[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60201-60203]
[FR Doc No: 2017-27279]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6716]

New Insights for Product Development and Bioequivalence
Assessments of Generic Orally Inhaled and Nasal Drug Products; Public
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``New Insights for
Product Development and Bioequivalence Assessments of Generic Orally
Inhaled and Nasal Drug Products.'' The purposes of the workshop are to
present the outcomes from the research projects conducted under the
Generic Drug User Fee Amendments (GDUFA) Regulatory Science Research
Program; discuss how regulatory science initiatives have helped address
regulatory science knowledge gaps by providing insights on factors that
influence the performance of generic orally inhaled and nasal drug
products (OINDPs); share the Agency's experience on the utility of
novel analytical tools and methods developed under the regulatory
science initiative for generic OINDP product development and
bioequivalence assessments; and obtain input from the public on what,
when, where, and how analytical methods and procedures should be
applied in the development and review of abbreviated new drug
applications (ANDAs) for complex OINDPs.

DATES: The public workshop will be held on January 9, 2018, from 8:30
a.m. to 4:30 p.m. Individuals who wish to attend the workshop must
register by December 30, 2017. Submit either electronic or written
comments on this public workshop by February 14, 2018. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503 B+C), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before February 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 14, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6716 for ``New Insights for Product Development and
Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug
Products.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Renishkumar Delvadia, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4704, Silver Spring, MD 20993, 240-402-
7979, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Regulatory Science Enhancements section of the GDUFA
Reauthorization Performance Goals and Program Enhancement Fiscal Years
2018-2022 (GDUFA II Commitment Letter) (available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf) FDA committed to ``conduct internal and external
research to support fulfilment of submission review and pre-ANDA
commitments.'' This continues commitments made in the GDUFA Program
Performance Goals and Procedures for fiscal years 2013 through 2017
(GDUFA I Commitment Letter) (available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf). For
complex OINDPs, this research is intended to support the development of
scientific guidance and Agency policy to clarify the ANDA pathway for
OINDPs and aid our understanding about the critical product attributes
relevant for in vivo performance of OINDPs. This work has led to the
development of tools beneficial to both industry and FDA for developing
and evaluating generic OINDPs. This regulatory science research
includes, but is not limited to, the following: (1) Identification of
critical formulation and device attributes of generic OINDPs; (2)
development of clinically relevant in vitro tools for prediction of in
vivo regional drug deposition and dissolution from OINDPs; (3)
development of computational fluid dynamic (CFD) and physiologically-
based pharmacokinetic (PBPK) models for prediction of the local and
systemic exposure of drugs delivered through OINDPs and to assess their
applicability in generic OINDP development programs; and (4)
identification, validation, and standardization of novel techniques
that can be used for future bioequivalence assessments for generic
OINDPs.
    Since its commencement in 2012, the GDUFA Regulatory Science
Research Program has continuously aided our understanding about the
critical product attributes that are relevant for in vivo performance
of OINDPs, and has led to the development of tools beneficial to both
industry and FDA for developing and assessing generic OINDPs. Several
external and internal research projects have been initiated under the
GDUFA Regulatory Science Research Program. The outcomes from these
research studies have provided valuable insight about the factors
influencing the performance of OINDPs and have helped the Agency fill
regulatory science gaps in this area. For instance, advanced modeling
tools developed under this initiative, such as CFD and PBPK, can
provide insights about patient-device interactions and information
about both local and systemic bioavailability, which can better
characterize critical device and formulation attributes to further our
understanding of generic drug-device combination products. Clinically
relevant mouth-throat and nasal models are another example of this
research which have shown good in vivo correlations in predicting
regional drug deposition; these physical models allow us to predict the
impact of certain performance characteristics of OINDPs on regional
drug deposition in a realistic manner, potentially without the need for
conducting comparative clinical endpoint studies. Similarly,
Morphologically Directed Raman Spectroscopy (MDRS), a novel particle
sizing method explored under the initiative, has shown promise in
differentiating nasal suspension formulations of different drug
particle sizes, and has opened the possibility of a new regulatory
pathway for the approval of generic nasal suspension products without
the need to conduct a comparative clinical endpoint study. Another
research outcome developed under the science initiative for OINDPs has
been work involving in-vitro dissolution methods, which are providing
insights on the bridge between local drug deposition and its downstream
systemic bioavailability. Our enhanced understanding about OINDPs from
these regulatory science-based initiatives have informed us during the
development of product-specific guidances for OINDPs, resulting in the
publication of more than 39 product-specific guidance documents since
the implementation of GDUFA in 2012.
    To enhance communication of recent advances, including those
supported by GDUFA funds, FDA plans to hold a public workshop on new
analytical methods and assessment criteria for characterization of
OINDPs.

II. Purpose and Scope of the Workshop

    The purposes of the workshop are as follows:
    1. To present the outcomes from the research projects initiated
under the GDUFA Regulatory Science Research Program;
    2. To discuss how regulatory science initiatives have helped
address regulatory science gaps by providing insight on factors that
influence the performance of OINDPs;
    3. To share the Agency's experience on the utility of novel
analytical tools and methods developed under the regulatory science
initiative for OINDP product development and bioequivalence
assessments; and
    4. To obtain input from the public on what, when, where, and how
analytical methods and procedures should be applied in the development
and review of complex OINDP ANDAs for therapeutic equivalence.
    The scope of the workshop covers the current status of methods for
characterization and bioequivalence evaluation of generic OINDPs.
    The focus of this public workshop is on the evaluation of these new
methods for characterizing and demonstrating therapeutic equivalence of
OINDPs, including discussing the areas in which these methods may
significantly contribute to generic product development and regulatory
understanding, how and under what conditions the methods should be
conducted and evaluated, and inherent scientific challenges with this
complex class of products.
    Public input will improve FDA's current understanding of present
and future methods available for evaluating OINDP therapeutic
equivalence. The knowledge gained through this workshop discussion will
be summarized and disseminated to the scientific community by
publication(s).

