[Federal Register Volume 62, Number 22 (Monday, February 3, 1997)]
[Rules and Regulations]
[Pages 4911-4915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2500]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300450; FRL-5584-5]
RIN 2070-AB78


Carboxin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of the fungicide carboxin in or on the raw 
agricultural commodity onion seed in connection with EPA's granting of 
emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of carboxin on onion 
seed in California and New Jersey. This regulation establishes a 
maximum permissible level for residues of carboxin 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 January 17, 1998.
DATES: This regulation becomes effective February 3, 1997. This 
regulation expires and is revoked automatically without further action 
by EPA on January 17, 1998. Objections and requests for hearings must 
be received by EPA on April 4, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [OPP-300450], 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 number, [OPP-300450], should be 
submitted to: Public Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring a copy of objections and hearing requests to Rm. 1132, 
CM #2, 1921 Jefferson Davis Highway, 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: <a href="/cdn-cgi/l/email-protection#cda2bdbde0a9a2aea6a8b98da8bdaca0aca4a1e3a8bdace3aaa2bb"><span class="__cf_email__" data-cfemail="9df2ededb0f9f2fef6f8e9ddf8edfcf0fcf4f1b3f8edfcb3faf2eb">[email protected]</span></a>. 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. No Confidential Business Information (CBI) 
should be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible, 
Registration Division (7505W), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location, telephone number, and 
e-mail address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis 
Highway, Arlington, VA 22202, (703) 308-8337, e-mail: 
<a href="/cdn-cgi/l/email-protection#91e2f2f9f0f8f3fdf4bfe2e5f4e1f9f4ffd1f4e1f0fcf0f8fdbff4e1f0bff6fee7"><span class="__cf_email__" data-cfemail="295a4a4148404b454c075a5d4c59414c47694c594844484045074c5948074e465f">[email protected]</span></a>.
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 fungicide carboxin, 5,6-dihydro-2-methyl-1,4-oxathiin-
3-carboxanilide in or on onions (dry bulb) at 0.2 part per million 
(ppm). This tolerance will expire and be revoked automatically without 
further action by EPA on January 17, 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

[[Page 4912]]

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 Exemption for Carboxin on Onion Seed and FFDCA 
Tolerances

    The California Department of Pesticide Regulations and the New 
Jersey Department of Environmental Protection requested specific 
exemptions for use of carboxin on onion seed to control onion smut. The 
loss of Arasan 50 Red, the fungicide historically used to control onion 
smut, has resulted in an urgent, non-routine situation for growers. In 
the past, onion smut was controlled with thiram 50 percent wettable 
powder (Arasan 50 Red) seed treatments. However, the DuPont Company 
ceased manufacture of this product in 1985, and growers have since 
exhausted existing stocks of Arasan 50 Red. According to the 
Applicants, there are no other registered pesticides or alternative 
practices available that will control this disease. There are other 
thiram products registered for use as onion seed treatments, but the 
maximum label rates are too low to control onion smut.
    As part of its assessment of this application for an emergency 
exemption, EPA assessed the potential risks presented by residues of 
carboxin on onion seed. In doing so, EPA considered the new safety 
standard in FFDCA section 408(b)(2), and EPA decided to grant the 
section 18 exemption 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 carboxin will 
permit the marketing of onion seed treated in accordance with the 
provisions of the section 18 emergency exemptions. Consistent with the 
need to move quickly on the emergency exemptions and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment under section 408(e) 
as provided in section 408(l)(6). Although this tolerance will expire 
and be revoked automatically without further action by EPA on December 
31, 1997, under FFDCA section 408(l)(5), residues of carboxin not in 
excess of the amount specified in the tolerance remaining in or on 
onion seeds 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 carboxin meets the 
requirements for registration under FIFRA section 3 for use on onion 
seeds or whether a permanent tolerance for carboxin for onion seeds 
would be appropriate. This action by EPA does not serve as a basis for 
registration of carboxin 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 California to use this product on this crop under section 18 
of FIFRA without following all provisions of section 18 as identified 
in 40 CFR part 166. For additional information regarding the emergency 
exemptions for carboxin, 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 by EPA to pose no appreciable risk.
    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

