Re: Fwd: Sodium hypochlorite and Zebra -Quagga Mussels Uses 

### C) Joan Harrigan
-Farrelly to: Keith Pitts 10/18/2012 03:53PM Cc: Amy Roberts, Jonathan Birdsong, John Fournier, William Jordan , Mike Mendelsohn History: This message has been forwarded

. Keith, Greetings. Here is the information I was able to find on the zebra and quagga mussel thatwas added to the sodium hypochlorite label. Regards, Joan

zebra and quagga mussels

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.17

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Joan Harrigan Farrelly US Environmental Protection Agency Director, Antimicrobials Division Office of Pesticide Programs 1200 Pennsylvania Ave. N.W. Mailcode 7510P Washington, DC 20460 Physical Address One Potomac Yard 2777 Crystal Dr. Arlington, VA 22202 Phone: 703-603-8914

Keith Pitts Joan and Steven , I hope all is well with you. Ha

... From : Keith Pitts <kpitts@marronebio

.com> 10/08/2012 07:36:04 PM
To: Joan Harrigan-Farrelly/DC/USEPA/US@EPA, Steven Bradbury/DC/USEPA/US@EPA Cc: Date: Subject: Amy Roberts <ARoberts@TSGUSA

.COM>, John Fournier <jfournier@marronebio.com>, Jonathan Birdsong <jbirdsong@bwstrategies.com> 10/08/2012 07:36PM Fwd: Sodium hypochlorite and Zebra-Quagga Mussels Uses

Joan and Steven, I hope all is well with you. Have you been able to find anything out about the zebra and quagga mussel use that was added to a sodium hypochlorite label? thanks, Keith

---------- Forwarded message ----------From: Keith Pitts <kpitts@marronebio.com> Date: Tue, Sep 25, 2012 at 2:51 PM Subject: Sodium hypochlorite and Zebra-Quagga Mussels Uses To: bradbury.steven@epamail.epa.gov, Harrigan-Farrelly.joan@epa.gov Cc: Amy Roberts <ARoberts@tsgusa.com>, John Fournier <jfournier@marronebio.com>
Dear Steven and Joan, In August 2012, while researching approaches to address NPDES permitting requirements for Zequanox, we encountered sodium hypochlorite product labels that included zebra mussel control uses . The EPA database indicates the Antimicrobial Division approved the new use sometime in 2010. The new zebra and quagga mussels uses appear to be 20-40 times the previously assessed and registered treatment concentration (for disinfection) and much longer treatment durations than EPA has previously evaluated. After our collective experience with Zequanox, I would expect the new use to require a new risk assessment since chlorine treatments at efficacious concentrations are between dozens and thousands of times more toxic than Zequanox treatments, and treatment times are significantly longer than the 6-8 hours typically needed for pipe anti-fouling treatments using Zequanox. However, the EPA database does not provide any indication that any data to support the new use was submitted to EPA MBI did make multiple EPA contacts to understand a bit more about how these mussel-control uses had been added to the product label. On a cursory level, the informal feedback is that no new data was submitted to support these new uses on the sodium hypochlorite label (attached). MBI staff contacted EPA Ombudsmen and the Antimicrobials Division, via Sharon Carlisle and Sherada Hobgood, on August 17th to inquire as to whether or not EPA had completed additional risk assessments on chlorine or if these mussel-control uses had been allowed on product labels in error. To date, we haven't received a response to the inquiry. Could OPP review this situation and let us know has transpired? Please let me know if you need any additional information from us. Thanks for your help. Keith Keith Pitts Vice President, Regulatory and Government Affairs Marrone Bio Innovations 2121 Second St., Ste B-107 Davis, CA 95618 Office: 530-750-2800 ext. 212 Mobile: 240-463-4357 kpitts@marronebio.com www.marronebioinnovations.com This message and any associated attachments are confidential and intended solely for the use of the individual(s) or entity to whom it is addressed. If you are not the intended recipient you are hereby notified that any dissemination, copying or distribution of this message or attachments associated with this message, is strictly prohibited. If you have received this email in error please delete it.Although this email and any attachments are believed to be free of viruses or other defects, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Marrone Bio Innovations, Inc. or its affiliates. P.S. Please consider the environment

- do you really need to print this email?