III. Scope of Public Input Requested

    FDA seeks input from the public on when, where, and how to utilize
new methods for development of generic OINDPs and in the regulatory
review of bioequivalence. Specific topics to be addressed include:
    1. Identifying the areas in which new in vitro and computational
methods can contribute to the development of generic OINDPs;
    2. Discussing how in vitro testing for demonstrating OINDP
therapeutic equivalence should be conducted and evaluated; and
    3. Addressing the scientific challenges in assessing critical
quality attributes of OINDPs and in developing new

methods for demonstrating OINDP therapeutic equivalence.
    Registration: Persons interested in attending this public workshop
must register online by December 30, 2017, by going to https://www.fda.gov/Drugs/NewsEvents/ucm576064.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone. The workshop agenda and
other background materials will be available approximately 2 weeks
before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm576064.htm. The agenda will include time for questions and answers
throughout the day and for general comments and questions from the
audience following panel discussions.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by December 30, 2017, midnight Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided beginning at 8:30 a.m.
    If you need special accommodations due to a disability, please
contact Renishkumar Delvadia no later than December 30, 2017.
    Streaming Webcast of the public workshop: This public workshop will
also be webcast. A live webcast of this workshop will be viewable at
https://collaboration.fda.gov/r19djs3yfsf/ on the day of the workshop.
A video record of the workshop will be available at the same web
address for 1 year. If you have never attended a Connect Pro event
before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the
Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.

    Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27279 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P


facility is fundamentally different. The Agency must determine whether,
on the basis of one or more of these factors, the facility in question
is fundamentally different from the facilities and factors considered by
EPA in developing the nationally applicable effluent guidelines. The
regulation also lists four other factors (e.g., infeasibility of
installation within the time allowed or a discharger's ability to pay)
that may not provide a basis for an FDF variance. In addition, under 40
CFR 125.31(b) (3), a request for limitations less stringent than the
national limitation may be approved only if compliance with the national
limitations would result in either (a) a removal cost wholly out of
proportion to the removal cost considered during development of the
national limitations, or (b) a non-water quality environmental impact
(including energy requirements) fundamentally more adverse than the
impact considered during development of the national limits. EPA
regulations provide for an FDF variance for indirect dischargers at 40
CFR 403.13. The conditions for approval of a request to modify
applicable pretreatment standards and factors considered are the same as
those for direct dischargers.

	The legislative history of section 301(n) underscores the necessity for
the FDF variance applicant to establish eligibility for the variance.
EPA's regulations at 40 CFR 125.32(b) (1) are explicit in imposing this
burden upon the applicant. The applicant must show that the factors
relating to the discharge controlled by the applicant's permit which are
claimed to be fundamentally different are, in fact, fundamentally
different from those factors considered by the EPA in establishing the
applicable guidelines. An FDF variance is not available to a new source
subject to NSPS.

D. Other Clean Water Act Requirements  TC \l2 "E. Other Clean Water Act
Requirements

	Compliance with the provisions of this proposed rule would not exempt a
discharger from any other requirements of the CWA. Notable, if
construction activity results in the “discharge of dredged or fill
material” into waters of the U.S. the discharger at the C&D site must
obtain a separate permit under section 404 of the CWA.

XIX. Related Acts of Congress, Executive Orders, and Agency Initiatives

A. Executive Order 12866: Regulatory Planning and Review

 	Under section 3(f)(1) of Executive Order 12866   SEQ CHAPTER \h \r 1
(58 FR 51735, October 4, 1993), this action is an "economically
significant regulatory action”  SEQ CHAPTER \h \r 1  because it is
likely to have an annual effect on the economy of $100 million or more.
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for review under Executive Order 12866 and any changes made
in response to OMB recommendations have been documented in the docket
for this action.

	  SEQ CHAPTER \h \r 1 In addition, EPA prepared an analysis of the
potential costs and benefits associated with this action. This analysis
is contained in Section 8.3, Comparison of Social Cost and Monetized
Benefits in Chapter 8 of the Economic Analysis. A copy of the analysis
is available in the docket for this action and the analysis is briefly
summarized here. Table XIX-1 provides the results of the benefit-cost
analysis.

Table XIX-1. Total Annualized Benefits and Costs of the Regulatory
Options

Option	Social Costs

(2008 $ millions per year)	Monetized Benefits

(2008 $ millions per year)

Option 1	$132	$18

Option 2	$1,891	$333

Option 3	$3,797	$470

B. Paperwork Reduction Act  TC \l2 "A. Paperwork Reduction Act

	The information collection requirements in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR number 2336.01.

	Today's proposed option, Option 2, would require operators to perform
turbidity monitoring that would entail measuring and recording the NTU
level of effluent prior to discharge.

	EPA estimates that this provision would create a total annual burden of
about 224,000 hours for the proposed rule for permittees and about
25,000 hours for permitting authorities. This estimate is the
incremental burden above the currently-approved burden level for the EPA
and State construction general permits. EPA has received OMB approval
for the current permit requirements under control no. 2040-0188, "Notice
of Intent for Storm Water Discharges Associated with Construction
Activity under a NPDES General Permit." Burden is defined at 5 CFR
1320.3(b).

	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.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, EPA has established a public docket for this rule,
which includes this ICR, under Docket ID number [EPA-HQ-OW-2008-0465].
Submit any comments related to the ICR to EPA and OMB. See ADDRESSES
section at the beginning of this notice for where to submit comments to
EPA. Send comments to OMB at the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is
required to make a decision concerning the ICR between 30 and 60 days
after [Insert date of publication in the Federal Register.], a comment
to OMB is best assured of having its full effect if OMB receives it by
[Insert date 30 days after publication in the Federal Register.]. The
final rule will respond to any OMB or public comments on the information
collection requirements contained in this proposal.

C. Regulatory Flexibility Act

	The Regulatory Flexibility Act (RFA) generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.

For the purposes of assessing the impacts of today's rule on small
entities, small entity is defined as either a: (1) a small business as
defined by the Small Business Administration’s (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; or (3) a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field. EPA does not anticipate any impacts on
small organizations and impacts on small governments are covered under
the UMRA analysis section. The RFA provides that EPA generally define
small businesses according to the size standards established by the
Small Business Administration (SBA). The SBA established criteria for
identifying small businesses is based on either the number of employees
or annual revenues (13 CFR 121). These size standards vary by NAICS
(North American Industrial Classification System) code. For the C&D
industry NAICS categories (236 and 237) the small business annual
revenue threshold is set at $33.5 million. The SBA sets the small
business threshold for NAICS 2372 (Land Subdivision of NAICS 237) at $7
million. However, for the purpose of the economic analysis, EPA
allocated this sector amongst the four primary building construction
sectors: single-family housing, multifamily housing, industrial
building, and commercial and institutional building construction.

