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benoxacor Time-Limited Tolerances 2/97

Benoxacor; Time-Limited Tolerances for Residues 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for combined 
residues of 4-(dichloroacetyl)-3,4-dihydro-3-methyl-2H-1,4- benzoxazine 
(benoxacor) when used as an inert ingredient (safener) in pesticide 
formulations containing metolachlor in or on raw agricultural commodities for 
which tolerances have been established for metolachlor. This regulation is 
being issued in response to a petition for the establishment of a tolerance 
for residues of benoxacor requested by Ciba-Geigy Corp.

EFFECTIVE DATE: This regulation becomes effective February 14, 1997 and 
expires on February 14, 1998.

ADDRESSES: Written objections and hearing requests, identified by the docket 
control number, [OPP-300449], 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-300449], must also 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 22202.

A copy of objections and hearing requests filed with the Hearing Clerk may 
also be submitted electronically by sending electronic mail (e-mail) to: opp-
docket@epamail.epa.gov. Copies of objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and any form 
of encryption. Copies of objections and hearing requests will also be accepted 
on disks in WordPerfect 5.1 file format or ASCII file format. All copies of 
objections and hearing requests in electronic form must be identified by the 
docket control number [OPP-300449]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed on-line at many Federal Depository 
Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Kerry B. Leifer, Registration 
Division (7505W), Office of Pesticide Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone 
number, and e-mail address: Sixth Floor, Crystal Station #1, 2800 Crystal 
Drive Jefferson Davis Hwy., Arlington, VA, (703)-308-8811, e-mail: 
leifer.kerry @epamail.epa.gov. SUPPLEMENTARY INFORMATION: EPA, at the request 
of Ciba, Crop Protection, pursuant to section 408(d) of the Federal Food, Drug 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), is establishing tolerances for 
residues of the inert ingredient (safener) 4-(dichloroacetyl)-3,4- dihydro-3-
methyl-2H-1,4-benzoxazine (benoxacor) at 0.01 part per million (ppm) in or on 
raw agricultural commodities for which tolerances have been established for 
metolachlor. These tolerances will expire on February 14, 1998. A notice of 
filing of a tolerance petition, including the petitioner's summary of the 
information, data and arguments in support of their petition was published in 
the Federal Register on November 5, 1996 (61 FR 56954). 

There were no comments or requests for referral to an advisory committee 
received in response to the notice of filing. 

I. Background and Statutory Authority

A time-limited tolerance was established for benoxacor when used as an inert 
ingredient (safener) in pesticide formulations containing metolachlor in or on 
raw agricultural commodities for which tolerances have been established for 
metolachlor and published in the Federal Register on June 30, 1992 (57 FR 
29031). The time-limited tolerance expired on December 1, 1996. This time-
limited tolerance was established to allow for the submission and Agency 
review of chronic toxicity/oncogenicity data on benoxacor. The requisite 
chronic toxicity/oncogenicity studies in the rat and mouse were submitted by 
the petitioner; however, the Agency's review of the data is not yet complete. 
In order to allow the for the continued use of benoxacor as a safener in 
formulations of metolachlor while the EPA continues its review of the 
submitted oncogenicity data, the petitioner has requested that the time-
limited tolerance be extended until such time as the Agency is able to make a 
definitive determination as to the safety of the tolerance.

The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) was signed 
into law August 3, 1996. FQPA amends both the FFDCA, 21 U.S.C. 301 et seq., 
and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 
136 et seq. 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 408(b)(2)(D) specifies 
factors EPA is to consider in establishing a tolerance. Section 408(b)(3) 
requires EPA to determine that there is a practical method for detecting and 
measuring levels of the pesticide chemical residue in or on food and that the 
tolerance be set at a level at or above the limit of detection of the 
designated method. Section 408(b)(4) requires EPA to determine whether a 
maximum residue level has been established for the pesticide chemical by the 
Codex Alimentarius Commission. If so, and EPA does not propose to adopt that 
level, EPA must publish for public comment a notice explaining the reasons for 
departing from the Codex level. Section 408 governs EPA's establishment of 
exemptions from the requirement for a tolerance using the same safety standard 
as section 408(B)(2)(A) and incorporating the provisions of section 
408(b)(2)(C) and (D). Section 408(d) allows for the filing of a petition 
proposing the issuance of a regulation establishing, modifying, or revoking a 
tolerance or tolerance exemption for a pesticide chemical residue in or on a 
food. 

II. 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 effects 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 a reasonable certainty of no harm.

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 calculations 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.

III. 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. A 
time-limited tolerance was established for benoxacor when used as an inert 
ingredient (safener) in pesticide formulations containing metolachlor in or on 
raw agricultural commodities for which tolerances have been established for 
metolachlor and published in the Federal Register on June 30, 1992. The time-
limited tolerance expired on December 1, 1996.

