UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, DC 20460 

Mr. Keith Pitts 

Vice President, Regulatory Affairs 

Marrone Bio Innovations 

212 Second Street, Suite B-107 

Davis, CA 95618 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

FEB 1 0 L014 

Subject: Response to Your Letter of February 20, 2013 to Steven Bradbury Regarding Sodium Hypochlorite 

and Other Biocide Zebra Mussel Uses 

Dear Mr. Pitts: 

Thank you for your response to Joan Harrigan-Farrelly's October 17, 2012 correspondence and the detailed 

analysis provided. We evaluated the issues raised in your letter regarding 1) sodium hypochlorite risk 

concerns, 2) other biocides risk concerns, and 3) procedural issues related to sodium hypochlorite registration 

review, and have addressed them in this correspondence. 

As background to your concerns over risk assessment adequacy, we note that the agency's aquatic 

environmental risk assessment process for antimicrobial pesticides has progressed over time. For instance, at 

one time, recirculating cooling tower uses were considered indoor uses that did not require environmental 

assessments, while once through cooling tower uses were considered outdoor aquatic uses that did. With the 

promulgation of 40 CFR Part 158 W, the agency now includes both of these uses under the industrial 

processes and water systems use pattern and requires aquatic non-target organism toxicity data and performs 

non-target aquatic risk assessments for both. Similarly, what the agency has required in terms of aquatic 

non-target organism data has also changed over time. The aquatic animal data now typically required for 

industrial processes and water systems use patterns, including mulluscicide uses, are shown in Table 1 in 

Attachment 1. 

Further, as mandated in 1996 by the Food Quality Protection Act, the registration review program is the 

primary mechanism for the agency to assure that, as the ability to assess risk evolves and as policies and 

practices change, all registered pesticides continue to meet the FIFRA statutory standard of no unreasonable 

adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through 

the registration review program, the agency periodically reevaluates pesticides to make sure that as change 

occurs, products in the marketplace can still be used safely. We will certainly be evaluating the adequacy of 
past risk assessments and data supporting antimicrobial pesticide substances used in industrial processes and 

water systems, including those with mulluscicide uses, under this program. 

1. Sodium Hypochlorite 

With respect to the agency's review of sodium hypochlorite specifically, current risk assessment standards 

were considered along with current use patterns and allowed discharge rates. (You are correct that mussels 

were not specifically addressed. However, the mulluscicidal use is considered part of the cooling tower use 

pattern. 1 ) As explained in more detail below, the agency determined that no additional toxicology or 

ecological effects data are required and no additional risk assessment is needed to support current sodium 

hypochlorite uses. In coming to this conclusion, the agency took into consideration, among other things, the 

existence of scientifically sound water quality criteria for protection of aquatic life specific to chlorine and 

the existence of scientifically sound risk-based water quality criteria and drinking water criteria for 

protection of human health specific to chlorine and chlorination by-products. 

Ecological Effects Data Requirements 

In September of 2012, we determined that no further ecological effects data are needed to support the 

registration review of existing calcium and sodium hypochlorite uses, including the use for treatment of 

mollusks. All use patterns were considered in light of current practice during development of the Product 

Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review 

of Sodium & Calcium Hypochlorite Salt? (Fate and Ecological Scoping Document). Of all the use patterns 

registered for the hypochlorites, the use in cooling towers is one which would, under current practice, require 

the greatest amount of ecological effects data to continue to support registration. As discussed in the Fate 

and Ecological Scoping Document, however, all such data requirements were met both for aquatic and 

terrestrial animals. Indeed, not only are the data requirements met for aquatic animals, but except for aquatic 

invertebrate sediment testing, the data set is quite robust, as there are more data both in number of tests and 

diversity of species tested than required for a typical active ingredient registration. In part, this is because 

chlorine has been used as a water disinfectant for over a hundred years and in that time data have been 

published in the open literature and generated by the government on its effects to aquatic and terrestrial 

organisms. Public literature and agency generated studies can be used to satisfy data requirements, as 

discussed in 40 CFR Part 152.94. In the case of sediment testing, the physical-chemical characteristics of 

sodium hypochlorite result in such data not being needed to assess risk. (40 CFR Part 158.2240) 

