[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10269-10278]
[FR Doc No: 2021-03391]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2019-0372; FRL-10019-29-OW]

National Pollutant Discharge Elimination System (NPDES) 2021
Issuance of the Multi-Sector General Permit for Stormwater Discharges
Associated With Industrial Activity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final permit issuance.

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SUMMARY: All 10 of the Environmental Protection Agency's (EPA) Regions
are finalizing the 2021 National Pollutant Discharge Elimination System
(NPDES) general permit for stormwater discharges associated with
industrial activity, also referred to as the ``2021 Multi-Sector
General Permit (MSGP)'' or the ``final permit.'' This final permit
replaces EPA's administratively continued 2015 MSGP that expired on
June 3, 2020. EPA is issuing this permit for five (5) years to provide
permit coverage to eligible operators in all areas of the country where
EPA is the NPDES permitting authority, including Idaho (until July 1,
2021), Massachusetts, New Hampshire, New Mexico, Indian country lands,
Puerto Rico, the District of Columbia, and most U.S. territories and
protectorates. This Federal Register document summarizes the final
permit. EPA encourages the public to read the final permit and
accompanying fact sheet to better understand the final permit. The
final permit and fact sheet can be found at https://www.epa.gov/npdes/stormwater-discharges-industrial-activities.

DATES: The final permit becomes effective on March 1, 2021. This
effective date is necessary to provide dischargers with the immediate
opportunity to comply with Clean Water Act (CWA) requirements in light
of the expiration of the 2015 MSGP on June 3, 2020. In accordance with
40 CFR part 23, the 2021 MSGP shall be considered issued for the
purpose of judicial review on March 5, 2021. Under CWA section 509(b),
judicial review of this general permit can be requested by filing a
petition for review in the United States Court of Appeals within 120
days after the permit is issued. Under CWA section 509(b)(2), the
requirements in this permit may not be challenged later in civil or
criminal proceedings to enforce these requirements. In addition, this
permit may not be challenged in other agency proceedings. Deadlines for
submittal of a Notice of Intent (NOI) are provided in Part 1.3 of the
2021 MSGP. The 2021 MSGP also provides additional dates for compliance
with the terms of the permit.

FOR FURTHER INFORMATION CONTACT: For further information on the final
permit, contact the appropriate EPA Regional office listed in Section
I.F of this document, or Emily Halter, EPA Headquarters, Office of
Water, Office of Wastewater Management (4203M), 1200 Pennsylvania
Avenue NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This section is organized as follows:

Table of Contents

I. General Information
    A. Does this action apply to me?
    B. How can I get copies of these documents and other related
information?
    C. Who are the EPA regional contacts for the final permit?
II. Background of the Industrial Stormwater Program
III. Summary of the 2021 MSGP
    A. 2015 MSGP Litigation and National Academies Study
    B. Summary of Significant Final Permit Changes From the 2015
MSGP
    C. Summary of Changes From Proposed 2020 MSGP
IV. Implementation Assistance
V. Paperwork Reduction Act (PRA)
VI. 2021 MSGP Incremental Cost Analysis and Future Cost-Benefit
Considerations
VII. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
VIII. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
IX. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
X. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

I. General Information

A. Does this action apply to me?

    The final permit covers stormwater discharges to waters of the
United States from industrial facilities in the 30 sectors shown below:

    Sector A--Timber Products.
    Sector B--Paper and Allied Products Manufacturing.
    Sector C--Chemical and Allied Products Manufacturing.

    Sector D--Asphalt Paving and Roofing Materials Manufactures and
Lubricant Manufacturers.
    Sector E--Glass, Clay, Cement, Concrete, and Gypsum Product
Manufacturing.
    Sector F--Primary Metals.
    Sector G--Metal Mining (Ore Mining and Dressing).
    Sector H--Coal Mines and Coal Mining-Related Facilities.
    Sector I--Oil and Gas Extraction.
    Sector J--Mineral Mining and Dressing.
    Sector K--Hazardous Waste Treatment Storage or Disposal.
    Sector L--Landfills and Land Application Sites.
    Sector M--Automobile Salvage Yards.
    Sector N--Scrap Recycling Facilities.
    Sector O--Steam Electric Generating Facilities.
    Sector P--Land Transportation.
    Sector Q--Water Transportation.
    Sector R--Ship and Boat Building or Repairing Yards.
    Sector S--Air Transportation Facilities.
    Sector T--Treatment Works.
    Sector U--Food and Kindred Products.
    Sector V--Textile Mills, Apparel, and other Fabric Products
Manufacturing.
    Sector W--Furniture and Fixtures.
    Sector X--Printing and Publishing.
    Sector Y--Rubber, Miscellaneous Plastic Products, and
Miscellaneous Manufacturing Industries.
    Sector Z--Leather Tanning and Finishing.
    Sector AA--Fabricated Metal Products.
    Sector AB--Transportation Equipment, Industrial or Commercial
Machinery.
    Sector AC--Electronic, Electrical, Photographic and Optical
Goods.
    Sector AD--Reserved for Facilities Not Covered Under Other
Sectors and Designated by the Director.

    Coverage under the final 2021 MSGP is available to operators of
eligible facilities located in areas where the EPA is the CWA section
402 permitting authority. A list of eligible areas is included in
Appendix C of the final 2021 MSGP.

B. How can I get copies of these documents and other related
information?

    1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-2019-0372. Although all documents in the docket
are listed in an index, some information is not publicly available,
i.e., Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Publicly available docket
materials are available electronically through www.regulations.gov. Out
of an abundance of caution for members of the public and EPA staff, the
EPA Docket Center and Reading Room are currently closed to the public,
with limited exceptions, to reduce the risk of transmitting COVID-19.
When the EPA Docket Center and Reading Room re-open, publicly available
docket materials will be available in hard copy at the Water Docket in
the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution
Ave. NW, Washington, DC. The EPA Docket Center 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 is
(202) 566-1744, and the telephone number for the Water Docket is (202)
566-2426.
    2. Electronic Access. Electronic versions of this final permit and
accompanying fact sheet are available on the EPA's NPDES website at
https://www.epa.gov/npdes/stormwater-discharges-industrial-activities.
    An electronic version of the public docket is available through the
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at https://www.regulations.gov to view public comments,
access the index listing of the contents of the official public docket,
and to access those documents in the public docket that are available
electronically. For additional information about the EPA's public
docket, visit the Agency's Docket Center homepage at https://www.epa.gov/dockets. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the Docket Facility identified in Section
I.B.1.

