vvEPA
February 17, 2009
United States
Environmental Protection
Agency
Antimicrobials Divison
2009 Workplan
U.S. Environmental Protection Agency
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Work Plan
For
Fiscal Year 2009
Version 10
Last Modified 2/17/2009
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FY2009 Work Plan
Antimicrobials Division
Office of Pesticide Programs
Vision Statement
The Office of Pesticide Programs' Antimicrobials Division will ensure the protection of human
health and the environment as it uses the best science and regulatory efficiencies in its registration and
re-evaluation of chemicals used as pesticides against microbiological pests.
The Antimicrobials Division will support OPP's mission by:
• AD plans to meet 100% of its PRIA & FQPA deadlines.
• Register 3 New Chemicals, 27 New Uses, 65 Old FT actions, 65 Old NFT actions, 800 AMD FT
actions, 100 AMD NFT actions, and process 500 Notifications.
• AD will complete 15 Preliminary Workplans; 12 Final Workplans; 5 RED Addendum
Documents; complete 3 registration reviews for final decision; 80 Product Reregi strati on
Actions; Support BEAD on workshop to resolve UDT issues with OMB; and issue 15 DCI's
once approved by OMB. Request 30 DCFs from OMB.
I. Being an effective gateway to the market and an effective steward of pesticides already on the
market.
A. Gateway to the market (Registration)
AD acknowledges that it will only be able to achieve these performance objectives with support
from FED, BEAD, EFED, RD, FEAD, and SRRD particularly as it applies to registration
review and higher tiered risk assessments.
Meeting production targets, especially for registration actions, is somewhat dependent on the
availability and quality of the data to support the chemical, product and/or use and assumes no
renegotiations occur. Data deficiencies can result in the establishment of new time lines.
1. Pesticide Registration - New Active Ingredients
AD will work on 3 new active ingredient submissions. These decisions will provide
new chemistries to the antimicrobial marketplace and will be made in accordance with
the safety standards of FIFRA and FQP A and in the timeframes set forth under FQP A
and PRIA.
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New Active Ingredient Candidates for FY 2009
Chemical
Copper
omadine
Cetyl
pyridinium
chloride
Tetramethylol
acetylenediurea
Uses
antifoulant
Materials
preservative
Industrial
preservative
PRIA
Due
Date
1/28/09
3/6/09
4/15/09
Registrant
Arch Chemicals, Inc.
Vertellus Health &
Speicality
Products, LLC.
ThorGMBH
Branch
RMBI
RMBI
RMBI
Comments
Renegotiated
Renegotiated
May need
additional
renegotiation
2. Pesticide Registration - New Uses
AD will complete 28 decisions. These decisions will provide new use opportunities to
the antimicrobial marketplace and will be made in accordance with the safety standards
of FIFRA and FQPA and in the timeframes set forth under FQPA and PRIA.
New Use Candidates for FY2009
Chemical
Zinc pyrithione
Triethylene glycol
Alkyl* dimethyl benzyl
ammonium chloride
*(50%C14,40%C12,
10%C16)
Silver
Ethaneperoxoic acid
Hydrogen peroxide
Hydrogen peroxide
Peroxyacetic acid
Alkyl* dimethyl benzyl
ammonium chloride
1-Decanaminium, N-
decyl-N,N-dimethyl-,
chloride
1-Decanaminium, N,N-
dimethyl-N-octyl-,
chloride
Tolylfluanid
Alkyl* dimethyl benzyl
ammonium chloride
*(60%C14, 30%C16,
5%C18, 5%C12)
Alkyl* dimethyl
ethylbenzyl ammonium
chloride *(68%C1 2,
32%C14)
Uses
Textile
Air sanitizer
HVAC
Food contact
sanitizer
Aseptic
packaging
change
Laundry
(higher rate)
Materials
preservative
Roof coating
Preservative
uses
PRIA Due
Date
7/15/09
12/09/08
11/24/08
3/09/09
2/10/10
3/16/09
1/24/09
3/3/09
3/24/09
Registrant
Arch Chemicals,
Inc.
Prolitec, Inc.
