United States
         Environmental Protection
Prevention, Pesticides
And Toxic Substances
EPA 739-R-99-003
December 1999
v>EPA  Streamlining Registration
        of Antimicrobial Pesticides
         1998-1999 EPA Progress Report


           Antimicrobials Division
         Office of Pesticide Programs
      U.S. Environmental Protection Agenc
             Washington, DC

             December 1999

 This report was prepared by the Antimicrobials Division, Office of Pesticide Programs,
 U.S. Environmental Protection Agency.
 To contact the Antimicrobials Division:
 Fax:   703-308-4687
 e-mail: last name.firstname@epa.gov
 Mailing address
 Name of Person
 Antimicrobials Division (75IOC)
 401 M Street, SW
 Washington, DC 20460
 Division Director:                 Frank Sanders
 Acting Associate Division Director: Walter Francis
 Outreach Team:                   Yvette Hopkins (ph: 703-308-6214)
                                 Dennis Edwards (ph: 703-308-8087)
National Antimicrobial Information Network (NAIN)
ph 1-800-447-6349; fax 541-737-0761; e-mail: nain@ace.orst.edu;
Web site: http://ace.orst.edu/info/nain/
Monday through Friday 7:30am to 4:30pm, Pacific time.

To obtain additional copies of this report  (Pub # 739R99003)
National Service Center for Environmental Publications (NSCEP)
ph:  1-800-490-9198
fax: 513-489-8695
e-mail: http://www.epa.gov/epahome/publicat.htm (all lower case)

OPP web site: http://www.epa.gov/opp



      Definition, uses, and regulation of antimicrobial pesticides  	 1
      Jurisdiction of FDA and EPA over Antimicrobials in Food	 2
      Creation and Structure of Antimicrobials Division	 4

      New TBT Alternatives Registered	 5
      Review Periods Specified in 1996 FIFRA Amendments	 6
      Accomplishments	 6


      Pre-application Consultation on New Active Ingredients or New Uses  	 8
      Policies	 8
             40 CFR 152 and 156  	 9
             40 CFR 158 	 9
             The OECD Biocides Steering Group	 9
             NAFTA  	  10
             Liquid Chemical Sterilants 	  11
             Treated Articles Exemption	  11
             Guidance on Registration of Manufacturing Use Products (MUPs)	  12
      Responses to Requests for Information	  12

      Sources of Expertise  	  13
      Ensuring Efficac  	  13
             Developing Alternative Efficacy Tests for Hepatitis B Virus
                   (HBV) Virucides	  14
             Post-Registration Efficacy Testing of Public Health Antimicrobials	  14
             Alternative Treatments for Infectious Medical Waste	  15
             Role of Antimicrobials in Preventing Foodborne Infections	  16
      Other Science Issues	  17
             Exposure Research	  17

      Publicizing Enforcement Actions 	  18
      Presentations and Workgroups   	  18
      Stakeholder Meetings  	  19

CONTENTS (cont'd)

      Annual National Antimicrobials Workshop 	,	  19
      Coordination with Infection Control Specialists in Medical Facilities 	  20
      National Antimicrobial Information Network (NAIN)  	  20

      Reregistration Plans	  21
      Heavy Duty Wood Preservatives	  21

      In-House Training 	  21
      On-Site Education 	  22




                PESTICIDES 	  28

                               EXECUTIVE SUMMARY

       EPA has prepared this 1998-1999 progress report in response to a requirement in
Section 3(h)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
by the Food Quality Protection Act (FQPA) of 1996. The report describes FY 98 and FY 99
Agency actions related to streamlining registration and reregistration of antimicrobial pesticides in
order to improve EPA's ability to protect public health and the environment.  This report also
focuses on EPA's efforts to ensure that sound science underpins all antimicrobial decisions, and
that stakeholders have ample opportunity to provide input before final decisions are made.

       The Agency has made substantial progress in fulfilling the antimicrobial provisions of
FQPA.  A backlog of pending actions has been reduced from a high of 388 on
December 31,1996, to only 24 as of September 30,1999. All registration submissions with
FQPA review period deadlines were completed in shorter times than required. Proposed revisions
to rales in 40 CFR parts 152 and 156, which concern testing, labeling, and registering
antimicrobial pesticides, were published in the Federal Register on September 17, 1999, for
formal public comment.  The proposed revisions focus on streamlining registration procedures for
antimicrobial pesticides. Another proposed rule affecting 40 CFR part 158, which also concerns
testing antimicrobial pesticides, is scheduled to be published in FY 2000 for public comment.
The drafts of these proposals have benefitted from prior informal review by diverse stakeholder

       EPA has taken major steps to address  the proliferation of unregistered "treated articles,"
such as cutting boards and kitchenware, that make unlawful pesticidal claims, and could lead to
increased public health risks. Over 20 enforcement actions had been taken against non-complying
companies as of September 30, 1999, and more than $1,000,000 in fines were collected to further
assure compliance with the law.  EPA expects to issue a guidance document in FY 2000 that
clarifies which products may qualify for the "treated articles exemption," and therefore may be
exempt from registration.

       The Antimicrobials Division (AD) of EPA's Office of Pesticide Programs uses sound
science in its efforts to protect the public's health. More than one-half of AD's 5,000 registered
products are designed to protect humans from infectious disease. It is crucial that these products
perform as claimed after they are on the market. Therefore, the division supports an ongoing post-
registration testing program, currently giving highest priority to tuberculocides and hospital
disinfectants. As part of its program to develop and approve innovative test methods, the division
organized a workshop in July 1998 to discuss pros and cons of proposed new  test protocols for
virucides against Hepatitis B Virus (HBV).

       In March 1998, EPA approved several new antifouling paint products as alternatives to
tributyltin (TBT) products for protecting boat bottoms and hulls. These new antifoulants appear
to present less risk for the aquatic environment than TBT products, and are  expected to help speed
the world-wide phase-out of TBT antifoulant products.

       Sharing information with users of antimicrobial products benefits all parties.  As one
example, AD's ongoing relationship with the Association for Professionals in Infection Control
and Epidemiology (APIC) has led to suggestions for making hospital disinfectant labels and
packaging more "user friendly." EPA plans to increase its contact with stakeholders as it takes
steps to further streamline antimicrobial registration processes and continue to implement
provisions of FTJFRA designed to enhance protection of public health and the environment.

                          STREAMLINING REGISTRATION
                         OF  ANTIMICROBIAL  PESTICIDES

                             1998-1999 EPA Progress Report
                                  I. INTRODUCTION

       The landmark Food Quality Protection Act of 1996 (FQPA) was signed on August 3,
1996, by President Bill Clinton.  Its major goals were to better protect the public—especiall
children—from exposure to harmful pesticides in foods and to improve registration processes
related to non-food pesticides. The FQPA provisions amended the Federal Insecticide, Fungicide,
and Rodenticide Act (FCFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section
3(h) of the amended FEFRA (see Attachment A) addresses Antimicrobial Pesticide Registration
Reform and requires EPA to submit an annual progress report to the Committee on Agriculture of
the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the
Senate that covers three topics related to registration of antimicrobial pesticides. The yearl
reports, required until specific statutory goals are achieved, "shall include a description of-

       "(i)   measures taken to reduce the backlog of pending registration applications;

       "(ii) progress toward achieving reforms under this subsection [among other things,
       subsection describes new review deadline goals and types of streamlining processes EPA
       should consider to speed up antimicrobial pesticide registration decisions]; and

        "(iii)  recommendations to improve the activities of the Agency pertaining to
       antimicrobial registrations."

       This EPA report covers the Agency's activities during Fiscal Year (FY) 1998 and
FY 1999 in the three areas identified above.  But the report goes further, by showing how EPA is
responding to both the statutory requirements and the spirit of the law. Since the FQPA was
passed, significant changes have occurred in the way EPA manages antimicrobial registration
activities. The backlog of applications for registration  activities has been greatly reduced; fast-
track statutory deadlines are being met; registration submissions are being processed more quickl
than in the past; and outreach activities are involving stakeholders in an ongoing dialogue about
the best ways to protect human health and the environment while streamlining registration

Definition, uses, and regulation of antimicrobial pesticides

       According to FEFRA amendments, an antimicrobial pesticide is a pesticide that is intended
to "(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological
organisms, or (ii) protect inanimate objects, industrial processes or systems, surfaces, water, or

other chemical substances from contamination, fouling, or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime." Further, the intended use must be "exempt from, or
otherwise not subject to, a tolerance under Section 408 of the Federal Food, Drug, and Cosmetic
Act (FFDCA) or a food additive regulation under Section 409 of such Act." This categor
encompasses pesticides with a wide array of uses, such as preserving agents in paints,
metalworking fluids, wood supports, and many other products to prevent their deterioration.  The
statute includes provisions which exclude certain uses or products from the category.

