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### Table of Contents

**Contents**

I. Introduction

................................ ................................ ................................ .......................... 4

II. Scientific Assessment

................................ ................................ ................................ .......... 6

A. Human Health Assessment

................................ ................................ ................................ ........ 6

1. Risk Conclusions

................................ ................................ ................................ ................. 7

2. Human Incidents

................................ ................................ ................................ .................. 7

3. Tolerances

................................ ................................ ................................ ............................ 7

B. Environmental Assessment

................................ ................................ ................................ ....... 7

1. Environmental Fate and Exposures

................................ ................................ ..................... 7

2. Ecological Assessment

................................ ................................ ................................ ......... 7

3. Characterization of Ecological Risk

................................ ................................ .................... 8

4. Ecological Incidents

................................ ................................ ................................ ............. 9

5. Risk Conclusions

................................ ................................ ................................ ................. 9

C. Benefit s Assessment

................................ ................................ ................................ ................. 10

D. Endangered Species Assessment

................................ ................................ ............................. 10

E. Endocrine Disruptor Screening Program

................................ ................................ .................. 11

III. Proposed Interim Registration Review Decision

................................ ............................... 12

A. Risk Mitigation and Regulatory Rationale

................................ ................................ ........ 12

B. Proposed Interim Registration Review Decision

................................ ............................... 13

IV. Next Steps and Timeline

................................ ................................ ................................ .... 13

A. Interim Registration Review Decision

................................ ................................ ............... 13

B. Implementation of Mitigation Measures

................................ ................................ ............ 13

Appendix A: Summary of Proposed or Completed Actions Taken for DTEA

- HCl

................... 14

Appendix B: DTEA

- HCl Label Table

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### I. Introduction

This document is the Environmental Protection Agency’s (EPA or the a gency ) Proposed Interim Registration Review Decision for 2

- (decylthio)ethanamine hydrochloride ( herein referred to as

DTEA

- HCl) and is being issued pursuant to 40 CFR sections 155.56 and 155.58

. A registration

review decision is the a gency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insect icide, Fungicide, and Rodenticide Act (FIFRA). The

a gency may issue, when it determines it to be appropriate, a n interim registration review decision before completing a registration review. Among other things, the interim registration review

decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the regis tration

review. Further information and additional documents on DTEA

- HCl

, PC code 128963, case

5029 , can be found in EPA’s public docket (EPA

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- 0 336 ) at www.regulations.gov

.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the EPA based on scientific data showing that they will

not ca use unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, al l registered pesticides continue to meet the 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 a gency periodically reeval uates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided a t http://www2.epa.gov/pesticide

- reeva luation

.

In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

DTEA

- HCl is a liquid, organic industrial biocide commonly known by the trade name DTEA. There is one manufacturing

- use and one end

- use product registration of DTEA

- HC l

. The manufacturing

- use product, Antimicrobial DTEA Technical (99.8%), is registered for formulation of pesticide products for use in re

- circulating cooling water systems. These systems include evaporative condensers, heat exchange water systems, commercial and industrial cooling towers, influent systems such as flow

- through filters and lagoons, industrial water scrubbing systems and brewery pasteurizers. The end

- use product contains 15 % DTEA

- HCl and is registered for use to control bacterial, fungal, and al gal slimes.

DTEA

- HC l was first registered in 1993 but it is not marketed in the U

. S

. While e xposures described in the assessment presented in this document are not occurring at this time and are

theoretical

, the agency assumes that DTEA

- HCl could be use d at some time in the future. Therefore, the risk assessment covers any potential future exposure should the product be sold,

distributed

, and used in the U.S. Since DTEA very rapidly dissociates from DTEA

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5 exposure to registered uses of DTEA

- HCl will not result in unreasonable adverse effects to non

target aquatic and terrestrial organisms provided that label amendments are adopted

.