For example, Table 2 lists the aquatic animal data requirements and the number and type of studies used to 

develop the national ambient water quality criteria (NA WQC) for chlorine. These data were cited in the Fate 

and Ecological Scoping Document and the Na & Ca Hypochlorite Registration Review: Final Work Plan 

(FWP)3

. These data were available prior to 1988 and were used to develop the NA WQC for chlorine in 1984 

1 On a similar note, we investigated the concerns expressed in your November 18, 2013 email regarding the EarthTec 

label, EPA Registration No. 64962-1, and determined that the amendment to add zebra and quagga mussel pests did not 

involve a new site or use rate for elemental copper, but rather a new pest. See 

http://www.epa.gov/oppsrrd 1/REDs/cotmer red amend.pdf. 2 March 22, 2012, docket number EPA-HQ-OPP-2012-0004-0003 at http://www.regulations.gov 

3 September 2012, docket number EPA-HQ-OPP-2012-0004-0006 at http://www.regulations.gov 

Page 2 of7 
and 1986. As of 2013, these criteria remain unchanged. And while the criteria are decades old, this does not 

mean that they should be considered invalid or scientifically unsound. The Federal Water Pollution Control 

Act (FWPCA), Section 304(a)(1) provides, in pertinent part, that EPA "shall develop and publish ... criteria 

for water quality accurately reflecting the latest scientific knowledge." The FWPCA also provides that these 

criteria are to be revised from time to time to reflect the latest scientific knowledge. The EPA reviews 

existing NA WQC periodically and revises the criteria, if appropriate, based on new scientific data. Since 

1986, these periodic reviews have so far not resulted in any additional scientific data that materially change 

the NA WQC for chlorine. 

Finally, EPA did not require additional ecological effects data on halomethane4 disinfection by-products 

formed from use of hypochlorites because there is extensive information on this issue from a combination of 

ambient water quality criteria for halomethanes5

, the public literature, government generated studies, and 

models6

. 

Human Health Toxicology Data Requirements 

In the context of registration review, no additional toxicity or exposure data are anticipated as needed to 

support existing calcium and sodium hypochlorite uses, including the use for treatment of mollusks. All use 

patterns were considered in light of current practice during development of the Sodium Hypochlorite and 

Calcium Hypochlorite: Human Health Risk Assessment Scoping Document in Support of Registration 

Review1 (Human Health Scoping Document). As discussed and referenced in the Reregistration Eligibility 

Document Sodium and Calcium Hypochlorite Salti (RED) and Human Health Scoping Document, toxicity 

data were available not just for chlorine, but also for halomethanes including the trihalomethaneschlorination by-products. Accordingly, the agency believes the data base for chlorine and chlorination 

disinfection by-products is sufficient for purposes of conducting registration review. As pointed out 

previously, chlorine has been used as a water disinfectant for over a hundred years, and in that time data have 

been published in the public literature and developed by the government on its effects and effects of its 

chlorination by-products to mammals, in addition to data that has been submitted by registrants. The public 

literature and government generated data are of sufficient quality and quantity that the Office of Water has 

developed national ambient water quality criteria (A WQC) for halomethanes for the protection of waters 

designated for drinking water use and consumption of fish and shellfish and set maximum contaminant levels 

(MCLs) for drinking water. Current A WQC and MCL values for chlorine and hypochlorite chlorination byproducts are listed in Table 39

• While this table was not explicitly provided in the Human Health Scoping 

4 Chloromethane (methyl chloride) CAS# 74-87-3; dichloromethane (methylene chloride), CAS# 75-09-2; 

trichloromethane (chloroform) CAS# 67-66-3; bromodichloromethane CAS# 75-27-4; or dibromochloromethane CAS# 

124-48-l. 

5 http://water.epa.gov/scitech/swguidance/standards/criterialupload/200 I 10 12 criteria ambientwgc halomethanes80. 

~ ECOSAR http://www.epa.gov/opptlnewchems/tools/21 ecosar.htm 7 January 20, 2012; docket number EPA-HQ-OPP-2012-0004-0004 at http://www.regulations.gov 

8 February 1992; http://www.epa.gov/oppsrrdl/REDs/old reds/case0029.pdf 

9 http://water.epa.gov/drink/contaminants/basicinformation/disinfectionbyproducts.cfm 

Page 3 of7 
Document, these values were referenced as the basis for not needing to require any additional toxicity data. 

