2

Acrolein Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 5

Anticipated Risk Assessments for Registration Review 6

Timeline 9

Next Steps 9

Appendix – Additional Areas Considered in Acrolein’s

Registration Review 10

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Human Health Drinking Water Assessments for 

Acrolein. Chuck Peck, Thomas Steeger. August 11, 2015.

2. Acrolein: Human Health Assessment Scoping Document in Support of Registration Review.

Wade Britton, Austin Wray, Thurston Morton, Nathan Mottl. September 9, 2015.

3. BEAD Chemical Profile for Registration Review: Acrolein (000701). Carl Chen, Derek 

Berwald. August 17, 2015.

4. Acrolein: Tier I Review of Human Incidents and Epidemiology. Elizabeth Evans, Shanna 

Recore. June 30, 2015.

These and other supporting documents for the acrolein registration review case may be found in

the docket EPA-HQ-OPP-2015-0571 at http://www.regulations.gov.
3

OVERVIEW

The docket for Acrolein is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0571). 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. This Preliminary Work Plan (PWP) document 

summarizes what EPA's Office of Pesticide Programs knows about acrolein, identifies

anticipated data and assessment needs, identifies the types of information that would be 

especially useful to the Agency in conducting the review, and provides an anticipated timeline 

for completing the acrolein registration review.

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about acrolein and what types of new data or other 

information would be helpful for the Agency to receive as it moves toward a decision on 

acrolein. The Agency encourages all interested stakeholders to review the PWP, its Appendix, 

and support documents and to provide comments and additional information that will help the 

Agency’s decision-making process for this chemical. In addition to general areas on which 

persons may wish to comment, there are some areas identified in the PWP and Appendix about 

which the Agency specifically seeks comments and information. Interested stakeholders could 

include: environmental non-profit or interest groups; pesticide manufacturers; agricultural labor 

or commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large.

The PWP begins by listing the anticipated data needs for acrolein. Next, it discusses the statutory 

and regulatory authority for Registration Review. Then the document provides acrolein’s

chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a 

projected registration review timeline. Finally, the Appendix to this document includes 

identification and discussion of some topics that are considered generally in Registration Review 

along with some additional chemical case-specific information.
4

ANTICIPATED DATA NEEDS

The table below summarizes anticipated data needs for acrolein. For additional discussion of the 

anticipated data needs, see the Registration Review: Preliminary Problem Formulation for 

Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Assessments for 

Acrolein (8/11/15) and Acrolein. Human Health Assessment Scoping Document in Support of 

Registration Review (9/9/14).

Anticipated Data Needs for Acrolein Registration Review for Conventional Uses

Guideline 

Number Study Title

Test Material

Estimated 

Timeframe

(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

850.4150 Vegetative Vigor TEP 12

850.3020 Honey Bee Acute Contact Toxicity TEP 12

850.3030 Honey Bee Residue On Foliage TEP 12

850.3040 Field Testing For Pollinators TEP 24

Special 

Study Honey Bee Acute Oral Toxicity TGAI 12

Special 

Study Honey Bee Larval Toxicity TGAI 12

Special 

Study Honey Bee Adult 10-Day Toxicity TGAI 12

Special 

Study Honey Bee 21-Day Larval Toxicity TGAI 12

Anticipated Data Needs for Acrolein Registration Review for Antimicrobial Uses

Guideline 

Number Study Title Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

875.2500 Inhalation Post-application Monitoring Data TEP 24

TGAI = technical grade active ingredient

TEP = typical end use product

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 
5

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. 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 be used safely. Information on the 

registration review program is provided on EPA’s website1.

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. The regulations governing registration review begin at 40 CFR 155.40. The Agency 

will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket opening is 

the Agency’s opportunity to state what it knows about the pesticide and what additional risk 

analyses and data or information it believes are needed to make a registration review decision.

After reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of acrolein.

ACROLEIN CHEMICAL FACTS

PC code 000701

Case Number 2005

CAS Number 107-02-8

Year first registered 1959

Pesticide Type Herbicide, Algaecide, Microbiocide

Chemical class Imidazolinone

Reregistration Eligibility 

Decision (RED)

The RED was completed in 2008.

Cumulative group NA

40 CFR Citation There is no tolerance established for acrolein.

Non-pesticidal uses NA

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Kelly Ballard, ballard.kelly@epa.gov, (703) 305-8126

Antimicrobial Division, 

Chemical Review 

Manager

Stephen Savage, savage.stephen@epa.gov, (703) 347-0345

Antimicrobial Division, 

Product Manager

Demson Fuller, fuller.demson@epa.gov, (703) 308-8062

Registration Division, 

Product Manager

Heather Garvie, garvie.heather@epa.gov, (703) 308-0034

USE AND USAGE INFORMATION FOR ACROLEIN

 1 http://www.epa.gov/oppsrrd1/registration_review/
6

Please see the BEAD Chemical Profile for Registration Review: Acrolein (000701) in the 

registration review docket for more details.

Type of Pesticide Acrolein is an aquatic herbicide and microbiocide.

Use Sites There are no agricultural use sites for acrolein. (However, 

acrolein-treated water may be applied to agricultural fields as 

irrigation.)

Non-agricultural use sites for acrolein include irrigation canals,

irrigation reservoirs, and oilfield water injection systems.

Summary of Usage Current quantitative usage information for acrolein is unavailable, 

the most recent available usage data is from 2008.

Formulation Types Pressurized liquid and soluble concentrate/liquid.

Application Methods Acrolein is applied as a water treatment using injection 

equipment.