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for DTEA

- HCl

. A Reregistration Eligibility Decision (RED) was not issued by the agency for DTEA

- HCl as it was registered after 1984. The following timeline highlights significant events that have occurred during the registration review of DTEA

- HCl :

- Publication of DTEA

- HCl Summary Document , including the Preliminary Work Plan (PWP), for DTEA

- HCl was issued in September 2009 for a 60

- day public comment period.

- Final Work Plan (FWP) for DTEA

- HCl was posted December 16, 2009 after public

comments were addressed.

- Generic Data Call

- In notice (GDCI) for DTEA

- HCl was issued August 17, 2011

. Since the final work plan (FWP) was posted, the agency ’s practice for evalu ating ecological risks from recirculating cooling process water systems expanded to include evaluation of sediment exposure pathways and bioaccumulation up the aquatic food chain to terrestrial wildlife. Therefore, not all the data needed to address these exposure pathways was anticipated to be needed in the FWP.

- The 2

- (Decylthio)Ethanamine Hydrochloride (DTEA

- HCl), Human Health and Ecological Preliminary Risk Assessment for the Registration Review dated September 30, 2013 was posted for a 60

- day public comment period. One comment was received from Crop Life America (CLA) during the comment period. The comment is summarized and responded to below.

The agency anticipates publishing the 2

- (Decylthio)Ethanamine Hydrochloride (DTEA

- HCl) Prop osed Interim Registration Review Decision by March 201 6 in docket number EPA

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OPP

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- day public comment period.

Additional information on DTEA

- HCl can be found in EPA’s public docket

, EPA

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.

Comment Received from Crop Life America ( CLA)

Comment : Crop Life America commented that the preliminary risk assessment (PRA) for the registration review of DTEA

- HCl largely relied on screening level estimates of exposure compared to a threatened and endangered ( listed ) species level of concern (LOC). CLA further stated that screening tiers indicate whether a potential risk exis ts, but additional refinements to reduce uncertainties would indicate whether a risk of concern actually exists. CLA stated that it would be prem ature to evaluate what, if any, risk mitigation options may be suitable until a risk assessment including all a dditional data gathering and refinement has been completed to indicate what the risks actually are.

Response : EPA has reviewed the comments from Crop Lif e America ( C LA) on the preliminary

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6 of the implementation plan for assessing the risks of pesticides to threatened and endangered ( listed ) species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will add ress concerns specific to DTEA

- HCl in connection with the development of its final registration review decision for DTEA

- HCl.

In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. For further information on how the agency intends to assess risks to endangered species from the use of DTEA

- HCl please see section D of this document

. The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of address ing scientific differences between the EPA and the

Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk as sessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group ( SFIREG) meetings

. The agencies also held a stakeholder workshop s in April

2014 and October 2014 , allowing additional o pportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also

consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim A pproaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for DTEA

- HCl as part of completing this registration review.



### II. Scientific Assessment

A. Human Health Assessment

A summary of the a gency’s human health risk assessment is presented below in support of the registration review of DTE A

- HCl

. For detailed discussions of all a spects of the human health assessment, see th e 2

- (Decylthio)Ethanamine Hydrochloride (DTEA

- HCl), Human Health and Ecological Preliminary Risk Assessment for the Registration Review located in the public docket

at EPA

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.

Based on the label requiring closed

- loading, no quantitative occu pational human health risk assessment was conducted as the label requirement minimizes occupational exposure. For the human health risk assessment, no dietary risk assessment is necessary because dietary (food andDocket Number EPA

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7 drinking water) exposures are expected to be minimal based on use patterns and water treatment. Additionally, any discharged DTEA

- HCl is expected to become diluted in the receiving water body.

1. Risk Conclusions

DTEA

- HCl is currently not marketed or used in the U

. S

. and therefore, all estimated exposures are theoretical. However, if DTEA

- HCl is marketed and used in the future in the U.S. , EPA

believes that risks to h uman health from the use of DTEA

- HCl are expected to be minimal based

on current label language that m inimizes exposure

.

