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United States Environmental Protection Agency. ANTIMICROBIALS DIVISION Frank Sanders, Director. Topics to be Discussed. Background International Activities Changing Trends & Issues in the U.S. Metal Working Fluids Use of Structural Activity Relationship Process Antifoulant Paints

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United states environmental protection agency

United States Environmental Protection Agency


Frank Sanders, Director

Topics to be discussed
Topics to be Discussed

  • Background

  • International Activities

  • Changing Trends & Issues in the U.S.

    • Metal Working Fluids

    • Use of Structural Activity Relationship Process

    • Antifoulant Paints

    • Shock Policy

    • Pressure Treated Wood

    • Green Seal/Design for the Environment

    • Mold Policy

Background on epa regulatory program
Background on EPA Regulatory Program

  • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to register pesticide products, including antimicrobial pesticide products, for sale and distribution in the United States

  • EPA’s Antimicrobial Division is responsible for registering Antimicrobial Pesticides

Applicable statutes
Applicable Statutes

Food Quality Protection Act


Pesticide Registration

Improvement Act (PRIA)

Federal Food Drug

And Cosmetic Act


Federal Insecticide Fungicide

And Rodenticide Act


Tolerance Established

Product Registered

Primary functions under fifra
Primary Functions Under FIFRA

Manage the registration of pesticide products under the Federal Insecticide, Fungicide and Rodenticide Act

  • Pesticide registration (section 3)

    • New Chemicals

    • New Uses

    • Amendment

    • Old Chemical

Area of responsibility antimicrobials under fifra
Area of ResponsibilityAntimicrobials under FIFRA


Non AD:

The Antimicrobials Division regulates chemicals used in or on environmental surfaces, as well as in air or in water, they include:

Excluded from AD jurisdiction are:

Ad scope of work
AD Scope of Work

  • Currently there are more 200 active ingredients (Charted below)

  • Also, more than 5,000 products are registered with AD

    • Roughly 60% are public health products

  • More than 3.3 billion pounds used/yr (includes chlorine water treatment)

Major outputs
Major Outputs

  • Annually AD registers about:

    • 2 New Chemicals

    • 6 New Uses

    • 150 New Products

    • 900 Amendments

    • 500 Notifications

  • Annually AD also must issue about 4-10 RED’s per year until 2008 (then registration review begins)

Other areas of responsibility
Other Areas of Responsibility

  • AD also has the lead for:

    • Antimicrobial Homeland Security Coordination;

    • Antimicrobials Testing Program;

    • OECD Biocides Initiatives;

    • NAFTA Biocides Harmonization Initiatives;

    • 158W Data Requirement development;

    • Wood Preservatives (CCA, Pentachlorophenol and Creosote)

    • Antifoulants

    • And More….

International coordination
International Coordination

  • EPA’s Antimicrobial Program continues to enjoy a growing working relationship with its international counterparts.

  • Most activities are coordinated with or through the following organizations/initiatives:

    • European Union (EU)

    • North America Free Trade Agreement (NAFTA)

    • Organization for Economic Cooperation and Development (OECD)

Oecd projects
OECD Projects

  • Draft Test Guidelines for Leaching of Wood Preservatives from Treated Wood

    • The objective is to develop test guidelines that all countries can use in evaluating wood preservatives. EPA will be presenting its concerns during the Task Force meeting today.

  • Harmonization of Efficacy Test Methods for Antimicrobials used on Hard Surfaces and in Treated Articles

    • The objective is to develop harmonized test methods and performance standards for biocides used on hard surfaces and in treated articles.

    • The contractor presented a revised report to the Steering Group and it is envisioned that focus will be placed on the hard surface disinfectant for now.

  • Use of Biocides for Ships’ Ballast Water

    • AD is participating in an OECD discussion of work currently in progress in government and industry to address ballast water issues.

    • The TFB will consider whether they should be providing input in the broad arena of ballast water issues.

Oecd projects1
OECD Projects

  • Use of Biocides for Biosecurity

    • This is an area that has been opened up for the consideration of approaches to possibly evaluate efficacy testing of biocides which could be used to counter biosecurity threats.

