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 Assessment s for Registration Re view 6

Timeline 9

Next Steps 9

Appendix

– Additional Areas Considered in Acrolein ’s Registration Review 10

References:

This Preliminary Work Plan summarize s 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 Assessment s for

Acrolein

. Chuck Peck, Thomas Steeger

. August 11

, 201 5

.

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 1 7, 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

- 201 5

- 0 571 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

- 201 5

- 0 571 )

. 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 participat ion component to solicit input from interested stakeholders. The Agency intends, b y 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 p rocess 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 P WP begins by listing the anticipated data nee ds for acrolein

. Next, it discusses the statutory and regulatory authority for R egistration R eview. 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 R egistration R eview along with some additional chemical case

- specific information.4 ANTICIPATED DA TA NEEDS

The table below summarizes anticipated data need s 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 Drinkin g Water Assessments for

Acrolein ( 8 / 11 /1 5 ) 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)

8 35

. 4100 Aerobic Soil Meta bolism 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 T EP 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 envi ronment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability5 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. Informatio n on the registration review program is provided on EPA’s website 1

.

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 155.4 0

. T he 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 wil l develop a F inal W ork P lan (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) 30 8

- 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 a gricultural 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 wate r injection systems. Summary of Usage Current q uantitative usage informati on 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 Registrant s Baker Petrolite and Multi

- Chem Group, LLC No. of Registrations Three Section 3 products and six Section 24 (c) product s 2

Restricted Use Yes

ANTICIPATED RISK ASSES SMENTS FOR REGISTRATION REVIEW

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

. The most r ecent comprehensive human health risk assessment w as 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 Assessment s for

Acrolein ( 8 / 11 /1 5 ) and Acrolein: Human Health Assessment Scoping Document in Support of Registration Review (9/ 9 /15 )

.

During registration review, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessmen t, for all uses of acrolein

. For human health, EPA anticipate s 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 Produ ct 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

Eco logical 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 r egistration r eview to incorporate additional air monitoring data

. Post

- application Y An updated quantitative post

- application occupational exposure assessment is anticipated for r egistration

r eview 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 r eview.

Post

- application Y The need for a post

- application residential assessment (from volatilization ) will be considered for r egistration

r eview.

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, a dditional 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 ; appli cation methods and equipment ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per season ; and geographic limitations on use

.

• U se distribution ( e.g. , acreage and geographical distribution of rel evant use sites )

.

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

– national, state, and county

.

• Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

• Usage/use information for non

- agricultural uses.

• Typical application interval (days).

• S tate or local use restrictions

.

• Foreign technical registrants not listed above who supply technical acrolein to the US market (if applicable).

• Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

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

TIMELINE

EPA has created the following estimated timeline for the completion of acrolei n ’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 Development9 Registration Review for Acrolein

– Projected Registration Review Timeline

Activities Estimated Date

Final Work Plan 2016

– February

Issue DCI 2016

– April

– June

Data Submission 201 8

– April

– June

60

- Day Public Comment Period for Draft Risk Assessments 3 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 6 0

- 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 assess ments; see 40 CFR Part 155.53(c). For conventional pesticides, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.10 

### Appendix

– Additional Topics Considered in the Acrolein Re gistration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould be of particular use.

Trade Irritants:

Through the registration review proce ss, 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 (MRL s ) 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 Act 4

. In addition, n o Total Maximum Daily Load s (TMDL)

ha s been developed for acrolein 5

. More information on impaired water bodies and TMDLs can

be found at the Agency’s website 6

. 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 Data 7 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 compa red 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.htm11 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 specie s (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, includi ng 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 st udies 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 f rom the existing

hazard database. However, as required by FFDCA section 408(p), acrolein is subject to the endocrine screening part of the Endocrine Disr uptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (in cluding 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 ap proach 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 tha t 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 w as published on June 14, 2013 8 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 screenin g 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 inha lation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers 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 unethic al or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. A ll applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been

satisfied , and t here is no regulatory barrier to continued reliance on these studies

.

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