C. Who are the EPA regional contacts for the final permit?

    For the EPA Region 1, contact David Gray at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 2, contact Stephen Venezia at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>or for Puerto Rico contact Sergio Bosques at:
(787) 977-5838 or<EMAIL_ADDRESS>    For the EPA Region 3, contact Carissa Moncavage at:<PHONE_NUMBER>
or<EMAIL_ADDRESS>    For the EPA Region 4, contact Mike Mitchell at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 5, contact Andrea Schaller at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 6, contact Nasim Jahan at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 7, contact Mark Matthews at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 8, contact Paul Garrison at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 9, contact Eugene Bromley at:<PHONE_NUMBER> or
<EMAIL_ADDRESS>    For the EPA Region 10, contact Margaret McCauley at:<PHONE_NUMBER>
or<EMAIL_ADDRESS>
II. Background of the Industrial Stormwater Program

    Section 405 of the Water Quality Act of 1987 added section 402(p)
of the CWA, which directed EPA to develop a phased approach to regulate
stormwater discharges under the NPDES program. EPA published a final
regulation on the first phase of this program on November 16, 1990,
establishing permit application requirements for ``stormwater
discharges associated with industrial activity.'' See 55 FR 48065. In
that final regulation, EPA defined the term ``stormwater discharge
associated with industrial activity'' in a comprehensive manner to
cover a wide variety of facilities. See 40 CFR 122.26(b)(14). EPA
issues the 2021 MSGP under this statutory and regulatory authority.

III. Summary of the 2021 MSGP

    The 2021 MSGP replaces the administratively continued 2015 MSGP,
which was issued for a five-year term on June 4, 2015 and expired on
June 3, 2020 (see 80 FR 34403). EPA proposed a new MSGP for a 90-day
comment period from March 2 to June 1, 2020 (see 85 FR 12288). Since
the new MSGP was proposed in 2020, EPA hereinafter refers to the
proposed permit of the 2021 MSGP as the ``proposed 2020 MSGP.'' EPA
received 195 total comment letters and 1865 unique comments on the
proposed 2020 MSGP. EPA considered the comments submitted as part of
this public process when finalizing 2021 MSGP. Response to comments are
discussed in detail in a separate document, titled ``2021 MSGP Response
to Comments,'' which can be found in the docket (Docket ID No. EPA-HQ-
OW-2019-0372).
    The 2021 MSGP covers stormwater discharges from industrial
facilities in areas where EPA is the NPDES permitting authority in EPA
Regions 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10. This permit covers facilities
in the state of Idaho until the transfer of NPDES Permitting Authority
to Idaho for stormwater general permits on July 1, 2021. The geographic
coverage of this permit is listed in Appendix C of the permit. This
permit authorizes stormwater discharges from industrial facilities in
30 sectors, as shown in section I.A. of this document.
    Like the 2015 MSGP, the 2021 MSGP is structured in nine parts:
general

requirements that apply to all facilities (i.e., eligibility
requirements, effluent limitations, inspection and monitoring
requirements, Stormwater Pollution Prevention Plan (SWPPP)
requirements, and reporting and recordkeeping requirements) (Parts 1-
7); industrial sector-specific conditions (Part 8); and state and
tribal-specific requirements applicable to facilities located within
individual states or Indian Country (Part 9). Additionally, the
appendices provide the paper forms for the Notice of Intent (NOI), the
Notice of Termination (NOT), the Conditional No Exposure Exclusion
(also known as the No Exposure Certification or NEC), the Discharge
Monitoring Report (DMR), and the Annual Report, as well as step-by-step
procedures for determining eligibility with respect to protecting
National Historic Preservation Act-protected properties and Endangered
Species Act (ESA)-listed species and critical habitat, and for
calculating site-specific, hardness-dependent benchmarks.

A. 2015 MSGP Litigation and National Academies Study

    After the EPA issued the 2015 MSGP, numerous environmental non-
governmental organizations (NGOs) \1\ challenged the permit, two
industry groups \2\ intervened, and a Settlement Agreement was signed
in 2016 with all parties. The settlement agreement did not affect the
2015 MSGP but stipulated several terms and conditions that EPA agreed
to address in the proposed 2020 MSGP. One key term from the Settlement
Agreement stipulated that EPA fund a study conducted by the National
Academies of Sciences, Engineering, and Medicine's National Research
Council (NRC) on potential permit improvements, focused primarily on
monitoring requirements, for consideration in the next MSGP. In the
Settlement Agreement, EPA agreed that, when drafting the proposed 2020
MSGP, the Agency would consider the recommendations suggested in the
completed NRC Study.
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    \1\ Environmental NGOs included Waterkeeper Alliance,
Apalachicola Riverkeeper, Galveston Baykeeper, Raritan Baykeeper,
Inc. d/b/a NY/NJ Baykeeper, Snake River Waterkeeper, Ecological
Rights Foundation, Our Children's Earth Foundation, Puget
Soundkeeper, Lake Pend Oreille Waterkeeper, and Conservation Law
Foundation (collectively, ``Petitioners'').
    \2\ Industry intervenors included the Federal Water Quality
Coalition and the Federal Storm Water Association.
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    The NRC delivered the results of their study, Improving the EPA
Multi-Sector General Permit for Industrial Stormwater Discharges, in
February 2019. In Part III of the 2021 MSGP Fact Sheet, titled ``The
National Research Council (NRC) National Academies of Sciences (NAS)
Industrial Stormwater Study,'' EPA outlines in detail how the Agency
considered each recommendation from the NRC study in the proposed
permit and which proposed requirements informed by the NRC study the
Agency finalized in the 2021 MSGP. The NRC study can be found at the
following website: https://www.nap.edu/catalog/25355/improving-the-epa-multi-sector-general-permit-for-industrial-stormwater-discharges.