    • AD worked with others to prepare a white paper providing a summary of the issues associated with the development, efficacy testing and registration of biocidal products to counter threats posed by biowarfare agents

  • Emission Scenario Documents (ESDs) for: Insecticides Used in Stables and Manure

    • The Agency determined these ESDs would be of low priority because they are dealing with insecticides and not biocides after the proposal was made at the 2003 TFB Meeting.

    • AD has been invited by the TFB coordinator of this project to review and comment. It has been explained to the OECD these are of low priority.

Metal working fluids
Metal Working Fluids

  • The Agency is re-examining the toxicology data requirements to determine if a “tiered approach” is appropriate for MWF.

  • For closed systems with robust labeling restrictions, the Agency may register the product and conditionally require certain exposure data, if necessary.

  • Cancer studies may be held in reserve depending on the outcome of exposure data.

Metal working fluids1
Metal Working Fluids

  • Data Requirements are substantially different if used in an open system vs. an enclosed system

  • What is an “enclosed System”

    • Enclosed metalworking systems are defined as systems in which the metalworking machine or process is enclosed by a box or housing. Openings in the enclosure are limited to the minimum required to allow for part entry/egress, maintenance, or utility access.

    • The enclosure is provided with exhaust ventilation with the replacement air entering through the openings designed into the enclosure.

Metal working fluids2

Enclosed System (cont.)

The enclosure of the machine or process is designed to surround the machining operation such that when MWF aerosol is emitted from the machining operation, it is already contained within the enclosure, thereby isolating the operation from the employee and the workplace.

The aerosol is prevented from release at required enclosure openings by an inward flow of air generated by a slight negative pressure. Negative pressure is produced by extraction of air from the enclosure via a local exhaust ventilation system.

Metal Working Fluids

Metal working fluids3
Metal Working Fluids

  • When a registrant modifies his/her labeling to allow use of the proposed product for use only in “enclosed ‘metalworking systems”, then the Agency is willing to consider “reserving” certain toxicology data requirements

    • i.e., chronic, second developmental, and reproductive data -- pending registrant submission and Agency review of worker exposure data for “enclosed MWF system

Data requirements for an open system

Acute oral toxicity - rat

Acute dermal toxicity

Acute inhalation toxicity – rat

Primary eye irritation - rabbit

Primary dermal irritation

Dermal sensitization

Acute neurotoxicity - rat

Subchronic Testing

90-Day oral toxicity - rodent

90-Day oral toxicity - non-rodent

21/28-Day dermal toxicity

90-Day dermal toxicity

90-Day inhalation - toxicity - rat

90-Day neurotoxicity - rat

Chronic Testing

Chronic toxicity - rodent

Chronic toxicity -


Carcinogenicity - rat preferred

Carcinogenicty - mouse preferred

Developmental Toxicity and Reproduction

Prenatal developmental toxicity - rat preferred

Prenatal developmental toxicity - rabbit preferred

Prenatal developmental toxicity - dermal

Data Requirements for an Open System

Data requirements for an open system1

Reproduction and fertility effects

Developmental neurotoxicity


Bacterial reverse mutation assay

In vitro mammalian gene mutation

In vivo cytogenetics (mutagenicity)

Special Testing

Metabolism and pharmacokinetics

Companion animal safety

Dermal penetration

Scheduled controlled operant behavior

Peripheral nerve function

Neurophysiology: sensory evoked potentials


Worker Exposure Data

Exposure/monitoring study

Product use and description of human activity information

Dermal/inhalation exposures information during application and post-application scenarios

Data Requirements for an Open System

Use of structural activity relationship process for risk assessments
Use of Structural Activity Relationship Process for Risk Assessments

  • There is flexibility in FIFRA that allows the agency to consider other ways to assess risks without using FIFRA guideline studies.

  • We believe there is a scientific credible and defensible way to assess risk based on the way others within the agency assess non pesticide risks.

  • One way this has been done is by using the Structural Activity Relationship (SAR) process

    • In this process the chemical’s structural similarity to other similar chemicals, for which data is available, is used to determine toxicity

Opp s pesticide risk assessment process sar
OPP’s Pesticide Risk Assessment Process: SAR Assessments

  • With respect to pesticide chemical assessment, SAR is most appropriately used when addressing dietary risk such as evaluating hard surface, food contact disinfectants where residues are generally less than 200ppb.

