[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Rules and Regulations]
[Pages 26949-26954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12913]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300491; FRL-5718-2]
RIN 2070-AB78
Clopyralid; Pesticide Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of the herbicide clopyralid in or on the food commodity canola
in connection with EPA's granting emergency exemptions under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on canola in Idaho, Montana, Minnesota, North
Dakota and Washington. The tolerance will expire and is revoked on July
31, 1998.
DATES: This regulation becomes effective May 16, 1997. Objections and
requests for hearings must be received by EPA on or before July 15,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300491],
[[Page 26950]]
must be submitted to: Hearing Clerk (1900), Environmental Protection
Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees
accompanying objections and hearing requests shall be labeled
``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251. A copy of any objections and hearing requests
filed with the Hearing Clerk identified by the docket control number,
[OPP-300491], must be submitted to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person, bring a copy of objections
and hearing requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300491]. 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: Libby Pemberton, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Sixth Floor, Crystal
Station #1, 2800 Jefferson Davis Highway, Arlington, VA (703) 308-8326,
e-mail:pemberton.libby@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the herbicide clopyralid, in or on canola at 3 parts per
million (ppm). This tolerance will expire and be revoked by EPA on July
31, 1998. After July 31, 1998, EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.
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 FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA
amends FFDCA to bring all EPA pesticide tolerance-setting activities
under section 408 with a new safety standard and new procedures. These
activities are described below and discussed in greater detail in the
final rule establishing the time-limited tolerance associated with the
emergency exemption for use of propiconazole on sorghum (61 FR 58135,
November 13, 1996) (FRL-5572-9).
New Section 408(b)(2)(A)(i) of the FFDCA 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 and in residential settings,
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) of the FFDCA
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. Such tolerances can
be established without providing notice or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Clopyralid on Canola and FFDCA
Tolerances
EPA has authorized under FIFRA section 18 the use of clopyralid on
canola for control of perennial sowthistle and/or Canada thistle.
Biological and economic assessments indicate that an urgent, non-
routine situation exists for the canola crop in the states of North
Dakota, Minnesota, Montana, Idaho and Washington, and that losses near
100% will occur where thistle stands are thick. Perennial sowthistle
and Canadian thistle are particularly severe in cool, moist weather.
After having reviewed the submissions, EPA concurs that emergency
conditions exist for these states.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of clopyralid in or
on canola. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided 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 will permit the
marketing of canola treated in accordance with the provisions of the
section 18 emergency exemption. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation 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 is revoked on July
31, 1998, under FFDCA section 408(l)(5), residues of the pesticide not
in excess of the amounts specified in the tolerance remaining in or on
canola after that date will not be unlawful, provided the pesticide is
applied during the term of, and in accordance with all the conditions
of, section 18 of FIFRA. 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 clopyralid meets EPA's
registration requirements for use on canola or whether a permanent
tolerance for this use would be appropriate. This tolerance does not
[[Page 26951]]
serve as a basis for registration of clopyralid by a State for special
local needs under FIFRA section 24(c). Nor does this tolerance serve as
the basis for any State other than Idaho, Montana, Minnesota, North
Dakota, and Washington to use this pesticide 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 exemption for clopyralid, 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% 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 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, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). 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% 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.
Percent of crop treated estimates are derived from Federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (children 1 to 6
years old) was not regionally based.
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. EPA has sufficient data to assess the hazards of
clopyralid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for the time-limited tolerances for
residues of clopyralid in or on canola at 3 ppm. EPA's assessment of
the dietary exposures and risks associated with establishing this
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by clopyralid are
discussed below.
1. Acute toxicity. No toxicology studies were identified by the
Office of Pesticide Programs (OPP) which demonstrated the need for an
acute dietary risk assessment.
2. Short-term non-dietary inhalation and dermal toxicity. Based on
available data indicating that there was no evidence of toxicity by the
dermal or inhalation routes, non-dietary exposure risks were not
calculated.
3. Chronic toxicity. Based on the available chronic toxicity data,
OPP has established the RfD for clopyralid at 0.5 milligrams(mg)/
kilogram(kg)/day. The RfD was established based on an NOEL of 50 mg/kg/
day from a 2-year rat feeding study. Effects observed at the lowest
effect level (LEL) were decreased mean body weights in females. An
uncertainty factor of 100 was used.
4. Carcinogenicity. No evidence of carcinogenicity was seen in mice
or in rats fed clopyralid for 24 months.
