2 

### Aluminum Phosphide, Magnesium Phosphide, and Phosphine Preliminary

Work Plan – Table of Contents

Overview 4

Anticipated Data Needs 5

Statutory and Regulatory Authority 6

Chemical Facts 6

Use and Usage Information 7

Recent Actions 9

Anticipated Risk Assessments for Registration Review 9

Timeline 12

Next Steps 12

Appendix – Additional Areas Considered in the Aluminum Phosphide, Magnesium Phosphine, and Phosphine Registration Review 13

References:

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

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Dr inking Water Exposur e Assessments for Aluminum Phosphide, Magnesium Phosphide, and Phosphine. Lowit, M. and S. Wente. September 12, 2013.

2. Phosphide (Al, Mg) and Phosphine: Hum an-Health Assessment Scoping Document Supporting Registration Review. King, M. T. Morton, and S. Miller. September 11, 2013.

3. Aluminum Phosphide, Magnesium Ph osphide and Phosphine: Review of Human Incidents. Recore, S. and E. Evans. May 8, 2013.

4. PRD Label Report: Aluminum Phosphide. April 22, 2013.

5. PRD Label Report: Magnesium Phosphide. December 31, 2012.

6. PRD Label Report: Phosphine. January 29, 2013.3 7. BEAD Chemical Profile for Registration Review Phosphine (066500), Aluminum Phosphide (066501) and Magnesium Phosphide (066504). Cook, C. August 6, 2012.

These and other supporting documents for the aluminum phosphide, magnesium phosphide, and phosphine registration review case may be found in the docket EPA-HQ-OPP-2013-0081 at http://www.regulations.gov

.4 OVERVIEW

The docket for aluminum phosphide, magnesi um phosphide, and phosphine is now open, initiating the first public comment period for th is registration review (docket number EPA-HQOPP-2013-0081). This case includes the following active ingredients: aluminum phosphide and magnesium phosphide (hereafter referred to as “metal phosphides”) a nd phosphine. Zinc phosphide is not included in this registration review case.

Phosphine is a colorless gas registered for use ag ainst stored-product insect pests and vertebrate pests, mainly rodents. It is formulated as a pr essurized gas and it is also the active ingredient for the metal phosphides. The metal phophides are formulated as impregnated materials, pellets/tablets, and granules which releas e phosphine gas upon exposure to atmospheric

moisture.

This Preliminary Work Plan (PWP) document expl ains what EPA's Office of Pesticide Programs knows about the metal phosphides and phosphine, hi ghlighting 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 antici pated timeline for completing the registration review for the metal phosphides and phosphine.

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 know s about the metal phosphides and phosphine and what types of new data or othe r information would be helpful fo r the Agency to receive as it moves toward a decision on the metal phosphides and phosphine. The Agency encourages all

interested stakeholders to review the PWP and Appendix an d 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-prof it or interest groups; pesticide manufacturers; agricultu ral labor or commodity groups; commerc ial, institutional, residential, and other users of pesticides ; or the public at large.

The Preliminary Work Plan begins by listing th e anticipated data need s for the metal phosphides and phosphine. Next, it discusses the statutory and regulatory aut hority for Registration Review. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for the metal phosphides and phosphine. Finally, the Appendix to this document includes identification and

discussion of some areas that ar e considered generally in Registration Review along with some additional chemical case-specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data n eeds for the metal phosphides and phosphine. For

additional discussion of the anti cipated data needs, see the Registration Review: Preliminary Problem Formulation for Environmental Fa te, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Al uminum Phosphide, Magnesium Phosphide, and Phosphine and Phosphide (Al, Mg) and Phosphine: Human-Health Assessment Scoping Document Supporting Registration Review

.

Table 1: Anticipated Data Needs for th e Aluminum Phosphide, Magnesium Phosphide and Phosphine Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Alum inum Phosphide, Magnesium Phosphide, and Phosphine

875.1700 Product use information TEP 12

875.1400 Inhalation exposure for applicators TEP 24 875.2500 Post-application inhalation exposure 2 TEP 24

NonGuideline Extended one-generation reproduction study via

inhalation route phosphine 36

NonGuideline Special acute inhalation study phosphine 24

NonGuideline Ambient air monitoring study TEP 36

NonGuideline Monitoring data on fumigated commodities TEP 24

NonGuideline Terrestrial plant toxicity phosphine 12

NonGuideline Avian acute inhalation toxicity phosphine 24

NonGuideline Honeybee acute vapor exposure study phosphine 24

TGAI = technical grade active ingredie nt; TEP = typical end-use product;

1 On June 27, 2012, EPA announced certain revisions in harmonized 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 Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

2 This study is needed to assess post-application expo sures for workers within and near structural fumigation facilities/operations or who work with treated commodities/materials.6 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

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 the metal phosphides and phosphine.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for the metal phosphides and phosphine.

