[Federal Register Volume 64, Number 111 (Thursday, June 10, 1999)]
[Rules and Regulations]
[Pages 31124-31129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14760]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300858; FRL-6080-4]
RIN 2070-AB78
Aminoethoxyvinylglycine; Temporary Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary tolerance for residues
of aminoethoxyvinylglycine in or on food commodities of the stone fruit
crop group. Abbott Laboratories requested this tolerance under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. The tolerance will expire on April 1, 2001.
DATES: This regulation is effective May 13, 1999. Objections and
requests for hearings must be received by EPA on or before August 9,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300858], 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-300858], 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: opp-docket@epa.gov. Copies of electronic 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
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300858].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway,
Biopesticides and Pollution Prevention Division (7511C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 902W43, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 308-8263, greenway.denise@epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 1999
(64 FR 11872) (FRL-6067-5), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as
amended by the Food Quality Protection Act of
[[Page 31125]]
1996 (FQPA) (Pub. L. 104-170) announcing the filing of a pesticide
petition (PP 9G5048) for a temporary tolerance by Abbott Laboratories,
1401 Sheridan Road, North Chicago, IL 60064. The notice included a
summary of the petition prepared by Abbott Laboratories, the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.502 be amended by
establishing a temporary tolerance for residues of the biochemical
plant regulator aminoethoxyvinylglycine, in or on food commodities of
the stone fruit crop group. The proposed temporary tolerance level of
0.170 part per million (ppm) was inadvertently not stated in the notice
of filing. This tolerance will expire on April 1, 2001.
Under section 408(g)(1) of the FFDCA, a regulation issued under
subsection (d)(4) shall take effect upon publication unless the
regulation specifies otherwise. In this case, the temporary tolerance
will be effective on May 13, 1999.
Section 801 of the Congressional Review Act (CRA), 5 U.S.C. 801,
generally requires that, before a rule may take effect, the agency
promulgating the rule must submit a rule report to each House of
Congress and to the Comptroller General of the United States. Section
808 allows the issuing agency to make a rule effective sooner than
otherwise provided by the CRA if the agency makes a good cause finding.
EPA has determined that there is good cause for making today's rule
final prior to submission to Congress because the timing is such that
immediate action was necessary to allow farmers to sell and distribute
certain stone fruit produce with residues of this product this year.
This pesticide is only applied once during the growing season, and this
must be done 7-14 days prior to the beginning of the harvest period.
The harvest season for certain stone fruits is very early in the year.
Many of the tests sites for these stone fruits are located in the
Southern region of the United States. Thus, in order to provide for the
sale and distribution of certain stone fruit produce with residues of
this pesticide in 1999 and to optimize the benefits of the experimental
use of the pesticide, approval of the use was necessary in May of this
year. Furthermore, the Agency has provided notice and comment for this
rulemaking action and no comments were received. The Agency has also
provided a 60-day objection period in this final rule as required by
section (g)(2) of the FFDCA. See Unit V. of this preamble for further
information. Thus, further notice and public procedure are unnecessary.
The Agency finds that this constitutes good cause to provide for an
immediate effective date pursuant to 5 U.S.C. 808(2).
I. Background and Statutory Findings
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. . . .''
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 (62 FR 62961, November 26, 1997) (FRL-5754-7).
II. 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
aminoethoxyvinylglycine and to make a determination on aggregate
exposure, consistent with section 408(b)(2), for a temporary tolerance
for residues of aminoethoxyvinylglycine on food commodities of the
stone fruit crop group at 0.170 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
Because the technical active ingredient being evaluated in the
associated Experimental Use Permit (275-EUP-82) is a conditionally
registered section 3 pesticide product, EPA has previously 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 aminoethoxyvinylglycine are discussed in
this unit, and presented in the Federal Register of May 7, 1997 (62 FR
24835) (FRL-5713-5) and in a subsequent correction to the Final Rule,
which appeared in the Federal Register of October 29, 1997 (62 FR
56089) (FRL-5751-5).
B. Toxicological Endpoints
1. Acute toxicity. A battery of acute toxicity studies placed
technical aminoethoxyvinylglycine in Toxicity Categories III and IV.
