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metolachlor (Dual) Time-Limited Tolerance on Spinach 11/96

[Federal Register: November 29, 1996 (Volume 61, Number 231)]
[Rules and Regulations]
[Page 60617-60622]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300443; FRL-5574-7]
RIN 2070-AB78
Metolachlor Pesticide Tolerance; Emergency Exemption For Use on
Spinach
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of the herbicide metolachlor in or on the raw
agricultural commodity spinach in connection with EPA's granting of
emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of metolachlor on
spinach in Arkansas, Oklahoma, Texas and Virginia. This regulation
establishes a maximum permissible level for residues of metolachlor in
this food 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 15, 1998.
DATES: This regulation becomes effective November 29, 1996. This
regulation expires and is revoked automatically without further action
by EPA on November 15, 1998. Objections and requests for hearings must
be received by EPA on January 28, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket number, [OPP-300443], 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, Office of Pesticide Programs
(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 number, [OPP-300443], 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
[[Page 60618]]
person, bring a copy of objections and hearing requests to Rm. 1132, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300443]. 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. Additional information on electronic submissions can be
found below in this document.
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:
collantes.margarita@epamail.epa.gov.
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 herbicide metolachlor, 2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide in or on spinach at
0.3 part per million (ppm). This tolerance will expire and be revoked
automatically without further action by EPA on November 15, 1998.
I. Background and Statutory Authority
    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities were discussed in detail in the final rule
establishing a tolerance for an emergency exemption for use of
propiconazole on sorghum (61 FR 58135, Nov. 13, 1996).
    New section 408(b)(2)(A)(i) allows EPA to establish a tolerance
(the legal limit for a pesticide chemical residue in or on a food) only
if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
    Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
    In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Metolachlor on Spinach and FFDCA
Tolerances
    On September 13, 1996, the Texas Department of Agriculture availed
itself of the authority to declare the existence of a crisis situation
within the State, thereby authorizing use under FIFRA section 18 of
metolachlor on spinach for control of various weeds. The States of
Arkansas, Oklahoma, and Virginia have also requested specific
exemptions for use of metolachlor on spinach in those States to control
various weeds. Emergency conditions are determined to exist due to the
loss of Antor 4E, diethatyl ethyl, a herbicide used on spinach. NOR-AM
Chemical Company no longer manufactures Antor and stocks were exhausted
from 1993 production. Furthermore, at the present there is no
preemergence herbicide registered to control annual weeds in spinach.
Roneet E6 is the only herbicide registered for use on spinach at
planting; however, it has proven ineffective as a preemergence control
for weeds.
    As part of its assessment of these applications for crisis
declaration and emergency exemptions, EPA assessed the potential risks
presented by residues of metolachlor on spinach. 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 be
consistent with the new safety standard and with FIFRA section 18. This
tolerance for metolachlor will permit the marketing of spinach 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
[[Page 60619]]
revoked automatically without further action by EPA on November 5,
1998, under FFDCA section 408(l)(5), residues of metolachlor not in
excess of the amount specified in the tolerance remaining in or on
spinach 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 metolachlor meets the
requirements for registration under FIFRA section 3 for use on spinach
or whether a permanent tolerance for metolachlor for spinach would be
appropriate. This action by EPA does not serve as a basis for
registration of metolachlor by a State for special local needs under
FIFRA section 24(c). Nor does this action serve as the basis for any
States other than those listed above to use this product on spinach
under section 18 of FIFRA without following all provisions of section
18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemptions for metolachlor, 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 (MOE) 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. Metolachlor is already registered by EPA for numerous food
and feed uses, as well as use on outdoor residential lawn, numerous
ornamental plants and trees, highway rights-of-way and recreational
area use. EPA has also assessed the toxicology data base for
metolachlor in its evaluation of applications for registration on
spinach. Thus, EPA has sufficient data to assess the hazards of
metolachlor and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for the time-limited tolerances for
residues of metolachlor on spinach at 0.3 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 Office of Pesticide Programs (OPP) has established the RfD for
metolachlor at 0.10 milligrams(mg)/kilogram(kg)/day. The RfD for
metolachlor is based on a 1-year feeding study in dogs with a NOEL of
9.7 mg/kg/day and an uncertainty factor of 100. Decreased body weight
gain was the effect observed at the Lowest Effect Level (LEL) of 33 mg/
kg/day.
    2. Acute toxicity. OPP has determined that data do not indicate the
potential for adverse effects after a single dietary exposure.
    3. Short-term toxicity. OPP has determined that an intermediate
term risk assessment is appropriate for occupational and residential
routes of exposure. OPP recommends that the NOEL of 100 mg/kg/day,
taken from the 21-day dermal toxicity study, be used for these MOE
calculations. Effects observed at the lowest observed effect level
(LOEL) of 1,000 mg/kg/day are dose-related increases in minor
histopathological alterations of the skin, total bilirubin (females),
absolute and relative liver weights (males), and relative kidney
weights (females). However, no acceptable reliable dermal exposure data
to assess these potential risks are available at this time. OPP did
[[Page 60620]]
not identify an inhalation exposure intermediate-term hazard.
