2 

### Aldicarb Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 3

Statutory and Regulatory Authority 4

Chemical Facts 5

Use and Usage Information 5

Recent Actions 6

Anticipated Risk Assessments for Registration Review 7

Timeline 9

Next Steps 10

Appendix – Additional Areas Considered in Aldicarb’s Registration Review 11

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. EFED Registration Review Probl em Formulation for Aldicarb

. Federoff and Jones. May 24, 2012.

2. Aldicarb. Human Health Assessment Scopi ng Document in Support of Registration Review. Olinger, Taylor, and Dawson. May 16, 2012.

3. BEAD Chemical Profile for Registration Review: Aldicarb (098301)

. Brassard, Stebbins, and

Berwald . December 8, 2011.

4. Aldicarb: Review of Human Inci dents. Recore. March 14, 2012.

These and other supporting documents for the aldi carb registration review case may be found in the docket EPA-HQ-OPP-2012-0161 at http://www.regulations.gov

.3 OVERVIEW

The docket for aldicarb is now open, initiati ng the first public comment period for this registration review (docket number EP A-HQ-OPP-2012-0161). Aldicarb is an N -methyl carbamate insecticide that is marketed only as a granular product with a concentration of 15 percent active ingredient. Aldica rb is registered for use to control soil borne pests including mites, various insects, and nematodes. There are no residential uses of aldicarb. Aldicarb products are used in agricultural areas and are re gistered for use on cotton, dry beans, peanuts, soybeans, sugar beets, and sweet potatoes. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Progr ams knows about aldicarb, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing

aldicarb’s review.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t aldicarb and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on aldicarb. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional inform ation that will help the Agency’s decisionmaking 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 stakeholde rs could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The PWP begins by listing the anticipated data needs for aldicarb. Next, it discusses the statutory and regulatory author ity for Registration Review. Then the document provides aldicarb’s chemical facts, use and usage info rmation, recent actions, the anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix to this

document includes identification a nd discussion of some areas that are considered generally in Registration Review along with some addi tional chemical case-specific information.

ANTICIPATED DATA NEEDS

The table below summarizes anticipated data need s for aldicarb. For additional discussion of the anticipated data needs, see the EFED Registration Review Problem Formulation for Aldicarb

and Aldicarb - Human Health Assessment Scopi ng Document in Support of Registration Review

.4 Anticipated Data Needs for Aldicarb’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.6100 Terrestrial field dissipation study 1 TGAI for parent,

aldicarb sulfoxide

and aldicarb sulfone 12

835.6200 Aquatic field dissipation study 1 TGAI for parent,

aldicarb sulfoxide

and aldicarb sulfone 12

850.2100 Avian acute oral toxicity test (passerine species) TGAI 12

850.2300 Avian reproduction test (mallard duck) TGAI 24

850.4100 Terrestrial plant toxicity, seedling emergence,

Tier II 2 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor, Tier

II 2 TEP 12

870.7800 Immunotoxicity TGAI 12
TGAI = technical grade active ingred ient; 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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website 3

.

1 See footnote 7 of 40 CFR 158.1300. EPA anticipates requiring only the environmental chemistry analytical

methods and independent laboratory (ILV) portions of this guideline for soil and water, rather than the full field dissipation study.

2 The DCI expected to be issued will provide that a Tier I plant study may be conducted in lieu of a Tier II study

with the understanding that any adverse effects observ ed by the Tier I study would necessitate conduct and submission of a Tier II study as well.

3 http://www.epa.gov/oppsrrd1/registration_review/5 The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration 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 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 docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of aldicarb.

