US Environmental Protection Agency
Office of Pesticide Programs
Quality Management Plan
Biological and Economic Analysis
Division
Microbiology Laboratory Branch
Office of Pesticide Programs
September 2009

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Quality Management Plan
2009
Office of Pesticide Programs
Biological and Economic Analysis Division
Microbiology Laboratory Branch

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PREPARED BY:
NAME: Kiran Verma
TITLE: Quality Assurance Officer, Microbiology Laboratory Branch
SIGNATURE:	 DATE:	
CONCURRENCES:
NAME: Susan Lawrence
TITLE: Branch Chief, Microbiology Laboratory Branch
SIGNATURE:	DATE:
NAME: Betsy Grim
TITLE: OPP Director of Quality Assurance
SIGNATURE:
DATE:

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A.	PROGRAM OVERVIEW
I.	Antimicrobial Testing Program (ATP)	5
II.	Plant Incorporated Protectant Program	5
III.	Homeland Security Research	6
IV.	CDC Select Agent Research	8
V.	Biofilm	8
VI Virology Testing Program	8
B.	MANAGEMENT AND ORGANIZATION
I.	General Organizational structure	9
II.	Mission	10
III.	Policy on Quality Assurance	10
IV.	Responsibilities	11
V.	Resource Allocation	13
C.	QUALITY SYSTEM AND DESCRIPTION
I.	Principle Components	14
II.	Process	16
D.	PERSONNEL QUALIFICATION AND TRAINING
I.	Policy	19
II.	Qualifications and Training	19
III.	Proficiency Testing/Uncertainty	20
E.	EXTRAMURAL AGREEMENTS AND PROCUREMENT OF ITEMS
AND SERVICES	21
F.	DOCUMENTS AND RECORDS
I.	Process for Recording and Maintaining Data	23
II.	Quality Assurance Records	24
III.	Archives and Disposition	25
G.	COMPUTER HARDWARE AND SOFTWARE	25
H.	PLANNING	26
I.	IMPLEMENTATION OF WORK PROCESSES	27
J. ASSESSMENT AND RESPONSE	27
K. QUALITY IMPROVEMENT	28
L. REFERENCES	29
M. LIST OF APPENDICES	30

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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 has ongoing initiatives to evaluate the
efficacy of antimicrobial pesticides, validate methods for detection of proteins and DNA in
genetically modified plants ("Plant Incorporated Protectants"or PIP), and conduct basic and
applied research on methods and surrogates for evaluating the efficacy of antimicrobials against
biothreat agents and other emerging pathogens.
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 AO AC or ASTM, are used by the laboratory to
monitor the efficacy of hospital disinfectants and tuberculocides currently registered by the
Agency. The laboratory also 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. Biothreat agents,
such as anthrax, as well as emerging public health pathogens present new challenges in the
regulatory and enforcement arenas.
The development and validation of methods to detect protein and DNA in genetically
modified agricultural commodities such as corn, soybeans, cotton, and potatoes constitutes
another laboratory program. Methods are submitted by the registrant to support the conditional
registration of PIPs. The laboratory evaluates the registrant's method to determine if it is
suitable for detection of DNA or protein in the commodity. The laboratory works closely with
U.S. Department of Agriculture to facilitate this process.
Decontamination and remediation of sites contaminated with biothreat 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
can not 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.

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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 titers for evaluating new
microorganisms, evaluating technique sensitive steps and quality control procedures, and
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. The laboratory is one of two EPA microbiological laboratories which have
Biosafety Level 3 capability to help during a public health emergency.
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 certain state laboratories, perform efficacy tests using the same
parameters (contact time, dilution of product) as noted on the product label. 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: http://www.epa.gov/oppbeadl/methods/atmpindex.htm
II.	Plant Incorporated Protectant (PIP) Method Validation Program
EPA regulates Plant Incorporated Protectants (PIP) materials that enable a plant to protect
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,

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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 is available if method validation
is required.
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 and to guard against manufacturer's false claims (core program activities). 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 Prevention, Pesticides,
and Toxics Substances (OPPTS) has taken action to address this directive and 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. OPP has responsibility for regulating antimicrobial products which are used to control
pathogenic bacteria, viruses and other microorganisms on inanimate surfaces. 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. 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 health and safety requirements for
handling and testing virulent bio-threat agents are difficult to satisfy for most laboratories, and
without surrogates, efficacy testing of virulent species would be limited to a few laboratories.

