[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Rules and Regulations]
[Pages 66459-66464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32003]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300747; FRL-6038-5]
RIN 2070-AB78
Cymoxanil; 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
residues of cymoxanil (2-cyano-N-[(ethylamino)carbonyl]-2-
(methoxyimino) acetamide) in or on dried hops. This action is in
connection with a crisis exemption declared under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on dried hops. This regulation establishes a maximum
permissible level for residues of cymoxanil in this food commodity
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. The
tolerance will expire and is revoked on April 15, 2000.
DATES: This regulation is effective December 2, 1998. Objections and
requests for hearings must be received by EPA on or before February 1,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300747], 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-300747], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), 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. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300747]. 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 (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9364, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 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 cymoxanil (2-cyano-N-[(ethylamino)carbonyl]-
2-(methoxyimino) acetamide), in or on dried hops at 1 part per million
(ppm). This tolerance will expire and is revoked on April 15, 2000. 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. 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 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 (November 13, 1996, 61 FR
58135)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
[[Page 66460]]
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 tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Cymoxanil on Hops and FFDCA Tolerances
On July 16, 1998, the Idaho Department of Agriculture availed
itself of the authority to declare the existence of a crisis situation
within the state, thereby authorizing use under FIFRA section 18 of
cymoxanil on hops for control of downy mildew.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of cymoxanil in or on dried
hops. In doing so, EPA considered the 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 safety standard and with
FIFRA section 18. 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 April 15, 2000,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on dried hops
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by this tolerance at the time of that
application. 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.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether cymoxanil meets EPA's
registration requirements for use on hops or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of cymoxanil 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 to use this pesticide on this crop under section
18 of FIFRA without following all provisions of EPA's regulations
implementing section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for cymoxanil,
contact the Agency's Registration Division at the address provided
above.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the Final Rule on Bifenthrin Pesticide
Tolerances (November 26, 1997, 62 FR 62961)(FRL-5754-7).
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 cymoxanil
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of 2-
cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide on dried hops
at 1 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the 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 cymoxanil are
discussed below.
1. Acute toxicity. For females 13+, the developmental no observed
adverse effect level (NOAEL) = 4 mg/kg/day based on an increase in
skeletal malformations of the cervical and thoracic vertebrae and ribs
at 8 milligrams/kilogram/day (mg/kg/day). EPA has determined that the
10x factor to account for enhanced sensitivity of infants and children
should be reduced to 3x. For acute dietary risk assessment, a margin of
exposure (MOE) of 300 is required for protection of females 13+ from
acute dietary exposure to cymoxanil. A dose and endpoint were not
selected for the general U.S. population and infants and children
because there were no effects observed in oral toxicological studies
including maternal toxicity in the developmental toxicity studies in
rats and rabbits that could be attributable to a single exposure
(dose).
2. Chronic toxicity. EPA has established the Reference dose (RfD)
for cymoxanil at 0.013 mg/kg/day. This RfD is based on a NOAEL of 4.08
mg/kg/day and an uncertainty factor of 300. NOAEL established from a
combined chronic toxicity/carcinogenicity study in rats, based on
decreases in body weight and body weight gain, reduced food efficiency
and histopathological lesions in the eyes and testes of males at 30.3
mg/kg/day lowest observed effect level (LOEL). EPA has determined that
the 10x factor to account for enhanced sensitivity of infants and
children should be reduced to 3x.
3. Carcinogenicity. Based on the lack of evidence of
carcinogenicity in mice and rats at doses that were judged to be
adequate to asses the carcinogenic potential, cymoxanil was classified
as a ``not likely'' human carcinogen.
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B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.503) for the residues of 2-cyano-N-[(ethylamino)carbonyl]-2-
(methoxyimino) acetamide, in or on potatoes. In addition, a time-
limited tolerance in or tomatoes has also been established. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from cymoxanil 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 acute exposure analysis for female
(13+) subgroup was performed using tolerance level residues and 100
percent crop treated and resulted in an acceptable MOE of 300.
ii. Chronic exposure and risk. EPA has concluded that the percent
of the RfD that will be utilized by chronic dietary exposure to
residues of cymoxanil is less than 5% for all population subgroups. EPA
does not consider the chronic dietary risk to exceed the level of
concern.