B. Summary of Significant Final Permit Changes From the 2015 MSGP

    The 2021 MSGP includes several new or modified requirements from
the 2015 MSGP.
    1. Streamlining of permit. EPA streamlined and simplified language
throughout the final permit to present the requirements in a more clear
and readable manner. Regarding the structure of the permit, Part 4
(Monitoring) was previously Part 6 in the 2015 MSGP; Part 5 (Corrective
Actions and AIM) was previously Part 4 in the 2015 MSGP; and Part 6
(SWPPP) was previously Part 5 in the 2015 MSGP. Formatting the final
permit in this new order (Monitoring, followed by Corrective Actions
and AIM, then SWPPP requirements) provides the information in a
sequential way as the latter parts often refer back to requirements in
previous parts of the permit. This new structure should enhance
understanding of and compliance with the permit's requirements. EPA
also made a few additional edits to improve permit readability and
clarity. EPA revised the wording of many eligibility requirements to be
an affirmative expression of the requirement instead of assumed
ineligibility unless a condition was met. For example, Part <IP_ADDRESS>
reads ``If you discharge to an `impaired water' . . . you must do one
of the following:''. In comparison, the 2015 MSGP reads ``If you are a
new discharger or a new source . . . you are ineligible for coverage
under this permit to discharge to an `impaired water' . . . unless you
do one of the following:''. EPA also numbered permit conditions that
were previously in bullet form to make it easier to follow and
reference the permit conditions. Finally, the language of the final
permit was changed from passive to active voice where appropriate
(e.g., ``Samples must be collected . . .'' now reads ``You must collect
samples . . .'').
    2. Public sign of permit coverage. The 2021 MSGP includes a new
requirement that operators must post a sign of permit coverage at a
safe, publicly accessible location in close proximity to the facility.
This notice must include basic information about the facility (e.g.,
the NPDES ID number), information that informs the public on how to
request the facility's Stormwater Pollution Prevention Plan (SWPPP),
and how to contact the facility and EPA if stormwater pollution is
observed in the discharge. This requirement will make the procedure for
requesting a SWPPP easily understandable by the public and improve
transparency of the process to report possible violations. Operators
are not required to post a sign of their permit coverage where other
laws or local ordinances prohibit such signage. See Part 1.3.5 of the
permit and fact sheet.
    3. Consideration of stormwater control measure enhancements for
major storm events. The 2021 MSGP requires that operators consider
implementing enhanced stormwater control measures for facilities that
could be impacted by major storm events, such as hurricanes, storm
surge, and flood events. EPA is not requiring operators to implement
additional controls if the operator determines such controls to be
unnecessary, but EPA is requiring operators to consider the benefits of
selecting and designing control measures that reduce risks to their
industrial facility and the potential impact of pollutants in
stormwater discharges caused by major storm events. See Part 2.1.1 of
the permit and fact sheet.
    4. Monitoring changes.
     Indicator monitoring for pH, TSS, and COD for subsectors
without benchmark monitoring. The 2021 MSGP includes a new provision
that requires certain operators to conduct indicator analytical
monitoring for three parameters--pH, Total Suspended Solids (TSS), and
Chemical Oxygen Demand (COD)--quarterly for the duration of the permit.
This requirement applies to all operators in the following subsectors
that do not have sector-specific benchmark monitoring requirements in
the 2021 MSGP: B2, C5, D2, E3, F5, I1, J3, L2, N2, O1, P1, R1, T1, U3,
V1, W1, X1, Y2, Z1, AB1, AC1, and AD1. Indicator monitoring is
``report-only'' and does not have a threshold or baseline value for
comparison, therefore no follow-up action is triggered or required
based on the sampling results. The requirement in Part 2.2.1 that the
operator's discharge be controlled as necessary such that the receiving
water of the United States will meet applicable water quality standards
still applies. These three parameters will provide operators and EPA
with a baseline and comparable understanding of industrial

stormwater discharge quality, broader water quality problems, and
stormwater control measure effectiveness at these facilities. See Part
<IP_ADDRESS>.a of the permit and fact sheet.
     Indicator monitoring for polycyclic aromatic hydrocarbons
(PAHs) for certain sectors/activities. The 2021 MSGP includes a new
provision that requires certain operators to conduct report-only
indicator analytical monitoring for polycyclic aromatic hydrocarbons
(PAHs) bi-annually (twice per year) during their first and fourth years
of permit coverage. This requirement applies to the following
operators: Operators in all sectors with stormwater discharges from
paved surfaces that will be sealed or re-sealed with coal-tar sealcoat
where industrial activities are located during coverage under this
permit; operators in sectors A (facilities that manufacture, use, or
store creosote or creosote-treated wood in areas that are exposed to
precipitation), C (SIC Code 2911), D, F, H, I, M, O, P (SIC Codes 4011,
4013, and 5171), Q (SIC Code 4493), R, and S. Indicator monitoring is
``report-only'' and does not have a threshold or baseline value for
comparison, therefore no follow-up action is triggered or required
based on the sampling results. The requirement in Part 2.2.1 that the
operator's discharge be controlled as necessary such that the receiving
water of the United States will meet applicable water quality standards
still applies. EPA determined that the sectors and activities listed
above are likely to have industrial activities with potential petroleum
hydrocarbon exposure to precipitation that could result in the
discharge of PAHs in stormwater based on a review of EPA's sector-
specific fact sheets and a detailed literature review included in the
docket (ID No. EPA-HQ-OW-2019-0372). PAH monitoring data will provide
operators and EPA with a baseline and comparable understanding of
industrial stormwater discharge quality with respect to discharges of
PAHs at these facilities. EPA plans to use the indicator monitoring
data collected to conduct an initial quantitative assessment of the
levels of PAHs in industrial stormwater, further identify industrial
activities with the potential to discharge PAHs in stormwater, and
inform future consideration of PAH benchmark monitoring for sectors
with the potential to discharge PAHs in stormwater. See Part <IP_ADDRESS>.b
of the permit and fact sheet.
     Updating the benchmark monitoring schedule. The 2021 MSGP
requires that applicable operators conduct benchmark monitoring
quarterly in their first and fourth years of permit coverage. EPA
reminds operators and the public that benchmark thresholds are not
effluent limitations. This permit requires benchmark monitoring as
gauge of the performance of facilities' stormwater control measures.
Benchmark monitoring begins in the first full quarter of permit
coverage for four quarters. In the 2015 MSGP, an operator that did not
exceed the four-quarter annual average for a given parameter in the
first four quarters of permit coverage could discontinue benchmark
monitoring for that parameter for the remainder of the permit. Under
the 2021 MSGP, an operator that does not exceed the four-quarter annual
average for a given parameter in the first four quarters of permit
coverage can now discontinue benchmark monitoring for that parameter
for the next two years (i.e., the next eight quarters). Quarterly
benchmark monitoring then resumes for all parameters for another four
quarters in the fourth year of permit coverage, and if the operator
does not exceed the four-quarter annual average for a given parameter,
it can discontinue benchmark monitoring for that parameter for the
remainder of their permit coverage. If, during either the first or
fourth year of monitoring, the annual average for any parameter exceeds
the benchmark threshold, the operator must comply with Part 5
(Additional Implementation Measures responses and deadlines) and
continue quarterly benchmark monitoring for four quarters until results
indicate that annual average for the parameter(s) is no longer
exceeded. Under the new schedule, regardless of when the operator
discontinued monitoring for any benchmark parameter, monitoring resumes
for all parameters for four quarters in the fourth year of permit
coverage, unless the permit has already expired. It is possible that an
operator with continued benchmark exceedances in years two and three of
permit coverage will be required to continue monitoring through their
second and third years of permit coverage. In the scenario where the
operator receives results in their third year of permit coverage that
the benchmark threshold is no longer exceeded, the operator is still
required to monitor again in their fourth year of permit coverage.
    The principle underpinning this schedule is that the relief period
from benchmark monitoring between the first and fourth year decreases
if benchmark exceedances continue and additional monitoring is
required. During this time, operators may also be conducting continued
benchmark monitoring in compliance with AIM for certain parameters that
have ongoing exceedances. The extended benchmark monitoring schedule
under the 2021 MSGP will ensure that operators have current data on
their industrial stormwater discharges and stormwater control measure
effectiveness throughout their permit coverage and will help identify
potential adverse effects from modifications in facility operations and
personnel over time. See Part <IP_ADDRESS> of the permit and fact sheet.
     Updating benchmark values. EPA updated the benchmark
monitoring thresholds in the 2021 MSGP for aluminum, copper for
discharges to freshwater, selenium for discharges to freshwater, and
cadmium based on revised current CWA section 304(a) national
recommended aquatic life water quality criteria and suspended the
benchmark monitoring thresholds for magnesium and iron based on lack of
documented acute toxicity. The 2021 MSGP also allows operators who
exceed the revised benchmark thresholds for discharges to freshwater
for aluminum and copper to demonstrate to EPA that their discharges do
not result in an exceedance of a facility-specific value calculated by
the operator using the national recommended water quality criteria
multi-variable models in-lieu of the applicable 2021 MSGP benchmark
threshold. See Parts 4.2.2 and 8 of the permit and fact sheet.
    EPA also received some comments related to developing wet-weather
criteria. At this time, EPA does not plan to develop wet-weather
criteria as the Agency believes aquatic life water quality criteria are
appropriate protective values for ambient waters and MSGP's benchmark
thresholds. The Agency may consider the validity of exploring a wet-
weather criteria approach in the future, however.
     Additional Implementation Measures. The 2021 MSGP includes
revisions to the Additional Implementation Measures (AIM) requirements
for benchmark monitoring exceedances that were included in the proposed
2020 MSGP. EPA revised these provisions to address concerns raised in
public comments. Both the proposed 2020 MSGP and the final 2021 MSGP
maintain a three-level structure of advancement and responses triggered
by benchmark exceedances and keep follow-up actions clear, timely, and
proportional to exceedance frequency and duration. The final 2021 MSGP
AIM requirements reduce costs and complexity from the proposal by
creating stepwise, sequential advancement through the AIM levels