2. Human Incidents

There is no human incident information in the agency’s incident data system (IDS) from 1993 to

2015 since DTEA

- HCl is currently not marketed or used in the U.S.

3. Tolerances
No tolerance or exemption from tolerance has b een established by EPA for DTEA

- HCl

.



### B. Environmental Assessment

A summary of the a gency’s environment risk assessment is presented below in support of the registration review of DTEA

- HCl

. DTEA

- HCl is diluted to concentration of 15% and formulat ed to treat water systems. In the past the cooling tower use was considered an “indoor use” and

exposure to non

- target organisms was not expected. Under the 40 CFR 158W codified in 2013

, this use is now subject to an evaluation to determine if exposure to non

- target organisms is occurring and if so, to determine appropriate mitigation

. For detailed discussions of all a spects of

the ecological risk assessment, see the 2

- (Decylthio)Ethanamine Hydrochloride (DTEA

- HCl), Human Health and Ecological Preliminary Risk Assessment for the Registration Review located in the public docket at EPA

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.

1. Envi r onmental Fate and Exposures

In solution

, DTEA

- HCl is persistent under abiotic conditions at pH 5, 7, and 9. Its solubility is low in water. The Henry’s law constant value indicates that DTEA

- HCl has a moderate tendency to volatilize from water surfaces to air. Its half life in air is about 3 hours, and i t is not likely to persist in air. It is immobile on soil surfaces, and sludge surfaces. It is not ready biodegradable. Its Log Kow is high which indicates that it is likely to be bioaccumulative. The dissipation pathway appears to be binding to soil/sedim ents and therefore, the possibility of adverse effects on benthic organisms exists

.

2. Ecological Assessment

According to the product label, there are two methods of treatment for control of bacteria, fungi, and algae in recirculating cooling water systems: (1) intermittent or slug method and (2) continuous feed method. For both methods of treatment, the label specifies application rates of

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8 treatment. Maintenance treatmen ts can range from 0.5 to 25 fluid ounces of product per 1000 gallons of water for the intermittent or slug method of application and 0.5 to 2 fluid ounces of product per 1000 gallons of water for the continuous feed method. Initial treatment of fouled

syst ems can range from 6 to 41 fluid ounces of product for both intermittent/slug and continuous

feed methods.

Potential exposures and risks to DTEA

- HCl from releases of blowdown water from recirculating cooling towers to surface water were examined for the f ollowing circumstances:

• maintenance treatments versus initial treatments for fouled systems;

• large

- size versus moderate

- size recirculating cooling towers;

• high

- end versus average case scenarios from E

- FAST , EPA’s model that provides screening level esti mates of the concentration of chemicals released to air, surface water, landfills, and from consumer products ; and

• wastewater treatment versus no wastewater treatment prior to discharge of

blowdown water to surface water

.

In the case where no treatment o f blowdown water is assumed, the industrial releases module of

E

- FAST is run assuming no removal. In the case where it is assumed that blowdown water undergoes wastewater treatment prior to discharge, the industrial releases module of E

- FAST is

run assumin g 93 % removal based on activated sludge sorption isotherm data that indicate that

from 93 to 98 % of DTEA

- HCl is removed during wastewater treatment via sorption to activated sludge. Surface water concentrations are estimated based on the distribution of pl ant flows and stream flows from the Steam Electric Power Plants SIC code. Model results are expressed as days per year of exceedance of concentrations of concern (COC) for aquatic organisms downstream of recirculating cooling towers.

3. Characterization of Ec ological Risk

Risks to Freshwater Organisms based on Maintenance T reatment s Scenarios

There are exceedances of COC for aquatic organisms for the average case scenarios examined at

the lowest environmental release for moderate

- size cooling towers of 0.0 3 kg/site/day (0.5 ppm)

when wastewater treatment is assumed. However, the only COC exceeded is that for endangered freshwater invertebrates (1.7 ppb), and that exceedance is only for one day of 360 days per year

of release.