2. From drinking water. EPA has calculated drinking water levels of
concern for acute exposure to cymoxanil in drinking water for females
(13+ years old) to be 280 parts per billion (ppb). For chronic (non-
cancer), the drinking water levels of concern are 440 and 120 ppb for
U.S. population, children (1-6 years old), respectively. EPA has
determined that cymoxanil and its degradates should not pose a threat
to ground water. The estimated maximum concentration of cymoxanil in
surface water is 4.13 ppb.
i. Acute exposure and risk. The maximum estimated concentrations of
cymoxanil in surface water are less than EPA's levels of concern for
cymoxanil in drinking water as a contribution to acute aggregate
exposure. Taking into account the present uses and this proposed use,
EPA concludes with reasonable certainty that residues of cymoxanil in
drinking water would not result in unacceptable levels of aggregate
human health risk at this time.
ii. Chronic exposure and risk. The maximum estimated concentrations
of cymoxanil in surface water are less than EPA's levels of concern for
cymoxanil in drinking water as a contribution to chronic aggregate
exposure. Taking into account the present uses and this proposed use,
EPA concludes with reasonable certainty that residues of cymoxanil in
drinking water would not result in unacceptable levels of aggregate
human health risk at this time.
3. From non-dietary exposure. Cymoxanil is not currently registered
for use on residential non-food sites.
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.''
EPA does not have, at this time, available data to determine
whether cymoxanil 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,
cymoxanil 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 cymoxanil has a common mechanism of toxicity
with other substances. For more information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the Final Rule
for Bifenthrin Pesticide Tolerances (November 26, 1997, 62 FR 62961).
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. From the acute dietary (food only) risk assessment,
a high-end exposure estimate was calculated for the subgroup, females
13+ years. The maximum estimated concentrations of cymoxanil in surface
and ground water are less than EPA's levels of concern for cymoxanil in
drinking water as a contribution to acute aggregate exposure.
Therefore, EPA concludes with reasonable certainty that residues of
cymoxanil in drinking water do not contribute significantly to the
aggregate acute human health risk at the present time.
2. Chronic risk. Using the Dietary Exposure Evaluation Model, EPA
has concluded that aggregate exposure to cymoxanil from food will
utilize 2% of the RfD for the U.S. population. The major identifiable
subgroup with the highest aggregate exposure is children (1-6 years
old) ``discussed below.'' EPA generally has no concern for exposures
below 100% of the RfD because the RfD represents the level at or below
which daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health. The estimated average concentrations
of cymoxanil in surface and ground water are less than EPA's levels of
concern for cymoxanil in drinking water as a contribution to chronic
aggregate exposure. Therefore, EPA does not expect the aggregate
exposure to exceed 100% of the RfD.
Short- and intermediate-term aggregate exposure takes into account
chronic dietary food and water (considered to be a background exposure
level) plus indoor and outdoor residential exposure.
3. Aggregate cancer risk for U.S. population. A cancer risk
assessment is not needed since cymoxanil was classified as a ``not
likely'' human carcinogen.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to cymoxanil residues.
D. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of cymoxanil, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. This is the case. The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from maternal pesticide exposure during
gestation. 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 (MOE) 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 MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability)) and not the additional tenfold
MOE/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
[[Page 66462]]
toxic properties of a compound do not raise concerns regarding the
adequacy of the standard MOE/safety factor.
EPA determined that for cymoxanil, the 10x factor for the enhanced
sensitivity of infants and children will be reduced to 3x for the
following reasons:
a. There was no sensitivity to perinatal animals following pre-
and/or postnatal exposure with cymoxanil. In one prenatal developmental
toxicity study in rabbits, where sensitivity was suggested by
observations of developmental toxicity at a dose which was not
maternally toxic, the lower developmental NOEL was attributed to
inadequacies in study design and conduct.
b. There were no data gaps for the assessment of potential effects
on offspring following in utero and/or postnatal exposure to cymoxanil
via the standard screening studies required by 40 CFR Part 158.
However, following a weight-of-the-evidence review of the database,
which suggested that neuropathological lesions could result from long-
term exposure to cymoxanil, a developmental neurotoxicity study in rats
was recommended.
ii. Developmental toxicity studies. The NOAEL was 4 mg/kg/day and
the LOEL was 8 mg/kg/day based on an increase in skeletal malformations
of the cervical and thoracic vertebrae and ribs; at 32 mg/kg/day, cleft
palate was also observed.