       Antimicrobials are especially important because many are public health pesticides. The
help to control microorganisms (viruses, bacteria, and other microorganisms) that can cause
human disease. Antimicrobial public health pesticides are used as disinfectants in medical
settings, where they are present in products used in cleaning cabinets, floors, walls, toilets, and
other surfaces. Proper use of these disinfectants is an important part of infection control activities
employed by hospitals and other medical establishments. According to the most recent data
available from the Centers for Disease Control, 1.9 million patients out of 35.9 million hospital
admissions were infected during their hospital stay.  A substantial decrease in that number would
be a significant public health accomplishment. EPA also registers many consumer products as
disinfectants, which consumers use to decrease the number of microbes on surfaces such as toilet
bowls or sinks.  Because microbes are invisible and users cannot determine if the disinfectant is
working, EPA reviews public health pesticides for efficacy as well as safety.

Jurisdiction of FDA and EPA over Antimicrobials in Food

       Before FQPA was enacted, EPA and FDA shared responsibility for regulating
antimicrobial substances that could result in residues in food. These antimicrobial substances
included products that control microorganisms that may be present in or on food, in water that
contacts food, and on surfaces and articles that may come in contact with food (e.g., counter tops).
The FQPA amendments to the FFDCA had the significant impact of shifting some food safet
authority previously exercised by FDA to EPA.

       Subsequent to the enactment of FQPA, Congress  passed the Antimicrobial Regulation
Technical Corrections Act of 1998 (ARTCA) on October 30, 1998, as an amendment to FFDCA.
According to the legislative history that accompanied the amendment, the following are the
jurisdictional authorities for FDA and EPA for food  contact  antimicrobials.

       Consistent with FDA's traditional broad regulatory authority of food products and
processing, FDA regulates under the FFDCA residues in  food from use of antimicrobials in food
processing and packaging.

       Consistent with EPA's traditional role in reviewing uses of antimicrobials in agricultural
applications, EPA retains authority to regulate residues of antimicrobials used on raw agricultural
commodities and water used for washing these commodities. Such antimicrobials would also be
regulated as pesticides under FTFRA .

       EPA also has regulatory authority over residues of the fumigants ethylene oxide and
propylene oxide under FTFRA and the FFDCA whether these fumigants are used on raw or
processed food.

       The following table provides a handy reference to the two agencies' jurisdictional
responsibilities at a glance.

Table 1. Jurisdiction under FFDCA over residues of antimicrobial substances
                                  in or on fooda
Use sites/categories
1. Edible raw agricultural
2. Process water that
contacts edible food
3. Edible processed food
4. Animal drinking water
5. Permanent or semi-
permanent food-contact
6. Production of food
packaging materials and in
or on finished materials,
including plastic, paper, and
Subcategories, if applicable
a. Pre- and post-harvest field
use on crops
b. In a food processing
facilit b
c. Consumer use (e.g., home
a. Post-harvest treatment0 of
raw agricultural commodities
b. In a food processing facilit
c. Consumer use (e.g., home
produce washes for raw
agricultural commodities)
All usesd
Uses other than animal drugs
All sites, including food
processing facilities
All, regardless of whether the
food to be packaged is a raw or
processed food
Current Jurisdiction
under FFDCA

Use sites/categories
7. Production of food-
contact articles, other than
food packaging
Subcategories, if applicable
a. No intended antimicrobial
effect in the finished article;
any ongoing effect is not an
effect on the surface of the
b. An intended ongoing
antimicrobial effect on the
surface of the finished article
Current Jurisdiction
under FFDCA
       The term "food" is defined according to FFDCA sec. 201(f).
       bEPA has used this term for convenience in this overview table. FFDCA sec. 2(q)(l)(B) describes the scope
of activities to include "locations where food is prepared, packed or held for commercial purposes."
       °EPA has used this term for convenience in this overview table. FFDCA sec. 2(q)(l)(B) describes the scope
of these treatments to include (1) treatments in facilities where the treatment does not change the raw agricultural
status of the food; and (2) treatments applied during transportation between the field and the treatment facility.
       Includes spices, except ethylene oxide, which is regulated by EPA.

Creation and Structure of Antimicrobials Division

       In February 1997, EPA's Office of Pesticide Programs (OPP) created its Antimicrobials
Division (AD) to provide the structure and staff needed to respond to the law. While OPP is
responsible for the regulation of  all pesticides, AD is responsible for all activities related to
regulation of antimicrobial pesticides. Currently, the division has 64 full time staff; 8 Senior
Environmental Employees (SEE's), 2 stay-in-school's,  1 intern, and 2  full-time staff on detail.

       During 1998, AD modified its organizational structure so it could serve the public more
effectively (see Attachment B for AD's organization chart). Science activities to support
regulatory actions are handled by two branches instead of one: the Risk Assessment and Science
Support Branch (RASSB) and the Product Science Branch (PSB). This change provides more
effective management control for a science  staff of more than 25 people. The change also largel
separates registration activities related to active ingredients (handled by RASSB) from activities
related to end-use products (handled by PSB).

       Registering and reregistering active ingredients requires intense analysis of a relativel
small number of submissions and products.  By contrast, registering and reregistering end-use
products requires less intensive analysis for a much larger number of submissions and products.
In terms of scientific specialties,  RASSB staff specialize in analyzing data on product chemistr
(active ingredient focus), pesticide residue chemistry, toxicology, ecological effects,
environmental fate, and environmental and  human exposure. PSB staff address efficacy, product
chemistry, and product toxicology.

       These organizational modifications have also created a focus for outreach and
reregistration.  There is now an Outreach Team, and a Reregistration Team and its supporting
science team, RASSB Team 3. The Outreach Team handles all antimicrobial activities related to
outreach, communications, enforcement, and liaison with states and regions, thus allowing for
strategic planning and coordination. Similarly, the Reregistration Team is organizing and
implementing AD's reregistration strategy to identify milestones and ensure that deadlines are
met. RASSB's Team 3 ensures that science support is available to the Reregistration Team.


       EPA reviews public health and non-public health pesticides for safety and efficacy in
accordance with review periods mandated by FQPA. As part of this registration process, the
Agency also seeks ways to introduce safer antimicrobial products in a timely fashion. To that end,
AD encourages the development of antimicrobial products that can serve as reduced-risk
alternatives to existing products that pose higher health and environmental risks.

New TBT Alternatives Registered

       On March 20, 1998, the Antimicrobials Division registered five alternatives to tributyltin
(TBT) antifouling paint products. These alternatives contain the new active ingredient, Irgarol, in
combination with copper to enhance efficacy.  The new antifouling products are approved for
vessels of any size, and appear to present less risks to the environment than TBT products.

       Antifouling paints are paints applied to the underwater portions of boats, ships, and other
marine structures to protect against the attachment of fouling organisms. These organisms include
bacterial slimes, underwater grasses, tubeworms, and barnacles, which can increase fuel
consumption from drag as the vessel moves through  the water.

       Several unique features to protect human health and the environment mark EPA's review
of TBT alternatives. EPA is requiring extensive environmental data, such as sediment toxicit
studies, to determine the toxicity of antifoulants after they bind to sediments. In addition,
registrants are providing data for estimating exposures to applicators and other shipyard workers
to help ensure that their risks are minimized.

       The Agency is also working with the International Maritime Organization in support of the
proposed phase-out of TBT antifoulants, beginning in the year 2003.