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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, IAs 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 IAs, 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 OPPTS, a multi-tiered research plan has been developed
and initiated. Interagency Agreements (IAs) have been established with federal research partners
(U.S. Army and the U.S. Food and Drug Administration) to assist EPA in this effort. 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.
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
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. In addition,
surrogates of biothreat agents are being evaluated. The health and safety requirements for
handling and testing virulent bacterial agents in this project are difficult to satisfy for most
laboratories, and without a less dangerous surrogate, efficacy testing will be limited to a few
laboratories. One important criterion for the selection of a surrogate is the resistance of surrogate
microbe to standard antimicrobial chemicals, i.e., the cells of an acceptable surrogate must

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exhibit comparable or higher resistance compared to the bioterrorism agent of interest. The
surrogate should be genetically similar to the agent in question, easily procurable, easily
cultured, and should be able to be safely handled in BSL 1 or 2 labs. In support of the surrogate
studies, projects designed to evaluate, develop and standardize procedures to initiate, maintain,
and store test cultures will be conducted. In addition, the persistence of microbes on surfaces
will be examined to determine the use period for inoculated carriers.
IV.	Center for Disease Control and Prevention (CDC) Select Agent Laboratory
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 biothreat 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. .
V.	Biofilm
MLB has initiated 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 ultimate goal is to provide
the technical basis for selection and validation of a set of procedures to grow biofilm and
evaluate the efficacy of antimicrobial chemical against biofilms. 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.

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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.
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), and the EPA Office of Research and Development
(ORD) and 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.
B. MANAGEMENT AND ORGANIZATION
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, Plant Incorporated Protectants, or Homeland Security) the staff

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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 workplan. The SSA directs and administers laboratory programs related
to Homeland Security initiatives including oversight on contract deliverables. The TL provides
oversight for antimicrobial testing, method validations, and general laboratory quality control
procedures.
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, particularly for
sporicidal chemicals, method validations for PIPs, and research related to the ATP initiatives.
Mission program support for the efficacy evaluations of tuberculocides and hospital disinfectants
is also provided by three state laboratories. The laboratory uses extramural agreements (contract,
IAGs, 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. The objectives of the Good Laboratory Practices (GLP) program, 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, ISO 17025 accreditation is contemplated in the near future and a gap
analysis has been conducted to address key challenge areas.
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 (methods, quality control, equipment,
quality assurance, and chain of custody). Study protocols which provide the detail for each
independent study are developed and reviewed and approved by the client organizations. A

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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 quality
assurance programs.
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. Accreditation under ISO 17025 is goal that has been
established for the laboratory to meet in several program areas within the foreseeable future.
Resources have been allocated for accreditation against the ISO 17025 standard and the Branch
Chief, QAU, and staff are committed to meeting the established standard. 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 for each laboratory.
IV. Responsibilities
Agency policy mandates that the laboratory operate in conformance with GLPs. This
requires the laboratory to utilize 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 action is taken to address deficiencies noted during audits of laboratory
data or practices.
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 is
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. In addition, the Associate Director of the Biological and
Economic Analysis Division meets quarterly with the three laboratory quality assurance units 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

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can report directly to the Associate Director. The Associate Director has been delegated
authority by the Division Director, BEAD, to act on issues associated with the laboratories.
The appointed QAU for the laboratory is responsible for determining whether all SOPs,
QA/QC, and GLP requirements are met. The QAU is responsible for reviewing the quality of
data and study reports, and conducts on-site 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 has access to the master schedule of testing activities and works in
cooperation with the Team Leader to prepare an annual audit schedule. The QAU maintains files
of master copies of all SOPs, master schedules of testing activities, audit schedules, and records
of audits and responses
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
matters.
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 advisor provides technical and scientific advice to the laboratory in all
program areas. The science advisor has responsibility for leading scientific initiatives to
enhance, augment, or develop laboratory capabilities to support ongoing regulatory and
Homeland Security initiatives. The science advisor provides expert advice, counsel, and
leadership on laboratory studies, 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 Management System Reviews (MSRs) to ensure that QA
activities are carried out according to the QA Management Plan.
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.

