DocketNumberEPA-HQ-OPP-2014-0544 www.regulations.gov



### 4-chlorophenoxyacetic acid ( 4-CP A) Combined WorkPlan, Summary Document, and Proposed Interim Registration Review Decision Case Number 2115

August 15, 2014

Approved by:

## B.~heryd P 

## Mk'--<<j'U Yt-<-.._ ,

## ~ Richard P. Keigwin, Jr. Director Pesticide Re-evaluation Division
Date: 

### F;

### /lsj~o ;.c.f

### 4-CPA- Table ofContents Introduction 3 Statutory and Regulatory Authority 3 4

-CP A Chemical Facts 4 Use and Usage Information 4 Recent Actions 5 Scientific Assessments 5 Combined WorkPlan, SummaryDocument, and Proposed Interim Registration Review Decision 7 Next Steps and Timeline 8 Appendix A- Additional Areas Considered in the 4-CPA Registration Review 8
References: This document summarizes the Environmental Protection Agency's currentposition based onthe following documents: 

### 1. EFED PreliminaryRiskAssessmentto ClassifyRegistered4-CP A Uses as De Minimus Risk to Listed/Non ListedSpecies and "No Effects" Determination. Edward Odenkirchen, Ph.D., Senior Science Advisor. June 5, 2014. 2. 4

-ChlorophenoxyaceticAcid. Human Health RiskAssessment in Support of Registration Review. Ideliz Negron-Encarnacion, AnaRivera-Lupianez, Seyed Tadayon, Ronnie J Bever Jr., Ph.D. July 17, 2014. 3. BEAD Chemical Profile for Registration Review: 4-CPA andSalts (010401). Sunil Ratnayake, SepehrHaddad, and Derek Berwald. May 3, 20 12
. 4. 4-ChlorophenoxyaceticAcid, andSalts: Tier IReview of Human Incidents
. ShannaRecore, ElizabethEvans. June 26, 2014.
These and other supporting documents for the 4

-CPA registrationreview case maybe found in the docketEPA

-HQ-OPP-201 4-0544 athttp://www.regulations.gov.

2INTRODUCTION The docket for 4-chlorophe n oxyacetic ac id (4-CPA) is now open (EPA- HQ-OPP- 2014 - 0544), in itiating the first public comment period for this registration re view. This document is the Environmental Protection Agency ' s (EPA or the Agency) com b ined Work Plan, Summary Document, and Proposed Interim Registration Review Decision for 4 -CP A. It i s being issued

pursuant to 40 CFR Sections 1 55.50 , 155.56, and 155 .58. This document explains what E PA's Office of Pesticide Programs knows about 4-CP A, highlighting an t icipated data and assessment needs and providing an anticipated timeline for completing 4 - CP A review. I t a l so includes the Agency's Proposed Interim Regist r ation Rev i ew Decision for 4 - CP A. In add i tion to genera l areas on which the pub li c may wish to comment, the Append ix highlights top i cs of special interest to the Agency where addit i ona l information cou ld be of particular use. A registrat i on revie w decision is the Agency ' s determinat i on whether a pesticide meets, or does not meet, the standard for registration under the Federal In s ecticide, F ungicide, and Rodenticide Act (FIFRA) . The Agency may issue, when it determines it to be appropriate, a proposed interim registratio n review decision before comp l eting registration r e view . Among other things, the proposed interim registration review decision may require new risk mitigation measures, impose interim risk miti g at i on measures, identify data or information r e qu i red t o complete the review, and in c l ude schedu le s for submitting the requ i red data, conducting the new risk assessment and comple t ing registration review. The pest i c id e 4 - CP A is a plant growth regulator registered for use exclusively as a soaking agent for mung bean sprouts in g r eenhouse operations to prevent root formation and, the r eby, is intended to improve the sorting and handling of the mung bean sprouts for packaging . A ll of the use occurs indoors. 4 - CP A is applied in a dilute solution of 2 to 3 mg/ L of active ingredient to a water bath t o soak batches of about 3 500 pounds of beans. Once the beans hav e soaked for several hours, they are washed to remove the surface residues, and are then germinated i ndoo r s for several days. After sprouting , the hulls and roots are discarded, and the remaining port i on is packaged and so l d for human consumption. The Reregistration E li gibility Decision document (RED) for 4-CP A was completed on March 1, 1997. EPA reassessed 4-CP A tolerances in the 2003 TRED. F or further information about 4- CPA, additional documents can be found in E PA's public docket (E P A-HQ-OPP-2014-0544) at www .regu l ations . g o v. STATUTORY AND REGULATORY A U THORITY The Food Quality Protection Act (FQP A) of 1996 mandated a registration review program. A ll pesticides dist r ibuted or sold in the U.S. generally m u st be registered by EPA , based on scientific data showing t h at they will not cause unreasonable risks t o human health or the en v ironment when used as directed on product l abeling. The reg i stration review program is intended to make sure that, as the a bility to assess risk evolves an d as policies and practices

change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environmen t. Changes in science, public policy , and pesticide use practices will o ccur over tim e . Through the registration review program , the