with clear ``resetting'' to baseline status if benchmark thresholds and
responses are met within the required deadlines. EPA reminds operators
and the public that benchmark thresholds are not effluent limitations.
This permit requires benchmark monitoring as a gauge of the performance
of facilities' stormwater control measures. The other corrective action
conditions, subsequent action deadlines, and documentation requirements
in Part 5.1 remain the same as in the 2015 MSGP.
    In Part 5.2, AIM is triggered by an exceedance of a benchmark
monitoring parameter, which can occur from two ``triggering events'':
Either an exceedance of the four-quarterly annual average for a
parameter, or from fewer than four quarterly samples if a single sample
or the sum of any sample results within the sampling year exceeds the
benchmark threshold by more than four times for a parameter (this
result indicates that an exceedance of the annual average is
mathematically certain).
    There are three AIM levels in the 2021 MSGP: AIM Level 1, Level 2,
and Level 3. All operators subject to benchmark monitoring requirements
begin in baseline status at the start of their permit coverage. An
operator would progress linearly through the three AIM levels if an
exceedance triggering event occurs and continues. If an exceedance
triggering event occurs while in baseline status, an operator would
enter AIM Level 1. If a triggering event occurs while in Level 1, an
operator proceeds to AIM Level 2. If a triggering event occurs while in
Level 2, an operator proceeds to AIM Level 3. The operator is required
to respond with increasingly robust control measures and continued
benchmark monitoring with each subsequent AIM level. The operator is
``reset'' to baseline status from any AIM level if benchmark thresholds
and responses are met within the required deadlines.
    After an exceedance triggering event occurs, an operator must
continue quarterly monitoring for the parameter(s) that caused the AIM
triggering event at all affected stormwater discharge points, until
four additional quarters of monitoring do not result in an exceedance
triggering event. The deadlines for implementing AIM responses remains
the same as in the proposed permit for Levels 1 and 2 (within 14 days
of receipt of lab results, unless infeasible, then within 45 days). The
deadline for Level 3 has been extended to allow time for scheduling and
completing installation of stormwater control measures (identify the
schedule for installing controls within 14 days; install controls
within 60 days, unless infeasible, then within 90 days). EPA may grant
an extension to the specified deadlines for AIM Level 2 and AIM Level 3
based on an appropriate demonstration by the operator as outlined in
Parts <IP_ADDRESS> (AIM Level 2 Deadlines) and <IP_ADDRESS> (AIM Level 3
Deadlines).
    The following five exceptions to the AIM requirements are available
for an exceedance triggering event at any AIM level: (1) Natural
background sources, (2) run-on, (3) a one-time abnormal event, (4) a
demonstration that discharges of copper and aluminum do not result in
an exceedance of facility-specific criteria using the national
recommended water quality criteria in-lieu of the applicable MSGP
benchmark threshold, and 5) a demonstration that the benchmark
exceedance does not result in any exceedance of an applicable water
quality standard. AIM requirements increase regulatory certainty while
ensuring that discharges are sufficiently controlled to protect water
quality. See Part 5.2 of the permit and fact sheet.
     Impaired waters monitoring. Under the 2021 MSGP, operators
discharging to impaired waters without an EPA-approved or -established
total maximum daily load (TMDL) must complete annual monitoring for
discharges of certain pollutants to impaired waters. Impaired waters
monitoring begins in the first year of permit coverage, starting in the
first full quarter of permit coverage. Monitoring is required for one
year at each discharge point for all pollutants for which the waterbody
is impaired, just as in the 2015 MSGP, after which the operator can
discontinue monitoring for the next two years for any pollutant that is
not detected. Annual monitoring must continue for any pollutant that is
detected in the discharge. Required annual monitoring then resumes in
the fourth year of permit coverage for one year for those pollutants
that are both causing impairments and are associated with the
industrial activity and/or are a required benchmark parameter for the
operator's subsector(s), including any pollutant(s) for which the
operator previously discontinued monitoring. After monitoring in the
fourth year of permit coverage is completed, the operator can
discontinue monitoring for the duration of their permit coverage for
any pollutant that is not detected. Again, annual monitoring must
continue for any pollutant that is detected in the stormwater
discharge. For waters identified as impaired by acidity or heat, annual
monitoring must continue where the measured pH or temperature exceeds
the range of acceptable values assigned to the water consistent with
applicable water quality standards. The extended impaired waters
monitoring schedule under the 2021 MSGP will ensure that operators
affirmatively determine in their first year of permit coverage that a
parameter causing an impairment is not present at the facility before
narrowing the list of monitored parameters in the fourth year. The
updated schedule ensures operators periodically check on their
potential contributions to impairments in their industrial stormwater
discharges throughout their permit coverage. See Part <IP_ADDRESS>.a of the
permit and fact sheet.