EPA has reassessed the toxicology data base for benoxacor including new 
reproductive, chronic and carcinogenicity studies provided by the petitioner 
as part of this action to extend the time-limited tolerances for benoxacor. 
EPA has sufficient data to assess the hazards of benoxacor and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), for 
the time-limited tolerances for residues of benoxacor at 0.01 ppm in or on raw 
agricultural commodities for which tolerances have been established for 
metolachlor. 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 has 
established the RfD for benoxacor at 0.004 milligrams (mg)/ kilogram(kg)/day. 
This RfD is based on a 2-year feeding study in rats with a NOEL of 0.4 
mg/kg/day and an uncertainty factor of 100. The uncertainty factor of 100 was 
applied to account for inter-species extrapolation (10) and intra-species 
variability (10). Increased non- neoplastic lesions of the stomach (including 
epithelial hyperplasia) and liver (including centrilobular enlargement and 
hepatocyte vacuolation in males) were the effects observed at the lowest 
effect level (LEL) of 2.0 mg/kg/day.

2. Acute toxicity. Based on the available acute toxicity data, EPA has 
determined that benoxacor does not pose any acute dietary or nondietary risks.

3. Carcinogenicity. Based upon findings of a carcinogenic effect in the 
nonglandular stomach of rats and mice, benoxacor has been referred to the 
Office of Pesticide Program's Health Effects Division Cancer Peer Review 
Committee for classification as to its carcinogenicity. It is scheduled for 
review and classification in February 1997. The Agency has determined that, 
for the purposes of this time-limited tolerance and until such time as the 
Peer Review Committee makes a determination regarding the nature of the 
carcinogenic response and mode of action of benoxacor, a risk assessment of 
benoxacor utilizing the RfD derived from the chronic toxicity data is 
appropriate due to the nature of the tumor (forestomach) and the low incidence 
of tumors at the high dose level of 41 mg/kg/day.

B. Aggregate Exposure

For the purpose of assessing chronic dietary exposure from benoxacor, EPA 
considered the proposed benoxacor tolerance of 0.01 ppm and the raw 
agricultural commodities for which tolerances have been established for 
metolachlor. There are no other established U.S. tolerances for benoxacor, and 
there are no other registered uses for benoxacor on food or feed crops in the 
United States. In conducting this exposure assessment, EPA assumed tolerance 
level residues and 100 percent crop treated, resulting in a large overestimate 
of dietary exposure and protective of any chronic dietary exposure scenario. 
Other potential sources of exposure of the general population to residues of 
pesticide chemicals are residues in drinking water and exposure from non-
occupational sources. There is no established Maximum Concentration Level for 
residues of benoxacor in drinking water and no health advisory levels for 
benoxacor in drinking water have been established.

Review of the environmental fate data submitted by the petitioner indicates 
that benoxacor is mobile and hydrolyzes slowly at low pH's, but rapidly 
degrades in the soil (half-life of 49 days under aerobic conditions and 70 
days anaerobically). Although the Agency does not have available data to 
perform a drinking water assessment at this time, exposure to residues of 
benoxacor in drinking water is not expected to result in unacceptable 
aggregate risk. This conclusion is based on the low application rate, the lack 
of significant acute oral toxicity, and the low percentage of the RfD occupied 
by dietary exposure, as well as an assessment of other pesticide chemicals 
which shows that except for highly mobile, persistent and acutely toxic 
chemicals, a significant contribution to aggregate risk to drinking water is 
unlikely.

EPA has evaluated the estimated non-occupational exposure to benoxacor. All 
metolachlor products to which benoxacor is added as a safener are commercial 
agricultural products not registered for residential use. The potential for 
non-occupational exposure to benoxacor by the general population is therefore 
unlikely except for the potential residues in food crops discussed above. 
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to 
establish, modify, or revoke a tolerance or tolerance exemption, the Agency 
consider "available information" concerning the cumulative effects of a 
particular pesticide chemical's residues and "other substances that have a 
common mechanism of toxicity." While the Agency has some information in its 
files that may turn out to be helpful in eventually determining whether a 
pesticide chemical shares a common mechanism of toxicity with any other 
substances, EPA does not at this time have the capability to fully resolve the 
scientific issues concerning common mechanism of toxicity in a meaningful way. 
EPA has begun a pilot process to study this issue further through the 
examination of particular classes of pesticide chemicals. The Agency hopes 
that the results of this pilot process will enable the Agency to apply common 
mechanism issues to its pesticide risk assessments. At present, however, the 
Agency does not know how to apply the information in its files concerning 
common mechanism issues to risk assessments. Therefore, the Agency believes 
that in most cases there is no "available information" concerning common 
mechanism that can be applied to tolerance decisions. "Available information" 
as used in this context includes both the toxicity data, as well as policies 
and methodologies for conducting cumulative risk assessments. In most cases, 
although data may be available, policies and methodologies have not been 
developed to permit their use. When the Agency has determined that a 
particular pesticide chemical may share a significant common mechanism with 
other chemicals, a tolerance decision may be affected by common mechanism 
issues. Conversely, when the Agency has determined that a pesticide chemical 
does not share a common mechanism of toxicity with other chemicals, the 
tolerance decision will state this and provide supporting information. Where 
the Agency cannot determine whether a common mechanism of toxicity is 
operating because of lack of available information, a tolerance decision will 
be based upon the best available and useful information for the individual 
chemical, and a risk assessment will be performed for the individual chemical 
assuming that no common mechanism of toxicity exists. 

