[Federal Register: June 2, 2006 (Volume 71, Number 106)]
[Notices]
[Page 32115-32117]
[DOCID:fr02jn06-106]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-2006-0001]
RIN 1660-ZA13

Privacy Act of 1974; The National Flood Insurance Program (NFIP)
Claims Appeals System of Records

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice of Privacy Act system of records.

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SUMMARY: Pursuant to the Privacy Act of 1974, the Department of
Homeland Security gives notice that the Federal Emergency Management
Agency is establishing a new system of records entitled ``The National
Flood Insurance Program Claims Appeals Process.'' This appeals process
is mandated by section 205 of the Bunning-Bereuter-Blumenauer Flood
Insurance Reform Act of 2004.

DATES: The new system of records will be effective July 3, 2006, unless
comments are received that result in a contrary determination.

ADDRESSES: You may submit comments, identified by DHS DOCKET NUMBER:
FEMA-2006-0001 by one of the following methods:
    Federal e-Rulemaking Portal: http://www.regulations.gov. Follow the

instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>Include Docket Number FEMA-2006-0001 in
the subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail: Rules Docket Clerk, Federal Emergency Management Agency,
Office of General Counsel, Room 406, 500 C Street SW., Washington, DC
20472; Maureen Cooney, Acting Chief Privacy Officer, 601 S. 12th
Street, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Rena Y. Kim, Privacy Act Officer, Room
406, 500 C Street, SW., Washington, DC 20472; (telephone) (202) 646-
3949; Maureen Cooney, Acting Chief Privacy Office, 601 S. 12th Street,
Arlington, VA 22202.

SUPPLEMENTARY INFORMATION: Pursuant to the Privacy Act of 1974, the
Department of Homeland Security (DHS) is establishing a new system of
records to be maintained by the Federal Emergency Management Agency
(FEMA). The new system of records is entitled the ``National Flood
Insurance Program (NFIP) Claims Appeals Process.''
    Congress created the NFIP (42 U.S.C. 4001) in 1968 to reduce future
flood losses through flood hazard identification, floodplain management
(i.e., land use controls and building codes), and insurance protection.
NFIP coverage is available to all owners and occupants of insurable
property in a participating community upon payment of a premium.
    FEMA was designated by Congress to be the administrator of the
NFIP. In 1983, FEMA partnered with the private insurance industry in
its efforts to expand the NFIP policy base. This partnership between
FEMA and the private sector property insurance companies is termed the
Write Your Own (WYO) program. Under the WYO program, private insurers
agree to issue flood policies in their own name and take responsibility
for policy administration, claims processing, marketing, and sales.
Private insurers handle all claims issued in their name, and adjust and
settle flood loss claims consistent with their general claims
practices. Over 95 percent of flood polices in force are maintained by
WYO Companies.
    Because the WYO Companies are responsible for all administrative
activities associated with the flood insurance policies they write,
they also maintain policyholder information for

the policies they write. FEMA, however, has access to these records as
part of its oversight role. Once FEMA obtains the WYO Company's records
of an individual policyholder, the records become a part of FEMA's
system of records.
    The remaining policies in force are written and maintained directly
by FEMA via a contractor known as the NFIP Servicing Agent, and are
considered part of FEMA's system of records. The NFIP Servicing Agent
serves as a private insurance company and writes NFIP flood insurance
policies on behalf of the Federal government.
    FEMA also utilizes a contractor to support program management and
oversight activities. This contractor is responsible for the
administration of FEMA's system of records for the NFIP insurance
policy information.
    Section 205 of the Bunning-Bereuter-Blumenauer Flood Insurance
Reform Act of 2004 (FIRA), 42 U.S.C. 4011, requires that FEMA establish
an appeal process for flood insurance policyholders who wish to dispute
decisions made by any insurance agent or adjuster, insurance company,
or by a FEMA employer or contractor with respect to:
     Claims (request for payment associated with losses from
floods);
     Proofs of Loss (statement of the amount claimed, sworn,
and signed by the policyholder); and
     Loss estimates relating to the flood insurance policy.
    The NFIP Appeals Procedure provides the policyholder a voluntary
option for resolving problems relating to flood insurance without
proceeding to a lawsuit. Because this appeals process is completely
voluntary, a policyholder still has the option of instituting a lawsuit
without utilizing this process. In other words, the appeals process is
not an administrative prerequisite to the policyholder's option of
proceeding directly to litigation.
    When a policyholder opts to appeal, FEMA will request information
relevant to their appeal that includes the following personally
identifying information:
     Individual Policyholder Name: The name of the person
requesting an appeal.
     Policyholder Address: Policyholder address/place where the
loss occurred, which may be a home address.
     Policyholder Telephone Number: Policyholder telephone,
where the individual can be reached, which may be a home phone number.
     Personal Property Claimed: A list of personal property
claimed as damaged and the subject of the appeal and relevant
information.
     Policyholder statement of facts: The policyholder's
statement of why he is contesting the claim's disposition and
supporting proof or records to document the policyholder's position.
     Appeal letter from the policyholder. May include any of
the ``individually identifying'' information already described above.
     Appeal decision letter from FEMA--This decision letter
will include FEMA's appeal decision and inform the policyholder of
further recourse with respect to the disposition of the claim.
    The appeals process authorized by FIRA is intended to resolve claim
issues and is not intended to grant coverage or limits that are not
provided by the policy contract. Filing an appeal does not waive any of
the policyholder's requirements for perfecting a claim, nor does it
extend any of the time limitations established in the policy insurance
contract. Participating in the appeals process is completely voluntary
on the part of the individual policyholder. The appeal process is not
an administrative prerequisite to litigation, but is an additional
remedy available to policyholders. Therefore, only the information
required to resolve the dispute will be requested.
    This proposed new system of records developed for the NFIP Claims
Appeals Process will be used for this appeals process only.
    The Privacy Act embodies fair information principles in a statutory
framework governing the means by which the United States Government
collects, maintains, uses, and disseminates personally identifiable
information. The Privacy Act applies to information that is maintained
in a ``system of records.'' A ``system of records'' is a group of any
records under the control of an agency from which information is
retrieved by the name of the individual or by some identifying number
such as property address, or mailing address symbol, assigned to the
individual. The NFIP Claims Appeals Process System is such a system of
records.
    The Privacy Act requires each agency to publish in the Federal
Register a description denoting the type and character of each system
of records that the agency maintains, and the routine uses that are
contained in each system in order to make agency record keeping
practices transparent, to notify individuals regarding the uses to
which personally identifiable information is put, and to assist
individuals to more easily find such files within the agency. Below is
the description of the NFIP Claims Appeals Process system of records.
    In accordance with 5 U.S.C. 552a(r), DHS has provided a report of
this new system of records to the Office of Management and Budget and
to Congress.
DHS/FEMA/Mitigation/Mitigation-1

System name:
    NFIP Claims Appeals Process.

Security classification:
    Unclassified.

System location:
    The database will be maintained at FEMA Headquarters at 500 C
Street, SW., Washington, DC 20472.

Categories of individuals covered by the system:
    The system covers the individual NFIP policyholders who are
appealing decisions on their flood insurance claim.

Categories of records in the system:
    Information is collected from individual NFIP policyholders, who
have voluntarily opted to appeal the disposition of their flood
insurance claim. In addition, FEMA collects individual policyholder
information from the WYO Companies that service the policies which are
the subject of appeals in order to make a determination on these
appeals. The ``individually identifying information'' collected
includes the policyholders name, address where the loss occurred,
telephone number, a list of personal property that is claimed to be
damaged and is the subject of the appeal, the policyholder's statement
of facts about the claim, the policyholder's statement why the claim's
disposition is being disputed and supporting proof or records to
document the policyholder's position, correspondence pertaining to the
appeal which may include the foregoing individually identifying
information, and FEMA's appeal decision.

Authority for maintenance of the system:
    Section 205 of the Bunning-Bereuter-Blumenauer Flood Insurance
Reform Act (FIRA) of 2004, 42 U.S.C. 4011.

Purpose(s):
    These records are collected for the purpose of FEMA's review and
determination on NFIP flood insurance individual policyholder's claim
appeals, so that FEMA may determine whether additional payment to the
individual policyholder is warranted.

Routine uses of records maintained in the system, including categories
of users and the purposes of such uses:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, all or a portion of the records or
information contained in this system may be disclosed outside DHS as a
routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
    A. To the Government Accountability Office (GAO), DHS Office of the
Inspector General (OIG), or other organization for the purposes of
performing authorized audits or oversight of the NFIP program.
    B. To a Congressional office from the record of an individual in
response to an inquiry from that Congressional office made at the
request of the individual to whom the record pertains.
    C. To FEMA contractors as necessary to provide an appeal
resolution.
    D. To the Department of Justice (DOJ), the United States Attorney's
Office, or a consumer-reporting agency for further collection action on
any debt in relation to the appeals process, when circumstances
warrant.
    E. Where a record, either on its face or in conjunction with other
information, indicates a violation or potential violation of law--
criminal, civil or regulatory--the relevant records may be referred to
an appropriate Federal, State, territorial, tribal, local,
international, or foreign agency law enforcement authority or other
appropriate agency charged with investigating or prosecuting such a
violation or enforcing or implementing such law.
    F. To DOJ or other Federal agency conducting litigation or in
proceedings before any court, adjudicative or administrative body,
when: (1) FEMA, or (2) any employee of FEMA in his/her official
capacity, or (3) any employee of FEMA in his/her individual capacity
where DOJ or FEMA have agreed to represent the employee, or (4) the
United States or any agency thereof, is a party to the litigation or
has an interest in such litigation and when the records are determined
by FEMA to be arguably relevant to the proceeding.