C. Summary of Changes From Proposed 2020 MSGP

    After considering information and comments received, the following
proposed requirements were either not finalized or have been modified
in the 2021 MSGP relative to the proposed 2020 MSGP:
    1. Expanding the permit eligibility requirement for discharges to a
federal CERCLA site beyond EPA Region 10. EPA is limiting this
eligibility criterion to MSGP facilities in EPA Region 10 states and
Indian Country. EPA has extensive information that stormwater
discharges are a source of CERCLA site recontamination in Region 10.
EPA Region 10 has seen both the actual recontamination of Superfund
Sites from stormwater discharge points and the potential for
recontamination from source control information gathered at Superfund
Sites not yet cleaned up. EPA adds in the 2021 MSGP that such
facilities in Region 10 submit the required information to the EPA
Regional Office in their NOI via the NPDES eReporting Tool (NeT) for
the MSGP, which will be reviewed for 30 days prior to the standard 30-
day review period for all NOIs.
    2. Adding an eligibility criterion regarding coal-tar sealcoat. EPA
is not finalizing the eligibility criterion regarding coal-tar sealcoat
that was included in the proposed 2020 MSGP. EPA is instead
implementing a holistic activity-based approach for addressing
discharges of PAHs in stormwater associated with industrial activity.
The 2021 MSGP requires industrial facilities to complete ``report-
only'' indicator analytical monitoring bi-annually (i.e., sample twice
per year) during the first and fourth year of permit coverage for PAHs
if the facilities initially seal or re-seal coal-tar sealcoat on paved
surfaces where industrial activities are located, as well other
specific sectors with potential petroleum hydrocarbon

exposure to stormwater. The indicator monitoring, specified in Part
4.2.1 of the 2021 MSGP, is ``report-only'' and does not have a
threshold or baseline value for comparison nor does it trigger follow-
up actions. This pollutant focused approach to evaluating activities
and sectors that may contribute PAHs to stormwater discharges will
allow the Agency to use the indicator monitoring data collected to
conduct an initial quantitative assessment of the levels of PAHs in
industrial stormwater, further identify industrial activities with the
potential to discharge PAHs in stormwater, and inform future
consideration of potential PAH benchmark monitoring for sectors with
the potential to discharge PAHs in stormwater.
    3. Modifying the permit authorization timeframe if a new facility
had a pending enforcement action. EPA is not finalizing the proposed
extended authorization timeframe that would have extended the review
period for new NOIs for facilities that have a pending enforcement
action. However, EPA updates the NOI form in the 2021 MSGP to include
new questions specifically to identify if there is a pending
enforcement action related to stormwater.
    4. Providing an inspection-only option in lieu of benchmark
monitoring. EPA is not finalizing an inspection-only option in the 2021
MSGP. EPA acknowledges the validity of the NRC Study recommendation to
provide an alternative compliance option for low-risk facilities;
however, the Agency does not currently have sufficient information or a
fully-vetted approach to identify which facilities should be considered
``low-risk.'' EPA will continue to collect information, including the
indicator monitoring data required in the 2021 MSGP, to support future
consideration of an inspection-only option for low-risk facilities.
    5. Requiring universal benchmark monitoring for pH, TSS, and COD
applicable to all sectors. EPA is not finalizing universal benchmark
monitoring for pH, TSS, and COD as proposed. Instead, the 2021 MSGP
includes a new provision that requires certain operators to conduct
indicator analytical monitoring for pH, TSS, and COD quarterly for the
duration of the permit. This ``indicator monitoring'' requirement
applies to all operators in subsectors that do not have sector-specific
benchmark monitoring requirements in the 2021 MSGP. For the final
permit, indicator monitoring is ``report-only'' and does not have a
threshold or baseline value for comparison, therefore no follow-up
action is triggered or required.
    Requiring sector-specific benchmark monitoring for Sector I (Oil
and Gas Extraction), Sector P (Land Transportation and Warehousing),
and Sector R (Ship and Boat Building and Repair Yards). EPA is not
finalizing benchmark monitoring requirements for Sectors I, P, and R as
proposed. Upon reconsidering the recommendations of the NRC regarding
``Sectors Not Subject to Benchmark Monitoring'' and the ``Need for
Periodic Monitoring Reviews,'' EPA now acknowledges that the NRC
highlighted Sectors I, P, and R as ``examples [to] show that monitoring
requirements within the MSGP are not consistently applied'' and that
``[s]ector-specific monitoring requirements for all sectors should be
rigorously reviewed to assess whether the monitoring requirements are
appropriate to ensure control of stormwater pollution and determine
whether benchmark monitoring requirements should be adjusted.''
Contrary to the proposed 2020 MSGP Fact Sheet, which incorrectly
interpreted the NRC study as ``recommend[ing] that EPA require
benchmark monitoring for Sectors I, P, and R,'' EPA now recognizes that
the NRC did not recommend the Agency require benchmarks for these
sectors, but rather provided them as examples of ``Sectors Not Subject
to Benchmark Monitoring'' and for highlighting the ``Need for Periodic
Monitoring Reviews.'' The NRC notes that these examples ``highlight the
need for updated evaluations of pollutant potential and opportunities
for pollutant reduction through implementation of additional SCMs.''
    EPA recognizes it misinterpreted the actual recommendations of the
NRC report in this instance, and the Agency acknowledges the NRC
Study's recommendation for additional sector-specific data-gathering
efforts. EPA commits to address the specific recommendations of the NRC
regarding ``Sectors Not Subject to Benchmark Monitoring'' and the
``Need for Periodic Monitoring Reviews'' in future proposals of the
MSGP. At this time, EPA is requiring indicator monitoring for pH, TSS,
and COD for facilities in subsectors that do not have sector-specific
benchmark monitoring requirements in the 2021 MSGP, which includes
subsectors I1, P1, and R1. The indicator monitoring will provide
operators and EPA with a baseline and comparable understanding of
industrial stormwater discharge quality, broader water quality
problems, and stormwater control effectiveness at these facilities, as
recommended by NRC. EPA will use the results of the indicator
monitoring to re-assess the need for additional chemical-specific
benchmark monitoring for the next reissuance of the MSGP.
    6. Modifying the method for determining natural background
pollutant contributions from the 2015 MSGP. In the 2021 MSGP, EPA
retains the 2015 MSGP no net contribution method to applying the
natural background exception for several reasons. The 2015 MSGP method
is consistent with existing EPA policy concerning the establishment of
site-specific water quality criteria based on natural background
conditions. See EPA's Office of Science and Technology memorandum,
Establishing Site Specific Aquatic Life Criteria Equal to Natural
Background (November 5, 1997). Additionally, the 2015 MSGP response to
comments stated that ``the CWA does not allow EPA or states to set a
site-specific criteria equal to the natural background plus an
otherwise protective level . . . since doing so could raise the level
of the pollutant in the water body that might [be] above the natural
background, which would not be protective of aquatic life, at a
minimum.'' See Natural Background Exception to Benchmark Monitoring (p.
5-6) in Response to Public Comments--EPA NPDES 2015 Multi-Sector
General Permit (MSGP), June 4, 2015. Public comments also raised a
variety of concerns to EPA that the proposed subtraction method is
counter to the ``solely attributable'' standard and is not appropriate
for the MSGP.
    7. Requiring sector-specific fact sheet checklists to be used as
part of AIM Tier 2 in Appendix Q. EPA is not finalizing Appendix Q in
the 2021 MSGP. Instead, EPA maintains the existing industrial
stormwater fact sheet series as guidance. In the 2021 MSGP, after AIM
Level 2 is triggered, the Level 2 response requires the operator to
generally implement additional pollution prevention/good housekeeping
measures. EPA encourages facilities to consult the existing MSGP
industrial stormwater fact sheet series for guidance on recommended
stormwater control measures appropriate to comply with AIM Level 2. EPA
plans to work with external stakeholders to thoroughly revise the
sector-specific fact sheets.