Aeris
Technologies
Ltd
ETI H2O, Inc
FMC
Ecolab
Mason Chemical
Company
Lanxess
Mason Chemical
Company
Branch
RMBI
RMBI
RMBI
RMBI
RMBI
RMBI
RMBI
RMBI
RMBI
Comments
Renegotiated
On Target
On Target
Renegotiated
On Target
On Target
On Target
On Target
On Target
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Alkyl dimethyl benzyl
ammonium chloride
Alkyl* dimethyl benzyl
ammonium chloride
1-Decanaminium, N-
decyl-N,N-dimethyl-,
chloride
1-Decanaminium, N,N-
dimethyl-N-octyl-,
chloride
2,6-Dimethyl-m-dioxan-4-
ol acetate
Silver chloride
Alkyl* dimethyl benzyl
ammonium chloride
Zincsulfate
monohydrate
Hydrogen peroxide
Ethaneperoxoic acid
Hydrogen peroxide
Dowicil 1M 75
Preservative
Bromine Chloride
Thymol
Cu-HDO
49403-GT
4 chloro-3,5-xylenol
Carbamic Acid
CupricOxide/Poly-B
1258-RGGR Calcium
Hypochlorite
83691-G Sodium
Hypochlorite
Triadimefon 39967-AO
Bromine
Application
rate increase
Materials
preservative
wallboard
Preservative
uses
Preservative
uses
Food contact
sanitizer
Swimming
pools
Commercial,
industrial,
institutional
use
Aseptic
packaging
Add Mineral
Slurries
Food
Contact
Sanitizer
Food contact
sanitizer
Aquatic Use
Material
Preservative
New use-
Leather
Increase
Retention
Rate in
wood
Swimming
Pool Uses
Toothbrush
Wood&
Material
Preservative
Drinking Water
2/28/09
1/26/09
5/6/09
6/12/09
5/16/09
4/10/09
4/24/09
8/20/09
10/08
11/08
1/09
4/09
4/09
4/09
4/09
4/09
5/09
7/09
8/09
Brinton
Products. LTD.
Mionix
Corporation
Dow
Clariant
Coporation
Stephan
Arch Chemicals,
Inc.
Clean Earth
Technologies,
LLC
Solvay
Dow
Albemarle
Toxcel
Toxcel
Clariant
Dow
Rutgers Organic
Arch
D. B. Square
LanXess Corp.
Halo Source
RMB1
RMB1
RMB1
RMB1
RMB1
RMB1
RMBI
RMB1
RMB2
RMB2
RMB2
RMB2
RMB2
RMB2
RMB2
RMB2
RMB2
RMB2
RMB2
On Target
On Target
On Target
On Target
On Target
On Target
Renegotiated
On Target
Complete
(withdrawn)
Complete
(registered)
Renegotiated
Renegotiated
On Target
On Target
On Target
On Target
On Target
On Target
On Target
3. Other PRIA Actions
Protocols - Develop criteria for tier 1 & tier 2 protocol reviews. Complete all internal
protocol reviews within the PRIA time lines. Post existing protocols to AD's website.
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4. Other Registration Activities
a. Make Barrier Determinations
The Agency is currently considering "barrier exemption" requests and intends to
complete them in FY09. There are no PRIA or FQPA due dates associated with
these actions.
B. Stewardship of Products on the Market
1. Registration Review
Complete 14 Scoping Assessments (SAs)\Preliminary Work plans (PWPs) and 13
Final Work Plans (FWPs).
