2 

### Hydramethylnon Preliminary Work Plan

– Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessment s for Registration Review 7

Timeline 9

Next Steps 9

Appendix

– Additional Areas Considered in Hydramethyln on’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 Drinking Water Exposure Assessments for Hydramethylnon

. Odenkirchen, Zhong

. November 15, 2012

.

2. Hydramethylnon. Human Health Assessment Scoping Document in Support of Registration

Review

. Doherty, Oonnithan, Scol lon

. November 20, 2012

.

3. BEAD Chemical Profile for Registration Review: Hydramethylnon (Pyrimidinone) (PC Code 118401)

. Mallampalli, Haddad, Lee

. September 10, 2012

.

4. Hydramethylnon: Review of Human Incidents

. Recore

. July 19, 2012

.

5. PRD Label Data Report: Food/Feed & Non

- Food/Non

- Feed Uses Considered in Registration Review Work Planning

. July 18, 2012.

These and other supporting documents for the hydramethylnon registration review case may be

found in the docket EPA

- HQ

- OPP

- 2012

- 0869 at http://www.regulations.gov

.3 OVERVIEW

The docket for hydramethylnon is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2012

- 0869 )

. Hydramethylnon is a slow

acting stomach toxicant insecticide registered for use against ants

, cockroaches , crickets, earwigs, silverfish, and termites

. Hydramethylnon products are primarily used to control ants in

non

- crop lands such as lawns, turf, and non

- bearing nursery stoc k. Hydramethylnon is also registered for the control of household ant species and cockroaches in nonfood use areas in and around domestic dwellings and commercial establishments. In addition to those uses, hydramethylnon is registered for use on grasses, rangelands, and in pineapple orchards. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs

knows about hydramethylnon , highlighting anticipa ted 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 hydramethylnon’s review

.

The registration review process was designed to include a public participation 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 hydramethylnon and what types of new data

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

. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will help t he 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. Interest ed 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 Preliminary Wo rk Plan begins by listing the anticipated data needs for hydramethylnon

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides hydramethylnon’s chemical facts, use and usage information, recent acti ons, the anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in R egistration R eview along with some additional chemical case

- specific

information.4 ANTICIPATED DATA NEEDS

The table below summarizes anticipated data needs for hydramethylnon

. The environmental data needs are primarily driven by the outdoor broadcast application of loose granules. 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 Exposure Assessments for Hydramethylnon and Hydramethylnon. Hu man Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for Hydramethylnon’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.2240 Aquatic photodegradation TGAI 12

835.4300 Aerobic Aquatic Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 24

850.1025 Acute toxicity estuarine and marine organisms (oyster shell growth) TGAI 12

850.1300 Freshwater invertebrate life cycle 1 TGAI 12

850.1 350 Saltwater invertebrate life cycle 1 TGAI 12

850.1400 Fish early

- life stage toxicity test (freshwater and estuarine/marine) 2 TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.4100 Seedling emergence and seedling growth 3 TEP 12

850.4150 Terrestrial plant toxicity, v egetative vigor 3 TEP 12

850.4400 Aquatic plant toxicity test using Lemna spp 3 TGAI 12

850.45 00 Algal toxicity 3 TGAI 12

850.4550 Cyanobacteria toxicity 3 TGAI 12

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation for soil and

water 3 TGAI

870.7800 Immunotoxicity TGAI 12
TGAI = technical grade active ingredient; TEP = typical end

- use product ; Degr. = degradate

1 The anticipated DCI will specify that t esting with either a freshwater invertebrate or an estuarine/marine invertebrate (for a species with a valid acute toxicity test) is to be performed . T he resulting acute to chronic ratio (ACR) will then be applied to the other invertebrates.

2 The anticipated DCI will specify that testing with either a freshwater fish or an estuarine/marine fish (for a species with a valid acute toxicity test) is to be performed

. T he resulting acute to chronic ratio (ACR) will then be applied

to the other fish.

3 On June 27, 2012, EPA announced certain revisions in har monized guideline series 850

– Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 00285 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 ability 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

s ure that as change occurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website 4

.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicid e, 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

. 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 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 F inal W ork P lan (FWP) and anticipated schedule for the registration review of hydramethylnon

.