These values are periodically reviewed and updated by EPA. 

Risk Assessment of Hypochlorite Mollusk Use Pattern 

In the case of hypochlorite registrations, the Agency took into consideration that scientifically sound water 

quality criteria for protection of aquatic life exist for chlorine and that scientifically sound risk-based water 

quality criteria and drinking water regulations for protection of human health also exist for chlorine and 

chlorination by-products. 

In general, FIFRA labels do not provide site specific facility discharge limits for cooling towers. FIFRA 

labels provide maximum use rates at a facility, and in some cases also provide guidance on the need for 

pretreatment. However, the label does not mean that all facilities can use the product at the given rate and 

expect not to exceed water quality standards. For instance, given two facilities with the same discharge 

instream flow rates, end of pipe antimicrobial concentration, and same water body designated use(s) 10, one 

facility may be able to use the antimicrobial product at the label rate and the other may not be able to use the 

antimicrobial product or may need to use it at a lower rate because one has a mixing zone, 11 •

12•13 but the other 

one does not. The Agency ensures that site specific conditions are taken into consideration before use at a 

given facility by including the label language requiring notice to National Pollutant Discharge Elimination 

System (NPDES) Permitting Authority before water treated with an antimicrobial pesticide can be 

discharged. Such language is on the Dixichlor Max label and other labels for sodium hypochlorite use for 

mussels. 

Formally adopted numeric criteria and standards are the legal basis for including water-quality based effluent 

limitations in NPDES permits to ensure a specific discharge meets instream water quality standards. The 

FWPCA requires discharges to meet instream water quality standards. (See section 301(b)(l)(C), 33 U.S.C. 

131l(b)(l)(C)). Where state or national ambient water quality criteria exist, permit writers use this 

information along with information about the specific discharge source and instream water quality standards 

to establish water-quality based permit limits for the specific use site. States may include policies generally 

affecting the application and implementation of instream water quality standards, such as mixing zones, low 

flows and variances. Where formally adopted numeric criteria for an antimicrobial do not exist, permit 

writers can use other sources of information to develop limits, such as public literature, government 

generated data, models, and risk assessments conducted by the Office of Pesticide Programs, to inform the 

site-specific facility water-quality based discharge permit limits. 

10 Examples of designated use categories: protection of aquatic life; protection of human health related to consumption 

of fish and shellfish; recreation (primary contact, secondary contact); domestic water supply; livestock irrigation; 

navigation. 

11 According to EPA's Technical Support Document for Water Quality-based Toxics Control (TSD) (USEPA, 1991), "a 

mixing zone is an area where an effluent discharge undergoes initial dilution and is extended to cover the secondary 

mixing in the ambient waterbody. A mixing zone is an allocated impact zone where water quality criteria can be 

exceeded as long as acutely toxic conditions are prevented." (Water quality criteria must be met at the edge of a mixing 

zone.)" 

12 http://water.epa.gov/scitech/swguidance/standards/mixingzones/about.cfm 13 http://water.epa.gov/scitech/swguidance/standards/mixingzones/docs.cfm 

Page 4 of7 
Aquatic Life 

An ecological risk assessment for the hypochlorites specific to the mollusk use was unnecessary because of 

the given state of knowledge regarding chlorination, its chemistry, the existence of formally adopted water 

quality criteria for chlorine, toxicity information on chlorination by-products of concern, and existing label 

language. As discussed previously, while the aquatic life criteria have remained unchanged since their 

adoption, they have undergone review by the Office of Water, they are considered scientifically sound, and 

they are legally enforceable (state water quality criteria can be more stringent). Information provided by an 

additional risk assessment would not result in any additional label change or modification of the enforceable 

water quality criteria. While Dixichlor Max, for example, has a higher use rate for mollusks than other 

hypochlorite labels, this does not allow contravention or override of water-quality based discharge permit 

limits that would be imposed under NPDES (compliance with which is already required on the label). 