iii. Reproductive toxicity study. For parental systemic toxicity,
the NOAEL was 100 ppm (6.5 mg/kg/day for males, 7.9 mg/kg/day for
females) and LOEL was 500 ppm based on reduced premating body weight,
body weight gain, and food consumption for P males; and decreased
gestation and lactation body weight for F1 females. For offspring
systemic toxicity, the NOAEL was 100 ppm (6.5 mg/kg/day for males, 7.9
mg/kg/day for females) and the LOEL was 500 ppm (32.1 mg/kg/day for
males, 40.6 mg/kg/day for females) based on decreased F1 pup viability
on postnatal days 0-4 and on a significant reduction in F2b pup weight.
iv. Pre- and post-natal sensitivity. The developmental toxicity and
multigeneration reproduction study data demonstrated no indication of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to cymoxanil. Overall, in the developmental toxicity
studies in rats and rabbits, and in the 2-generation reproductive
toxicity study with cymoxanil in rats, offspring toxicity was observed
only at treatment levels which were toxic to parental adults.
v. Conclusion. There were no data gaps for the assessment of
potential effects on offspring following in utero and/or postnatal
exposure to cymoxanil via the standard screening studies required by 40
CFR Part 158. However, following a weight-of-the-evidence review of the
database, which suggested that neuropathological lesions could result
from long-term exposure to cymoxanil, a developmental neurotoxicity
study in rats is required. There is a complete toxicity database for
cymoxanil and exposure data is complete or is estimated based on data
that reasonably accounts for potential exposures.
2. Acute risk. The large acute dietary MOEs calculated for females
13+ years old provides assurance that there is a reasonable certainty
of no harm for both females 13+ years and the pre-natal development of
infants.
3. Chronic risk. Using the exposure assumptions described above,
EPA has concluded that aggregate exposure to cymoxanil from food will
range from 1% for nursing infants less than one year old, up to 5% for
children (1-6 years old). EPA generally has no concern for exposures
below 100% of the RfD because the RfD represents the level at or below
which daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health. Despite the potential for exposure
to cymoxanil in drinking water and from non-dietary, non-occupational
exposure, EPA does not expect the aggregate exposure to exceed 100% of
the RfD.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to cymoxanil residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in tomatoes and potatoes is adequately
understood. For purposes of this action, EPA was willing to translate
these data to hops. The residues of concern in hops are cymoxanil per
se, as specified in 40 CFR 180.503.
B. Analytical Enforcement Methodology
An adequate enforcement method (DuPont Method AMR 2358-92,
unpublished) is available to enforce the proposed tolerance on hops.
Quantitation is by GLC using a nitrogen/phosphorus detector.
Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305-5229).
C. Magnitude of Residues
Residues of cymoxanil are not expected to exceed 1.0 ppm in/on
hops, dried. Secondary residues are not expected in animal commodities
as no feed items are associated with this section 18 use.
D. International Residue Limits
There are no Codex, Canadian or Mexican residue limits established
for cymoxanil on hops. Therefore, no compatibility problems exist for
the proposed tolerance on hops.
E. Rotational Crop Restrictions
Residues in rotational crops are not expected as hops fields are
not rotated.
V. Conclusion
Therefore, the tolerance is established for residues of 2-cyano-N-
[(ethylamino)carbonyl]-2-(methoxyimino) acetamide in dried hops at 1
ppm.
VI. 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 February 1, 1999, file written objections to any
aspect of this regulation 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
[[Page 66463]]
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is
requested, the objections must include a statement of the factual
issues on which a hearing is requested, the requestor's contentions on
such issues, and a summary of any evidence relied upon by the requestor
(40 CFR 178.27). A request for a hearing will be granted if the
Administrator determines that the material submitted shows the
following: There is genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issues in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as 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.
VII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
controlnumber [OPP-300747] (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 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C)
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:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use ofspecial 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.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under FFDCA section 408
(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
under FFDCA section 408 (l)(6), such as the tolerance in this final
rule, do not require the issuance of a proposed rule, the requirements
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not
apply. Nevertheless, the Agency has previously assessed whether
establishing tolerances, exemptions from tolerances, raising tolerance
levels or expanding exemptions might adversely impact small entities
and concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance acations published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on
[[Page 66464]]
matters that significantly or uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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 United States prior
to publication of the rule in the 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: October 15, 1998.
James Jones,
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 180.503 is amended, by alphabetically adding to the
table in paragraph (b), the commodity to read as follows:
Sec. 180.503 Cymoxanil; tolerance for residues.
(a) * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Hops, dried..................... 1 4/15/00
------------------------------------------------------------------------
[FR Doc. 98-32003 Filed 12-1-98; 8:45 am]
BILLING CODE 6560-50-F