In order to evaluate potential impacts of today’s proposal on small
businesses, EPA convened a SBREFA panel for this rulemaking on September
10, 2008. EPA held an outreach meeting with Small Entity Representatives
(SERs) on September 17, 2008. A list of SERs and the outreach materials
sent to SERs are included in the docket (see DCN XXXXX - XXXXX). EPA,
OMB and SBA prepared a panel report, which is also included in the
docket (see DCN XXXXX).

	After considering the economic impacts of today’s proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Overall, EPA
estimates that in a typical year there will be 82,000 in-scope firms,
and of this total, approximately 78,000, or about 96 percent, are
defined as small businesses. For this option, EPA estimates that about
618 small businesses would experience costs exceeding 1 percent of
revenue and 51 small businesses would incur costs exceeding 3 percent of
revenue. Both numbers represent very small percentages of the in-scope
small firms. The 618 firms estimated to incur costs exceeding 1 percent
of revenue represent about 0.4 percent of all small C&D sector firms and
0.8 percent of estimated potentially in-scope small businesses. The 51
firms estimated to incur costs exceeding 3 percent of revenue are again
very small percentages at less than one-tenth of a percent of both small
business counts. Therefore, EPA does not consider the preferred option
to have the potential to cause a significant economic impact on a
substantial number of small entities.

	In developing the current set of proposed options, EPA considered
potential affects on small firms, as demonstrated by the inclusion of a
one to less than ten acre project size category for each option. The
regulatory requirements for these small size projects are considered to
be significantly less burdensome than those for the larger size
projects. Although small firms do not directly equate to small projects,
EPA’s review of the construction industry suggests that smaller firms
tend to undertake smaller projects.

Therefore, EPA considers the inclusion of a separate small site size
category with less burdensome requirements to be an effective way to
address potential impacts on small firms. We continue to be interested
in the potential impacts of the proposed rule on small entities and
welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

	Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), P.L.
104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with "Federal mandates" that may
result in expenditures to State, local, and tribal governments, in the
aggregate, or to the private sector, of $100 million or more in any one
year. Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.

EPA has determined that this rule contains a Federal mandate that may
result in expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or the private sector in any one
year. Accordingly, EPA has prepared under section 202 of the UMRA a
written statement which is summarized below.

Consistent with the intergovernmental consultation provisions of section
204 of the UMRA EPA has already initiated consultations with the
governmental entities affected by this rule. EPA took and responded to
comments from government entities on the earlier proposed C&D rule. To
help characterize the potential impacts to government entities EPA has
gathered state government data on NOI submissions, and from US Census
data and Reed Construction Data, EPA has compiled information on how
much construction activity is undertaken by government entities. EPA has
routinely consulted with EPA regional offices who maintain direct and
regular contact with state entities. Finally, EPA met directly with and
solicited data from all the state Stormwater Coordinators who attended
EPA’s Annual Stormwater Conference in 2007. As part of the financial
impact analysis, EPA looked specifically at the impact on government
entities resulting from both compliance with construction site
requirements and from administering the additional monitoring reports
submitted by in-scope firms. Table XIX-2 shows the results of this
analysis. For more information on how this analysis was performed see
Section 9-1 Assessing Costs to Government Entities in Chapter 9 of the
Economic Analysis.

Table XIX-2 Impacts of Regulatory Options on State & Local Governments
(million 2008 $)

 	Option 1	Option 2	Option 3

Compliance Costs

Federal	$2.3	$34.0	$66.5

State	$4.4	$68.1	$128.2

Local	$25.1	$390.7	$735.8

Administrative Costs

Federal	$0.0	$0.0	$0.0

State	$0.0	$0.1	$0.2

Local	$0.0	$0.6	$1.0

Total Costs

Federal	$2.3	$34.0	$66.5

State	$4.4	$68.2	$128.4

Local	$25.1	$391.3	$736.8

Source: Economic Analysis

In developing this rule, EPA consulted with small governments pursuant
to its plan established under section 203 of the UMRA to address impacts
of regulatory requirements in the rule that might significantly or
uniquely affect small governments. To ensure that the proposed Options
were not disproportionately affecting small government entities EPA
analyzed impacts on small government entities. The assessment of impacts
on small governmental entities involved two steps: (1) identifying small
government entities (i.e., those serving populations of less than
50,000, (5 U.S.C. 601[5])), (2) estimating the share of total government
costs for the regulatory options incurred by small governments, and (3)
estimating the potential impact from these costs based on comparison of
small government outlays with small government revenue and outlays. For
details of this analysis see Section 9.2 Assessing Costs and Impacts on
Small Government Entities in Chapter 9 of the Economic Analysis. Table
XIX-3 has the results of the small government entity impact analysis.

Table XIX-3 Impacts of Regulatory Options on Small Government Units
(million 2008 $)

 	Option 1	Option 2	Option 3

Compliance Costs

Small Government Entities	$11.8 	$183.6 	$345.8

Administrative Costs

Small Government Entities	$0.0 	$0.3 	$0.5

Total Costs

Small Government Entities	$11.8 	$183.9 	$346.3

Small Government Impact Analysis Concepts

Total Revenues	125,515	125,515	125,515

Total Costs as % of Total Revenues	0.01%	0.15%	0.28%

Capital Outlay	13,455	13,455	13,455

Total Costs as % of Total Capital Outlay	0.09%	1.37%	2.57%

Construction Outlay Only	8,529	8,529	8,529

Total Costs as % of Total Construction Outlay	0.14%	2.16%	4.06%

Source: Economic Analysis

E. Executive Order 13132: Federalism

	Executive Order 13132, entitled “Federalism” (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
“meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.”
“Policies that have federalism implications” is defined in the
Executive Order to include regulations that have “substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.”

	This proposed rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government, as
specified in Executive Order 13132. The proposed rule would not alter
the basic state-federal scheme established in the Clean Water Act under
which EPA authorizes states to carry out the NPDES permitting program.
EPA expects the proposed rule would have little effect on the
relationship between, or the distribution of power and responsibilities
among, the federal and state governments. Thus, Executive Order 13132
does not apply to this rule.