Pretreatment of chlorinated waters such as dechlorination prior to discharge is a well known option to allow a 

facility to use chlorination and meet water quality standards. In the Zebra Mussel Chemical Control Guide 

(USGS, 200014), this is evident in the discussion about the practice when chlorination is used: 

The actual permit limitation for facilities discharging to surface waters is based on a calculation 

specific for each plant and receiving stream. Because of water quality considerations, some plants 

practicing chlorination for disinfection are required to dechlorinate. In such cases the limits may 

vary from non detectable concentrations to 0.05 mg/L. Where water quality consideration have not 

been determined to be a factor, the established limits of 1.5 to 2.0 mg/L chlorine residua/for critical 

water (defined as those waters which come into close human contact, such as lakes and rivers used 

for drinking water, shell .fishing, and for contact water sports) and 1.0 to 2.0 mg/Lfor non critical 

water are appropriate. 

An aquatic ecological risk assessment is typically conducted where the antimicrobial is one that does not 

have a formally adopted A WQC. Under these circumstances, the need for an aquatic ecological risk 

assessment and its setting of endpoints, understanding of fate, exposure analysis and modeling becomes more 

critical to understanding and characterizing risk and aiding the Agency in appropriate label language. It also 

provides a source for permit writers to develop appropriate site specific discharge limits, require 

pretreatment, or deny use such that instream water quality standards are met. 

Human Health Risks 

A drinking water risk assessment for the mollusk use was not necessary as the A WQC are already risk-based 

values 15: 

EPA's section 304(a) human health guidelines attempt to provide criteria which minimize or specify 

the potential risk of adverse human effects due to substances in ambient water (45 FR 79347). 

14 Sprecher, S.L. and K.D. Getsinger. US Army Corps of Engineers, Engineer Research and Development Center. 

Environmental Laboratory ERDC/EL TR-00-l. 

15 http://water.epa.gov/lawsregs/rulesregs/ntr/index.cfm 

Page 5 of7 
EPA's section 304(a) criteriafor human health are based on two types of biological endpoints: (1) 

carcinogenicity and (2) systemic toxicity (i.e., all other adverse effects other than cancer). Thus, 

there are two procedures for assessing these health effects: one for carcinogens and one for noncarcinogens. 

Methods used to conduct these risk assessments are from time to time updated. The most recent is EPA's 

(2000) Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health 

Technical Support Document, Volume 1: Risk Assessment16• The current AWQC were updated using these 

methods. The formally adopted human health A WQC are legally enforceable criteria (state water quality 

criteria can be more stringent). Information provided by an additional drinking water risk assessment would 

not result in any additional label change or modification of the enforceable water quality criteria. While, for 

example, Dixichlor Max has a higher use rate for mollusks than other hypochlorite labels, this does not allow 

contravention or override of water-quality based discharge permit limits which would be imposed under 

NPDES, compliance with which is already required on the label. 

2. Biocides other than Hypochlorites 

Mulluscicides and their registration review status are listed in Table 4 in Attachment 1. Many of these 

biocides have been determined as requiring specific biocide/ antimicrobial aquatic risk assessments. Through 

the registration review program, the agency will be evaluating the adequacy of data/risk assessments 

supporting these biocides. These substances and their registration review status are listed below in Table 4, 

and we encourage Marrone Bio Innovations to engage in the public process available under registration 

review for these substances. 

Unlike the hypochlorite registrations, the agency was not able to take advantage of a formally adopted 

ambient water quality criteria (A WQC) for many of the biocides, other than the hypochlorites, for our 

antimicrobial/biocide evaluations. Under the CW A, where formally adopted numeric criteria for an 

antimicrobial do not exist, NPDES permit writers can use other sources of information to develop limits, 

such as public literature, government generated data, models, and risk assessments conducted by the OPP, to 

inform the site-specific facility water-quality based discharge permit limits. 

To be clear, we agree with you that the addition of new use rates to antimicrobial pesticide products used in 

industrial processes and water systems triggers the need for an updated risk assessment or, at a minimum, a 

determination as to why such an update is not needed, and I have recently emphasized these points to my 

leadership team in the Antimicrobial Division. 