These registration review actions represent the Division's contribution to the overall
OPP registration review performance goals. Completion of PWPs is achieved when
the Notice of Availability (NOA) is published in the Federal Register and the
associated public docket is opened. The interim milestones presented below will be
used to track progress:
Preliminary Work Plan Process Milestones
Chemical
Draft SAs
toRMB2
Draft
PWP
Peer
Review
Panel
Revised
SAs and
PWP
Brief DD
Final SAs
and PWP
Open
Docket
Quarter 1
Citric Acid, and salts
Mineral Acids
Ethanolamine, 2-
3H-l,2-Dithiol-3-one,
4,5-dichloro
10/31/08
10/31/08
10/31/08
10/31/08
11/7/08
11/7/08
11/7/08
11/7/08
11/13/08
11/13/08
11/13/08
11/13/08
12/1/08
12/1/08
12/1/08
12/1/08
12/8/08
12/8/08
12/8/08
12/8/08
12/15/08
12/15/08
12/15/08
12/15/08
Complete
Complete
Complete
Complete
Quarter 2
Inorganic Halides
Bromine Chloride
Zinc Salts
Bromine
p-Chloro-m-xylenol
1/30/09
1/30/09
1/30/09
1/30/09
1/30/09
2/6/09
2/6/09
2/6/09
2/6/09
2/6/09
2/12/09
2/12/09
2/12/09
2/12/09
2/12/09
2/27/09
2/27/09
2/27/09
2/27/09
2/27/09
3/5/09
3/5/09
3/5/09
3/5/09
3/5/09
3/12/09
3/12/09
3/12/09
3/12/09
3/12/09
3/25/09
3/25/09
3/25/09
3/25/09
3/25/09
Quarter 3
Silver Compounds
4/30/09
5/7/09
5/14/09
5/28/09
6/4/09
6/11/09
6/24/09
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2-
(Decylthio)ethanamine
Hydrochloride
2,4-
Imidazolidinedione, 3-
bromo- 1 -chloro-5 ,5-
dimethyl
4/30/09
4/30/09
5/7/09
5/7/09
5/14/09
5/14/09
5/28/09
5/28/09
6/4/09
6/4/09
6/11/09
6/11/09
6/24/09
6/24/09
Quarter 4
Tris(HOCm-)
Nitromethane
OBPA
Peroxy Compounds
7/30/09
7/30/09
7/30/09
8/6/09
8/6/09
8/6/09
8/13/09
8/13/09
8/13/09
8/27/09
8/27/09
8/27/09
9/3/09
9/3/09
9/3/09
9/10/09
9/10/09
9/10/09
9/23/09
9/23/09
9/23/09
Final registration review work plans are considered complete upon signature by Division
Director and posting to the existing docket. The following interim milestones will be used
to track progress:
Final Work Plan Process Milestones
Chemical
Response to
Comments
Draft FWP
Final FWP
FWP Docketed
Quarter 1
Oxazolidine-E
Caprylic Acid
11/3/08
11/3/08
11/24/08
11/24/08
12/15/08
12/15/08
Complete
Complete
Quarter 2
Biobor
Nuosept 145
11/3/08
11/3/08
11/24/08
11/24/08
12/15/08
12/15/08
12/17/08
12/17/08
Quarter 3
Citric Acid, and salts
Mineral Acids
HMAE
3H-l,2-Dithiol-3-one,
4,5-dichloro
5/13/09
5/13/09
5/13/09
5/13/09
6/3/09
6/3/09
6/3/09
6/3/09
6/23/09
6/23/09
6/23/09
6/23/09
6/25/09
6/25/09
6/25/09
6/25/09
Quarter 4
Inorganic Halides
Bromine Chloride
Bromine
p-Chloro-m-xylenol
Zinc Salts
8/3/09
8/3/09
8/3/09
8/3/09
8/3/09
8/24/09
8/24/09
8/24/09
8/24/09
8/24/09
9/14/09
9/14/09
9/14/09
9/14/09
9/14/09
9/16/09
9/16/09
9/16/09
9/16/09
9/16/09
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Post-RED Implementation
Complete 5 RED Addendum DocumentsYMemoranda.
The reregi strati on decisions listed below will be amended as a result of new data
becoming available or other comments received on the RED decision. These
actions will also begin the implementation process for Product Reregi strati on in
some cases. Not all of the interim milestones will apply depending on the nature of
the action.