For the average case scenarios , e stimated DTEA

- HCl concentrations in sediments ( 0.004 to

0.216 mg/kg

- sediment) under a range of organic carbon levels do not exceed the chronic DTEA

HCl NOAEC (No Observed Adverse Effect Concentration) values for benthic organisms (0. 77 to 8.4 mg/kg

- sediment) indicating no chronic risks assuming waste water treatment prior to discharge

.

For the large cooling tower, high end scenarios, estimated DTEA

- HCl concentrations in

sediments ( 11.2 to 613 mg/kg

- sediment) under a range of organic c arbon levels exceed the chronic NOAEC values for benthic organisms indicating the potential for chronic effects to theDocket Number EPA

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9 aquatic benthic organisms under the maximum label use rate. For the no wastewater treatment scenario prior to discharge, the risks are in dicated to be greater.

Risk to Freshwater and Estuarine /Marine Organisms Based on Initial Treatments of a Fouled System Scenarios

For the purpose of assessing exposures to aquatic organisms from initial treatment applications,

it is assumed that environmental releases of DTEA

- HCl to surface water via cooling tower blowdown water occur for one day.

Potential risks for freshwater aquatic organisms ha ve been identified. Additionally, t he agency has no toxicity data for estuarine/marine organisms to show that they would be less sensitive to exposure to DTEA

- HCl than freshwater organisms. In the absence of data, EPA assumes that the

use and release of DTEA

- HCl to estuarine and marine systems would result in risks of concern for estuarine and marine aqu atic organisms.

Risks to Piscivorous Birds and Mammals: Maintenance Use with Wastewater Treatment Prior to Discharge

Quantitative a cute risk c an not be calculated for birds because the acute oral LD 50 is greater than the highest residue level tested. Fur ther, on a dietary basis the potential DTEA

- HCl residues in the upper trophic level are more than 10 times lower than the residue levels tested. Therefore, it is unlikely that acute levels of concern (LOCs) for listed and nonlisted birds will be exceeded

.

4. Ecological Incident s

DTEA

- HCl is currently not marketed or used in the U.S. For the period from 1993 to 2015, t here is no ecological incident information on this product in the agency ’s incident database

.

5. Risk Conclusions

There are several uncertai nties associated with th e ecological risk assessment. On the hazard assessment, EPA made conservative assumptions based on the lack of definitive toxicity data on benthic organisms, estuarine and marine organisms, aquatic plants and chronic data for birds.

Risks to non

- target birds and mammals are expected to be minimal. There is a potential risk to birds that consume fish that are exposed to releases from large towers treated at the maximum treatment rate without wastewater treatment prior to release.

The re are potential risks to all aquatic organisms from releases of cooling tower waters including releases of water which has been treated in a wastewater treatment facility prior to release. Aquatic invertebrates and algae are more sensitive to DTEA

- HCl tha n are freshwater fish, but all aquatic organisms would be affected if a release occurs. Maintenance treatments which result in daily releases (360 days/year) are expected to result in greater risks than initial treatments that result in single (one time) r elease.Docket Number EPA

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10 Benthic organisms would be exposed to DTEA

- HCl as it sorbs to sediment. Chronic risks are estimated for treatments of large towers and high rates with no chronic risks for benthic organisms from moderate size towers treated at low rates.



### C. Bene fits Assessment

Although DTEA

- HCl is registered in the U.S., it has not been marketed. There is no benefits assessment for this product.



### D. Endangered Species Assessment

Consistent with EPA's responsibility under the Endangered Species Act (ESA), the Agency

will evaluate risks to federally listed species from registered uses of pesticides in accordance

with the Joint Interim Approaches developed to implement the recommendations of the April 2013 National Academy of Sciences

· (NAS) report, Assessing Risks to Endangered

and Threatened Species from Pesticides. The NAS report 1 outlines recommendations on specific scientific and technical issues related to the development of pesticide risk

assessments that EPA and the Services must conduct in connection with their obligations

under the ESA and FIFRA. EPA will address concerns specific to DTEA

- HCl in connection

with the development of its final registration review decision for DTEA

- HCl

.