       Since 1988, the United States and other industrialized countries have prohibited the use of
antifoulants containing TBT on non-aluminum-hulled vessels shorter than 25 meters. The length
restriction was chosen because only these smaller boats can enter shallow, slow moving water,
where TBT products cause the greatest ecological damage to aquatic life.  This prohibition greatl
reduces the number of vessels and the total surface area on which TBT can be used, thereb
decreasing TBT exposure to aquatic organisms. Despite noticeable improvement in levels of TBT

in the water column at U.S. sites in the 10 years since the TBT restrictions took effect, TBT is still
present in the aquatic environment at levels that harm organisms such as snails and oysters.
While some environmentally preferable antifoulants are now available, and others that are
potentially  preferable are in development, the availability of substitutes for TBT that have
adequate effective lifetimes and are economical remain of great concern to the shipping industr
and U.S. shipyards.

Review Periods Specified in 1996 FIFRA Amendments

       The Food Quality Protection Act of 1996 (FQPA) amended FIFRA to establish ambitious
review period goals for actions related to registering most antimicrobial pesticides (see Table 2;
Attachment A, Sec.  3(h)(2)). The amendments also established alternative review periods, which
were the same or longer than those in FIFRA Sec. 3(h)(2). Because the Agency did not issue final
antimicrobial pesticide review regulations by the statutory deadline (April 28, 1998), these
alternative review periods are now in force (see FIFRA Sec. (3)(h)(3)(D)).  Missing any of these
alternative review periods may provide grounds for an applicant to seek review by a court, unless
the applicant  and the Agency agree to a later date..

       To better serve its applicants, EPA decided to implement the shorter review periods
voluntarily for all submissions received after November 1,1996. During FY 98 and FY 99, EPA
made all decisions on covered applications within the review periods established by FQPA.  The
Agency intends to continue to meet these shorter review period deadlines, even though the
statutory requirements now in effect allow EPA to adhere to the more generous alternative review
periods.  By making regulatory decisions within the  shorter review periods, EPA is meeting both
the intent of the law and the needs of registrants and the public for faster decisions.


       During FY 98 and 99, EPA continued to meet FQPA review periods for making  regulator
decisions on virtuall all covered applications (FIFRA (Sec. 3(h)(3)(D)). As seen in Table 2, the
Antimicrobials Division made 2420 decisions on the major regulatory categories in FY 98 and
1858 in FY 99.  These decisions resulted in 953 new or amended products  (excluding
notifications1) in FY 98 and 959 new or amended products (excluding notifications) in FY 99. In
other accomplishments related to FQPA, AD further reduced its backlog of pending actions..
       'Notification refers to a company's addition of relevant information to a label (i.e., information on product
efficacy, product composition, or other characteristics of an antimicrobial product that do not relate to pesticide
claims or activity).

Table 2. Number and Types of Actions that the Antimicrobials Division Completed Within the
                   Prescribed FQPA Review Periods in FY 98 and FY 99.

Old Chemical (Fast Track1)
Old Chemical (Non-Fast Track)
Amendments (Fast Track)
Amendments (Non-Fast Track)
           Track is defined as any action completed in 90 days or less.

      EPA's backlog of pending actions on antimicrobials was down to 28 items at the end of
FY 98 and 24 items at the end of FY 99 (Table 3). Overall, EPA's antimicrobial backlog
continues to remain approximately 1% of the total number of regulatory receipts (over 2,000 in
FY 99).  Because EPA has been meeting FQPA review period deadlines as described above, the
backlog consists only of actions that are not subject to specified review periods in the FQPA 1996
amendments to FIFRA.

Table 3.  Number and Types of Items in Antimicrobials Division Backlog, September 30,1999.

Action items



New use









fast track







       Non-FQPA action items, such as actions on certain antifoulant paints and on food use pesticides, are those
for which FIFRA does not specify review times. Non-FQPA items are counted in the backlog if EPA does not meet
review period goals that it set voluntarily.

                           IV. STREAMLINING ACTIVITIES

       To meet the statutory goals for decision-making based on the Section 3(h)(2) review
period deadlines in the FQPA amendments to FIFRA, AD needs to ensure that it uses efficient
processes and that it clearly lays out its policies in new rules and guidelines.  The Division has
made significant progress in improving its processes and in developing a new antimicrobial rule,
which is now in the proposal stage.

Pre-application Consultation on New Active Ingredients or New Uses

       EPA encourages registrants and applicants to contact the Agency at any time with
questions or concerns.  AD believes such consultations should result in better applications and
faster decisions. To save time and resources, AD strives to respond to questions and concerns
before scheduling a meeting. When a meeting is deemed necessary, EPA will ask the company to
provide an agenda and certain other written materials beforehand, and to produce a summary after
the meeting. EPA's written response to the summary will be the official record of the meeting.


       Since late 1996, EPA has been working toward revising Pesticide Registration and
Classification Procedures (40 CFR 152), Labeling Requirements for Pesticides and Devices (40
CFR 156), and Data Requirements for Registration (40 CFR 158) so they include information and
procedures specifically designed for antimicrobial pesticides. Registration requirements for
antimicrobials differ somewhat from those of other pesticides. For example, EPA requires special
tests to ensure efficacy of public health pesticides when the pests are invisible disease-causing
microbes, rather than insects or rodents that may be harboring disease organisms. Similarly,

determining human and ecological risks from exposure to antimicrobial pesticides requires
different types of measurements and models than those needed for pesticides largely applied to
crops and other plants. In view of these and other differences, EPA decided that each rule should
get a special antimicrobials section. From the earliest stages of the revisions, EPA sought
comments from stakeholders, whose suggestions were incorporated into the first draft texts
released in spring 1997, as well as into subsequent drafts.

40 CFR 152 and 156

       A proposed rule affecting  parts 152 and 156 was published for public comment in the
Federal Register on September 17,  1999. It proposes to establish procedures for the registration
of antimicrobial products including time frames for decisions on applications for registration; to
establish labeling standards for antimicrobial public health products which will ensure that
antimicrobial products are labeled appropriately for the level of protection they provide; and, to
exempt certain antimicrobial products from FIFRA regulation. In addition, a number of general
provisions were proposed that are not associated with antimicrobial pesticides.

40 CFR 158

       40 CFR Part 158 (Data Requirements for Registration) specifies the types of data and
information that EPA generally requires so that it can decide whether to register a pesticide. For
food use pesticides, EPA also uses the submitted data to determine whether to. grant a tolerance or
an exemption from a tolerance.

       Part 158 contains data requirements for all pesticides, although the requirements for
registering agricultural pesticides  are different from those for registering antimicrobials. The
Food Quality Protection Act (FQPA) of 1996 amendments to FIFRA direct EPA to clarify data
requirements for registering antimicrobial products.  To fulfill this requirement, the Agency is
preparing a proposed rule, Part 158, subpart W, that will present data requirements for
antimicrobial active ingredients and end use products. In June 1997, EPA released  a draft that
reflected comments from many sources. It was examined by OPP's Scientific Advisory Panel
(SAP)  and also made available to AD's list of stakeholders and other interested parties.  The
formal regulation proposal process for Part 158, subpart W is expected to begin in FY 2000.

The OECD Biocides Steering Group

       In 1996, the member countries of the Organization for Economic Cooperation and
Development (OECD) recommended that work be initiated to examine how member countries
regulate non-agricultural pesticides (e.g., antimicrobial pesticides, antifouling paints, wood
preservatives). As a result, in  1997, the OECD Pesticide Working Group conducted a survey of
member countries to explore ways to:

       •      improve understanding of how member countries regulate  the broad class of
              chemical agents known as biocides or non-agricultural pesticides;  and

       •      provide information that could be used to prepare the way for future efforts to
             increase international cooperation in the regulation of biocides

       In keeping with these objectives,  the OECD Biocides Steering Group (BSG) was created
in June 1998. The BSG, which includes AD as the Agency's representative, met on
June 10-11,1998, to focus on:

       •      The harmonization of data requirements for antimicrobial pesticides;
       •      The development/revision of test guidelines for antimicrobial pesticides;
       •      The harmonization of human and environmental exposure and risk assessment
             procedures for antimicrobial pesticides; and
       •      Increasing cooperation between regulatory authorities in the evaluation of
             antimicrobial pesticides

       Based on these meetings, the OECD issued a report, Proposals for Future Work
Programme On Biocides/Non-Agricultural Pesticides, in September 1998.  The report
recommended, among other things, that "risk reduction" be added as another activity for the
OECD Biocides work effort.  The OECD Pesticide Working Group concurred with this report and

       Since then, the BSG has met on several dates in 1999 and has focused on additional areas
such as information technology and the creation of world-wide web sites. In addition, the BSG
held one workshop in October 1999-and is planning another for June 2000--on exposure
assessment related to wood preservation (see section on "Heavy Duty Wood Preservatives").