Agency periodically reevaluates pes t i c i des to make sure that as change occu r s, products in the 3marketplace can be used safely. Information onthis program is provided at www.epa.gov/oppsrrdl/registration review/. The Agency is implementing the registrationreviewprogram pursuantto Section 3(g) of FIFRA, and will review eachregistered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governingregistrat ion review begin at 40 CFR 155.40
. The Agency will consider benefits information and data as required by FIFRA. The public phase ofregistration reviewbegins when the initial docket is opened for eachcase. The docket is the Agency's opportunity to state what it knows about the pesticide and what additional risk analyses and dataorinformation itbelieves are needed to make a registration review decision. 4-CPA CHEMICAL FACTS

PC code 019401 CaseNumber 21 15 CAS Number 122-83

-3 Year first registered 1969 Pesticide Type Conventional Chemica l Chemical class Phenoxy ReregistrationEligibility March 1997 

## ! Decision (RED) Tolerance Reassessment April 4, 2003 Eligibility Decision (TRED) Cumulative Group EPAhas not made a commonmechanism oftoxicity finding as to 4-CP A and any other substances, and4

-CPA does not appear to produce a toxic metabolite produced by other substances. 40 CFRCitation Tolerances are establishedinthe 40 CFR 

### §180.202 for residues of 4-CPA inion mung bean sprouts at 0.2 ppm. Dua l-use Conventional pesticidal uses only Non

-pesticidal uses No non-pesticidal uses of4

-CPA Pesticide Re-evaluation Miguel Zavala, zavala.miguel@epa.gov, 703

-347

-0504 Division, Chemical Review Manager Registration Division, Tony Kish, kish
.tony@epa
.gov, 703-308

-9443 ProductManager USE AND USAGEINFORMATION 4-CPA is registered for use in the food industry as a plantgrowthregulator to restrict root growth during seed germinat ion ofmung beans. Below is a summary ofthe use/usage of4-CPA. For more details please see BEAD Chemical Profile for Registration Review: 4-CPA andSalts (010401), May 3, 2012.

4Summary of Use 4-CP A is applied to a water bat h to soak mung beans. The beans soak fo r severa l hours, are washed, and then germ i nated i ndoors fo r severa l days. After sprou t ing, the hulls and roots are discarded, and the remaining portion is packaged and sold for human consumption. Use Sites Indoor use . Summary of Usage 10 - 20 lbs active ingredien t are used annually nationwide Formu l at i on Type(s) Amorphous powder Technical Registrant(s) ConAgra Foods No. of Registrations 1 Restricted Use No

RECENT ACTIONSThe r e are no r ecent actions for 4-CP A. SCIENTIFIC ASSESSMENTS A summary of the Agency's human health and environmental fate and ecological risk assessme n ts, 4-Chlorophenoxyacetic Acid. Human Health Risk Assessment in Support of Registration Review (July 1 7, 2014) and EFED Preliminary Risk Assessment to Classify

Registered 4-CP A Uses as De Minimus Risk to Listed/Non Listed Species and "No Effects" Determination. (June 5, 2014) is presented below. For t h e detai l ed risk assessments, see the 4 - CPA pub l ic docket (EPA-HQ-OPP

- 20 1 4 - 0544) at www.regulations.gov. Human Health Assessment Hazard Characterization and Risk The toxico l ogica l database is considered adequate for characterizing hazard and assessing risk from 4 - CP A. No additional shtdies are anticipated to be needed for regist r ation review. Dietary Exposure Assessment A chronic dietary (food on l y) exposure and risk assessment was conducted using tolerance-leve l residue values for mung bean and assuming 1 00% of crop treated. Drinking water is not an ant i cipated exposure pathway, as application of 4-CP A occurs indoors and the use is limited. The chronic dietary risk for 4-CP A was below the Agency's level of concern for the general population and all population subgroups.

