2 

### Table of Contents

Contents

I. Introduction

................................ ................................ ................................ ............................. 3

II. Scientific Assessments

................................ ................................ ................................ ............ 5

A. Human Health Assessment

................................ ................................ ................................ .... 5

Hazard Characterization

................................ ................................ ................................ .......... 5

Dietary Exposure Assessment

................................ ................................ ................................ . 5

Residential and Occupational Exposure

................................ ................................ ................. 5

Aggregate Risks

................................ ................................ ................................ ...................... 5

Food Tolerances

................................ ................................ ................................ ...................... 5

Human Incidents

................................ ................................ ................................ ..................... 5

B. Environmental Assessment

................................ ................................ ................................ ... 6

Environmental Fate, Exposure, and Risk

................................ ................................ ................ 6

Endangered Species Assessment

................................ ................................ ............................ 6

Ecological Incidents

................................ ................................ ................................ ................ 6

Endocrine Disruptor Screening Program

................................ ................................ ................ 6

III. Proposed Interim Registration Review Decision

................................ ................................ . 8

IV. Next Steps and Timeline

................................ ................................ ................................ ...... 83



### I. Introduction

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision for piperalin and is being issued pursuant to 40 CFR sections

155.56 and 155.58

. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The A gency may issue, when it determines it to be appropriate, a proposed interim registration review decision before completing a registration review. Among other things, the proposed interim registration review decision may require new risk mitigation measure s, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further

informa tion on piperalin , additional documents can be found in EPA’s public docket (EPA

- HQ

OPP

- 2009

- 0483 ) at www.regulations.gov

.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing tha t they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and pr actices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency p eriodically reevaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov /oppsrrd1/registration_review/

.

In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for regis tration.

The first pesticide product containing p iperalin was registered in 1964 for use to treat powdery mildew fungal infections of ornamental plants in greenhouses. Currently, piperalin is registered exclusively for use to control powdery mildew on orn amental plants, shrubs, vines, and trees grown in commercial greenhouses and other similar enclosed structures with nonporous coverings. There are no register ed outdoor or residential uses. The Reregistration Eligibility Decision document (RED) for piperalin was completed in 1994.

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for piperalin (case

3114 ) in 2009

. The following highlights significant events that have occurred during the registration review of piperalin :

 September, 20 09

- Publication of Piperalin Summary Document for a 60

- day public comment period . The Summary Document included the P reliminary W ork P lan (PWP) and was accompanied by the scoping document and problem formulation.4

 March, 20 10

- Final Work Plan (FWP) for Piperalin was issued

-- n o public comments were received during the 60

- day comment period for the Piperalin PWP; thus

, the FWP did not modify the PWP.

 September, 2010

– Generic Data Call

- In (GDCI) for Piperalin issued, requiring a number of human health toxicity studies. Because of the low toxicity of piperalin, after additional analysis all studies were waived

.

 March, 2014

– The Agency published the P reliminary Ecological Risk Assessment for the Registration Review of Piperalin and the Registration Review Preliminary Human Health Risk Assessment for Piperalin for a 60

- day public comment period. One comment in support of EPA’s No Effects determination was received from the Center for Biological Diversity during the comment period

.

 September, 2014

– The Agency is now publishing the Piperalin Proposed Interim Registration Review Decision , dated September 24

, 2014 in docket number EPA

- HQ

OPP

- 2009

- 0483 fo r a 60

- day public comment period.

Additional information on piperalin can be found in EPA’s public docket

, EPA

- HQ

- OPP

2009

- 0483 , accessed at www.regulations.gov

.5



### II. Scientific Assessments

A. Human Health Assessment

A summary of the Agency’s human health risk assessment is presented below. The Agency used the HED scoping document, its supporting documents, and the most updated Agency science policies and risk assessment methodologies to prepare a qualitati ve risk assessment in support of the registration review of piperalin . The most recent human health r isk assessment was conducted in March, 2014

. For a detailed discussion, see the Piperalin: Qualitative Preliminary Risk Assessment for Registration Revie w, published in March, 2014 in the public docket EPA

HQ

- OPP

- 2009

- 0483

, which can be accessed on http://www.regulations.gov/

.

Hazard Characterization

The toxicology database is limited but sufficient for assessing risks from piperalin

. No toxicological endpoints of concern have been identified for risk assessment based on its low toxicity, limited exposure scenarios, and the low percentage a ctive ingredient in the product

. Acute toxicity studies range fro m toxicity category III or IV.

Dietary Exposure Assessment

Based on the use pattern, dietary exposure from food and drinking water is unlikely to occur. Therefore, no dietary assessment is needed.

Residential and Occupational Exposure

Based on the registered uses, there are no residential exposures for piperalin; therefore, a residential exposure assessment is not needed

.

A screening level occupational hand l er an d post

- application risk assessment indicated all risk via

the dermal and inhalation routes of exposure were below the level of concern

.

Aggregate Risks

The potential for residential exposure is low because the registered uses are limited to commercial greenhouses and/or other confined structures . Therefore, a ggregate exposure

assessments were not needed.

Food Tolerances

There are no food uses for piperalin and there are no tolerances or exemptions from tolerances

for piperalin

.

