Docket Number EPA-HQ-OPP-2014

- 0544 www.regulations.gov



## 4-Chlorophenoxyacetic Acid (4

- CPA) Interim Registration Review Decision Case Number 2115 December 2014

Approved b y :



### cu..,tL...P **4->** Ri chard P. Keigwin, Jr. Director Pesti c ide Re-evaluation Division

### 4-CPA -Table of Contents Introduction 3 

### Statutory and Regulatory Authority 4 

### 4-CPA Chemical Facts 4 

### Us e and Usage Information 

### 5 Recent Actions 5 

### Scientific Assessments 

### 5 Interim Registrat io n R ev iew Decision 

### 8 Ne xt Steps 8


### References: This document summarizes the Environmental Protecti on Agency's current position based on the following document s: 1
. EFED Preliminary Risk Assessment to Classify Registered 4-CP A Uses as De Minimus Risk to Listed/Non Listed Species and "No Effects " Determination. Edward Odenkirchen, Ph.D., Senior Science Advisor. June 5, 2014. 

### 2
. 4-Chlorophenoxyacetic Acid. Human Health Risk Assessment in Support of Registration Review. ldeliz Negr6n-Encarnaci6n, Ana Rivera-Lupianez, Seyed Tadayon, Ronnie J Bever Jr ., Ph.D. Ju ly 1 7 ,2 014. · 3. BEAD Chemical Profilefor Registration Review : 4-CPA and Salts (01040 1 ). Sunil Ratnayake, Sepehr Had dad , and Derek Berwald. May 3, 2012. 4
. 4

- Chlorophenoxyac etic Acid , and Salts: Tier I Review of Human In cidents. S hanna Recore, Elizabeth Evans. June 26, 2014.
These and other supporting documents for the 4-CPA reg i stration review case may be found in th e docket EPA

- HQ-OPP-2014-0544 at http://w. ¥W .regulations.gov.

2I. INTRODUCTION This document is the Environmental Protec t ion Agency's (EPA or the Age n cy) Interim Registration R eview D ecis ion fo r 4

- chlorophenoxyacetic acid (4-CPA) , pur s uan t to 40 CFR 

### § 155.56 and § 155 .58
. A registration review decision

**~s** the Agency's determination that a pesticide meets, or doe s not mee t, the standard for regist r ation in the Federal Insecticide , Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it deems appropriate, an interim registration review decisi on before completing a registration rev iew. Among other things, the interim registrat ion review decision may ( 1) require new risk mitigation measures; (2) impose interim risk mi tigation measures; (3) identify data or information required to complete the review; and (4) include schedules for submitting the required data , conducting the new risk assessme nt, and complet ing the registration re view. FIFRA, as amen de d by the Food Quality Protection Act (FQPA) of 1 996, mandated the continuo us re v iew of existing pesticides. A ll pe sticides distributed or so ld in the United States generally must be regi stered by EPA, based on scientific data showing that they will not cause unreasonab le ri sks to human health or the environment wh en used as directed on product labe li ng. The registratio n review program i s intended to make sure that , as the ability to assess and reduce risk evolves and as pol ic ie s and practices change, all registered pesticides continue to meet the statutory standard of n o unreasonable adverse effect to human health or the environment. Through the registration review program , the Agency p eriod i call y reevaluates pesticides to make sure that as these chang es occur, pr<:>ducts in the marketplace can be safely used. Information on this program is provided at: http: //www.epa . gov/ oppsrrd 1 /registration review/
. In 2006, the Agency implemented the Registration Review program pursuant to FIFRA Sectio n 3(g) and will review each re gistered pesticide every 15 years to determine wheth er it continues to meet the FIFRA sta ndard for registration
. The pe sticide 4-CPA is a plant growth regulator registered for use exclusively as a soaki n g ag ent for mung bean sprouts in greenhouse operat ions to prevent root formation whi ch improves the sorting a nd hand ling of the mun g bean spro uts for packag in g. All of the use occurs indoors. 4-CPA i s app li ed in a dil ute solution of 2 to 3 mg/L of active ingredient to a water bath to soak batches of about 3500 pounds of beans. Once the beans ha ve soaked for se veral hours , they are washed to re m ove the surface residues , and are then germinated indoors for sev eral days. After sprouting , the hulls and roots are di scarded , and the remaining portion is packaged and sold fo r human consumption. EPA completed the Reregistration Eligibility Decision (RED) for 4

- CPA in March 1997 and re assessed 4-CPA to leran ces in the 2003 Tole rance Reassessment Progr ess and Ri sk Management Decision. EPA fo rmally initiated reg i stration review for 4 -CPA in 20 14, with the posting of the 4- CP A Combined Work Plan , Summa ry Document, and Proposed Interim Registration Review De c i sion on Septemb er 24 , 2014 for a 60-day comment per i od. EPA received comments from the Center for Biological Diversity , which agreed with the Agency's finding regarding en d angered and threate ned (listed) spec ies. EPA also so licited comments on th e spec ific topics of environmental just i ce, water quality concerns, and trade irritants , but no comments or information were received on those issues.