  • In this case the Agency may revise its tier one data requirements to include a literature search and a SAR analysis.

Tier 1 data adjustment
Tier 1 Data Adjustment Assessments

  • 90 day oral subchronic, rodent

  • 1 developmental study

  • Mutagenicity testing battery

  • Added data: Literature search

  • SAR

Data requirement adjustment
Data Requirement Adjustment Assessments

  • Depending on the outcome of the review of the literature search and SAR analysis, the following data will be held in reserve:

    • 90-day subchronic oral study, non-rodent

    • 2-generation reproduction study

    • Other studies as warranted from concerns raised in the literature search/SAR

Where can sars data be used
Where Can SARs Data Be Used? Assessments

  • EPA can use SARs analysis data in areas where little data exist – such in the indirect food use arena

  • EPA data requirements for indirect food additives

    • Estimated daily intake <200 ppb

    • Estimated daily intake >200 ppb

What is an antimicrobial food use
What is an antimicrobial food use? Assessments

  • Direct application to food (not processed food)

  • Product not applied directly to food, but is used in such a way that food may reasonably be expected to bear inadvertent residues through indirect contact with a treated surface or substance

Examples of antimicrobial food uses

Commercial Assessments

Food Processing Equipment

Deli equipment

Dairy Equipment

Milk lines

Field Washes

Application to animal drinking water

Animal premise treatment (now non-food but may be revisited in the future)


Kitchen counter tops



Stove tops


High chairs

Fruit and vegetable rinses

Examples of Antimicrobial Food Uses

Epa indirect food data requirements 200 ppb
EPA Indirect Food Data Requirements (<200 ppb) Assessments

  • Mutagenicity battery

  • Subchronic oral toxicity test in rodent species

  • Developmental toxicity study

  • SAR

  • Literature search

Reserved toxicity testing
Reserved Toxicity Testing Assessments

  • Reserve studies pending results of SAR, Lit search and Tier 1 review

    • Subchronic oral toxicity test in non-rodent species (dog)

    • 2-Generation reproductive toxicity test

Epa indirect food data requirements 200 ppb1
EPA Indirect Food Data Requirements (>200 ppb) Assessments

  • All data below 200 ppb, plus

  • 2 carcinogenicity studies

  • 2 chronic feeding studies

  • Developmental toxicity study in second species

  • Metabolism study

Recent developments in toxicity testing
Recent developments in toxicity testing Assessments

  • Literature search

  • SAR

  • Mutagenicity battery

  • Subchronic oral toxicity study in rodent species

Antifoulant paint use alternatives for tbt
Antifoulant Paint Use Alternatives for TBT Assessments

  • AD has expedited new registration applications for antifoulant paint products intended to replace TBT products.

  • Most TBT antifoulant products are now cancelled.

  • EPA is continuing its discussions with NAVSEA (Naval Sea Systems Command) regarding new antifoulant paints that might fit their needs.

  • These types of initiatives should provide more protection to the ecological environment.

Defining the term shock for swimming pools
Defining the Term “Shock” for Swimming Pools Assessments

  • What does the term shock mean?

  • Is it a pesticide claim?

  • Is it a non pesticide claim?

  • Is it both a pesticide claim and a non pesticide claim?

  • Does the term Shock apply to swimming pools, hot tubs, spas and drinking water wells

Defining the term shock for swimming pools1
Defining the Term “Shock” for Swimming Pools Assessments

  • Preliminary Determination

    • AD discuss these questions with Industry, Health Care Professionals, State Representatives, EPA Regions and a host of others. Most believe that the term shock should be considered a pesticide claim.

    • The manufacturers of the chemical that is used for water clarity agreed with the Agency’s proposed new term “shock oxidizer” and would consider this term a non pesticide claim.

    • An Enforcement Alert has been developed as well as notification that will appear on the EPA web page.

Sodium bromide in pools and spas
Sodium Bromide in Pools and Spas Assessments

  • AD is concerned about outdoor pool applications of sodium bromide – it appears that bromate is formed

  • AD’s concern is based on data recently submitted

  • There is limited data on bromate concentration in pools from application of sodium bromide

  • Sodium bromate indoor swimming pool and spa applications are not a significant concern based on the lack of UV light

  • AD is awaiting confirmatory data to support this assumption

Data requirements for wood preservatives
Data Requirements for Wood Preservatives Assessments

  • Data needed to assess Cr +6 risk.

