Antimicrobial Pesticide Registration for the Removal of Bacteria from Stormwater Runoff

Transcription

1 Antimicrobial Pesticide Registration for the Removal of Bacteria from Stormwater Runoff Mark B. Miller, P.G. Research Scientist Chattanooga, Tennessee (888) SESWA 9 th Annual Regional Stormwater Conference October 8-10, 2014 Charleston, South Carolina

2 Topics we ll explore. Using Pesticidal Stormwater BMPs to Meet Bacteria TMDLs What is FIFRA? Pesticide Product vs. Pesticide Device Product Registration and Public Health Claims Current and Proposed Approaches to Bacterial BMPs EPA and SESWA State s Pesticide Websites E. Coli in fresh waters Enterococcus in marine waters

3 ? So What s the Problem? There is a disconnection between Bacteria TMDLs and Pesticidal BMPs Water quality controls and laws have focused on minimizing potentially harmful effects of pesticides in surface water and groundwater. TMDLs and CZMPs establish bacteria limits with little or no regard for methods to remove bacteria from surface water. Few traditional stormwater management designs are effective for bacteria removal, and some may actually increase bacterial pollution. Pesticidal products are increasingly used to remove bacteria from stormwater runoff and some may not comply with pesticide regulations.

4 Typical Sources of Bacteria Pollution Urban Stormwater Runoff Sanitary Sewer Overflows and Sewer Line Break Discharges Poorly Treated Sewage Agricultural Runoff Septic Systems Boating Waste Beachgoers Waterfowl Wild animals Pet Waste * From: A Guide to Water Quality at Vacation Beaches, NRDC 18 th Edition, 2008.

5 Beaches Environmental Assessment and Coastal Health Act of 2000 BEACH Act Example Established Coastal Zone Management Plans (CZMPs) which includes bacteria monitoring

6 ADEM/ADPH Beach Monitoring Program Microbiological Analyses Dauphin Island East End, Gulf of Mexico Latitude: most recent º N Longitude: º W advisory status: see advisory key below 08/19/14 Date Collected Enterococcus Count/100 ml * Enterococcus Geo. Mean 08/19/14 8 xxxx 08/03/14 < 1 xxxx 07/23/14 21 xxxx 07/09/14 12 xxxx 06/25/ /12/14 resample /11/ /04/14 resample /30/14 resample /29/14 resample /28/14 > 200 xxxx

7 South Carolina Beach Monitoring Program Advisory Trigger: Enterococci >104 cfu/100 ml E. coli >126 cfu/100 ml

8 Fecal Coliform BMP Monitoring Results (Source: International Stormwater BMP Database 2007) Red = inflow Blue = outflow Key: DB= Detention Basin GS= Grass Swales HD=Manufactured Devices MF= Media Filters RP= Retention Ponds WC=Wetland Channels At Press for Publication in Stormwater Magazine May/June 2008, Can Stormwater BMPs Remove Bacteria? New Findings from the International Stormwater BMP Database

9 ? Is this an effective solution? Sign at a city park in TN

10 ? Do pesticides offer a solution for bacteria removal? SCOPE OF PESTICIDE USE Need to strike an ongoing balance between the benefits of pesticide use and potential hazards to human health and the environment.

11 ? What is FIFRA? Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 7 U.S.C y Controls the manufacture, sale and use of a broad range of chemical and biological pest controls, as well as substances used to control plant growth. FIFRA Webpage

12 ? What Federal agency regulates pesticides under FIFRA? U.S. Environmental Protection Agency All states, D.C., territories and tribal lands require registration of Pesticide Products

13 FIFRA Basics Provides for federal regulation of pesticide distribution, sale and use. All pesticides distributed or sold in the U.S. must be registered (licensed) by EPA. Before EPA may register a pesticide under FIFRA, applicant must show, among other things, that using the pesticide according to specifications will not generally cause unreasonable adverse effects on the environment. o Taking into account the economic, social and environmental costs and benefits of pesticide use, or o a human dietary risk from residues from pesticide use per FFDCA.

14 Definition of Pest under FIFRA 2(t) (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other microorganism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest under 136w(c)(1) of this title.