ALDICARB CHEMICAL FACTS

PC code 098301

Case Number 0140

CAS Number 116-06-3 Year first registered 1970 Pesticide Type Insecticide, acaricide, and nematicide

Chemical class Carbamate Reregistration Eligibility Decision (RED) September 2007

Cumulative group N -methyl carbamate 4

40 CFR Citation Tolerances for aldi carb are established in 40 CFR 180.269.

Pesticide Re-evaluation Division, Chemical Review Manager Susan Bartow, bartow.susan@epa.gov, 703-603-0065

Registration Division, Product Manager John Hebert, hebert.john@epa.gov, 703-308-6249

USE AND USAGE INFORMATION

Please see the BEAD Chemical Profile for Regist ration Review: Aldicarb (098301) in the registration review docket for more details.

Summary of Use Aldicarb is a systemic carbamate insecticide, acaricide, and nematicide registered for use on agricultural crops. Aldicarb is used on cotton primarily for control of thrips. On peanuts, aldicarb is used to control nematodes and thrips and to provide suppression of leafhoppers and spider mites. On dry beans, aldicarb is used to control nematodes, seedcorn maggots, and aphids. On soybeans, aldicarb is used to control nematodes, Mexican bean beetle, and thrips. On sugar beets, aldicarb is used to control nematodes and sugar beet root maggots. On

4 EPA issued the N-methyl carbamate revised cumulative ri sk assessment for comment on September 26, 2007. The

assessment is available at Regulations.gov in docket number EPA-HQ-OPP-2007-0935

.6 sweet potatoes, aldicarb is used to control nematodes.

Use Sites Aldicarb is registered for use on cotton, dry beans, peanuts, soybeans, sugar beets, and sweet potatoes. It is not registered for nonagricultural/residential use. Summary of Usage During the years of 2006-2010, on average, approximately 3.7 million pounds of aldicarb was used to treat 3.6 million acres. Formulation Type(s) The only labeled formulation for aldicarb is granular. Application Method(s) Aldicarb may be applied as a soil treatment using ground equipmentby any of the following methods: sidedress, band/T-band, and infurrow treatment. Technical Registrant(s) Baye r CropScience; AgLogic, LLC No. of Registrations 3 Section 3 products 5 and 1 Section 24(c) product

Restricted Use Yes

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Usage data for sweet potatoes (e.g., pounds activ e ingredient (lbs ai ) applied, total area treated, percent of the crop treated).

 Confirmation of the following label informa tion: application methods and equipment; maximum application rates; frequency of application, applica tion intervals, and maximum number of applications per season; geographic limitations on use.

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

 Median and 90 th percentile reported use rates (lbs ai/1,000 sq ft) from usage data – national, state, and county.

 Application timing (date of firs t application and application in tervals) – national, state, and county.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply te chnical aldicarb to the US

market.

RECENT ACTIONS

On August 16, 2010, Bayer CropScience signed a Memo randum of Agreement with the Agency

that resulted in the removal of the citrus and potato uses from the Temik 15G label and a phaseout of all remaining uses of Temik 15G by 2018. Citrus and potato uses were terminated from the Temik 15G registration on May 9, 2012 (FRL-9348-2).

On December 22, 2011, the Agency registered a new aldicarb end use product (Meymik 15G) from AgLogic, LLC for use on cotton, dry beans, peanuts, soybeans, sugar beets, and sweet potatoes. On January 20, 2012, the Agency regist ered a new aldicarb technical product (Meymik Technical) from AgLogic, LLC.

5 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).7 ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health ri sk assessment for aldicarb was completed in February 2007 in preparation for the Reregist ration Eligibility Decision. The most recent ecological and environmental fate risk asse ssment was completed in September 2006 for the same purpose. Findings and conclusions from th ese risk assessments are summarized in the EFED Registration Review Problem Formulation for Aldicarb and Aldicarb - Human Health Assessment Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of aldicarb. For human health, EPA anticipates the need to conduct revised dietary an d occupational risk assessments during registration review. If toxico logical endpoints or po ints of departure are revised based on the data that are anticipated to be required for registration review, they will be considered in the new assessments, as well as an y changes to the standard operating procedures or default exposure assumptions.