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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
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 the 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 certified 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 10th 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

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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 customer's 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.
C. QUALITY SYSTEM AND DESCRIPTION
I. Principal Components
The Agency's policy and program requirements to implement the mandatory QA
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 principal components of the laboratory's quality system are the Quality Assurance
Management Plan, the Agency's Good Laboratory Practices, Standard Operating Procedures,

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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 CI02105.0 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
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 IAG 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 unique laboratory studies.
The protocols provide the detail necessary to recreate the study.

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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, 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 Client organizations
provide feedback on study 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.
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 visitations 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.

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The Team Leader in consultation with the analysts is responsible for addressing each finding
or observation. A reason for the noncompliance, 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
improvements.
•	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 through the audit process. The Branch
Chief, Team Leader, and Senior Science Advisor are provided with a copy of the finding.
The Team Leader 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
action plan will include the steps necessary to avoid recurrence of the non-conformance
issue. If it is necessary to develop data to address the issue, the Team Leader 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 will be terminated. The Branch Chief will be
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 one time 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 (IAGs) 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

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

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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 and resulting corrective actions are handled at the Branch Chief
level. Documents related to customer complaints are maintained by the Branch Chief.
D. PERSONNEL QUALIFICATIONS AND TRAINING
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,
ADM-04.
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 scientist.
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.

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The laboratory staff is trained in 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 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 AO AC 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. 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 #5.
For the PIP method validation program, the laboratory participates in the USD A 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.

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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.
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 AO AC International and with Montana State University.
Statistical services are used for study design, analysis of data, and review of proficiency
exercises.
E. EXTRAMURAL AGREEMENTS AND PROCUREMENT OF ITEMS AND
SERVICES
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 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 on a monthly basis 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,

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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.
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.
Interagency Agreements (IAs) with U.S. Army Edgewood Chemical and
Biological Center (ECBC), Aberdeen Proving Ground, MD, and the U.S. FDA
(Denver District Laboratory, Winchester Engineering and Analytical Center
Laboratory, White Oak Campus Laboratory) have been developed to provide
funding for personnel resources and the equipment and supplies expended or
consumed during the project. ECBC and FDA provide expertise and technical
support in the collaborative testing of test methods, surrogates, and
decontamination chemicals. The IAs expire in December 2009. Efforts are under
way to develop research priorities and new IAs.
•	Several project initiatives will be facilitated by AO AC INTERNATIONAL
(AO AC), a standard-setting organization. AO AC 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. AO AC will provide the experts necessary to evaluate the protocols
according to relevant AO AC guidelines and policies for method modifications
and validation studies. AO AC shall provide MLB with the necessary tools to
ensure an expeditious review and work with MLB to ensure the protocol is in the
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

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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 AO AC
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.
F. DOCUMENTS AND RECORDS
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
analysts.
The laboratory utilizes an environmental monitoring and alarm system (Rees
System/EMAS) to collect environmental data electronically for refrigerators, freezers, incubators

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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 in individual labeled containers 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
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

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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. The Branch Chief shall
have keys for access to these files. Copies of external audits, responses, and corrective actions
are maintained by the QAU and the Branch Chief. These records are maintained on paper since
signatures are required.
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.
G. COMPUTER HARDWARE AND SOFTWARE
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. 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 monitors temperatures of
refrigerators, freezers, incubators and sample storage rooms. The EMAS is loaded on a small
stand alone computer and is password protected.

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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 ChIM, 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.
H. PLANNING
In FY 2010, the laboratory will continue with antimicrobial efficacy initiatives,
Homeland Security related research, biofilm and virology initiatives and efficacy method
research and development. Antimicrobial product testing will continue at the laboratory under
the Direct Shipment initiative. Testing support is provided by the 3 state laboratories under
contract. Laboratory projects are captured on the OPP Microbiology Laboratory Branch FY
2010 Annual Workplan. 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
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.