15 Definition of Pesticide under FIFRA 2(u) (1) any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, [and] (2) any substance or mixture of substance intended for use as a plant regulator, defoliant or dessicant FIFRA defines pesticide in terms of the intent underlying the use of a substance, not the inherent characteristics of a substance.

16 EPA has adopted regulations that a pesticide is any substance (or mixture of substances) intended for pesticidal purpose (40 C.F.R ) and lists three factors to be addressed in deciding whether a substance is intended for pesticidal purposes: 1. Whether the person who distributes or sells the substance claims that it has a pesticidal purpose or use or contain an active ingredient (AI) that can be used to manufacture a pesticide, 2. Whether the substance contains an AI and has no commercially valuable use other than for a pesticidal purpose or use or for the manufacture of a pesticide; and, 3. Whether the person who distributes or sells the substance has actual or constructive knowledge that the substance will be used or is intended for use for a pesticidal purpose. Labels or advertising material that recommend a product for use against a pest may be clear evidence of intent.

17 Three Categories of Pesticides Conventional Chemical Pesticides o Synthetic chemicals used mostly to kill insects, weeds and fungi Biopesticides o Naturally occurring substances that control pests (biochemical pesticides), microorganisms that control pests (microbial pesticides), and pesticidal substances produced by plants containing added genetic material (plant-incorporated protectants, PIPs) Antimicrobial Pesticides o Substances or mixtures of substances intended to destroy or suppress the growth of harmful microbiological organisms, and pesticides that protect inanimate objects and surfaces from organisms such as bacteria, viruses or fungi.

18 Substances Not Subject to FIFRA s Registration Requirement Substances Not Within the Regulatory Definition of Pesticide 1. Substances not used against a pest. o Includes products intended only for micro-organisms, internal parasites or nematodes in or on living humans or animals o Fertilizer intended only to aid the growth of desired plants o Products intended to force bees from hives for honey collection 2. Substances without a pesticidal effect o Deodorizers, bleaches, cleaning agents o Products to attract pests for survey or detection o Products intended to provide a physical barrier against pest access 3. Research & Development substances

19 Substances Not Subject to FIFRA s Registration Requirement Products Exempted From Some or All FIFRA Requirements 1. Antimicrobial products not subject to regulation under RCRA are not subject to FIFRA s storage, disposal and transportation provisions unless the Administrator determines otherwise. 2. Pesticides regulated by another Federal agency. Includes paint containing a biocide, pheromones, preservatives for biological specimens, foods used to attract pests 3. Custom blends, usually a pesticide and fertilizer under certain conditions 4. Emergency Exemptions to prevent significant economic loss, quarantine, public health control or crisis intervention 5. Transfers of Unregistered Pesticides under limited conditions for production 6. Nitrogen stabilizers to prevent or hinder nitrification, denitrification, ammonia volitilization or urease production through action affecting soil bacteria 7. Liquid chemical sterilants for critical or semi-critical medical devices

20 Pesticide Product vs. Pesticide Device Pesticide Product contains a substance or mixture of substances (active ingredient(s)) that is intended to destroy, repel, prevent or mitigate (lessen the severity of) a pest. This includes substances that attract pests to lessen their impact, for example by attracting pests to a trap. Pesticide products must be registered with EPA unless it qualifies for an exemption. Pesticide Device any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom. (FIFRA 2(h)).

21 Pesticide Device Works by physical or mechanical means, as opposed to chemical or biological agent. EPA does not require registration for pesticide devices. However, devices are regulated in that false or misleading claims cannot be made about the effectiveness of devices. If a manufacturer is making claims about a device, they should have scientific data to backup the claims. Examples: Ultraviolet light (UV) systems, ozone generators, water filters and air filters without substance(s) which are pesticides, and ultrasonic devices for which claims are made to kill, inactivate, entrap or suppress the growth of fungi, bacteria, or viruses.

22 ? So, what does this mean? BMPs that make any claim regarding the BMP s ability to trap, destroy or mitigate bacteria by mechanical means are devices for the purposes of FIFRA, particularly if by the actions of the seller or buyer it can be reasonably inferred that the BMP is intended to perform this function.

