US Environmental Protection Agency
Office of Pesticide Programs

Office of Pesticide Programs
Microbiology Laboratory
Environmental Science Center, Ft. Meade, MD

Quality Management Plan (QMP) - 2011

July 2011

       Quality Management Plan
      Office of Pesticide Programs
Biological and Economic Analysis Division
   Microbiology Laboratory Branch


NAME: KiranVerma

TITLE: Quality Assurance Officer, Microbiology Laboratory Branch

SIGNATURE:                          DATE:

NAME: Susan Lawrence

TITLE: Branch Chief, Microbiology Laboratory Branch

SIGNATURE:                             DATE:
NAME: DeniseRice

TITLE: OPP Director of Quality Assurance

SIGNATURE:                             DATE:
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      I.     Antimicrobial Testing Program (ATP)                            5
      II.    Plant Incorporated Protectant Program                            5
      III.    Homeland Security Research                                    6
      IV.    CDC Select Agent Research                                    9
      V.    Biofilm                                                     9
      VI    Virology Testing Program                                      9
      I.     General Organizational structure                                 10
      II.    Mission                                                     11
      III.    Policy on Quality Assurance                                    11
      IV.    Responsibilities                                              12
      V.    Resource Allocation                                           15
      I.     Principle Components                                         16
      II.    Process                                                     17
      I.     Policy                                                      21
      II.    Qualifications and Training                                     21
      III.    Proficiency Testing /Uncertainty                                 22
   AND SERVICES                                                     24
      I.     Process for Recording and Maintaining Data                       26
      II.    Quality Assurance Records                                     27
      III.    Archives and Disposition                                       27
G. COMPUTER HARDWARE AND SOFTWARE                              27
H. PLANNING                                                          28
I. IMPLEMENTATION OF WORK PROCESSES                              29
J. ASSESSMENT AND RESPONSE                                         30
K. QUALITY IMPROVEMENT                                            31
L. REFERENCES                                                        31
M. LIST OF APPENDICES                                                 33

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 A. Program Overview
       The Office of Pesticide Program's (OPP), Biological and Economic Analysis Division
(BEAD), Microbiology Laboratory Branch (MLB) provides microbiological laboratory services
to the Program office  and other federal and state partners  necessary to support pesticide
regulatory  and enforcement  programs.   The laboratory's   current  initiatives include  the
evaluation of the efficacy of antimicrobial pesticides, method development for antimicrobials
including new product types and emerging pathogens, evaluation of a new quantitative efficacy
test method for a wide range of microorganisms  (to support harmonization of efficacy data
across OECD member countries), and support to the EPA Office of Emergency Management for
verification  of a rapid viability PCR based method  for detection  of bio-threat agents in
environmental samples.

       A significant component  of the  laboratory's mission is the evaluation of the efficacy of
antimicrobial products with public health claims that are registered by the EPA- products used to
kill or suppress the growth of infectious microorganisms on inanimate  objects and surfaces.
Standard methods, such as those published by AOAC or ASTM, are used by  the laboratory to
monitor the efficacy  of hospital disinfectants and tuberculocides  currently registered by the
Agency.  The laboratory works to improve the current methods by developing data to  support
editorial  and procedural modifications.  Development and adoption  of  new quantitative test
methods used to determine the efficacy of antimicrobials is a key  priority. Bio-threat agents,
such as anthrax, as well as emerging  public health  pathogens  present new challenges in the
regulatory and enforcement arenas.

       Decontamination and remediation of sites contaminated with bio-threat agents has lead to
the laboratory's role  in the development of suitable methods and surrogates  for evaluating
antimicrobial products for Homeland Security purposes.  The laboratory is working closely with
the EPA Office of Research  and Development (ORD) and other federal partners to meet the
Agency's Homeland Security needs.  The laboratory has developed contractual agreements and
interagency  agreements to leverage laboratory resources.   Various studies are underway to
enable the Program to regulate antimicrobial products used for Homeland Security purposes.

       In  FY 2009, the laboratory  established the capacity to  test viruses (Virucidal  Testing
Program).  Equipment, supplies, materials, space and personnel were  allocated  to support this
effort.  The initial test system uses feline calicivirus as a surrogate for human norovirus.  Human
noroviruses are the leading cause of outbreaks for non-bacterial gastroenteritis worldwide and
cannot be grown in  laboratory, thus the need to test  surrogates.  It is anticipated  that the
laboratory will continue to invest in additional cell line/virus combinations as necessary to
evaluate label claims for antimicrobials in the future.

       The laboratory is also working on new pathogens, such as Clostridium difficile,  and has
invested  time  in  the evaluation  of methods for  growing and  treating bacterial  biofilm.
Developing suitable growth and recovery media  to achieve sufficient liters for evaluating new
microorganisms,  evaluating technique  sensitive  steps  and quality control  procedures,  and

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addressing other method specific issues is underway.  The laboratory adds new programs as the
needs of the Office change in order to meet the regulatory mandates.

       The Microbiology Laboratory Branch is located at Environmental Science Center, Fort
Meade, MD.  The Environmental  Science  Center houses Region  3  and Office of Pesticide
Programs laboratories, technical and  support personnel.   The MLB wing includes Biosafety
Level 2 and 3 laboratories necessary to conduct work with pathogenic microorganisms.  The
laboratory is registered under the Centers for Disease Control and Prevention  (CDC) Select
Agent Program.

I.      Antimicrobial Testing Program (ATP)

       This program was initiated in  response to findings presented by  the Government
Accounting Office (GAO) that the EPA lacked assurance that antimicrobial products registered
by the Agency were efficacious. EPA has focused its efforts on evaluating registered products
that  are  most  crucial to  infection control  (sterilants,  tuberculocides,  and  hospital-level
disinfectants).  The manufacturer of any product bearing a public health  claim  is required to
submit efficacy data to the Antimicrobials Division (AD) of OPP to substantiate the product's
effectiveness and AD  evaluates and registers antimicrobials. OPP's Microbiology Laboratory
Branch, in conjunction with three  state laboratories, perform efficacy tests  using the  same
parameters (contact time, dilution of product) as noted on the product label or registration data.
The client, the Antimicrobials Division (AD), defines the testing criteria.  If testing demonstrates
that a product does not provide acceptable levels of control of target microorganisms, EPA's
Office of Regulatory Enforcement may take action against the manufacturer.  The Agency has
completed  testing of  sterilant products,  and  is currently  testing  approximately 800 EPA-
registered hospital-level disinfectants and 150 tuberculocides.  The laboratory  uses standard
methods such  as those published by AOAC International and ASTM International (American
Society for Testing and Materials) and Standard Operating Procedures (SOPs) to determine the
efficacy  of  hard surface  disinfectants against  infectious microorganisms.   The laboratory's
Standard Operating Procedures (SOPs) for testing, quality control, and equipment calibration can
be  accessed at  the  web  site:  The
laboratory's scope of accreditation  under ISO  17025 includes the  standard  methods used to
evaluate disinfectants and tuberculocides under this program.   The laboratory's accreditation
certificate and scope of accreditation issued by A2LA once available  will be posted on the
laboratory website.  It is not anticipated that additional advertising with respect to the ISO 17025
accreditation status of the laboratory will be required. If management determines that additional
advertising is necessary, the laboratory will follow the current A2LA Advertising Policy with
respect to the activities under the scope of accreditation and use of the A2LA symbol (P101 -
Reference to A2LA Accredited Status, A2LA Advertising Policy).
II.     Plant Incorporated Protectant (PIP) Method Validation Program

       EPA regulates Plant Incorporated Protectants (PIP) materials that enable a plant to protect

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itself from  pests  such as insects, viruses and  fungi  by producing  its own pesticide. The
Biopesticides and Pollution Prevention Division (BPPD) is responsible for regulating PIPs.  A
PIP plant in the field, however, cannot be distinguished visually from a conventional plant.  So,
current PIP registration guidelines require registrants to submit a method for the detection of the
unique PIP DNA sequence, as well as a method to detect the protein expressed by that unique
DNA sequence.  OPP's Microbiology Laboratory validates  detection methods submitted with
registration applications.  The registrant's methods and an Independent Laboratory Validation
(ILV) are provided to the laboratory by the client and serve as the basis for the method validation
study.    This  program is  not  currently active  but  the  equipment  and Standard  Operating
Procedures are available if method validation is required in the future.

III.    Homeland Security Research

       OPP has the responsibility for regulating antimicrobial products,  including sporicides,
used to treat and decontaminate inanimate surfaces. BEAD'S Microbiology  Laboratory Branch
(MLB) is responsible  for conducting testing of antimicrobial products to ensure products are
effective.  The  Laboratory's resources   and  expertise are also  well suited to meet  ongoing
Homeland Security needs for improved  and  standardized efficacy test methods to ensure that
decontamination products are effective in inactivating bioterrorism agents.

       Homeland  Security Presidential  Directive  10  directs EPA to take the federal  lead for
"developing specific standards,  protocols, and capabilities to address the risks of contamination
following a biological weapons  attack  and  developing  strategies, guidelines, and plans for
decontamination of persons, equipment,  and facilities."  EPA's Office of Chemical Safety and
Pollution Prevention (OCSPP) is addressing this directive to significantly improve the nation's
ability to treat contaminated sites  and  to  allow for  safe re-occupancy.   Developing proven
standard  methods for evaluating and testing the effectiveness of antimicrobial decontamination
products, such as those used to decontaminate facilities contaminated in 2001 with spores of
Bacillus  anthracis (anthrax) is critical for protecting public health.  In response to this directive,
the OPP  MLB is spearheading an effort to update and  improve the quality  of existing regulatory
test methods and  to validate new quantitative procedures  to determine the  performance  of
antimicrobial pesticides.  Test methods for testing non-spore forming bio-threat agents such as
Francisella, Yersinia and Brucella are also covered under this project.

       In July 2007, an EPA  Scientific Advisory Panel (SAP) was convened  on the guidance on
test methods for demonstrating efficacy  of antimicrobial  products (sporicidal decontaminants)
for inactivating B. anthracis spores. As an outcome of the meeting, the SAP provided a number
of suggestions on the selection of surrogates and coupon materials.