Table 2 provides a summary of the current regulatory status of hydramethylnon.

Table 2: HYDRAMETHYLNON CHEMICAL FACTS

PC code 118401

Case Number 2585

CAS Number 67485

- 29

- 4

Year first registered 1980 Pesticide Type Slow

- acting stomach toxicant insecticide

Chemical class T rifluoromethyl aminohydrazone

R eregistration Eligibility Decision (R E D) December 1998

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable

4 http://www.epa.gov/oppsrrd1/registration_review/6 40 CFR Citation Tolerances for hydramethylnon are established in § 180.395 for use on grass (forage and hay) and pineapple

. Dual

- use Conventional pesticidal uses only

. Non

- pesticidal uses No non

- pesticidal uses of hydramethylnon.

Pesticide Re

- evaluation Division, Chemical Review Manager Steven Snyderman, snyderman.steven@epa.gov , 703

- 347

- 0249

Registration Division

, Product Manager Mark Suarez, suarez.mark@epa.gov , 703

- 305

- 0120

USE AND USAGE INFORMATION

Please see the BEAD Chemical Profile for Registration Review: Hydramethylnon (Pyrimidinone) (PC Code 118401) in the registration review docket for more details

.

Table 3: USE AND USAGE INFORMATION

Summary of Use Slow

- acting stomach toxicant insecticide registered for use against

ants , termites

, cockroaches , crickets, earwigs, and silverfish

. Use Sites Registe red a gricultural sites include: fruit and nut crops

, pineapple

, g rasses, pastures and rangeland

.

Registered n on

- agricultural sites include: golf courses, livestock (sleeping quarters, corrals and holding areas), and poultry facilities (including poultry h ouses), forest lands, nursery stock, ornamental turf and trees, mulch, storage areas (feed/food), pet kennels, horse trailers, zoos, farm or agricultural structures and equipment, households (private or commercial domestic dwellings),

uncultivated nonagricultural uses, sewers, schools, commercial transportation facilities, food and feed processing plants or areas, eating establishments, food marketing, storage and distribution facilities, and hospitals and related institutions. Summary of Usage EPA has very limited usage data for hydramethylnon

. A review of the available proprietary and public databases did not show any reported agricultural usage data. Formulation Type(s) Granular, pellet/tablet

, gel formulations, bait stations, impregnated

mater ials and ready

- to

- use solutions

. Application Method(s) Products can be applied via granular pellet

, aerial broadcast

, or individual mound treatments and via impregnated materials

, though often deployed in bait stations that can be used in residential or

industrial structures. Technical Registrant (s) BASF Corporation and Bell Laboratories Inc. No. of Registrations 37 Section 3 products 5

Restricted Use No

5 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).7 Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

• Information on the design of bait station s

.

• C onfirmation 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

.

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

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

– national, state, and county

• A pplication timing (date of first application and application intervals)

– national, state, and county

• U sage/use information for non

- agricultural uses (e.g., food handling/processing

establish ments, in and around commercial and institutional facilities)

• Typical application interval (days)

• S tate or local use restrictions

• F oreign technical registrants not list ed above who supply technical hydramethylnon to
the US market

RECENT ACTIONS

There are no recent actions for hydramethylnon.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for hydramethy lnon was completed for a registration

- related new use request in 2003 on pineapples

. T he most recent ecological and environmental fate risk assessment was completed in 2003 for the same purpose

. Findings and conclusions from these risk assessments are summarized in the Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Hydramethylnon and

H

ydramethylnon. Human Health Assessment Scoping Document in Support of Registration

Review

.

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

. EPA does not anticipate the need to update dietary, res idential, or occupational

risk assessment s in registration review , unless the Agency determines that new data or changes to the standard operating procedures / default exposur e assumptions could alter the previous risk

conclusion s.

The table below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.8 Table 4: Anticipated Risk Assessments for Hydramethylnon’s Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Y Regarding degradates of concern: The Agency has

concluded that t he stressor of concern is the parent hydramethylnon

. Two known major degradates 6 will

not be assessed further because of the low toxi city based on the ECOSAR analysis. However, several

un identified degradates from photolysis and anaerobic degradation studies will be assumed as the par ent hydramethylnon unless they are properly identified.