Food Tolerances A tolerance of0.2 ppm is established in the 4 0 CFR §180 . 202 for residues of4-CPA in/on bean, mung, sprouts. The tolerance expression currently includes measurement of residues of parent 4-CP A and its me t abolite 4-ch l orophenol. T he Agency has comp l eted an evaluation of the established tolerance and determined that: (1) the tolerance expression needs to be modified

in accordance with current Agency policy for writing tolerance expressions; and, (2) to exclude measurement of the metabo li te 4-ch l orophenol because it is no longer considered a metabolite of risk concern . 5Canadahas established a maximumresidue limit (MRL) of2 ppm for residues of4-CPA inion mung beans. EPA's 0.2 ppm tolerance is based on updatedresidue datathat has not been submitted to Canada. TheAgency will pursue harmonizingtolerances with Canadawhere possible during registrationreview. Formore information please refer to 4-Chlorophenoxyacetic Acid. Human Health RiskAssessment in Support of RegistrationReview (July 17, 2014). Residentialand OccupationalExposure A residential handler and post-applicationexposure assessment is not needed for registration review because there are no registered residential uses of4-CPA. Foroccupational use, the Agency believes that the potential for exposure to 4-CPA during pesticide handling operations exists, but is very low. Based on a conservative quantitative assessment of occupational handler exposure and risk, no risks ofconcern were identified. Occupational postapplication exposure was not quantitatively assessed. However, based on4-CPA's use pattern and lowexposure potential, the occupational handler assessmentis expected to be protective of potential worker post-applicationexposure. 

### Environmental Assessment EPA conducted a qualitative environmental fate and eff ects assessmentfor 4-CPA and has determined that ef fects to non-target species are unlikely. EPA consideredpotential 4-CPA exposure to non-target organisms, available information on the toxicity of4-CPA from ecological structure activity relationships, and annual usage information. Spentmungbean soaking solution can be disposed ofdown municipal wastewater drains and represents a completeexposure pathway to downstream receiving waters. However, there is a low likelihood for significant toxicity to aquatic organisms, the taxamostlikely to beexposedvia a wastewater discharge scenario, based on predictions from ecological structure activity relationships. In addition, the 20 pounds of4-CPA used annually is expected to be geographically disperse and greatly diluted before reaching receiving waters. ThreatenedandEndangeredSpecies Based on the type and extent ofuse, the low expected toxicity predicted by quantitative structure activity relationships, andthe highly diffuse nature ofthe use site coupled with extremely low annual usage, the Agencyconcludes that effects onthe environment are not reasonably expected to occurfrom the registered use of4-CPA. Therefore, the EPA anticipates making a "no effects" determination under the Endangered Species Act (ESA) for all listed species and no adverse modification ofdesignated cr itical habitat for such species is expected from the registered use of4- CPA. 

### Endocrine DisruptorScreeningProgram Asrequired by FIFRA and FFDCA, EPA reviews numerous studies to assesspot ential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments ofcarcinogenicity, neurotoxicity, developmental, reproductive, and general orsystemictoxicity. 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 ofits most recentregistration decision for 4-CPA, EPA 6reviewed these data and se l ected the most sensitive endpoints for relevant risk assessment scenarios from the ex i sting hazard database. However, as require d by FFDCA section 408(p ), 4- C P A is subject to the e nd ocr ine s creening part of the Endocrine Di s rupt or Scree ning Program (EDSP). EPA has d eve l oped t he EDSP to dete rmi ne whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effec t produced by a "natura lly occurring estrogen , or othe r suc h endocrine effects as the Administ rat or may designa t e." Th e EDSP employs a two -tie red approach to making the statuto ril y requir ed determinat ions . Tier 1 cons i sts of a battery of 11 screening assays to identify the potential of a chemical s ubstance to interact wi th the estrogen, androgen , or thyroid (E, A, or T) hormonal systems. C h em ical s that go through T i e r 1 screeni n g and are found to have the potent ial to int eract with E, A, o r T h ormonal sys t e m s will proceed to th e next stage of th e EDSP where E PA will determine w hich , i f any, of the Tier 2 tests are necessary based on the a vai labl e

data. T ier 2 testing is designed to identify any adverse e ndocrine-rel ated effects caused by the su b stance, and establish a d ose - res p onse relationship between the dose and the E, A, or T effect. Under FFDCA section 408(p ), the Agency must screen all pesticide chemicals. B etwee n October 2009 and February 20 10 , E PA issued t est orders / data call -i ns for the first g ro u p of 67 che micals , which contains 58 pesticid e active ingredients and 9 inert ingredients. A second list of chemicals id ent ifi e d for EDSP screening was publi she d on Jun e 1 4, 2013 1 and includes some pest i c ide s scheduled for Registrat ion Re v iew and che micals found in water. Fo r further information on th e sta tu s of the EDS P , th e po li c i es and procedur es, th e li sts of chemicals, future li sts, the t e st guidelines and the Ti er 1 screening battery, please visit our website . 2 In this Pr oposed In te rim R egistrat i on Review Decision, EPA i s making no human health o r env ir onmental safety findings associate d with the EDSP screen i n g of 4-C P A. Before comp l eting this Registration Review , the Agency will make an EDSP FFDCA section 408(p) determination. COMBINED WORK PLAN, SUMMARY DOCUMENT, AND PROPOSED INTERIM REGISTRATION REVIE W DECISION In a ccordance with 40 CF R Sections 155.50 , 1 55.56, and 155.58 , the Agency is issuing this combined Work Plan , Summary D ocument, and Proposed Interim R eg i stra tion R eview Decision. E xcept for the EDS P component of the 4-CPA r egistrat i o n review case, the Agency has made the following pro p osed interim decisions: ( 1) no additio nal data are required at this time; and (2) no changes to the affected r eg i stratio n s or th e ir labe li ng are needed at this t im e . E PA has not identified a ny ri s ks o f co n cern t o human health. Curre n tly r egis t ere d uses of 4-CP A are not expected to resu l t in adverse effects to listed o r non -li s ted species, or cri tical hab i tat. As such, EPA anticipates making a " no effect " determination under the ESA for all listed species 1 See http: // www.regulations.gov /# !documentDetaii:D - EPA-HQ-OPPT