       A key priority related to the Agency's  Homeland Security efforts has been the evaluation
and development of quantitative methodology to replace or augment qualitative methods such as
the AOAC Use-dilution method and AOAC method 966.04, Sporicidal Activity of Disinfectants.
Data  generated  from  AOAC  Method   966.04 are  more  relevant to clinical  settings than
decontamination scenarios involving buildings and environmental surfaces. As a component of a

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short-term  strategy to address federal regulatory needs,  several technical limitations associated
with AOAC  Method 966.04 are being addressed by MLB through the method modification
process.   Compared  to  the  presence/absence  outcome associated with  qualitative methods,
quantitative  methods  such  as  AOAC  Method  2008.05  (Three-Step  Method)  provide a
conventional, quantitative measure of efficacy - log reduction.  In 2008, MLB's research led to
an official validation of the Three Step Method (TSM) for liquids on hard nonporous surfaces by
AOAC. In 2009, the TSM was officially modified to include porous coupons.

       MLB  will use specific SAP recommendations to establish research priorities  for the B.
anthracis work.  Surrogate  microbes for  both spore formers  and vegetative bacteria  are a
fundamental aspect of testing the performance of antimicrobial products, and the use of safe-to-
handle surrogates for efficacy testing of bio-threat agents is supported by the EPA.  The selection
and testing of coupon materials,  porous and non-porous, relevant to environmental surfaces are
important initiatives associated  with this research program.  Ultimately,  the data and  study
conclusions will be  used to  develop/supplement regulatory guidelines  for antimicrobials  and
decontamination products to be used in the treatment of buildings and environmental surfaces.

       Homeland Security projects consist of procedural modifications to methods, validation of
new methods, and comparative testing of methods.  An  annual work plan will be developed as
projects are completed and others are initiated. Timelines and deliverables associated with MLB
work plan, Interagency Agreement (IA) and contracts will form the basis for research priorities
and  project  management.  Single  and  multi-laboratory validation  trials are   necessary to
demonstrate  repeatability,  reproducibility,  technical  soundness, and to verify  that the  data
supports the applicability of the  method.  Collaborators, namely those under contract and lAs,
assist EPA with this  effort. Volunteer laboratories may  also participate in this project. Agency
priorities and guidance from the Antimicrobials Division of OPP will be considered as the
program is implemented and new projects are developed.

       Through funding  provided by OCSPP, a multi-tiered research plan  has been developed
and  initiated.   An Interagency Agreement  (IA) has  been established with (the  U.S.  Army's
Edgewood Chemical Biological  Center (ECBC) to assist EPA in this effort.  In part, the work
associated with this IA will build on accomplishments achieved under the previous IA,  especially
the laboratory  testing of virulent biological warfare agents  (BWAs).  The  scope  of this IA
includes the preparation  of manuscripts for  publication, evaluation of quantitative efficacy test
methods for antimicrobial chemicals and to  provide the  data and study conclusions to the EPA
necessary  to  establish  regulatory  decisions for  products  to be  used in  the  treatment of
environmental  surfaces contaminated with virulent B. anthracis and vegetative BWAs  such as
Francisella, Yersinia and Brucella.  ECBC will carry out a series of studies designed  to expand
the scope of current test  methodologies such as the Three Step Method, to improve the quality
and  consistency of the efficacy  data, and to evaluate disinfectants against vegetative  BWAs.
Projects may  consist of procedural  modifications to methods,  pre-validation studies on new
methods, and side-by-side comparative testing. Single and multi-lab oratory validation trials may
be necessary to demonstrate repeatability, reproducibility, technical soundness, and to verify that
the data supports the applicability of the method.

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       AOAC  INTERNATIONAL (AOAC) has  been  contracted to assist  EPA with  the
procedural, technical, analytical,  and statistical  peer  review for  acceptance  of study  design
protocols  and  associated data,  and the publication  of validated  methods  for  determining
disinfectant efficacy, particularly  for bioterrorism agents.   AOAC will provide the necessary
expertise, through committees and appropriate advisory panels, to review and approve validation
and collaborative study protocols.  AOAC will publish methods and related information. MLB
has published two papers on the  development and validation of quantitative test  methods for
sporicidal  decontaminants, including research on  surrogates and coupon materials:  1) Tomasino
et al., JAOAC, Vol. 91,  No.4, 2008 (Determining the Efficacy  of Liquid Sporicides against
Spores of Bacillus  subtilis on a Hard Nonporous  Surface Using  the  Quantitative Three Step
Method), and 2) Tomasino et al., JAOAC, Vol.  93, No. 1, 2010 (Use of Alternative Carrier
Materials in AOAC Official Method 2008.05). Additional projects will build upon these efforts.
MLB is interested in the evaluation of additional standardized porous materials (e.g., HTR,  a
polymer based substance) and their utility in the quantitative Three Step Method.

       In  addition, the  EPA  Office  of Emergency  Management (OEM)  approached  the
laboratory in  the summer of 2010, to provide laboratory services to  evaluate a Rapid Viability
Polymerase Chain  Reaction  (RV-PCR) method initially developed by Lawrence Livermore
Laboratory (LLNL) for  EPA as a research method  for detection  of Bacillus anthracis in
environmental samples. OEM provided equipment, supplies, and materials for the method. Two
scientists from MLB spent two weeks on site at LLNL training on the method.  The Phase I of
the Bio-Response  Operational Testing and  Evaluation (BOTE),  an interagency project, was
conducted during April-May 2011 to evaluate field-level facility biological remediation studies
of various  decontamination technologies. The tests were performed using intentional release
(aerosolization) of  spores of Bacillus  atrophaeus subspecies globigii (BG), a surrogate for
Bacillus anthracis,  the microbial  agent  for anthrax. Three  decontamination methods, namely,
fumigation with vaporized hydrogen peroxide (VHP), fumigation with chlorine dioxide (C1O2),
and a treatment process including the use of pH-adjusted bleach, were assessed with in-between
re-setting and re-staging of the facility.  Sixty-two wipe samples including the field and positive
and negative  controls were processed for evaluation under BOTE exercise.  The method uses
processing steps to  1) recovery of spores from wipes 2) collection of spores by filtration, and 3)
incubation  of spores for viability and multiplication is  followed by subsequent DNA extraction
and real-time PCR analysis. The RV-PCR method uses PCR analysis, pre- and post-incubation,
and exploits the change in the PCR cycle threshold (Ct) value as an indicator for the presence of
viable spores  or cells. The approach referred  to as "rapid viability" (RV).  For all field samples,
field blank samples, and  laboratory positive and negative control  samples for all  three events
(pre- and post-decon), both culture and RV-PCR  data were recorded.  Evaluation of the method
led to suggested modifications to the method with particular attention to the DNA extraction
technique  (e.g., incorporation of heat-mediated  lysis  for DNA extraction) and evaluation of
interferences  in TO samples (e.g., dilution  of TO samples).   A second exercise (Phase II) is
anticipated with updated RV-PCR protocol in September 2011.

IV.    Center for Disease Control and Prevention (CDC) Select Agent Laboratory

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       The OPP Microbiology Laboratory has registered and been granted a certificate under the
CDC Select Agent Rule (Public Health Security and Bioterrorism Preparedness and Response
Act of 2002).  The laboratory wing includes Biosafety Level 3 laboratories which enable the
laboratory to  provide  critical laboratory capacity  in  the  event of a bio-threat event.   The
laboratory is part of the Environmental Laboratory Response  Network  (ELRN) which is  a
nationwide laboratory network which is available to provide capabilities and capacity during an
environmental event. The ELRN is coordinated by the EPA. The registration certificate extends
to June 2014; CDC may audit the laboratory at any time to determine continued compliance with
requirements of the  Select Agent Rule  (42 CFR Part  73).  Nine individuals have approved
Security  Risk Assessment from the Federal  Bureau of Investigation to work with the  select

V.     Biofilm

       MLB has initiated a Biofilm Research Program to develop and evaluate efficacy test
methods  for growing and treating bacteria in biofilms,  and to provide the data, analyses, and
study conclusions necessary to support/establish regulatory guidelines for products with claims
to treat environmental surfaces colonized by biofilm. When necessary, research priorities will be
formed jointly in conjunction with the Antimicrobials Division. The laboratory  submitted a one-
step biofilm efficacy test method to ASTM in April 2011 for consideration as a standard method.
The  development of performance standards  (log  reduction  of  biofilm) and  acceptable label
claims will be determined as the research proceeds.

VI.    Virucidal testing Program

       A primary focus of MLB is the efficacy evaluation of antimicrobial products (used to kill
or suppress  the  growth of infectious microorganisms on inanimate objects and surfaces) with
public health claims that are registered by the EPA.  Applied research on the evaluation and
development of methods used to determine the efficacy of antimicrobials is a key priority. The
laboratory has traditionally focused on bacteria. Given issues with viral gastrointestinal illness,
avian influenza, and  preparedness issues associated with pandemic  influenza, the laboratory has
expanded its services to test viruses and their appropriate surrogates as the microbial agents for
virucidal claims.  The Virucidal Testing Program (VTP) will focus on the testing of disinfectants
against viruses. The  program is currently on hold due to other pressing priorities.

Additional Functions

       1.     Operate  a  pre-regi strati on testing  program to   verify  selective  antimicrobial
              efficacy claims and assure the quality and integrity of registrant-submitted data.

       2.     Serve as a source of technical information regarding test methodology to referee
              disputes, and confirm test sample results from state government laboratories.

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       3.     Provide technical and training support to state laboratories.
       4.      Carry out  development  of new  antimicrobial test  methods,  including  the
              evaluation of potential screening or rapid methods.

       5.      Participate in  collaborative ("round robin") efficacy testing of new test methods
              for evaluating antimicrobial products.

       6.      Participate in data audits and GLP  inspections of commercial/industrial labs
              which conduct efficacy testing of disinfectants and antimicrobial devices.

       7.      Serve as expert witness in Agency conducted hearings.

       The  client base includes the Antimicrobials Division (AD),  the  Biopesticides and
Pollution Prevention Division (BPPD), the EPA Office of Emergency Management (OEM), and
the EPA Office  of Research and Development (ORD) as  well as other government and state
Agencies.  Core program work  is conducted in consultation with the  client.  Review and
signature of the study protocols is at the client level.


I.      General Organizational Structure

       The general organization structure of the Office of Pesticide Programs and Biological and
Economic Analysis Division is included in Appendices A-l and A-2.   MLB is one of three
laboratories  providing  laboratory, technical, and scientific support to the Office  of Pesticide
Programs.  The laboratory's general organizational structure is outlined in the appendix. The
Branch Chief of the Microbiology  Laboratory Branch is  considered top management for the
purposes of implementation of the principles of the QMP.   The Branch Chief has overall
responsibility  for  management  of the  work, personnel,  resources, and administrative and
programmatic functions for the Branch.  The  Branch Chief reports  to the Director  of the
Biological and Economic Analysis Division (BEAD).