2. Chronic toxicity. Using an uncertainty factor of 1,000, EPA has
established the reference dose (RfD) for aminoethoxyvinylglycine at
0.002 milligrams/kilogram of body weight/day (mg/kg bwt/day). This RfD
is based on a no observed adverse effect level (NOAEL) of 2.2 mg/kg
bwt/day from a subchronic toxicity study that demonstrated reduced body
weight gain, food consumption, and food efficiency; increased severity
and incidence of reversible kidney and liver effects; and discoloration
of the liver.
C. Exposures and Risks
1. From food and feed uses. Time-limited tolerances, to expire
April 1, 2001, were previously established at 0.08 ppm (40 CFR 180.502)
for the residues of aminoethoxyvinylglycine, in or on the food
commodities apples and pears. This rule establishes a temporary
tolerance at 0.170 ppm, to expire April 1, 2001, for the residues of
aminoethoxyvinylglycine in or on food commodities of the stone fruit
crop group. Risk assessments were conducted by EPA to assess dietary
exposures from the additional stone fruit uses of
aminoethoxyvinylglycine proposed for the Experimental Use Permit 275-
EUP-82 via PP 9G5048 as follows:
A worst-case scenario (using tolerance level residues for both the
existing apple/pear use and for the experimental stone fruit use, and
100% crop treated) aggregate risk assessment was prepared. The reported
assessment includes exposure to aminoethoxyvinylglycine through food.
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological
[[Page 31126]]
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. In the case of
aminoethoxyvinylglycine, because there were no acute toxic endpoints,
no acute dietary risk assessments were required or performed.
ii. Chronic exposure and risk. The endpoint and dose level selected
for assessment of chronic dietary risks are based on a 90-day feeding
study with an uncertainty factor of 1,000 and use a RfD of 0.002 mg/kg
bwt/day determined from a NOAEL of 2.2 mg/kg bwt/day. In considering
the sensitivity of infants and children the thousand-fold safety factor
includes an additional uncertainty factor of 10 for incompleteness of
data until a 2-generation reproduction study in rats is completed. The
study was a condition of registration of the subject active ingredient,
and interim data have been submitted to the Agency. The results of the
chronic dietary exposure analysis indicate a reasonable certainty of no
harm to the U.S. population or subpopulations, including infants and
children, as the result of the pesticidal uses of
aminoethoxyvinylglycine on apples, pears, and stone fruits.
2. From drinking water. Studies of the potential for
aminoethoxyvinylglycine to be present in water have not yet been
conducted. As a worst-case scenario, residue levels in water were
calculated to be 0.0012 ppm by assuming that 10% of the applied
treatment could drift into nearby drinking water sources. This
conservative approach is consistent with a worst-case exposure
scenario.
i. Acute exposure and risk. In the case of aminoethoxyvinylglycine,
because there were no acute toxic endpoints, no acute risk assessments
based on drinking water exposure were required or performed.
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 NOAEL'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
exposure from contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause
aminoethoxyvinylglycine to exceed the RfD if the temporary tolerance
being considered in this document were granted. The Agency has
therefore concluded that the potential exposures associated with
aminoethoxyvinylglycine 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 temporary tolerance is granted.
3. From non-dietary exposure. Aminoethoxyvinylglycine is currently
not 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 aminoethoxyvinylglycine 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,
aminoethoxyvinylglycine 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 aminoethoxyvinylglycine has
a common mechanism of toxicity with other substances. For 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 (62
FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. For risk assessment purposes, there were no acute
endpoints identified for aminoethoxyvinylglycine.
2. Chronic risk. Using the Theoretical Maximum Residue Contribution
(TMRC) exposure assumptions described in this unit, EPA has concluded
that aggregate exposure to aminoethoxyvinylglycine from food (the
current section 3 apple and pear uses plus the experimental stone fruit
use) will utilize 6.9% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is 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. Despite the potential for exposure to
aminoethoxyvinylglycine in drinking water (there is no non-dietary,
non-occupational exposure because neither the Experimental Use Permit
nor the section 3 registrations involve residential use), 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 aminoethoxyvinylglycine residues.
3. 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 residues of aminoethoxyvinylglycine.