B. Exposures and Risks
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking
[[Page 26952]]
water (whether from groundwater or surface water), and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses). In evaluating food exposures, EPA takes into account
varying consumption patterns of major identifiable subgroups of
consumers, including infants and children.
1. From food and feed uses. Tolerances have been established (40
CFR 180.431) for residues of clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) in or on a variety of food commodities,
including meat, fat, and meat byproducts of cattle, goats, hogs,
horses, poultry, and sheep; and milk. Risk assessments were conducted
by EPA to assess dietary exposures and risks from clopyralid as
follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. The Agency has determined that this
risk assessment was not required.
ii. Chronic exposure and risk. For the purpose of assessing chronic
dietary exposure from clopyralid, EPA assumed tolerance level residues
and 100% of crop treated for the proposed and existing food uses of
clopyralid. These conservative assumptions result in overestimation of
human dietary exposures.
2. From drinking water. Studies indicate clopyralid is persistent
in the field, very soluble in water, does not hydrolyze, and is very
mobile in soil. Therefore, clopyralid has the potential to leach to
ground water and/or contaminate surface water through dissolved
residues in runoff. There is no entry for clopyralid in the
``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September
1992). There is no established Maximum Concentration Level (MCL) for
residues of clopyralid in drinking water. No drinking water health
advisory levels have been established for clopyralid.
i. Acute exposure and risk. The Agency has determined that this
risk assessment was not required.
ii. Chronic exposure and risk. Because the Agency lacks sufficient
water-related exposure data to complete a comprehensive drinking water
risk assessment for many pesticides, EPA has commenced and nearly
completed a process to identify a reasonable yet conservative bounding
figure for the potential contribution of water related exposure to the
aggregate risk posed by a pesticide. In developing the bounding figure,
EPA estimated residue levels in water for a number of specific
pesticides using various data sources. The Agency then applied the
estimated residue levels, in conjunction with appropriate toxicological
endpoints (RfD's or acute dietary NOEL's) and assumptions about body
weight and consumption, to calculate, for each pesticide, the increment
of aggregate risk contributed by consumption of contaminated water.
While EPA has not yet pinpointed the appropriate bounding figure for
consumption of contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause clopyralid to
exceed the RfD if the tolerance being considered in this document was
granted. The Agency has therefore concluded that the potential
exposures associated with clopyralid in water, even at the higher
levels the Agency is considering as a conservative upper bound, would
not prevent the Agency from determining that there is a reasonable
certainty of no harm if the tolerance is granted.
3. From non-dietary exposure. Clopyralid is registered by EPA for
outdoor Christmas tree plantations, grasses grown for seed, fallow
cropland, non-cropland and other non-food uses.
i. Acute exposure and risk. The Agency has determined that this
risk assessment was not required.
ii. Chronic exposure and risk. The Agency has determined that a
chronic non-dietary exposure does not exist for clopyralid.
iii. Short- and intermediate term exposure and risk. The Agency has
determined there are no short- and intermediate endpoints of concern.
Therefore, this risk assessment is not required for clopyralid.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether clopyralid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
clopyralid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that clopyralid has a common mechanism of toxicity
with other subtances.
C. Aggregate Risks and Determination of Safety For U.S. Population
1. Acute risk. There are no acute dietary endpoints of concern;
therefore an acute aggregate risk assessment is not required for
clopyralid.
2. Chronic risk. Using the conservative TMRC exposure assumptions
described above, EPA has concluded that aggregate exposure to
clopyralid from food will utilize 12% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is children (1 to 6 years old), discussed below. EPA
[[Page 26953]]
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate exposure
over a lifetime will not pose appreciable risks to human health.
Despite the potential for exposure to clopyralid in drinking water, EPA
does not expect the aggregate exposure to exceed 100% of the RfD. EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to clopyralid residues.
3. Short- and intermediate-term risk. EPA has determined there are
no short- and intermediate-endpoints of concern; therefore, this
aggregate risk assessment is not required for clopyralid.
D. Aggregate Cancer Risk for U.S. Population
EPA has determined that there is no evidence of carcinogenicity in
rats or mice for clopyralid; therefore, an aggregate cancer risk
assessment is not required for clopyralid.
E. Aggregate Risks and Determination of Safety for Infants and Children
In assessing the potential for additional sensitivity of infants
and children to residues of clopyralid, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard margin of exposure and uncertainty factor (usually
100 for combined inter- and intra-species variability) and not the
additional tenfold margin of exposure/uncertainty factor when EPA has a
complete data base under existing guidelines and when the severity of
the effect in infants or children or the potency or unusual toxic
properties of a compound do not raise concerns regarding the adequacy
of the standard margin of exposure/safety factor.