Disclosure to consumer reporting agencies:
    Privacy Act information may be reported to consumer reporting
agencies pursuant to 5 U.S.C. 552a(b)(12).

Policies and practices for storing, retrieving, accessing, retaining,
and disposing of records in the system:
Storage:
    The hard copy files and the electronically scanned document files
will be maintained at FEMA Headquarters at 500 C Street, SW.,
Washington, DC 20472.

Retrievability:
    Hard copy files and the electronically scanned document files are
retrieved by the individual flood insurance policyholder's name or
property address.

Safeguards:
    Information in this system is safeguarded in accordance with
applicable laws, rules and policies, including the DHS Information
Technology Security Program Handbook. All records are protected from
unauthorized access through appropriate administrative, physical, and
technical safeguards. These safeguards include restricting access to
authorized personnel who have a need-to-know, using locks, and password
protection identification features. DHS file areas are locked after
normal duty hours and the facilities are protected from the outside by
security personnel.
    Each authorized individual working on the NFIP appeals procedure
will have access only to information necessary to perform his or her
official duties. Activity logs (audit trails) are maintained for all
operating systems, applications, and middleware. A periodic review is
conducted to monitor all user access. Incident response procedures are
established to address reported security incidents as quickly as
possible. Use of the access database will be carefully monitored and
reviewed on a periodic basis by the system administrator.

Retention and disposal:
    The paper copy of the appeal letter and supporting documentation
that are sent to FEMA by the individual with the appeal letter, and
FEMA's response letter reflecting its appeal decision constitute the
official copy of the records. Electronically scanned copies will be
kept as back up. FEMA will retain both the paper and electronic copies
for six years and three months. This retention schedule has been
approved by the National Archives and Records Administration (NARA).
The NARA authority is N1-311-86-1 2A12 (a)(2) FIA File 12-2.

System Manager and address:
    Director of Claims, Mitigation Division, Federal Emergency
Management Agency, 500 C Street, SW., Washington, DC 20472.

Notification procedure:
    A request for access to records in this system may be made in
writing to the System Manager identified above, or to the Privacy Act
Officer, DHS/FEMA, Office of General Counsel (GL), Room 406, 500 C
Street, SW., Washington, DC 20472, in conformance with 6 CFR part 5,
subpart B and 44 CFR part 6, which provide the rules for requesting
access to Privacy Act records.

Record access procedures:
    See Notification procedure above. Request for access must comply
with DHS and FEMA regulations for Privacy Act requests.

Contesting record procedures:
    Policyholders typically contest their records with their service
provider (WYO or NFIP Servicing Agent). Virtually all of theses
disputes are successfully handled through that mechanism. However,
policyholders may also contest their records using the process outlined
in the Notification procedures section above. State clearly and
concisely the information being contested, the reasons for contesting
it and the proposed amendment to the information sought.

Record source categories:
    The ``individually identifying'' information may come from the
individual NFIP policyholder and/or the entity servicing the policy.

Exemptions claimed for the system:
    None.

    Dated: May 25, 2006.
Maureen Cooney,
Acting Chief Privacy Officer, Department of Homeland Security.
 [FR Doc. E6-8625 Filed 6-1-06; 8:45 am]

BILLING CODE 4410-10-P


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]
[Page 34526]
[DOCID:fr17jn10-146]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Ritron, Incorporated

[Waiver Petition Docket Number FRA-2009-0015]

    Ritron, Incorporated (Ritron) seeks a waiver of compliance from
certain provisions of 49 CFR part 232, Brake System Safety Standards
for Freight and Other Non-Passenger Trains and Equipment. Specifically,
Section 232.409(d)--Inspection and testing of end-of-train devices,
which requires the telemetry equipment to be tested for accuracy and
calibrated, if necessary at least every 368 days. It also requires that
the date and location of the last calibration or test, as well as the
name of the person performing the calibration or test, be legibly
displayed on a weather-resistant sticker or other marking device
affixed to the outside of both the front and the rear unit.
    This petition concerns Ritron models DTX-445 and DTX-454 radio
transceiver modules. While the DTX-445 is a new product, it is similar
in mechanical and electrical design to the model DTX-442, and its field
reliability statistical performance should be representative of the
performance of the DTX-445. The DTX-454 is an established product,
having been in production for 7 years. These modules are used in a
large number of U.S. railroad head-of-train (HOT) and end-of-train
(EOT) devices manufactured and sold by various companies. The Ritron
DTX transceiver module line has been in production from 4 to 8 years,
depending upon the specific module. These transceivers use a master
reference oscillator to determine the frequency stability of the
transmitted signal. The actual transmitted signal is phase-locked to
this master oscillator by the phase-locked loop (PLL). Circuitry within
the PLL determines when the system is in ``lock'' and will prevent or
inhibit transmission if the transmitted signal is not on frequency. The
master oscillator, itself, is specified to a much higher accuracy than
that required by Federal regulations. This oscillator is used in all of
Ritron's extensive radio offerings and, to date, has never had a
failure due to being out of tolerance.
    In addition, the modulation circuitry used in the DTX radios is
based upon very stable limiting operational amplifiers followed by
passive filters and potentiometers. This has proven to be extremely
reliable and has not produced any failures related to out-of-band
emissions. The power control circuitry is different in the various
versions of the DTX family, but is based either on a closed loop final
amplifier current sensing design or an open loop lookup table. Both
have shown to work well in the field and are believed to have caused
little, if any, service issues.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0015) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within 30 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on June 10, 2010.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2010-14479 Filed 6-16-10; 8:45 am]
BILLING CODE 4910-06-P


1 February 24, 2006 MEMORANDUM Subject: Considering Household Costs on an Incremental Basis From: Kira Smith, TAB Jonathan Shefftz, Industrial Economics, Incorporated Thru: Dan Olson Team Leader To: Record EPA stated in its February 2006 Federal Register notice, Small Drinking Water Systems Variances   Revision of Existing National Level Affordability Methodology and Methodology to Identify Variance Technologies that are Protective of Public Health, that it is considering using the incremental costs of providing water rather than the cumulative costs as the basis for its affordability determination. This is a change from the Agency's current approach, which adds incremental costs to an expenditure baseline to determine affordability. An incremental approach would not calculate or consider household water bills, nor would it provide a ceiling on the total increase in household costs due to the cumulative effects of different drinking water rules. The Agency believes that an incremental approach would be more appropriate than the current cumulative approach for the following reasons:   An incremental approach is consistent with EPA's Science Advisory Board ( SAB) and National Drinking Water Advisory Council ( NDWAC) recommendations.   An incremental approach applies only to the National Primary Drinking Water Rule ( NPDWR) being promulgated.   An incremental approach avoids the possibility that the order in which EPA promulgates a rule determines whether a rule will be considered affordable.   A cumulative approach may lead to large cost increases at the system level.   Doing away with the expenditure baseline of a cumulative approach eliminates concerns associated with the regional variability of water bills and the accuracy of baseline values over time.   An incremental approach allows EPA to rely on a more representative data source to calculate median household income ( MHI) for small systems.

An incremental approach is consistent with SAB and NDWAC recommendations Currently, EPA determines if affordable compliance technologies are available to small systems by comparing the current household cost of water plus the estimated additional cost to comply with a new rule to an affordability threshold equal to 2.5 percent of MHI ( about $ 1,000). 2 Both the SAB and the NDWAC recommended that EPA eliminate the expenditure baseline and evaluate the affordability of each set of regulations incrementally. The SAB believed that the use of an expenditure baseline could potentially cause early regulations to be considered affordable, whereas later, if the affordability threshold is exceeded, even regulations with trivial costs could be found unaffordable to small systems. The NDWAC recommended that EPA replace its current approach with an incremental approach because it is " theoretically sounder, is simpler to administer, and has greater transparency than the current EPA method."

An incremental approach applies only to the NPDWR being promulgated An incremental approach applies only to the regulation for which affordability is being evaluated. In contrast, the cumulative approach considers not just the cost of treatment to comply with the new standard but also takes into account the current household cost for water. Since systems ultimately pass water treatment costs through to customers, this includes costs for existing water system improvements, which may involve treatment for odor control, taste, or other items not regulated under NPDWRs, as well as costs for distributing and storing water. These costs may not be relevant for determining whether a system can afford to comply with NPDWRs.