    4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), the
Carcinogenicity Peer Review Committee (CPRC) has classified metolachlor
as a Group C chemical, possible human carcinogen, based on (a) the
increased incidence of adenomas and combined adenomas/carcinomas in
female rats, both by pair-wise and trend analysis and the replication
of this finding in a second study, (b) negative mutagenicity studies,
and (c) comparative metabolism studies indicating that metolachlor has
a different metabolic profile than acetochlor and alachlor with regard
to the quinone imine metabolite. Based on these findings, the CPRC
recommended that the NOEL of 15.7 mg/kg/day, from the 2-year feeding
study [MRID#: 00129377] in rat, and the MOE approach be used for
quantification of risk.
B. Aggregate Exposure
    Tolerances for residues of metolachlor in or on food/feed
commodities are currently expressed in terms of the combined residues
(free and bound) of the herbicide metolachlor [2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide] and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound
(40 CFR 180.368(a), (b), and (c)).
    For the purpose of assessing chronic dietary exposure from
metolachlor, EPA assumed tolerance level residues and percent of crop
treated refinements to estimate the Anticipated Residue Contribution
(ARC) from the proposed and existing food uses of metolachlor. The use
of percent of crop treated data for most of the existing food uses in
this analysis results in a more refined estimate of exposure than the
TMRC.
    Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational sources. Based on the available studies used in EPA's
assessment of environmental risk, metolachlor appears to be moderately
persistent and ranges from being mobile to highly mobile in different
soils. Data collected from around the United States provides evidence
that metolachlor leaches into ground water, occasionally at levels that
exceed the Lifetime Health Advisory (HA) Level of 100 parts per billion
(ppb). The ``Pesticides In Groundwater Database'' (EPA 734-122-92-001,
Sept. 1992), indicates that metolachlor residues were detected in wells
in 20 States. Levels exceeded the lifetime HA in three wells located in
Wisconsin, New York, and Montana. In eight other States concentrations
in some well waters exceeded 10 percent of the HA. Incident reports
submitted under 6(a)(2) of FIFRA describe 47 detections of metolachlor
in the groundwater of 7 States at concentrations ranging from 0.11 ppb
to 116 ppb. Metolachlor is not yet formally regulated under the Safe
Drinking Water Act; therefore, no enforcement Maximum Concentration
Level (MCL) has been established for it. Metolachlor also has
relatively high health advisory levels (1 to 10 day HA level of 2,000
ppb and lifetime HA level of 100 ppb).
    Although residue levels of metolachlor exceeding the lifetime HA of
100 ppb have been measured, the 1 to 10 day HA level of 2,000 is not
exceeded in any well measured and residues over time in these wells are
highly unlikely to exceed the lifetime HA of 100 ppb anywhere. As part
of the risk mitigation in the metolachlor Registration Eligibility
Document (RED), additional label restrictions designed to minimize
ground and surface water contamination are required. Groundwater
concerns may be mitigated by adhering to these label restrictions and
advisory statements.
    Previous experience with 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.
Based on this experience and OPP's best scientific judgement, and
considering the low percent of the RfD occupied by dietary exposure
estimates including spinach (0.6 percent RfD for U.S. population), EPA
does not anticipate that combined exposure from drinking water and
dietary exposure would result in an ARC that exceeds 100 percent of the
RfD. Therefore, the EPA concludes that potential metolachlor residues
in drinking water are not likely to pose a human health concern.
    There are residential uses of metolachlor and EPA acknowledges that
there may be short-, intermediate-, and long-term non-occupational
exposure scenarios. OPP has identified a toxicity endpoint for an
intermediate-term residential risk assessment. However, no acceptable
reliable exposure data to assess these potential risks are available at
this time. Given the time-limited nature of this request, the need to
make emergency exemption decisions quickly, and the significant
scientific uncertainty at this time about how to aggregate non-
occupational exposure with dietary exposure, the Agency will make its
safety determination for this tolerance based on those factors which it
can reasonably integrate into a risk assessment.
    At this time, the Agency has not made a determination that
metolachlor and other substances that may have a common mode of
toxicity would have cumulative effects. Given the time limited nature
of this request, the need to make emergency exemption decisions
quickly, and the significant scientific uncertainty at this time about
how to define common mode of toxicity, the Agency will make its safety
determination for this tolerance based on those factors which it can
reasonably integrate into a risk assessment. For purposes of this
tolerance only, the Agency is considering only the potential risks of
metolachlor in its aggregate exposure.
C. Safety Determinations For U.S. Population
    Based on the completeness and reliability of the toxicity and
consumption data, EPA has concluded that dietary exposure to
metolachlor will utilize 0.6 percent of the RfD for the U.S.
population. As mentioned before, EPA does not expect that chronic
exposure from drinking water would result in an aggregate exposure
which would exceed 100 percent of the RfD. EPA concludes that there is
a reasonable certainty that no harm will result from aggregate exposure
to metolachlor residues.