	In the spirit of Executive Order 13132, and consistent with EPA policy
to promote communications between EPA and State and local governments,
EPA specifically solicits comment on this proposed rule from State and
local officials.

F. Executive Order 13175 (Consultation and Coordination with Indian
Tribal Governments)

	Executive Order 13175, entitled "Consultation and Coordination with
Indian Tribal Governments" (65 FR 67249, November 6, 2000), requires EPA
to develop an accountable process to ensure "meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications."

	"Policies that have Tribal implications" is defined in the Executive
Order to include regulations that have 'substantial direct effects on
one or more Indian Tribes, on the relationship between the Federal
government and the Indian Tribes, or on the distribution of power and
responsibilities between the Federal government and Indian Tribes. This
proposed rule does not have tribal implications. It will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal government and Indian Tribes, or on the distribution
of power and responsibilities between the Federal government and Indian
tribes as specified in Executive Order 13175. Today's proposed rule
contains no Federal mandates for Tribal governments and does not impose
any enforceable duties on Tribal governments. Thus, Executive Order
13175 does not apply to this rule. In the spirit of Executive Order
13175, and consistent with EPA policy to promote communications between
EPA and Tribal governments, EPA specifically solicits comment on this
proposed rule from tribal officials.

G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks

	Executive Order 13045, "Protection of Children from Environmental
Health Risks and Safety Risks" (62 FR 19885, April 23, 1997) applies to
any rule that: (1) is determined to be "economically significant" as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets both
criteria, the Agency must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by the Agency.

	This proposed rule is not subject to Executive Order 13045 because it
does not concern an environmental health or safety risk that EPA has
reason to believe may have a disproportionate effect on children. This
rule is based on technology performance, not health or safety risks.

H. Executive Order 13211 (Energy Effects)

	This rule is not a "significant energy action" as defined in Executive
Order 13211, "Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use" (66 FR 28355, May 22, 2001) because
it is not likely to have a significant adverse effect on the supply,
distribution, or use of energy. The treatment systems required by most
sites affected by today's proposed rule rely on treatment techniques
that do not utilize mechanical equipment. The proposed rule may require
larger sediment basins in certain cases and some sites would need to
operate treatment systems designed to reduce the turbidity of stormwater
discharges, and therefore may result in the use of additional fuel for
construction equipment conducting excavation and soil moving activities
or to operate electrical generators to power pumps. EPA determined that
the additional fuel usage would be insignificant, relative to the total
fuel consumption at construction sites and the total annual U.S. fuel
consumption.

I. National Technology Transfer and Advancement Act

	Section 12(d) of the National Technology Transfer and Advancement Act
(NTTAA) of 1995, (Public Law 104-113, section 12(d); 15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standard bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.

	The Agency is not aware of any consensus-based technical standards for
the types of controls contained in today's proposal. EPA welcomes
comments on this aspect of the proposed rulemaking and, specifically,
invites the public to identify potentially-applicable voluntary
consensus standards and to explain why such standards should be used in
this regulation.

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

Executive Order 12898 (59 FR 7629 (Feb. 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.

	EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or
low-income population. The proposed rule will reduce the negative
effects of discharges from construction sites in the nation’s waters
to benefit all of society, including minority communities.

XX. Solicitation of Data and Comments

A. General Solicitation of Comment   TC \l2 "B. General Solicitation of
Comment

	EPA encourages public participation in this rulemaking. EPA asks that
commenters address any deficiencies that they perceive in the record
supporting this proposal and that suggested revisions or corrections to
the rule, preamble or record be supported by data. EPA invites all
parties to coordinate their data collection activities with the Agency
to facilitate cost-effective data submissions. Please refer to the FOR
FURTHER INFORMATION section at the beginning of this preamble for
technical contacts at EPA.

B. Specific Solicitation of Comments and Data  TC \l2 "A. Specific
Solicitation of Comments and Data

	EPA solicits comments on all aspects of today's proposal. In addition
to the various topics on which EPA has solicited comments throughout
this proposal, EPA specifically solicits comments on the following:

1. EPA is proposing an effluent limit for turbidity. EPA solicits
comments on the need to regulate additional pollutants or require
monitoring of additional parameters, specifically pH. High pH can result
from discharges of concrete truck washout as well as from stormwater
that flows over recently placed concrete. EPA solicits comments on
whether an effluent limit for pH is needed. Such a limitation would not
be developed using the statistical methodology used to develop the
turbidity limitation. Instead, EPA typically establishes a range of
acceptable values from 6 to 9 to protect against extreme acidity or
alkalinity.

2. EPA is proposing that construction activity located in areas of the
country that have an annual R-factor of less than 50 not be required to
meet the turbidity standard. EPA solicits comment on the use of the
annual R-factor as an applicability provision. EPA also solicits comment
on incorporating a seasonal R-factor applicability provision, similar to
the waiver provision for small construction sites currently in place
under the Phase II regulation, into this regulation. (EPA’s rainfall
erosivity factor calculator can be found at   HYPERLINK
"http://cfpub.epa.gov/npdes/stormwater/lew/lewcalculator.cfm"
http://cfpub.epa.gov/npdes/stormwater/lew/lewcalculator.cfm ). EPA
solicits comment on the appropriate seasonal R-factor to consider, as
well how it would be implemented. EPA is aware that R-factor information
may not be widely available in Alaska, Hawaii and the U.S. territories.
EPA solicits comment on the availability of R-factors in these areas.
EPA also solicits comments on using annual precipitation instead of
R-factor as an applicability provision for Alaska, as well as for other
areas where R-factor information is not readily available.

3. EPA solicits comments on other factors related to soil type, climate
or soil erosivity that should be considered as potential applicability
provisions. EPA considered annual precipitation as an applicability
provision in concert with or in place of an annual R-factor
applicability criterion. EPA solicits comments on the merits of an
annual precipitation applicability criterion.

