[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: [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-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, 
[email protected].

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, [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 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:

     [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.

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