       The laboratory Senior Science Advisor and the Team Leader report directly to the Branch
Chief on technical, work planning,  and  administrative issues.  The Senior Science Advisor or
Team Leader may act for the Branch Chief during absences from the office. Depending on the
program (Antimicrobial Testing, Homeland Security, R & D) the staff report to the Team Leader
(TL) or senior science advisor (SSA) on technical issues.   The TL or  SSA will report  to the
Branch Chief on progress of the laboratory studies toward  meeting the goals established  in the
annual workplan. The SSA  directs and administers laboratory programs related to extramurally
funded Homeland Security initiatives, core program antimicrobial testing, research on the OECD
and other quantitative test methods, and oversight on contract deliverables.  The TL provides
oversight for , BOTE project, general laboratory quality control procedures, and selected R & D
projects (C. difficile in particular).

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       The Laboratory's Quality Assurance Unit (QAU) has primary quality assurance oversight
and  operates  independent  of  the  analysts  and  management  team.    See  section  on
"responsibilities" for more detail on the responsibilities of the QAU.  The QAU reports directly
to the laboratory Branch Chief.

II.     Mission

       The mission of the program office is the regulation and oversight of pesticide products.
The  overarching theme of work underway at the laboratory is to provide microbiological
laboratory support to  the  Office  of Pesticide Programs.   The focus of the programs  at the
laboratory change as OPP's needs change. In recent years, the focus has been on the efficacy
evaluation of antimicrobials, efficacy method development and modifications,  research related
to the ATP methods, PCR  based method for anthrax detection, and development of methods for
novel product types (towelettes)  and emerging pathogens (for example,  Clostridium difficile).
Mission program  support  for the efficacy and formulation  evaluations of tuberculocides and
hospital disinfectants is also provided by three state laboratories. The laboratory uses extramural
agreements (contract, lAGs, grants) to facilitate the development of data  necessary  to meet the
Program goals.

III.    Policy on Quality Assurance

       The goal of the Agency-wide Quality System is to ensure that environmental programs
and decisions  are  supported by  data  of the type and quality needed and expected for their
intended use. On February 23, 2004, the Agency's Science Policy Council issued a new Agency
Policy Directive, Assuring the Competency of Environmental Protection  Agency Laboratories.
To assure the quality of data generated by our  laboratories, all the laboratories operated by EPA
need  to  maintain  a  documented  Quality  System that  at  a minimum complies  with the
requirements of the EPA  Quality  System as defined by EPA CIO 2105.0  May  2000, EPA
Quality Manual for Environmental Programs.  Where appropriate accreditation programs are
available for one or more components of a given laboratory's operations, the laboratory will seek
accreditation for those components.  Consistent with this policy,  MLB is GLP compliant and
ISO 17025  compliant  for  selected methods as defined in the laboratory's  scope of accreditation
for testing  under the  Antimicrobial Testing Program.   The  laboratory  accreditation body  is

       The  objectives of the  Good  Laboratory  Practices  (GLP)  program,  ISO   17025
accreditation, the overarching quality assurance (QA) program, and quality control (QC) checks
are to ensure the validity and accuracy of the data.  The laboratory follows the prescribed
laboratory practices identified in the Good Laboratory Practice Standards (40 CFR Part 160) and
has been audited and  found to be GLP compliant.   The management fully supports a  robust
Quality Assurance Program and  has allocated resources to  support a Quality Assurance Unit
required to ensure  a strong and active program.  In addition, the management is committed to
meeting the requirements  of  the ISO 17025  standards  for methods within  the scope  of the

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accreditation. The laboratory continually  strives  to  improve the effectiveness of the quality
systems and seeks feedback from the laboratory clients on a regular basis.
       The  QMP  provides the overall  framework for  the laboratory's  Quality  Assurance
Program.  Quality Assurance Project Plans support the key program  areas; the  Antimicrobial
Testing Program,  the Plant Incorporated Protectant  method validation  program,  and  the
Homeland Security initiatives.  Standard Operating Procedures (SOPs) form the basis for work at
the laboratory and are numbered by program element (microbiological methods, quality control,
equipment, quality assurance,  chain  of custody and administrative).   Study protocols  which
provide the detail for each independent study are developed and reviewed and approved by  the
client organizations.  A schedule is followed for review and revision of the  SOPs. As required
by GLPs, an audit schedule is developed each year which includes internal technical system
audits, books and records audits, and  audits of individual studies.  The laboratory is also subject
to external technical and management systems audits which serve to  identify any deficiencies in
the overarching quality assurance program.   External audits  are  also  conducted to ensure
compliance with Good Laboratory Practices and ISO  17025 requirements.  Deficiencies  are
addressed as necessary though a corrective action process.

       The Branch Chief and QAU are committed to meeting the necessary quality assurance
requirements and compliance or accreditation standards for the organization. The laboratory is
compliant with the Good Laboratory Practice Standards  (GLPs) and has  been audited on a
regular basis against this  standard.   Once  accreditation  under ISO  17025  is  achieved,  the
laboratory will comply with the International Standard for the methods under the scope of
accreditation and will continually work to improve the effectiveness of the management system.
The coordination for ISO  17025 accreditation for the OPP laboratories is managed out  of  the
BEAD Immediate Office (IO) and  support is provided via a workgroup consisting of laboratory
management  and the Quality Assurance Units from  each  of the laboratories.  The  senior
management  is fully committed to adhering  to the ISO 17025 requirements  and  working to
continually improve the laboratory's quality system.

IV.    Responsibilities

       The Laboratory Competency  Policy Directive mandates that the laboratory  operate in
conformance with the  Agency's Quality Policy and seek accreditation where applicable. The
laboratory accomplishes this by adherence to the Good Laboratory  Practice Standards and  by
following the ISO 17025  standard for testing and calibration laboratories.   The   laboratory
utilizes a prescribed quality  assurance program with  thorough  documentation  of  all quality
control activities.  Senior management is responsible for allocating resources and  support to  the
Quality Assurance Officer (QAO) as necessary to implement the recommended quality assurance
activities of  the laboratory.   The Branch Chief is responsible  for  ensuring that corrective
actions/preventive actions are taken to address deficiencies noted during audits of laboratory data
and to prevent such deficiencies.

       All  staff involved in conducting laboratory assessments is responsible for ensuring that
required quality control measures are  carried out as prescribed in the  SOPs.  Laboratory staff  are

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responsible for the intra-laboratory review of data generated under the program.
       The laboratory has an assigned Quality Assurance Officer (QAO) and an alternate QAO.
The two person team is designated as the Quality Assurance Unit (QAU). The QAO has primary
responsibility for Quality Assurance activities;  the alternate provides support when the QAO is
not available or as the laboratory workload warrants.  The QAU operates independently of the
laboratory management team and is free to conduct audits, review books and records, evaluate
analyst capabilities, develop and implement proficiency programs, and evaluate training needs as
they relate to Quality Assurance.  The QAU works closely with the laboratory management team
(Branch Chief, Team Leader, and Senior Science Advisor) to address issues and concerns about
the day to day operations and activities of the  laboratory.  The QAU reports to the Laboratory
Branch Chief on areas of responsibility.  The  QAU coordinates the process of documenting,
investigating, and follow-up on non-conformances and corrective action plans for studies using
methods listed under the laboratory's scope of accreditation under ISO 17025. In addition, the
Quality Assurance Officers can approach the Director of the Biological and Economic Analysis
Division or the OPP Director of Quality Assurance to address concerns, discuss outcomes, and
provide support for improvements to the Quality Systems.  If QA related  issues cannot be
resolved between the QAU and Branch Chief, the  QAU can report directly to the Division
Director or Associate Director.

       The appointed QAU for the laboratory is responsible for determining whether all SOPs,
QA/QC, and GLP and ISO-17025 requirements are met.  The QAU reviews the quality of data
and  study  reports,  conducts on-site planned  audits,  and  makes  unscheduled  visits for
observations to assess whether the testing and general laboratory operations are  carried out in
accordance with approved SOPs.  The QAU maintains the master schedule of testing activities
and works in cooperation with the Team Leader/senior science  advisor to prepare an annual audit
schedule.  The  QAU maintains files of master copies of all SOPs, master schedules  of testing
activities, audit schedules, records of audits and responses, non-conformance reports, and records
related to corrective and preventive actions.

       In conjunction with the Branch Chief and Associate Director, the QAU operates to ensure
that the laboratory meets  the specifications, goals, and objectives of the Quality Management
Plan (QMP). The QAU reports directly to the MLB Branch Chief on administrative or technical

       The  Senior  Science Advisor (SSA) and the  Team Leader (TL) report  directly to the
Branch Chief. Managerial authority is delegated first to the Senior Scientist, then Team  Leader,
or senior ranking microbiologist as necessary during Branch Chiefs absence. The Team Leader
is  responsible for the coordination of core testing  activities and support of analysts in the
Laboratory.  In addition, technical oversight of the laboratory programs is provided by the Senior
Science Advisor.  The SSA provides technical  and scientific advice to the laboratory in all
program areas and  has responsibility for  leading scientific initiatives to enhance, augment, or
develop laboratory's capabilities  to support  ongoing  regulatory  and  Homeland Security
initiatives.   The SSA  provides expert advice, counsel,  and  leadership on laboratory  studies,

                                                                              July 2011
                                                                           Page 14 of 38
contractual, and research needs.
       The QAU also has access and a line of communication to the OPP Director of Quality
Assurance (DQA). The DQA provides guidance to the QAU on quality assurance practices and
procedures, audit schedules, training, and other activities.  The  OPP DQA provides support for
internal and external audits, review of Quality Management Plans, and gives advice on quality
assurance related issues.  The OPP DQA  is responsible for final approval of the Quality
Management Plan, and conducts annual Management  System Reviews (MSRs) to ensure that
QA activities are carried out according to the QA Management Plan and deficiencies identified
during management system reviews are adequately addressed by the laboratory.

       Quality  Assurance Project  Plans  (QAPPs) for new program areas  are  developed as
needed and are approved by the QAO or alternate.  The type of plan will be dependent upon the
work to be performed.  Refer to the Appendix for the list of the QAPPs currently in place.  Each
year, the QAO  is also responsible for preparing the laboratory's contribution  to OPP's Quality
Assurance Annual Report and Work Plan (QAARWP).

