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## Fosamine Ammonium Final Work Plan Registration Review

November 2010

Case No. 2355

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### Dat ePage 2 of 7 Fosamine Ammonium Final Work Plan

Introduction: This is the Environmental Protection Agency’s (EPA’s) Final Work Plan (FWP) for the registration review of fosamine ammonium. Th e FWP includes the expected registration review timeline. The FWP also addresses public comments received concerning the Preliminary Work
Plan in the Summary Document , which was posted in the fosamine ammonium registration review docket (EPA-HQ-OPP-2010-0215), and a ny other comments concerning the initial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Agency believes are needed to make a registration review decision.

The Agency is implementing the new registra tion review program and will review each registered pesticide every 15 years to determin e whether it continues to meet the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA) standard for registration. Changes in science, public policy, and pesticide use practices will occur over time. The registration review program is intended to make sure that, as the ab ility to assess risk evolves and as policies and practices change, all registered pesticides contin ue to meet the statutory standard. The public phase of registration review begins when the ini tial docket is opened for e ach case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/

.

Fosamine ammonium is an herbicide register ed for use on non-agricultural rights-of way, industrial sites, fencerows, pine plantations, and sewage disposal areas. Formulated as a water soluble liquid, fosamine ammonium functions as a plant growth regulator. There are no residential uses and no residential exposures from th e registered uses are anticipated. Tolerances are not currently established for fosamine ammoni um since there are no registered food or feed
uses. Fosamine ammonium was fi rst registered in 1975 and the re registration eligibility decision (RED) was issued in 1995.

Comments Received on Preliminary Work Plan Comments on the fosamine ammonium PWP were submitted during the public comment period by the fosamine ammonium registrant E.I. Du Pont de Nemours and Co., the FIFRA Endangered Species Task Force (FESTF), and the Physicians Committee for Responsible Medicine (PCRM). The 60-day public comment period on the fosa mine ammonium PWP began on June 23, 2010 and closed on August 23, 2010. These comments did not change the work plan or timeline

established in the PWP. In addition, through the PWP, EPA solicited comments on three specific topics: environmental justice, water body impairment, and trade irritants. No comments or information were received during the comment period concerning these topics.

Risk Assessment and Data Needs:

Ecological Risk:

• The most recent ecological risk assessment for fosamine ammonium was completed in 1994 to support the RED.Page 3 of 7 • The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for fosamine ammonium . The ecological risk assessment planned during registration review will allow the Agency to determine whether fosamine ammonium’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or

National Marine Fisheries Service (the Services), as appropriate.

• The Agency will require the following data in order to conduct a complete ecological risk assessment, including an endangered speci es assessment, for fosamine ammonium:

o GLN 850.2100 Avian acute oral toxic ity study (passerine species)

o GLN 850.1400 Fish early life-stage (freshwat er) (Rainbow trout, Bl uegill sunfish)

o GLN 850.1300 Aquatic invertebrate life-c ycle (freshwater) (Water flea)

• Please refer to the document, Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Wate r Assessments for Fosamine Ammonium,

located in the docket for a deta iled discussion of the anticipate d risk assessment and data

needs.

Human Health Risk:

• The most recent human health risk assessmen t for fosamine ammonium was completed in 1994 to support the RED.

• A dietary (food only) exposure assessment is not anticipated for fosamine ammonium because there are no registered food or feed uses. However, a new drinking water exposure and risk assessment is an ticipated for registration review.

• Based on the registered uses, the Agency does not anticipate conducting a residential exposure assessment for this registra tion review of fosamine ammonium.

• The Agency does not intend to conduct an aggregate risk assessment as there are no food/feed uses, and no residentia l uses of fosamine ammonium.

• The most recent occupational exposure and risk assessments for fosamine ammonium were conducted in 1994 to support the RED. An updated occupational exposure and risk assessment, that incorporates updated assessment methodologies, will be conducted during this registration review.

