[Federal Register Volume 64, Number 134 (Wednesday, July 14, 1999)]
[Rules and Regulations]
[Pages 37870-37875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17777]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300889; FRL-6089-8]
RIN 2070-AB78
Fosetyl-Al; Pesticide Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of fosetyl-Al [Aluminum tris (O-ethylphosphonate)] in or on
succulent peas. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing seed treatment use of the
pesticide on peas. This regulation establishes a maximum permissible
level for residues of fosetyl-Al 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 September 31, 2000.
DATES: This regulation is effective July 14, 1999. Objections and
requests for hearings must be received by EPA on or before September
13, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300889], 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-300889], 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 (CM #2),
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@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-300889].
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: Stephen Schaible,
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. 271, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703)308-9362,
schaible.stephen@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, is establishing a tolerance for residues of the
fungicide fosetyl-Al, in or on peas, succulent at 1.0 parts per million
(ppm). This tolerance will expire and is revoked on September 31, 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 Findings
The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is
[[Page 37871]]
``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 Fosetyl-Al on Peas, Succulent and FFDCA
Tolerances
According to the Applicant, wet conditions in 1998 contributed to
severe outbreak of downy mildew in many pea fields in Washington and
Idaho. There is concern that a significant outbreak of downy mildew
will occur in 1999 because oospores have the ability to survive for 10-
15 years. Because of a lack of resistance to the pathogen in
commercially grown pea varieties and development of resistance in the
pest population to the commercially used fungicides metalaxyl and
menfenoxam, an emergency situation has arisen. EPA has authorized under
FIFRA section 18 the seed treatment use of fosetyl-Al on peas for
control of downy mildew in Washington and Idaho. After having reviewed
the submission, EPA concurs that emergency conditions exist for these
States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fosetyl-Al in or on peas.
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 September 31,
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
peas, succulent 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 fosetyl-Al
meets EPA's registration requirements for use on peas 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 fosetyl-Al 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 Washington and 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
fosetyl-Al, contact the Agency's Registration Division at the address
provided under the ``ADDRESSES'' section.
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 (62 FR 62961, November 26, 1997) (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 fosetyl-
Al and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of
fosetyl-Al on peas, succulent at 1.0 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 fosetyl-Al are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. No appropriate endpoint attributable to a single
dose exposure was identified in acute oral toxicity studies. Therefore,
risk assessments for these exposure scenarios were not conducted.
2. Short- and intermediate-term toxicity. No toxicological
endpoints of concern were identified for short-term and intermediate-
term dermal exposure or inhalation exposure for all time periods. Risk
assessments for these exposure scenarios were not conducted.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for fosetyl-Al at 2.5 milligrams/kilograms/day (mg/kg/day). This RfD is
based on a no observed adverse effect level (NOAEL) of 250 mg/kg/day,
taken from a 2-year chronic study in dogs in which testicular
degeneration was observed at the lowest observed adverse effect level
(LOAEL) of 500 mg/kg/day. An uncertainty factor (UF) of 100 was
employed to account for inter- and intraspecies variability. As the 10x
safety factor was removed, the chronic
[[Page 37872]]
population adjusted dose (cPAD) is equal to the RfD. The cPAD is
calculated by dividing the RfD by the appropriate safety factor in
situations where it is decided an additional safety factor should be
retained. The cPAD will differ from the RfD in situations where the
decision is made to retain either a 10x or 3x safety factor.
4. Carcinogenicity. Fosetyl-Al is unlikely to pose a carcinogenic
hazard to humans. Effects observed in rats occurred under extremely
high doses, under conditions not anticipated to occur outside of the
laboratory.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.415) for the residues of fosetyl-Al, in or on a variety of raw
agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures and risks from fosetyl-Al 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 1-day or single exposure. No toxicological endpoints were
identified which could be attributable to a single dietary exposure.
Therefore, a risk assessment for this exposure scenario was not
conducted.
ii. Chronic exposure and risk. Tolerance level residues and 100%
crop treated were assumed to calculate theoretical maximum residue
contributions (TMRCs) from published and proposed uses for the United
States (U.S.) population and population subgroups. Chronic exposure for
the U.S. population represents 3% of the cPAD.
2. From drinking water. Fosetyl-Al is not expected to reach ground
or surface water under most conditions. The residues that do reach
surface water will likely be rapidly degraded by microbial metabolism.
There is no established Maximum Contaminant Level (MCL) for residues of
fosetyl-Al in drinking water.
The Agency has calculated drinking water levels of comparison
(DWLOCs) for chronic exposure to fosetyl-Al residues in surface and
ground water. These DWLOCs are calculated by subtracting from the cPAD
the respective chronic dietary exposure attributable to food to obtain
the acceptable exposure to fosetyl-Al in drinking water. Default body
weights (70 kg for males, 60 kg for females, and 10 kg for infants and
children) and default drinking water consumption estimates (2 L/day for
adults, 1 L/day for infants and children) are then used to calculate
the actual DWLOCs. The DWLOC represents the concentration level in
surface water or ground water at which aggregate exposure to the
chemical is not of concern.
Using Generic Expected Environmental Concentration (GENEEC) and
Screening Concentration in Ground Water (SCI-GROW) models (for surface
and ground water, respectively), the Agency has calculated chronic Tier
I Estimated Environmental Concentrations (EECs) for fosetyl-Al for use
in human health risk assessments. These values represent the upper
bound estimates of the concentrations of fosetyl-Al that might be found
in surface water and ground water assuming the maximum application rate
allowed on the label of the highest use pattern. The EECs from these
models are compared to the DWLOCs to make the safety determination.
i. Acute exposure and risk. No toxicological endpoints were
identified which could be attributable to a single dietary exposure.