In the case of benoxacor, EPA has not yet determined whether to include this 
chemical in a cumulative risk assessment. This tolerance decision therefore 
does not take into account common mechanism issues. The Agency will reexamine 
the tolerances for benoxacor during the tolerance reassessment process or when 
the time-limited tolerance approaches expiration.

C. Determination of Safety for U.S. Population 

1. Chronic risk. Based on the completeness and reliability of the toxicity 
data, EPA has concluded that dietary exposure to benoxacor will utilize 4.8 
percent of the RfD for the U.S. population. EPA generally has no concern for 
exposures below 100 percent of the RfD. Acceptable, reliable data are not 
available to quantitatively assess risk from drinking water. However, EPA 
concludes that there is a reasonable certainty that no harm to the U.S. 
population will result from aggregate exposure to benoxacor residues. 

2. Acute risk. Due to the minimal acute toxicity of benoxacor, there are no 
concerns for acute dietary, occupational, and non- occupational exposures to 
benoxacor.

D. Determination of Safety for Infants and Children 

In assessing the potential for additional sensitivity of infants and children 
to residues of benoxacor, EPA considered data from developmental toxicity 
studies in the rat and rabbit and a 2-generation reproduction study in rats. 
The developmental toxicity studies are designed to evaluate adverse effects on 
the developing organism resulting from pesticide chemical exposure during 
prenatal development to one or both parents. Reproductive toxicity studies 
provide information relating to effects from exposure to a pesticide chemical 
on the reproductive capability of mating animals and data on systemic 
toxicity.

Based on current toxicological data requirements, the data base for benoxacor 
relative to pre- and post-natal toxicity is complete. EPA notes developmental 
toxicity NOELs of 100 mg/kg/day in rats and 12.5 mg/kg/day in rabbits. 
Developmental toxicity was observed in rats at 400 mg/kg/day; these effects 
occurred in the presence of maternal toxicity. In rabbits, developmental 
alterations were noted at the maternally toxic dose of 62.5 mg/kg/day. The 
developmental NOELs are more than 250- and 31-fold higher in the rats and 
rabbits respectively, than the NOEL of 0.4 mg/kg/day from the chronic 
toxicity/oncogenicity study in rats, which is the basis of the RfD. 

In the 2-generation reproductive toxicity study in rats, the reproductive 
toxicity NOEL of 4.57 mg/kg/day was greater than the parental (systemic) 
toxicity NOEL (3.55 mg/kg/day in males and 4.51 mg/ kg/day in females. The 
NOEL of 4.57 mg/kg/day for reproductive (pup) toxicity was 11-fold higher than 
the NOEL of 0.4 mg/kg/day from the chronic toxicity/oncogenicity study in 
rats,, which is the basis of the RfD. The reproductive (pup) lowest observed 
effect levels (LOEL) of 64 mg/kg/day (first generation; F1) and 72.25 
mg/kg/day (second generation; F2) are based on decreased body weights on 
lactation day 21. 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 (i.e., that infants and children 
might be more sensitive than adults) to benoxacor exposure. 

FFDCA section 408 provides that EPA shall apply an additional uncertainty 
(safety) factor for infants and children in the case of threshold effects to 
account for pre- and postnatal toxicity and the completeness of the data base 
unless EPA concludes that a different margin of exposure (safety) is 
appropriate. EPA believes that reliable data support using standard 
uncertainty factors (usually 100x for combined inter- and intraspecies 
variability) and not the additional uncertainty factor when EPA has a complete 
data base and when the severity of the potential effect in infants and 
children or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the traditional uncertainty factors. 
Based on current toxicological data requirements the data base for benoxacor 
relative to pre- and postnatal toxicity is complete. As mentioned above, 
because both developmental and reproductive effects occurred in the presense 
of parental (systemic) toxicity, these data do not suggest an increased pre- 
or postnatal sensitivity of children and infants to benoxacor exposure. 
Therefore, EPA concludes, upon the basis of reliable data that a 100-fold 
uncertainty factor is adequate to protect the safety of infants and children 
and an additional safety factor is not warranted.