• The Agency will require the following data in order to support a human health risk

assessment for fosamine ammonium:

o GLN 870.3465 90-Day Inhalation Toxicity (rat)

o GLN 870.3700b Developmental Toxicity (rabbit)Page 4 of 7 o GLN 870.7800 Immunotoxicity

• Following the submission of the additional toxicological data, the Agency plans to update the human health toxicity profile.

• Please refer to the document, Fosamine Ammonium. Hum an Health Assessment Scoping Document in Support of Registration Review, located in the docket for a detailed discussion of the anticipated risk asse ssment and data needs for human health.

Other Anticipated Data Needs:

• GLN 830.7050 UV/Visible Light Ab sorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Requi rements) for registration of a pesticide (food and non-food uses). The Agency antici pates requiring this study to obtain basic information about the compound’s identity/com position and the wavelengths at which the compound may be susceptible to photochemical degradation.

Timeline: EPA has created the following estimated timeline for the completion of the fosamine ammonium registration review. This timeline has been s hortened since the PWP to account for a shorter period between issuance of the DCI and data su bmission, since the Agency will not be requiring any studies that take more than one year to conduct.

Registration Review for Fosamine Ammonium – Projected Registra tion Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – June Close Public Comment 2010 – August Case Development

Final Work Plan 2010 – November Issue Data Call-in (DCI) 2011 – July – Sept. Data Submission 2012 – July – Sept. Open Public Comment Period for Preliminary Risk Assessments 2014 – Jan. – March Close Public Comment Period 2014 – April - June Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2014 – July - Sept.

Close Public Comment Period 2014 – Oct. – Dec. Final Registration Review Decision a nd Begin Post-Decision Follow-up 2015 Total (years) 5Page 5 of 7 Summary of Comments Receive d During Docket Opening: The fosamine ammonium registration review docket was open for a 60-day public comment period which began on June 23, 2010 and closed on August 23, 2010. During that time, E.I. DuPont de Nemours and Co., the FIFRA Endangered Species Task Force (FESTF), and the Physicians Committee for Responsible Medicine (PCRM) submitted comments which are summarized below. The comments did not change the work plan or timeline set out in the preliminary work plan. Consequently, this docum ent makes final the work plan for the fosamine ammonium registration review process.

For a more detailed response regarding the comments, please see the memos in the docket, EFED Response to Comments on Preliminary Problem Formulation for Regi stration Review of

Fosamine Ammonium (10/5/2010) and Fosamine Ammonium: Response to Comments on the Human Health Risk Scoping Document in Support of Registration Review

.

PCRM Comment: The Physicians Committee for Responsible Medicine (PCRM) submitted a comment that it supports the use of newly revised OECD test gui deline (TG 223) for acute avian oral toxicity testing (GLN 850.2100).

Agency Response: The Agency thanks PCRM for its comments. Cu rrently, the Agency is awaiting completion of the validation process for OECD TG 223. Until validation is complete, studies using this guideline will not be classified. Therefore, at this time the Agency ca nnot say whether or not avian acute oral toxicity studies done under th e new OECD test guidelines (TG 223), will be acceptable to meet the Agency's data requirements.

FESTF Comment: The FIFRA Endangered Species Task Force (FESTF) submitted a comment informing the Agency that DuPont, the leading technical re gistrant for fosamine ammonium, is a FESTF

member and therefore entitle d to rely on FESTF data.

Agency Response: The Agency thanks FESTF for its comment and will consider it as it conducts the registration

review of fosamine ammonium.

DuPont Comment:
DuPont argued for the Agency to consider limitin g the aquatic chronic toxicity testing to the

invertebrate Daphnia magna instead of rainbow trout.

Agency Response:
The Agency noted that 40 CFR Part 158.630 requires both Guideline 850.1300 (aquatic invertebrate life cycle) and 850.1400 (f ish early-life stage) studies fo r all terrestrial, forestry and residential uses. In addition, available toxicity data for fosamine ammonium show the chemical to be more toxic to fish than to aquatic inverteb rates. Finally the Agency noted that the lack of data (i.e. only one species test) will limit the fl exibility the Agency and registrants have inPage 6 of 7 complying with the Endangered Species Act, whic h could result in restrictions for fosamine ammonium use that might prove to be unnecessary gi ven data to address this area of uncertainty.