4. EPA is proposing that construction activity located in areas with
less than 10 percent soil clay content, by mass, not be required to meet
the turbidity standard. EPA solicits comments on the feasibility and
ease of implementation of the proposed 10 percent clay content
applicability criteria. Specifically, EPA requests comments on how
permittees could demonstrate that soils on their construction sites
contain less than 10 percent clay content. EPA envisions permittees
using available soil survey data as a way of establishing applicability,
or permittees conducting laboratory analysis of soils present on-site.
For example, ASTM D-422 (Standard Test Method for Particle-Size Analysis
of Soils) could be specified. EPA request comment on these two
approaches. Specifically, EPA requests comments on the availability of
soil survey data for the entire U.S. (including Alaska, Hawaii and the
U.S. territories) and also the appropriate laboratory methods or
standards that should be used by permittees to analyze soils on their
sites. EPA also solicits comments on the number of samples that should
be collected, the type and location of samples to be collected (i.e.,
should EPA consider that the applicability provision apply to topsoil or
should EPA consider all soils expected to be exposed during the duration
of the construction project). EPA solicits comments on how to aggregate
or weight soil data for different areas of the site and for different
soil horizons. EPA also solicits comment on whether the proposed 10
percent clay content value is an appropriate value to use for an
applicability provision of the turbidity standard.

5. EPA is proposing that C&D sites required to meet the turbidity limit
provide storage and treatment for runoff expected from the local 2-year,
24-hour storm. EPA solicits comments on whether this volume is adequate,
or whether additional storage (such as runoff from the 10-year, 24-hour
storm or the 25-year, 24-hour storm) or less storage (such as runoff
from the 1-year, 24-hour storm) should be required. EPA also solicits
comments on whether specific analytical approaches or models (such as
TR-55) should be used by permittees to calculate runoff volumes and
storage requirements and whether specific assumptions in these models
(such as specifying minimum runoff curve numbers that must be used)
should be mandated through the regulation.

6. EPA solicits data on the costs and performance of stormwater
treatment systems and construction site erosion and sediment controls.
EPA specifically solicits comments on treatment systems other than
chitosan-enhanced filtration that could be used by permittees to meet
the proposed turbidity limit. EPA requests costs and performance data
for these systems, as well as information on specific locations, project
types or soil types for which these systems would be applicable. EPA
also solicits comments on the costs to install conventional sediment
basins.

7. EPA has based its baseline assumptions on requirements currently
contained in state construction general permits. EPA has not considered
existing local or municipal requirements or regulations that may be more
stringent than requirements contained in state general permits. EPA
solicits comments and data on existing or proposed state, local and
municipal requirements that are more stringent than the data used in
EPA’s analysis so that EPA may more accurately characterize the
baseline of regulatory programs nationwide. EPA also solicits comments
on the extent to which water quality standards or Total Maximum Daily
Loads are requiring a higher level of control than currently required by
state construction general permits.

8. EPA solicits comments on the modeling approach used to estimate
sediment generation and reductions due to the proposed option, which is
described in the Development Document. EPA also solicits information and
data on concentrations of pollutants, including sediment, turbidity,
TSS, nutrients, metals, organics and other pollutants typically found in
construction site stormwater discharges. EPA solicits comments on ways
in which the load and pollutant removal estimates generated in support
of this proposal can be improved, and how EPA’s load estimates and
benefits estimation methodologies can incorporate consideration of
pollutants other that sediment.

9. EPA has used NOI data from approximately 38 states. EPA solicits NOI
data from other states, as well as other data that can be used to
estimate the annual number of construction sites in the U.S. and the
proportion of sites that would be subject to today’s proposed
regulations.

10. EPA solicits comments on the typical duration of construction
projects, the percent of construction projects acres that are disturbed,
and the typical duration that soils are exposed.

11. EPA solicits comments on the ability of dischargers to meet a
numeric turbidity limit using passive, instead of active systems and the
costs and performance of available technologies. EPA solicits comments
on basing a turbidity limit on passive systems at a level of 50 NTUs (or
some other level) and the costs and pollutant load reductions that would
be attributable to such a standard. EPA solicits comments on the
applicability provisions of such as standard (i.e., should a 50 NTU (or
some other level) standard apply to all permitted sites, only sites
above 10 acres, should the standard include consideration of R-factor,
annual precipitation or soil clay content, or other factors). EPA
solicits information on the potential toxicity of polymers used in
wastewater treatment, especially those used or marketed for use in
stormwater treatment. EPA further solicits information on regulator and
industry strategies and methods for avoiding any toxic effects of
polymers used on construction sites.

12. EPA solicits comments on the ability of dischargers located in areas
with R-factors less than 50 and with less than 10% soil clay content to
meet a numeric turbidity limit and what technologies would be necessary
to meet the proposed standard under Option 2 using conventional BMPs or
passive treatment systems. Specifically, EPA requests comment on whether
or not these sites, due to low rainfall, soil erosivity and low clay
content, could meet the proposed Option 2 turbidity standard using
conventional BMPs and at a substantially lower costs than ATS.

13. EPA solicits comments on whether national standards regulating peak
flowrates from sediment basins should be included in the effluent
guideline in order to limit channel erosion and what specific criteria
or standards, such as matching predevelopment peak discharge rates for a
specific design storm (such as the 1-year, 24-hour or 2-year, 24-hour)
should be included.

14. EPA solicits comments on whether perimeter controls should be
designed to remove a specific particle size and on any specific design
or performance criteria that should be established for perimeter
controls.

15. EPA solicits comments on the costs and feasibility of requiring that
flow from silt fences discharge through a vegetated filter strip or
buffer before leaving the construction site.

16. EPA solicits comments on ways in which permittees could certify that
soils on their C&D site would not exceed the percent clay criteria
associated with the turbidity limit.

17. EPA solicits comments on requiring porous baffles in sediment basins
as minimum requirements nationwide and whether the draft porous baffle
design standards published by the North Carolina Department of
Transportation (see DCN XXXXX) would be appropriate, or if other design
standards are appropriate.

18. EPA solicits comments on whether the detention time requirements
proposed for sediment basins are appropriate and if other detention time
requirements should be considered. EPA solicits comments on whether
sediment basin requirements should address any other factors, such as a
minimum surface are or a discharge rate per unit watershed area. EPA
solicits data on effectiveness of any alternative criteria.