Post-RED Implementation Process Milestones
Chemical
Risk Assessment
to RMB2
Stakeholder
Interaction
Closes
Revised Risk
Assessment
Draft
Addendum/Memo
Brief DD
Final Addendum/
Memo
Quarter 2
Phenols and Salts
Iodine
12/20/08
12/20/08
1/29/09
1/29/09
2/17/09
2/17/09
3/3/09
3/3/09
3/17/09
3/17/09
3/24/09
3/24/09
Quarter 3
DGH
12/30/08
2/27/09
5/13/09
6/4/09
6/18/09
6/25/09
Quarter 4
Zinc Pyrithione
Dimethyldithiocarbamate
salts
5/15/09
5/15/09
7/1/09
7/1/09
7/31/09
7/31/09
8/21/09
8/21/09
9/3/09
9/3/09
9/16/09
9/16/09
2. Product Reregistration
Complete 80 Product Reregistration Actions
These product reregi strati on actions represent the Division's contribution to the
overall OPP product reregi strati on performance goals. These actions may include
product reregistrations, amendments, suspensions and/or cancellations. This goal
accounts for over 58% of the anticipated number of pending products beginning
FY2009. Progress meetings are held monthly with the Deputy Office Director.
3. Data Call-Ins
Request OMB Clearance for 15 generic data call-in (GDCI) and product spedific
Data Call-Ins (PDCI) packages related to reregi strati on and 15 GDCI packages in
support of registration review - Total requests = 30
Issue 30 DCIs upon approval including some which were submitted to OMB in
FY'08.
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This entire activity does rely in part on the timeliness of OMB's review and
approval which presents a significant uncertainty to planning.
II. Homeland Security (Biodefense and Food/Agriculture Defense)
Homeland Security Presidential Directive (HSPD)-9 ("Defense of United States Food and
Agriculture") describes the President's national policy to prevent, detect, respond to and recover from
terrorist attacks, major disasters, and other emergencies for U.S. agricultural and food production
systems. Among other things, HSPD-9 states, "The Secretaries of Homeland Security, Agriculture,
and Health and Human Services, the Administrator of the Environmental Protection Agency,
and the heads of other appropriate Federal departments and agencies, in consultation with the Director
of the Office of Science and Technology Policy, will accelerate and expand development of current
and new countermeasures against the intentional introduction or natural occurrence of catastrophic
animal, plant, and zoonotic diseases." AD (with support from BEAD) will assist USDA with research
to determine the efficacy of disinfectants against highly pathogenic Foreign Animal Diseases (FAD)
by entering into a five year Interagency Agreement (IA) with USDA and providing funding,
management, and technical input for this project. The IA is entitled, "Disinfectant Efficacy Testing for
Foreign Animal Disease (FAD) Agents." This research program is intended to fill a major data gap
that exists for efficacy data for disinfectants used to inactivate FADs that pose the greatest potential
threat to agricultural animal populations and the U.S. economy.
Homeland Security Presidential Directive (HSPD)-IO ("Biodefense for the 21st Century") describes
the President's national policy to prevent, detect, respond to and recover from an attack with biological
weapons. Biodefense includes the testing and approval of chemical decontaminants ("antimicrobials")
for use in neutralizing or reducing biological pathogens. Because no antimicrobials are currently
registered for inactivating Bacillus anthracis spores and most biological warfare agents and because
there is a need to fill this gap, AD's activities will focus on (1) assisting BEAD in developing efficacy
test methods for antimicrobial products intended to be used against biological warfare agents or
significant, emerging pathogens, (2) issuing draft efficacy guidelines (Section 810.2100) for sterilants
and sporicidal decontaminants intended to inactivate anthrax spores, (3) reviewing and making
registration decisions on applications for registration of products intended to inactivate Bacillus
anthracis spores, and (4) coordinating appropriate homeland security issues with the Office of
Emergency Management (OEM) and the Office of Homeland Security (OHS).
Another homeland security-related effort concerns defining prions as "pests" under FIFRA so that
products intended to be used against prions are required to be registered as antimicrobial pesticides.
Prions are the putative causative agent for "transmissible spongiform encephalopathies" (TSE) such as
"mad cow" disease in cattle, scrapie in sheep, and Creutzfeldt-Jakob disease in humans. In September
2003, OPPTS decided that prions are pests. In September 2007, the AA/OPPTS signed an Early
Guidance memo directing OPP to develop a Notice of Proposed Rulemaking (NPRM) that will
propose to incorporate that decision into EPA's regulations (i.e., 40 CFR 152.5). This rulemaking is
being tracked in RAPIDS and SCOUT. The NPRM is currently planned to be presented to the FIFRA
Scientific Advisory Panel in April 2009 and signed by the AA/OPPTS in March 2010.