1. Developmental toxicity studies. The developmental toxicity NOELs
of > 250 mg/kg/day (HDT) in both rats and rabbits demonstrate that
there is no developmental (pre-natal) toxicity present for clopyralid.
EPA further notes that the developmental NOELs are fivefold higher in
both rats and rabbits, respectively, than the NOEL of 50 mg/kg/day from
the 2-year feeding study in rats, which is the basis for the RfD.
2. Reproductive toxicity study. In the two-generation reproductive
toxicity study in rats, the pup toxicity NOEL of 1,500 mg/kg/day (HDT)
was greater than the parental (systemic) toxicity NOEL of 500 mg/kg/
day.
3. Pre- and post-natal sensitivity. The above findings suggest that
post-natal development in pups is not more sensitive and that infants
and children may not be more sensitive to clopyralid than adult
animals. The pup NOEL is thirtyfold higher than the RfD NOEL of 50 mg/
kg/day.
4. Acute risk. The Agency has determined that this risk assessment
was not required.
5. Chronic risk. EPA has concluded that the percent of the RfD that
will be utilized by chronic dietary exposure to residues of clopyralid
ranges from 11% for nursing infants (<1 year="" old)="" up="" to="" 14%="" for="" children="" 1="" to="" 6="" years="" 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.="" the="" addition="" of="" potential="" exposure="" from="" clopyralid="" residues="" in="" drinking="" water="" is="" not="" expected="" to="" result="" in="" an="" exposure="" which="" would="" exceed="" the="" rfd.="" 6.="" short-="" or="" intermediate-term="" risk.="" the="" agency="" has="" determined="" there="" are="" no="" short-="" and="" intermediate="" endpoints="" of="" concern.="" therefore,="" this="" risk="" assessment="" is="" not="" required="" for="" clopyralid.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" clopyralid="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" the="" residue="" of="" concern="" is="" clopyralid="" (3,6-dichloro-2-pyridinecarboxylic="" acid).="" b.="" analytical="" enforcement="" methodology="" adequate="" methods="" for="" purposes="" of="" data="" collection="" and="" enforcement="" of="" tolerances="" for="" clopyralid="" are="" available.="" a="" method="" for="" determining="" clopyralid="" residues="" is="" described="" in="" pam,="" vol.="" ii.="" c.="" magnitude="" of="" residues="" residues="" of="" clopyralid="" are="" not="" expected="" to="" exceed="" 3="" ppm="" in="" canola="" as="" a="" result="" of="" this="" use.="" clopyralid="" does="" not="" concentrate="" in="" canola="" processed="" by-products="" (refined="" oil="" and="" meal).="" existing="" meat/milk/="" poultry="" and="" egg="" tolerances="" should="" be="" adequate="" to="" cover="" secondary="" residues="" which="" result="" from="" feeding="" canola="" meal="" from="" treated="" canola.="" d.="" international="" residue="" limits="" there="" are="" no="" canadian,="" mexican,="" or="" codex="" maximum="" residue="" levels="" established="" for="" residues="" of="" clopyralid="" on="" canola.="" vi.="" conclusion="" therefore,="" a="" tolerance="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" is="" established="" for="" residues="" of="" clopyralid="" in="" canola="" at="" 3="" ppm.="" 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="" july="" 15,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" 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="" [[page="" 26954]]="" 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="" 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-300491]="" (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="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" 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 will be kept in paper form. Accordingly,
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 which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia 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. Nonetheless, the Agency has previously
assessed whether establishing tolerances or exemptions from tolerance,
raising tolerance levels, or expanding exemptions adversely impact
small entities and concluded, as a generic matter, that there is no
adverse impact. (46 FR 24950, May 4, 1981).
Under 5 U.S.C. 801(a)(1)(A) of 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 8, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.431, paragraph (b) is amended by revising the
introductory text, the column headings to the table, in the third
column of the table by changing ``July 31, 1998'' to read ``7/31/98''
and by adding an entry for canola to the table.
Sec. 180.431 Clopyralid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide clopyralid in connection with
use of the pesticide under section 18 emergency exemptions granted by
EPA. The tolerances will expire and are revoked on the dates specified
in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Canola..................................... 3 7/31/98
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 97-12913 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