19. EPA solicits comments on whether it would be feasible to require
construction sites to maintain a minimum cover factor for soils based on
the C-factor in RUSLE. For example, would it be feasible to require
permittees to document in their SWPPP or erosion and sedimentation
control plan the various phases of their project and calculate an
area-weighted C-factor for each phase. Permittees would be required to
meet a minimum average C-factor for the entire site during all phases of
the project. Such a standard could vary based on the size of the site,
with a lower average C-factor applying to larger sites. EPA solicits
comments on the costs and feasibility of such an approach, and comments
on what the specific C-factors should be for sites of various sizes (or
other criteria) under such a standard. EPA solicits comments on the
appropriate C-factors that would apply to various rolled erosion control
products, hydromulches and other types of ground covers and erosion
control products currently in use by the industry.

20. EPA solicits comments on whether or not the guideline should
establish maximum slope lengths before a grade break or linear sediment
control must be provided for steep slopes. EPA solicits comments on
appropriate slope lengths for various slope values. EPA points readers
to the March 18, 2008 Draft California CGP (see DCN XXX) for an example.

21. Under the current permitting system, permittees (such as a
developer) may sell or transfer control of a property to a builder or
several builders and file for an NOT at some point during the course of
the project, thus ending permit coverage for the developer. The builder
or builders assuming control of the property would then be the
permittee(s). If the project, while under control of the developer, was
subject to the proposed turbidity limit because the project was over 40
acres in size and met the R-factor and clay content applicability
provisions, and the project was sold to two builders, each controlling
20 acres, neither builder now controls more than 30 acres. As a result,
there is some question as to whether or not the turbidity limit would
still apply and which of the builders would be responsible for meeting
the turbidity limit. EPA solicits comments from permitting authorities
on if, and how, the proposed turbidity limit applicability provisions
should be structured and the regulatory language structured so that the
project remains subject to the turbidity limit until the entire project
is completed.

22. EPA solicits comments on the need for text in the rule language
regarding proper operation and maintenance and chemical dosages of
chemical treatment systems, or whether these requirements should be
addressed through guidance.

23. EPA’s proposed option includes an applicability provision tied to
the RUSLE R-factor. However, certain areas of the U.S., such as parts of
Idaho, have a low annual R-factor but can experience high erosivity
during certain times of the year, such as when rain occurs on snow or
partially frozen ground. Also, for some cold mountainous climates, most
of the erosivity is attributable to snowfall, instead of rainfall. EPA
solicits comments on how to address applicability of the turbidity
standard in areas such as these, and whether the rule language should
include specific requirements regarding calculation of an R-factor for
these areas or whether these issues should be addressed through guidance
issued by EPA and/or left to the discretion of the permitting authority.

24. EPA solicits comments on the proper techniques for turbidity
measurement in the field to demonstrate compliance with today’s
proposal. EPA has an approved analytical method for turbidity (EPA
Method 180.1 Rev 2.0). However, EPA is not proposing that a specific
analytical method be used to demonstrate compliance. EPA’s intent with
today’s proposal is to allow turbidity measurements to be made in the
field using properly calibrated portable turbidity meters, or a properly
calibrated automated turbidity meter coupled with a data logger, which
typically is a component of ATS. EPA solicits comments on whether EPA
Method 180.1 Rev 2.0 is appropriate in this case, or whether a revised
method or other guidance would be needed in order to reduce monitoring
burden and allow for the use of equipment commonly available and in use
by ATS operators.

25. EPA solicits comments on whether the effluent limit for turbidity
should be a daily maximum value, as proposed today, or an instantaneous
maximum based on continuous measurement. With a daily maximum, no
individual measurements could be above the limit. With an instantaneous
maximum, there could be a provision for brief exceedances of the limit.
See 40 CFR 401.17 for an example of pH effluent limitations under
continuous monitoring. EPA solicits comments on whether a similar
approach should be applied for turbidity, and what specific excursion
criteria would be appropriate.

C. Guidelines for Submission of Analytical Data

	EPA requests that commenters to today’s proposed rule submit
analytical and flow data to supplement data collected by the Agency
during the regulatory development process. To ensure that commenter data
may be effectively evaluated by the Agency, EPA has developed the
following guidelines for submission of data.

1. Types of Data Requested

	EPA requests paired influent and effluent treatment data for systems
capable of reducing the turbidity of stormwater runoff from construction
sites. EPA prefers paired influent and effluent treatment data, but also
solicits unpaired data as well.

	For the systems treating C&D stormwater, EPA requests paired influent
and effluent treatment data from BMPs and treatment systems. Submission
of effluent data alone is acceptable, but the commenters should provide
evidence that the influent concentrations contain treatable levels of
the pollutants. EPA also prefers individual measurements, rather than
averages, to better evaluate variability, but will consider averages if
individual measurements are unavailable. If commenters sample their
stormwater to respond to this proposal, EPA encourages them to sample
both the influent and effluent to BMPs and treatment systems and provide
the individual measured values.

	EPA prefers that the data be submitted in an electronic format. In
addition to providing the measurement of the pollutant in each sample,
EPA requests that sites provide the detection limit (rather than
specifying zero or ‘ND’) if the pollutant is non-detected in the
stormwater. Each measurement should be identified with a sample
collection date, the sampling point location, and the flow rate at that
location. For each sample or pollutant, EPA requests that the chemical
analytical method be identified.

	In support of the treatment data, commenters should submit the
following items if they are available: a process diagram of the
treatment system that includes the sampling point locations; treatment
chemical addition rates; laboratory reports; influent and effluent flow
rates for each treatment unit during the sampling period; a brief
discussion of the treatment technology sampled; and a list of C&D
operations contributing to the sampled wastestream. If available,
information on capital cost, annual (operation and maintenance) cost,
and treatment capacity should be included for each treatment unit within
the system.

2. Analytes Requested

	EPA requests analytical data for any pollutant parameters that
commenters believe are of concern in the C&D industry. Of particular
interest are turbidity, TSS, and pH data. Commenters should document the
method used for all data submissions. 	Submissions of analytical data
should include any available documentation of QA/QC procedures; however,
EPA will still consider data submitted without detailed QA/QC
information. If commenters sample their stormwater to respond to this
proposal, EPA encourages them to provide detailed documentation of the
QA/QC checks for each sample.

  TC \l1 "XX. Solicitation of Data and Comments

List of Subjects in 40 CFR part 450

Environmental protection, Construction industry, Land development,
Erosion, Sediment, Stormwater, Water pollution control.