The table below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.

Anticipated Risk Assessments for Aldicarb’s Registration Review

Type of Risk Assessment Include? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The Agency will evaluate ecological risk, environmental fate, and risks to Federally-listed threatened and/or endangered (listed) species from registered uses of aldicarb.

Human Health Dietary

Food TBD 1 A revised dietary risk assessment may be required depending on the review of the cotton field trial studies (although the stud ies are not likely to substantially affect the di etary risk assessment), and drinking water modeling results. If the new drinking water model estimates are significantly higher than estimates in the current dietary risk assessment, the Agency will prepare a revised assessment.8 Anticipated Risk Assessments for Aldicarb’s Registration Review

Type of Risk Assessment Include? Notes

Drinking water Y A drinking wate r exposure assessment will be conducted to support future human health risk assessments for aldicarb to reflect label changes due reregistration, new percent crop area (PCA) estimates for surface water and new Tier 2 ground water modeling consistent with final guidance documents. The drinking water assessment will incorporate model

estimates of aldicarb resi dues of concern in surface and ground waters. Currently, the residues of concern include aldicarb parent, aldicarb sulfoxide, and

aldicarb sulfone. Occupational Handlers (mixers, loaders, applicators) TBD The Agency may conduct a revised occupational exposure and risk assessment during registration review if toxicological e ndpoints change, based on the data expected to be require d, or the Agency identifies significant changes in its in terpretation and use of the Pesticide Handlers Exposure Database (PHED)-based exposure data used in the previous assessment of

aldicarb. Post-application N The Agency does not believe that there is a significant potential for post-applicati on exposures from aldicarb based on the manner in which it is applied and soil incorporated, the timing of application, the frequency of application, and the lack of known activ ities that

would occur in the treated areas that might contribute to exposure. Also, the Agency does not believe that there is any significant potential for chemical trespass into adjoining areas such as residential neighborhoods.

Residential Handlers, post-application, incidental oral, and

recreational N Aldicarb is not registered for use in residential settings. Therefore, a resi dential exposure assessment is not required.

Other Aggregate TBD An aggregate assessment typically evaluates the combined risk from dietary and residential exposures.

Since there are no residentia l uses of aldicarb, only

food and water are included in the aggregate risk assessment. If the new drinking water estimates exceed previous estimates and a new dietary risk assessment is conducted, then a new aggregate

assessment would be conducted.9 Anticipated Risk Assessments for Aldicarb’s Registration Review

Type of Risk Assessment Include? Notes

Cumulative TBD The Agency will determine if there is any new

information which would affect the cumulative risk assessment. Should the Agency determine that new information on aldicarb or another N-methyl

carbamate is available that could potentially impact

the cumulative risk assessme nt and result in a risk of concern, the Agency may revisit the cumulative risk

assessment. Tolerances Y The tolerance expressi on should be revised to ensure that it appropriately covers the metabolites and degradates of aldicarb and th at it specifies the residues to be measured for each commodity. In addition, the Agency may need to establish a tolerance in/on cotton gin by-products once crop field trial studies submitted to the Agency have been reviewed.

1 TBD = To be determined upon review of additional data. If the data do not significantly affect the exposure and risk estimates, the Agency will continue to rely upon existing assessments.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).

TIMELINE

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

review.

Registration Review for Aldicarb – Pr ojected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Comment Period 2012 - June Close Public Comment 2012 - August Case Development

Final Work Plan 2012 - November

Issue DCI 2013 – July – Sept.

Data Submission 2015 – July – Sept. Open Public Comment Period for Draft Risk Assessments 2017 – Jan. – March

Close Public Comment Period 2017 – April – June Registration Review Decision10 Registration Review for Aldicarb – Pr ojected Registration Review Timeline

Activities Estimated Date Open Public Comment Period for Proposed Registration Review

Decision 2017 – July – Sept.