Human Incidents

A review of the Main and Aggregate Incident Data System (IDS) in February 2014 for the time period from January 1, 2009 to February 11, 2014 indicates that there are no reported human incidents associated with the use of piperalin. A review of the National Institute of Occupational6

Safety and Health Sentinel Event Notification System fo r Occupational Risks (NIOSH

SENSOR

- Pesticides), for the time period from 1998 to 2010, indicates that there was one incident in which the product Pipron® was associated with a low

- severity, work

- related occurrence of pruritis (itchy skin) in California in 2001. These i ncident data indicate that the risk posed to human hea lth by piperalin i s minimal and there does not appear to be a concern at this time that would warrant further investigation

.

B. Environmental Assessment

A summary of the Agency’s environmental risk assessment for piperalin is presented below. For detailed discussions of all aspects of the environmental risk assessment, see the Registration Review: Preliminary Ecological Risk Assessment an d Endangered Species Effects Determination for Piperalin published on March 4, 2014 i n the public docket EPA

- HQ

- OPP

- 2009

- 0483

, which

can be accessed on http://www.regulations.gov/

.

Environmental Fate

, Exposure
, and Risk

The single registered use of piperalin is for ornamental (non

- food) crops in an enclosed, indoor greenhouse environment with an impermeable roof, and as such, there is a lack of a complete exposure pathway from the use site to non

- target terrestr ial and aquatic organisms.

In addition to an incomplete exposure pathway based on the use pattern, piperalin has a low total usage amount nationally and a relatively limited geographic use. Therefore, EPA has determined that a full ecological risk asses sment for piperalin is not necessary based on de minimis exposure. The expectation of no exposure, and therefore no risk, to non

- target organisms in this assessment is based on the presumption that piperalin use is limited to indoors, as is specified on th e label.

Endangered Species Assessment

T here is no reasonable expectation for any registered use of piperalin to cause direct or indirect adverse effects to threatened and endangered species

. No adverse modification of critical habitat is expected from t he use of piperalin

. This is because p iperalin is registered for use solely in commercial greenhouses and other similar enclosed structures with nonporous coverings. EPA

has made a “no effect” determination under the Endangered Species Act (ESA) for all listed species and designated critical habitat for such species and has therefore concluded that

consultation with the Fish and Wildlife Service and the National Marine Fisheries S ervice under

ESA s ection 7(a)(2) is not required.

Ecological Incidents

A review of the Ecological Incident Information System (EIIS) maintained by the Agency’s Office of Pesticide Programs (OPP) in January 2014 indicates that there are no reported ecologic al incidents associated with the use of piperalin. A review of OPP’s Incident Data System (IDS) in February 2014 indicates that there was one incident in which the product Pipron® was associated with minor damage to plants. A search of the American Bird

Co nservancy’s Avian Incident Monitoring System (AIMS) Database in January 2014 did not7

indicate any reported incidents in birds involving the use of piperalin. In general, an absence of reported incidents cannot be construed as the absence of incidents thoug h.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 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 include 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. For 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 most recent registration decision for piperalin , 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), piperalin is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredie nts) may have an effect in humans or wildlife similar 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 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 fou nd to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage 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 a ny adverse endocrine

- related effects 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 Feb ruary 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 and incl udes some 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 , please visit our website. i 2

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

1 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

2 http://w ww.epa.gov/endo/8



### III

. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this proposed

interim registration review decision document. EPA’s proposed Interim Registration Review

Decision determination for piperalin is that (1) no additional data are required at this time; and (2) no changes to the affected registrations or their l abeling are needed at this time

. In addition, EPA does not expect piperalin to hav e direct or indirect adverse effects to non

- listed and listed species or to adversely modify any designated critical habitat for such species and has made a “no effect” determination under the Endangered Species Act (ESA) for all listed species and designa ted critical habitat for such species. This proposed interim decision does not cover the EDSP component of the piperalin registration review case.

In the Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects Determin ation for Piperalin , additional label language was suggested to clarify the intended use directions for the piperalin product, Pipron. There was some uncertainty about the potential for runoff from contaminated potting soil or water discharged from a gree nhouse that could produce runoff capable of entering any irrigation or drainage ditch, canal, or other body of water. After receiving additional use information from the piperalin registrants and confirming the information with EPA’s Biological and Econom ic Analysis Division, EPA believes that given the current use patterns of piperalin and the low national usage, risk of exposure from water discharge or potential runoff from contaminated potting soil is low. Piperalin is applied to the upper surface of le aves, so little residue is expected to be contained within the potting soil or other growing media. Runoff from greenhouses is not likely to reach surface waters, as piperalin binds tightly to soil. Over ninety percent of pip eralin is applied in California ; many California greenhouses employ a variety of good management practices aimed at minimizing the impact of water discharge from greenhouses, such as run

- off water quality monitoring, collection and recycling, and improved irrigation methods. 3 Therefore, EPA is not proposing to requir e any additional labeling changes for products containing piperalin.



### I V. Next Steps and Timeline

A. Interim Registration Review Decision

A Federal Register Notice will announce the availability of this P roposed I nterim R egistration

R eview D ecision for piperalin and allow a 60

- day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA may issue an I nt erim R egistration R eview

D ecision for piperalin (case 3478 ). However, a final decision for piperalin may be issued without having previously issued an interim decision

. A final decision on the piperalin registration

review case will occur after an EDSP FFD CA section 408(p) determination has been mad e.

3 Nurseries Surveyed in Southern California Adopt Best Practices for Water Quality. Mangiafico, Salvatore S. California Agriculture . January, 2010.