Keith Pitts Vice President, Regulatory and Government Affairs Marrone Bio Innovations 2121 Second St., Ste B-107 Davis, CA 95618 Office: 530-750-2800 ext
. 212 Mobile: 240-463-4357 kpitts@marronebio

. com www.marronebioinnovations.com This message and any associated attachments are confidential and intended solely for the use of the individual(s) or entity to whom it is addressed. If you are not the intended recipient you are hereby notified that any dissemination, copying or distribution of this message or attachments associated with this message, is strictly prohibited. If you have received this email in error please delete it. Although this email and any attachments are believed to be free of viruses or other defects, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Marrone Bio Innovations, Inc. or its affiliates. P.S. Please consider the environment

- do you really need to print this email? [attachment "Sodium Hypochlorite- 12.5 Bacticide.pdf" deleted by Joan Harrigan-Farrelly/DC/ USEPA/US]

### Dear KeithBelow is a response to your September 25 email raising questions concerning the Antimicrobials Divisionregistration ofa sodiumhypochlorite productthat included zebra mussel and quagga mussel control uses. Specifically, you asked that we explain the basis for what appeared to be different approaches usedbyAD and the Biopesticides and PollutionPreventionDivisiontoward the chlorine-based product and another product, Zequanox, approved by BPPD 

### for a similaruse. SodiumHypochloriteMolluscacides Let me begin with some historical information onEPA's registration ofsodiumhypochlorite products. For many decades, sodiumhypochlorite labels have contained instructions for outdoor aquatic use sites such as cooling towers. AD records indicate that zebra mussels were first listed as pests on sodiumhypochlorite product labels in 1997 (EPA Reg. No. 813-15). At that time, EPA approved an increased use rate of20 ppm, compared to 10 ppm for the slimicide and algicide uses. Quaggamussels appear to have been added later; use rates and sites are the same as for zebra mussels and quagga mussels. The product label that was attached to your email (EPA Reg. No. 72315-6) first had zebra and quagga mussels added in 2008

. Throughout the time that the agencyhas registered sodiumhypochlorite products for outdoor use, wehaverecognized that sodiumhypochlorite is toxic to aquatic organisms. As explained in more detail below, OPP's approach to the regulation ofthese products rests on our conclusion that risk was adequately mitigatedbythe use ofthe following precautionary labeling and requirement for NPDES permitting: 

### ENVIRONMENTALHAZARDS Thisproduct is toxic tofish. Do notdischarge into lakes, streams, ponds orpublic waterways unless in accordance with aNPDESpermit. Forguidance, contact the regional office of the U.S. Environmental ProtectionAgency. " As you are aware, "[a]n NPDES permit will generally specify an acceptable level ofa pollutant orpollutantparameter in a discharge (for example, a certain level ofbacteria)

..." http://cfpub.epa.gov/npdes/faqs.cfm?program id=45. "When assessing point source discharges to determine whether controls based on water quality standards are necessary, an NPDES permitting authority should conduct an analysis to determine whether the discharge causes, has the "reasonablepotential" to cause, or contributes to an excursion ofany water quality criteria in the receiving water." http://cfpub.epa.gov/npdes/wqbasedpermitting/wqoverview.cfm The Agency published the

### Ambient Water Quality Criteriafor Chlorine inJanuary 1985. Extensive non-target aquatic organism data were used to setthe water quality criteria and these criteria impact NPDES permitrequirements. "Thirty-three freshwater species in 28 genera have been exposedto TRC [(Total Residual Chlorine)] and the acute values range from 28**~giL** 

### for Daphniamagna to 710**~giL** 

### for the threespine stickleback. Fish and invertebrate species had similarranges ofsensitivity. Freshwater chronictests havebeen conducted with two invertebrate and one fish species, and the chronic values for these 3 species ranged from less than 3.4 to 26**~giL ,**  