_____________________

Stephen L. Johnson, Administrator.

For the reasons set out in the preamble, EPA proposes to amend title
40, chapter I of the Code of Federal Regulations to add a new part 450:

PART 450–CONSTRUCTION AND DEVELOPMENT POINT SOURCE CATEGORY

	Subpart A–General Provisions

Sec.

450.10	Applicability.

450.11	General definitions.

	Subpart B–Construction and Development Effluent Guidelines

450.21	Effluent limitations reflecting the best practicable technology
currently available (BPT).

450.22	Effluent limitations reflecting the best available technology
economically achievable (BAT).

450.23	Effluent limitations reflecting the best conventional pollutant
control technology (BCT).

450.24	New source performance standards (NSPS).

Authority: Sections 301, 304, 306, 308, 402, 501 and 510 of the Clean
Water Act, as amended; 33 U.S.C. 1311, 1314, 1316, 1318, 1342, 1361 and
1370.

Subpart A–General Provisions

§ 450.10	Applicability.

This part applies to discharges associated with construction activity
required to obtain NPDES permit coverage pursuant to 40 CFR
122.26(b)(14)(x) and (b)(15).

§ 450.11	General definitions.

The following definitions apply to this part:

(a) Commencement of construction means the initial removal of vegetation
and disturbance of soils associated with clearing, grading, excavating,
or other construction activities.

(b) Construction activity includes, but is not limited to, clearing,
grading, excavation, and other site preparation work related to
construction of residential buildings and non-residential buildings, and
heavy construction (e.g., highways, streets, bridges, tunnels,
pipelines, transmission lines and industrial non-building structures).

(c) Minimize means to reduce and/or prevent using available control
measures (including best management practices) that reflect best
industry practices.

(d) New Source means any source from which there will be a discharge
associated with construction activity that will result in a building,
structure, facility, or installation subject to new source performance
standards elsewhere under subchapter N.

(e) Erosion as used in this part means the process of carrying away soil
particles by the action of water.

(f) Sediment basin means a structure designed to detain sediment laden
stormwater long enough to allow sediment to settle in the basin and then
discharge stormwater at a controlled rate through an engineered outlet
device.

Subpart B– Construction and Development Effluent Guidelines

§ 450.21	Effluent limitations reflecting the best practicable
technology currently available (BPT).

Except as provided in 40 CFR 125.30 through 125.32, any point source
subject to this subpart must achieve the following effluent limitations
representing the application of the best practicable control technology
currently available (BPT).

(a) Erosion Controls. During all phases of construction activity,
provide and maintain effective erosion controls in accordance with
established industry practices on all disturbed areas of the
construction site to minimize the discharge of sediment and other
pollutants. Erosion controls are considered effective when bare soil is
uniformly and evenly covered with vegetation or other suitable
materials, stormwater is controlled so that rills and gullies are not
visible, sediment is not visible in runoff from these areas and channels
and streambanks are not eroding. Disturbed areas must be stabilized
using erosion controls immediately after any clearing, grading,
excavating or other earth disturbing activities have permanently or
temporarily ceased. Assessment of erosion potential and appropriate
erosion controls must take into account the rainfall, topography, soil
types, climate, and vegetation or other cover at each site. Erosion
controls implemented at the site must, at a minimum be designed and
installed to achieve the following:

(1) Stabilize disturbed soils immediately when earth disturbing work has
temporarily or permanently ceased. Stabilization measures must be
implemented immediately on any portion of the site whenever final grade
is reached or when earth disturbing work has been stopped on that
portion of the site and will not resume for a period exceeding 14
calendar days.

(2) Control stormwater volume and velocity within the site to minimize
soil erosion.

(3) Minimize the amount of soil exposed for the duration of the
construction activity as well as at any one time during the construction
activity.

(4) Control stormwater discharges, including both peak flowrates and
total stormwater volume, leaving the site to prevent channel and
streambank erosion and erosion at outlets.

(5) Preserve topsoil and natural vegetation.

(6) Minimize soil compaction by construction equipment in areas that
will not contain permanent structures or where compaction is not
necessary for structural integrity. In disturbed areas that will not
contain structures or where compaction is not necessary for structural
integrity, utilize deep ripping and decompaction of soils and
incorporate organic matter to restore infiltrative capacity.

(7) Provide and maintain natural buffers around surface waters.

(8) Minimize the construction of stream crossings.

(9) Sequence/phase construction activities to minimize the extent and
duration of exposed soils.

(10) Minimize disturbance of steep slopes.

(11) Implement erosion controls specifically designed to prevent soil
erosion on slopes.

(12) Establish temporary or permanent vegetation, such as grass or sod,
or use non-vegetative controls such as mulch, compost, geotextiles,
rolled erosion control products, polymers or soil tackifiers to
stabilize exposed soils.

(13) Divert stormwater that runs onto the site away from disturbed areas
of the site.

(b) Sediment Controls. Provide and maintain effective sediment controls
in accordance with established industry practice to minimize the
discharge of sediment from the site. Effective sediment controls include
a variety of practices that are designed to remove sediment within the
range of particle sizes expected to be present on the site, taking into
account rainfall, topography, soil types, climate and vegetation at each
site and the proximity to storm drain inlets and receiving waters.
Sediment controls must be installed, operated, and maintained in
accordance with established industry practices to minimize the discharge
of sediment and other pollutants from the site. Install appropriate
sediment controls prior to the commencement of construction and maintain
during all phases of construction activity. Effective sediment controls
must include, at a minimum, the following:

Establish and maintain perimeter control measures for any portion of the
down-slope and side-slope perimeter where stormwater will be discharged
from disturbed areas of the site. Perimeter controls include, but are
not limited to, BMPs such as diversion dikes, storm drain inlet
protection, filter berms, and silt fencing. Perimeter control measures
along the down-slope perimeter of the site must be installed following
the contours of the land. Discharge stormwater from perimeter controls
through vegetated areas and functioning stream buffers.

Control discharges from silt fences using a vegetated filter strip or
vegetated buffer at least six feet in width.

Minimize the length of slopes and install linear sediment controls along
the toe, face and at the grade breaks of exposed and erodible slopes.