       Finally, under NAFTA (North American Free Trade Agreement), the United States,
Canada, and Mexico have formed a Technical Working Group (TWO). The goal of the TWO is
to develop a coordinated pesticides regulatory framework among NAFTA partners to address
trade irritants, build national regulatory/scientific capacity, coordinate scientific and regulator
decisions on pesticides, and to share the review burden.

       The work of the TWG has already begun to pay dividends by addressing specific trade
irritants, developing a better understanding of each regulatory agency's assessment practices,
working to harmonize each country's procedures and requirements, and encouraging pesticide
registrants to make coordinated data submissions to the three NAFTA countries to facilitate joint

       Under the auspices of the NAFTA TWG, EPA and its Canadian counterpart Agency, Pest
Management Regulatory Agency (PMRA) are cooperating on the reevaluation of heavy duty wood
preservatives. In addition, the NAFTA TWG developed an antimicrobial harmonization project,
predating the OECD activity. Because the goals of the NAFTA work and the OECD work are ver
similar, the NAFTA work is now dovetailed with that of the OECD.


Liquid Chemical Sterilants

       As a result of FQPA amendments, EPA issued guidance in January 1998 (PR
Notice 98-2, Jan. 15, 1998) that delineated whether FDA or EPA would be responsible for various
categories of liquid chemical sterilants.

       EPA retains jurisdiction for all pesticide uses of chemical sterilants that are not liquid
(e.g., ethylene oxide) and for liquid chemical sterilants used on surfaces or objects that are not
critical or semi-critical devices (e.g., sterilants used on veterinary equipment).

Treated Articles Exemption

       EPA regulations in 40 CFR 152.25(a) exempt certain treated articles and substances from
regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FJJFRA) if specific
conditions are met. The specific regulatory language is:

       Section 152.25 Exemptions for pesticides of a character not requiring FIFRA regulation

       "The pesticides or classes of pesticides listed in this section have been determined to be of a character not
       requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended
       for use, and used, only in the manner specified.

       (a) Treated articles or substances. An article or substance treated with, or containing, a pesticide
       to protect the treated article or substance itself (for example, paint treated with a pesticide to protect
       the paint coating, or wood products treated to protect the wood against insect or fungus infestation),
       if the pesticide is registered for such use."

       Known as the "Treated Articles Exemption," section 152.25(a) provides  an exemption
from all requirements of FIFRA for qualifying articles or substances treated with, or  containing a
pesticide, if: (1) the incorporated pesticide is registered for use in or on the article or substance,
and; (2) the sole purpose of the treatment is to protect the article or substance itself.  A treated
article or substance that does not meet both conditions, is not eligible for the "treated articles
exemption" and may be subject to regulation under FIFRA as a pesticide. Since the treated
articles exemption is limited to protection of the article or substance itself, implied or explicit
public health claims are not allowed under the exemption. Examples of such claims would
include, but not be limited to, "kills germs," "effective against E. Coli and staph," "reduces risk of
cross contamination from bacteria" and "controls allergy causing microorganisms."

       In recent years, however, the marketplace has experienced a proliferation of non-exempt
products that are treated with pesticides and bear implied or explicit public health claims for
protection against bacteria, fungi and viruses, as well as specific claims against pathogenic
organisms which may cause food poisoning, infectious diseases or respiratory disorders.
Examples of such articles  include toothbrushes, denture cleansers, children's toys and related
items, kitchen accessories such as cutting boards, sponges, mops, shower curtains, cat litter,
vacuum cleaner bags, pillows, mattresses and various types of finished consumer textiles.

       The Agency is concerned about these products because, in addition to their status as
unregistered pesticides, they potentially increase public health risks. By using antimicrobial
treated articles of unproven effectiveness, consumers may potentially be increasing their risk of
disease. If people believe that a treated article contains an agent designed to control disease-
causing organisms, they may not properly clean this article with soap and water, an effective
procedure for minimizing the spread of harmful bacteria.

       In order to discourage this spread of non-exempt treated articles, the Antimicrobials
Division, in conjunction with the Office of Enforcement and Compliance Assurance and the
Regions, has developed a comprehensive strategy to identify and remove these products from the
marketplace. Refer to Section VL, Outreach Activities, for a listing of notable successes in this
area.  In addition to these enforcement actions, EPA formally requested comments on a draft
notice that is intended to clarify current Agency policy with respect to the applicability of the
treated articles exemption to antimicrobial pesticides (Federal Register, 19256, April 17,  1998).
AD has met with various stakeholder groups, trade organizations, and individual companies over
the past year to solicit as wide a range of opinion as possible in developing this guidance. The
Agency expects to issue a final notice in early 2000.

Guidance on Registration of Manufacturing Use Products (MUPs)

       The Antimicrobials Division has changed its policy on registration of manufacturing use
products.  This revision was presented in the form of a guidance document, and in discussion, at a
stakeholders meeting held on March 26,  1998. The Agency now registers an active ingredient or a
manufacturing use product (MUP) only if an end-use product has already  been registered, or is
being registered concurrently.  (An MUP is a pesticide that is sold to a person or company for the
purpose of producing an end-use product; an MUP cannot itself be used for an end-use pesticidal
purpose.) The end-use product application can come from a different company than the MUP
application. Before May 1,1998, AD registered MUPs without associated end-use products.
However, AD believes that this procedure was confusing. It gave the impression that a use
pattern was registered when EPA approved the MUP, although no actual use could take place
until an end-use product was registered.  Also, it was inconsistent with the procedures used b
other parts of EPA's  pesticide program.  So, AD has revised its policy to be consistent with the
rest of the program, and less confusing to registrants and users.

Responses to Requests for Information

       To focus the myriad outreach activities of the division, AD created an Outreach Team with
the AD ombudsman as acting team leader.  The Outreach Team typically receives approximatel
25 to 30 phone calls, e-mails, and faxes per day from people wanting general or detailed
information about antimicrobials activities. Most requests relate to:

•      Cutting edge policy issues, such as those associated with treated articles or products for
       treating medical waste;


•      Information on whether a product is registered and for which uses;
•      Registering an antimicrobial pesticide;
•      Obtaining advice on how a proposed label needs to be changed to meet FIFRA
       requirements; and
•      Ascertaining whether a product or company is in compliance with FIFRA.

       By responding promptly and knowledgeably to calls from reporters and writers, the
Outreach Team helps ensure that AD receives fair and accurate media coverage. A notable
success was the cover story about the Antimicrobials Division in the April 1998 issue of
Materials Management in Health Care.  AD is preparing a manual that would describe
registration procedures specific to antimicrobial pesticides which should be distributed to
stakeholders for comment by February 2000.

                             V.  USING SOUND SCIENCE

Sources of Expertise

        To help  guarantee that regulatory decisions related to antimicrobials incorporate sound
science, approximately one-half of the Antimicrobials Division staff are scientific and technical
experts. Contractors supplement AD staff efforts by reviewing studies and developing
preliminary risk assessments for EPA decisionmaking. AD also uses the FIFRA Scientific
Advisory Panel (SAP) as the primary external peer review group.

Ensuring Efficacy

       More than 50% of antimicrobial pesticides are public health pesticides, intended to control
disease-causing microorganisms such as E. coli, HTV, and the tuberculosis bacterium. EPA
reviews public health antimicrobial pesticides for efficacy as well as safety for two major reasons.
First, if these products are ineffective, people may get sick or remain sick longer, potentiall
leading to public health problems. Second, unlike larger pests such as weeds and weevils,
microbes are invisible, and users cannot generally determine whether products are working.
Therefore, EPA expends significant resources in evaluating test methods and determining
performance standards to ensure that public health antimicrobials work as they claim. The
Antimicrobials Division also supports experimental studies to develop new methods for testing
and validating the efficacy of antimicrobials.  (Attachment C describes the categories of
antimicrobial public health pesticides.)