23 Pesticide Devices are subject to these FIFRA provisions The prohibition against false and misleading labeling Establishment registration and reporting Books, records and establishment inspections Violations, enforcement and penalties Export and import regulations Other requirements declared necessary by the Administrator

24 Pesticide Device Some devices are not regulated. For example, any device that depends more upon the performance of the user than the performance of the device itself to be effective. Flyswatter Mouse Trap

25 Terms Considered by EPA as Public Health Claims (from EPA Pesticide Registration Notice ) Unqualified antimicrobial activity Antibacterial Bactericidal Germicidal Kills pathogenic bacteria Effective against E. coli and Staphylococcus Provides a germ-resistant or bacteria-resistant surface Controls gram positive and negative bacteria Sterilant Disinfectant Non-specific claim of beneficial impact on public health Not limited to these terms

26 Current Approaches to Antimicrobial Stormwater Treatment EPA Registered Pesticide Product (chemical-based) EPA Registered Pesticide Device (mechanical) Land based, Public Domain BMPs (mechanical) No EPA Pesticide Product Registration (chemical-based) No EPA Device Registration (mechanical) Proprietary Media Filtration using Active Ingredient applied to substrate Ultraviolet light (UV) 1. Bioretention cells 2. Bioswales 3. Constructed wetlands 4. Porous Pavement 5. Sand filters 6. Organic filters 7. Infiltration 8. Green roofs 9. Retention ponds 10. Detention basins 11. Others 1. Proprietary Media Filtration using Active Ingredient 2. Direct dosing of liquid Active Ingredient via BMP 1. Natural based proprietary media filtration 2. Porous pavers 3. Modular wetlands

27 Example: Antimicrobial Active Ingredient Quaternary amine, antimicrobial sword (~28Å = µm, mm)

28 Proposed Registration of Antimicrobial Treatment Technologies for Stormwater EPA Registered Pesticide Product (chemical-based) EPA Registered Pesticide Device (mechanical) Land based BMP (public domain) Gray area

29 State, Tribal Lands, Territories & Dist. of Columbia Registrations Must first hold EPA registration and accepted label (typically 2-3 years to obtain) Application process, fees and renewal periods vary by agency Registrations for: New Active Ingredient Significant New Uses of an Active Ingredient Restricted Use Pesticide (RUP) Experimental Use Permits (EUP) Special Local Needs (SLN) Emergency Exemptions (EE) SLN permit usually obtained in collaboration with EPA and includes annual fee

30 ? Why gray area for land based BMPs? Land based, public domain BMPs typically rely on mechanical treatment A mechanical BMP that makes a public health claim may need to be a registered pesticide device with EPA If the land based BMP is installed specifically to remove bacteria, that would meet the health claim and intent criteria So..should public domain BMPs be subject to pesticide law and registration requirements?

31 EPA Pesticides Homepage EPA Regulating Antimicrobial Pesticides EPA Pesticide Registration Manual EPA Pesticide Product Label Search LS:1

32 State Pesticide Agencies w/in SESWA Region ALABAMA sions/pesticide-management FLORIDA /Divisions-Offices/Agricultural- Environmental-Services/Business- Services/Pesticide GEORGIA aspx KENTUCKY /product-registration.html MISSISSIPPI bpi/bpi-pesticide-program.htm NORTH CAROLINA SOUTH CAROLINA pesticide_regulation/index.html TENNESSEE shtml

33 You can search for a registration

34 In conclusion While water quality monitoring data can be used for action item purposes (e.g., beach closure), there is a real lack of solutions to achieve sustainable levels of bacteria reduction in stormwater runoff FIFRA provides a regulatory framework for implementing stormwater BMPs to control bacteria Antimicrobial products are increasingly appearing in the marketplace and in some cases may not comply with FIFRA FIFRA distinguishes between chemical-based Pesticide Products and mechanical-based Pesticide Devices and their associated registration rules An argument can be made that engineered design practices that carry a public health claim to control bacteria may be subject to FIFRA device rules

35 Mark Miller