       For Homeland  Security projects,  the Senior Science Advisor  serves as the Principal
Investigator (PI)  and has  the overall responsibility  for the technical conduct of the projects.
Quality assurance issues are addressed in the laboratory through consultation of the QAO with
the Team Leader, Senior Science Advisor and Branch Chief.  Issues not amenable to resolution
at this  level are resolved between the Associate Director and Branch Chief. If resolution cannot
be achieved, the matter is raised to the Division Director.  On issues of a complex nature, the
management team may  consult with the OPP DQA.

       The Laboratory generates enforcement sensitive data.   Access to this data is limited to
internal EPA  personnel  within the  Antimicrobials Division  and the Office  of Regulatory
Enforcement.   Development of testing  protocols for these  studies  may require access to
Confidential Business Information (CBI) submitted by the antimicrobial product registrant under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Access to FIFRA CBI is
given only to Federal, contract and NOWCC employees who need the information in the conduct
of official  Government Business  and only after  certain requirements have  been  met.   The
requirements include a FIFRA security briefing, review of the FIFRA security manual, approval
from the division director, and completion of the FIFRA Access Authorization  Agreement.
Training and renewal of access authorization is required on an annual basis.

       All EPA  employees are required to be  familiar with  the  government-wide  ethics
regulations and the EPA supplemental ethics regulations which include rules for EPA employees
regarding prohibited financial interests  and outside employment.  The  Standards of Ethical
Conduct for Employees of the Executive Branch are defined in 5 Code of Federal Regulations
(CFR) Part 2635. In addition, the EPA has defined the general principles of public service and
each employee is required to take annual ethics training.

V.     Resource Allocation

                                                                               July 2011
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       Resources for the implementation of quality  assurance practices in the laboratory are
allocated on  an annual basis.  The  laboratory has assigned a QAO and an  alternate QAO,
collectively known at the Quality Assurance Unit  (QAU).  The  QAU attends  Agency quality
assurance training as well as other training provided by private entities. Other staff and analysts
are also trained as the need arises and adequate resources are available.  Traveling and training
funds are set aside for this purpose on an annual basis.  Capital investments are made to improve
the quality assurance aspects of the laboratory program.  If extramural  resources are required,
suppliers and contractors must meet the appropriate quality control and assurance requirements
as  identified  in the Agency's quality assurance guidelines.   Equipment  calibration and
certification by ISO 17025 accredited vendors is an integral part of the QA program.

       In consultation with the staff and upon general direction from the client organizations, the
laboratory develops  an annual  workplan which  identifies the project, estimated quarter(s) in
which the work will be performed, the outputs/deliverables,  estimated completion date, the
assigned analyst, and the estimated resource  allocation to a  10*  of an Full Time Equivalent
(FTE).  An FTE is defined  as approximately 2080 hours of work per year.  The workplan is
shared with the client organizations.  The Division Director  is responsible for  negotiating any
changes to the workplan with the client organizations.  Changes to the workplan may be made
throughout the year if necessary to support program initiatives.  Laboratory initiatives fall under
the Agency's Goal 4; Healthy Communities and Ecosystems.

       Work is assigned to  individuals or small  teams.  Status meetings are held  on a regular
basis in order for the analyst/teams to provide updates to the Branch Chief and senior staff on the
progress toward meeting the goals in the workplan, to address technical or resource issues, to
review the data and findings, and to plot next  steps. The QAU is involved in the technical and
workplan discussions.   The importance of meeting customers' needs is stressed.  The client
organizations are involved  in the work planning process and concur on study protocols and
process related SOPs.  The  annual workplan is revisited throughout the year with the staff, as
well as senior management (Division  Director  and  associate)  and the  client organizations.
Adjustments  are made  as necessary based on feedback from the various organizations and
management levels.

       Performance  objectives  and the importance of the assigned work are  shared with the
analysts throughout the year. Performance  goals for each individual are established in  annual
performance plans through the Agency's performance  system (PARs).  The goals are established
by management and  the individual and are reviewed periodically throughout the year.  A  mid-
year and end of the year performance review with  each employee is required.


I.      Principal Components

       The Agency's  policy and program  requirements to implement the  mandatory QA

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programs are contained in EPA CIO 2105.0. As stated in EPA CIO 2105.0, "the primary goal of
the QA program is to ensure that all environmentally related  measurements supported by the
EPA produce data of known and acceptable quality."  The quality of data is known when "all
components associated with its derivation are thoroughly documented, such documentation being
verifiable and defensible."  As of October 16, 1989, the Agency requires that efficacy studies
performed by registered laboratories in support of submissions under FIFRA be conducted in
compliance with Good Laboratory Practice (GLP) regulations.

       The laboratory is charged with verification of efficacy  claims of hospital disinfectants,
including products which  also make tuberculocidal  claims.  As enforcement  actions may be
taken based on the efficacy data generated by the laboratory, it is committed to producing data of
known, acceptable, traceable,  and defensible quality.   In addition, data generated in other
program areas is used to make recommendations  which affect the regulation of pesticides,
particularly antimicrobials and plant incorporated protectants (PIPs).  The laboratory operates in
conformance with GLPs and with a quality system in place with thorough documentation of all
quality control measures to support the testing program.   The  laboratory also follows the ISO
17025 standard for methods defined under the laboratory's scope of accreditation.

       The principal components of the laboratory's quality system are the Quality Assurance
Management Plan, the Agency's Good Laboratory Practice Standards, ISO 17025 (for selected
efficacy test methods), Standard Operating Procedures, Quality Assurance Projects Plans,  and
Study Protocols.  Essential quality control measures are integrated into the SOPs which form the
basis of laboratory operations.  The SOPs are reviewed at least once every three years, and are
revised as necessary. This promotes continual improvement of the SOPs and assessment  of the
adequacy of quality control requirements.

The basic structure of the document system is as follows:

    •   Quality Management Plan (QMP) - establishes  the overarching principles of the quality
       system in the laboratory. All Agency organizational units governed by EPA CIO 2105.0,
       CHG 2 shall document their quality system in a Quality Management Plan (QMP). The
       QMP is a policy statement describing how an EPA organization shall comply with the
       requirements of EPA CIO 2105.0 CHG 2. Quality systems encompass the management
       and technical activities necessary to plan, implement, and assess  the effectiveness of QA
       and QC operations applied to environmental programs.

    •   Quality Assurance Project Plan.  EPA policy requires that all work performed by or on
       behalf of EPA involving the collection of environmental data shall be  implemented in
       accordance with an Agency-approved Quality Assurance Project Plan (QAPP). The
       QAPP defines  and documents how specific data  collection activities shall be planned,
       implemented, and assessed during a particular project. Guidance on developing QAPPs,
       including examples of QAPP elements, may be found in Guidance on Quality Assurance
       Project Plans (QA/G-5) (EPA 1998). The QAPP is a critical planning document for any
       environmental data operation since it documents how environmental data operations are

                                                                               July 2011
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       planned, implemented, documented, and assessed during the life cycle of a program,
       project,  or task. The planning includes  the  "stakeholders"  (i.e., the data users, data
       producers, decision makers, etc.) to ensure that all needs are defined adequately at the
       outset and that the planning for quality  addresses the specific needs defined.  The
       laboratory has five Quality Assurance Project Plans currently in place; 1) QAPP for the
       Antimicrobial Testing Program; 2) QAPP for the Plant Incorporated Protectant Method
       Validation Program; 3) QAPP for Homeland  Security research initiatives, 4) QAPP for
       Biofilm and 5) QAPP for Virology Testing Program. Quality Assurance Project Plans are
       required for all extramural projects as part of the contract and TAG planning process.

   •   Standard Operating Procedures (SOPs).  A Standard Operating Procedure is a document
       which provides  step-by-step  description of  how a  specific operation,  method,  or
       procedure  is performed. The laboratory has  SOPs for administrative, chain of custody,
       quality control, equipment calibration and maintenance, microbiology, special  programs
       (PIP, Biofilm and Virology) and quality assurance procedures.  An index of the SOPs is
       an attachment to the QMP.

   •   Study Protocols - The laboratory develops study protocols for all antimicrobial testing
       program (ATP)  studies,  research  studies and other unique laboratory studies.  The
       protocols provide the detail necessary to recreate the study.

       Collectively, these documents provide  the structure and framework for documenting the
laboratory practices  and procedures.   Other  documents necessary  to support the  laboratory
programs including laboratory audits, books and records inspections, logbooks, notebooks, and
data recording sheets complement the documents noted above.

II.     Process

   •   Development of Documentation

       Documents are developed to provide  guidance, instruction,  operating procedures, and
   structure to the laboratory program.   Overarching principles of the laboratory's Quality
   System are identified in  the  Quality Management Plan  (QMP).   Standard  Operating
   Procedures (SOPs) establish the framework for operational principles and detailed guidance
   for test methods, equipment calibration and maintenance, preparation of media and reagents,
   data recording, records  maintenance,  and preparation of reports.   For each overarching
   laboratory program, a Quality Assurance Project Plan (QAPP) is developed.  The laboratory
   has QAPPs for the Antimicrobial Testing Program, the Plant Incorporated Protectant method
   validation program, the virology program,  and Homeland  Security research initiatives.
   Under each  QAPP, study protocols are developed which provide the detail and outline for
   conducting  a   particular laboratory  study.    Collectively, these  documents  provide  the
   framework for the laboratory programs. All documents are developed collaboratively with
   the client organizations and staff.  All documents are reviewed by the QAU prior to final
   signoff and  approval by the Branch Chief.  Client organizations provide feedback on study

                                                                            July 2011
                                                                        Page 18 of 38

design and protocols.  Substantive changes to study protocols are reviewed with the client
and approval documentation is included in the study folder, notebook, or binder.   The client
serves as the study sponsor for the purposes of the study protocol.

   Once the study design and protocol or approach is approved, the study is conducted and
the data is tabulated using standard  forms or in a laboratory notebook.   SOPs  provide
guidance for how to capture the data. Periodic audits, peer review of the data, and review of
logbooks and records are conducted.

•  Peer Review and Audit Reports

   The peer review  and QAU review of all  raw data and  all final reports ensure that the
quality control requirements are being met. Regular audits  of general laboratory operations
and performance of testing methods  are also essential parts of the Laboratory's  quality
system. The QAO is responsible for conducting internal audits to determine whether SOPs
are being used and followed correctly. The QAO also makes unannounced visits to observe
laboratory operations.   These ongoing activities  provide for continual assessment of the
effectiveness of quality control procedures.

