[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Rules and Regulations]
[Pages 31738-31742]
[FR Doc No: 2022-11173]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0339; FRL-9298-02-OCSPP]

Pyridate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
pyridate in or on lentil, dry, seed and rapeseed subgroup 20A. Belchim
Crop Production US Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 25, 2022. Objections and
requests for hearings must be received on or before July 25, 2022, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0339, is available online at
https://www.regulations.gov or in-person at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room and the OPP Docket is (202) 566-
1744. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0339 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
July 25, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0339, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F8885) by Belchim Crop Protection N.V./S.A., c/o Belchim Crop
Protection US Corporation, 2751 Centreville Rd., Suite 100, Wilmington,
DE 19808. The petition requested that 40 CFR 180.462 be amended to
establish tolerances for residues of the herbicide pyridate calculated
as the stoichiometric equivalent of pyridate, in or on the commodities
lentils at 0.40 parts per million (ppm) and Rapeseed Subgroup (Crop
Subgroup 20A) at 0.015 ppm. That document referenced a summary of the
petitioned prepared by Belchim Crop Protection, the registrant, which
is available in the docket, https://www.regulations.gov. There were no
comments received in response to the Notice of Filing.
    Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing the tolerance for rapeseed crop subgroup 20A at a
different level than petitioned-for and is revising the commodity
definition. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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 in infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 and to make a
determination on aggregate exposure for pyridate including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with pyridate 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 toxicological database for pyridate is adequate for hazard
characterization, toxicity endpoint selection, and Food Quality
Protection Act (FQPA) Safety Factor (SF) consideration. The available
toxicity database for pyridate indicates that the nervous system is the
toxicological target in studies where pyridate was administered via
gavage or capsules, with the dog and the rat showing similar levels of
sensitivity once bodyweight scaling is considered. The neurotoxic
effects were associated with the peak plasma concentrations, occurred
within a few hours of treatment, and resolved in less than 24 hours of
the bolus dose from gavage or capsule administration. The
neurobehavioral effects do not appear to be accumulative or progressive
since the effects in the subchronic dog study occurred at approximately
the same dose where effects were seen in the chronic dog study and were
generally resolved within 6 hours of treatment. No evidence of
neurotoxicity was observed in the studies where pyridate was
administered via the diet (feed) following subchronic or chronic
dietary exposure. Effects observed following dietary (feed) exposure
were generally limited to systemic toxicity, primarily reductions in
bodyweight. Additionally, there were no effects seen at the limit dose
in the dermal toxicity study.
    There was no evidence of increased susceptibility to the fetus or
offspring in the available developmental and reproduction toxicity
studies. Developmental (missing and unossified sternebrae and decreased
bodyweight in fetuses) and offspring effects (decreased bodyweights)
were seen in the presence of maternal toxicity in rats. An increased
incidence of abortions was also noted in the developmental toxicity
study in rabbits at the highest dose tested.
    Pyridate is classified as ``Not Likely to be Carcinogenic to
Humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by pyridate as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled ``Pyridate. Human Health
Risk Assessment for the Proposed New Section 3 Registration on Lentils,
Rapeseed Subgroup 20A, Popcorn, and Seed Corn.'' (hereinafter referred
to as ``Pyridate Human Health Risk Assessment'') on pages 25-27 in
docket ID number EPA-HQ-OPP-2021-0339.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    A summary of the toxicological endpoints for pyridate used for
human risk assessment can be found in the Pyridate Human Health Risk
Assessment on pages 13-16.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyridate, EPA considered exposure under the petitioned-for
tolerances as well as all existing pyridate tolerances in 40 CFR
180.462. EPA assessed dietary exposures from pyridate in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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. Such effects were identified
for pyridate.
    In conducting the acute dietary exposure assessment, EPA used the
2005-2010 food consumption data from the U.S. Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). The acute dietary
exposure assessment is unrefined, assuming tolerance-level residues,
100% crop treated (100 PCT) for all commodities, and default processing
factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2005-2010
food consumption data from the NHANES/WWEIA. The chronic dietary
exposure assessment is unrefined, assuming tolerance-level residues,
100 PCT for all commodities, and default processing factors.
    iii. Cancer. EPA has classified pyridate as ``Not Likely to be
Carcinogenic to Humans'' as there was no evidence carcinogenicity in
either of the rodent cancer studies; therefore, a cancer dietary
assessment was not performed.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for pyridate in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of pyridate. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-medels-used-pesticide.
    Based on the Pesticides in Water Calculator (PWC; version 1.52),
the estimated drinking water concentrations (EDWCs) of pyridate are
estimated to be 363 parts per billion (ppb) for acute dietary exposures
and 256 ppb for chronic dietary exposures.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Pyridate is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common