Table 2: Chemical Facts for Aluminum Phosphide, Magnesium Phosphide, and Phosphine

Aluminum Phosphide Magnesium Phosphide Phosphine

PC code 066501 066504 066500

Case Number 0025 0645 7608

CAS Number 20859-73- 8 12-057-74-8 7803-51-2 Year first registered 1958 1979 1999 Pesticide Type Insecticide, rodenticide Chemical class Fumigant Reregistration Eligibility Decision (RED) 1998 1998 Registered after 1984. Not subject to

review under reregistration.

3 http://www.epa.gov/oppsrrd1/registration_review/7 Table 2: Chemical Facts for Aluminum Phosphide, Magnesium Phosphide, and Phosphine

Tolerance

Reassessment Eligibility Decision (TRED) Not applicable.

Cumulative group Not applicable. The meta l phosphides and phosphine have not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation Tolerances are establishe d for residues of the metal phosphides and phosphine in 40 CFR §180.225 Dual-use The metal phosphides and phosphi ne are registered for conventional pesticidal uses only and have no registered antimicrobial or biopesticidal uses. Non-pesticidal uses There are no identified non-pesticidal uses of the metal phosphides or phosphine.

Pesticide Re-evaluation Division, Chemical Review Manager Dana Friedman, friedm an.dana@epa.gov, (703) 347-8827

Registration Division, Product Manager Venus Eagle, eagle.venus@epa.gov, 703-308-8045

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage inform ation for the metal phosphides and phosphine.

Please see the BEAD Chemical Profile for Registration Review Phosphine (066500), Aluminum Phosphide (066501) and Magnesium Phosphide (066504) in the registration review

docket for more details.

Table 3: Aluminum Phosphide, M agnesium Phosphide, and Phosphine Use and Usage Information Summary of Use Phosphine is a colorless gas registered for use against storedproduct insect pests and ve rtebrate pests, mainly rodents. It is the active ingredient for the metal phosphides, which emit phosphine after contact with atmospheric moisture. Phosphine is one of the major chemical alternatives to post-harvest uses of methyl bromide, which has been phased out under the Montreal Protocol except for some special exemptions.

Use Sites Agricultural Uses: Phosphine is registered for use on numerous stored raw commodities (i.e. tree nu ts, dried fruits, cereal grains), animal feed and feed ingredients, and processed foods (i.e. candy, bakery mixes, crackers, cheese, meat products).

Non-Agricultural Uses: Phosphine may be used as a space fumigation (mills, food plants, warehouses); as a vehicle fumigation (railcars, trucks, vans,8 Table 3: Aluminum Phosphide, M agnesium Phosphide, and Phosphine Use and Usage Information containers);; and as a vessel or ship fumigation. Phosphine is also registered for use on numerous non-food commodities and other

non-food items. These incl ude tobacco, cloth fibe rs, feathers, hair, wood and wood products, paper, tires, and beehives..

In addition, metal phosphine pellets/ta blets are registered for use for rodent control, especially burrowing pests. Summary of Usage EPA has very limited usage data for the metal phosphides and phosphine. According to Kline and Company

, during the 2002- 2003 time periods, aluminum phosphide was the leading active ingredient used on stored grains (wheat, com, rice, and soybeans) with 791,000 pounds sold, which was 43% of the market.

Based on information from California’s Department of Pesticide Regulation’s use reports, use of these fumigants in recent years has been above average, particularly th at of phosphine. This increase is explained by two major factor s, a new phosphine product was

introduced that allows for better control and target fumigations and the reduction of availability of methyl bromide in this market

because of the Montreal Protocol obligations. Formulation Type(s) Phosphine is formulated as a pres surized gas. The metal phosphides are formulated as impregnated materials, pellets/tablets, and granules. Application Method(s) Cylinderi zed canisters of phosphine may be pre-blended or blended on site, and dispensed with car bon dioxide or forced air using blending equipment.