[[Page 4913]]

extrapolations or margin of exposure calculation based on the 
appropriate NOEL) may 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. Carboxin is not registered for residential use. Uniroyal 
Chemical Company has submitted a petition tolerance for the use of 
carboxin on onion (dry bulb) to the Agency; however, it is pending 
review. Based on the information submitted to the Agency, EPA has 
sufficient data to assess the hazards of carboxin and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), 
for the time-limited tolerances for residues of carboxin on onion seed 
at 0.2 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 
carboxin at 0.1 milligrams(mg)/ kilogram(kg)/day. The RfD for carboxin 
is based on a 2-year feeding study in rats with a NOEL of 10 mg/kg/day 
and an uncertainty factor of 100. Decreased body weight gain, increased 
mortality and decreased organ weight (heart, kidney, and spleen) was 
the effect observed at the Lowest Effect Level (LEL) of 15 mg/kg/day.
    2. Acute toxicity. Based on available acute toxicity data, OPP has 
determined that the NOEL of 75 mg/kg/day from the developmental 
toxicity study in rabbits should be used to assess risk from acute 
toxicity. The maternal/developmental effects observed at the LEL of 375 
mg/kg/day were abortions. The relationship between abortions produced 
by direct maternal toxicity (i.e. stress) and those effects mediated by 
reproductive/developmental mechanisms can not be clearly differentiated 
at this time. The population subgroup of concern for this risk 
assessment is females 13 years of age and older. This subgroup is 
representative for both maternal and fetal effects.
    3. Carcinogenicity. Carboxin's carcinogenicity has not been 
classified by the Reference Dose (RfD) Committee. However, when last 
reviewed in 1986, there was no evidence of carcinogenicity in rats or 
mice.

B. Aggregate Exposure

    Tolerances for residues of carboxin in or on food/feed commodities 
are currently expressed in terms of the combined residues (free and 
bound) of the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-
carboxanilide) and its sulfoxide metabolite (5,6-dihydro-3-
carboxanilide-2-methyl-1,4-oxathiin-4-oxide), expressed in or on 
certain raw agricultural commodities ranging from 0.01 ppm in eggs to 
0.5 ppm in beans, hay, barley and wheat (see 40 CFR 180.301). For the 
purpose of assessing chronic dietary exposure from carboxin, EPA 
assumed tolerance level residues and 100 percent of crop treated 
refinements to estimate the TMRC from all established food uses for 
carboxin as well as the proposed use on onion seed. There are no 
livestock feed items associated with this section 18 request, so no 
additional livestock dietary burden will result from this section 18 
registration. Therefore, existing meat/milk/poultry tolerances are 
adequate.
    Other potential sources of exposure of the general population to 
residues of pesticides are residues in drinking water and exposure from 
non-occupational (non-dietary) sources. Based on the available studies 
used in EPA's assessment of environmental risk, carboxin is persistent 
and leaches into groundwater. There are no established Maximum 
Concentration Levels (MCLs) for residues of carboxin in drinking water. 
Health Advisory (HA) Levels for carboxin in drinking water for adults 
are 4 and 0.7 mg/L (longer term and life time HA levels respectively) 
and 1 day, 10 day, and longer term HA levels are all 1 mg/L for 
children.
    The Agency does not have available data to perform a quantitative 
drinking water risk assessment for carboxin at this time. However, 
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 onion seed (1.0 percent RfD for U.S. population), 
EPA does not anticipate that combined exposure from drinking water and 
dietary exposure would result in a TMRC that exceeds 100 percent of the 
RfD. Therefore, the EPA concludes that potential carboxin residues in 
drinking water are not likely to pose a human health concern.
    Carboxin is not registered for residential use. Non-occupational 
exposure to the general population is therefore not expected and not 
considered in aggregate exposure estimates.
    At this time, the Agency has not made a determination that carboxin 
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 carboxin in its aggregate 
exposure.

[[Page 4914]]

C. Safety Determinations For U.S. Population

    EPA has concluded that dietary exposure to carboxin will utilize 
1.0 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 carboxin residues. For the 
population subgroup of concern, females 13+ and older (accounts for 
both maternal and fetal exposure), the calculated Margin of Exposure 
(MOE) value is 25,000. MOE values over 100 do not exceed the Agency's 
level of concern for acute dietary exposure. EPA concludes that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to carboxin residues.

D. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of carboxin, EPA considered pre- and post-
natal toxicity studies in rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity study in rats 
does not meet current guideline requirements due to the lack of 
maternal or developmental effects. In the maternal/developmental 
toxicity study in the rat the NOEL was >40 mg/kg/day highest dose 
tested and the NOEL in rabbits was 75 mg/kg/day with a LEL of 375 mg/
kg/day based on abortions. In addition, the acute dietary MOE for 
pregnant women 13+ years old is 25,000. This large MOE supports the 
conclusion that there are no developmental (prenatal) concerns for both 
females 13+ years and the pre-natal development of infants from 
aggregate residues of carboxin.
    In the 2-generation reproductive toxicity study in the rat, the 
reproductive/developmental toxicity NOEL of 10 mg/kg/day was greater 
than the parental (systemic) toxicity NOEL of 1 mg/kg/day which 
demonstrates that pup toxicity occurred in the presence of maternal 
toxicity. This finding suggests that post-natal development in pups is 
not more sensitive and that infants and children may not be more 
sensitive to carboxin than adult animals. This information, together 
with the uncertainty factor of 100 utilized to calculate the RfD for 
carboxin, is considered adequate protection for infants and children 
with respect to prenatal and postnatal development against dietary 
exposure to carboxin residues.
    EPA has concluded that the percent of the RfD that will be utilized 
by chronic dietary exposure to residues of carboxin ranges from 0.7 
percent for females 13+ to 2.4 percent for non-nursing infants (<1 year 
old). The calculated acute MOE for the population subgroup of concern, 
females 13+ and older, value is 25,000. Both chronic and acute dietary 
exposure risk assessments assume 100 percent crop treated and use 
tolerance level residues for all commodities (TMRC estimates). 
Refinement of the dietary risk assessment by using percent crop treated 
and anticipated residue (ARC) data would reduce dietary exposure. 
Therefore, both of these risk assessments are also an over-estimate of 
dietary risk. Consideration of ARC and percent crop treated would 
likely result in an ARC which would occupy a percent of the RfD that is 
likely to be significantly lower than the currently calculated TMRC 
value. Additionally, the acute dietary MOE would be greater than the 
current MOE. The addition of potential exposure from carboxin 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 carboxin residues.
    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, based on reliable data, that said 
additional safety factor is unnecessary. 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 carboxin in plants and animals is adequately 
understood for the purposes of this tolerance. There are no Codex 
maximum residue levels established for residues of carboxin on onion 
seed. Adequate methods for purposes of data collection and enforcement 
of tolerance for carboxin residues are available. Methods for 
enforcement of tolerances in/on various plant and animal commodities 
are listed in the Pesticide Analytical Manual (PAM) Vol. II as Method I 
and Method II.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of carboxin on onion 
seed at 0.2 ppm. This tolerance will expire and be automatically 
revoked without further action by EPA on January 17, 1998.

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 April 4, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) and may also request a hearing on those objections. 
Objections and hearing requests must be filed with the Hearing Clerk, 
at the address given above (40 CFR 178.20). A copy of the objections 
and/or hearing requests filed with the Hearing Clerk should be 
submitted to the OPP docket for this rulemaking. The objections 
submitted must specify the provisions of the regulation deemed 
objectionable and the grounds for the objections (40 CFR 178.25). Each 
objection must be accompanied by the fee prescribed by 40 CFR 
180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32).
    Information submitted in connection with an objection or hearing 
request

[[Page 4915]]

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

    EPA has established a record for this rulemaking under docket 
number [OPP-300450] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, 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.
    Electronic comments may be sent directly to EPA at:
    <a href="/cdn-cgi/l/email-protection#771807075a1318141c1203371207161a161e1b5912071659101801"><span class="__cf_email__" data-cfemail="80eff0f0ade4efe3ebe5f4c0e5f0e1ede1e9ecaee5f0e1aee7eff6">[email protected]</span></a>.

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the address in ``ADDRESSES'' 
at the beginning of this document.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply.
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

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

    Dated: January 21, 1997.

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. 180.301, by designated the existing text as paragraph 
(a) and by adding a new paragraph (b) to read as follows:


Sec. 180.301 Carboxin; tolerances for residues.

*    *    *    *    *
    (b) A time-limited tolerance is established for residues of the 
combined residues (free and bound) of the fungicide carboxin [5,6-
dihydro-2-methyl-1,4-oxathiin-3-carboxanilide) and its sulfoxide 
metabolite (5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-oxide), 
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.

----------------------------------------------------------------------------------------------------------------
                        Commodity                             Parts per million      Expiration/Revocation Date 
----------------------------------------------------------------------------------------------------------------
Onion Seed...............................................                      0.2              January 17, 1998
----------------------------------------------------------------------------------------------------------------


[FR Doc. 97-2500 Filed 1-31-97; 8:45 am]
BILLING CODE 6560-50-F


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