[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: 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. 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:
schaible.stephen@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 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:="">opp-docket@epamail.epa.gov.
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
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Onion Seed............................................... 0.2 January 17, 1998
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[FR Doc. 97-2500 Filed 1-31-97; 8:45 am]
BILLING CODE 6560-50-F