       In September 1997, EPA asked the SAP about criteria for accepting new test
methodologies, given rapidly changing technologies and knowledge. The SAP responded that
EPA should remain flexible and open-minded about accepting new test methods, but that EPA
should take steps to ensure that new efficacy test methods are reproducible, accurate, precise, and
validated. However, the SAP stated that EPA need not necessarily wait for completion of the
standard validation procedures, which can take a long time, before approving new methods under

specified conditions. The panel suggested a few streamlined procedures EPA could use to choose
promising new test methods.

Developing Alternative Efficacy Tests for Hepatitis B Virus (HBV) Virucides

       In 1996, the Agency registered an HBV disinfectant whose product performance testing
requirement was met, in part, by a study using chimpanzees as test subjects. In recent years,
companies have not been able to develop new HBV disinfectants because of the difficulty,
expense, and ethical issues associated with using chimpanzees, and because other species do not
become infected with the human virus. When AD brought this problem before OPP's Scientific
Advisory Panel (SAP) in September 1997, the panel recommended that EPA consider alternative
test systems using surrogate viruses, such as the duck HBV, that do not require the use of
chimpanzees in testing.

       To ensure that all interested and knowledgeable experts contribute to development of a
new protocol, AD held a workshop in Crystal City, VA, in July 1998.  Participants included
individuals from academia, industry, testing laboratories, and the Federal government.
Discussions centered around the criteria for choosing a protocol, and discussion about the pros
and cons of in vivo methods (using live animals such as ducks or woodchucks) and in vitro
methods (e.g., using duck liver cells) for determining viable viruses after treatment. The Agenc
expects to publish a Federal Register Notice in FY 2000 in which we will reply to the comments
received by the Agency regarding such protocols.  Additionally, we will announce the conditions
for our acceptance of efficacy data for future registrations.

Post-Registration Efficacy Testing of Public Health Antimicrobials

       BEAD and AD are jointly responsible for efficacy testing of public health antimicrobials.
To provide greater testing capacity and additional laboratory resources, the Agency has also
recently awarded funding to several state laboratories.

       OPP is in the midst of a three-phase program to ensure that registered public health
antimicrobial pesticides remain effective after they are on the market.  The phases are based on a
priority system, addressing hospitals first, which are most critical from a public health standpoint.
The first phase, completed in 1993, consisted of testing liquid chemical sterilants.  OPP is
currently in phase two, which consists of testing 150 tuberculocides, 98% of which also make
hospital disinfectant claims.  Therefore,  tuberculocides are concurrently evaluated for both
tuberculocidal and hospital disinfectant efficacy. The highest priority  for testing is given to
hospital tuberculocides whose efficacy is questionable based on formal reports under FIFRA
section 6(a)(2), or on other reliable information. As of FY 99, EPA has tested 31 tuberculocides
for tuberculocidal activity. The results of this testing are expected in FY 2000.  Of 24 products
tested for hospital disinfectant efficacy, 18 passed  and 6 failed.  After tuberculocide testing is
completed, the program will evaluate hospital disinfectants without tuberculocidal claims, again
giving high priority to those with questionable efficacy.  If a product fails efficacy testing, EPA

initiates an enforcement case review and prepares for appropriate corrective action, which ma
include regulatory action under FIFRA.

       Faced with the daunting task of testing 150 tuberculocides for efficacy, OPP is considering
procedures to streamline the process while continuing to protect public health. For example, OPP
is currently investigating the usefulness of a screening strategy.  If a tuberculocidal product fails
the Association of Official Analytical Chemists' (AOAC) use dilution test, the product will be
referred to the Office of Enforcement and Compliance Assurance (OECA) for immediate
enforcement action rather than continuing with the more time-consuming tuberculocidal test.
This strategy recognizes that no disinfectant claims are possible if a product fails the use dilution
test. Another option being considered is to batch products into groups that relied on the same
efficacy data to support their registrations ("me too"  products).

       In February 1999, the OPP Microbiology Laboratory relocated from Cincinnati, OH, to
the Environmental Science Center, a new 140,000-square foot state-of-the-art laboratory at Ft.
Meade, MD, located between Washington DC, and Baltimore, MD. The new facility will allow
the current testing program to expand.

Alternative Treatments for Infectious Medical Waste

       EPA's goal for medical waste regulation is to ensure that treatment of medical wastes
protects public health without putting an unreasonable burden on companies seeking a FIFRA

       Medical wastes may contain blood and other  body fluids, as well as healthcare items such
as needles, tubing, and surgical gauze, which may contain infectious microorganisms. The
Resource Conservation and Recovery Act (RCRA) does not regulate medical waste as a
hazardous waste. Currently, states are responsible for regulating this waste and ensuring that its
treatment and disposal do not endanger the public's health. Medical waste treatments which use
chemical means are regulated as pesticides under FIFRA. The two standard treatment methods
for medical waste have been 1) incineration, which is expensive and may lower outdoor air
quality, and 2) autoclaving, which is also expensive and has limited capacity.

       Alternative treatments can provide economic and public health benefits.  One major type
of alternative treatment is solidifiers or encapsulants  used in suction canisters to immobilize and
reduce infectivity of the waste in the canister. Using a variety of efficacy performance criteria,
many states have developed lists  of canister systems  whose treated waste is of low enough
infectivity to be allowed in municipal solid waste landfills that meet the requirements of Subtitle
D  of RCRA.  Because of the lower dollar costs, medical facilities prefer to dispose of medical
waste in landfills rather than by incineration or autoclaving.

       The Agency is discussing potential efficacy testing requirements for medical  waste
treatment with state regulators, producers, and users to minimize duplicate testing, since most
states already have criteria for approving alternative treatments of medical waste. The Agenc


expects to request comments on a draft Pesticide Registration Notice outlining the Agency's
proposed policy in this area in the year 2000.

       To further ensure coordination, EPA participates in activities of the State and Territorial
Association of Alternative Treatment Technologies (STAATT), the primary stakeholder group
grappling with regulatory and testing issues concerning  medical waste.

Role of Antimicrobials in Preventing Foodborne Infections

       Antimicrobial pesticides play a major role in preventing foodborne diseases, which
continue to have a major impact on health in the United States and elsewhere in the world.
Approximately 1,000 antimicrobial pesticide products are registered for use on food and food
contact surfaces as disinfectants, sanitizers, and preservatives.  A major purpose of the
disinfectants and sanitizers is to control microorganisms that cause human disease. These
products are public health pesticides and must meet strict efficacy performance standards before
EPA approves them for use. Preservatives are not considered public health pesticides, because
they are intended to prevent spoilage or discoloration of food, rather than to control
microorganisms that cause human disease. Therefore, EPA reviews preservatives for safety but
not usually for efficacy.  To help ensure that the food use pesticides are safe when used as
directed, EPA sets a "tolerance" (the maximum amount of pesticide residue allowed in the food)
or determines that a tolerance is not needed because there is no residue of concern.

       With evidence of millions of cases of foodborne infections and several thousand deaths
being attributed to these infections, EPA is seeking ways to decrease foodborne infections
associated with fresh fruits and vegetables  (produce). To further this goal, the Antimicrobials
Division asked OPP's Scientific Advisory Panel (SAP) for advice in determining the efficacy of
products that consumers use for washing produce. The  SAP responded that consumers have few
approved options for reducing microbial loads on fresh produce.  To fill this gap, the SAP noted
that EPA could consider developing a new registration  category,  such as "antimicrobial  wash," as
an interim measure.  EPA is discussing testing methodology and performance standards  with
various groups that are interested in making such products available to consumers.

       EPA is also participating in interagency efforts to prevent foodborne infections. This issue
is of special concern to the Antimicrobials Division, which registers many consumer products
designed to combat the occurrence of foodborne infectious microorganisms. EPA, HHS, and
USD A launched the  National Food Safety Initiative in May 1997. EPA participates in one of the
initiative's projects,  a private-public "Partnership for Food Safety Education," whose goal is to
improve food handling in homes and in retail establishments. The Partnership is developing
educational activities and a coordinated  publicity campaign, anchored by a green frog-like Fight-
Bad character whom both adults and children love to hate.