mechanism of toxicity finding as to pyridate and any other substances
and pyridate does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that pyridate has a common mechanism of toxicity with other
substances.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility to the fetus or offspring in the available
developmental and reproduction toxicity studies. Developmental (missing
and unossified sternebrae and decreased bodyweight in fetuses) and
offspring effects (decreased bodyweights) were seen in the presence of
maternal toxicity in rats. An increased incidence of abortions was also
noted in the developmental toxicity study in rabbits at the highest
dose tested. Since these effects occurred in the presence of comparable
or more severe maternal toxicity, they were not considered evidence of
qualitative susceptibility. Furthermore, the selected points of
departure are protective of these effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for all exposure scenarios. That decision is
based on the following findings:
    i. The toxicology database for pyridate is complete and includes
acceptable developmental and reproductive toxicity studies for
evaluating sensitivity for infants and children.
    ii. There are adverse neurotoxic effects observed in the database
for pyridate both in the acute neurotoxicity (ACN) and in other
studies, including the subchronic rat and chronic and subchronic dog,
with effects such as emesis, ataxia, salivation, dyspnea, tremors, and
prostration in dogs; and hypoactivity and excessive salivation in rats.
However, these effects were only observed in studies where the test
animals were exposed to a concentrated bolus of the chemical (gavage/
capsule) and not in studies in which animals were exposed through the
diet. These neurotoxic effects increased rapidly in incidence within 1-
3 hours after dosing and gradually resolved over the next 8-12 hours
and do not show progression in chronic studies. EPA concluded based
upon a weight-of-evidence approach that the subchronic neurotoxicity
study was not required for risk assessment at this time. Although there
is evidence of neurotoxicity, concern is low since the selected
endpoints for this chemical are protective of these effects.
    iii. There was no evidence of increased quantitative or qualitative
susceptibility in the developmental toxicity studies in rabbits or rats
or the reproduction toxicity study in rats.
    iv. There is no residual uncertainty in the exposure database. The
dietary assessment is based on high-end assumptions such as modeled,
high-end estimates of residues in drinking water, assuming 100 PCT and
tolerance-level residues. In addition, there are no residential uses
proposed for pyridate at this time. These assessments will not
underestimate the exposure and risks posed by pyridate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure estimates from dietary consumption
of food and drinking water, EPA has concluded that acute exposure to
pyridate from food and water will utilize 33% of the aPAD for all
infants less than 1-year old, the most highly exposed population
subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure of
pyridate from food and water will utilize 18% of the cPAD for all
infants less than 1-year old, the population group receiving the
greatest exposure.
    3. Short- and intermediate-term risks. Short- and intermediate-term
exposure takes into account short- and intermediate-term residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). A short-term adverse effect and an
intermediate-term adverse effect were identified; however, pyridate is
not registered for any use patterns that would result in short- or
intermediate-term residential exposure. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposure plus chronic dietary exposure. Because there is no short- or
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for pyridate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, pyridate is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyridate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography with ultraviolet detection (UV-HPLC)) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits

(MRLs) established by the Codex Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
    Codex has not established an MRL for pyridate in/on lentils or
rapeseed subgroup 20A.

C. Revisions to Petitioned-For Tolerances

    For rapeseed subgroup 20A, the registrant proposed a tolerance of
0.015 ppm, which is less than the limit of quantitation (LOQ) of the
enforcement method. Therefore, EPA is establishing a tolerance of 0.05
ppm for rapeseed subgroup 20A, which is the LOQ of the method employed
in the crop field trials. EPA also adjusted the commodity definition
for rapeseed subgroup 20A to use standard terminology. In addition, EPA
dropped the trailing zero from the lentil tolerance value to be
consistent with current Agency rounding practices.

V. Conclusion

    Therefore, tolerances are established for residues of pyridate, in
or on lentil, dry, seed at 0.4 ppm and rapeseed subgroup 20A at 0.05
ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances 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.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 19, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.462, the table in paragraph (a) is amended by:
0
a. Adding a table heading; and
0
b. Adding the commodities ``Lentil, dry, seed'' and ``Rapeseed subgroup
20A'' to the table in alphabetical order.
    The additions read as follows:

Sec.  180.462   Pyridate; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------

                                * * * * *
Lentil, dry, seed.............................................       0.4

                                * * * * *
Rapeseed subgroup 20A.........................................      0.05

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-11173 Filed 5-24-22; 8:45 am]
BILLING CODE 6560-50-P


IMPORTANT NOTE TO USER:

The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your OEI Desk Officer. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ Office of Solid Waste and Emergency Response/ Office of Solid Waste 2. OMB control number b. G None a. 2050 0149 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title RCRA Expanded Public Participation 8. Agency form number( s) ( If applicable) ICR # 1688.04 9. Keywords Public Participation, RCRA permitting, RCRA Expanded Public Participation 10. Abstract EPA promulgated requirements for providing additional opportunties for the public to be involved in the RCRA permitting process. These requirements are intended to provide equal access to information to all stakeholders inthe permitting process: the permitting agency, the permit applicant, and the affected community. The required activities and information are needed to help assure timely and effective public participation in the RCRA permitting process.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. X Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 33 b. Total annual responses _ 33_ 1. Percentage of these responses collected electronically _____ _ 0 % c. Total hours requested 3,005 d. Current OMB inventory 7,253 e. Difference  4,248 f. Explanation of difference 1. Program Change 0 2. Adjustment  4,248 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 1 b. Total annual costs ( O& M) $ 3 c. Total annualized cost requested $ 4 d. Current OMB inventory $ 9 e. Difference $ 5 f. Explanation of difference 1. Program change _ 0 2. Adjustment  5 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Toshia King Phone: 703/ 308 7033 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95