   Audit reports are  submitted by the QAO to the Team Leader, Senior Science Advisor and
Branch  Chief and the analysts  within the specified timeframe for completion of the audit.
Responses must  be returned to the QAO and Branch Chief within an agreed upon timeframe.
The Team Leader in consultation with the analysts is responsible for addressing each finding
or observation.  A reason for the non-conformance, as well as a plan for corrective action, is
required. If the QAO finds the corrective action deficient, the situation is discussed with the
QA Manager for the Office of Pesticide Programs, the Team Leader  and the Branch Chief.
These procedures are detailed in  Laboratory  SOP QA-01,  Quality Assurance Unit  and its
Functions.  The corrective actions are documented and filed  in a central  location. Follow up
is  conducted to  determine if the corrective action has the desired effect.  The QAU meets
with  the Branch  Chief to discuss the  corrective  action  plans  and to review  process

•  Handling of Non-Conformance Issues

   If it is determined that the laboratory  has a non-conformance issue or there is a required
corrective action, the QAU will initiate the action following the procedures noted in Standard
Operating Procedure, ADM-07 (Non-conformance reports) and  ADM-08 (Corrective  and
Preventive Actions.  The analysts, Branch Chief, Team Leader, and Senior Science Advisor
are involved in the process of identifying  non-conformances, evaluating the root cause of the
non-conformance, and addressing any corrective  or preventive actions, if necessary.   The
Quality Assurance Officer in consultation with the senior team is responsible for determining
the actions necessary to address the non-conformance issue and notifying the client if the
finding affects the outcome  of a study. The corrective action will include the steps necessary
to avoid recurrence of the non-conformance.  If it is necessary to develop data to address a

                                                                            July 2011
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scientific issue related to a non-conformance, the Team Leader or Senior Scientist will
initiate the development of a study protocol.  All corrective actions including the action plan
and data summary are tabulated in a binder which is maintained by the QAU.

   If the non-conformance issue occurs during the conduct of a study and is determined to
affect the outcome of the study, the study may be terminated in accordance with the standard
procedures.  The Branch Chief is  notified  of the findings and will make a decision as to
whether to terminate the study.  A termination memo will be issued which documents the
reason for termination of the study,  the plan to address the non-conformance, and the plan for
re-initiating the study. The termination memo will be filed with the study and included in the
corrective action binder.  The client will be notified and the study will be re-initiated when
the issue is resolved.

•  Preventive Actions

   On an ongoing basis, the QAU will review the corrective  actions and determine if non-
conformance issues are recurring or onetime events.  For recurring events, the  QAU will
recommend to the Branch Chief a plan for resolving or rectifying the problems. Continuous
improvement of the laboratory's procedures and systems for  conducting work is critical to
the integrity and quality of the data  and is a major theme of ISO 17025.

•  Extramural Agreements

   The  laboratory  has  established numerous  extramural  contracts  and  Interagency
Agreements (lAGs)  in order to support the Homeland  Security  research  objectives. The
Agency's  contracting regulations  require that data is developed in accordance with the
Agency's Data Quality Objectives  and Quality Assurance requirements. Quality  Assurance
requirements are built in to Requests for Proposals (RFPs) and  Technical Evaluation Criteria.
The  preparedness of  each participating  laboratory,  including  the  OPP Microbiology
Laboratory,  is  assessed by  the MLB Senior  Science  Advisor (or  designee)  and Quality
Assurance Unit (QAU) prior to initiation of the study to ensure compliance with the Quality
Assurance Project Plan and associated study protocol.  Readiness reviews are conducted in
advance  of the initiation  of research.    The  expected level of quality assurance for
organizations operating under extramural agreements with the laboratory is consistent with
EPA Good Laboratory Practices.  Numerous guidance documents, standard methods and
SOPs are used to maintain data quality.  Proper record keeping and archiving are  performed
to ensure the defensibility and  re-constructability or reanalysis of the study. The client was
consulted to determine if ISO  17025  or Good Laboratory Practices were required for data
developed by the three state laboratories to support the activities of the Antimicrobial Testing
Program.   The client   requested    adherence to the  Good Laboratory Practice (GLPs)

   Staff performing the  assays must be familiar with  standard microbiological techniques
such as aseptic transfer, serial  dilutions, plate counts and microbe identification.   Scientists

                                                                            July 2011
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and analysts involved in testing shall be familiar with each efficacy method and associated
procedure  (e.g.,  carrier counts,  neutralization  confirmation) and will be  proficient  in
conducting each designated efficacy test method.  In-house practice sessions are required for
each  laboratory  to  build  proficiency  with  each  method  prior  to  official  testing.
Documentation of practice and training for projects is maintained in a training file.  Where
possible, EPA SOPs and standard forms are used for those operations which have become or
will  become routine, including test methodology, analytical procedures and  calibration
procedures.  SOPs that  are comparable to EPA's may be used; however, their use requires
concurrence by the Senior  Scientist (or  designee) or the EPA Quality  Assurance Unit.
Electronic  spreadsheets  and email  are  considered  official  documentation  and will be
maintained and archived accordingly. Test chemicals, media and reagents are tracked using
assigned media preparation numbers.  No official chain of custody documentation is required
for test chemicals evaluated in Homeland Security research; however, specific information
on source, identification, and volume received is maintained and archived. Upon completion
of each  study, a peer  review of the data  entry/tabulation is performed  by  laboratory
personnel.  A draft report of the findings or data summary is compiled and forwarded to each
lab's Quality Assurance personnel for  review.  The  designated  QAO at each facility will
review and comment on the  data and supporting information  before  submission  to  the
statistician.  Data may be rejected if microbial contamination occurs at a level unacceptable
to MLB.

•  Client Communication

   The Microbiology Laboratory communicates with the client  organizations on a regular
basis.  The  current client base is the Antimicrobials Division, the Biopesticides and Pollution
Prevention  Division, the Office of Enforcement  and Compliance Division, the Office  of
Research and Development, the Office of Emergency Management, as well as administrative,
technical and  programmatic support from the program office  and contracts office.  The
laboratory holds  regular meetings with the Branch  Chief of Product Science Branch  of
Antimicrobial Division.  The client has  agreed that for the purposes of efficacy testing under
the Antimicrobial Testing Program (ATP) that the laboratory data that is generated must be
in compliance with Good Laboratory Practice Standards, 40 CFR Part 160. The design and
conduct  of laboratory studies is  done with the client organization with  final  signatures by
both parties.  Amendments to the studies are done as necessary and with  the approval of the
client.  Data may  be presented both orally and in written format.  Formal technical reports or
summaries of data are delivered to the client.

   If certain parameters of the  study  do  not fall  within the prescribed requirements (for
example, the carrier counts for a study fall  outside the established range) the client is
contacted.   The  study  may be  repeated  as  requested by the  client.   Conversations  are
documented and maintained with the study file.

   Customer complaints (SOP ADM-06)  and resulting  corrective actions (SOP ADM-08)
are handled as outlined in the appropriate Standard Operating Procedures.

                                                                                July 2011
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I.      Policy

       The   Agency  encourages  the   continued  training,  certification,   and  professional
development of the laboratory staff to meet program objectives.  Resources are allocated for
these activities on a continuing basis.  Training is obtained through formal academic training,
equipment specific training  provided  by the vendor,  formal  in-house refresher training  on
microbiological  techniques and methods, and project specific training  on standard methods.
Documentation of training is  maintained in a binder as specified in the laboratory training SOP,

II.     Qualifications and Training

       The work performed at the laboratory consists of microbiological and chemical  assays.
Analysts are  required to use standard laboratory  equipment, as well as new technology specific
to the mission of the program.  Analysts must meet the minimum qualifications set  forth in
Handbook 118 for microbiologists, or  for biologists with a minimum of 20  semester hours in
microbiology and related studies.  Personnel job applications, curricula vitae, etc. are maintained
by the Branch Chief. Job descriptions and training records for each employee,  as specified under
the GLPs Section 160.29(b),  are maintained in the laboratory training binder and are available
for inspection.

       Student assistants  and interns are required to have basic  microbiology and chemistry
courses at the college  level.   On-the-job training will be  provided to each  student by senior
laboratory personnel on laboratory specific practices  and procedures.   Students may work
independently on assigned research projects with direction and guidance from the laboratory
Team Leader or Senior Science Advisor.

       All laboratory staff is  required to have 24 credits of general laboratory safety training as
specified under the Agency guidelines.  A refresher class of 8 credits is  required on an annual
basis.  If specific personal protective equipment  such as respirator is required, the analyst must
be certified.

       The laboratory  staff is trained  in the laboratory operations through  review of SOPS,
QA/QC requirements, chain-of-custody procedures, and record keeping requirements.  New staff
members  receive extensive hands-on  training  from the  Team Leader  or senior analysts  on
methods and  procedures used in the laboratory.  Staff obtains experience by performing practice
trials including  handling  of  cultures,  disinfectants, chemicals, etc.  The Quality Assurance
Officer provides training on various aspects of quality control procedures.  Methods related to
safety and health practices are also covered by the ESC Industrial Hygienist  and the  facility
safety officer.  Training by the vendors of specialized microbiology laboratory  equipment (e.g.
confocal  microscope,  Vitek™ 2  Compact  Identification  system  for microorganisms)  is

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 conducted as needed. QA training is recorded in the training file for each employee.

        For  professional  development,  analysts are  encouraged  to  attend  seminars  and
 professional meetings  such  as  those of the  American Society for Microbiology (ASM),
 Association of Official Analytical Chemists (AOAC) International, Association of Practitioners
 for Infection Control (APIC) and Analytical Excellence through Industry Collaboration (AEIC),
 etc.  Information on new  equipment is obtained through trade journals, trade shows, and vendor
 demonstrations.  Specific training needs related to successful performance of laboratory duties,
 available through AOAC  International, the National Institutes of Health (NIH), the US Food and
 Drug Administration, state laboratories, or other organizations,  may be identified and submitted
 as training requests. Funding for training is allocated during the annual budget planning process.

        The  Agency, through  its Office of Environmental Information Quality Staff,  provides
 basic training courses in quality assurance for Quality Assurance Officers.  BEAD management
 supports the QA program by providing funding for training and travel.  BEAD allocates funding
 for the QAO to participate in EPA's annual QA conferences.