Other Science Issues

Exposure Research

       When assessing exposure, it is important to have reliable exposure information and
models. Scientists from AD and other parts of OPP have been active in developing and testing
models to assess exposures under different scenarios. While it is crucial that these models not
underestimate exposures, it is also important that they not overestimate levels by so much that
companies spend resources unnecessarily on providing field data or on taking steps to reduce
exposures that are already considered safe.

       As one example, AD uses the SWIMODEL to estimate exposure of swimmers, including
children, to swimming pool pesticides and their breakdown products. With almost 200 active
ingredients registered for use in swimming pools, the SWIMODEL provides an inexpensive,
quick method of estimating exposures. As a tier accuracy test, the SWIMODEL does not require
field data, but depends only on the physico/chemical properties of the pesticide.  In one test of
validity, the SWIMODEL gave exposure estimates that were close to the estimates obtained using
biological data and a Physiologically-Based PharmacoKinetics (PB/PK) model. These results
indicate that the SWIMODEL is a reasonable model to use in place of field measurements for
providing estimates of exposure to swimming pool chemicals.

       Exposure of workers to metalworking fluids is another area of AD concern, since more
than 70 antimicrobial chemicals, used in more than 200 products, are registered as metalworking
fluid preservatives. Metalworking fluids, also called metalcutting fluids, are fluids used during
machining and grinding of tools, machine parts, and other metal products to carry away debris,
protect work surfaces, and reduce friction and heating between the cutting tool and the work
surface. AD scientists have determined that dermal exposure, especially to hands and arms, is an
important source of worker exposure whereas, previously, aerosol inhalation was the onl
exposure formerly considered by other Agencies such as the Occupational Safety and Health
Administration (OSHA) and the National Institute of Occupational Safety and Health (NIOSH).

       In conjunction with efforts by EPA's Health and Effects Division to reduce residential
exposure, AD also is investigating the methods available for estimating human exposures when
pesticides are released from treated  articles, such as carpets, paints, or kitchen cutting boards.
Two methods are under evaluation:

       •      the small chamber test, which measures pesticide release from an article or
             material (e.g., paint)  into air, thus providing a way to estimate inhalation exposure;

       •      the migration cell method, which measures the amount of pesticide released from
             an article into a solvent, thereby helping to determine oral and dermal exposure.

       In addition to producing human exposure models, AD is in the early stages of developing
environmental models.  These will be used in determining environmental exposures from use of
pesticides in antifoulant paints, once-through industrial water systems, and wood products treated
with preservatives.

                            VI. OUTREACH ACTIVITIES

       The Antimicrobials Division considers it essential to encourage ongoing communication
with our diverse stakeholders: registrants; environmentalists; users such as consumers and
infection control specialists; EPA staff; various federal, state, and local agencies; professional
and interest groups.  Major outreach activities are described below.

Publicizing Enforcement Actions

       Enforcement and compliance assistance are major outreach components and priorities with
EPA. As such, AD has increased its enforcement-related actions. During the FY 98 and
FY 99, the Antimicrobials Division processed and resolved 85 Enforcement Case Reviews
(ECRs) for unregistered antimicrobial pesticides and treated articles, misbranded devices and
pesticides; conducted numerous enforcement settlement label reviews; sent over 100 letters to
manufacturers and marketers who have inquired about whether their product is regulated under
FIFRA; and prepared over 100 referrals to the Office of Enforcement and Compliance Assurance
about products which AD had received complaints. The best-publicized enforcement actions
involved actions against companies selling "treated articles," such as cutting boards, toys, sponges
and kitchenware and humidifiers, with unlawful public health claims. Over 20 enforcement
actions had been taken against non-complying companies as of September 30, 1999, and more
than $1,000,000 in fines were collected to further assure compliance with the law.  (See page 11
for an extended discussion of treated articles.)

       To help regions  take appropriate enforcement actions, AD's ombudsman has visited six of
the ten regional offices in FY 98 and 99 and talked with staff about EPA's registration and
enforcement procedures for antimicrobial pesticides.

Presentations and Workgroups

       AD representatives gave approximately 45 presentations between October 1997 and
September 1999 to describe activities and clarify policies. Groups that requested AD speakers
included industry associations, government training programs, various interagency and partnership
organizations, and states and regions. In addition to making formal presentations, AD shares
information about antimicrobials by participating in numerous workgroups, such as the Pesticide
Program Dialogue Committee (PPDC); the OECD Biocides Steering Group (discussed on page
9); the Partnership for Food Safety Education; and the State FIFRA Issues Research and
Evaluation Group (SFIREG).

       In June 1999, AD held its 3rd national workshop (which was a two-day basic training
session on "How to Register Antimicrobial Pesticides") with industry.  This resulted in a change
in the way AD coordinates the workshops in order to continue meeting the need to conduct this
type of outreach during an era of shrinking resources.  AD is recommending that all major
associations work together to jointly sponsor the national workshops. It is also allowing the
associations to decide among themselves which of them will take the lead to coordinate and fund
the year 2000 workshop.

Stakeholder Meetings

       As a major part of its outreach activities, AD holds stakeholder meetings which are
announced in the Federal Register and are open to anyone with an interest in antimicrobial
pesticides.  Attendance has increased at these meetings, an indication that participants find the
information exchange valuable. The three FY 98 meetings were held October 21,1997,
February 3,  1998, and March 26, 1998.  In FY 99, AD held a stakeholder meeting on
October 8, 1998, and participated in a CSMA-sponsored antimicrobial workshop in March 1999.

       The range of topics and interests of attendees has broadened since the early meetings. In
addition to updates on antimicrobials registration issues, meetings have featured:

       •       Discussions on alternative treatments for disposing of medical waste;
       •       Improving labels and packaging of hospital disinfectants;
       •       Development of experimental test methods for estimating human exposure to
              pesticides in treated articles;
       •       The possibility of self-certification of testing laboratories;
       •       Science issues concerning the efficacy of raw fruit and vegetable washes; and
       •       Alternative test methods for registering Hepatitis-B virucides.

Annual National Antimicrobials Workshop

       More than 375 people attended AD's Second Annual Antimicrobials Workshop on
June 15 and 16, 1998, in Washington, DC. The diversity of attendees attested to the success of
the workshop's theme, "Building Bridges and Maintaining Open Communications." Participants
included stakeholders from various federal agencies, states, Canada, industry, academia, medical
and public health organizations, and the user and producer communities. Plenary and breakout
sessions covered a wide range of topics, including: Jurisdiction in Preventing Foodborne Illness;
Efficacy Test Methodologies; Treated Articles Exemption; FDA/EPA Jurisdiction for Food
Contact Articles; Revision of 40 CFR 152, 156, and 158; and Controlling Infections in Hospitals.

       Feedback indicated that participants considered the workshop a great success, and that
they were looking forward to another. A joint workshop focusing on registration was held in
June 1999 with several trade associations representing registrants of antimicrobial pesticides.

Coordination with Infection Control Specialists in Medical Facilities

       One of AD's successful outreach activities involves the Association for Professionals in
Infection Control and Epidemiology (APIC). APIC has the formidable task of trying to reduce the
number of nosocomial (hospital-acquired) infections occurring in the United States, current!
estimated at more than 2,000,000 annually. Because approximately 1,000 of AD's
5,000 registered products are hospital disinfectants, AD has opened a dialogue with APIC
members to explore areas of mutual interest.

       AD staff have been featured speakers at several local APIC chapter meetings. Topics
included:  federal jurisdiction of germicides, efficacy testing, the Memorandum of Understanding
between the American Hospital Association and EPA on reducing waste volumes.  APIC also
provided comment to the Agency supporting the direction of the draft notice on treated article
exemption. (See page 11 of this report). Members are infection control specialists who work
primarily in health care settings.

       APIC members indicated a need to know which agency to call with specific questions
about infection control practices and products. AD staff, with the input of employees at other
agencies, have prepared a document to answer APIC's most immediate questions. Future
activities may include: arranging site visit exchanges between AD staff and APIC members;
making APIC training courses available to AD staff; and exchanging views on making labels
more "user friendly."