### with acute-chronic ratios from 3

.7 to greater than 78. The acute sensitivities of24 species

### ofsaltwater animals in 21 generahavebeen determined for CPO [(Chlorine Produced Oxidants)], and the LC50s range from 26 f.lg/L for the eastern oysterto 1,418 f.lg/L for a mixture oftwo shore crab species. This range is very similarto that observed with freshwater species, and fish and invertebrate species had similar sensitivities. Only one chronic test has been conducted with a saltwater species, Menidiapeninsulae, and inthis test the acute-chronic ratio was 1.162. The available data also indicate that aquatic plants are moreresistant to chlorine than fish and invertebrate species. The procedures described in the "Guidelines for Deriving Numerical National Water Quality Criteria for the Protection ofAquatic Organisms and TheirUses" indicate that exceptpossibly where a locally important species is very sensitive, freshwater aquatic organisms and their uses should notbe affected unacceptably ifthe four-day average concentration oftotal residual chlorine does not exceed 11 f.lg/L more than once everythree years onthe average and ifthe onehour average concentration does not exceed 19 f.lg/L more than once every three years onthe average. Theprocedures described in the "Guidelines for Deriving Numerical National Water Quality Criteriafor the Protection ofAquatic Organisms and TheirUses" indicate that exceptpossibly where a locally important species is very sensitive, saltwater aquatic organisms and their uses should notbe affected unacceptably ifthe four-day average concentration ofchlorine-produced oxidants does not exceed 7.5 f.lg/L more than once every three years onthe average and ifthe one-hour average concentration does not exceed 13 f.lg/L more than once everythree years on the average." p. 17-18. See http://water.epa.gov/scitechfswguidance/standards/upload/2001 10 12 criteria ambientwqc chl orine1984.pdf

. 

### Pseudomonasflourescens molluscacides BPPD decided to impose specific data requirements onZequanox becausethe active ingredient, 

### Pseudomonasfluorescens CL 145A, raises uniquerisk considerations that differ from conventional (chemical) pesticides. A particular concern is that the active ingredient is a living bacteriumthat could proliferate inthe environment. Theuse patterns for 

### Ps.fluorescens CL 145A may result in discharges of

### Ps.fluorescens CL 145A into water, with concomitant exposure to non-target aquatic organisms. 

### Ps.fluorescens is an opportunisticfish pathogen, and therefore, applications ofthe end-useproducts could presentrisks to fish, and perhaps other nontarget aquatic organisms (e.g., early-stage larval or "veliger" mussels/bivalves). BPPD determined that the application for registration of

### Pseudomonasfluorescens CL 145A did not adequately address the Tier 1data requirements for non-target aquatic organisms. Additionally, EPAcould not adequately estimate the potential exposure to nontarget aquatic organisms. Therefore, BPPD concluded that it could not make the FIFRA determination (i.e., no unreasonable adverse effects to the environment) without 1) the inclusion ofappropriate mitigation measures as terms ofregistration (i.e., discharge limitations and monitoring), and 2) the requirement that MBI submit additional non-target studies to enableEPA to complete its risk assessment for the active ingredient and confirm that use in accordance with label directions will notresult in unreasonable adverse effects to the environment.Conclusion In sum, while sodiumhypochloriteproducts and Zequanox are approved for use against zebra and quagga mussels, at the time EPA was considering the two applications, the agency had far more data on chlorine toxicity and exposure in aquatic environments than on

### Ps. Fluorescens CL145A. Moreover, regulatory controls, in the form ofa requirement for anNPDES permitto cover a discharge, existed at the time ofthe sodiumhypochlorite registrations. OPPregarded the NPDES permitprogram as capable ofaddressing the aquatic risks for chlorine discharges because EPAhad established chlorine water quality criteria levels, which were linkedto those permits for point source discharge. Although

### Ps. Fluorescens CL145A molluscacide uses would also require NPDES permits, we are not aware ofwater quality criterialevels being available for 

### Ps.flourescens. Thus, EPA needed data to support the specific discharge levels that were established viathe terms ofthe

### Pseudomonasflourescens molluscacide registrations. You may obtain additional background informationfrom the Sodium and Calcium Hypochlorite 1986 Registration Standard, 1992 ReregistrationEligibilityDocument, and 2012 Registration Review Final WorkPlan. Should you have anyfurther questions, please contact Mike Mendelsohn, Acting ChiefofRegulatory Management Branch II, at (703) 308-8715 or mendelsohn.mike @epa.gov.

BestRegards, Joan