3. Procedural Issues Related to Sodium Hypochlorite Registration Review 

Finally, you indicate in your letter that" ... interested parties were prevented from submitting comments on 

the scoping document, for which the comment period had already closed by the time the public had been 

notified in April that the case had been moved up to 2012." We note that under the registration review 

program chemical specific public comments are sought on preliminary work plans, proposed risk 

16http://water.epa.gov/scitech/swguidance/standards/criterialhealthlmethodology/upload/2005 05 06 criteria humanhe 

alth method supportdoc.pdf 

Page 6 of7 
assessments, and proposed decisions. The Product Chemistry, Environmental Fate, and Ecological Effects 

Scoping Document in Support of Registration Review of Sodium & Calcium Hypochlorite Salts that you 

claim you were prevented from commenting on was a supporting document to the preliminary work plan. 

This type of supporting document does not go through a separate comment period outside of the preliminary 

work plan comment period. Opportunity was made by the agency to comment on the preliminary work plan 

and the comment period closed on May 29, 2012 (77 FR 18810). 

Although the comment period has closed, we have placed your 2/20/2013 and 9/25/2012letters, this letter, 

and Joan Harrigan-Farrelly's response in the Sodium and Calcium Hypochlorite Registration Review public 

docket. 

cc: Robert McNally 

Sincerely, 

Antimicrobials 

J.~~j~~ Division (751 OP) 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

Page 7 of7 

Attachment 1 to Susan Lewis's 2014 Letter to Keith Pitts of Marrone Bio Innovations 

Table 1. Typical Aquatic Animal Data Requirements for Use in Industrial Processes and Water 

System Uses 

Aquatic Animal Data Requirements 

TypeofTes~ Number of Tests 

Acute freshwater fish toxicity 2 species (one warm water and one cold water) 

Acute freshwater invertebrate 1 species 

Acute estuarine/marine mollusk 1 species (either a shell deposition or an embryo/larval test) 

toxicity 

Acute estuarine/ marine fish 1 species 

toxicity 

Acute estuarine/ marine shrimp 1 species 

toxicity 

Fish early life stage 1 species (the more sensitive of the freshwater or estuarine/marine 

species) 

Aquatic invertebrate life-cycle 1 species (more sensitive of the freshwater or estuarine/marine species) A 40CFR Part 158.2240 

Table 2. Aquatic Animal Data Requirements for Use of Hypochlorites in Cooling Towers and Studies 

A va1 "I a e bl to S atlsty . f Th ese D a ta R equuements 

Aquatic Animal Data Requirements for HypochloritesA.8 Available Studies Cited in 

Type of Teste Number of Tests Scoping Document 

Acute freshwater fish toxicity 2 species (one warm water and one 20 species (>80 tests), includes 

cold water) both cold and warm water species, 

and preferred test species 

Acute freshwater invertebrate 1 species 12 species (>20 tests), includes 

preferred test species (3 of these 

species were freshwater mollusks) 

Acute estuarine/marine mollusk 1 species (either a shell deposition or 1 species 

toxicity an embryo/larval test) 

Acute estuarine/ marine fish 1 species 11 species (12 tests), includes 

toxicity I preferred test species 

Acute estuarine/ marine shrimp 1 species 7 species (11 tests), includes 

toxicity I preferred test species 

Fish early life stage 1 species (the more sensitive of the Freshwater a higher tier life cycle 

freshwater or estuarine/marine test with 1 species (2 tests); 

species) Saltwater: 1 species (1 test) 

Aquatic invertebrate life-cycle 1 species (more sensitive of the Freshwater: 2 species 

freshwater or estuarine/marine 

species) 

A40CFR Part 158.2240 

8 Aquatic plant testing data requirements include 4 algal species and I vascular species (40CFR 158.2250), studies are available for each species, the 

type of data available provides supplemental information. No additional testing was required to characterize risk. 

Page 1 of 5 
c Sodium and calcium hypochlorite physical-chemical properties do not trigger concerns that toxicity to benthic invertebrates is under represented by 

water column testing; therefore sediment testing is not required. 