An incremental approach avoids the possibility that the order in which EPA promulgates a rule determines whether a rule will be considered affordable An incremental approach ( does not include baseline expenditures) avoids the possibility that the order in which EPA promulgates NPDWRs is a key determinant in whether a rule will be considered affordable. Exhibit 1 illustrates the difference over time, and for each size class, between the current methodology and an incremental methodology that sets affordability at 0.75 percent of median household income, i. e., about $ 300. In each case the incremental threshold is less than half of the cumulative expenditure margin. ( Note that the incremental thresholds in Exhibit 1 are applied to incremental treatment costs for the median sized system; applying them instead to the 10th percentile system would further decrease affordability.) Conceptually, as EPA promulgates additional rules a cumulative approach might act as a brake" on future water bill increases whereas an incremental approach would not have this effect. Data that describe projected future income levels and water rates suggest that this difference could become a factor in future decision making. 3 Exhibit 1. Projected Affordability Thresholds Size Class Median Household Income ( Nominal) Median Water Bill ( Nominal) Expenditure Margin Based on 2.5% Cumulative Threshold 0.75% Incremental Threshold 2005: 25 500 $ 44,544 $ 299 $ 810 $ 330 501 3,300 $ 40,872 $ 294 $ 730 $ 310 3,301 10,000 $ 42,459 $ 285 $ 780 $ 320 2010: 25 500 $ 52,516 $ 369 $ 940 $ 390 501 3,300 $ 48,976 $ 386 $ 840 $ 370 3,301 10,000 $ 50,103 $ 321 $ 930 $ 380 2015: 25 500 $ 62,036 $ 455 $ 1,100 $ 470 501 3,300 $ 58,803 $ 508 $ 960 $ 440 3,301 10,000 $ 59,239 $ 363 $ 1,100 $ 440 Note: 1. All income figures in this table are inflated to the dates listed from the 2000 U. S. Census by first adjusting them at the ratio between the 1999 and 2004 national MHI as estimated here: http:// www. census. gov/ hhes/ www/ income/ histinc/ h06ar. html. They are then adjusted from 2004 at the ratio of the CPI values for the respective dates. 2. Expenditure Margin and Incremental Threshold estimates are rounded to nearest ten.

Exhibit 2 lists projected MHI and water bill growth rates. Exhibit 3 illustrates projected water costs relative to income. 1 If these projected trends continue, the two smaller size classes might expect water bills to grow faster than income. This means that a cumulative affordability methodology would be more likely to find future rules unaffordable the further in the future they are promulgated, as more of that methodology's expenditure baseline would be consumed by rising water bills, leaving less room for compliance costs.

1 A few caveats apply to these data and to any conclusions to be drawn from them: ° The future projection of water bills is extrapolated from only a five year historical period; ° The future projection is based upon a relatively small sample size that may not be representative of all small water systems; and, ° Small system MHI growth may not equate to Consumer Price Index ( CPI) growth in the future. From 2000 to 2001, the national average MHI increased by approximately 0.6 percent, while the CPI increased by approximately 2.8 percent. 4 Exhibit 2. Projected Growth Rates for Water Bills and Income Size Class Nominal Cumulative Growth Rate Nominal Annual Growth Rate Annual Rate of Inflation Real Annual Growth Rate Projected Growth Rate 2005 10 MHI ( Between 1990 and 2000 U. S. Census) 25 500 49.35% 4.09% 3.00% 1.06% 3.35% 501 3,300 54.29% 4.43% 3.00% 1.39% 3.68% 3,301 10,000 49.62% 4.11% 3.00% 1.08% 3.37% Water Bills ( Between 1995 and 2000 CWSS) 25 500 24.40% 4.46% 2.47% 1.94% 4.25% 501 3,300 32.81% 5.84% 2.47% 3.29% 5.62% 3,301 10,000 13.76% 2.61% 2.47% 0.14% 2.40% Notes: 1. Real annual growth rate is based on nominal annual growth rate net of annual rate of inflation, which in turn is based on CPI growth over the relevant historical period. 2. Projected growth rate is based on combining the real annual growth rate with an average of estimated future CPI growth, which in turn is based on an average of forecasts from the Congressional Budget Office and the Office of Management and Budget. Sources: 1. 1990 U. S. Census 2. 2000 U. S. Census 3. 1995 Community Water Systems Survey 4. 2000 Community Water Systems Survey 5 The cumulative approach may lead to large cost increases The cumulative methodology could lead to larger cost increases at the system level, and thereby fail in its intended role to act as a " brake" on water bill increases for these systems. This outcome could occur because the expenditure baseline increases as a result of a new regulation by an amount equal to the average cost of the regulation across all households in a particular size category. This cost averaging occurs because of the timing with which EPA promulgates new rules and the frequency with which EPA currently administers the Community Water System Survey ( CWSS, the baseline's primary data source). The CWSS is a national survey that EPA has collected fairly regularly since 1977. The survey requests operating and financial information from a sample of community water systems in the United States. EPA conducted its last CWSS in 2000, although the results were not fully tabulated and available until several years later. Since 2000, however, EPA has promulgated a number of new drinking water rules. As a result, except in the period immediately following the publication of CWSS, the water bill data from the CWSS would understate the actual baseline because it would not reflect the costs of new rules. Therefore, EPA calculates the approximate number of households in systems serving less than 10,000 people and averages costs for new rules across these households. EPA must average across all households instead of just those in systems affected by each rule because of an inability to identify each system whose costs are affected by each rule. Exhibit 4 illustrates how updating the baseline resulted in relatively modest increases in most cases following the promulgation of five recent drinking water regulations. However, new regulations typically impose much higher costs on the relatively small subset of the approximately 50,000 small systems in the United States that must modify or install treatment technology to comply with the regulations. For example, only 5.5 percent of the systems in each small system size category are expected to modify or install treatment technology in response to the recently established maximum contaminant level for arsenic. In other words, unless a large percentage of small systems incur higher treatment related costs, the increase in the expenditure Exhibit 3. Water Costs Relative to Income over Time ( Nominal Dollars)

0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 1.2%

2005 2006 2007 2008 2009 2010 2011 2012 2013 201 Year Nominal Water Bill as a % of Nominal MHI 25 500 501 3,300 3,301 10,000 6 baseline will remain relatively modest and the cumulative methodology's " braking" potential, at least for the subset of systems that require additional treatment, will be constrained.

Exhibit 4. Updating the Expenditure Baseline Size Class 25 500 501 3,300 3,301 10,000 Households 1,985,492 7,695,205 9,982,561 Arsenic Total Cost $ 21,983,158 $ 39,665,263 $ 33,333,158 Update to Baseline $ 11.07 $ 5.15 $ 3.34 DBP I Total Cost $ 31,780,878 $ 113,142,868 $ 168,788,558 Update to Baseline $ 16.01 $ 14.70 $ 16.91 Filter Backwash Total Cost $ 202,551 $ 550,520 $ 594,064 Update to Baseline $ 0.10 $ 0.07 $ 0.06 Long Term 1 Total Cost $ 3,360,836 $ 11,333,536 $ 9,422,178 Update to Baseline $ 1.69 $ 1.47 $ 0.94 Uranium Total Cost $ 7,664,974 $ 5,757,186 $ 6,666,514 Update to Baseline $ 3.86 $ 0.75 $ 0.67 Notes: 1. Total costs are reported as calculated in the economic analysis and then updated to September 2005 dollars. 2. The increase to the baseline is the total cost divided by the number of households in a given size class ( estimated by the May 2001 Drinking Water Baseline Handbook). Therefore, changes in the demographic estimates ( i. e., number of systems and number of households per system) do not affect total cost, but do affect the baseline updates.

Eliminating a baseline eliminates regional water bill variability Doing away with the expenditure baseline eliminates concerns associated with the regional variability of water bills and the accuracy of baseline values over time. As Exhibit 5 illustrates ( with figures inflated to the September 2005 Producer Price Index), water bills vary across geographic regions in all small system size classes. These differences, ranging from about 40 to 80 percent depending on the size class, illustrate the challenge of setting a baseline for nationwide application.

Exhibit 5. Regional Median Water Bills Size Class Midwest Northeast South West 25 500 $ 233 $ 288 $ 311 $ 359 501 3,300 $ 219 $ 320 $ 288 $ 394 3,301 10,000 $ 248 $ 351 $ 276 $ 298 An incremental approach allows EPA to rely on a more representative data source to calculate median household income for small systems EPA currently calculates the cumulative affordability threshold based on MHI using the results of the 1995 CWSS. The CWSS database includes the necessary information to calculate household water bills, which is a key component under the current cumulative affordability 7 methodology. The CWSS does not provide income measures for small drinking water systems, but it does provide information on the geographical area that the system serves. Therefore, the Agency can link U. S. Census data to each system in the CWSS. Each CWSS collects data from several hundred small systems, which represent about one percent of the entire universe of small systems. Furthermore, the 2000 CWSS sampling was not intended to be randomly distributed. Instead, the goal was to achieve a higher response rate by dispatching interviewers to individual systems for on site data collection ( rather than relying on mailed forms). The need to maximize the efficiency of in person data collection dictated a cluster pattern. By contrast, the Safe Drinking Water Information System ( SDWIS) is EPA's national regulatory compliance database. SDWIS is a census of all public water systems that is updated continually, containing contact, location, inventory, and violation information. SDWIS therefore covers the entire universe of small drinking water systems across the nation. Just like the CWSS, SDWIS does not provide income measures for small drinking water systems, but it does provide information on each system's location. U. S. Census data can thereby be linked to each system in SDWIS. Unlike the CWSS, SDWIS does not contain the information required to estimate household water bills. For the cumulative affordability methodology, the CWSS was necessary for its water bill data, but EPA's option for public comment would change its small system affordability determination to an incremental methodology. Under such a methodology, water bill data are no longer necessary, eliminating the need to rely on CWSS. Therefore, adopting SDWIS for the income estimation component of the affordability methodology is now feasible, as well as preferable given its greater accuracy from the universal coverage of small systems. Exhibit 6 calculates MHI for systems that appear in both the 2000 CWSS and January 2004 SDWIS. The goal is to determine whether income calculations for the same subset of systems are similar when based upon different techniques for estimating each system's service area. The exhibit's first column ( i. e., " Median CWSS") reports the MHI for all systems in both the 2000 CWSS and SDWIS based on the census tracts served by the system, as identified in the 2000 CWSS. The third column ( i. e., " Median SDWIS") calculates MHI for the same systems, yet uses the zip code contact information ( as provided in earlier SDWIS freezes), as a proxy for the area served. In absolute terms, and especially relative to standard deviation, Exhibit 6 suggests that the SDWIS zip codes ( instead of the 2000 CWSS census tracts) can reasonably approximate MHI. 8 Exhibit 6. Systems in Both 2000 CWSS and SDWIS Size Class Median CWSS ( by tract) Standard Deviation Median SDWIS ( by zip) Standard Deviation Sample Size 25 500 $ 45,921 $ 19,000 $ 44,657 $ 17,783 212 501 3,300 $ 40,280 $ 13,948 $ 39,668 $ 13,238 152 3,301 10,000 $ 41,594 $ 14,680 $ 41,839 $ 14,967 123 Notes: 1. A total of 521 small systems appear in both SDWIS and 2000 CWSS, but only 487 had zip codes that could be linked to the U. S. Census MHI tables ( with the remainder having unavailable or inaccurate zip code information). 2. SDWIS figures are based on the " freeze" as of January 2004, reflecting data from fourth quarter 2003. 3. All income figures in this table are inflated to the present from the 2000 U. S. Census by first adjusting them at the ratio between the 1999 and 2004 national MHI as estimated here: http:// www. census. gov/ hhes/ www/ income/ histinc/ h06ar. html. They are then adjusted from 2004 to September 2005 at the ratio of the CPI values for the respective dates.