    As discussed earlier, quantitation of cancer risk using the MOE
approach was recommended by the CPRC using the NOEL of 15.7 mg/kg/day
from the 2-year feeding study in rats. However, as noted in the
metolachlor RED, because the RfD is set on a NOEL of 9.7 mg/kg/day from
the 1 year feeding study in dogs, dietary cancer concerns are
adequately addressed by the chronic exposure analysis using the RfD.
D. Determination of Safety for Infants and Children.
    In assessing the potential for additional sensitivity of infants
and children to residues of metolachlor, EPA considered pre- and post-
natal toxicity data. EPA notes that the developmental toxicity NOELs of
300 mg/kg/day (in rats) and greater than or equal to 360 mg/kg/day (HDT
in rabbits) demonstrate
[[Page 60621]]
that there is no developmental (prenatal) toxicity present for
metolachlor in the absence of maternal toxicity. EPA notes that there
was developmental toxicity in rats at 1,000 mg/kg/day (but not in
rabbits). The developmental NOELs are more than 30- and 37-fold higher
in the rats and rabbits, respectively, than the NOEL of 9.7 mg/kg/day
from the 1-year feeding study in dogs, which is the basis of the RfD.
In the 2-generation reproductive toxicity study in the rat, the
reproductive/developmental toxicity NOEL of 15 mg/kg/day was less than
the parental (systemic) toxicity NOEL of greater than 50 mg/kg/day. The
reproductive/developmental NOEL was based on decreased pup body weight
during late lactation. The NOEL for post-natal pup effects occurred at
a level which is below the NOEL for maternal toxicity. This finding
suggests that post-natal development in pups is more sensitive and that
infants and children may have a greater sensitivity to metolachlor than
adult animals. EPA notes that the NOELs are 1.5-fold (reproductive) and
greater than 5-fold higher (parental) than the NOEL of 9.7 mg/kg/day
from the 1-year feeding study in dogs, which is the basis of the RfD.
The reproductive/developmental LEL of 50 mg/kg/day was based on reduced
pup body weight at postnatal days 14 and 21 for the first generation
(F1 pups) and at post natal days 4, 14, and 21 for the second
generation (F2 pups). Because the second generation (F2) pups are in
the offspring of adults that have been exposed throughout their
lifetime, including in utero exposure, there is the possibility that
body weight decreases observed in these second generation offspring are
an indication of increased susceptibility.
    EPA has concluded that the percent of the RfD that will be utilized
by chronic dietary exposure to residues of metolachlor ranges from 1.0
percent for children 7 to 12 years old, up to 2.1 percent for non-
nursing infants (<1 year old). However, this calculation assumes
tolerance level residues for all commodities and is therefore an over-
estimate of dietary risk. Refinement of the dietary risk assessment by
using anticipated residue data would reduce dietary exposure. As
mentioned before, the addition of potential exposure from metolachlor
residues in drinking water is not expected to result in an exposure
which would exceed the RfD. EPA therefore concludes that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to metolachlor.
    As mentioned above, dietary cancer concerns for infants and
children are adequately addressed by the chronic exposure analysis
using the RfD.
    FFDCA section 408 provides that EPA may 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. Should an additional uncertainty factor be deemed
appropriate, when considered in conjunction with a refine exposure
estimate, it is unlikely that the dietary risk will exceed 100 percent
of the RfD. Therefore, EPA concludes that this tolerance will not pose
an unacceptable risk to infants and children.
V. Other Considerations
    The metabolism of metolachlor in plants and animals is adequately
understood for the purposes of this tolerance. There are no Codex
maximum residue levels established for residues of metolachlor on
spinach. Adequate methods for purposes of data collection and
enforcement of tolerance for metolachlor residues are available.
Methods for determining the combined residues of metolachlor and its
metabolites, as the derivatives CGA-37913 and CGA-49751, are described
in PAM, Vol. II, as Method I (plants; GC-NPD) and Method II (animals;
GC-MS).
VI. Conclusion
    Therefore, a tolerance in connection with the FIFRA section 18
emergency exemptions is established for residues of metolachlor in
spinach at 0.3 ppm. This tolerance will expire and be automatically
revoked without further action by EPA on November 15, 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, 2996 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-300443]. 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
[[Page 60622]]
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).
    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 a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
    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.
List of Subjects in 40 CFR Part 180
    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides 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 Sec. 180.368, by adding and reserving paragraph (d) and
adding a new paragraph (e) to read as follows:
Sec. 180.368  Metolachlor; tolerances for residues
*      *      *      *      *
    (d) [Reserved]
    (e) A time-limited tolerance is established for the combined
residues (free and bound) of the herbicide metolachlor [2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide] and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound
in connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerance is specified in the following
table. The tolerance expires and is automatically revoked on the date
specified in the table without further action by EPA.
------------------------------------------------------------------------
                                Parts per
          Commodity              million     Expiration/Revocation Date
------------------------------------------------------------------------
Spinach......................          0.3             November 15, 1998
------------------------------------------------------------------------
[FR Doc. 96-30468 Filed 11-27-96; 8:45 am]
BILLING CODE 6560-50-F