- 2009-0477-0074 for the final second list of chem i cals. 2 h ttp: // www.epa.gov / endo/ 7and no adverse modification ofdesignated cr itical habitat for such species is expected for all currently registered uses of4-CPA
. NEXT STEPS AND TIMELINE A Federal RegisterNotice will announce the availability ofthis combined Work Plan and Summary Document and ProposedInterim Registration Review Decision for 4

-CPA and allow a 60

-day comment per iod
. Ifthere are no significantcomments oradditional information submitted to the docketduring the commentperiod that leads the Agency to change its decision, EPA may issue an Interim Registration Review Decisionfor 4-CPA (case 2115), in accordance with 40 CFR Sections 155.56 and 155.58. A final decision on the 4-CPA registrationreview case will also occurafter an EDSP FFDCA section 408(p) determination has been made. EPA has created the following estimatedtimeline for the completion of4-CPA

. . registratiOn revtew: Registration Review for 4-CPA- Projected Registration Review Timeline Activities Estimated Date Openingthe Docket and Combined WorkPlan, Summary Document, and Interim Registration ReviewDecision Open Public Docket and Public Comment Period for Combined Wor k 2014- Sept Plan, Summary Document, and Proposed I nterim RegistrationReview Decision ClosePublic CommentPeriod 2014- Nov Interim Registration Review Decision and Begin Post-Decision Follow-up3 2015- January
I Total (years) 0.5 I

3 A final decision on the 4-CPA registration review case, in accordance with 40 CFR Section155. 158, will occur after an EDSP FFDCA section 408(p) determination has been made. 8Appendix- Additional Areas Considered in the 4-CP A Registration Review PUBLIC COMMENTS AND FEEDBACK: Guidance for Commenters: The areas below highlight topics of spec i a l in terest to the Agency where your comments, data submissions, or reference to sources of ad dit iona l informa t ion could be of particular use. Trade Irritants: Through the registration review process, the Agency int ends to solicit information on trade irritants and, to the extent feasible, take s t eps toward facilitating irritan t resolution. The Agency will work to harmonize tolerances and international maximum res i due limits (MRLs) and may modify tolerance l eve l s to do so, when possible. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack ofMRLs o r disparit i es between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern. As desc r ibed above, the U.S. and Canada have different tol erance /MRL l eve l s for 4-CP A on mung bean sprouts based on residue data submitted to the respective pesticide regulatory agencies. EPA is interested to learn of any trade irr itant issues arising from this disparity in levels. Water Quality:

4-CP A is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 4 In addition, no Total Maximum Daily Loads (TMDL) have been developed for 4-CPA. 5 More information on impaired water bodies and TMDLs can be found at the Agency ' s website. 6 The Agency invites submission of water quality data for this pesticide. To the extent possible, data sho uld conform to the quality s t andards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OP P 's Reg i stration Review Risk Assessment and Afanagement Process 7 in order to ensure they can be used quantitatively or qualitatively in pes ticid e r i sk assessments. Environmental Justice: EPA seeks to achieve environmental justice, the fair treatment an d mean i ngful involvement of all people, regardless of race, color , n ational orig i n, or income, in the development , impl ementat ion , and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a resu l t of their location, cultural practices, or o ther factors, may have atypical, unusually high exposure t o 4-CPA compared to the gene r a l population. Please comment if you are aware of any sub-populations that may have atypical , unusually high exposure compared to the general population . 4 http: // iaspub.ep a.g ov / tmd l waters 1 0 / attains nation cy.cause detai l 303d?p cause group i d = 88 5 5 http: // i as p ub.e p a.gov / tmd l waters I 0 / attains nation.tmdl pollutant deta i l?p po ll utant group id = 885&p pollutant grou p name = PESTICIDE S 6 http: // www .epa. g ov / owow / tmd l / 7 http: // www.epa.gov / oppsrrd ! / registration r e view / water qua l i ty sop.htm 9