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries

Services (the Services), and the U.S. Department of Agriculture released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species

from pesticides. These Interim Approaches were developed jointly by the agencies in

response to the NAS recommendations, and reflect a common approach to risk assessment
shared by the agencies as a way of addressing scientific differences between the EPA and the

Services. Details of the joint Interim Approaches are contained in the November 1, 2013

white paper
, Interim Approaches for National

- Level Pesticide Endangered Species Act

Assessments Based on the Recommendations of the National Academy of Sciences April

2013 Report.

Given that the agencies are continuing to develop and work toward implementation of the

Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this Proposed Interim Registration Review Decision for DTEA

- HCl does not contain a complete ESA analysis, including effects determinations for specific listed species or designated critical habitat.

While the agencies continue to develop a common method for ESA analysis, the preliminary

risk assessment for the registration review of D T EA

- HCl describes the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to
focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete

risk assessments for listed species and their designated critical habitats, these methods will

1 http://www.nap.edu/catalog.php?record_id=18344Docket Number EPA

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11 be applied to subsequent analyses of DTEA

- HCl as part of completing this registration

review.



### E. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. Thes e studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss,

and sex ratios in of fspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of the reregistration decisions for DTEA

- HCl beginning in 1993, EPA reviewed these data yet never selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database presumably because the hazard database was very limited and only occupational exposure was expected. However, as re quired by FFDCA section 408(p), DTEA

- HCl is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required

deter minations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adv erse endocrine

- related effects caused by the substance, and

establish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2 010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. DTEA

- HC l is not among the group of 58 pesticide active ingredients on the initial list to be screened und er the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call ins, requiring the submission of EDSP screening assays for DTEA

- HCl

.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website: http://www.epa.gov/endo/

.

In this i n terim decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of DTEA

- HC l . Before completing this Registration Review,

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### III

. Proposed Interim Registration Review Decision

A. Risk Mitigation and Regulatory Rationale

Although there are no human health risks of concern, potential ecological risk s of concern were

identified . To address these concerns, the agency is proposing label amendments

.

Th e theoretical quantitative ecological risk assessment indicated exceedance of levels of concern for exposure of aquatic organisms for both federally threatened and endangered (listed) species in the water column and exceedance of levels of concern for aquatic benthic invertebrates. Aquatic fo od chain transfer and bioaccumulation of DTEA

- HCl was identified to potentially pose risks to mammals and birds , but this risk is considered to be unlikely

. The risk assessment did not model estuarine/marine water bodies; therefore, the agency does not kno w what the risk would look like (no data were available to do the modeling). Estuarine/marine water bodies are tidal in nature and thus similar or greater risk than the freshwater assessment was assumed.

T h e ecological risk assessment us ed conservative assumptions such as daily blowdown discharge , which is unlikely in practice

. Additionally, t he assessment indicated that frequency of

use drives the risks of concern. T he agency believes the following labeling changes will reduce the likelihood of exposure and risk if DTEA

- HCl is marketed and used in the future in the U.S. :

• Add instructions to the D irections F or U se to not discharge blowdown directly to bodies of water, such as:

o “Cooli ng water system blowdown must not be discharged to lakes, streams, ponds , estuaries, oceans or other waters unless in accordance with the requirements of a National Pollutant Discharge Permit (NPDES). Blowdown discharge must be sent to a secondary waste water treatment facility with activated sludge or be treated with a simila r biological treatment process.”

o Currently, this language is partly address ed in the Hazard S tatements section. However, it must be in the directions for use section.

• L imit use of maintenance treatment of the intermittent or slug method to not more than

ev ery four days (96 hours)

.

• Add instructions to the D irections F or U se for not discharging to esturine/marine water

bodies , such as:

o “Do not discharge to estuarine/marine water bodies.”