Pellets/tablets may be spread along the surface of a commodity, through a probe/pipe into the commodity, or using a dispensing machine. They may also be placed in a tray near the commodity.

Pellets or tablets are placed into the rodent burrows. These products may not be used in burrows that are within 100 feet of a building that is, or may be, occupied by humans and/or domestic

animals. Technical Registrant(s) Aluminum Phosphide: All registrations are end-use products. Enduse registrants are: Bernardo Chemicals, Inc., D&D Holdings, Inc., Douglas Products and Packaging Company, ROC Enterprises, LLC, and United Phosphorus, Inc.

Magnesium Phosphide: All registrations are end-use products. End-use registrants are: D& D Holdings, Inc. and United Phosphorus, Inc.9 Table 3: Aluminum Phosphide, M agnesium Phosphide, and Phosphine Use and Usage Information Phosphine: All registrations are end-use products. The end-use registrant is Cytec Industries.

No. of Registrations Aluminum Phosphide: Section 3 products: 20

Magnesium Phosphide: Section 3 products: 5

Phosphine: Section 3 products: 2

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/use information for agricultural and non-agricultural uses including: indoorfumigation of raw agricultural commodities, animal feeds, processed food commodities, nonfood commodities in sealed containers or stru ctures, and outdoor fumigation of burrows to control rodents and moles in non-domestic areas, non-cropland, and agricultural areas.

 Information about the characteri stics of the treatm ent facilities in which phosphine is used including building size (dimensions), em ission control devices (if any), and the number, size, and relative location of stacks a nd vents that serve as the release points during phosphine aeration operations.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; aer ation methods and equipment; maximum application rates; frequency of appl ication, and applic ation intervals.

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

 Median and 90 th percentile reported use rates from usage data – national, state, and
county.

 Typical application timing (date of first applic ation and application in tervals) – national, state, and county.

 State or local use restrictions.

 Foreign technical registrant s not listed above who supply technical metal phosphides or phosphine to the US market.

RECENT ACTIONS

In 2010, the Agency expanded and clarified rest rictions on aluminum and magnesium phosphide products to better protect bystander s from exposure. The new restric tions prohibit all uses of the metal phosphide products around resi dential areas and increase bu ffer zones for treatment around non-residential buildings that could be occupied. Additional information on these restrictions is

located at http://www.epa.gov/oppsrrd1/reregistrati on/alphosphide/aluminum-magnsm-phosfs.html.10 On March 21, 2013, the Agency accepted a label amendment to the phosphine products for an

increase in the use rate and to add certain food and non-food commodities that were already on the metal phosphide labels.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for the metal phosphides was completed in June 1998 in preparation for the Reregistration Eligibil ity Decision (RED) and subsequently updated in December 1998 to provide dietary exposure and risk estimated with the Dietary Exposure Evaluation Model (DEEM). The most recent ecological and environmental fate risk assessments were completed in 1998 fo r RED and in 2010 concerning the risk to several federally threatened and endangered species. Findings and conclusions from these risk

assessments are summarized in the Registration Review: Prelimi nary Problem Formulation for Environmental Fate, Ecological Risk, Endange red Species, and Drinking Water Exposure Assessments for Aluminum Phosphide, Magnesium Phosphide, and Phosphine and Phosphide (Al, Mg) and Phosphine: Human-Health Asse ssment Scoping Docume nt Supporting Registration

Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an e ndangered species assessment, for the metal phosphides and phosphine. For human health, EP A anticipates the need to conduct revised dietary, residential, and occupational risk assessments during regi stration review. If toxicological endpoints or points of departure are revised based on th e data that are anticipated to be required for registration review, they will be considered in the new assessments, as well as any changes to the standard operating pro cedures or default exposure assumptions.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.

Table 4: Anticipated Risk Assessments for th e Aluminum Phosphide, Magnesium Phosphide, and Phosphine Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The stressors of concern will be the metal phosphides and phosphine. Phosphine released from structures or within burrows comprise the primary exposure pathways of concern for terrestrial organisms. Aquatic exposure to phosphine is assumed minimal. Terrestrial (above ground) a nd aquatic exposure to the metal phosphides is not expected.

Incidents Will check for updates For a discussion of reporte d ecological incidents for the metal phosphides and phosphine, see page 12 of

the Problem Formulation.