Establish, use and maintain stabilized construction entrances and exits.
Install, utilize and maintain wheel wash stations to remove sediment
from construction equipment and vehicles leaving the site.

Remove any sediment and other pollutants, including construction
materials, from paved surfaces daily to minimize discharges from the
site. Washing sediment and other pollutants off paved surfaces into
storm drains is prohibited unless those storm drains discharge to a
sediment basin or other sediment control on the site.

 Establish, use and maintain controls and practices to minimize the
introduction of sediment and other pollutants to storm drain inlets.

Control sediment and other pollutants from dewatering activities and
obtain and comply with any state or local discharge standards or permits
for dewatering activities. Discharges from dewatering activities are
prohibited unless treated to minimize the discharge of pollutants and
sediment within the range of particle sizes expected to be present on
the site.

For common drainage locations that serve an area with 10 or more acres
disturbed at one time, install and maintain a sediment basin to control
and treat the stormwater runoff. The permitting authority may allow
alternative controls where alternative controls provide an equivalent or
better level of pollutant reduction. The sediment basin must
incorporate, at a minimum, the following requirements:

Provide a water storage volume for the calculated volume of stormwater
runoff from the local 2 year, 24-hour storm for the entire watershed
area draining to the basin until final stabilization of the disturbed
area. Alternatively, a sediment basin providing a water quality storage
volume of 3,600 cubic feet per acre of total watershed area draining to
the basin must be provided until final stabilization of the disturbed
area. If water will be flowing onto the construction site from up-slope
and into the basin, the calculation of sediment basin volume must also
account for this volume.

In addition to the water storage volume, a sediment storage volume of at
least an additional 1,000 cubic feet per acre of disturbed land area
directed to the basin must be provided. If water will be flowing onto
the construction site from up-slope and into the basin, the calculation
of the sediment storage volume must also account for this volume.

 The effective length of the basin must be at least four times the width
of the basin.

 Sediment basins must include and utilize an outlet device, such as a
skimmer, designed to withdraw water from the surface of the water
column. If a basin is to be used during freezing conditions which would
interfere with the operation of an outlet device designed to withdraw
water from the surface of the water column, then an alternative means of
dewatering may be used only during periods of freezing conditions.

Discharges from sediment basins must be regulated in a manner that
maximizes the residence time of the water in the basin. The dewatering
time must consider the range of soil particle sizes and the settling
time for soil particles expected to be present on the construction site.
The dewatering time for the water storage volume must be at least 72
hours, unless otherwise specified by the permitting authority. However,
in no case shall the dewatering time be less than 24 hours. The design
of the sediment basin must address factors such as the amount,
frequency, intensity and duration of stormwater runoff, soil types, soil
particle sizes, and other factors affecting pollutant removal
performance.

Direct stormwater discharges from sediment controls to seep berms and
level spreaders or utilize spray or drip irrigation systems to
distribute stormwater to vegetated areas and functioning stream buffers
to increase sediment removal and to maximize infiltration.

(c)	Pollution Prevention Measures. During all phases of construction
activity, provide and maintain effective pollution prevention measures
in accordance with established industry practice to control the
discharge of pollutants from the site. Effective pollution prevention
measures include a variety of recognized and accepted industry practices
that minimize the discharge of pollutants from the site taking into
account the specific circumstances at each site. Pollution prevention
measures must be implemented to achieve, at a minimum, the following:

Prohibit the discharge of construction wastes, trash, and sanitary waste
in stormwater;

Prohibit the discharge of wastewater from washout of concrete, stucco,
paint, and cleanout of other construction materials;

Prohibit the discharge of fuels, oils, or other pollutants used in
vehicle and equipment operation and maintenance;

Prohibit the discharge of pollutants resulting from the washing of
equipment and vehicles where soaps or solvents are used;

Prohibit the discharge of pollutants resulting from the washing of
equipment and vehicles using only water to remove sediment, unless wash
waters, such as water from wheel wash stations, are treated in a
sediment basin or alternative controls that provide equivalent or better
treatment;

Implement measures to minimize the exposure of stormwater to building
materials, landscape materials, fertilizers, pesticides, herbicides,
detergents, and other liquid or dry products. Implement appropriate
chemical spill prevention and response procedures. Any spills and leaks
that do occur shall be immediately addressed in a manner that prevents
the discharge of pollutants.

Prevent stormwater runoff from contacting areas with uncured concrete to
minimize changes in stormwater pH.

§ 450.22 	Effluent limitations reflecting the best available technology
economically achievable (BAT).

		Except as provided in 40 CFR 125.30 through 125.32, any point source
subject to this subpart must achieve the following effluent limitations
representing the degree of effluent reduction attainable by the
application of the best available technology economically achievable
(BAT):

For construction activity located at a site with 10 percent or greater
by mass of soils less than 2 microns in diameter (down to the graded and
excavated level of the site), and that has an annual rainfall erosivity
factor (R factor) of 50 or higher as defined by the Revised Universal
Soil Loss Equation (for construction activity located in Alaska or a
U.S. territory where the R factor applicable to the activity has not
been calculated, the 30-year average total annual precipitation of 20
inches or more shall be used in place of the R factor):

The effluent limitations specified in § 450.21 shall apply.

Except as provided by paragraph (a)(3) of this section, for any
construction activity of 30 or more acres, the discharge of stormwater
shall not exceed the value listed in the following table:

Pollutant or pollutant property	Maximum for any time (NTU)*

Turbidity	13

* - Nephelometric turbidity units.

The requirements of paragraph (a)(2) do not apply to the discharge of
pollutants in the overflow from the sediment basin or other storage
impoundment whenever rainfall events, either chronic or catastrophic,
cause an overflow of stormwater from a sediment basin or other
impoundment designed, constructed and operated to contain runoff from a
2-year, 24-hour rainfall event.

For any construction activity subject to this Subpart and not specified
in paragraph (a) of this section, the effluent limitations are the same
as those specified in § 450.21.

§ 450.23	Effluent limitations reflecting the best conventional
pollutant control technology (BCT).

		Except as provided in 40 CFR 125.30 through 125.32, any point source
subject to this subpart must achieve the following effluent limitations
representing the application of the best conventional pollutant control
technology (BCT): The effluent limitations are the same as those
specified in § 450.22.

§ 450.24	New source performance
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