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III. Enhancement of OPP's Science and Policy Framework
A. AD is working with OECD and NAFTA on global data harmonization efforts such as:
1. Update final draft guidance for NAFTA labels for hard surface disinfectants as
necessary and continue to identify and establish joint review related initiatives.
2. Continue as the Project Manager Co-Chair overseeing the OECD validation testing
of a new quantitative hard surface disinfectant test method. Continue to work with
BEAD on method improvements for the quantitative test.
3. Continue working with OECD to finalize the Guidance Document on the Evaluation
of the Efficacy of Antimicrobial Treated Articles with Claims for External Effects.
Support efforts to advance guidance document to full OECD Test Guideline
Validation.
4. Continue working with OECD to finalize the Draft OECD Guidance Document for
Establishing the Efficacy of Biocides Used in Swimming Pools and Spas.
Participate on an ad hoc group (other participates: Australia, Ireland, Spain, the UK)
to explore developing guidelines, at a minimum, for pools and spas.
5. Support development of proposed OECD Test Guidelines and Guidance documents
(e.g., proposed OECD antifoulant release rate methodology). (Ongoing effort)
6. Support development of proposed OECD harmonization efforts or projects that may
arise (e.g., possible project re: harmonization of human and/or environmental
exposure/risk assessments for ballast water uses). (Ongoing effort)
B. Work with other Federal Agencies
1. Continue working with Federal and state government agencies on mold remediation
and address other environmental issues.
2. Clostridium difficile: Work with CDC, FDA, academia, and the BEAD
Microbiology Laboratory to identify a target strain and sporulation medium for
achieving high liters of spores to be used in testing products against Clostridium
difficile spores. Issue interim guidelines for conducting testing to support
Clostridium difficile label claims.
3. Working with the U. S. Coast Guard (USCG), develop policy and technical
procedures related to ballast water (BW) management, both domestically and
internationally. Provide technical expertise to the USCG who has the lead on
regulation of ballast water uses in U. S. (Ongoing effort)
C. Work with Other Program Offices (Outside of OPP)
1. Working with OPPT, develop guidance and/or a framework for Structure Activity
Relationship (SAR) analyses and environmental modeling. (Ongoing effort)
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2. Coordinate a stakeholder process exploring the re-use, recycling and/or disposal of
treated wood products at the end of their service life (e.g. railroad ties and utility
poles). This activity will involve extensive interactions with OPPT and OSWER.
The results of this process will be captured as a Post-RED Implementation activity.
3. Ammonia Petition -Continue meetings with OW to discuss use of ammonia in the
disinfection of drinking water. Make a final determination on the Petition.
4. Monitor and support OPPT/ORD development of Agency-wide cancer and non-
cancer toxicological endpoints for formaldehyde. Once the endpoints have been
finalized OPP may need to revisit its previous decisions on formaldehyde and
formaldehyde-releasing chemicals.
5. Will coordinate Post-RED Implementation activities for Iodine with the Office of
Water. OW expressed interest in the risk assessment and risk management
decisions for Iodine during the comment period and OPP is exploring ways to
address their concerns in a possible addendum to the RED.
D. Other Program Efforts (Within OPP)
1. Work with BEAD and commercial microbiology testing laboratories to improve test
methods for towelette products.
2. Participate in the steering committee that will manage the development and
validation of methods for hard surface uses against biofilm.
3. Work with BEAD and industry to conduct a workshop to investigate procedural
enhancements to the AOAC Use-Dilution Method. Publish FR Notice announcing
AOAC Use-Dilution Method Workshop (FY'09)
E. Pesticide Environmental Stewardship Program (PESP)
1. Coordinate activities such as the HVAC PR notice with the Antimicrobials Sector in
the PESP program. The National Air Duct Cleaners Association (NADCA) are
charter PESP partners.
2. Continue to coordinate key label/science issues with the American Public Health
Laboratories (APHL).
