2 Introduction:

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of piperalin. The FW P includes the expected registration review time line. The FWP also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document, which was posted on the pipera lin registration review docket ( EPA-HQ-OPP-2009-0483 ). 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’s implementation of the registrati on review program requi res review of 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 that 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

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Piperalin was first registered in 1964 to treat powdery mildew f ungal infections of ornamental plants in greenhouses. Currently, piperalin is registered exclusiv ely for use to control powdery mildew on ornamental plants, shrubs, vines, and trees grown in commercial greenhouses and

other similar enclosed structures with nonporous coverings. There are no registered outdoor or

residential uses.

Comments Received on the PWP:

The piperalin registration review docket recei ved twelve comments during the 60-day comment period on the PWP, which began on Septem ber 23, 2009 and ended on November 23, 2009. The comments received do not change the data and risk assessment needs or the timeline detailed in the piperalin PWP. However, a mistake was noted in the timeline detailed in the piperalin PWP.

The PWP indicated the Final Work Plan would be completed in January, instead of the correct date, which is February 2010.

This document finalizes the work plan for th e piperalin registration review process. A description of the comments recei ved and the Agency’s response to these comments is available in the “Summary of Comments and Agency Responses” section of this document.3 Risk Assessment and Data Needs:

The Agency anticipates updating the occupational human health risk assessment for piperalin.

Ecological Risk

• Based on both the indoor-only use pattern for pi peralin and EPA’s determination that, when used according to the label, environmental exposures from piperalin are negligible, the Agency believes that the currently registered uses of piperalin will have no effect on listed species or their designated critical habitat. As a result, the Agen cy does not anticipate undertaking any further assessment relative to the Endange red Species Act. If, in the future, piperalin is considered for registration for uses that could result in environmental exposures, further analysis will be undertaken to determine potential effects to fede rally listed threatened or endangered species and their designated habitats.

• Please refer to Registration Review: Preliminary Probl em Formulation for Ecological Risk, Environmental Fate, Endangered Species, and Drinking Water Assessments for Piperalin

, dated May 28, 2009, located in the pipe ralin docket, for further details.

Human Health Risk

• The Agency anticipates developing an upda ted occupational exposure assessment during registration review. A new occupational risk assessment is anticipated to incorporate the toxicity data that the Agency expects to require and to make necessary updates and changes based on any standard protocols, assumptions, and algorithms that may have changed since the last occupational exposure assessment was conducted.

• The Agency anticipates requiring the following toxicology studies:

○ 28-Day Inhalation Toxi city Study (GLN 870.3465)

○ Reproductive Toxicity Study (rat) (GLN 870.3800)

○ Developmental Toxicity Study (rabbit) (GLN 870.3700b)

○ Neurotoxicity Battery (Acute a nd Subchronic Studies) (GLN 870.6200)

○ Immunotoxicity (GLN 870.7800)

• Please refer to Piperalin: Human Health Assessment Scoping Document in Support of Registration Review, dated August 25, 2009, located in the piperalin docket, for a detailed discussion of the anticipated human health risk assessment needs.

Other Data Needs

• The Agency anticipates requiring the following product chemistry study:

○ UV/Visible Absorption (GLN 830.7050)4 Endocrine Disruptor Screening Program:

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered ap proach 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 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 quantitative relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA is issu ing test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticid e active ingredients and 9 inert ingredients.

This list of chemicals was selected based on th e potential for human exposure through pathways such as food and water, residen tial activity, and certain post-app lication agricultural scenarios.

This list should not be construed as a lis t of known or likely endocrine disruptors.

Piperalin is not among the group of 58 pesticide active ingredients on th e initial list to be

screened under the EDSP. Under FFDCA sec. 4 08(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issu ing future EDSP orders/data call-ins for all Registration Review cases, including those for which EPA has already opened a Registration Review docket for a pestic ide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pl ease visit our website: http://www.epa.gov/endo/.5 Timeline:

EPA has created the following estimated timeline for the completion of the piperalin registration

review.

Registration Review for Piperalin Projected Registration Review Timeline

Milestone Estimated

Month/Year Opening the Docket Open Docket & Public Comment fo r Preliminary Work Plan Sept. 2009

Close Public Comment Nov. 2009 Case Development

Final Work Plan Feb. 2010

Issue DCI Oct.-Dec. 2010

Data Submission Oct.-Dec. 2012 Open Public Comment for Prelimin ary Risk Assessment Apr.-Jun. 2014 Close Public Comment Period July-Sept. 2014 Registration Review Decision Open Public Comment for Pr oposed Registration Review

Decision Oct.-Dec. 2014

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

Total 6 years

Summary of Comments and Agency Responses:

The piperalin registration revi ew docket was open for a 60-day comment period beginning on September 23, 2009. During that time, the Agency received one comment from the registrant

and several comments from commercial flower growers in California. The Agency has

concluded that these comments do not warrant a change in the work plan or the timeline set out in the PWP. Therefore, this document is the fina l work plan for the pipe ralin registration review

process.

In the PWP, the Agency solicited comments on th ree specific topics: environmental justice, water body impairment, and trade irritants. No comments or information were received during the comment period concerning these issues.

Summary of comments from SePRO Corp., 2G Roses LLC, CA Cut Flower Commission, Koch Mesa Nursery Inc., Green Valley Floral Inc., Ocean Breeze International, B&H Flowers, Kitayama Brothers Inc., and Dramm & Echter Inc.

1. Comment: The commenters explained how piperali n is an essential component of the Integrated Pest Management programs em ployed by greenhouse ornamental flower growers. Piperalin is the only active ingr edient available domestically for curative control of powdery mildew infections. In the absence of piperalin products growers6 would have to rely on various broad spect rum preventative fungicides, which would increase exposure to potentially harmful chem icals. Furthermore, the added expense of alternatives to piperalin products would put domestic flower growers at a competitive disadvantage against intern ational growers with acce ss to piperalin products. Commenters are not aware of any safety in cidents ever having been reported.

Response: The Agency appreciates the feedb ack and will take the comments into

consideration duri ng the risk assessment process.

2. Comment: SePRO Corp. commented on their intention to seek waivers for the registration review data requi rements based on the low-volum e of production and use of piperalin.

Response: The Agency will consider waiver requests either as a response to the piperalin DCI or prior to th e issuance of the DCI depending on when they are received.

Next Steps:

The Agency plans to develop a Data Call-In Noti ce for piperalin and plans to issue it in late2010. This new information will be used to conduct a human health risk assessment for piperalin.