are listed in 40 CFR 180.482. EPA has also 
assessed the toxicology data base for tebufenozide in its evaluation of 
applications for registration on peppers. Thus, EPA has sufficient data 
to assess the hazards of tebufenozide and to make a determination on 
aggregate exposure, consistent with section 408(b)(2), for the time-
limited tolerances for residues of tebufenozide on peppers at 0.5 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, 
the Agency has established the RfD for tebufenozide at 0.018 
milligrams(mg)/kilogram(kg)/day. The RfD is based on a 1 year feeding 
study in dogs with a NOEL of 1.8 mg/kg/day and an uncertainty factor of 
100. Decreased red blood cells, hematocrit, and hemoglobin and 
increased heinz bodies, reticulocytes, and platelets were observed at 
the Lowest Observed Effect Level (LOEL) of 8.7 mg/kg/day.
    2. Acute toxicity. No appropriate acute dietary endpoint was 
identified by the Agency. This risk assessment is not required.
    3. Carcinogenicity. Using its Guidelines for Carcinogen Risk 
Assessment published September 24, 1986 (51 FR 33992), OPP has 
classified tebufenozide as a Group ``E'' chemical (no evidence of 
carcinogenicity) based on the results of carcinogenicity studies in two 
species. There was no evidence of carcinogenicity in a 2-year rat study 
and an 18-month mouse study.

B. Aggregate Exposure

    Tolerances for residues of tebufenozide are currently expressed as 
benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2(4-
ethylbenzoyl)hydrazide. Tolerances currently exist for residues on 
apples and walnuts (see 40 CFR 180.482).
    For purposes of assessing the potential dietary exposure under this 
tolerance, EPA assumed tolerance level residues and 100 percent of crop 
treated to estimate the TMRC from all established food uses for 
tebufenozide as well as the proposed use on peppers. Peppers and pepper 
products are not considered livestock feed items; thus, there is no 
reasonable expectation that measurable residues of tebufenozide will 
occur in meat, milk, poultry, or eggs under the terms of these 
emergency exemptions.
    Other potential sources of exposure of the general population to 
residues of pesticides are residues in drinking water and exposure from 
non-occupational sources. Review of environmental fate data by the 
Environmental Fate and Effects Division suggests that tebufenozide is 
moderately persistent to persistent and mobile, and could potentially 
leach to groundwater and runoff to surface water under certain 
environmental conditions. There is no established Maximum Concentration 
Level for residues of tebufenozide in drinking water. No drinking water 
health advisory levels have been established for tebufenozide.
    The Agency does not have available data to perform a quantitative 
drinking water risk assessment for tebufenozide at this time. However, 
in order to mitigate the potential for tebufenozide to leach into 
groundwater or runoff to surface water, precautionary language has been 
incorporated into the product label. Also, previous experience with 
more persistent and mobile pesticides for which there have been 
available data to perform quantitative risk assessments have 
demonstrated that drinking water exposure is typically a small 
percentage of the total exposure when compared to the total dietary 
exposure. This observation holds even for pesticides detected in wells 
and drinking water at levels nearing or exceeding established MCLs. 
Considering the precautionary language on the label and based on 
previous experience with persistent chemicals, EPA does not anticipate 
significant exposure from residues of tebufenozide in drinking water.
    Tebufenozide is not registered for either indoor or outdoor 
residential use. Non-occupational exposure to the general population is 
therefore not expected and not considered in aggregate exposure 
estimates.
    At this time, the Agency has not made a determination that 
tebufenozide and other substances that may have a common mode of 
toxicity would have cumulative effects. For purposes of this tolerance 
only, the Agency is considering only the potential risks of 
tebufenozide in its aggregate exposure.

C. Safety Determinations for U.S. Population

    Using the conservative exposure assumptions described above and 
taking into account the completeness and reliability of the toxicity 
data, EPA has concluded that dietary exposure to tebufenozide will 
utilize 4.5 percent of the RfD for the U.S. population. EPA generally 
has no concern for exposures below 100 percent of the RfD because the 
RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. EPA concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to tebufenozide residues.

D. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of tebufenozide, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from pesticide exposure during prenatal development to one or 
both parents. Reproduction studies provide information relating to 
effects from exposure to the pesticide on the reproductive capability 
of mating animals and data on systemic toxicity.
    Developmental toxicity was not observed in developmental studies 
using rats and rabbits. The NOEL for developmental effects in both rats 
and rabbits was 1000 mg/kg/day (HDT), which is the limit dose for 
testing in developmental studies.
    In the two-generation reproductive toxicity study in the rat, the 
reproductive/developmental toxicity NOEL of 12.1 mg/kg/day was 14-fold 
higher than the parental (systemic) toxicity NOEL (0.85 mg/kg/day). The 
reproductive (pup) LOEL of 171.1 mg/kg/day was based on a slight 
increase in both generations in the number of pregnant females that 
either did not deliver or had difficulty and had to be sacrificed. In 
addition, the length of gestation increased and implantation sites 
decreased significantly in F1 dams Because these reproductive effects 
occurred in the presence of parental (systemic) toxicity, these data do 
not suggest an increased post-natal sensitivity to children and infants 
(that infants and children might be more sensitive than adults) to 
tebufenozide exposure.
    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 that a different margin of safety is 
appropriate. Based on current toxicological data discussed above, EPA 
concludes that an additional uncertainty factor is not warranted and 
that the RfD at 0.018 mg/kg/day is appropriate for assessing aggregate 
risk to infants and children.

[[Page 60631]]

    Using the conservative exposure assumptions described above, EPA 
has concluded that the percent of the RfD that will be utilized by 
aggregate exposure to residues of tebufenozide ranges from 6.0 percent 
for children 7-12 years old, up to 44.7 percent for non-nursing 
infants. Therefore, taking into account the completeness and 
reliability of the toxicity data and the conservative exposure 
assessment, EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
tebufenozide residues.

V. Other Considerations

    The metabolism of tebufenozide in plants is adequately understood 
for the purposes of this tolerance. There is no Codex maximum residue 
level established for residues of tebufenozide of peppers. There is a 
practical analytical method (liquid chromatography with ultraviolet 
detection) for detecting and measuring levels of tebufenozide in or on 
food with a limit of detection that allows monitoring of food with 
residues at or above the level set by the tebufenozide tolerance. EPA 
has provided information on this method to FDA. The method is available 
to anyone who is interested in pesticide residue enforcement from: By 
mail, Calvin Furlow, Public Response and Program Resources Branch, 
Field Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. 
Office location and telephone number: Crystal Mall #2, Rm 1128, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, 703-305-5805.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of tebufenozide in 
peppers at 0.5 ppm. This tolerance will expire and be automatically 
revoked without further action by EPA on November 30, 1997.

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 January 28, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) and may also request a hearing on those objections. 
Objections and hearing requests must be filed with the Hearing Clerk, 
at the address given above (40 CFR 178.20). A copy of the objections 
and/or hearing requests filed with the Hearing Clerk should be 
submitted to the OPP docket for this rulemaking. The objections 
submitted must specify the provisions of the regulation deemed 
objectionable and the grounds for the objections (40 CFR 178.25). Each 
objection must be accompanied by the fee prescribed by 40 CFR 
180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32).
    Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as Confidential Business Information (CBI). Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2. A copy of the information that does not contain 
CBI must be submitted for inclusion in the public record. Information 
not marked confidential may be disclosed publicly by EPA without prior 
notice.

VIII. Public Docket

    A record has been established for this rulemaking under docket 
number [OPP-300446]. A public version of this record, which does not 
include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 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 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).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply.
    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

[[Page 60632]]

and pests, Reporting and recordkeeping requirements.

    Dated: November 20, 1996.
Daniel M. Barolo,
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 180.482, by redesignating the existing section as paragraph 
(a) and adding a new paragraph (b) to read as follows:


Sec. 180.482   Benzoic acid, tolerances for resdues  .

    *    *    *    *    *
    (b) A time-limited tolerance is established for residues of the 
insecticide benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2(4-
ethylbenzoyl)hydrazide, in connection with use of the pesticide under 
section 18 emergency exemptions granted by EPA. The tolerance is 
specified in the following table. This tolerance expires and is 
automatically revoked on the date specified in the table without 
further action by EPA.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Peppers.........................  0.5                 November 30, 1997 
------------------------------------------------------------------------


[FR Doc. 96-30475 Filed 11-27-96; 8:45 am]
BILLING CODE 6560-50-F