Close Public Comment Period 2017 – Oct. - Dec. Registration Review Decision a nd Begin Post-Decision Follow-up 2018 Total (years) 6 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 i ssue a Final Work Plan for the registration

review of aldicarb.

6 The timeline could be affected by a cumulative group risk assessment for the N -methyl carbamates.11 

### Appendix – Additional Areas Considered in Aldicarb’s Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, 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, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

Aldicarb is identified as a cause of impairment, as defined under sec tion 303(d) of the Clean Water Act, for one water body in California, base d on information provided at California EPA’s

State Water Resources Control Board’s website 7 . No Total Maximum Daily Loads (TMDLs) have been developed for aldicarb 8 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 9

. The Agency invites submission of water quality data for this pesticide. To the extent possible, data should c onform to the quality standards in Appendix

A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Re view Risk Assessment and Management Process 10
in order to ensure they can be used quantitative ly or qualitativel y in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to aldica rb 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.

7 http://maps.waterboards.ca.gov/webmap/303d/file s/2010_USEPA_approv_303d_List_Final_122311.xls

8 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

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

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm12 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for aldicarb. The ecological risk asse ssment planned during registration review will allow the Agency to determine whether aldicarb’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed sp ecies) or their designate d critical habitats. When an assessment concludes that a pesticid e’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fisheries Service (the Se rvices), as appropriate.

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action Network

North America filed a lawsuit in the United States District Court for the Northern District of California, against the EPA for allegedly fail ing to undergo consultation with the Services regarding the effects of over 350 pesticides, including aldi carb, on over 200 endangered and threatened species throughout the U.S. (Center fo r Biological Diversity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.)

.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its re registration decision for aldicarb, 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), aldicarb is subject to the endocrine screening part of the Endocrine Disruptor Screenin g Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pest icide active ingredients and 9 iner t ingredients. Aldicarb is not13 among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for aldicarb. For further information on the status of the EDSP, the policie s and procedures, the lis t of 67 chemicals, future lists, the test guidelines and the Tier 1 screeni ng battery, please visit our website 11

.

HUMAN STUDIES:

Occupational

Past aldicarb risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to de termine their dermal and inhalation exposure. Many such studies, involving exposur e to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Databa se. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databa ses, 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 prevai ling at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subj ects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on

these studies.

Aldicarb-specific Human Studies

Past aldicarb risk assessments have relied in part on an intentional dos ing human oral study for selection of points of de parture. The Human Studies Review Board (HSRB) discussed the study extensively during a meeting held on April 2-4, 2006 and concluded that the cholinesterase data from the aldicarb human study were reliable for use in the aldicarb singl e chemical aggregate risk assessment. Additionally, it was concluded that there was no clear and convincing evidence of significant deficiencies in th e ethical procedures that could have resulted in serious harm (based on the knowledge available at the time the study was conducted), nor that information provided to participants seriously impaired their informed consent. In the course of registration review EPA will reconsider this study, as we ll as any other research involving intentional exposure of human subjects to aldi carb brought to its attention. If EPA decides to rely on any of these studies, EPA will ensure that all applicab le regulatory requirement s are met, including, but not limited to, the requirements for EPA ethics review and Human Studies Review Board review of certain research involving inten tional exposure of human subjects.

AGRICULTURAL HEALTH STUDY:

Aldicarb is among several agricultural chemical s included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaboration of the National Institute of Environmental Health Sciences (NIEHS), the Nati onal Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and H ealth (NIOSH). Designe d as a large long-term epidemiological study, the AHS collects and analyzes data on the health and work practices of

11 http://www.epa.gov/endo/14 nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study before any disease developed. The study focu ses particularly on fa rmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall he alth outcomes for people who differ in whether they have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they ca n show some statistical associations. More information on the AHS can be found at: http:/ /aghealth.nci.nih.gov. EPA is monitoring the results of the AHS and will consider this study in the registration review of aldicarb as appropriate.