3. Working with the IPM Institute of North America which is pilot testing an
antimicrobial evaluation tool for their IPM Star program (a written school
assessment tool), widely used in schools across the U.S. (partnering with Sherry
Glick, BPPD Schools Sector Lead).
F. Additional Initiatives
1. Publish the 810 efficacy guidelines specifically for sterilant, disinfectant, and
sanitizer products for public comment.
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2. Continue the update of the 810 efficacy guidelines for air, water, and textile
materials.
3. Evaluate the possibility of adopting the American Dental Association/American
National Standards Institute (ADA/ANSI) guidelines and test methods for
antimicrobial pesticide uses in dental unit waterlines.
4. Present HVAC PR Notice by 12/9/08 to SFIREG; Issue HVAC PR Notice in final
form by 6/18/09.
5. Hold 158W workshop on 11/6/08. Proposed Rule for 158W was published on
October 3, 2008.
6. Obtain OD agreement on revised ATP program plan. Implement new testing and
communications strategies.
7. Expand the use of Structural Activity Relationship (SAR) evaluations in human
health and ecological risk assessments.
8. Update OECA on which companies marketing ion generators expressed interest in
registering their product. Companies that did not already submitted the required
documentation may be subject to enforcement action.
9. Continue to provide input on pandemic influenza preparedness plans. Develop a list
of registered products with human Influenza label claims.
10. Complete the majority of all general ECR's within the established OECA
timeframes.
11. Continue to integrate enforcement compliance requests (ECRs) from the ATP
program into the general ECR tracking program.
12. Support development of a framework to register new pesticide active ingredients
that utilize nanotechnology. This framework should consider scientific
uncertainties, policy, and regulatory implications. The work will be accomplished
through an intra-office workgroup and in coordination and consultation with other
EPA offices, other Federal agencies, other countries and stakeholders.
13. Continue to assist in OPP-wide efforts to evaluate use of "eco-labeling" for
pesticide products, including evaluating the appropriateness of the DfE program for
pesticide products. Initial recommendations from the PPDC Workgroup on
Comparitive Safety Statements will be made to full PPDC in October 2008.
14. Working with American Chemistry Council (ACC) to assess environmental
exposure (using new modeling approach) from uses of copper (Cu) which includes
copper-impregnated roof shingles and copper-treated wood structures (e.g., decks,
fences). Critical to finalizing the environmental risk portion of copper RED (due for
completion in FY09).
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15. Participate in OPP workgroup to develop options for implementing Globally
Harmonized Systems for OPP labels and provide recommendations and options for
implementation in OPP.
16. Continue coordination with other offices in EPA for comments on mold guidance
PR-Notice. The guidance will be submitted to OMB for the significant guidance
determination in FY09.
17. Draft second FR Notice notice further clarifying that the Agency has determined
certain devices are pesticides and therefore are subject to FIFRA regulations.
Notice will establish timeline and process for obtaining registration.
18. The Antimicrobial Exposure Assessment Task Force II (AEATF II) is in the process
of submitting exposure study protocols for generating generic exposure data on a
broad range of use patterns and associated application methods to support
registration and re-registration by its member companies. AD will review the
protocols and prepare associated materials for presentation and submission to the
Human Subjects Review Board (HSRB). After the studies are completed, AD will
review the results and prepare associated materials for a follow-up presentation to
the HSRB. It is anticipated that AD will attend the HSRB meetings twice a year,
presenting one or two AEATF protocols or studies each time.
19. Fuel Ethanol Production - Publish a guidance document for antimicrobial use in the
ethanol fermentation process on our web site. Get final concurrence from FDA.
20. In an effort to improve upon the consistency of antimicrobial labeling, AD will
implement a QA/QC Program for Labels. This Program includes a 10% review of
antimicrobial labeling related to both registration and reregi strati on. The review
will take place every Thursday and before the final label has been approved.
IV. OPP's Overall Programmatic Management to Allow Us to Better Deliver on Our Vision
A. Information Management/Information Technology
1. PRISM- Review requirements and work with ITRMD and the other divisions to
effectively implement PRISM as a solution strategy / application to unify and
replace current systems including OPPIN and related Lotus Notes databases.