 III.    Proficiency Testing/Uncertainty

       In order to reduce potential variability in results and to assess the performance of analysts
in conducting pertinent laboratory functions, MLB is  currently  developing  a proficiency testing
program for methods used for efficacy testing under the Antimicrobial Testing Program.  AOAC
International has been tasked (under a contract) with facilitating the development of the program.
Operations (modules) that are expected to be evaluated include basic  microbiology laboratory
tasks  such as use of pH meters, weigh balances, and spectrophotometers, and performing product
efficacy tests. The proficiency testing program will be used to identify training needs and SOP
deficiencies.  The Team Leader, in conjunction with  the Senior Science Advisor,  is responsible
for implementing the program and evaluating the results.  Assistance from  the  QAO will be
provided as  necessary to ensure the quality of data. Refer to the "OPP Microbiology Laboratory
Response to the EPA Laboratory Competency Policy Directive, Implementation Plan", Reference

        For the PIP method validation program, the laboratory  participates in the USDA Grain
 Inspection,  Stockyards  and  Packers  Administration (GIPSA) proficiency  program for  the
 detection of biotechnology events.  Blind samples are sent to the laboratory for screening.  The
 laboratory returns the data to GIPSA for analysis, and the results are  posted for each laboratory.
 The PIP method validation program has been static for several years.  Method validation work
 under this program is not anticipated within the next fiscal year.

        For the Homeland Security research, quality  assurance readiness reviews and  in-house
 practice sessions are used to develop and monitor  proficiency in conducting microbiological
 techniques associated with test methods prior to the initiation of the research.

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       MLB recognizes the importance of uncertainty of measurement, or error, associated with
the lab's activities. Where possible, certified media and reagents and specialized equipment (e.g.,
specific types  and sizes of pipettes,  volumetric glassware) are used  in the laboratory's  assays.
Rigorous quality assurance, staff training,  and calibration  of equipment such as balances,  pH
meters and  spectrophotometers  are  used  to  increase reproducibility of data.  Equipment  for
quantitative assays such as positive  displacement pipettes and cuvettes are performance tested
and validated by the manufacturer. Quantitative efficacy tests are replicated by the laboratory to
provide within-lab standard deviation values, or when necessary, are performed by more than
one laboratory to provide between-lab standard deviation values.  The laboratory utilizes AOAC-
validated methods for the ATP program and is seeking third-party validation of new methods
under the Homeland Security initiative.

   Furthermore,  charting of quantitative data such as carrier counts is used to  monitor  the
outcome of laboratory methods.  In addition, the services of a statistician are available under two
extramural contracts; a contract  with AOAC  International and with  Montana State University.
Statistical services  are  used for study design, analysis  of data, and review of  proficiency

   Uncertainty for quantitative tests will be determined using a statistical approach.  First, logio-
transform  each data point used to determine  the uncertainty and then  determine the mean and
standard deviation of those data points.  For data sets with 20 or more  data points, multiply  the
standard deviation by 2 to determine the expanded uncertainty (coverage factor k = 2). For data
sets with less than 20 data points, determine k (find the value for n-1  degrees of freedom, where
n is equal to the number of data points that make up the mean, from the Student's t Distribution
Table at the 95% confidence interval) and then multiply the standard deviation by k to determine
the expanded uncertainty.  Uncertainty measurements will be listed as the mean ฑ k and will be
recorded in a logbook.  The measurements may be  updated as needed (i.e.,  when  a sufficient
number of additional data points have been generated).


       The  Laboratory procures services and supplies from external vendors.  The laboratory
purchases media, reagents, consumable supplies,  equipment, and other materials used in  the
conduct of laboratory studies from reputable vendors (VWR,  Fisher Scientific  etc.)  The
materials must meet the specifications  outlined in a standard method or procedure.  Quality
checks are conducted (for example,  sterility  and performance of media) on  a regular basis to
ensure that the quality  meets  the  laboratory's  needs. Microorganisms for the  studies  are
purchased from reputable  vendors (ATCC, bioMerieux, Remel) and  are checked to ensure that
their culture and morphological characteristics are consistent with established standards.

       As part of an internal quality control program, the laboratory verifies the quality of
deionized water used in making media, reagents, and to dilute disinfectants during  efficacy
testing.   As discussed in the  laboratory Standard  Operating Procedure (SOP)  for  quality

                                                                               July 2011
                                                                           Page 24 of 3 8

assurance of purified water, de-ionized water is checked for total heavy metals, specific heavy
metals  (Cadmium,  Lead,  Nickel,  Zinc,  Copper,  and  Chromium),  total organic  carbon,
conductivity, total chlorine residual and heterotrophic plate counts.  Monitoring of total chlorine
residual is performed by the  EPA/OPP Microbiology Laboratory.  Monitoring of total heavy
metals, specific heavy metals,  total organic carbon, conductivity and heterotrophic plate counts is
performed by QC laboratories (1205 Industrial Blvd., Southampton, PA 18966-0514, 215-355-
3900). QC Laboratories is certified by the State of Maryland Department of Health and Mental
Hygiene Laboratories  Administration as a State Certified Water Quality Laboratory.  Following
each round of sample analysis, vendor forwards the analytical results to the  OPP Microbiology
laboratory. The laboratory staff analyzes the results as described in the SOP.

       Laboratory balances, weights, timers, NIST-traceable thermometers,  hygrometers, Rees
system and  spectrophotometers  are certified by contract vendors on an annual basis to ensure
accuracy.  The Vitek 2 Compact system, for automated identification of microorganisms and
Pipettes (Rainin) are factory certified  and serviced annually.  ELISA reader verification plates
are sent out for traceable certification every two years.  Preventative maintenance on large
equipment, including biological  safety  cabinets (BSCs), fume hoods, and autoclaves is provided
by the building's Facility Manager. The Facility Manager utilizes outside  vendors  to service
these pieces of equipment and to annually certify the BSCs and fume hoods.  In-house
calibration procedures and frequencies for other apparatus used in the laboratory are detailed in
the appropriate Equipment (EQ) and Quality Control (QC) SOPs.  If appropriate, ISO 17025
accredited vendors and calibration equipment are preferred.

       For Homeland Security-related  projects, the following extramural agreements have been
established following the Agency's procedures for development of extramural agreements. Any
changes to the  agreements or contracts are done formally, in writing,  through the appropriate
Agency approval process. The Agency has different requirements for oversight dependent on the
funding vehicles  (contracts,  grants, or interagency  agreements).   Certified  Agency project
officers, familiar with the work to be done, are assigned to the extramural agreements.

       An Interagency Agreement (lAs) with U.S. Army Edgewood Chemical and Biological
       Center (ECBC), Aberdeen Proving Ground, MD. has been developed to provide funding
       for personnel resources and the  equipment and supplies expended or consumed during the
       project.  ECBC provide expertise and technical support in the collaborative testing of test
       methods, surrogates, and decontamination chemicals. The IA expires in2015.

       •     Several project initiatives will be facilitated by AOAC INTERNATIONAL
             (AOAC), a standard-setting organization.  AOAC is under contract with MLB and
             will coordinate the review and third-party approval of validation protocols by a
             world-recognized experts, statisticians, safety advisors, and appropriate
             committees. AOAC will provide the experts necessary to evaluate the protocols
             according to relevant AOAC guidelines and policies for method modifications
             and validation studies. AOAC shall provide MLB with the necessary tools to
             ensure an expeditious review and work with MLB to ensure the protocol is in the

                                                                               July 2011
                                                                           Page 25 of 3 8

              necessary format and all the components of the protocol are submitted.
       •      A contract with Montana State University (MSU) has been established to provide
              laboratory support for disinfectant test method development and standardization
              with emphasis on biofilm. In addition the MSU contract provides for statistical
              support and associated consultation on experimental design, protocol
              development, performance standards, and assistance with the preparation and
              presentation of oral and written materials.
       •      Dr. Martin Hamilton, Big Sky Statistical Analysts, is a statistician assisting on the
              MLB research initiatives.  Dr. Hamilton is a sub-contractor under the AOAC
              contract and the MSU contract.
       •      Under OPPT's contract with Battelle, MLB will support and coordinate
              Homeland Security studies as necessary and as funding will allow.  The EPA
              Deputy Project Officer assigned to the Battelle contract is Ron Morony (National
              Program Chemicals Division); however, MLB will prepare the Task Orders and
              assist in the management and review aspects.
       •      MLB contributes Homeland Security funding to ORD to support collaborative test
              method and surrogate studies conducted by ORD and Battelle (contractor).
       •      Contracts with the North Carolina Department of Agriculture, Ohio Department
              of Agriculture and Michigan Department of Agriculture laboratories to provide
              disinfectant efficacy testing of EPA registered hospital disinfectants and test
              method development.
       •      Inoculated porcelain penicylinders and spore suspensions are purchased from
              Presque Isle Cultures, 3804 West Lake Rd., P.O. Box 8191, Erie, PA 16505.

Other Assistance Agreements

          •   The laboratory  uses staff resources obtained  under the National  Older Worker
              Career Center (NOWCC) grant. These individuals are hired as research assistants
              and have technical backgrounds suitable to the research environment. They assist
              the EPA analysts with research studies, quality control procedures, preparation of
              media, supplies  and reagents, and other activities.


I.      Process for Recording and Maintaining Data

       Forms  associated with  the Standard  Operating Procedures (Appendices A5  and A6) are
used for documenting laboratory data and supporting information.  Certain information may be
documented using prepared data recording forms;  these forms were  developed  to maintain
consistency in recording of information and to provide a pre-established report format to clients.
When standard forms are not available (for unique data collection activities or one time projects),
the data may be recorded  in a laboratory notebook following the procedures  outlined in SOP-
ADM-05.   For tracking  purposes, notebooks  are pre-numbered and  assigned to  individual

                                                                               July 2011
                                                                           Page 26 of 3 8
       The  laboratory  utilizes  an  environmental  monitoring  and  alarm  system  (Rees
System/EMAS) to collect environmental data electronically for refrigerators, freezers, incubators
and sample storage rooms.   Data is  collected through a network of wireless environmental
monitoring  devices that use  radio  frequency to transmit and  receive  data  about current
conditions. The system provides emergency notifications through a phone tree if equipment falls
outside the established parameters.

