Docket Number EPA-HQ-OPP-20 15-0571 

www.regulations.gov 

Acrolein Final Work Plan 

Registration Review 

Case Number 2005 

March 2016 

Approved by: 

Director 

Pesticide Re-evaluation Division 

Approved by: -~ steVeKniZl1ef 

Director 

Antimicrobials Division 

Date: 
INTRODUCTION 

This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of acrolein. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the acrolein registration 

review docket (EPA-HQ-OPP-20 15-057 1 ). Acrolein is a restricted use herbicide and algicide 

used for the control of submerged and floating aquatic weeds and algae in irrigation canals and 

irrigation reservoirs. Acrolein is also a restricted use broad-spectrum microbiocide used to 

control bacteria and fungi in oilfield water injection systems, and to remove hydrogen sulfide in 

oilfield operations. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. Changes in science, public policy, and pesticide use practices occur over time. The 

registration review program is intended to make sure that, as the ability to assess risk evolves and 

as policies and practices change, all registered pesticides continue to meet the statutory standard. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency's website. ' 

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received during the public comment period for the PWP concerning anticipated data 

needs. expected risk assessments, or the estimated timeline identified in the PWP, and a 

summary of the Agency's responses to those comments. This section is followed by registration 

review planned data needs, risk assessments expected to be conducted, and the projected 

registration review timeline for acrolein. Lastly. there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

Since the PWP was issued, there have been two minor changes to the registration review of 

acrolein. First, a data requirement was added to the Planned Data Needs table, guideline number 

860.1400, a residue study for fish and shellfish, that is required based on the use of acrolein in 

reservoirs. This was previously referenced in the PWP as part of the Anticipated Risk 

Assessments table under the Tolerances section. Second, the test material for guideline 

850.3020, the honey bee acute contact toxicity study, has been changed from typical end use 

product (TEP) to technical grade active ingredient (TGAI). Both changes have been reflected in 

the Planned Data Needs table below. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period for the acrolein PWP, which opened on October 2, 

2015 and closed on December I, 2015, the Agency received one public comment. The comment 

was submitted by the Center for Biological Diversity (CBD). 

1 hnp://www.epa.gov/oppsrrd 1/registration_revicw/ 

2 
CBD's comment does not address the anticipated data requirements nor the timeline described in 

the PWP. In the PWP, EPA also solicited comments on the specific topics of environmental 

justice. water quality concerns, and trade irritants, but no comments or information were received 

on those issues. 

This section summarizes the public comment and provides the Agency's response. The public 

comment in its entirety is located in the docket, EPA-HQ-OPP-20 15-0571. 

Comment submitted by CBD in EPA-HQ-OPP-2015-0571-0007. 

Comment: CBD 's commentsfocus on the EPA's duty to consult with the U.S. Fish and Wildlife 

Service and the National Marine Fisheries Service (the Services) on the registration review of 

acrolein in accordance with the Endangered Species Act (ESA). CBD 's comments mention 

various aspects of the risk assessment process, including use of the best available data to 

develop endangered species risk assessments, and evaluation of effects on endangered and 

threatened (listed) species and their designated critical habitat. CBD also expresses concern 

regarding the rigor of the Agency 's preliminmy determinations regarding the effects of acrolein 

on listed species and their designated critical habitat. 

Response: EPA has reviewed the comments from CBD on the registration review docket 

opening for acrolein and plans to address many of the concerns raised by CBD as part of the 

implementation plan for assessing the risks of pesticides to listed species based on the 

recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will 

address concerns specific to acrolein in connection with the development of its final registration 

review decision for acrolein. 

ln November 2013, the EPA, along with the Services and the USDA, released a summary of 

their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim 

Approaches were developed jointly by the agencies in response to the NAS report 

recommendations, and reflect a common approach to risk assessment shared by the agencies as a 

way of addressing scientific diffe rences between the EPA and the Services. The NAS report2 

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. 

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 stakeholder workshops in April 

and October 2014, and in April 2015, allowing additional opportunities 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 Approaches for National-Level Pesticide 

2 http://www.nap.edu/catalog.php?record_id= I8344 

3 
Endangered Species Act Assessments Based on the Recommendations of the National Academy 

of Sciences April2013 Report .. 3

, dated November I , 2013. 

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 problem fonnulation supporting this FWP for acrolein 

does not describe the specific ESA analysis, including effects determinations for specific listed 

species or designated critical habitat, to be conducted during registration review. ln the 

ecological problem formulation document for acrolein, EPA described the screening-level risk 

assessment to determine the potential effects of acrolein on all taxa of non-target wildlife and 

plants, which will assume that listed species and their designated critical habitats may be present 

in the vicinity of the application of acrolein. This screening-level 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. While the agencies 

continue to develop a common method for ESA analysis, the planned screening-level risk 

assessment for the registration review of acrol ein will describe the level of ESA analysis 

completed for this particular registration review case. Once the agencies have fully developed 

and implemented the scientific methods necessary to complete risk assessments for listed species 

and their designated critical habita ts, these methods will be applied to subsequent analyses for 

acrolein as part of completing this registration review. 

PLANNED DATA NEEDS 

The table below summari zes planned data needs for acrolein based on the Registration Review: 

PreliminGJy Problem Fon nufationfor Environmental Fate, Ecological Risk, Endangered 

Species, and Drinking Water Assessments for Acrolein (8/ 11/1 5) and the Acrolein. Human 

Health Assessment Scoping Document in Support of Registration Review (9/9114) documents. 