Technical Registrants Baker Petrolite and Multi-Chem Group, LLC

No. of Registrations Three Section 3 products and six Section 24(c) products2

Restricted Use Yes

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive ecological risk assessment for acrolein was completed in 2008 to 

support the RED. The most recent comprehensive human health risk assessment was also 

completed in 2008 to support the RED. Findings and conclusions from these risk assessments are 

summarized in the Registration Review: Preliminary Problem Formulation for Environmental 

Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Assessments for 

Acrolein (8/11/15) and Acrolein: Human Health Assessment Scoping Document in Support of 

Registration Review (9/9/15).

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 anticipated registration review risk assessments based on the 

Problem Formulation and Scoping Document.

 2 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home).
7

Anticipated Risk Assessments for Acrolein Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate

Comprehensive ecological 

risk assessment, including 

endangered species 

Y

Ecological Incidents Will check 

for updates

For a discussion of reported ecological incidents for 

acrolein, see page 13 of the Problem Formulation.

Human Health

Dietary

Food Y If a drinking water assessment is conducted, the 

Agency may also revise the cancer dietary assessment 

for subsistence fishermen.

In addition, if the use of acrolein in reservoirs is not 

withdrawn, then the Agency will consider the need to 

establish a tolerance for acrolein in/on fish, and 

consequently a need to assess potential dietary 

exposure.

Drinking water Y The need for a drinking water assessment will be 

considered during registration review.

Occupational

Handlers (mixers, loaders, 

applicators)

Y An updated quantitative occupational handler exposure 

assessment may be needed for registration review to 

incorporate additional air monitoring data.

Post-application Y An updated quantitative post-application occupational

exposure assessment is anticipated for registration 

review for both the aquatic herbicide use as well as the 

bacteriocide use.

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 The Agency has not determined whether acrolein 

shares a common mechanism of toxicity with other 

chemical substances.
8

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 of the 

RED.

In addition, if the use of acrolein in reservoirs is not 

withdrawn, the Agency will evaluate the need for 

tolerances for acrolein in/on fish and shellfish.

Human Health Incidents Will check 

for updates

For a discussion of reported human health incidents for 

acrolein, see pages 9-10 of the Scoping Document and 

the Acrolein: Tier I Review of Human Incidents and 

Epidemiology document.

Guidance for Commenters: For both the aquatic herbicide and bacteriocide uses of 

acrolein, additional areas of use and usage related information and ecological information

requested for this registration review, and of particular interest to EPA, is described below.

• Confirmation of the following label information: sites of application; 

formulations; application methods and equipment; maximum application rates; 

frequency of application, application intervals, and maximum number of 

applications per season; and geographic limitations on use.

• Use distribution (e.g., acreage and geographical distribution of relevant use sites).

• Median and 90th percentile reported use rates (lbs ai/A) from usage data –

national, state, and county.

• Typical application timing (date of first application and application intervals) –

national, state, and county.

• Usage/use information for non-agricultural uses.

• Typical application interval (days).

• State or local use restrictions.

• Foreign technical registrants not listed above who supply technical acrolein to the 

US market (if applicable).

• Ecological incidents (non-target plant damage and avian, fish, reptilian, 

amphibian and mammalian mortalities) not already reported to the Agency.

• Water quality monitoring data (see Appendix for further details).

TIMELINE

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

review.

Registration Review for Acrolein – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and Public Comment Period 2015 – September

Close Public Comment 2015 – November

Case Development
9

Registration Review for Acrolein – Projected Registration Review Timeline

Activities Estimated Date

Final Work Plan 2016 – February

Issue DCI 2016 – April – June

Data Submission 2018 – April – June

60-Day Public Comment Period for Draft Risk Assessments3 2019 – October –

December

Registration Review Decision

60-Day Public Comment Period for Proposed Registration Review 

Decision 

2020 – July –

August

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

Total (years) 6

NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of acrolein.

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

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.
10

Appendix – Additional Topics Considered in the Acrolein Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern.

Water Quality:

Acrolein is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act4

. In addition, no Total Maximum Daily Loads (TMDL) 

has been developed for acrolein5

. More information on impaired water bodies and TMDLs can 

be found at the Agency’s website6

. The Agency invites submission of water quality data for 

this pesticide. To the extent possible, submissions should include the key data elements noted in 

the OPP Guidance for Submission of State and Tribal Water Quality Monitoring Data7 in order 

to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to acrolein compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.

 4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

5

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

6 http://www.epa.gov/owow/tmdl/

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
11

ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been 

conducted for acrolein. The ecological risk assessment planned during registration review will 

allow the Agency to determine whether acrolein’s use has “no effect” or “may affect” federally 

listed threatened or endangered species (listed species) or their designated critical habitats. When 

an assessment concludes that a pesticide’s use “may affect” a listed species or its designated 

critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National 

Marine Fisheries Service (the Services), as appropriate.

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. These 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 offspring. 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 its re-registration decision for acrolein, EPA reviewed these data 

and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p), acrolein 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 

determinations. 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 adverse 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 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals 

identified for EDSP screening was published on June 14, 20138 and includes some pesticides 

scheduled for registration review and chemicals found in water. Acrolein is included on the 

Revised Second List of Chemicals for Tier 1 Screening of the EDSP. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors.

 8 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.
12

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.9

HUMAN STUDIES:

Occupational and Residential

Past acrolein risk assessments rely in part on data from studies in which adult human subjects 

were intentionally exposed to a pesticide to determine their dermal and inhalation exposure.

Many such studies, involving exposure to many different pesticides, comprise generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED), the Agricultural 

Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task Force 

(ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic 

exposure databases, and has found no clear and convincing evidence that the conduct of any of 

them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies.

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