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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, is moving toward ISO 17025 accreditation and
will meet the requirements of the ISO standard.
I. IMPLEMENTATION OF WORK PROCESSES
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.
The laboratory is working toward meeting the requirements for accreditation of the
BEAD laboratories (ISO 17025 standard) during the fiscal year 2010.
J. ASSESSMENT AND RESPONSE
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
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

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(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
file.
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
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.
K. QUALITY IMPROVEMENT

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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.
L. REFERENCES
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-2008)
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 2010 Work plan
7.	OPP Microbiology Laboratory Response to the EPA Laboratory Competency Policy
Directive, Implementation Plan
8.	Office of Pesticide Programs, Quality Management Plan, 2009-2010
9.	Microbiology Laboratory Branch Standard Operating Procedures (SOPs)
(see Appendix A-4).

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M. LIST OF APPENDICES
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
Procedures
Appendix A-5: Index of Plant Incorporated Protectant (PIP) Standard Operating
Procedures

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APPENDIX A-l
ORGANIZATION OF OPP

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APPENDIX A-2
ORGANIZATION OF BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION

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Appendix 3
OPP-Microbiology Laboratory
Quality Assurance Organization

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APPENDIX A-4
Index of ATP Standard Operating Procedures
OPP Microbiology Laboratory
Antimicrobial Testing Program SOPs
SOP
Title
EQ-01-05
Calibration and Maintenance of pH Meters
EQ-02-04
Calibration of Thermometers
EQ-03-04
Calibration and Maintenance of Weigh Balances
EQ-04-04
Systems Check for the Beckman (DU Series 500) Spectrophotometer
EQ-05-04
Calibration and Maintenance of Timers
EQ-06-04
Calibration of Kimble Class A Burets
EQ-08-04
Verification of Volume Dispensed and Maintenance of Oxford Automatic
Dispensor and Hamilton Microlab 500
EQ-09-01
Use of Petrifilm and Petriscan for Research Applications
EQ-10-00
Use and Maintenance of Orbital Shakers
MB-01-05
Biosafety in the Laboratory
MB-02-04
Test Microbes for the AO AC UDM, AO AC GSPT, G TT, AO AC CTB, and
the AO AC SAT: Culture Initiation, Culture Maintenance and Quality Control
MB-03-04
Screening Carriers Used in Disinfectant Efficacy Testing
MB-04-05
Determining Carrier Counts
MB-05-07
AO AC Use Dilution Method for Testing Disinfectants
MB-06-04
Testing of Spray Disinfectants Against Staphylococcus aureus, Pseudomonas
aeruginosa, and Mycobacterium bovis (BCG)
MB-07-04
Confirmatory Tuberculocidal Method for Testing Disinfectant Efficacy
MB-09-02
Disinfectant Towelette Test against S. aureus and P. aeruginosa
MB-10-03
Media and Reagents Used in Efficacy Testing of Disinfectants
Retired 09-04-08
MB-11-02
Neutralization Confirmation Assay for Disinfectant Products Tested Against
Mycobacterium bovis BCG
MB-12-01
Neutralization Confirmation Procedure for Products Evaluated with the
AO AC Sporicidal Activity Test (Bacillus Species) Retired 02-04-08
MB-13-01
Handling Spills of Biohazardous Material
MB-15-01
AO AC Sporicidal Activity Test (Bacillus Species)
MB-16-01
Quantitative Suspension Test Method for Determining Tuberculocidal
Efficacy of Disinfectants Against Mycobacterium bovis (BCG)
MB-17-01
Neutralization Conf. Procedure for Products Evaluated with the AO AC UDM
and AO AC GSPT (Staphylococcus aureus and Pseudomonas aeruginosa)
MB-18-00
Use and Operations of the Receiving Room (D122)
MB-19-00
SOP for Growing & P.aeruginosa Biofilm Using the CDC Biofilm Reactor
MB-20-00
Evaluation of Antimicrobial Products against P. aeruginosa biofilm