Incidents Y For a discussion of hydramethylnon reported ecological incidents, see page 16 of the Problem

Formulation.

Human Health Dietary

Food N It is unlikely that a new assessment will be needed, unless the planned drinking water assessment determines significant estimated residues in drinking

water from surface water sources

. Drinking water Y The Agency plans to conduct an assessment of drinking water from surface water sources only, since hydramethylnon appears to have a low potential for groundwater contamination. Occupational Handlers (mixers, loaders, applicators) N Absent any new toxicity or exposure data, changes to the standard operating procedures, or default exposure assumptions, t he Agency plans to rely on previous

assessments where there was no risk estimates of concern associated with hydramethylnon handler or

post

- applicat ion occupational exposure. Post

- application N

Residential

Handlers N There is very low potential for dermal and inhalation exposures to residential handlers due to the properties of the gel formulation and bait

- station packaging. Post

- application N

Other Aggregate N E valuates the combined risk from dietary and residential exposures. Based on current estimated risk levels a new quantitative aggregate risk assessment is not likely to be necessary.

Cumulative N/A Hydramethylnon has not been identified as a member of a common mechanism group

.

6 1,5

- bis(alpha, alpha, alpha

- trifluoro

- p

- tolyl)

- 1,4

- pentadien

- 3

- one ( CL98,724, 28%) and 4H

- pyrimido [2

- 1

- c]as

triazio

- 4

- one1,6,7,8

- tetrahydro

- 7,7

- dimethyl

- 3

- [p

- (trif luoromethyl)

- styryl] (CL247,176, 25.2% and 30.5%)9 Tolerances Y The tolerance expression for hydramethylnon will be
reviewed during registration review to ensure that it
appropriately covers the metabolites and degradates

of hydramethylnon and that it specifies the residues to
be measured for each commodity.

Incidents Y For a discussion of hydramethylnon’s reported human incidents, see page 10 of the Scoping Document.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• E c 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 fo r further details)

.

TIMELINE

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

.

Table 5: Registration Review for Hydramethylnon

– Projected Registration Review

Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period 2012

– December

Close Public Comment 2013

– February Case Development

Final Work Plan 2013

– May

Issue DCI 2014

– Jan

– March

Data Submission 2016

– Jan

– March

30

- day Public Comment Period for Draft Risk Assessments 2017

– July

– Sept. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision 2018

– Jan

– March

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2018 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 hydramethylnon

.10 

### Appendix

– Additional Areas Considered in Hydramethylnon’s Registration

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 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 (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:

Hydramethylnon is not identified as a cause of impairment for any water bodies liste d as impaired under section 303(d) of the Clean Water Act 7

. In addition, n o Total Maximum Daily

Load s (TMDL) have been developed for hydramethylnon 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 conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 10 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 mean ingful 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 Agen cy 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 hydramethylnon compared to the general population. Please comment if y ou are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

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

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

gro up_name=PESTICIDES

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

10 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 hydramethylnon

. The ecological risk assessment planned during registration review will allow the Agency to determine whether hydramethylnon’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their d esignated 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 (th e Services), 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 Environmental Pro tection Agency (EPA) for allegedly failing to undergo

consultation with the United States Fish and Wildlife Service and the National Marine Fisheries Service regarding the effects of over 350 pesticides, including hydramethylnon , on over 200 endangered and threatened species throughout the United States (Center for 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 numerous studies to assess potential a dverse 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 i nclude 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. F or 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 reregistration decision for hydramethylnon

, 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), hydramethylnon is subject to the endocrine screening part of the Endo crine 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 occurri ng 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 stag e 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 relatio nship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between12 October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contain s 58 pesticide active ingredients and 9 inert ingredients. Hydramethylnon is not 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 issue future

EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for hydramethylnon

. 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 screeni ng battery, please

visit our website 11

.

HUMAN STUDIES :

Occupationa l and Residentia l

Past hydramethylnon risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal a nd 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 fundamentall y 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, an d there is no regulatory barrier to continued reliance on these studies.

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