       The data from  analyses of samples and the data from the ongoing QA/QC activities are
reviewed by the data recorder and then peer reviewed by another staff member.   Whenever the
internal quality control checks  or audits  indicate non-conformance to accepted protocols and
procedures, corrective action is  taken.   The vast majority of ATP data are qualitative in nature.
For those methods which require construction of charts, standard curves, plotting survivors vs.
time as in the Quantitative Suspension Test Method (QSTM), the curves would be developed as
described in the  method and as reflected in the SOP.  For quantitative  tests, log reduction
estimates  are  calculated using spreadsheet  software.   Standard curve and calibration  data
generated for Enzyme-linked Immunosorbent Assay (ELISA) method validations are analyzed
using Ascent Software provided with the Multiskan Ascent microplate reader.

       Test data  will be recorded  manually or automatically through computer/ instrument
interfaces.  A  complete  audit trail will follow any entry.  Original copies  of any hand-written
results will be maintained.

       For the Antimicrobial Testing Program reports, the draft report is peer reviewed and then
procedures are followed as specified in the SOP for generation of a final  report to the client.
Other reporting mechanisms may be used to report findings from  laboratory  studies dependent
on the needs  of the  client.   The  laboratory stores the draft  performance report,  the final
performance report, and associated memoranda by product.  All raw data, performance reports
and quality control records are maintained in the archive room.  Records are retained in the
designated space at the ESC for the length of time listed in the laboratory's retention  schedule.
Records are archived as specified in the retention schedule.

II.     Quality Assurance Records

       Records of routine quality control activities are recorded  in laboratory notebooks.  In
accordance  with  GLP's,   the  laboratory's  quality  control   practices  include   thorough
documentation of laboratory operations; the original documents are kept on file as specified in
the SOP.  As SOPs are revised, the original controlled  copy (O version) is marked as obsolete
and retired to the archives. All other controlled copies of the SOPs are destroyed.

       Handwritten amendments to SOPs are not acceptable.  Amendments to SOPs  are issued
in accordance  with ADM-02. Handwritten amendments to study protocols may be allowed as
necessary to conduct the study within  a timely manner. The amendment is noted, initialed and
dated by the analyst. If the change is  deemed to be substantive by the Team Leader or Senior

                                                                               July 2011
                                                                           Page 27 of 3 8
Science Advisor, the approval of the client is attached (typically done via email).
       Copies of all audit reports are archived.  The MLB Branch Chief, or designated staff shall
be responsible for the files in the event of the QA Officer's absence. In addition, the QAO
maintains electronic copies of all memoranda related to QA activities. Copies of external audits,
responses, and corrective  actions are  maintained by the  QAU and the Branch Chief.  These
records are maintained on paper or may be stored electronically as scanned PDF documents.

III.    Archives and Disposition

       The retention schedule for the  Laboratory documents is contained  in the SOP ADM-03
for Records  and  Archives.  The records management practices for MLB are consistent with the
U.S. EPA Records Schedules and the policies of the Agency's National Records Management
Program. Records will be retained in the laboratory for the length of time listed in the file plan
unless volume warrants a transfer to a records archive area. When the retention time for a set of
records has passed, the records will be destroyed.

       The location of these records is in a secured room at the ESC. Individual files are kept in
filing cabinets within this room.  The QAO, Team Leader,  Senior Science Advisor, Branch Chief
and authorized analysts shall have access to these filing cabinets.


       Computer security at the Environmental Science Center is based on the Agency's security
policy for the EPA national communications network including basic controls to ensure a secure
network infrastructure which integrates  confidentiality, authenticity,  availability, and integrity
into  the  system.   Systems are  in place to  protect the  Agency's infrastructure and  critical
information  assets from internal and external threats, to ensure information technology resources
are consistent with a secure network design, to protect information resources from unauthorized
use or threats, and to support the Agency in achieving  its  mission.   These procedures and
policies are identified by the Agency's  Office of Technology Operations and Planning.

       All workstations at the ESC require an ID  and password to login.  Workstations are
equipped with various programs to protect against spyware, spam, and viruses.  All servers and
major network equipment are placed in  secure locations and the files on  the servers are given
certain rights for each user as they log into the network. Employees are required to take annual
information  security training and records management training.

       The Laboratory does not currently transfer raw data electronically although the laboratory
may share data summaries electronically as PDF documents.   Certain equipment can store data
electronically  such  as the  Vitek  2  Compact,   an automated   identification  system  for
microorganisms, used in the laboratory for confirmatory organism identification.   Software for
the systems  is upgraded when necessary during annual maintenance.  Another system which
stores data electronically is the Rees environmental monitoring and alarm system (EMAS) which

                                                                               July 2011
                                                                            Page 28 of 3 8

monitors temperatures of refrigerators, freezers,  incubators and sample  storage rooms.  The
EMAS is loaded on a small stand alone computer and is password protected.

       An ESC  facility-wide Chemical Inventory  Management System (ChIMฎ by Vertere) is
used by the OPP Microbiology Laboratory to track reagents and media.  Functionality of the
System includes: Chemical Identification, Individual Item tracking, Safety Data, and Inventory
History.  The chemical inventory management system,  or ChEVI,  enables  users to search a
database to determine if a needed chemical is already present in the laboratory.  The software
meets the Agency's standards.

       The laboratory has developed an automated system for maintaining an inventory and
tracking expiration dates for laboratory chemicals, reagents, and other materials in Access.  The
laboratory will use standard  Agency software (Access, Excel) to chart certain information such
as carrier counts, media performance etc., in order to identify outlier data points and information.
Results obtained by the laboratories involved in the Antimicrobial Testing Program are being
entered into an Oracle database so that trends or unusual findings can be monitored.

       Files that are maintained in electronic format using standard Agency software are subject
to the same retention schedule.  They may be maintained on user share files or other electronic
storage systems.


       In FY 2011/2012,  the laboratory will continue with antimicrobial efficacy initiatives,
Homeland  Security related  research, biofilm, PCR based methodology, and efficacy method
research and  development.  Antimicrobial product testing will continue at the laboratory under
the Direct  Shipment  initiative  and through  the  official sample  collection  process.   Testing
support is provided by the three state  laboratories under contract to the Agency.  Laboratory
projects are captured on the OPP Microbiology Laboratory Branch FY 2011 and 2012  Annual
Workplans. New initiatives are reviewed and  approved at the Branch Chief level consistent with
the OPP Program goals.   The laboratory works closely with the client base in the development
of the yearly work plans to ensure  that the laboratory projects  mesh  with the needs  of the
regulatory programs.

       For new  projects  outside  the  regular  core programs, such  as research projects or
collaborative  exercises, the laboratory will develop a QAPP for each project.  The QAPP will
include the necessary  criteria such as project manager, goals,  schedule, type of data to be
generated, performance measures, QA/QC activities,  audits, requirements for analysis of data,
appropriate statistical measures, and  other parameters  necessary to  ensure the validity and
reliability of the data.  Each Quality Assurance Project Plan will be reviewed and approved by
the laboratory's Quality Assurance Officer prior to initiating the project.

       Annual, internal technical and system audits will be conducted by the QAO based on the
testing/research schedule of the laboratory and any issues identified through prior audits.   These

                                                                               July 2011
                                                                           Page 29 of 3 8

audits will be both scheduled and unannounced.  The tentative schedule will be developed by the
QAO and Team Leader in the first quarter of  each fiscal year and adjusted to accommodate
events such as changes in sample collection receipts or new collaborative testing.

       The laboratory will request audits from external  sources annually.  These  audits may
cover technical, management system, and GLP  reviews.  The Laboratory will consult with the
OPP Director  of Quality Assurance in  scheduling these audits.  In addition, the Microbiology
laboratory,  along  with  other  BEAD  laboratories, are seeking ISO 17025 accreditation for
selected methods as defined in the scope of accreditation, and meets the requirements of the ISO


       The senior management for the program is responsible for  ensuring that the work is
implemented according to the developed schedule and plan.  As operations or priorities change,
the management will identify the critical processes that are necessary to ensure the validity of the
data.  If the changing priorities require the development of new SOPs, revisions to the QMP, or
implementation of QAPP's, the management is responsible for the development of the necessary
quality assurance practices. Any change which may impact the quality of the data generated by
the laboratory will be done formally through the QAO.

       The current  Standard  Operating  Procedures for  the  laboratory are assigned control
numbers. The laboratory's quality assurance officer is responsible for assigning the control copy
numbers. If changes are made the QAO will verify that revisions are appropriate, that the review
and signature procedures are followed,  and the previous version is appended, or retired and the
new SOP is put into practice.

       The laboratory Team Leader is  responsible for the development of the  routine product
testing and method development work related to  efficacy test methods. If the work is interrupted
or unanticipated problems occur,  he/she will revise the schedule accordingly.  The laboratory
Senior Science Advisor is responsible for the technical direction of the laboratory programs and
provides oversight and  technical guidance  to  the laboratory scientists and oversight to the
extramural agreements for Homeland Security initiatives.

       Work  processes  for methods under the  ISO 17025 standard  will be adjusted  to ensure
consistent adherence to the requirements outlined in the standard with particular attention to non-
conformances, corrective and  preventive actions, and addressing customer complaints.   These
activities will require additional time on the part of the laboratory staff and management.


       The generation of quality data is the responsibility of each laboratory employee.  Each
individual on the laboratory team is trained on the use of laboratory  equipment, quality control
practices, characteristics  of the  microorganisms, confirmatory  techniques, recording of data

                                                                               July 2011
                                                                           Page 30 of 38

elements, appropriate means of correcting any entry errors, and other daily operational activities
which may impact the validity of the generated data.  Adherence to appropriate quality control
and quality assurance activities is identified as a critical element in each laboratory employee's
performance standard.

       The QAU will conduct audits of ongoing studies as outlined in the laboratory SOP (QA-
01: Functions of the Quality Assurance unit). An audit schedule is developed  each  year to
conduct in-lab inspections  of certain  procedures, review books  and records, and arrange for
external audits.  The results are documented and provided to the analysts, Team Leader, Senior
Science Advisor and Branch Chief.  If during an audit,  the QAU determines that significant
deviations or  factors were observed  that call into question the validity  of the data  or the
procedure,  the unit may recommend that the study be terminated and  repeated  using the
appropriate procedures.  The study is deemed to be terminated and a formal memorandum to the
file is prepared which notes the circumstances under which  the study was found to be lacking.
The QAU recommends and follows up on corrective actions and maintains the corrective action

       The QAO will review the results of proficiency testing, once the program  is developed,
with the laboratory Team Leader and Senior  Science Advisor and make recommendations for
follow-up action, if required.