IV. Implementation Assistance

    Following issuance of the 2021 MSGP, EPA plans to provide further
assistance to industrial operators and other interested parties on
various aspects of this new permit. The following activities or
documents are planned:

    1. National webcast--EPA will host at least one webcast in February
2021 that will provide an overview of the 2021 MSGP and an opportunity
for participants to ask questions. EPA will announce details of all
webcasts and post webcast recordings on the industrial stormwater
website at https://www.epa.gov/npdes/stormwater-discharges-industrial-activities.
    2. Revisions to sector-specific fact sheets for PFAS (guidance)--To
recognize that industrial facilities can conduct activities that use,
store, manufacture, transfer, and/or dispose of PFAS-containing
materials and in alignment with EPA's ``Interim Strategy for Per- and
Polyfluoroalkyl Substances in Federally Issued National Pollutant
Discharge Elimination System Permits: Recommendations from the PFAS
NPDES Regional Coordinators Committee,'' EPA revised each of the
sector-specific fact sheet guidance documents to include practices that
could be used by operators to minimize PFAS in stormwater discharges.
EPA will continue to work with stakeholders to further update these
sector-specific fact sheets with additional emerging stormwater control
measures that could be used by industrial operators.
    3. Other templates and guidance--EPA will also update existing
forms and guidance for developing SWPPPs, conducting monitoring,
performing inspections and visual assessments, and provide tutorials
and training materials for how to submit forms and data to EPA via NeT-
MSGP.
    4. Benchmark monitoring tracking spreadsheet--EPA will also develop
a spreadsheet that industrial operators may use to calculate whether
their quarterly benchmark monitoring data results in an exceedance (AIM
triggering condition).

V. Paperwork Reduction Act (PRA)

    The information collection activities in this permit have been
submitted for approval to the Office of Management and Budget (OMB)
under the PRA. The Information Collection Request (ICR) document that
EPA prepared has been assigned EPA ICR number 2612.02, OMB Control No.
2040-0300. You can find a copy of the ICR in the docket for this permit
(Docket ID No EPA-HQ-OW-2019-0372), and it is briefly summarized here.
    CWA section 402 and the NPDES regulations require collection of
information primarily used by permitting authorities, permittees
(operators), and EPA to make NPDES permitting decisions. The burden and
costs associated with the entire NPDES program are accounted in an
approved ICR (EPA ICR number 0229.23, OMB control no. 2040-0004).
Certain changes in this permit require revisions to the ICR to reflect
changes to the forms and other information collection requirements. EPA
is reflecting the paperwork burden and costs associated with this
permit in a separate ICR instead of revising the existing ICR for the
entire program for administrative reasons.
    EPA is collecting new information as part of the 2021 MSGP. The NOI
form was updated from the 2015 MSGP to collect new information related
to the following: Added two questions to determine if PAH indicator
monitoring in Part <IP_ADDRESS>.b should apply; added questions for
operators in New Mexico only (based on CWA section 401 conditions
specific to operators in New Mexico in Part 9 of the permit); added the
SIC code field for co-located activities; added an additional option
for Sector G ore answer selections; added an additional option for
operators to upload/attach their SWPPP (in additional to the existing
options from the 2015 MSGP); for new dischargers only, added a question
to indicate if the facility has a pending enforcement action related to
industrial stormwater by EPA, a state, or a citizen; and added
questions related to endangered species protection criterion
determination and Criterion C3 form information, historic properties
determination, new dischargers to impaired waters eligibility
information, and CERCLA-related eligibility information to the NOI form
in NeT-MSGP in lieu of providing information to EPA via email
communication or in another form to streamline or reduce burden.
    EPA made no changes to the Notice of Termination (NOT)
requirements. For the Annual Report form, EPA added the requirement to
include AIM responses for the 2021 MSGP. For the No Exposure
Certification form, EPA made no changes to the information collected,
but finalized a change of the acronym for the No Exposure Certification
from NOE to NEC.
    For the Discharge Monitoring Report (DMR) form, EPA updated the
form to match the language included in the permit as follows: Updated
Part 3.d of the form to allow operators to indicate if monitoring was
for indicator monitoring; updated Part 3.l of the form to match the
abnormal event exception; added Part 3.n (demonstration that discharges
of copper do not result in an exceedance of facility-specific criteria)
and Part 3.o (demonstration that discharges of aluminum do not result
in an exceedance of facility-specific criteria) to match the permit.
    Respondents/affected entities: Industrial facilities in the 30
sectors shown in section I.A of this document in the areas where EPA is
the NPDES permitting authority.
    Respondent's obligation to respond: Compliance with the MSGP's
information collection and reporting requirements is mandatory for MSGP
operators.
    Estimated number of respondents: EPA estimates that approximately
2,508 operators will receive coverage under the 2021 MSGP.
    Frequency of response: Response frequencies in the 2021 MSGP vary
from once per permit term to quarterly.
    Total estimated burden: EPA estimates that the information
collection burden of the 2021 MSGP is 68,460 hours per year. Burden is
defined at 5 CFR 1320.3(b).
    Total estimated cost: EPA estimates that the final information
collection cost of the 2021 MSGP is $2,461,813 per year.
    An 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. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. EPA responded to
ICR-related comments in the final permit.

VI. 2021 MSGP Incremental Cost Analysis and Future Cost-Benefit
Considerations

    The cost analysis accompanying this final permit monetizes and
quantifies certain incremental cost impacts of the final permit changes
as compared to the 2015 MSGP. EPA analyzed each change in the 2021 MSGP
considering the previous permit's (i.e., the 2015 MSGP) requirements.
The objective of this cost analysis is to show where or to what extent
the 2021 MSGP requirements impose an incremental increase in
administrative and compliance costs (such as sampling and monitoring
costs) on operators in relation to costs that are already accounted for
in the 2015 MSGP.
    More broadly, EPA notes that additional unquantified costs and
benefits result from this action. In developing the next MSGP (or
another NPDES general permit, as appropriate), EPA plans to estimate
the broader impacts arising from these actions, including costs and
benefits. Estimates under consideration may include: (1) Assessing how
costs and benefits are attributed between the MSGP and applicable water
quality standards (including TMDLs) that may be in effect; (2)
developing a new modeling

framework to assess how regulated entities understand and implement
control measures relating to existing and new permit obligations; (3)
examining whether any underlying cost and benefit assumptions need to
be updated; (4) examining more broadly how EPA can analyze benefits
when developing permits; (5) developing more robust approaches to
assessing uncertainties associated with the analytic approaches,
including how to quantitatively assess uncertainties of key
assumptions; and (6) developing a framework to analyze the effect of
cooperative federalism.
    EPA expects the incremental cost impact on entities that will be
covered under the 2021 MSGP, including small businesses, to be minimal.
EPA anticipates the incremental administrative and compliance cost for
new or modified permit requirements will be $338-$632 per operator per
year; or $1,690-$3,157 per operator over the 5-year permit term. A copy
of EPA's incremental cost analysis for the final permit, titled ``Cost
Analysis for the Final 2021 Multi-Sector General Permit (MSGP),'' is
available in the docket (Docket ID No. EPA-HQ-OW-2019-0372). The cost
analysis indicates that while there will be an incremental increase in
the costs of complying with the 2021 MSGP, these costs will not have a
significant economic impact on a substantial number of small entities.