Table 3. Human Health National Ambient Water Quality Criteria and Office of Drinking Water 

MCL s ~ or Chi onnean d Chi onna ti on B P d iY- ro uc ts 

National Ambient Water Quality Criteria for Drinking Water 

Compound 

Human Health from: Re2ulations 

Water and Aquatic Organism MCLAIMRDL 

Or2anism In2estion Consumption Only 

Chlorine (as Ch) none none 4,000 J.lg/L 

Halomethane disinfection by-products 

Chloromethane (or methyl chloride) 0.19 J.lg/L8 15.7 J.lg/LB none 

Dichloromethane (or methylene 4.6 J.lg/LB,C 590 J.lg/LB,C 5J1g!L chloride) 

Trichloromethane (or chloroform) 5.7 J.lg/LB,D 470 J.lg/LB SeeiTHMs 

Chlorodibromomethane 0.40 J.lg/LB,C 13 J.lg/LB,C SeeiTHMs 

Dichlorobromomethane 0.55 J.lg/L B,C 17J.lg/LB,C SeeiTHMs 

Tribromomethane (or bromoform) 4.3 J.lg/LB,C 140 J.lg/LB,C SeeiTHMs 

Total Trihalomethanes (ITHMs) See individual THMs See individual THMs 80 J.lg/L 

Haloacetic acids0 none none 60 J.lg/L 

A Maximum contaminant level in drinking water (byproducts); Maximum residual disinfectant level (chlorine). 

8 Value presented is for a 10-6 incremental increase of cancer risk over a lifetime. Alternate risk levels may be obtained by moving the decimal point 

(e.g., for a risk level of 10'5

, move the decimal point in the recommended criterion one place to the right). 

cThis criterion reflects the EPA's q1 *or RID, as contained in the Integrated Risk Information System (IRIS) as of May 17,2002. The fish tissue 

bioconcentration factor (BCF) from the 1980 Ambient Water Quality Criteria document used to derive the original criterion was retained in each case. 

0 monochloroacetic acid; dichloroacetic acid; trichloroacetic acid; bromoacetic acid; dibromoacetic acid 

Page 2 of 5 
Table 4. Status of Registration Review Actions for Active Ingredients with Aquatic Molluscicide Uses 

' . Registration -1 '. 

Review Summary Active PC 

Ingredient Code Case# Document/ Registration Review Final Work Plans (FWPs) 

Preliminary Work 

Plans (PWPs) 

Alkyl trimethylenediamines 3014 Q1 2015 Q3 2015 

(ATMDs;J7 

N-(coco alkyl) 067301 

trimethylenediamine 

Inorganic Halides 14 4051 Completed 03/18/2009 Completed 09/23/2009 

Sodium Bromide 013907 (EPA-HQ-OPP-2009-

(Note: Used in 0168) 

presence of 

activators such as 

hypochlorites, 

chlorine gas, 

potassium 

monopersulfate, 

or ozone to form 

hypobromous 

acid) 

Na andCa 0029 Completed 03/28/2012 Completed 09-28-2012 

Hypochlorites19 (EPA-HQ-OPP-2012-

Sodium 014703 0004) 

Hypochlorite 

Peroxy Compounds 4072 Docket opened Completed 03/3112010 

Hydrogen 000595 0912009 (EPA-HQperoxide OPP-2009-0546) 

Ethaneperoxoic 063201 

acid 

Dihalodialkylhydantoin.l1 3055 Docket opened Q1 2014 

(Note: these react to release 06/19/2013 (EPA-HQhypochlorous acid, and OPP-2013-0220) 

degradates: DMH and EMHJ 

2,4-Imidazo- 006315 

lidinedione, 1-

bromo-3-chloro5,5-dimethyl 

1,3-dichloro-5,5- 028501 

dimethylhydantoin 

1 ,3-Dichloro-5- 128826 

ethyl-5-

methylhydantoin 

Chlorine dioxide 4023 Q3 2015 Q1 2016 

Sodium chlorite 020502 

(Note: used with 

hypochlorite at 

application site 

to form chlorine 

dioxide) 

Chlorine dioxide 020503 

17 Case also includes PC Codes 067302; 067309; 067310; 067313 18 RED Case also included PC Codes 013902 and 013905 and RR Case includes these plus 075605 19 Case also includes PC Code 014701 (Calcium hypochlorite) 2