       The QAO has authority to audit any laboratory data  or practices.  Any deficiencies will
be brought to the attention  of the Team  Leader, Senior Science Advisor and Branch Chief and
immediate action will be taken to correct the deficiencies.  The QAO will recommend external
audits as appropriate.   These audits are typically done with a team of Agency scientists  with
expertise in microbiology and chemistry.  The audit team presents results  to the laboratory
management and corrective  action is the responsibility of the  senior management team.

       External  audits  for the purposes  of determining compliance with the  Good Laboratory
Practices,  system  documentation, and management  review are arranged  on a  regular basis
consistent with the annual audit  schedule. The findings are documented and reviewed by the
Branch Chief and Quality Assurance Unit.  Any corrective actions that are taken are documented
and maintained by the QAU.  A formal response is provided  to the external auditor  by the
Branch  Chief.  The response identifies the deficiencies, corrective actions, and any follow up
activities that are planned.  Preventive action plans are developed to prevent the problems from
occurring in the future.

       The laboratory  uses  a  variety  of management  tools to  ensure  adequate planning,
documentation and to verify the integrity and the accuracy of the work. Project specific planning
is  done thru the development of QAPPs and  study protocols.  Audits are conducted to ensure
compliance with the SOPs,  study protocols, and the QA systems. Assessments include internal
and external  audits, observations, peer  review of data, quality control checks of equipment,
supplies and  materials, performance evaluations, and management and system reviews.  The
workplan is revisited on a  quarterly basis to  determine the adequacy of personnel  and other

                                                                             July 2011
                                                                         Page 31 of 38

resources to accomplish the established goals.  Overall audit findings, corrective actions taken,
staff training, and customer comments and complaints are reviewed by the Branch  Chief and
QAU to evaluate the effectiveness of the laboratory's quality programs.


       The current practices and activities identified in the QA management plan work to ensure
the validity and reliability of the data generated by the laboratory. The internal audits, external
audits,  and review schedule of the SOPs provide opportunities for assessment and improvement
of the quality systems. Communications between the laboratory team, quality assurance officer,
and management encourage the exchange of information which is necessary to improve ongoing
activities.    The team  meets  on a  regular  basis to  exchange information  and to  make
improvements to data forms, SOPs, and facility practices.  The team is integrating automation
into  the current practices.  The  team also interfaces with laboratory customers  and  support
services to share information and exchange ideas.


1.      OPP Microbiology laboratory, Antimicrobial Testing Program - Quality Assurance
       Project Plan (ATP-QAPP)

2.      OPP Microbiology laboratory Plant Incorporated Protectant QAPP (PIP-QAPP-2007-01)

3.      OPP MLB Homeland Security QAPP (HS-QAPP-2010)

4.      OPP Microbiology Laboratory Biofilm QAPP (BF-QAPP- 2008)

5.      OPP Microbiology laboratory Virology Testing Program QAPP (VTP-QAPP-2008)

6.      OPP Microbiology Laboratory Fiscal Year 2011 Work plan

7.      OPP Microbiology Laboratory Response to the  EPA  Laboratory  Competency  Policy
       Directive, Implementation Plan

8.      Office of Pesticide Programs, Quality Management Plan,  2006

9.      Microbiology Laboratory Branch  Standard Operating Procedures (see Appendix A-4).

                                                                            July 2011
                                                                        Page 32 of 38


      Appendix A-l:   Organizational Chart - Office of Pesticide Programs

      Appendix A-2:   Organizational Chart - Biological and Economic Analysis Division

      Appendix A-3:   OPP Microbiology Laboratory- Quality Assurance Organization

      Appendix A-4:   Index of Antimicrobial Testing Program (ATP) Standard Operating

      Appendix A-5:  Index of Plant Incorporated Protectant (PIP) Standard Operating

                                                                  July 2011
                                                               Page 33 of 38
                             APPENDIX A-l
                        ORGANIZATION OF OPP
                               OFFICE OF
                          PESTICIDE PROGRAMS

                             OFFICE OF THE
       FIELD &
                             BIOLOGICAL &
                           ECONOMIC ANALYSIS

                                                            July 2011
                                                         Page 34 of 38
                          APPENDIX A-2

Lab (Bay St.





Herbicide Microt
& Laboi
Insecticide Bra

jiology Science
"atory Information
nch & Analysis

                                         Appendix 3
                             OPP-Microbiology Laboratory
                            Quality Assurance Organization
                                                                                   July 2011
                                                                               Page 35 of 38
 Jack Housenger
Interagency agreement
Lisa Smith
ASPH (Association of
Schools of Public
Erick Christensen
Susan Lawrence
Branch Chief
OPP Microbiology Laboratory
                             OPP-Microbiology Laboratory
                             Quality Assurance

                             Kiran Verma
                             Quality Assurance Officer
  OPP- Microbiology
  Laboratory Scientists:
  -M.Jason Duncan
  -Jafrul Hasan
  -Knoxley Japal
  -Rebecca Pines
  -Marc Rindal
  -Luisa Samalot-Freire
  -Stephen Tomasino
  -Ella Witherspoon
  -Ann Broderick
  -Charles Odeyale
  -Denis Franks
  -Michele Cottrill
  OPP-Quality Assurance
  Denise Rice
  703- 347-0282
                                      Michele Cottrill
                                      Quality Assurance
                                      Officer and Laboratory

     Solid One-Way Arrow = Supervisory

  Dashed One-Way Arrow =Advisory/Team Leader
Dashed Two-Way Arrow = Advisory and Collaboration

                                                  July 2011
                                              Page 36 of 38
            APPENDIX A-4
Index of ATP Standard Operating Procedures
      OPP Microbiology Laboratory
Antimicrobial Testing Program SOPs
MB- 11 -03
MB- 13 -03
MB- 16-01
MB- 17-01
MB- 19-01
Calibration and Maintenance of pH Meters
Maintenance and Calibration of Thermometers and
Calibration and Maintenance of Weigh Balances
Systems Check for the Beckman (DU Series 500) Spectrophotometer
Calibration and Maintenance of Timers
Calibration of Kimble Class A Burets
Verification of Volume Dispensed and Maintenance of Oxford Automatic
Dispenser and Hamilton Microlab 500
Use of Petrifilm and Petriscan for Research Applications
Use and Maintenance of Orbital Shakers
Biosafety in the Laboratory
Tracking of Test Microorganisms
Screening Carriers Used in Disinfectant Efficacy Testing
AOAC Use Dilution Method for Testing Disinfectants
Germicidal Spray Products as Disinfectants Against Staphylococcus aureus,
Pseudomonas aeruginosa, and Mycobacterium bovis (BCG)
Tuberculocidal Activity of Disinfectants: II Confirmative in vitro test for
Determining Tuberculocidal Activity.
Disinfectant Towel ette Test against S. aureus and P. aeruginosa and S.
Media and Reagents Used in Microbiological assays Including Performance
Assessment and Sterility Verification
Neutralization Confirmation Assay for Disinfectant Products Tested Against
Mycobacterium bovis (BCG)
Handling Spills of Biohazardous Material
AOAC Sporicidal Activity of disinfectants Test (Bacillus x porcelain comp.)
Quantitative Suspension Test Method for Determining Tuberculocidal
Efficacy of Disinfectants Against Mycobacterium bovis (BCG)
Neutralization Conf. Procedure for Products Evaluated with the AOAC UDM
and AOAC GSPT (S. aureus, P. aeruginosa and S. enterica)
Bio-safety Practices for Handling Select Agent in room (D-122)
SOP for Growing a P. aeruginosa Biofilm Using the CDC Biofilm Reactor
Quantitative TSM for efficacy of Liquid sporicides against spores ofB.subtilis
on a Hard Non-porous Surface

   July 2011
Page 37 of 38
Antimicrobial Testing Program SOPs
Disinfectant Sample Preparation
Disinfectant Towel ette test against M. bovis (BCG)
Testing of M bovis using the Germicidal Spray Products as Disinfectants Test
OECD Quantitative method for evaluating bactericidal activity of
microbicides used on hard, non-porous surfaces
Quality Assurance of Purified Water
Monitoring of Laboratories for airborne contaminants
Glass Washing and Detergent Residues Test
Monitoring Environmental parameters of Incubators, Refrigerators, and
Freezers, Labs and Sample Storage Rooms
Use and Maintenance of Biological Safety Cabinets
Monitoring Temperature/Humidity of the Sample Storage Room
Establishment of Control Numbers and Tracking Laboratory Supplies
Performance Verification of Autoclaves
Sterility Assessment of Disinfectant Product Samples
Verification of Digital Pipettes Using the PCS 2 Pipette Calibration System
Determining the Presence of Microbial Contamination in Disinfectant
VITEK 2 Compact: Use, Maintenance and Quality Control Procedures
Performance Verification of the Yamato Drying Oven
Quality Assurance Unit and its Functions
Preparation and Maintenance of Master Schedule
Preparation and Review of Performance Reports for Efficacy Testing
Preparation and Review of Standard Operating Procedures (SOPs)
Records and Archives
OPP Microbiology Laboratory Training
Guidelines for Use and Maint. of Laboratory Notebooks and Project Binders
Customer feedback/complaints
Non-conformance reports
Corrective and Preventive Actions
Disinfectant Sample Login and Tracking
Initiation Propagation & Preservation of Crandell Rees Feline Kidney cell
Initiation Propagation Enumeration & preservation of feline calicivirus
Virucidal effectiveness test using feline calicivirus as surrogate for Norovirus

                                                  July 2011
                                               Page 38 of 38
            APPENDIX A-5
Index of PIP Standard Operating Procedures
      OPP Microbiology Laboratory
Plant Incorporated Protectant Method Validation Program SOPs
Use of Lab oratory Notebooks
Plant Incorporated Protectant Method Validation Program
Login and Tracking of Technical Materials
Performance Verification of the GeneAmp PCR System 9700
Performance Verification of PCR Amplification in the
PE Biosystems GeneAmp PCR System 9700
Performance Verification and Maintenance of the Microplate
Operation and Maintenance of the Eppendorf Centrifuge Model 5804R
Operation and Maintenance of the Labsystems Wellwash 4 Mk 2
Automatic Microplate Washer
Use and Maintenance of the Rainin Single Channel Pipettes,
Multi-channel Pipettes, and Repeater Pipette
Use and Maintenance of the Polytron PT 3 100 Laboratory
Workflow Through the Laboratory
Conducting a Method Validation Pre-Review