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Antimicrobial Testing Program SOPs
SOP
Title
MB-21-00
Quantitative TSM for efficacy of Liquid sporicides against spores of B.subtilis
MB-22-00
Disinfectant Sample Preparation
MB-23-00
Disinfectant Towelette test against M. bovis (BCG)
MB-24-00
Testing ofM bovis using the GSPT
QC-01-04
Quality Assurance of Purified Water
QC-02-03
Air/Surface Monitoring of Microbiology Laboratories
QC-03-04
Glass Washing and Detergent Residues Test
QC-05-05
Monitoring Temperature of Incubators, Refrigerators, and Freezers
QC-06-04
Use and Maintenance of Biological Safety Cabinets
QC-08-04
Monitoring Temperature/Humidity of the Sample Storage Room
QC-09-04
Establishment of Control Numbers and Tracking Laboratory Supplies
QC-10-03
Media and Reagents: Examination and Expiration Time (Retired 05/05/09)
QC-11-03
Performance Assessment and Sterility Verification of Prepared Media and
Reagents. (Retired 05/05/09)
QC-13-04
Performance Verification of Autoclaves
QC-14-04
Monitoring Temperature of Water Baths for Holding (Tempering) Media
Retired (05/05/09)
QC-15-04
Media and Reagent Preparation: Assigning Prep and Sterilization Run
Numbers (Retired 05/05/09)
QC-18-04
Sterility Assessment of Disinfectant Product Samples
QC-19-04
Calibration of Eppendorf Pipettes Using the PCS 2 Pipette Calibration System
QC-21-01
Use of the AO AC Use Dilution Test and the Germicidal Spray Products Test
without Test Microbes to Determine the Presence of Microbial Contamination
in EPA-Registered Hospital Disinfectants
QC-22-01
VITEK 2 Compact: Use, Maintenance and Quality Control Procedures
QC-23-01
Performance Verification of the Yamato Drying Oven
QA-01-04
Quality Assurance Unit and its Functions
QA-04-03
Master Schedule Preparation
ADM-01-03
Preparation and Review of Disinfectant Performance Reports
ADM-02-03
Preparation and Review of Standard Operating Procedures (SOPs)
ADM-03-03
Records and Archives
ADM-04-02
OPP Microbiology Laboratory Training Program
ADM-05-01
Guidelines for Use and Maint. of Laboratory Notebooks and Project Binders
COC-01-04
Disinfectant Sample Login and Tracking
VTP-01-01
Init. Prop.and Preservation of Crandell Rees Feline Kidney cell line
VTP-02-01
Init. Prop. Enumeration And preservation of feline calicivirus
VTP-03-01
Virucidal effectiveness test using feline calicivirus

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APPENDIX A-5
Index of PIP Standard Operating Procedures
OPP Microbiology Laboratory
Plant Incorporated Protectant Method Validation Program SOPs
01
PIP-ADM-01-01
Use of Laboratory Notebooks
02
PIP-COC-01-01
Plant Incorporated Protectant Method Validation Program
Login and Tracking of Technical Materials
03
PIP-EQ-01-01
Performance Verification of the GeneAmp PCR System 9700
04
PIP-EQ-02-01
Performance Verification of PCR Amplification in the
PE Biosystems GeneAmp PCR System 9700
05
PIP-EQ-03-01
Performance Verification and Maintenance of the Microplate
Photometer
06
PIP-EQ-04-01
Operation and Maintenance of the Eppendorf Centrifuge Model 5804R
07
PIP-EQ-05-01
Operation and Maintenance of the Labsystems Wellwash 4 Mk 2
Automatic Microplate Washer
08
PIP-EQ-06-01
Use and Maintenance of the Rainin Single Channel Pipettes,
Multi-channel Pipettes, and Repeater Pipette
09
PIP-EQ-07-01
Use and Maintenance of the Polytron PT 3100 Laboratory
Homogenizer
10
PIP-MB-01-01
Workflow Through the Laboratory
11
PIP-MB-02-01
Conducting a Method Validation Pre-Review

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