E. 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 aminoethoxyvinylglycine, EPA considered data
from developmental toxicity studies in the rat. A 2-generation
reproduction study in the rat is pending and was a condition of the
section 3 registration for the subject active ingredient. Interim data
on the first generation have been received by the Agency. 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 ten-
fold margin of safety for infants and children in the case of threshold
effects to account for pre-and postnatal toxicity and the completeness
of the data base 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
[[Page 31127]]
appreciable risk to humans. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability) and not the additional ten-fold 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 toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor. In
this case, due to the incompleteness of the data, the Agency used a
thousand-fold uncertainty factor in the RfD calculations, and
previously imposed a requirement for a 2-generation reproduction study
in rats. The thousand-fold uncertainty factor includes an additional
uncertainty factor of 10 to protect infants and children.
ii. Developmental toxicity studies. In a developmental toxicity
study in rats by oral gavage, a NOAEL of 1.77 mg active ingredient/kg
bwt/day was determined for both developmental and maternal toxicity.
iii. Reproductive toxicity study. Two-generation rat reproduction
data are pending, as a condition of the section 3 registration. Interim
data on the first generation have been submitted to the Agency.
iv. Conclusion. Due to the incomplete data set (2-generation rat
reproduction data, a condition of registration for the active
ingredient are pending), the Agency used a thousand-fold uncertainty
factor in the RfD calculations. The thousand-fold uncertainty factor
includes an additional uncertainty factor of 10 to protect infants and
children. The data adequately support the conditional 1997 registration
of the active ingredient and also adequately support the temporary
tolerance level of 0.170 ppm proposed for the experimental stone fruit
use.
2. Acute risk. For risk assessment purposes, there were no acute
endpoints identified for aminoethoxyvinylglycine.
3. Chronic risk. Using the conservative exposure assumptions
described in this unit, EPA has concluded that aggregate exposure to
aminoethoxyvinylglycine from food will utilize 50.9% of the RfD for
infants and children. 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 aminoethoxyvinylglycine in drinking water (there is no non-dietary,
non-occupational exposure because neither the Experimental Use Permit
nor the section 3 registered products are for residential use), 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
to infants and children from aggregate exposure to
aminoethoxyvinylglycine.
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
aminoethoxyvinylglycine residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The metabolism of aminoethoxyvinylglycine in plants and animals is
adequately understood for the purposes of these temporary tolerances.
B. Analytical Enforcement Methodology
The submitted analytical method, High Performance Liquid
Chromatography (HPLC)/Fluorescence detector, is acceptable; it is also
verified and validated.
Adequate enforcement methodology 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, (703) 305-5229.
C. Magnitude of Residues
The experimental program (275-EUP-82) specifies a single
application of 50 grams of active ingredient be applied 7-14 days prior
to anticipated harvest. For the purposes of the temporary tolerance,
the magnitude of residues was evaluated in/on peaches at proposed and
exaggerated label rates. After application of proposed label rates,
residue levels were below the level of quantitation, if detectable at
all, within 5 days of application. Exaggerated rates (up to 4 times the
proposed label rates) demonstrated rapid decline of residues to below
quantifiable levels by 14 days after application. The limit of
quantitation (LOQ) is 0.170 ppm and the limit of detection (LOD) is
0.050 ppm.
D. International Residue Limits
There are no Codex Alimentarius Commission (Codex) Maximum Residue
Levels (MRLs) for residues of aminoethoxyvinylglycine.
IV. Conclusion
Therefore, the temporary tolerance, to expire April 1, 2001, is
established for residues of aminoethoxyvinylglycine in or on food
commodities of the stone fruit crop group at 0.170 ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation 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 August 9, 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 under ``ADDRESSES'' section (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). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
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
[[Page 31128]]
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.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300858] (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 Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. 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 specficed 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
on the basis of a petition under FFDCA section 408(d), such as the
temporary 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
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 actions 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 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 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
[[Page 31129]]
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.
VIII. 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. Section 808 allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and public procedure is impracticable,
unnecessary or contrary to the public interest. This determination must
be supported by a brief statement. 5 U.S.C. 808(2). As stated
previously, EPA has made such a good cause finding, including the
reasons therefor, and established an effective date of May 13, 1999.
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 action 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 13, 1999.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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. 321(q), 346a, and 371.
2. In Sec. 180.502, in paragraph (a), by alphabetically adding the
following commodity to the table:
Sec. 180.502 Aminoethoxyvinylglycine; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
* * * * *
Stone fruit crop group............................ 0.170 04/01/01
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-14760 Filed 6-9-99; 8:45 am]
BILLING CODE 6560-50-F
