Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

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### Contents

I. INTRODUCTION............................................................................................................. 3

II. SCIENTIFIC ASSESSMENTS ....................................................................................... 4

A. HUMAN HEALTH RISK ASSESSMENT ..................................................................... 4

1. Hazard and Risk Characterization ........................................................................... 4

2. Food Tolerances .......................................................................................................... 4

3. Human Incidents......................................................................................................... 5

4. Deficiencies .................................................................................................................. 5

B. ENVIRONMENTAL ASSESSMENT .......................................................................... 6

1. Environmental Fate, Exposure, and Risk ................................................................ 6

2. Ecological Incidents .................................................................................................... 6

3. Endangered Species Assessment ............................................................................... 7

C. ENDOCRINE DISRUPTOR SCREENING PROGRAM .......................................... 8

III. PROPOSED INTERIM REGISTRATION REVIEW DECISION ............................. 9

IV. NEXT STEPS AND TIMELINE ................................................................................... 10 Appendix A: Quinclorac Label Table ...................................................................................... 11Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

3 I. INTRODUCTION

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision for quinclorac (PC code 128974) and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A regi stration review decisi on 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 Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other th ings, the interim registration re view decision may: 1) require new risk mitigation measures; 2) impose interim risk mitigation measures; 3) identify data or information required to complete the review ; and 4) include schedules for submitting the required data, conducting the new risk assessmen t and completing the registration review. For further information on quinclorac, additional documents can be found in EPA’s public docket (EPA-HQ-OPP-2007-1135) at www.regulations.gov

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FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pestic ides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on sc ientific data showing that 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 intende d to make sure that, as the ability to assess and reduce risk evolves and as polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonable a dverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluates pes ticides 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 regist ration 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 FIFR A standard for registration.

The first pesticide product containing quinclo rac was registered in 1992. Quinclorac is a systemic herbicide registered for use in controlling certain broadl eaf and grass weeds. Currently registered uses of quinclorac in clude turf grasses, sorghum, wh eat, rangeland/pasture, rights-ofway/fencerow/hedgerow, grass grown for s eed, fallow land, grass forage/fodder/hay, rice, rhubarb, and certain low growi ng berries. Because quinclora c was not registered until 1992, it was not subject to reregistrati on and therefore no Reregistration Eligibility Decision document (RED) for this chemical was completed.

Pursuant to 40 CFR §155.50, the Agency form ally initiated registration review for quinclorac (case 7222). The following highlights si gnificant events that have occurred during the registration review of quinclorac and can be found in public docket (EPA-HQ-OPP-2007- 1135, accessed at www.regulations.gov) :Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

4  December 19, 2007 –The Quinclorac Summary Document was published for a 60-day public comment period. The Summary Document included the Preliminary Work Plan (PWP) and was accompanied by the scoping document and problem formulation.

 June 12, 2008– Final Work Plan (FWP) for quinclorac was posted. Two comments were received but they did not modify the PWP.

 January 2010 – Generic Data Call-In No tice (GDCI) for quinclorac was issued.

 June 26, 2013 - The Agency published the human health risk assessment Quinclorac: Risk Assessment In Support of Regist ration Review and for New Proposed Use on Rhubarb and Berry, low growing, except Strawberry, Subgroup 13-07H and the ecological risk assessment Registration Review - Ecologi cal Risk Assessment for Quinclorac for a 60-day public comment period. No comments were received during the comment period.

 September 2014 – The Agency is now publishing the Quinclorac Proposed Interim Registration Review Decision for a 60-day public comment period.

II. SCIENTIFIC ASSESSMENTS

A. HUMAN HEALTH RISK ASSESSMENT

A summary of the Agency’s human health ri sk assessment is presented below. The Agency used the HED scoping document, its supporting documents, and the most updated Agency science policies and risk assessment me thodologies to prepare a quantitative risk assessment in support of the registration review of quinclorac. The most recent previous human

health risk assessment was conducted in Nove mber, 2012. For a detailed discussion, see the

document Quinclorac: Risk Assessment In Support of Registration Review and for New Proposed Use on Rhubarb and Berry, low growing, except Strawberry, Subgroup 13-07H., published in the public docket EPA-HQ-OPP-2007-1135, which can be accessed on http://www.regulations.gov/

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1. Hazard and Risk Characterization

Quinclorac (technical grade material) has a lo w order of acute toxicity as demonstrated by Toxicity Category III by the or al, dermal, and inhalation routes . The chemical is a mild eye irritant, is not a skin irritant, but was positive for dermal sensitization. All acute and chronic dietary risk estimates for quinc lorac are below EPA’s level of concern. The exposure scenarios for residential and occupational exposure yield ri sk estimates that do not exceed EPA’s level of

concern.