VII. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action.'' Accordingly, EPA
submitted this action to OMB for review under Executive Orders 12866
and 13563 (76 FR 3821, January 21, 2011), and any changes made in
response to OMB recommendations will be documented in the docket for
this action (Docket ID No. EPA-HQ-OW-2019-0372).

VIII. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    This action does not have disproportionately high and adverse human
health or environmental effects on minority populations, low-income
populations and/or indigenous peoples, as specified in Executive Order
12898. EPA has determined that the 2021 MSGP will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because the requirements
in the permit apply equally to industrial facilities in areas where EPA
is the permitting authority, and the provisions increase the level of
environmental protection for all affected populations.

IX. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. With limited exceptions,
EPA directly implements the NPDES program in Indian country as no tribe
has yet obtained EPA authorization to administer the NPDES program. As
a result, almost all eligible facilities with stormwater discharges
associated with industrial activities in Indian country fall under
EPA's MSGP or may be covered under an individual NPDES permit issued by
EPA.
    EPA consulted with tribal officials under EPA's Policy on
Consultation and Coordination with Indian Tribes early in the process
of developing this permit to have meaningful and timely input into its
development to gain an understanding of and, where necessary, to
address the tribal implications of the permit. A summary of that
consultation and coordination follows.
     June 26, 2019--EPA initiated a tribal consultation and
coordination process for this action by sending a ``Notice of
Consultation and Coordination'' letter to all 573 federally recognized
tribes. The letter invited tribal leaders and designated consultation
representative(s) to participate in the tribal consultation and
coordination process. The consultation period was from July 8 to
September 9, 2019.
     July 10, 2019--EPA presented an overview of the current
2015 MSGP and potential changes for the reissuance of the MSGP to the
National Tribal Water Council.
     August 1, 2019--EPA held an informational webinar for
tribal representatives. A total of 19 tribal representatives
participated in the webinar.
    EPA solicited comment from federally recognized tribes early in the
reissuance process. Tribes and tribal organizations submitted one
letter and three emails to EPA, and EPA addressed those comments in the
final permit and/or sent the requested information to the tribes.
Records of the tribal informational webinar and a consultation summary
summarizing the written comments submitted by tribes are included in
the docket for this action (Docket ID No. EPA-HQ-OW-2019-0372). EPA
also notes that the Agency completed the CWA section 401 certification
procedures with all authorized tribes where this permit applies. EPA
will provide email notification to tribes of the final 2021 MSGP.

X. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy and has not otherwise been designated by
the Administrator of the Office of Information and Regulatory Affairs
as a significant energy action.

    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Dennis Deziel,
Regional Administrator, EPA Region 1, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Jeffrey Gratz,
Deputy Director, Water

Division, EPA Region 2, pursuant to the settlement agreement entered in
Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No. 15-2091 (2d Cir.).
That notice of final permit issuance with the original signature and
date is maintained by EPA. For administrative purposes only, and in
compliance with requirements of the Office of the Federal Register, the
undersigned EPA Official re-signs the notice of final permit issuance
for publication, as an official document of the Environmental
Protection Agency. This administrative process in no way alters the
legal effect of this notice of final permit issuance upon publication
in the Federal Register.

    Dated: February 11, 2021.
Jeffrey Gratz,
Deputy Director, Water Division, EPA Region 2.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Carmen Guerrero-
Perez, Director, Caribbean Environmental Protection Division, EPA
Region 2, pursuant to the settlement agreement entered in Waterkeeper
Alliance, Inc. et al. v. U.S. EPA, No. 15-2091 (2d Cir.). That notice
of final permit issuance with the original signature and date is
maintained by EPA. For administrative purposes only, and in compliance
with requirements of the Office of the Federal Register, the
undersigned EPA Official re-signs the notice of final permit issuance
for publication, as an official document of the Environmental
Protection Agency. This administrative process in no way alters the
legal effect of this notice of final permit issuance upon publication
in the Federal Register.

    Dated: February 11, 2021.
Carmen Guerrero-Perez,
Director, Caribbean Environmental Protection Division, EPA Region 2.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Catherine Libertz,
Director, Water Division, EPA Region 3, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Catherine Libertz,
Director, Water Division, EPA Region 3.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Jeaneanne Gettle,
Director, Water Division, EPA Region 4, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Jeaneanne Gettle,
Director, Water Division, EPA Region 4.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Tera Fong,
Director, Water Division, EPA Region 5, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Tera Fong,
Director, Water Division, EPA Region 5.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Charles Maguire,
Director, Water Division, EPA Region 6, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Charles Maguire,
Director, Water Division, EPA Region 6.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Jeffery Robichaud,
Director, Water Division, EPA Region 7, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Jeffery Robichaud,
Director, Water Division, EPA Region 7.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Darcy O'Connor,
Director, Water Division, EPA Region 8, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Humberto Garcia,
Acting Director, Water Division, EPA Region 8.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Tom[aacute]s
Torres, Director, Water Division, EPA Region 9, pursuant to the
settlement agreement entered in Waterkeeper Alliance, Inc. et al. v.
U.S. EPA, No. 15-2091 (2d Cir.). That notice of final permit issuance
with the original signature and date is maintained by EPA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned EPA Official re-
signs the notice of final permit issuance for publication, as an
official document of the Environmental Protection Agency. This
administrative process in no way alters the legal effect of this notice
of final permit issuance upon publication in the Federal Register.

    Dated: February 11, 2021.
Tom[aacute]s Torres,
Director, Water Division, EPA Region 9.

    This notice of final permit issuance of the Environmental
Protection Agency was signed on January 15, 2021, by Daniel Opalski,
Director, Water Division, EPA Region 10, pursuant to the settlement
agreement entered in Waterkeeper Alliance, Inc. et al. v. U.S. EPA, No.
15-2091 (2d Cir.). That notice of final permit issuance with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the notice of
final permit issuance for publication, as an official document of the
Environmental Protection Agency. This administrative process in no way
alters the legal effect of this notice of final permit issuance upon
publication in the Federal Register.