National Antimicrobial Information Network (NAIN)

       NAIN received 1,932 inquiries in 1998, more than double the 800 it received in 1996, and
1,707 in 1999. The National Antimicrobial Information Network (NAIN) is a toll-free telephone
and internet service that provides a wide variety of information about antimicrobial pesticides.
Organized as a cooperative effort between Oregon State University and EPA, NAIN maintains
information on toxicology, health effects and safety of antimicrobial pesticides.  It also maintains
lists of antimicrobial products registered with EPA, including sterilants, disinfectants,
tuberculocides, and products effective against HB V and HIV.  NAIN provides information on
EPA regulation and registration of antimicrobial pesticides, and helps callers interpret product
labels and permitted uses. The Web site, which receives about 20,000 hits annually, contains
regulatory and policy documents to help keep interested parties up-to-date about antimicrobial

       More  than one-half the callers are from the medical community, with manufacturers and
the general public accounting for most of the remainder. Most callers request information about
specific products or types of products; the next largest set of calls covers regulation, registration,
and complaints, including complaints about unregistered or ineffective antimicrobial products.

       While continuing to respond to all inquiries, NAIN is undertaking the following additional
activities: 1) maintain, enlarge, link, and publicize its antimicrobial web site, and 2) develop

documents and fact sheets that answer frequently asked questions and that provide information on
common antimicrobial products.

                               VII. REREGISTRATION

Reregistration Plans

       In  1998, AD created a Reregistration Team to coordinate and manage regulatory efforts
related to reregistration of antimicrobial pesticides.  Under FEFRA, EPA is undertaking a
comprehensive review of pesticides registered before 1984 to ensure that they meet current safet
standards, and that public health pesticides also meet current efficacy requirements. AD is slated
to make decisions on 40 active ingredients and approximately 3300 associated products b
FY 2002.

       The following 10 active ingredients and their products are scheduled for reregistration
decisions in FY 2000: The wood preservatives pentachlorophenol, creosote, and chromated
copper arsenicals (CCA); bis-2-butene; zinc omadine; benzisothiazolin, irgasan, amical 48,
chlorine dioxide, and 4-amyl phenol.

Heavy Duty Wood Preservatives

       One of the projects organized under the NAFTA TWG and its subcommittees is a joint
United States/Canadian project called "Cooperative Reregistration/Reevaluation of the Three
Heavy Duty Wood Preservatives."  These are pentachlorophenol (PCP), chromated copper
arsenicals (CCA), and creosote. In addition to the United States and Canada, the State of
California, which has its own regulations for registering antimicrobial pesticides, is an active
participant in the project.

       AD has taken the lead on the risk assessment for CCA and PCP, where one of the major
issues concerns levels of dioxins as contaminants.

                      VIII. TRAINING AND EDUCATING STA

In-House Training

       AD has set up its own training program. AD held eleven training sessions during FY 98
and FY 99, covering such topics as the Agency's treated articles policy; how to review a label;
how metal cutting fluid products are used, discussion of the label review manual, and some CSF
training.  Through this in-house training, the science and regulatory staffs develop a better
understanding of what each group does so they can better work together.

On-Site Education

       AD staff have visited more than a dozen companies and other sites that make, test, or use
antimicrobial products. These visits allow staff to obtain first-hand familiarity with the activities
of the industry AD regulates. The visits also provide informal occasions for AD and industry to
learn about each other's needs.  For example, AD visitors to wood preserving plants learned about
measures taken to prevent worker exposures to the pesticides. AD staff also explain the EPA
regulatory process to company personnel.

       AD and the sites benefit from these visits. EPA's presentation and handouts explain the
registration process and the role of AD staff in reviewing applications. Companies have asked for
clearer guidance on complying with FIFRA, and on making their applications easier for EPA to

                                 IX. LOOKING AHEAD

        The Antimicrobials Division has set ambitious goals to continue to protect public health
and the environment, while improving service to registrants and other stakeholders.  The Agenc
expanded its post-registration efficacy testing of tuberculocides and other hospital disinfectants in
its new testing laboratory in Ft. Meade, MD in FY 99. This activity is crucial to ensuring that
public health pesticides remain effective after they are on the market. With a strategic plan and
contract support in place, AD's reregistration activities are moving forward on schedule, helping
to ensure that pesticides that were registered many years ago meet current safety and efficac
standards. Outreach and cooperative interagency activities are also expanding, especially in
preventing foodborne infections and preventing hospital-acquired infections.  The division is
participating in several interagency food safety activities, and is increasing its contacts with
industry and consumer associations, as well as with  FDA and USDA. To enhance its role in
preventing hospital-acquired infections, EPA is working closely with health and user groups, state
and local organizations, and OSHA and FDA.

       Proposed revisions to 40 CFR 152 and 156 were published for public  comment in the
Federal Register on September 17,1999.  Proposed revisions to 40 CFR 158  are expected to be
published in FY 2000 for public comment. Implementing the new procedures for registering
antimicrobial pesticides will satisfy the major provisions in FQPA related to antimicrobial
pesticides. After these rules are in place, the Agency will be in a position to determine whether
further changes or recommendations might be appropriate.

                          Attachment A


15	FIFRA	Sec. 2

        (1) N GENERAL. - The term "antimicrobial pesticide" means a pesticide that
               (A) is intended to-
                       (i) disinfect, sanitize, reduce, or mitigate growth or development
               of microbiological or development of microbiological organisms; or
                       (ii) protect inanimate objects, industrial processes or systems,
               surfaces, water, or other chemical substances from contamination,
               fouling, or deterioration caused by bacteria, viruses, fungi, protozoa,
               algae, or slime; and
               (B) in the intended use is exempt from, or otherwise not subject to,
        a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act
        (21 U.S.C. 346a and 348) or a food additive regulation under section regulation
        under section 409 of such Act.
         (2) EXCLUDED PRODUCTS. - The term  "antimicrobial pesticide" does not
                include -
                (A) a wood preservative or antifouling paint product for which a
        claim of pesticidal activity other than or in addition to an activity described in
        paragraph (1) is made;
                (B) an agricultural fungicide product; or
                (C) an aquatic herbicide product.
        (3)  NCLUDED PRODUCTS. - The term "antimicrobial pesticide" does not
 include any other chemical sterilant product (other than liquid chemical sterilant
 products exempt under subsection (u)), any other disinfectant product, any other
 industrial microbiocide product, and any other preservative product that is not excluded
 by paragraph (2).
 33	FIFRA	   Sec. 3

        (1) EVALUATION OF PROCESS.-To the maximum extent practicable consistent with
 the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate
 to evaluate the risks, the Administrator shall  identify and evaluate  reforms to the
 antimicrobial registration process that would reduce review periods existing as of the date
 of enactment of this subsection for antimicrobial pesticide product registration applications
 and applications for amended registration of antimicrobial pesticide products, including
               (A) new antimicrobial active ingredients;
               (B) new antimicrobial end-use products;
               (C) substantially similar or identical antimicrobial pesticides; and
               (D) amendments to antimicrobial pesticide registrations.