° Case also includes PC Code 063604 21 RED Case also included PC Code 006137 and the RR Case also includes this PC Code and 028500, 128989, and 006322 

Page 3 of5 
. Registration 

Active PC Review Summary 

Ingredient Code Case# Document/ Registration Review Final Work Plans (FWPs) 

Preliminary Work 

Plans (J:»WPs) 

Copper compounds 0636 Docket opened Completed 03/28/2011 

Copper sulfate 024401 09/22/2010 (EPA-HQpentahydrate OPP-2010-0212) 

Endothall and salts 2245 -- Endothall, 038905 

mono(N,Ndimethyl alkyl 

amine) salt 

Glutaraldehyde 043901 2315 Q4 2014 IQ2 201s 

Dodecylguanidine 044303 0161 -- hydrochloride 

2-Phenylp_henol and Salts<' 2575 Docket opened Q2 2014 

o-Phenylphenol 064103 9/25/2013 (EPA-HQOPP-2013-0524) 

Poly(oxy-1,2- 069183 3034 Q42015 Q2 2016 

ethanediyl-

(dimethylimino )-

1,2-

ethanediyl(dimethyl 

imino )-1 ,2-

ethanediyl 

dichloride) (a.k.a. 

Busan 77) 

Polyquaternary ammonium 0350 Q4 2015 Q2 2016 

compoundi3 

Alkyl* dimethyl 069105 

benzyl 

ammonium 

chloride 

(ADBAC) 

*(40% C12; 50% 

C14; 10% C16) 

ADBAC(5% 069104 

C12; 60% C14; 

30% C16; 5% 

C18) 

Dialkyl* methyl 069119 

BAC *(5% C12; 

60%C14; 30% 

C16; 5% C18) 

Alkyl* dimethyl 069154 

ethylbenzyl AC 

*(68% C12; 32% 

C14) 

Alkyl* dimethyl 069175 

BAC *(67% 

C12, 25% C14, 

7% C16, 1% 

C18) 

Aliphatic alkyl quaternaries 

(DDACy24 

3003 Q4 2015 Q2 2106 

22 Case also includes PC Code 0641 04 and 064108 23 Case also includes 069106; 069107; 069111; 069112; 069122; 069125; 069129; 069134; 069137; 069140; 069141; 069154; 069157; 069171; 

069171;069175;069184;069189;069194; 128928; 169108;and169159 24 RED Case included PC Code 069146; 069165; 069166; 069173 and the RR Case includes these plus 018101; 129012 

Page 4 of 5 
Registration 

Active PC Review Summary 

Ingredient Code Case# Document/ Registration Review Final Work Plans (FWPs) 

Preliminary Work 

Plans (PWPs) 

1- 069149 

Decanaminium, 

N-decyl-N,Ndimethyl-, 

chloride 

Decyl isononyl 069207 -- Completed 03/31/2010 Completed 08/05/2010 

dimethyl (EPA-HQ-OPP-2010-

ammonium 0005) 

chloride (DIDAC) 

Inorganic Chlorates' 4049 TBD TBD 

Sodium chlorate 073301 

(Used to generate 

chlorine dioxide 

at use site) 

Niclosamide 077401 2455 Completed 3/2012013 Completed 08/02/2013 (EPA-HQ-OPP-2013-0137) 

(EPA-HQ-OPP-2013-

0137) 

Methiocarb 100501 0577 Completed 6/25/2010 Completed 12/08/2010 (EPA-HQ-OPP-2010-0278) 

(EPA-HQ-OPP-2010-

0278) 

Methylisothiazolinone (a.k.a. 3092 Q2 2015 TBD 

DMO) 

5-Chloro-2- 107103 

methyl-3(2H)-

isothiazolone 

2-methyl-3(2H)- 107104 

isothiazolone 

2-Propen-1- 128727 -- Q1 2015 Q3 2105 

aminium, N,Ndimethyl-N-2-

propenyl, chloride, 

homopolymer 

Bronopol 216400 2770 Completed 06129/2011 Completed 12/30/2011 

(Note: (EPA-HQ-OPP-2011-

Formaldehyde is a 0421) 

degradate) 

25 Case also includes PC Code 073302; 073303; and 530200 

Page 5 of 5