2. Food Tolerances

US pesticide tolerances for qui nclorac are liste d under 40 CFR 180.463.Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

5 As a result of registration review, EPA reco mmends that the tolerance on Grain, aspirated

fractions be revoked. Data have be en received demonstrat ing that the tolerance is not needed, as residues on aspirated grain fracti ons (AGF) are no higher than th e tolerances on the grains.

Based on the recalculated dietary burdens for livestock and the data from the available cattle and poultry feeding studies, the current tolerances for livestock commodities are adequate, with the exceptions of the tolerances on poultry meat byproducts and hog fat and meat byproducts. The existing tolerances for poultry meat byproducts and hog fat and meat byproducts are too high. Therefore, the tolerances for these livestock commodities should be lowered to 0.05 ppm. Lowering the tolerances on these commodities will also harmonize the U.S. tolerances with the existing Canadian MRLs for poultry m eat byproducts and hog fat and meat byproducts.

In addition, the Agency no longer considers rice straw to be a significant livestock feedstuff (OPPTS 860.1000, Table I, ChemSAC memo 6/30/08). Therefore, the current tolerance for residues of quinclorac on rice straw may be revoked.

A complete summary of the proposed tolera nce changes for quinclorac in registration review appear on Page 10 of the Quinclorac Human Health Risk Assessment, document EPAHQ-OPP-2007-1135-0017 at regulations.gov.

3. Human Incidents

Overall, only a moderate number of incident s have been reported involving quinclorac. A 2007 human health review by EPA for quinclor ac identified two incidents in the Main and Aggregate Incident Data System (IDS) from 199 9 to 2007; five quinclora c cases in the Poison Control Centers (PCC) database from 1993 to 2005; and no incidents in the National Institute of Occupational Safety and Health Sentinel Even t Notification System for Occupational Risks (NIOSH SENSOR) data from 1998 to 2003. An incident review conducted in 2012 found an

increase in the number of incidents since the previous incident review performed in 2007, a change most likely due to the removal in 2007 of a self-imposed restriction by the registrant that all quinclorac products used to treat residen tial turf could be app lied only by a certified applicator. The vast majority of th ese incidents were of low severity.

4. Deficiencies

The following deficiencies were noted in the Human Health Risk Assessment:

 The risk assessment indicated that the use of quinclorac on rice and cranberry fields requires additional residue data to be provide unless all labels prohibit use of treated water from rice and cranberry fields in aquaculture.

o Since the publication of the risk assessme nt, EPA has verified that all quinclorac product labels contain the follo wing restriction: “Do not us e treated rice fields for aquaculture of edible fish and crustaceans (crayfish).” No additional data or changes are needed to address this concern.

 A new analytical standard for the quinclorac DMA salt for the EPA National Pesticide Standards Repository.Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

6 B. ENVIRONMENTAL ASSESSMENT

During registration review, the Agency identifi ed risk concerns fo r terrestrial plants. For detailed discussions of all aspects of th e environmental risk assessment, see the Registration Review - Ecological Risk Assessment for Quinclorac , published on June 26, 2013 in the public docket (EPA-HQ-OPP-2007-1135) which can be accessed on http://www.regulations.gov/ . A summary of the Agency’s environmental risk assessment for quinclorac is presented below.

1. Environmental Fate, Exposure, and Risk

The ecological risk assessment concluded that quinclorac posed a risk concern for direct effects to non-target lis ted and non-listed terrestrial plant spec ies across most uses and use sites for quinclorac. The LOC was also exceeded for listed aquatic vascular plants from use of quinclorac on rice. The potential for risk to te rrestrial plants indicate d by LOC exceedances is supported by documented plant incidents involv ing the use of quinclorac. In particular, ecological effects data indicate th at tomatoes are especially sens itive to quinclorac and incidents involving tomatoes associated with the applicati on of quinclorac to rice have been reported in

northeast Arkansas.

Regardless of the use or app lication rate, a risk concern was not identified for direct effects to birds, reptiles, and terrestrial-phase amphibians; mamma ls; terrestrial invertebrates; freshwater fish and aquatic-phase amphibians; estuarine/marine fish; freshwater invertebrates; estuarine/marine invertebrates; and aquatic non-vascular plants.