The following areas will be the major focus for AD during the requirements and
1st phase implementation of PRISM:
a. Document Management - Continue to work on the OPP Scanning
Workgroup to consolidate scanning efforts office-wide and to develop
a structure and format for housing all our electronic documents and
records which will be supported by the agency approved software -
Documentum (The OPP Enterprise Document Management System).
b. Electronic Labeling & Data Submission - Continue to encourage
registrants to submit information electronically as well as develop
strategies for improving how we handle and process these submissions
quickly and efficiently.
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c. e-Submission - Work with ITRMD to develop a workflow and process
for handling electronic submission in OPP specifically registration and
reregi strati on processes and workflow for AD.
2. Web Content Management /Public Documents - Continue to create HTML and
PDF documents for antimicrobial information being released to the public by
posting on EPA's website under the direction of ITRMD's Web Team in
conformance with all EPA standards and guidelines. This includes the transition
to the new Federal Register templates, Federal Docket Management System
(FDMS), and use ofRegulations.gov for release of public information.
3. GovTrip - Continue to process travel for Division employees and using
GovTrip as the online booking agent.
4. PeoplePlus/TAIS - Time and Attendance Management will be supported by the
timekeeper and administrative staff for all divisional employees using the
PeoplePlus system.
5. Correspondence Tracking- Continue tracking divisional correspondence not
tracked through other databases using the AD Correspondence Tracking System
developed in Lotus Notes and Chronological Files maintained by administrative
assistants. For over a year, AD has tracked AX, AL, and OPPTS
correspondence via the Agency's Correspondence Management System (CMS),
and will continue its efforts to support these systems.
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B. Results/Measures:
AD continues to collaborate with other Divisions to evaluate its human health indicators and
measures with regards to EPA and OPP's efficiency. Following are some measures and data sources
the Division will continue to evaluate and monitor:
1. Confirm the Efficacy of Hospital Disinfectants
The Antimicrobial Testing Program (ATP) was initiated in response to findings
presented by the Government Accounting Office (GAO) which indicated 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). ATP
Implementation provides increased assurance antimicrobial products used in hospital
settings are efficacious potentially reducing the incidence of nosocomial infections.
AD will review industry provided and other related data that may demonstrate
antimicrobial product effectiveness in reducing disease and infection outbreaks. Initial
finding and data sources should be presented by stakeholders by Spring 2009.
2. Homeland Security Readiness — Decontamination
Anthrax/Decontamination Product Listing — Once one or more products have been
registered with a claim to inactivate B. anthracis spores (anthrax-related), post a list of
those products on AD's web site. It is possible that one product may be registered in
FY2009.
AD is developing draft guidance on efficacy testing required to support an anthrax-
related claim. This draft guidance is expected to be made available for public comment
in FY 2009 as an amendment to the 810 efficacy guidelines.
The EPA-USDA Interagency Agreement (IA) outlines three tasks to be completed in
FY2009: (1) develop a Quality Assurance Project Plan (QAPP), (2) conduct a literature
search for efficacy studies involving foreign animal disease agents, and (3) develop and
select standardized laboratory techniques to measure the efficacy of decontamination
products. These tasks will provide the foundation for efficacy testing to be conducted
in subsequent one-year segments that will continue under the IA.