1. Chronic risk. Based on the TMRC exposure estimates, EPA has concluded that 
the percentage of the RfD that will be utilized by dietary exposure to 
residues of benoxacor ranges from 3.3 percent for pregnant females 13+ years 
old, up to 20 percent for non-nursing infants.

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 requirements, the data base for benoxacor relative to pre- 
and post-natal toxicity is complete. As mentioned above, because reproductive 
effects occurred in the presence of parental (systemic) toxicity, these data 
do not suggest an increased post-natal sensitivity of children and infants to 
benoxacor exposure, and therefore an additional safety factor was not applied. 
EPA concludes that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to benoxacor residues.

2. Acute risk. Due to the minimal acute toxicity of benoxacor, EPA concludes 
that there is a reasonable certainty of no harm for infants and children 
resulting from acute dietary or non-occupational exposures to benoxacor.

IV. Other Considerations

The nature of the residue in plants and animals is adequately understood for 
this tolerance. There are no Codex maximum residue levels established for 
residues of benoxacor on commodities for which a tolerance for metolachlor 
exist. Adequate enforcement methodology, GC/ NPD, is available to enforce the 
tolerance expression. An analytical methodology for the determination of 
benoxacor and its metabolites in plant and animal commodities (Ciba Analytical 
Method AG536(C)) is available 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. 

V. Conclusion

Therefore, time-limited tolerances are established for residues of benoxacor 
when used as an inert ingredient (safener) in pesticide formulations 
containing metolachlor in or on raw agricultural commodities for which 
tolerances have been established for metolachlor. These tolerances will expire 
on February 14, 1998. 

VI. 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 the new section 
408(d) 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 its current procedural regulations with appropriate adjustments to 
reflect the new law.

Any person may, by April 22, 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 requester's contentions on such issues, and 
a summary of any evidence relied upon by the requester (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 requester would, if established, resolve one or more of such issues in 
favor of the requester, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues in the manner sought by the 
requester 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. 

VII. Public Docket

A record has been established for this rulemaking under docket number [OPP-
300449]. 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. EPA has also established a special record for post-FQPA tolerances which 
contains documents of general applicability. This record can be found in the 
same location.

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.

VIII. Regulatory Assessment Requirements 

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must 
determine whether the regulatory action is "significant" and therefore subject 
to review by the Office of Management and Budget (OMB) and the requirements of 
the Executive Order. Under section 3(f), the order defines "a significant 
regulatory action" as an action that is likely to result in a rule: (1) Having 
an annual effect on the economy of $100 million or more, or adversely and 
materially affecting a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local or tribal 
governments or communities (also referred to as "economically significant"); 
(2) creating serious inconsistency or otherwise interfering with an action 
taken or planned by another agency; (3) materially altering the budgetary 
impacts of entitlement, grants, user fees, or loan programs or the rights and 
obligations thereof; or (4) raising novel legal or policy issues arising out 
of legal mandates, the President's priorities, or the principles set forth in 
this Executive Order. Pursuant to the terms of this Executive Order, EPA has 
determined that this rule is not "significant" and is therefore not subject to 
OMB review.

This action does not impose any enforceable duty, or contain any "unfunded 
mandates" as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4), or require prior consultation 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 tolerances established on the basis of a petition under section 408(d) 
of FFDCA do not require issuance of a proposed rule, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act (RFA), 5 
U.S.C. 604(a), do not apply. Prior to the recent enactment of the FFDCA, EPA 
had treated such rulemakings as subject to the RFA; however, the amendments to 
the FFDCA clarify that no proposal is required for such rulemakings and hence 
the RFA is inapplicable.

Under 5 U.S.C. 801(a)(1)(A), 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(a).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural 
commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: February 14, 1997.

Peter Caulkins,
Director, Registration Division, 
Office of Pesticide Programs. 

Therefore, 40 CFR Chapter I is amended as follows: 

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.

2. By revising Sec. 180.460 to read as follows: 

Sec. 180.460 Benoxacor; tolerances for residues. 

Tolerances are established for residues of the inert ingredient (safener) 
benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2H-1,4- benzoxazine) when 
used in pesticide formulations containing metolachlor in or on raw 
agricultural commodities for which tolerances have been established for 
metolachlor. These tolerances expire on February 14, 1998.
[FR Doc. 97-4495 Filed 2-20-97; 8:45 am]