2. Ecological Incidents

A review of the Ecological Incident Information System (EIIS) maintained by the Agency’s Office of Pesticide Programs (O PP) on August 10, 2012 indicated two reported ecological incidents associated with the use of quinclorac) associated with the use of quinclorac. Both incidents involved plant damage to tomatoes in Arkansas from drift exposure as a result of aerial applications to rice. These incidents ultimately resulted in tomato growers of Poinsett County, Arkansas, filing a petition for cancellation of quinc lorac. A study by the University of Arkansas in response to complaints by tomato growers was initiated in 1999. The study reported detectable amounts of quinclorac in ambient air over tomato fields , chemical residues in tomato plant tissues, and documen ted varying degrees of abnormal growth symptoms consistent with those known to be caused by quinclorac, but concl uded that it was not po ssible to determine the specific sources of the airborne quinclorac because on many days when quinclorac was detected in air samples, there was no reported applicatio n within 5 miles of th e experimental site.

Additional incidents are reported to the Agency in aggregated form. Pesticide registrants report certain types of incidents to the Agency as aggregate c ounts of incidents occurring per product per quarter. For quinclorac, registrants have reported no fi sh and wildlife incidents, 481 minor plant incidents, and no other non-target incidents as of August 10, 2012. The total number

of actual incidents associated w ith the use of quinclorac may be higher than what is reported to the Agency. Incidents may go unreported since eff ects may not be immediat ely apparent and/or readily attributed to the use of a chemical.Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

7 No incidents involving birds were reported in the Avian Monitoring Information System (AIMS), which is maintained by the Ameri can Bird Conservatory, as of August 10, 2012.

3. Endangered Species Assessment

In November 2013, the EPA, along with the U. S. Fish & Wildlife Service (USFWS), the

National Marine Fisheries Service (NMFS) (collectively, the Servi ces), and the U.S. Department of Agriculture (USDA) released a summary of th eir joint Interim Approaches for assessing risks to listed species from pesticides. The Inte rim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific

differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments

that EPA and the Services must conduct in connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presen ted the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues Research and Evaluation Group ( SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholde rs to comment on the Interim Approaches. As part of a phased, iterative process for deve loping the Interim Approaches, the agencies will also consider public comments on the Interim Appr oaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are

contained in the white paper “Interim Approaches for Natio nal-Level Pesticide Endangered Species Act Assessments Based on the Recommenda tions of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this Proposed Interim Registration Review Decision for quinclorac does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated crit ical habitat. Of 1456 listed species that may be affected by the use of quinclorac as identified in the 2013 ecological risk assessment, a “no effect” determination for direct and indirect effects can be made for 87 species based on a lack of geographical overlap between the species and quinclorac uses. A preliminary assessment has, on a coarse biological and geographical data se t, identified potential

concerns for effects on individuals of the remain ing 1369 species. It is possible that additional information and further analysis will lead to species-specific determinations of no effect; may effect, not likely to advers ely affect; or may effect, lik ely to adversely affect.

Future assessment work will allow EPA to focus its future evaluations on the types of species where the potential for effects exists onc e the scientific methods being developed by the agencies have been fully vetted. Once the agenci es have fully developed and implemented the scientific methods necessary to complete risk assessments for e ndangered and threatened (listed)Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

8 species and their designated crit ical habitats, these methods will be applied to subsequent analyses for quinclorac as part of completing this regi stration review.

C. ENDOCRINE DISRUPTO R SCREENING PROGRAM

As required by FIFRA and FFDCA, EPA review s numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute,

subchronic and chronic toxici ty, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or syst emic toxicity. These studies include endpoints which may be susceptible to endocrine influenc e, including effects on endocrine target organ histopathology, organ weights, es trus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard asse ssments, EPA evaluates

acute tests and chronic studies that assess growth, developmen tal and reproductive effects in different taxonomic groups. As part of its most recent registration decision for quinclorac, EPA

reviewed these data and select ed the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), quinclorac is subject to the endocrine screeni ng 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 hu mans or wildlife similar to an effect produced by a “naturally occurring estr ogen, 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 w ith the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal sy stems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Ti er 2 tests are necessary based on the available data. Tier 2 testing is designe d to identify any adverse endocr ine-related effects caused by the substance, and establish a dose-re sponse relationship between the dos e 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, including quinclorac, identified for EDSP screening was published on June 14, 2013 1
and includes some pesticides scheduled for Re gistration Review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endo crine disruptors. For further information on the status of the EDSP, the policies and procedures, th e lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 2

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

chemicals.

2 http://www.epa.gov/endo/Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

9 In the interim, EPA is making no human h ealth or environmental safety findings

associated with the EDSP screeni ng of quinclorac. Before comp leting this registration review, the Agency will make an EDSP FFDCA section 408(p) determination.

