2 MALAIC HYDRAZIDE FINAL WORK PLAN

Introduction

This is the Environmental Protection Agency’s (EPA’s) Final Work Plan (FWP) for the registration review of maleic hydrazide. The FWP includes the expected registration

review timeline. The FWP also addresse s public comments received concerning the Preliminary Work Plan in the Summary Document , which was posted in the maleic hydrazide registration review docket (EPA-HQ-OPP-2009-0387), and any other comments concerning the ini tial docket postings. The Summary Document provided information on what EPA knows about the pest icide 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 R odenticide 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 ma ke sure that, as the ability to assess risk evolves and as policies and pract ices change, all registered pe sticides continue to meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Inform ation on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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Maleic hydrazide, case 0381, consists of tw o pesticides (maleic hydrazide and maleic hydrazide potassium salt). Maleic hydraz ide and maleic hydr azide potassium salt (hereafter referred to as male ic hydrazide ) are growth regula ting herbicides registered for use on tobacco, onions, non-beari ng citrus, potatoes, turf, airports, indu strial land, lawns, recreational areas, ornamental plants, resident ial areas, and utility and rights-of-way land. Maleic hydrazide is formulated as a techni cal chemical, water dispersible granule, emulsifiable concentrate, and ready-to-use solution.

Comments Received on Preliminary Work Plan

One comment was received on the maleic hydrazide Preliminary Work Plan (PWP) during the 60-day public comment period, which began on September 23, 2009 and closed on November 23, 2009. This comment 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.3 Risk Assessment and Data Needs

Ecological Risk:

• The most recent ecological risk assessment was completed in March of 1994 in support of the EFED Summary Reregistra tion Eligibility Document for maleic hydrazide.

• The Agency has not conducted a risk assessment that supports a complete endangered species determination. The eco logical risk assessment planned during registration review will allow the Agency to determine whether the use of maleic hydrazide has “no effect” or “may aff ect” 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 anticipates needing the fo llowing data in order to conduct an endangered species and non-target ecol ogical risk assessment for maleic hydrazide.

o (GLN 850.2100) Avian oral t oxicity (Passerine species)

o (GLN 850.1400) Fish early-life st age toxicity (freshwater)

o (GLN 850.1300) Daphnid chronic toxicity

• The Agency has identified hydrazine as a contaminant in technical grade maleic hydrazide. As part of the registration review of maleic hydrazide, the Agency will review open literature for additional data on hydrazine and compare the modeled expected environmental concentr ation (EEC) values to the available aquatic toxicity data.

• For more information regarding the stat us and review of ecological fate and effects of maleic hydrazide, please refer to the document: Registration Review – Preliminary Problem Formula tion for the Ecological Risk Assessment of Maleic Hydrazide in the maleic hydrazide registra tion review docket (EPA-HQ-OPP2009-0387)

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Human Health Risk:

• The most recent human health assessment for maleic hydrazide was completed in September of 2005 in support of the Tole rance Reassessment E ligibility Decision (TRED).4 • Based upon a 28-day inhalation toxicity study which was submitted in January of 2009, the Agency anticipates a potentia l revision of the occupational and

residential assessments.

• At the time of the TRED, risk to resi dential users of maleic hydrazide was not considered by the Agency because products were limited to professional applicators only. However, si nce that time, new labels have been approved that permit application by homeowners. Theref ore, the Agency anticipates that the registration review of maleic hydrazide may also include a residential handler

assessment.

• The Agency anticipates conducting a ne w aggregate assessment that will incorporate data from the anti cipated residential assessment.

• The most recent drinking water assessment was completed in May of 2005, and is anticipated to be adequate for risk assessment purposes during the registration review of maleic hydrazide.

• The Agency anticipates requiring the fo llowing studies, in accordance with the revised CFR Part 158, to conduct a compre hensive human health risk assessment for the registration review of maleic hydrazide.

o (GLN 870.7800) Immunotoxicity study

o (GLN 870.6200a) Acute neurotoxicity

o (GLN 870.6200b) Subchronic neurotoxicity

• Hydrazine is a contaminant in technica l grade maleic hydrazide for which the Agency established an upper limit of 15 ppm.

• For more information on the status and re view of the human health effects of maleic hydrazide, please refer to the document: Maleic Hydrazide: Human Health Scoping Document in Support of Registration Review in the maleic hydrazide registration review docket (EPA-O PPTS-OPP-2009-0387) for a detailed discussion of previous human health assessments.

Timeline

EPA has created the following estimated timeline for the completion of the maleic hydrazide registration review.

Registration Review for Maleic Hydrazide

Projected Registration Review Timeline

Milestone Date Opening the Docket Open Docket & Public Comment Period for Maleic Hyrazide September 2009

Close Public Comment Period November 20095 Case Development Final Work Plan January 2010

Issue DCI Oct. – Dec. 2010

Data Submission Oct. – Dec. 2012 Open Public Comment for Preliminary RA Apr. – June 2014 Close Public Comment Period July – Sept. 2014 Registration Review Decision Open Public Comment for Proposed Regist ration Review Decision Oct. – Dec. 2014

Close Public Comment Period Jan. – Mar. 2015 Final Reg. Review Decision and begin post-decision follow-up 2015

Total 6 years

Summary of Comments Receive d During Docket Opening

The maleic hydrazide registration review doc ket was open for a 60-day public comment period which began on September 23, 2009. Du ring that time, the FIFRA Endangered Species Task Force (FESTF) submitted a comment which is summarized below. The comment did not change the work plan or time line set out in the preliminary work plan. Consequently, this document makes final the work plan for the maleic hydrazide registration review process.

Comment from FESTF The FESTF submitted a comment requesting that any technical registrant for maleic hydrazide who is not a member of the FESTF (or a company having met its data compensation obliga tions) be asked to provide a formal offer-to-pay to

FESTF for reliance on their data. In th eir comment, FESTF also noted that Chemtura Corporation is already entitled to rely on FESTF data; however Drexel Chemical Company (Drexel) and Fair Products, Inc, are not FESTF members.

EPA Response The Agency thanks FESTF for its comment and will consider this information as it conducts the maleic hydrazide registration review process.

Next Steps

The Agency will develop a data call-in (DC I) notice for the data gaps listed under the

“Risk Assessment and Data Needs” section above.

Both an ecological risk assessment, wh ich will include an endangered species assessment, and a human health risk assessm ent will be conducted as detailed in the

“Risk Assessment and Data Needs” section above.