In addition, EPA understands that the use of DTEA

- HCl may be effective at lower rates than currently indicated on labeling and believes that it is prudent to lower the rates on the labels accordingly . The following recommendations are being made:

o Reduce the upper bound for dosage rates for initial treatment of both the intermittent/slug method and continuous feed method to 25 fluid ounces (oz.) per 1,000 gallons of water.

 Current labels specify no more than 41 fluid oz.

o Reduce the upper bound for the dosage rate for maintenance treatment of the intermittent/slug method to 15 fluid o z. per 1,000 gallons of water.

 Current labels specify no more than 25 fluid oz.Docket Number EPA

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13 

### B. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the a gency is issuing this proposed

interim registration review decision document for DTEA

- HCl. It does not cover the Endangered Species Act or the Endocrine Disruptor Screening Program component, and this interim decision is being proposed pending their evaluation.



### I V. Next Step s and Timeline

A. Interim Registration Review Decision

A Federal Register N otice will announce the availability of this proposed interim registration

review decision for DTEA

- HCl and allow a 60

- day comment period

. If there are no significant comments or additional information submitted to the docket during the comment period that

leads the a gency to change its proposed decision, EPA may issue an interim registration review

decision for DTEA

- HCl (case 5029 ).

Howeve r, a final decision for DTEA

- HCl may be issued without having previously issued an

interim decision. A final registration review decision for the DTEA

- HCl case will depend upon both the result of an ESA Section 7 Endangered Species consultation with the U.S. Fish and Wildlife Service, and an EDSP FFDCA section 408(p) determination.



### B. Implementation of Mitigation Measures

Once the Interim Registration Review Decisio n is issued in final form, registrants will be required to submit proposed amended labels that include e cological risk mitigation and submit

them to the agency for approval within 60 days of such issuance. The mitigation measures and proposed label amendme nts are shown in Appendi ces A and B.Docket Number EPA

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14 Appendix A: Summary of Proposed or Completed Actions Taken for DTEA

- HCl



### Summary of Proposed or Completed Actions Taken for DTEA

- HCl
Registration Review Case#: 5029

PC Code: 128963 Chemical Type: Antimicrobial

Affec ted Population(s) Source of Exposure Route of Exposure Duration

of Exposure Risk(s) of

Concern Action(s)

Taken Comment

Humans Occupational

handler Inhalation,

dermal Acute Unassessed Label

revisions to require

closed delivery

systems Label

amendment completed prior

to risk

assessment stage of registration

review

Fishes Aquatic

invertebrates Aquatic plants Recirculating cooling

water system
blowdown Uptake through gills Acute

and

Chronic Acute and

chronic toxicity See proposed

label

revisions

outlined in Appendix BDocket Number EPA

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15 Appendix B : DTEA

- HCl Label Table

Summary of Proposed Labeling Changes for DTEA

- HCl

Description Proposed Amended Labeling Language for DTEA

- HCl

Products Placement on Label

End Use Products

Reduce discharge
blowdown directly to

bodies of water • Do not discharge blowdown directly to bodies of
water and specify secondary waste water treatment
with activated sludge or a similar biological

treatment process ; suggested labeling language s: “Cooling water system blowdown must n ot be
discharged to lakes, streams, ponds, estuaries, oceans or
other waters unless in accordance with the requirements

of a National Pollu tant Discharge Permit (NPDES).
Blowdown discharge must be sent to a secondary w aste water treatment facility with activated sludge or be
treated with a similar biological treatment process .” Directions for Use

Limit use of

intermittent or slug

method • L imit the use of the intermittent or slug method to
not more than every four days (96 hours)

. Directions for Use

Limit where there can
be discharge • “Do not discharge to estuarine/marine water bodies.” Directions for Use

Reduce certain use

rates • Reduce dosage rates for initial treatment of both the
intermittent/slug method and continuous feed

method to 25 fluid o z. per 1,000 gallons of water

• Reduce dosage rates for maintenance treatment of
the intermittent/slug method to 15 fluid o z. per 1,000
gallons of water

. Directions for Use