III. PROPOSED INTERIM REGI STRATION REVIEW DECISION

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this proposed interim registration re view decision document. EPA’s proposed Interim Registration Review Decision for quinclorac is that (1) no add itional data, other than analytical standards for the quinclorac DMA salt, are required at this time ; and (2) labeling changes are needed at this time to mitigate risks to terr estrial plants. EPA is requesting the registrant submit updated analytical standard for the quinclorac DMA salt to the EPA National Pesticide Standards Repository. A completed effects determinati on under the Endangered Species Act (ESA) for quinclorac is not included in this proposed in terim decision. With the exception of 87 species that do not overlap in geographic location with quinclorac use, it has not yet been determined whether quinclorac poses a risk from direct or indirect adverse effect s to non-listed and listed species or to adversely modify any designa ted critical habitat for such species.

On the basis of the findings of the 2012 hu man health risk assessment for quinclorac resulting in no risks above the Agency’s level of concern, no human health mitigation is being undertaken for quinclorac at this time by the Agency.

EPA plans to propose making various revisions to the current quinclorac tolerances. The tolerance on Grain, aspirated frac tions, will be revoked. The existing tolerances for poultry meat byproducts and hog fat and meat byproducts will be lowered to 0.05 ppm. In addition, the current tolerance for residues of quinclora c on rice straw may be revoked. Additional information on EPA’s proposed tolerance changes for quinclorac can be found on Page 10 of the Quinclorac Human Health Risk Assessm ent, document EPA-HQ-OPP-2007-1135-0017 at regulations.gov.

As discussed in the Environmental Fate, Expos ure, and Risk section of this document, quinclorac has been determined to pose a poten tial risk concern for non- target listed and nonlisted terrestrial plant sp ecies. To address this concern, the Agency is proposing various label changes for quinclorac registrations. These labe l amendments are intende d to reduce spray drift from the application of quinclorac products. EPA’s intention is to revise current quinclorac label language to establish a baseline le vel of protection against spray drif t that is consistent across all quinclorac products. All registrant s are encouraged to surpass th is baseline level of protection and submit revisions to quinclorac label language th at will reduce the risk of spray drift as much as possible given efficacy considerations. After discussion with all of the companies that are technical registrants for quinclor ac, the Agency is proposing the fo llowing label restrictions: all quinclorac labels shall limit (1) product droplet size during applic ations to medium or coarser droplet size according to the American Societ y of Agricultural and Biological Engineering (ASABE) standard; (2) a pplication release height to no grea ter than 30 inches from the ground limit for ground applications and no greater than 10 feet from th e ground or the top of the crop for aerial applications, unless a higher application height is required for r easons of pilot safety;Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

10 (3) wind speed during applications to be no gr eater than 10 mph; and (4) a product’s maximum single application rate to be no greater than 0.75 lb ai/A. Impl ementing these label changes will not entirely eliminate risks from quinclorac to a ll non-target terrestrial pl ants, but doing so will nevertheless reduce spray drift durin g quinclorac applications, thus establishing a higher level of environmental protection than that afforded by cu rrent labels by reducing the number of plants that might be exposed

In this proposed interim registration review decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of quinc lorac, nor is it making a complete endangered species finding. The Ag ency’s final registrati on review decision for quinclorac will depend upon both the result of an ESA Section 7 consultation with the Services, and an EDSP FFDCA section 408(p) determination.

IV. NEXT STEPS AND TIMELINE

In accordance with 40 CFR sections 155.56 and 155.58, the Agency is issuing this proposed interim registration review decision document, a nd placing it in the quinclorac registration review docket (EPA-HQ-OPP-2007-1135) for public comment for 60 days. A Federal Register Notice will announce the availab ility of this proposed interim registration review decision for quinclorac and initiate a 60-d ay comment period. Comments are especially welcomed by the Agency on the subject of pr oposed tolerance updates and the label language amendments proposed by EPA to mitigate risks to te rrestrial plants from us e of quinclorac. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its proposed decision, EPA will issue an interim registration review decisi on for quinclorac (case 7222).

Once the Interim Registration Review Decision is issued, registrants will need to submit amended labels that include the label change s summarized in Appendix A to the Agency for approval within 60 days.Docket Number EPA-HQ-OPP-2007-1135 www.regulations.gov

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### Appendix A: Quinclorac Label Table

Summary of Proposed Labeling Changes for Quinclorac End-Use Products

Application

Parameter Proposed Amended Labeling Language for Quinclorac Use Products Placement on

Label

Maximum Single Application Rate The maximum single application rate for qu inclorac is 0.75 lbs a.i./acre. All labeled rates must be updated to reflect this maximum rate. Directions for

Use

Droplet Size “Apply as a medium or coarser spray (ASABE standard 572).” Directions for

Use

Release Height For ground applications: “Do not release spray at a height great er than 30 inches above the ground.”

For aerial applications: “Do not release spray at a height greater than 10 feet above the ground or crop canopy.” Directions for

Use

Wind Speed “Do not apply when wind speeds are gr eater than 10 mph at the application

site.” Directions for

Use