The similarity of these income estimates supports using the zip code identifier in SDWIS as the basis for pairing U. S. Census income data with small drinking water systems, for which SDWIS has almost universal coverage. Exhibit 7 compares the MHI estimates using the subset of systems both in the 2000 CWSS and SDWIS. The second MHI column (" All SDWIS") represents the median household in the median system, as measured using SDWIS data.

Exhibit 7. Comparison of SDWIS MHI for Systems in 2000 CWSS to All SDWIS Systems Size Class SDWIS in CWSS CWSS Sample Size All SDWIS SDWIS Sample Size 25 500 $ 44,657 212 $ 44,544 27,178 501 3,300 $ 39,668 152 $ 40,871 13,265 3,301 10,000 $ 41,839 123 $ 42,459 4,308 Notes: 1. SDWIS reports ( as of the January 2004 " freeze") a total of 30,132, 14,263, and 4,661 systems in each of the three smallest size categories ( respectively), but those systems that were unable to have income estimates developed for them ( because of unavailable or inaccurate zip code information) were dropped from the calculations for this exhibit. 2. All income figures in this table are inflated to the present from the 2000 U. S. Census by first adjusting them at the ratio between the 1999 and 2004 national MHI as estimated here: http:// www. census. gov/ hhes/ www/ income/ histinc/ h06ar. html. They are then adjusted from 2004 to September 2005 at the ratio of the CPI values for the respective dates.


1Unless the context indicates otherwise, the terms " Director" and " State" are used interchangeably.

1 MEMORANDUM OF AGREEMENT BETWEEN THE COMMONWEALTH OF VIRGINIA AND THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION III I. GENERAL This Memorandum of Agreement ( hereinafter " MOA") establishes responsibilities and procedures pursuant to 40 CFR § 271.8 for the Commonwealth of Virginia ( hereinafter " State") Hazardous Waste Program authorized under Section 3006 of the Resource Conservation and Recovery Act ( hereinafter " RCRA" or the " Act") of 1976 ( 42 U. S. C. 6901 et seq.), as amended ( Public Laws 94 580, 96 482, 98 616), ( hereinafter " State Program" or " Program"), and the United States Environmental Protection Agency Region III ( hereinafter " EPA").

This MOA further sets forth the manner in which the State and EPA will coordinate in the State's administration and enforcement of the State's program and, pending additional authorization, EPA's administration of the non authorized provisions of the Hazardous and Solid Waste Amendments of 1984 (" HSWA"), and EPA's regulations thereunder. For purposes of this MOA, references to " RCRA" include HSWA.

This MOA is entered into on behalf of the State by the Director of the Department of Environmental Quality ( hereinafter ADirector") to the fullest extent of his authority to act as a representative of the Commonwealth in his capacity as Directorr, and by the Regional Administrator, EPA Region III ( hereinafter " Regional Administrator").

Nothing in this MOA will be construed to restrict in any way EPA's authority to fulfill its oversight and enforcement responsibilities and authorities under Subtitle C of RCRA. Nothing in this MOA will be construed to contravene any provision of 40 CFR part 271 or any other Federal law or regulation.

Further, nothing in this MOA shall be construed to restrict the Commonwealth in the administration of the State Program required in the Waste Management Act, § § 10.1 1400, et seq. of the 1950 Code of Virginia, as amended, or the Virginia Hazardous Waste Management 2 These policies and guidance include, at a minimum, the OSWER Consolidated Guidance; the Office of Enforcement and Compliance Assurance MOA guidance; RCRA Civil Penalty Policy dated October 26, 1990; National Criteria for a Quality Hazardous Waste Program; EPA's Hazardous Waste Civil Enforcement Response Policy ( March 1996), and any revision thereto; and the EPA Policy on Performance Based Assistance ( May 31, 1985); and the May 1, 1996 Advanced Notice of Proposed Rulemaking for the Corrective Action Program; Setting Customer Service Standards ( E. O. 12862, September 11, 1993); Improving Customer Service ( Fred Hanson, April 8, 1998); Federal Actions to Address Environmental Justice in Minority Populations and Low income Populations ( E. O. 12892, February 11, 1994); EPA OSWER Environmental Justice Action Agenda ( EPA 540/ R 95/ 023, 1995).

2 Regulations, Title 9, Environment, Virginia Administrative Code ( hereinafter " VAC 20 60 10 et seq.") or other state law.

Nothing in this MOA will be deemed to confer any rights or privileges on any person or entity not a party to this agreement.

The State and EPA ( hereinafter " Parties" or, individually, " Party") will review the MOA jointly at least once a year.

This MOA supersedes the MOA that became effective on September 29, 2000. This MOA may be modified upon the initiative of either Party to ensure consistency with State Program modifications or for any other purpose mutually agreed upon. Any revisions or modifications to this MOA will be in writing and must be signed by the Director and the Regional Administrator. This MOA will remain in effect until such time as EPA withdraws State Program authorization or the State voluntarily transfers authority to EPA according to the criteria and procedures established in 40 CFR § § 271.22 and 271.23, or until the MOA is superseded by a new MOA executed by the Parties.

II. POLICY STATEMENT Each of the Parties to this MOA is responsible for ensuring that its obligations under Subtitle C of RCRA are met. Upon granting of final authorization by EPA, the State will assume primary responsibility for implementing the authorized provisions of the State hazardous waste program within its boundaries. The State will conduct its hazardous waste program consistent with existing EPA program policies and guidancee, and intends to follow future EPA program policies and guidance, consistent with State law and regulations. EPA will retain its responsibility to ensure full and faithful execution of the requirements of RCRA, including direct implementation of HSWA in the event the State is not authorized to act thereunder. The Director and the Regional Administrator agree to maintain a high level of cooperation between their respective staffs in a partnership to assure successful and effective administration of the State Program. While EPA retains responsibility for the direct implementation of those provisions of HSWA for 3 which the State is not authorized, EPA and the State intend to coordinate the implementation of these provisions to the greatest degree possible.

Section 3006( g) of RCRA provides that hazardous waste requirements and prohibitions promulgated pursuant to HSWA are applicable in authorized States at the same time that they are applicable in unauthorized States with the exception of section 3006( f), " Availability of Information," which cannot be implemented by EPA in authorized States. If such HSWA requirements are less stringent than the State's authorized program, the State's rules would govern.

EPA will execute its required oversight functions of the authorized State Program to ensure full execution of the requirements of RCRA, to promote national consistency in the implementation of the hazardous waste program, to allow EPA to report to the President and Congress on the achievements of the hazardous waste program, and to encourage States and EPA to agree on the level of desirable technical support and joint efforts to prevent and to mitigate environmental problems associated with the improper management of hazardous wastes.

EPA will conduct oversight functions through written reporting requirements, permit overview, compliance and enforcement overview, and mid year and annual reviews of the State's program.

III. STATE PROGRAM REVIEW A. General The Regional Administrator will assess the State's administration and enforcement of the hazardous waste program on a continuing basis for equivalence and consistency with RCRA, with this MOA, and with all applicable Federal requirements and policies for the adequacy of enforcement. EPA will assess the State's administration and enforcement by reviewing information the State submits in accordance with this MOA, the State's RCRA § 3011 Grant Work Plan ( hereinafter " Grant Work Plan"), and through periodic reviews of the State's program activities. EPA may also employ other mechanisms to aid in its assessment of the State's program.

To ensure effective program review, the State agrees to allow EPA access to all records used in the administration of the program requested by the Regional Administrator, or his/ her designee, which are deemed necessary by EPA to review and evaluate the State Program and enforcement. The State does not waive any privileges it may assert in litigation under the Federal Rules of Civil Procedure.