    Dated: February 11, 2021.
Daniel Opalski,
Director, Water Division, EPA Region 10.
[FR Doc. 2021-03391 Filed 2-18-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Rules and Regulations]
[Page 32456-32460]
[DOCID:fr08jy09-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0888; FRL-8423-1]

Polyglyceryl Phthalate Ester of Coconut Oil Fatty Acids;
Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of polyglyceryl phthalate ester of coconut
oil fatty acids (PPECFA) when used as inert ingredients in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest. The Joint Inerts Task Force (JITF), Cluster Support Team
Number 23 submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of PPECFA.

DATES: This regulation is effective July 8, 2009. Objections and
requests for hearings must be received on or before September 8, 2009,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0888. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose

disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0888 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk as required by 40 CFR
part 178 on or before September 8, 2009.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0045, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background

    In the Federal Register of March 25, 2009 (74 FR 12856) (FRL-8399-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7465) by the JITF, Cluster Support Team Number 23 (CST 23), c/o
CropLife America, 1156 15th Street, NW., Suite 400, Washington, DC
20005, The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of the inert ingredient PPECFA (this substance is also
referred to throughout this document as PPECFA). That notice referenced
a summary of the petition prepared by the JITF, CST 23, the petitioner,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) in which the Agency revoked, under section
408(e)(1) of the FFDCA, the existing exemptions from the requirement of
a tolerance for residues of certain inert ingredients because of
insufficient data to make the determination of safety required by FFDCA
section 408(b)(2). The expiration date for the tolerance exemptions
subject to revocation was August 9, 2008, which was later extended to
August 9, 2009 (73 FR 45312 ) to allow for data to be submitted to
support the establishment of tolerance exemptions for these inert
ingredients prior to the effective date of the tolerance exemption
revocation.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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 to infants and children from aggregate exposure to the
pesticide chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
exemption from the requirement of a tolerance for residues of PPECFA
when used as inert ingredients in pesticide formulations applied to
growing crops or food-producing animals. EPA's assessment of exposures
and risks associated with establishing tolerances 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.
    PPECFA is not acutely toxic by the oral or dermal routes of
exposure and is slightly irritating to the eyes, and non-irritating to
the skin. It is not a skin sensitizer. There was no hazard identified
in a combined repeat dose rat reproductive/developmental screening
study at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) to
either parental animals or their offspring. There is no concern for
neurotoxicity, immunotoxicity or carcinogenicity for PPECFA.
    Specific information on the studies received and the nature of any
observed effects caused by PPECFA 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 http://
www.regulations.gov in document ``PPECFA; JITF CST 23 Inert
Ingredients)''. Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations, pp 5-7 in docket ID number EPA-
HQ-OPP-2008-0888.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
    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
greater than that 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 http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    There was no hazard identified in a combined repeated dose toxicity
study with the reproduction/developmental toxicity screening test in
rats with PPECFA at the limit dose of 1,000 mg/kg/day to either
parental animals or their offspring. Thus, due to their low potential
hazard and the lack of a hazard endpoint, the Agency has determined
that a quantitative risk assessment using safety factors applied to a
POD protective of an identified hazard endpoint is not appropriate.
    The Agency used a qualitative structure activity relationship (SAR)
database, DEREK11, to determine if there were structural alerts for
potential carcinogenicity of PPECFA. No structural alerts for
carcinogenicity were identified. PPECFA is not expected to be
carcinogenic.

C. Exposure Assessment

    1. Dietary exposure (from food and feed uses and drinking water).
Since an endpoint for risk assessment was not identified, a
quantitative exposure assessment for PPECFA was not conducted. Any
possible dietary exposure to PPECFA from its use as an inert ingredient
in pesticide products would be through consumption of food to which
pesticide products containing it have been applied and through drinking
water (from runoff).
    2. 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).There are no
residential uses for PPECFA.
    3. 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.''
    EPA has not found PPECFA to share a common mechanism of toxicity
with any other substances, and PPECFA does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that PPECFA does not have
a common mechanism of toxicity with other substances. For information
regarding

EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

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.
    The toxicity database for PPECFA is adequate for FQPA assessment
and the potential exposure is adequately characterized given the low
toxicity of the chemical. There was no hazard identified in a combined
repeat dose rat reproductive/developmental screening study at the limit
dose of 1,000 mg/kg/day to either parental animals or their offspring.
There is no concern for neurotoxicity, immunotoxicity or
carcinogenicity for PPECFA.
    Based on this information, there is no concern, at this time, for
increased sensitivity to infants and children to PPECFA when used as an
inert ingredient in pesticide formulations applied to growing crops or
to raw agricultural commodities after harvest and a safety factor
analysis has not been used to assess risk. For the same reason, EPA has
determined that an additional safety factor is not needed to protect
the safety of infants and children.

E. Aggregate Risks and Determination of Safety

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient through food, drinking water, and through other
exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
    No data were submitted for PPECFA with respect to plant and animal
metabolism or environmental degradation. Although the available
toxicity data for PPECFA did not show any toxicity at up to 1,000 mg/
kg/day (the limit dose), which addresses the issue of potentially toxic
in vivo metabolites, the Agency also considered degradation of PPECFA
in the environment particularly the potential for PPECFA to degrade to
alkyl phthalate esters. Alkyl phthalate esters such as bis(2-
ethylhexyl) phthalate (DEHP) have been shown to have concerns for
teratogenicity, carcinogenicity, liver toxicity, and male reproductive
toxicity. Based on physical and chemical characteristics and likely
degradation processes, PPECFA is expected to degrade in the environment
to phthalic acids, substances which do not exhibit the same toxicity as
alkyl phthalate esters and are not of toxicological concern.
    Since an endpoint for risk assessment was not identified, a
quantitative dietary risk assessment for PPECFA was not conducted.
Given the lack of concern for hazard posed by PPECFA, EPA concludes
that there are no dietary risks of concern as a result of exposure to
PPECFA in food and water. Additionally, since there are no residential
uses for PPECFA, a residential risk assessment was not performed. The
Agency has not identified any concerns for carcinogenicity relating to
PPECFA.
    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 residues of
PPECFA.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

     The Agency is not aware of any country requiring a tolerance for
PPPECFA nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of PPECFA when used as an inert ingredient in
pesticide formulations applied to growing crops or to animals.

VII. Statutory and Executive Order Reviews

    This final rule establishes exemptions under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule 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 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., 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 section 408(d) of FFDCA, such as the exemption 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition, this final rule
does not 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).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
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 this final rule in the Federal
Register. This final 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 25, 2009.

Lois Rossi,

Director, Registration Division, Office of Pestiicide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. 180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Polyglyceryl phthalate ester of                       Surfactants,
 coconut oil fatty acids (CAS                          related adjuvants
 Reg. Nos. 67746-6070-9                                of surfactants
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E9-15927 Filed 7-7-09; 8:45 am]

BILLING CODE 6560-50-S