DuPont Comment:
Based on the very low acute and chronic toxici ty demonstrated in the mammalian and bird studies already conducted, the regist rant believes that further te sting on a passerine species is

unwarranted.

Agency Response:
Avian Acute Oral Toxicity Test (850.2100) data are required for one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. The Agency noted that more than one species is required to avoid possible over- or under-estimation of risk and will allow for gr eater flexibility in compliance with the Endangered Species Act during the upcoming ecological assessment.

DuPont Comment:

DuPont noted several errors in the acute toxici ty categories listed in the Human Health Risk Scoping Document for fosamine ammonium.

Agency Response: DuPont is correct. Revised acute toxicity category designations fo r the exposure routes identified by DuPont will be included in the registration review assessment conducted for

fosamine ammonium.

DuPont Comment: DuPont disagrees with the Agency conclusion about the possible ne urotoxic effects of fosamine ammonium. Specifically, DuPont claims that the laboratory testing e ffects cited by EPA as

neurotoxic effects are more consistent with st ress from compound related systemic toxicity and not neurotoxicity.

Agency Response: DuPont’s comments on the significance and/or impli cations of effects observed in the acute neurotoxicity study in rats will be considered as part of the comprehensive assessment conducted for the registration review of fosamine ammonium.

DuPont Comment: DuPont requests the Agency waive the developmen tal toxicity study in non -rodent species cited as an anticipated data need in the Human Health Risk Scoping Document for fosamine ammonium. DuPont believes the study to be unn ecessary and likely to provide little value to a risk assessment. DuPont argued that these da ta are not necessary gi ven the product chemistry properties of fosamine ammonium; the unlikely rout es of significant expo sure; and the lack of toxicological effects seen in a developm ental toxicity study conducted on rats.Page 7 of 7 Agency Response:
The Agency does not agree with DuPont’s presump tion of no or low exposure via the oral and or dermal/inhalation routes; and, even if substa ntiated, would not precl ude the need for a developmental toxicity study in a second species. The Agency also noted that the fact that no effects were seen at high doses in one species does not preclude the n eed for a developmental study in a second species. For th ese reasons, the Agency will re quire a developmental toxicity study in non-rodent species to s upport registration review.

DuPont Comment : DuPont will consider providing a 28-day immuotoxici ty study if there is a DCI for this endpoint. Following the approach to sex and species sele ction outlined in the EPA Memorandum of June 16, 2009, Immunotoxicity Test Guideline: Respon se to CropLife America’s Comments, DuPont
thinks that the female mouse shoul d be used, as this is EPA’s defa ult when there are no data to support one sex or species over the other.

Agency Response : An immunotoxicity study is required under 40 CFR Part 158 as a part of the new data requirements for registration of a pesticide (food and non-food uses). If DuPont would like the Agency to review the study protocol prior to stu dy initiation, the Agency encourages DuPont to submit a study protocol prior as early as possibl e in order to meet th e 12 month study deadline that will required by the DCI.

Data Requirements Table

The Agency will issue a DCI for the following studies listed in both the PWP and FWP.

Data Requirement Guideline Number Listed In PWP Listed In FWP

Avian Acute Oral Toxicity Study (passerine species) 850.2100

Fish Early Life-Stage (freshwater) (Rainbow trout, Bluegill sunfish) 850.1400

Aquatic Invertebrate Life-Cycle (freshwater) (Water flea) 850.1300

90-Day Inhalation Toxicity (rat) 870.3465

Developmental Toxicity (rabbit) 870.3700b

Immunotoxicity 870.7800 UV/Visible Light Absorption 830.7050 The Agency’s anticipated data needs did not change and the Agency will issue a DCI for these

studies.