[Federal Register Volume 62, Number 35 (Friday, February 21, 1997)]
[Rules and Regulations]
[Pages 7941-7945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4495]
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DEPARTMENT OF TRANSPORTATION
40 CFR Part 180
[OPP-300449; FRL-5583-4]
RIN 2070-AB78
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
[[Page 7942]]
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
[[Page 7943]]
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.
[[Page 7944]]
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).
[[Page 7945]]
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]
BILLING CODE 6560-50-F