Therefore, a risk assessment for this exposure scenario was not
conducted.
ii. Chronic exposure and risk. Using the SCI-GROW model, the
maximum long-term EEC in ground water is not expected to exceed 0.0046
parts per billion (ppb). The chronic EEC in surface water is 9 ppb. The
DWLOC for the U.S. population was calculated to be 85,000 ppb. As even
the upper bound concentrations of fosetyl-Al in ground water and
surface water are not expected to exceed the DWLOC, the Agency
concludes with reasonable certainty that chronic exposure to fosetyl-Al
in drinking water is not of concern.
3. From non-dietary exposure. Fosetyl-Al is currently registered
for use on the following residential non-food sites: lawn, turf, and
ornamental plants. However, no toxicological endpoints of concern were
identified for short-term and intermediate-term dermal exposure or
inhalation exposure for all time periods, and risk assessments for
these exposure scenarios were not conducted. Long-term (chronic)
exposure is not expected for residential uses.
4. Cumulative exposure to substances with a 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 fosetyl-Al 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,
fosetyl-Al 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 fosetyl-Al 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 (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. No toxicological endpoints were identified which
could be attributable to a single dose exposure. Therefore, a risk
assessment for this exposure scenario was not conducted.
2. Chronic risk. Using the TMRC exposure assumptions described in
this unit, EPA has concluded that aggregate exposure to fosetyl-Al from
food will utilize 3% of the cPAD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is children,
1-6 years (discussed below). EPA generally has no concern for exposures
below 100% of the RfD (cPAD) 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. Estimated chronic environmental
concentrations of fosetyl-Al in surface water and ground water do not
exceed chronic DWLOCs calculated by the Agency. EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
3. Short- and intermediate-term risk. 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.
No toxicological endpoints of concern were identified for short-
term and intermediate-term dermal exposure or inhalation exposure for
all time periods. Risk assessments for these exposure scenarios were
not conducted.
4. Aggregate cancer risk for U.S. population. Fosetyl-Al is
unlikely to pose a carcinogenic hazard to humans. Effects observed in
rats occurred under extremely high doses, under conditions not
anticipated to occur outside of the laboratory.
[[Page 37873]]
5. 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 fosetyl-Al residues.
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 fosetyl-Al, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. 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 postnatal 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 intraspecies 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 toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental toxicity
study in rats, developmental effects in pups occurred only in the
presence of maternal toxicity and at four times the limit dose
(developmental LOAEL = 4,000 mg/kg/day). In the prenatal developmental
toxicity study in rabbits, no evidence of developmental toxicity was
seen at the limit dose.
iii. Reproductive toxicity study. In the multi-generation
reproduction study in rats, offspring effects occurred only at
parentally toxic dose levels.
iv. Pre- and postnatal sensitivity. The available studies showed no
evidence of increased susceptibility of fetus/pups in the developmental
or reproductive toxicity studies. The Agency supports removal of the
10x safety factor for aggregate risk assessment.
v. Conclusion. There is a complete toxicity database for fosetyl-Al
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures.
2. Acute risk. No toxicological endpoints were identified which
could be attributable to a single dietary exposure. Therefore, a risk
assessment for this exposure scenario was not conducted.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to fosetyl-Al from food
will utilize 6% of the cPAD/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.
Estimated chronic environmental concentrations of fosetyl-Al in surface
water and ground water do not exceed chronic DWLOCs calculated by the
Agency. EPA does not expect the aggregate exposure to exceed 100% of
the RfD.
4. Short- or intermediate-term risk. No toxicological endpoints of
concern were identified for short-term and intermediate-term dermal
exposure or inhalation exposure for all time periods. Risk assessments
for these exposure scenarios were not conducted.
5. 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 fosetyl-Al residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
The nature of the residue in plants is adequately understood. The
residue of concern is parent fosetyl-Al. There are no livestock feed
items associated with the proposed seed treatment use on peas.
B. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression (associated with petition number 5F3251). 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, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-
5229.
C. Magnitude of Residues
Residues of fosetyl-Al are not expected to exceed 1.0 ppm in/on
succulent peas as a result of the proposed seed treatment use on peas.
Secondary residues are not expected in animal commodities as there are
no feed items associated with succulent peas.
D. International Residue Limits
There are no Codex, Canadian or Mexican Maximum Residue Limits
(MRLs) for fosetyl-Al on peas.
E. Rotational Crop Restrictions
No rotational crop restrictions are required for this chemical, due
to its extremely short half-life in soil.
V. Conclusion
Therefore, the tolerance is established for residues of fosetyl-Al
in peas, succulent at 1.0 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 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 September 13, 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 the ``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.,
[[Page 37874]]
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, CM #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 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 regulation under docket
control number [OPP-300889] (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 Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #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.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. 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) (Public Law 104-4). Nor does it require any 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(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 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
[[Page 37875]]
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 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 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: June 28, 1999.
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. 321(q), 346(a) and 371.
2. In Sec. 180.415, by revising paragraph (b) to read as follows:
Sec. 180.415 Aluminum tris (O-ethylphosphonate); tolerances for
residues.
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the fungicide aluminum tris (O-
ethylphosphonate) in connection with use of the pesticide under section
18 emergency exemptions granted by EPA. This tolerance will expire and
is revoked on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Peas, succulent................. 1.0............... 9/31/00
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-17777 Filed 7-13-99; 8:45 am]
BILLING CODE 6560-50-F
