[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: [email protected]. 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, [email protected].

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, [email protected]. 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:

    [email protected]


    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