Review of the State's files may be scheduled periodically; however, the State agrees to allow EPA access to specific files more frequently as circumstances warrant, i. e., for enforcement actions. Program review meetings between the Director and the Regional Administrator, or their designees, will be scheduled at reasonable intervals not less than annually to review specific operating procedures and schedules, to resolve problems and to discuss mutual program concerns. These meetings will be scheduled at least fifteen ( 15) days in advance unless EPA and 4 the State agree to a different length of time. A tentative agenda for the meeting will be prepared in advance by EPA.

The Regional Administrator may also consider, as part of his regular assessment, written comments about the State's program administration and enforcement that are received from regulated persons, the public, and Federal, State and local agencies.

B. Identification of Priority Activities The State and EPA agree to develop, as a part of the State's Grant Work Plan, criteria for priority activities, including activities regarding handlers of hazardous waste. These criteria will be based on EPA program guidance, the Office of Enforcement and Compliance Assurance ( OECA) MOA, and priorities of the State and will be used to identify activities that should receive the highest priority during the grant period. They will be reviewed annually and revised as appropriate.

Activities that could be considered high priority include, but are not limited to, facilities to be inspected or permitted, facilities requiring corrective action, and enforcement against owners or operators of facilities with known or suspected contamination that pose a risk to human health or the environment.

IV. INFORMATION SHARING A. General This Section covers information sharing on miscellaneous elements of the RCRA program, including notification, RCRAInfo data, etc. Specific information sharing requirements for the other major program elements are covered in Sections V ( Permit Issuance), VI ( Permit Administration), and VIII ( Compliance Monitoring and Enforcement).

As the respective information needs of the State and EPA evolve, changes to this section of the MOA may be appropriate. During the annual review of this MOA, the Director and the Regional Administrator will carefully examine the following information sharing provisions and revise as appropriate.

EPA and State responsibilities regarding the maintenance and operation of the Resource Conservation and Recovery Information ( RCRAInfo) System are specified in the RCRAInfo Memorandum of Understanding ( MOU) negotiated between EPA Region III and the State and in the Grant Work Plan. Examples of responsibilities addressed in the RCRAInfo MOU include, but are not limited to, the following:

1. processing hazardous waste notification forms;

2. issuing EPA identification numbers; 5 3. submittal and use of compliance and enforcement information;

4. submittal and use of corrective action information;

5. processing hazardous waste permitting information; and 6. submittal of information to correct information which is inaccurate.

B. EPA Consistent with applicable law and regulations, EPA will:

1. keep the State informed in a timely manner of the content and meaning of Federal statutes, regulations, guidelines, standards, policy decisions, directives, and other factors that affect the State's Program. EPA will also provide timely technical guidance to the State. EPA will share with the State any national reports EPA develops from the data submitted through State reporting requirements;

2. make available to the State, as requested, other relevant information which the State needs to implement its approved program, subject to the conditions of 40 CFR part 2, such as:

a. Part A and Part B Permit Applications, whether received prior to the effective date of this MOA, or subsequent to the effective date of this MOA, and whether first received by the State or EPA,

b. copies of final permits and permit modifications,

c. notices of permit denials, and d. other information necessary to support the foregoing information; and 3. bring to the State's attention any comments it receives regarding the State's administration of the hazardous waste program.

As resources and circumstances allow, EPA will make available necessary training relating to RCRA Subtitle C to the State on request.

As resources allow, EPA agrees to provide technical assistance to the State in the review of permit applications, draft permits, permit modifications, closure/ post closure plans, etc., on request. 6 C. State The State agrees to inform the Regional Administrator in advance of any proposed program changes that would affect the State's implementation of the authorized program. Program changes of concern include modifications of the State's legal authorities ( i. e., statutes, regulations, and judicial or legislative actions affecting those authorities), modifications of Memoranda of Agreement or Understanding with other agencies, and modifications of resource levels that would have a negative impact on the State's ability to carry out the terms of this MOA ( i. e., available or budgeted personnel and funds). The State recognizes that program revisions must be made in accordance with the provisions of 40 CFR § 271.21, and that, until approved by EPA, revisions are not authorized as RCRA Subtitle C requirements.

EPA and the State will agree on the type and frequency of reports which the State will prepare for EPA to maintain oversight of the implementation of the State's authorized program. A specific list of reports and their frequency will be included in the Grant Work Plan and will constitute a grant commitment for the State. Reporting will include, but not be limited to, the following:

1. Government Performance and Results Act (" GPRA") goals and accomplishments;

2. Information required pursuant to 40 CFR § 270.5;

3. Biennial report summarizing the quantities and types of hazardous waste generated, transported, treated, stored, and disposed of in the State by October 1 of each even numbered year;

4. Copies of inspection reports, record reviews, and sampling results for all commercial facilities, treatment, storage, and disposal facilities ( TSDFs), large quantity generators ( LQGs), Federal facilities and non notifiers. For small quantity generators ( SQGs), the above reports need only be submitted where there are detected violations;

5. Copies of all enforcement actions, orders and judgments regarding commercial facilities, non notifiers, TSDFs, Federal facilities, generators and SQGs; and 6. Reports containing statistical summaries and charts of each quarter's accomplishments for compliance and enforcement. Where appropriate, facility information should be listed by category ( e. g., generators, TSDFs, etc) and include EPA ID numbers.

Pursuant to 40 CFR § 271.8, EPA reserves the right to request any information it deems necessary relating to the State's approved program in a manner to be specified in the Grant Work Plan. 7 The State agrees to provide permit and closure information to EPA as specified in the Grant Work Plan. A listing of the information which the State will submit to EPA and a submittal schedule will be included in the Grant Work Plan and will constitute a grant commitment for the State. Examples of the required information include, but are not limited to, the following:

1. Copies of permit applications submitted to the State and subsequent revisions or additions to these applications on or after the effective date of this MOA, for hazardous waste management facilities in the State, unless EPA has been sent a copy by the facility;

2. Copies of draft permits, proposed permit modifications, draft permit denials, and accompanying explanatory material for all hazardous waste management facilities in the State. EPA also may request copies of completeness and technical reviews for selected permits being worked on during the fiscal year;

3. Copies of all final permits issued, denied, modified, reissued or terminated;

4. The following closure/ post closure data:

a. Copies of the public notices announcing receipt of closure/ post closure plans and public hearings, if applicable;

b. Copies of the approved closure and post closure plans for all facilities;

c. Copies of the closure certifications for facilities signed by an independent registered professional engineer ( or an independent qualified soil scientist in cases of land treatment facilities) and the owner or operator;

d. Copies of the State's reports of inspections conducted during closure and after receipt of closure certification; and e. Copies of any notice placed in the property deed, or other instrument that is normally examined during a title search, annotating the existence of any closed disposal facility/ unit or cell.

The State may request technical assistance in the review of permit applications, draft permits, permit modifications, closure/ post closure plans, variances, waivers, etc. EPA will honor these requests as resources allow. The priorities for permitting will be reviewed annually.

Upon EPA's request, the State agrees to provide EPA with copies of reports or data resulting from any compliance inspection and subsequent enforcement actions.

The State agrees to send EPA a copy of each State decision granting any waiver or variance, within the scope of the authorized program, at the time such request is granted. 8 The State agrees to provide any pertinent information requested by the Regional Administrator or his designee within a mutually agreed upon time frame for EPA to carry out its oversight responsibilities. Unless otherwise specified, the above information will be sent to:

U. S. Environmental Protection Agency Region III Virginia Program Manager, 3WC21 1650 Arch Street Philadelphia, PA 19103 2029 In accordance with the provisions of 40 CFR § § 271.14 and 124.10( c) the State agrees to develop and maintain a public mailing list and have it readily available for EPA before public notice of an action by the State regarding a facility. An acceptable list may be specific to certain facilities, areas, or concerns; or the list may be a general State wide list used in all cases. This list should be kept current and accurate.

D. Obtaining and Sharing Information for National Data EPA is responsible for maintaining reliable national data on hazardous waste management. These data are used to report to the President and Congress on the achievements of the hazardous waste program and to support EPA's regulatory development efforts. Whenever EPA determines that it needs to obtain such data, EPA will first seek to gain them from the State, which agrees to supply this information to the Regional Administrator if readily available and as resources allow. If the State is unable to provide the information or if it is necessary to supplement the State information, EPA may conduct a special survey or perform information collection site visits after notifying the State. EPA will share with the State any national reports developed by EPA as a result of such information collection.

E. Emergency Situations Upon receipt of any information that the handling, storage, treatment, transportation, or disposal of hazardous waste is endangering human health or the environment, the Party in receipt of this information will immediately notify the other Party to this MOA by telephone of the situation.

1. For the State, during office hours, Department of Environmental Quality ( DEQ) Central Office, 804 698 4000 [ TDD 804 698 4021; FAX 804 698 4500] or 1 800 592 5482, after hours emergencies contact the DEQ regional office or the Department of Emergency Management ( DEM), 1 800 468 8892. DEQ offices and DEM offices are listed in the blue page local listing section of the telephone directory.

2. For the EPA, the twenty four ( 24) hour response number is ( 215) 814 9016. 9 F. Confidentiality The State agrees to give EPA access to all records used in the administration of the program requested by the Regional Administrator which are deemed necessary by EPA to review and evaluate the State Program and enforcement. The Commonwealth does not waive any privileges it may assert in litigation under the Federal Rules of Civil Procedure.