  • 1) Data from a study which measures and speciates the levels of chromium on the surface of wood treated with ACC.

  • A. Hand wipe study which measured levels of arsenic and Cr(III) and Cr(VI). The surface residue also must be evaluated to determine whether trivalent chromium will oxidize into hexavalent chromium under reasonable use conditions.

  • 2. Data regarding the levels of exposure and the valence state of the chromium from both the inhalation and dermal routes to workers treating wood with ACC as well as those persons in the treatment plants who come in contact with treated wood or otherwise are exposed to chromium.

Data requirements for wood preservatives1
Data Requirements for Wood Preservatives Assessments

  • Subsequently, we determined that we only wanted the inhalation exposure data. It is the agency general policy (AD and HED) to require PPE (gloves, long pants, long sleeved shirts) when a chemical is a dermal irritant and/or sensitizer.

  • 3. Data on the form and quantity of the preservative chemical residue (copper, trivalent and hexavalent chromium) released into the environment, and the fate of the released compounds will also be needed in order to confirm the results of our ecotoxicity assessment.

  • We originally required these data. However, we are satisfied with the use of the existing data for CCA.

  • 4. Data on the conditions under which the Cr (VI ) in the ACC treating solution reduces to Cr ( III ) in the wood.

Typical human exposure scenarios for pressure treated wood
Typical Human Exposure Scenarios for Pressure Treated Wood Assessments

Wood Preservatives

  • Application:

    • Pressure-treatment, thermal treatment, spraying, dipping, brushing, mixing/loading (dermal/inhalation)

  • Post-application:

    • Handling treated wood products (occupational – dermal/inhalation)

    • Contact with treated wood products (children: dermal, incidental oral)

Green seal design for the environment
Green Seal/Design for the Environment Assessments

  • The Agency has been approached by various registrants who would like to place the Green Seal on their product labeling

  • Green Seal is non-profit organization that charges a fee to assess whether or not a product meets its standards for being safe for the environment

  • The Agency’s claim board has not permitted the request because EPA’s regulations do not allow the following:

    • Logos cannot be false or misleading

    • No implied safety claims allowed

    • No comparative statements allowed

  • However, the Agency is looking at considering working with its Design for the Environment Program (OPPT) to find ways to help consumers identify reduced risk pesticides in the marketplace

Mold policy hurricane katrina
Mold Policy – Hurricane Katrina Assessments

  • The Agency does not require submission of efficacy data for products making claims to control mod and mildew.

  • The submission of efficacy data is required if the applicant lists a fungal species on the label.

  • Most of these products were registered to control mold growth for aesthetic purposes.

  • Registrants making residual or prevention claims have the following options:

    • Submit efficacy data to support claim

    • Delete mold claim from the label

  • AD has also been working with States recovering from Hurricane Katrina to provide guidance on dealing with the enormous issue of mold in the flooded areas of Mississippi and Louisiana

Other issues include
Other Issues Include…. Assessments

  • Norwalk Virus

  • Bio-terrorism -- Anthrax

  • Quantitative Carrier Testing II (QCT2)

  • Heating and Ventilation/ Air Conditioning (HVAC) Issues

  • Treated Articles

  • Material Surface Safety

  • 158(W)

  • Ballast Water: New Use Site

  • Biofilm protocols/registration: Dental unit water lines/hard surface disinfectant

Other issues include1
Other Issues Include…. Assessments

  • Level Playing Field compliance issues

    • Company “A” complies with registration requirements – company “B” is in the marketplace with unregistered product making the same claims as company “A”

  • Barrier Claims

  • Endangered Species


  • Medical Waste

  • Nail Salon Outbreaks… and more…

  • In conclusion
    In Conclusion Assessments

    • The world of antimicrobials is and will continue to push the bounds of present methodologies and science policies

    • In keeping pace with this ever changing market the Agency will continue to work closely with all its stakeholders and seek to understand all points of view so that it may continue to reap the benefit of an open and inclusive decision-making process