[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Rules and Regulations]
[Pages 60617-60622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30468]


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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: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-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: 
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the 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