EPA agrees to furnish to the State information in its files that is not submitted under a claim of business confidentiality and which the State needs to implement its program. Subject to the conditions in 40 CFR part 2, EPA will furnish the State information submitted to EPA under a claim of business confidentiality which the State needs to implement its program. All information EPA agrees to transfer to the State will be transferred in accordance with the requirements of 40 CFR part 2.

V. PERMIT ISSUANCE A. EPA Permitting Upon authorization of the State Program, EPA will suspend issuance of Federal permits for hazardous waste treatment, storage, and disposal facilities for which the State is receiving authorization. If EPA promulgates standards for additional regulations mandated by HSWA that are not covered by the State's authorized program, EPA will issue and enforce RCRA permits in the State for these new regulations until the State receives final authorization for equivalent State standards.

As the State receives authorization for additional provisions of HSWA, EPA will suspend issuance of Federal permits in the State for those provisions. If EPA promulgates new standards requiring a permit modification, EPA may, pursuant to 40 CFR § 270.42( b)( 6)( vii), extend the time period for final approval or denial of a modification request until such time that the State receives authorization for the new standards.

EPA will transfer any pending permit applications, completed permits or pertinent file information to the State within thirty ( 30) days of the approval of the State Program or other mutually agreed upon schedule in conformance with the conditions of this MOA.

B. State Permitting The State is responsible for expeditiously drafting, circulating for public review and comment, issuing, modifying, reissuing and terminating RCRA permits for those hazardous waste treatment, storage, and disposal facilities subject to the authorized provisions of the State's program. The State will do so in a manner consistent with RCRA, as amended by HSWA, this MOA, all applicable Federal requirements, the State's Program Description, the Grant Work Plan, and other State requirements. The State commits to meet the 2005 GPRA RCRA permitting goal, which requires that at least 90% of existing hazardous waste management 10 facilities have approved controls in place to prevent dangerous releases to air, soil and groundwater.

The State's permitting process will conform to 9 VAC 20 60 124 and 9 VAC 20 60 270, which are analogous to 40 CFR parts 124 and 270.

The State agrees to issue, modify or reissue all permits contained in the authorized portions of the State's program in accordance with 9 VAC 20 60 270, which is analogous to 40 CFR part 270, and to include as permit conditions all applicable provisions of 9 VAC 20 60 264, which is analogous to 40 CFR part 264. This MOA also applies to permits issued after final authorization, but for which the processing may have begun before final authorization.

In permits issued pursuant to the State's authorized program, the Department will ensure that compliance tasks are described in clear, unambiguous and plain language to the extent practicable. The compliance tasks should be clear, measurable and definable thereby lending themselves to greater enforceability. For example: " Conduct periodic inspections" should be replaced with " Inspect on a daily/ weekly/ biweekly/ monthly basis. A log book documenting inspections will be maintained at the facility for a period of 3 years."

The State agrees that any compliance schedule contained in permits it issues will require compliance with applicable standards as soon as possible.

The State agrees to consider all comments that EPA makes on permit applications and draft permits before issuing the permit or making the modification. The State will satisfy or refute in writing any EPA written comments on a particular permit application, proposed permit modification, or draft permit before issuing the permit or making the modification. In addition, the State agrees not to issue a permit or approve a modification in dispute until the Regional Administrator and the Director have exercised the dispute process in Section V. C. below.

The State agrees that no permit will be issued unless the public notice requirements are met, in accordance with 9 VAC 20 60 124.

The State agrees to submit to EPA no less than forty five ( 45) days prior to public notice those draft permits or proposed permit modifications identified for oversight in the Grant Work Plan.

The State agrees to submit copies of all final permits to EPA within ten ( 10) days of issuance.

C. EPA Review of State Permits In accordance with 40 CFR § 271.19, EPA may comment on any draft permit or proposed permit modification, whether or not EPA commented on the permit application. EPA may review file information at State offices or request a copy of any permit application, draft permit or proposed permit modification, statement of basis or fact sheet, and any supporting documentation that was considered in the development of any draft permit. The State will provide this information to EPA within seven ( 7) days of EPA's request. 11 While EPA may comment on any permit application, draft permit, or proposed permit modification, EPA will focus primarily on those facilities identified by the State or EPA in the Grant Work Plan or types of facilities identified as a priority in EPA national Guidance.

EPA will notify the State of its intent to comment on a State draft permit or proposed permit modification within thirty ( 30) days of receipt. EPA will comment within forty five ( 45) days of receipt or will request an extension to submit those comments as warranted. Where EPA indicates in a comment that issuance, modification, reissuance, termination or denial of the permit would be inconsistent with the approved State Program, EPA will include in the comment:

1. A statement of the reasons for the comment ( including the section of the State law or regulations that support the comment), and 2. The actions that should be taken by the State to address the comments ( including the conditions which the permit would include if it were issued by EPA.)

Generally, EPA and the State will attempt to resolve all EPA comments on an informal basis before a final action is taken by the State. If this is not successful, EPA will submit written comments to the State in accordance with 40 CFR § 271.19, and send a copy of those comments to the permit applicant. The State agrees not to proceed with a final action until it receives EPA's written comments and resolves EPA's comments as described below:

1. The State and EPA will attempt to reach agreement on permit conditions in dispute before the State issues a draft permit or approves proposed permit modifications to an existing permit.

2. Whenever there is a disagreement between their staffs on the terms of any RCRA permit to be issued by the State, the Director and the Regional Administrator, or their designees, agree to confer in a timely manner to resolve such disagreement. Unless otherwise agreed to, the Director and the Regional Administrator, or their designees, will work toward resolving all issues within thirty ( 30) days of their first involvement in the issues.

3. EPA will withdraw its comments in writing if satisfied that the State has met or refuted its concerns in writing and will provide the permit applicant with a copy of such withdrawal.

4. If the Director and the Regional Administrator are unable to resolve any issue for which EPA cannot withdraw its comment, the State will proceed to permit issuance. However, in accordance with 40 CFR § 271.19, EPA may take action under § 3008 of RCRA against a holder of a State issued permit on the ground that the permittee is not complying with a condition that the Regional Administrator, in commenting on that permit application, draft permit, or 12 proposed permit modification, stated was necessary to implement approved State Program requirements, whether or not that condition was included in the final permit.

Under § 3008( a)( 3) of RCRA, EPA may terminate a State issued permit in accordance with the procedures of 40 CFR part 124, or bring an enforcement action in the case of a violation of a State Program requirement. In exercising these authorities, EPA will observe the conditions established in 40 CFR § 271.19( e), and any other applicable authorities.

D. Coordinated Permitting Process The State and EPA agree to coordinate the issuance of permits, including joint permits, in the State for facilities subject to those provisions of HSWA for which the State does not have authorization. In accordance with § 3006( c)( 3) of RCRA, the State may enter into an agreement with the Administrator under which the State may assist in the administration of the requirements and prohibitions which take effect pursuant to HSWA. Details of coordinated permitting activities will be set forth in the Grant Work Plan, and will be reviewed and revised as often as necessary, but no less often than annually to assure their continued appropriateness. Upon authorization of the State for a permit related provision of HSWA, the details of any coordinated permitting activities set out in the Grant Work Plan will be amended to reflect the authorization.

EPA oversight of State corrective action decisions will be performed in accordance with work sharing responsibilities established in the Grant Work Plan, as resources allow. The State agrees to work cooperatively with EPA in achieving EPA's 2005 GPRA goals for corrective action environmental indicators, details of which will be established in the Grant Work Plan. The State will submit to EPA copies of draft corrective action decision documents ( e. g., approvals of reports and work plans, disapproval comment letters, permit modifications, permits and orders, statements of basis for proposed remedy and final remedy decisions) within seven ( 7) days of EPA's request. The State will consider and respond to EPA's comments on final corrective action decisions and will submit copies of all final corrective action decision documents to EPA within seven ( 7) days of issuance.

The State will conduct the RCRA authorized Corrective Action Program in a manner consistent with applicable EPA guidance and in a manner that promotes rapid achievement of cleanups, while protecting human health and the environment. Specifically, the State will, to the extent practicable:

1. adopt flexible, practical, results based approaches that focus on short term control of human exposure and migration of contaminated groundwater, with the longterm goal being final cleanup;

2. provide ready public access to information and meaningful opportunities for public involvement in the cleanup process; and 13 3. foster innovation, creativity, communication and technical expertise, focusing on accelerating cleanups and meeting program goals.

EPA will assist the State with all aspects of the RCRA cleanup program and support its efforts to conduct faster, focused and more flexible RCRA cleanups.

VI. PERMIT ADMINISTRATION A. EPA EPA will administer, pursuant to 40 CFR parts 124 and 270, the RCRA permits or portions of permits it has issued for facilities in the State until they expire or are terminated. EPA will be responsible for enforcing the terms and conditions of the Federal portions of the permits while they remain in force. Prior to authorization of additional authorities, EPA and the State may establish interim agreements that will allow State work sharing activities. When the State either incorporates the terms and conditions of the Federal permits in State RCRA permits, or issues State RCRA permits to those facilities, EPA will terminate those permits pursuant to 40 CFR parts 124 and 270.