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C. Resource Management
Gateway to Market
Goals for FY2009
Complete 3 new active ingredient decisions in
accordance w/ FIFRA and FQPA safety standards
while meeting FQPA and PRIA deadlines
Complete 27 new use decisions in accordance
w/FIFRA and FQPA while meeting FQPA and
PRIA deadlines
Develop criteria for tier 1 & tier 2 protocol reviews
Complete barrier exemption requests possibly as
early as 1st Quarter FY09
Complete request for Experimental use permit
possibly as early as the 1st Quarter FY09
Workplan Title
Registration: New Active
Ingredients
Registration: New Uses
Other PRIA Actions
Other Registration Activities-
Make Barrier Determinations
Other Registration Activities-
Make EUP Determinations
Gateway to Market
Item
Total FTEs
Total Travel $
Total Extramural $
Total Intramural $
Total
32
$20K
$837.5K
$2K
Stewardship of Products on the Market
Goals for FY2009
Complete 14 Scoping assessments
(SAs)]\Preliminary Work Plans (PWPs)
Complete 13 Final Work Plans (FWPs)
Complete 5 RED Addendum
DocumentsMVIemoranda
Complete 80 product reregistrations
Send 30 requests to OMB for Clearance
• 1 5 DCIs and PDCIs for all completed REDs
• 15 GDCI for support of Registration Review
Workplan Title
Registration Review
Registration Review
Post RED Implementations
Product Reregi strati on
Data Call-Ins
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Stewardship of Products on the Market
Mail 15 DCIs upon approval including ones
requested in FY08
Data Call-Ins
Assist BEAD in developing efficacy test methods
for antimicrobial products intended for use against
biological warfare agents or significant emerging
pathogens
Homeland Security and
Biodefense
Stewardship of Products on the Market
Item
Total FTEs
Total Travel $
Total Extramural $
Total Extramural/Homeland Security $
Total Intramural $
Total
22
$20K
$200K
$350K
$16K
Enhancement of OPP's Science and Policy Framework
Goals for FY2009
Workplan Title
Continue discussions between AD and
Canada, Mexico to develop guidance on
NAFTA label and joint review initiatives;
Continue working with OECD on
developing harmonized test guidelines for
hard surface disinfectants and treated
materials;
Continue working with OECD on
finalizing guidance document for efficacy
testing of swimming pool and spa products;
Expand the use of Structural Activity
Relationship process;
Work with OECD and NAFTA
• Continue working with Federal and State
Government agencies on mold remediation
activities.
Work with Other Federal Agencies
Continue collaborating with commercial
efficacy testing laboratories to develop
improvements to antimicrobial efficacy test
methods
Continue the update of the air, water, and
material textile product performance
guidelines for antimicrobial pesticides
Communicate HVAC PR Notice issues and
activities.
Other Initiatives
16
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Enhancement of OPP's Science and Policy Framework
Item
Total FTE
Total Travel $
Total Extramural $
Total Extramural for Technical NOWSEE Homeland
Security
Total Intramural $
Total
12
$3 OK
$25K
$65K
$2.2K
Overall Programmatic Management to Allow Us to Better Deliver On Our Vision
Goals for FY2009
• Document Management - Work
with OPP Scanning Group
• Records Management
• Information Management/
Technology
• Web Content Management
• Electronic Labeling an Data
Submission
• GovTrip
• PeoplePlus/TAIS
• Correspondence Tracking
• Quality Assurance/Quality Control
• Contracts
• Budget
• Human Resource
Continue collaboration with other
Divisions to collectively develop human
health indicators and measures with regards
to EPA and OPP's efficiency
Workplan Title
Information Management/Information
Technology
Results/Measures
Overall Programmatic Management to Allow Us to Better Deliver On Our Vision
Item
Total FTE
Total Travel $
Total Extramural $
Total Intramural $
Total
6
$10K
$25K
$2.2K
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Current Antimicrobials FTE Resources
(Table excludes DD, ADD, and EC's)
Activity
Administrative (Budget, Human
Resources, Facilities, Contract
Management and IT
Homeland Security
Ombudsman/Communications
Post-RED Follow-up
Product Reregistration
Registration
Registration Review
Senior Scientists
OECD/NAFTA
Special Projects (Policy & interpretative
• i -t -t \
guidance development)
Stay-in-School Students (2)
Leave Without Pay
TOTALS
IO RMBI
FTEs FTEs
4.5
1.0
2.0
0.1
7.8
2.5
1.0
4 2.1
1.0
1
14.0 13.0
RMBII
FTEs
2.5
2.0
7.0
5.5
1.0
18.0
RASSB
FTEs
2.0
8.0
6.5
0.25
0.25
17.0
PSB
FTEs
0.10
0.25
1.0
1.0
6.5
0.15
1.0
10.0
TOTAL
FTEs
4.6
1.25
2.0
5.5
3.1
29.3
12.0
2.65
1.25
7.35
2.0
1
72.0
18
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