Human Health Dietary11 Food Y A new dietary exposure and risk assessment may be required during Registration Review to incorporate potential changes to th e phosphine toxicological points of departure (PODs). Drinking water N Given the use pa ttern and the physical/chemical properties of the metal phosphides and phosphine, there is a low exposure potential for ground and

surface water. Occupational Handlers (mixers, loaders, applicators) Y A new occupational handler risk reassessment will incorporate new data, updated PODs, and, to the extent that they are availa ble, policies currently under development regarding assessment of fumigant

chemicals. Post-application Y A new occupational post-application risk reassessment will incorporate new data, updated PODs, and, to the extent th at they are available, policies currently under development regarding assessment of fumigant chemicals.

Residential Handlers N The metal phosphides and phosphine are restricted use pesticides, so residen tial handlers are prohibited from applying these products. Post-application N Metal phosphide and phosphine exposure to occupants of fumigated struct ures is expected to be negligible given proper ae ration procedures. Bystander Y Bystander risk (anyone not part of the fumigation) from metal phosphide and phosphine emissions from

treated commodities and structures will need to be evaluated based label prescr ibed use conditions, and if the PODs or uncertainty factors (UFs) change based on acute toxicological data identified.

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures. Cumulative N The metal phosphides and phosphine are not members of a cumulative group, so no cumulative risk assessment is planned.

Tolerances Y Tolerances are es tablished for residues of the fumigants aluminum phosphide, magnesium phosphide and phosphine gas in 40 CFR §180.225.

Incidents Will check for updates For a discussion of reported human incidents for the metal phosphides and phosphine see page 12 of the Scoping Document and the Aluminum Phosphide, Magnesium Phosphide and Phosphine: Review of

Human Incidents.12 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 timelin e for the completion of the metal phosphides and phosphine registration review in Table 5 below.

Table 5: Projected Aluminum Phosphi de, Magnesium Phosphide, and Phosphine Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2013 – September

Close Public Comment 2013 – November
Case Development

Final Work Plan 2014 – February

Issue DCI 2014 April - June

Data Submission 2017 April - June
60-day Public Comment Period for Draft Risk

Assessments 4 2018 Oct. – Dec.

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 April - June

Registration Review Decisi on and Begin Post-Decision Follow-up 2020

Total (years) 7

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 the metal phosphides and phosphine.

4 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.13 

### Appendix – Additional Areas Considered in the Aluminum Phosphide, Magnesium Phosphide, and Phosphine 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:

The metal phosphides and phosphine are not identifie d as a cause of impairment for any water bodies listed as impaired under sec tion 303(d) of the Clean Water Act. 5 In addition, no Total Maximum Daily Loads (TMDL) have been deve loped for the metal phosphides or phosphine. 6
More information on impaired water bodies and TMDLs can be found at the Agency’s website. 7
The Agency invites submission of wa ter quality data for this pesticide. To the extent possible, data should conform to the qua lity 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 8 in order to ensure they can be used quantitatively or qualitati vely 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 the metal phosphides or phosphine 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.

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

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

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

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm14 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for the metal phosphides or phosphine. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of the metal phosphides or phosphine “no effect” or “may aff ect” federally listed threatened or endangered species (listed species) or their de signated 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 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 most recent registration decision for the metal phosphides and phosphine, EPA reviewed these data and selected the mo st sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), the metal phosphides and phosphine are subject to the endocrine screening part of the Endocrine Disruptor Screening 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 inert ingredients. A second list of

chemicals identified for EDSP scr eening was published on June 14, 2013 9 and includes some

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

chemicals.15 pesticides scheduled for Registration Review and chemicals found in water

. 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, pleas e visit our website. 10

In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of the metal phosphides and p hosphine. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

HUMAN STUDIES:

Chemical-specific Human Studies

Past metal phosphide and phosphine risk assessments have relied in part on human studies which may have involved intentional e xposure to the metal phosphides a nd phosphine. In the course of registration review EPA will reconsider these studies, as well as any other research involving intentional exposure of human subjects to the metal phosphides and phosphine brought to its

attention. If EPA decides to re ly on any of these studies, EPA w ill ensure that all applicable regulatory requirements are met, including, but not limited to, the requirements for EPA ethics

review and Human Studies Review Board review of certain re search involving intentional exposure of human subjects.

AGRICULTURAL HEALTH STUDY:

Aluminum phosphide is among several agricultur al chemicals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaboration of th e 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 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 aluminum phosphide as appropriate.

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