B. State The State agrees to review all hazardous waste permits that were issued under State law before the appropriate effective date of authorization in accordance with 40 CFR § 271.13( d) and to modify, or revoke and reissue, those permits as necessary to require compliance with the authorized State Program. The State will notify EPA of any permits not equivalent to Federal permit requirements, including any permits that have been issued but are pending administrative or judicial appeal. Except for these non equivalent permits, once EPA has determined that the State has fulfilled the requirements of 40 CFR § 271.13( d), EPA will terminate the applicable Federal permit, or Federal portion of the permit, pursuant to the procedures in 40 CFR § 124.5( d), notify the State that the permit is terminated, and no longer administer those permits or portions of permits for which the State is authorized.

The State agrees to resolve all State permit appeals in a manner consistent with its authorized RCRA program, and the Virginia Administrative Process Act § § 2.2 4000 through  4033 of the Virginia Code.

C. Corrective Action Transition Pursuant to its authorized program, the State will be responsible for the issuance and enforcement of any new corrective action permits. EPA will continue to administer and enforce corrective action permits it has issued until they expire or they are terminated by EPA because the State has modified or issued a permit that is not less stringent than EPA's corrective action permit. Administration of the corrective action facility universe will be divided between EPA and the State in a manner consistent with the mutually agreed upon Corrective Action Transition Strategy and the Grant Work Plan. The Grant Work Plan will revise the division of the facility universe as 14 necessary and detail the work to be performed on permit issuance and corrective action work sharing activities. The State agrees to work cooperatively with EPA to meet EPA's share of the 2005 GPRA goals for Corrective Action Environmental Indicators, the details of which will be established in the Grant Work Plan.

Since the enactment of HSWA, EPA has managed all RCRA corrective action activities in the State. Immediately after authorization of the State's corrective action program on September 29, 2000, EPA began the transfer of RCRA corrective action permit responsibilities and workload to the State. EPA will continue to work with the State to determine when and how best to accomplish this task to minimize disruption of ongoing corrective action work and to achieve the best possible program outcomes. When making these determinations, EPA and the State will consider the following factors:

1. EPA's continued authority to administer EPA issued corrective action permits after authorization,

2. EPA's investment in and knowledge of ongoing corrective action permit activities at RCRA facilities in the State,

3. the need to attain national corrective action program goals established under the GPRA,

4. available resources,

5. skill and experience in the State's base program and corrective action program, and 6. the existence of EPA corrective action authorities beyond those related to permits ( e. g., RCRA § 3008( h)).

For example, major decision points reached in the administration of an EPA permit ( e. g., remedy selection) might cause EPA to consider transferring lead permit responsibility to the State for the next phase of corrective action.

Both Parties agree to continue to communicate and coordinate their respective corrective action activities at RCRA facilities. Where either Party can offer management, programmatic or technical assistance to assist the other in meeting site specific objectives or mutual program goals, such support will be provided to the extent resources and competing priorities allow. To the degree possible, specific plans and expectations to coordinate respective corrective action activities will be negotiated in RCRA Grant Work Plans.

Site specific corrective action work sharing activities will be defined in the State's Grant Work Plan.

Once high priority RCRA sites are permitted or otherwise addressed and it is determined that 15 GPRA goals will be achieved, facilities with medium and low priorities will be addressed.

EPA's authorization of the State's corrective action program, and provisions of this MOA, relate to corrective action permitting responsibilities under RCRA § § 3004( u) and ( v).

VII. VARIANCES, WAIVERS, AND DELISTING In the event circumstances arise which warrant such action, the State may exercise the variance authorities established in ' 10.1 1400 et seq. of the Code of Virginia and 9 VAC 20 60 1370 through 9 VAC 20 60 1435. The State agrees to provide EPA with a copy of each State decision ( regarding waivers, variances and delisting petitions, etc. as provided in the State Program at the time such requests are granted. The State agrees that it will not exercise its variance authority, including emergency administrative orders, unless the result will be at least as stringent as, and consistent with the Federal program, and consistent with the other State Programs. The State agrees that no variance will be granted unless the applicable public notice requirements are met, including those of 9 VAC 20 60 124 B. 9, and publication in the Virginia Register.

EPA will continue to process delisting petitions; however, EPA agrees to include the State in all pre petition discussions with petitioners, and EPA will notify the State within 7 days of receiving an official petition to delist a waste from a specific facility in the State, pursuant to 40 CFR 260.22. The Director, or his designee, will inform EPA in writing of the State's intent to participate in EPA's review and evaluation of the delisting petition. Delisting petitioners in the State will submit delisting petitions to the Regional Administrator and to the Director. In the event that these petitions are submitted to the State in lieu of EPA, the State will retain a copy and immediately forward the petition to EPA. When a petition is submitted to EPA, EPA will notify the petitioner of the need to submit a copy of the petition to the State. Should EPA require the assistance of the State in the review of the petition, this work sharing activity will be negotiated at the time the annual Grant Work Plan is being negotiated, or subsequently as an additional element to be added to or substituted into the work plan.

EPA will notify the State prior to publishing a proposed delisting determination in the Federal Register, and again notify the State when the final determination is made. A copy of the Federal Register Notice announcing EPA's tentative determination will be provided to the State. EPA will notify the State if any public comments are received on EPA's tentative determination and provide copies if requested. As necessary, and if requested, EPA agrees to coordinate with the State in the development of any response to comments. A copy of EPA's final determination on the petition, as published in the Federal Register, will be provided to the State. If the State concurs with an affirmative EPA decision on a delisting petition, the Director agrees to follow appropriate state procedures to officially incorporate EPA's rulemaking decision into the State's program. When EPA approves a delisting petition after the appropriate public comment period, the State will notify the facility that it must petition the State for a variance from the definition of hazardous waste. The State will review and reach a case decision on the variance requests in accordance with the Virginia Administrative Process Act so that the State can recognize EPA's approved exclusion until such time as the State is able to propose incorporation of the exclusion into its regulations during the next State rulemaking opportunity. The State will inform the 16 Regional Administrator when the final action has been completed in accordance with the Virginia Administrative Process Act.

VIII. COMPLIANCE MONITORING AND ENFORCEMENT Both EPA and the State are committed to maintaining a level playing field and establishing a credible deterrence to noncompliance throughout the regulated community. As a result, EPA and the State will work together to develop and implement a plan to coordinate compliance monitoring and enforcement activities. These activities may include but are not limited to identifying Federal and State priorities, developing and implementing inspection targeting methods, developing targeted inspection lists, exchanging information regarding ongoing Federal and State enforcement actions against significant noncompliers ( SNCs) and Secondary Violators as defined in EPA's Hazardous Waste Civil Enforcement Response Policy dated March 1996, or any revisions thereto, and VADEQ's Enforcement Manual.

Enforcement and compliance monitoring activities/ priorities will be outlined in the Office of Enforcement and Compliance Assurance's MOA guidance. EPA and the State will negotiate enforcement and compliance monitoring activities/ priorities and describe them in the State's grant Grant Work Plan.

A. EPA 1. Compliance Monitoring Nothing in the MOA will restrict EPA's right to inspect any establishment or other place where hazardous wastes are or have been generated, stored, treated, transported from or disposed of, or to bring an enforcement action against any person believed to be in violation of the State or Federal hazardous waste program or to exercise its authority under § § 3008( h), 3013, and/ or 7003 of RCRA. Before conducting any such inspection of a regulated facility, EPA will attempt to give the State at least seven days notice of EPA's intent to inspect in accordance with 40 CFR § 271.8( b)( 3)( i). Based on exigent circumstances, EPA may shorten this period. The State may participate in all inspections EPA conducts. EPA will coordinate oversight and training inspections with the State.

In an effort to improve enforcement coordination and clarify roles and responsibilities between EPA and the State, the lead agency of an inspection will routinely be the lead in any enforcement action to address RCRA violations discovered during the inspection. However, it is recognized that it may be more appropriate in some cases to defer enforcement action to the other agency. Discussion and mutual agreement will be sought in such cases.

2. Enforcement EPA may take enforcement action against any person determined to be in violation of RCRA in accordance with § 3008 of RCRA. EPA may also take enforcement action upon determining that the State has not taken timely or appropriate enforcement in a manner consistent with EPA's 17 Hazardous Waste Civil Enforcement Response Policy dated March 1996, or any revision thereto. EPA reserves its right to take independent enforcement actions in the State. When the State refers an enforcement case to EPA, the Agency will review the information provided and determine the appropriate Federal action, if any. Before issuing a complaint, compliance order or referral to the Department of Justice, EPA will give notice to the State.

After notice to the State, EPA may take action pursuant to RCRA § 3008, including action against the holder of a State issued permit, on the ground that the permittee is not complying with a condition of that permit. In addition, EPA may take action under § 3008 of RCRA against a holder of a State issued permit on the ground that the permittee is not complying with a condition that the Regional Administrator, in commenting on that permit application or draft permit, stated was necessary to implement approved State Program requirements, whether or not that condition was included in the final permit. EPA may take action under RCRA § 3008 in a manner consistent with EPA's Hazardous Waste Civil Enforcement Response Policy dated March 1996 or any revisions thereto, or the EPA Region III Non Compliance Response Policy for RCRA, Oil and EPCRA/ CERCLA Section 103.

Under § 3008( a)( 3) of RCRA, EPA may terminate a State issued permit in accordance with the procedures of 40 CFR part 124 or bring an enforcement action in the case of a violation of a State Program requirement. In exercising these authorities, EPA will observe the conditions established in 40 CFR § 271.19( e) and any other applicable authorities.