The planned data needs had two changes. First, a data requirement was added, guideline number 

860.1400, a residue study for fish and shellfish, that is required based on the use of acrolein in 

reservoirs. This was previously referenced in the PWP as part of the Anticipated Risk 

Assessments table under the Tolerances section. Second, the test material for guideline 

850.3020, the honey bee acute contact toxicity study, has been changed from typical end use 

product (TEP) to technical grade active ingredient (TGAI). Both changes have been reflected in 

the Planned Data Needs table below. The anticipated timeline for acrolein have not changed 

from what was identified in the PWP. 

3 hnp://www.epa.gov/espp/20 I 3/nas.html 

4 
Planned Data Needs for Acrolein Registration Review for Conventional Uses 

Estimated 

Guideline Study Title 

Timeframe 

Number Test Material (Months from 

receipt of DCI) 

835.4100 Aerobic Soil Metabolism TGAI 24 

850.2200 Avian Dietary Subacute Toxicity TGAI 12 

850.4100 Seedling Emergence TEP 12 

850.4 150 Vegetative Vigor TEP 12 

850.3020 Honey Bee Acute Contact Toxicity TGAI 12 

850.3030 Honey Bee Residue On Foliage TEP 12 

850.3040 Field Testing For Pollinators TEP 24 

860.1 400 Residue Study fo r f-ish and Shell fish TEP 24 

Special Pollinator Acute Oral Toxicity, Adult TGA I 12 Study 

Special Pollinator Acute Oral Toxicity, Larvae TGAI 12 Study 

Special Pollinator Chronic Oral Toxicity. Adult TGA I 12 Study 

Special Pollinator Chronic Oral Toxicity. Larvae TGAI 12 Study 

Planned Data Needs for Acrolein Registration Review for Antimicrobial Uses 

Guideline 

Number Study Title 

875.2500 Inhalation Post-application Monitoring Data 

TGAI = technical grade acllve mgred1ent 

TEP = typical end usc product 

RISK ASSESSMENTS FOR REGISTRATION REVIEW 

Estimated 

Timeframe 

Test Material (Months from 

receipt ofDCI) 

TEP 24 

During registration review. the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of acrolein. 

For human health, EPA anticipates the need to conduct revised dietary (drinking water). 

residential post-application (volatilization), and occupational (post-application) risk assessments 

during registration review. 

The table below summarizes the planned risk assessments for the registration review of acrolein. 

The planned assessments for acrolein have not changed from what was included in the PWP. 

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Planned Risk Assessments for Acrolein Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological y 

risk assessment, including 

endangered species 

Ecological Incidents Will check For a discussion of reported ecological incidents for 

for updates acrolein, see the Problem Formulation. 

Human Health 

Dietary 

Food y The need for a drinking water assessment will be 

Drinking water considered during registration review. If a drinking 

water assessment is conducted, the Agency may also 

revise the dietary assessment. 

Occupational 

Handlers (mixers, loaders, y An updated quantitative occupational handler exposure 

applicators) assessment may be needed to incorporate air 

monitoring data. 

Post-application y An updated quantitative post-application occupational 

exposure assessment is anticipated for both the aquatic 

herbicide use as well as the bacteriocide use to 

incorporate post-application air monitoring data. 

Residential 

Handlers N There are no proposed or current residential uses for 

acrolein; therefore, a quantitative residential handler 

exposure assessment is not anticipated to be needed for 

registration review. 

Post-application y The need for a post-application residential assessment 

(from volatilization) will be considered for registration 

review. 

Other 

Aggregate N The need for an aggregate assessment will be 

considered during registration review, contingent upon 

the determination on a drinking water analysis and/or a 

residential post-application analysis. 

Cumulative N EPA has not made a common mechanism of toxicity 

finding for acrolein and any other substance; and 

acrolein does not appear to produce a toxic metabolite 

produced by other substances. 

6 
Tolerances y The need for tolerances in crops will be re-evaluated 

once the nature of the residue study in a root and tuber 

crop is submitted, which was required as part ofthe 

registration eligibility document (RED) and was 

included in the Data Call-In Notice (GDCI-00070 1-

28207) as a result ofthe RED. This residue study is 

currently being conducted and will be submitted to the 

agency in 2016. 

In addition, based on the usc of acrolein in reservoirs, 

the agency will evaluate the need for tolerances for 

acrolein in/on fish and shellfish. 

Human Health Incidents Will check For a discussion of reported human health incidents for 

for updates acrolein. see the Scoping Document and the Acrolein: 

Tier I Reviell· ofHuman Incidents and Epidemiology 

document. 

TIMELINE 

EPA has created the following estimated timeline for the completion of the acrolein registration 

revtew. 

Registration Review for Acrolein- Projected Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and Public Comment Period 20 15 - September -

Completed 

Close Public Comment 2015 - NovemberCompleted 

Case Development 

Final Work Plan 2016 - March -

Completed 

Issue DC I 2016 - Aprii - June 

Data Submission 2018 - April - June 

60-Day Public Comment Period for Draft Risk Assessments4 2019 - October -

December 

Registration Review Decision 

60-Day Public Comment Period for Proposed Registration Review 2020 - July -

Decision August 

Registration Review Decision and Begin Post-Decision Follow-up 2021 

Total (years) 6 

The regulations governing Registration Review generally require the agency to provide a public comment period 

of ar least 30 calendar days fo r draft risk assessments: see 40 cr:R Part 15S.S3(c). For conventional pesticides. the 

agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 

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NEXT STEPS 

As noted previously, the Agency plans to require studies for acrolein through a Data Call-In 

Notice. expected to be issued in Apri I to June 20 16. 

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