 Attachment A (cont'd)

                                                                            Sec. 3
        (2) REVffiWTIME PERIOD REDUCTION GOAL.- Each reform identified under paragraph
(1) shall be designed to achieve the goal of reducing the review period following submission
of a complete application, consistent with the degree of risk, to a period of not more than
               (A) 540 days for a new antimicrobial active ingredient pesticide
               (B) 270 days for a new antimicrobial use of a registered active ingredient;
               (C) 120 days for any other new antimicrobial product;
               (D) 90 days for a substantially similar or identical antimicrobial product;
               (E) 90 days for an amendment to an antimicrobial registration that does
        not require scientific review of data; and
               (F)  90 to 180 days for an amendment to an antimicrobial registration that
        requires scientific review of data and that is not otherwise described in this
        (3) IMPLEMENTATION.-
               (A) PROPOSED RULEMAKING.-
                      (i) ISSUANCE.-Not later than 270 days after the date of enactment
               of this subsection, the Administrator shall publish in the Federal Register
               proposed regulations to accelerate and improve the review of antimicrobial
               pesticide products designed  to implement,  to the extent practicable, the
               goals set forth in paragraph (2).
                      (ii) REQUIREMENTS.-Proposed regulations issued under clause (I)
                             (I) define the various classes of antimicrobial use patterns,
                      including household, industrial, and institutional disinfectants and
                      sanitizing pesticides, preservatives, water treatment, and pulp and
                      paper mill additives, and other such products intended to disinfect,
                      sanitize, reduce, or mitigate growth or development of
                      microbiological organisms, or protect inanimate objects, industrial
                      processes or systems, surfaces, water, or other chemical substances
                      from contamination, fouling, or deterioration caused by bacteria,
                      viruses, fungi, protozoa, algae, or slime;
                             (II) differentiate the types of review undertaken for
                      antimicrobial pesticides;
                             (ffl) conform the degree and type of review to the risks and
                      benefits presented by antimicrobial pesticides and the function of
                      review under this Act, considering the use patterns of the product,
                      toxicity, expected exposure, and product type;
                             (IV) ensure that the registration process is sufficient to
                      maintain antimicrobial pesticide efficacy and that antimicrobial
                     pesticide products continue to meet product performance standards
                     and effectiveness levels for each type of label claim made; and
                            (V) implement effective and reliable deadlines for process
                     (iii)  COMMENTS.-In developing the proposed regulations, the

                              Attachment A (cont'd)

35  .  	FIFRA	Sec. 3

               Administrator shall solicit the views from registrants and other affected
               parties to maximize the effectiveness of the rule development process.
               (B) FINAL REGULATTONS.-
                      (i)  ISSUANCE.-The Administrator shall issue final regulations not
               later than 240 days after the close of the comment period for the proposed
                      (ii) FAILURE TO MEET GOAL.-If a goal described in paragraph (2y
               is not met by the final regulations, the Administrator shall identify the goal,
               explain why the goal was not attained, describe the element of the
               regulations included instead, and identify future steps to attain the goal.
                      (iii) REQUlREMENTS.-In issuing final regulations, the Administrator
                             (I) consider the establishment of a certification process for
                      regulatory actions involving risks that can be responsibly managed,
                      consistent with the degree of risk, in the most cost-efficient manner;
                             (II) consider the establishment of a certification process by
                      approved laboratories as an adjunct to the review process;
                             (HI) use all appropriate and cost-effective review
                      mechanisms, including
                                     (aa) expanded use of notification and
                             nonnotification procedures;
                                     (bb) revised procedures for application review; and
                                     (cc) allocation of appropriate resources to ensure
                             streamlined management of antimicrobial pesticide
                             registrations; and
                             (IV) clarify criteria for determination of the completeness
                      of an application.
              (C) EXPEDITED REVEEW.-This subsection does not affect the requirements
       or extend the deadlines or review periods contained in subsection (c)(3).
              (D) ALTERNATIVE REVIEW PERIODS .-If the final regulations to carry out
       this paragraph are not effective 630 days after the date of enactment of this
       subsection, until the final regulations become effective, the review period, beginning
       on the date of receipt by the Agency of a complete application, shall be
                      (i) 2 years for a new antimicrobial active ingredient pesticide
                      (ii) 1 year for a new antimicrobial use of a registered active
                      (iii) 180 days for any other new antimicrobial product;
                      (iv)  90 days for a  substantially similar or identical antimicrobial
                      (v)  90 days for an amendment to an antimicrobial registration that
              does not require scientific review of data; and

                             Attachment A (cont'd)

35	FIFRA	Sec. 3

                     (vi) 240 days for an amendment to an antimicrobial registration
             that requires scientific review of data and that is not otherwise described in
             this subparagraph.
             (E) WOOD PRESERVATlVES.-An application for the registration, or for an
      amendment to the registration, of a wood preservative product for which a claim of
      pesticidal activity listed in section 2(mm) is made (regardless of any other pesticidal
      claim that is made  with  respect to  the product) shall be  reviewed by the
      Administrator within the same period as that established under this paragraph for
      an antimicrobial pesticide product application, consistent with the degree of risk
      posed by the use of the wood preservative product, if the application requires the
      applicant to satisfy the same data requirements as are required to support an
      application for a wood preservative product that is an antimicrobial pesticide.
             (F) NOTIFICATION. -
                     (i) IN GENERAL.-Subject to clause (iii), the Administrator shall
             notify an applicant whether an application has been granted or denied not
             later than the final day of the appropriate review period under this
             paragraph, unless the applicant and the Administrator agree to a later date.
                     (ii) FINAL DEClsiON.-lf the Administrator fails to notify an applicant
             within the period of time required under clause (I), the failure shall be
             considered an agency action unlawfully withheld or unreasonably delayed
             for purposes of judicial review under chapter 7 of title 5, United States
                     (iii) Exemption.-This subparagraph does not apply to an application
             for an antimicrobial pesticide that is filed under subsection (c)(3)(B) prior
             to 90 days after the date of enactment of this subsection.
      (4) ANNUAL REPORT.-
             (A) SUBMISSION.-Beginning on the date of enactment of this subsection and
      ending on the date that the goals under paragraph (2) are achieved, the
      Administrator shall, not later than March 1 of each year, prepare and submit an
      annual report to the Committee on Agriculture of the House of Representatives and
      the Committee on Agriculture, Nutrition, and Forestry of the Senate.
             (B) REQUIREMENTS.-A report submitted under subparagraph (A) shall
       include a description of
                     "(i) measures taken to reduce the backlog of pending registration
                     "(ii) progress toward achieving reforms under this subsection; and
                     "(iii) recommendations to improve the activities of the Agency
             pertaining to antimicrobial registrations.

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                                   Attachment C

                             HEALTH PESTICIDES

        EPA classifies public health antimicrobials into categories that depend on the
stringency of the efficacy tests the product has passed.  These categories also determine
the sites where the pesticide may be used and the claims that are permitted on the label.

        Sterilant. An agent that destroys or eliminates all forms of microbial life in the
inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi,
fungal spores, and viruses.  Sterilants are commonly used in medical settings.

        Disinfectant.  An agent that destroys or irreversibly inactivates infectious or
other undesirable bacteria, pathogenic fungi, or viruses, but not necessarily bacterial
spores, on surfaces or inanimate objects. EPA registers three types of disinfectant
products, based upon submitted and reviewed efficacy data: 1) Limited Disinfectants; 2)
General or Broad-spectrum Disinfectants; 3) Hospital Disinfectants.  The three standard
test organisms for testing efficacy of disinfectants are: Staphylococcus aureus (gram-
positive); Salmonella choleraesuis (gram-negative); and Pseudomonas aeruginosa, a
gram-negative organism associated with  nosocomial infections more often than any other

        Limited Disinfectant: An agent whose use is limited to either gram-positive or
        gram-negative microorganisms.  For example, some pine oil toilet bowl products
        are effective only against gram-negative bacteria.

        General or Broad-spectrum Disinfectant: An agent that is effective against both
        gram-positive and gram-negative bacteria. Most household disinfectants fall in
        this group. Two major uses for general disinfectants are swimming pools and
        water purifiers.

       Hospital Disinfectant: An agent that is effective against Staphylococcus aureus;
       Salmonella choleraesuis; and Pseudomonas aeruginosa. These disinfectants can
       be used in hospitals, clinics, dental offices, and other healthcare facilities.

       A registrant that wants to market a hospital disinfectant as a virucide must
       provide data to EPA showing the product is effective against each specific virus
       the company wishes to list on its label.  Similarly, a registrant that wants a
       product approved as a tuberculocide must show that the product is effective
       against a Mycobacterium that EPA accepts as a surrogate for the actual
       tuberculosis bacterium.

       Sanitizer. An agent that reduces, but does not necessarily eliminate, the
microorganisms in the inanimate environment to levels considered safe by public health
codes or other regulations. The performance standard for sanitizers that may contact
food, including sanitizers used on surfaces that may contact food, is 99.999% (5-  log)
reduction of test microorganisms within 30 seconds; for non-food-use sanitizers, the

                              Attachment C (cont'd)

performance standard is 99.9% (3-log) reduction within 5 minutes.  Food sanitizers,
usually chlorine based products, are often used on raw agricultural products in the field to
reduce the microbial load, and either have tolerances or are exempt from tolerances.