EPA may exercise its authorities in accordance with RCRA § § 3008( h), 3013, and 7003. EPA and the State will negotiate the lead agency for oversight. In the Grant Work Plan, facilities will be prioritized and oversight activities established.

B. State 1. Compliance Monitoring The State agrees to carry out a timely and effective program for monitoring compliance of regulated hazardous waste facilities with applicable program requirements ( see 40 CFR § 271.15). As part of this program, the State will conduct compliance inspections to assess compliance with hazardous waste regulations, permit requirements, compliance schedules, and all other program requirements. State specific activities and priorities for compliance monitoring will also be included in the Grant Work Plan.

2. Enforcement The State agrees to take timely and appropriate enforcement action and agrees to make significant noncomplier ( SNC) determinations in a manner consistent with EPA's Hazardous Waste Civil Enforcement Response Policy dated March 1996, or any revisions thereto, and in accordance with VADEQ's Enforcement Manual, against all persons in violation of hazardous waste regulations, permit requirements, compliance schedules, and all other program requirements. 18 The State will maintain procedures for receiving and ensuring proper consideration of information about violations submitted by the public. The State agrees to retain all records for at least three years, unless there is an enforcement action pending. In that case, all records will be retained for three years after the action is resolved.

IX. EFFECTIVE DATE The Parties are executing this MOA because the State has revised its program and amended its regulations to incorporate changes to the Federal regulations through June 30, 2001. The State has initiated this Revision II of its authorization under 40 CFR § 271.21 to seek approval of the amended program. This MOA will be signed by the Director and the Regional Administrator and will become effective at the time the State's authorization takes effect, which will be the date set out in the Federal Register notice of the Regional Administrator's decision to grant authorization to the State.

COMMONWEALTH U. S. ENVIRONMENTAL PROTECTION AGENCY OF VIRGINIA REGION III DEPARTMENT OF ENVIRONMENTAL QUALITY BY: / s/ Robert G. Burnley BY: / s/ Donald S. Welsh TITLE: Director TITLE: Regional Administrator DATE: 5/ 3/ 05 DATE: 4/ 13/ 06


1               MR. WEIR:  My name is Thomas
 2   Weir, and I have been a resident of
 3   Philadelphia since 1970.  I have six children,
 4   three grandchildren, and a wife, whose
 5   profession is education, so I'm testifying as
 6   a private citizen of Philadelphia.
 7               I thank the United States
 8   Environmental Protection Agency for holding a
 9   public hearing in Philadelphia and for
10   proposing more stringent threshold in NAAQS
11   for ozone.
12               It is commonly known that ozone
13   poses a serious and costly health problem both
14   in acute effects of causing chest pain,
15   coughing and aggravating asthma and in a
16   longer term of stressing our health and
17   shortening our lives.
18               The technical work of the Clean
19   Air Scientific Advisory Committee ozone panel
20   members is the best information that we have
21   right now with regards to ozone exposure, and
22   we need to look closely at their
23   recommendations.  It is not right for EPA to
24   propose levels that are not supported by their
25   assessment.  Comments and reasons why the EPA
0334
 1   administrator recommends setting the standard
 2   should be included but not against the
 3   scientific review that has already been
 4   performed by CASAC.
 5               Ground-level ozone is the
 6   pollutant most often responsible for unhealthy
 7   air quality in Philadelphia.  Philadelphia was
 8   rated the second worst city for asthma
 9   sufferers in 2007 by the Asthma and Allergy
10   Foundation of America.  It is my opinion that
11   the current 8-hour standard of 0.080 parts per
12   million is insufficient to protect the public
13   health, especially of children, seniors, and
14   those with cardiovascular or respiratory
15   disease.
16               National standards that are
17   supported by our best scientific knowledge are
18   crucial to fighting this problem.  Since ozone
19   forms from organic vapors and nitrogen oxides
20   that travel across state boundaries,
21   Philadelphia cannot solve this problem on its
22   own.  The national air quality standards set
23   by EPA are vital for reducing air pollution
24   and protecting the health of our citizens.
25               Moreover, under the Clean Air
0335
 1   Act, air quality standards must be set at
 2   levels that protect public health, including
 3   the sensitive populations, with an adequate
 4   margin of safety.  In 2002, the Supreme Court
 5   unanimously ruled that protecting public
 6   health was the sole factor EPA should use in
 7   considering setting primary standards.  Cost
 8   and the methods of control are not to be
 9   considered.  Therefore, I believe EPA should
10   strengthen the ozone standard to 0.060 parts
11   per million, and this recommendation is based
12   on materials and guidance provided by the EPA
13   Clean Air Scientific Advisory Committee.
14               I also support a new form of the
15   secondary standard called W126 to account for
16   the cumulative effects of ozone on vegetation
17   during the months of the year when ozone
18   concentrations are high.  Vegetation, because
19   it's always exposed to the outside air, is a
20   unique indicator of the impact of ozone and
21   other pollutants on our ecosystem and is
22   relevant to our public health.
23               Many years ago, pollutants were
24   addressed separately.  For example, to bring
25   the city into compliance with the sulfur
0336
 1   dioxide standard, it was necessary to regulate
 2   the sulfur content of fuels being burned.
 3   Secondarily, this policy change helped to
 4   improve particulate emissions even though this
 5   was not the primary outcome of concern.
 6               But now we face a new situation.
 7   The formation of ozone, fine particulate, and
 8   toxic materials are closely related, and it is
 9   important to consider how strategies impact
10   all of these.  Increasing congestion in urban
11   areas and growing concerns about climate
12   change underscore the importance of
13   understanding and examining the
14   interrelationships of various pollutants and
15   what strategies will be needed to reduce the
16   impact on our health and lifestyle.
17               Thank you for the opportunity to
18   testify.
19               MR. PAGE:  Thank you very much,
20   Mr. Weir.  That may have been the last word
21   for the evening.  We thank you for coming by.
22               MR. WEIR:  I'm always last word.
23               MR. PAGE:  With six children, I
24   hope you're not the last to the table.  Thank
25   you very much for coming by.
0337
 1                       - - -
 2               (Whereupon, a recess was taken
 3   from 8:56 p.m. to 9:00 p.m.)
 4                       - - -
 5               MR. PAGE:  It's 9:00, and I think
 6   we've gone through all the speakers here for
 7   the evening, and there were no more registered
 8   speakers to show up, so I think we'll adjourn
 9   the hearing.  Thank you.
10                       - - -
11               (Whereupon, the hearing adjourned
12   at 9:00 p.m.)
13                       - - -
14
15
16
17
18
19
20
21
22
23
24
25
0338
 1            CERTIFICATE OF NOTARY PUBLIC
 2
 3     I, M. KATHLEEN MUINO, the officer before
 4   whom the foregoing deposition was taken, do
 5   hereby certify that the witness whose
 6   testimony appears in the foregoing deposition
 7   was duly sworn by me; that the testimony of
 8   said witness was taken by me in stenotype and
 9   thereafter reduced to typewriting under my
10   direction; that said deposition is a true
11   record of the testimony given by said witness;
12   that I am neither counsel for, related to, nor
13   employed by any of the parties to the action
14   in which this deposition was taken; and,
15   further, that I am not a relative or employee
16   of any counsel or attorney employed by the
17   parties hereto, nor financially or otherwise
18   interested in the outcome of this action.
19
20
21                        M. KATHLEEN MUINO
22                    Notary Public in and for the
                      Commonwealth of Pennsylvania
23
24
     My commission expires:
25   March 3, 2009


[Federal Register: August 24, 2009 (Volume 74, Number 162)]
[Notices]
[Page 42678]
[DOCID:fr24au09-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0048 and FDA 2009-E-0047]

Determination of Regulatory Review Period for Purposes of Patent
Extension; LEXISCAN

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for LEXISCAN and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human drug product.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product LEXISCAN
(regadenoson monohydrate). LEXISCAN is indicated for radionuclide
myocardial perfusion imaging in patients unable to undergo adequate
exercise stress. Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for LEXISCAN (U.S.
Patent Nos. 6,403,567 and 6,642,210) from CV Therapeutics, Inc., and
the Patent and Trademark Office requested FDA's assistance in
determining the patents' eligibilities for patent term restoration. In
a letter dated February 26, 2009, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of LEXISCAN represented the first
permitted commercial marketing or use of the product. Thereafter, the
Patent and Trademark Office requested that FDA determine the product's
regulatory review period.
    FDA has determined that the applicable regulatory review period for
LEXISCAN is 2,446 days. Of this time, 2,113 days occurred during the
testing phase of the regulatory review period, while 333 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
August 1, 2001. The applicant claims August 2, 2001, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 1, 2001,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: May 14, 2007.
FDA has verified the applicant's claim that the new drug application
(NDA) 22-161 was submitted on May 14, 2007.
    3. The date the application was approved: April 10, 2008. FDA has
verified the applicant's claim that NDA 22-161 was approved on April
10, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,024 days and
977 days of patent term extension, respectively.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by October 23, 2009. Furthermore, any interested person may petition
FDA for a determination regarding whether the applicant for extension
acted with due diligence during the regulatory review period by
February 22, 2010. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-20307 Filed 8-21-09; 8:45 am]

BILLING CODE 4160-01-S