### 3For further information o n the registration review of 4-CPA, see EPA 's public docket (EP A-HQOPP-2014-0544) at www.regulations
. gov. STATUTORY AND REGULATORY AUTHORITY The Food Quality Protect ion Act (FQPA) of 1996 mandated a re g i stration review program. All pesticide s d i st ribute d or sold in the U.S. generally must be regi stered by EPA, based on scientific data show ing that the y w ill not cause unreasonable ri sks to human health or the environment whe n u s ed as d irected on product labe ling. The regi stra ti on review program is inte nded to make sure th at, as the ability to assess ri s k evolves and as polici es and practices change, all registered pesticides continue to meet th e statutory standard of no unreasonable adverse effects to human health or the environmen t. Chan ges in science , public po licy , and pesticide use practices will occur over time. Throu gh the registration revi ew program, the Agency periodically r ee valuates pesticides to make sure that as change occurs , products in the marketplace can be u sed safely. Information on thi s program is provided at www.e pa.go v/oppsrrd 1 /registration review /
. The Agency is implementing the registrati o n rev iew program pur suant to Section 3 (g) of FIFRA, and will re v iew eac h registered pe sticid e every 15 years to dete rmine whether it continu es to meet the FIFRA standard for registratio n. The regulation s gove rning registration review begin at 40 CF R 1 55.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registrati o n review beg ins when th e initia l docket is opened for each case. The docket is the Agency 's opportunity to state what it knows about the pes ticide and what additio nal ri sk analyses and data or information it believes are needed to ma k e a registration review decision
. 4-CPA CHEMICAL FACTS

PC code 019401 Case Number 2115 CAS Number 122

- 83

- 3 Year first re g i stered 1969 Pesticide Type Conventiona l C hem ical Che mical class Phenoxy Rere g is tration Eligib ili ty March 1, 1997 Decision (RED ) Tolerance Reas sess m en t April 4 , 2003 E li gib ilit y Decision (TRED) Cumula tive Group EPA h as not made a common mechanism of toxicity find i ng as to 4-CP A and any other substance s, .and 4-CP A does not appear to produce a toxic m eta bolite produced by other substances. 40 CFR Citation To lerances are establi s hed in the 40 CFR 

### § 180. 2 02 for residues of 4-CPA in or o n mung bean spro uts at 0.2 ppm . No n-pesticidal uses No non-pes ticidal uses of 4-CP A Pesticide Re-evaluation Migue l Zavala , zavala. miguel @ epa.gov, 703

- 347 -0504 Division, Chemical Rev iew Manager 4Registration Division , Product Mana er T ony Ki sh , kish.tony @ epa.gov, 703-308-9443

USE AND USAGE INFORMATION 4-CPA is r egistered fo r use in the food indu st ry as a plant g rowt h regulator to restrict root growt h during seed germinat ion of mung beans. Below is a summary o f the u se/usage of 4

- CP A. For more details please see BEAD Chemical Profile for Registration R eview: 4

- CPA and Salts (0 10401 ), May 3 , 2012.

Summa ry of Us e 4-CP A is applied to a water bath to soak mung beans. The beans soak for several hours, ar e washed, and then germi nate d indoor s for several day s. After spro uting, the hull s and r oo ts are dis carded, and the remaining portion is p ackaged and so ld for hu man consumption. Use Sites Indo o r uses. S ummary of Usage 10-20 lbs ac tive ing red ient are used annuall y nationwi d e Formulation Type(s) Amorphous powder Technical Registrant( s) ConAgra Foods No. of Reg is trations 1 Restricted Use No I RECENT ACTIONS 

## I
There are no recent actions for 4

- C PA. SCIENTIFIC ASSESSMENTS A summary of th e Agency's human health and env ironmental fate a nd ecologica l ri s k assessments , 4-Chloroph e noxya c etic Acid. Human Health Risk Assessment in Support of Registration R e vie w (Jul y 17 , 20 14) and EFED Preliminary RiskAssessment to Classify Registered 4

- CP A Uses as De Min imus Risk to Listed/Non Listed Species and " No Effec t s " Determination. (.June 5 , 20 14) is presented below
. For the detailed risk assessments , se e the 4- CPA pub lic docket (EP A-H Q-OPP-2014-0544) at www.regulation s.gov . Human Health Assessment Haza rd Characte rization and Risk The toxicolo gical database is considered adequate for characteri z in g haza rd and as sess ing ri sk from 4-CPA. No addi ti o nal studies are anticipated to be needed for r egis tration re view. Die tary Exposure Asse ss ment A c hronic d ietary (foo d o nl y) exposure and ri sk assessment was co nducted using to lerance-level re s id u e values fo r mung bean and assuming 1 00% of crop t re ated
. Drinking water is not an anticipated exposure pathway, as ap plication o f 4 -CP A occurs indoor s and the use is limited
. The chronic di et ary risk for 4

- CPA was be low the Age n cy's leve l of concern for the general population and a ll popu l ation subgroup s. 5Food Tolerances A tolerance of 0.2 ppm is established in the 40 CFR § 180.202 for residues of 4-CPA in/on bean, mung, sprouts. The tolerance expression currently includes measurement of residues of parent 4-CPA and its metabolite 4-chlorophenol. The Agency has completed an evaluation of the estab li shed tolerance and determined that the tolerance expression needs to be modified in accordance with current Agency policy for writing tolerance expressions and to exclude measurement of the meta bo li te 4-chlorophenol because it is no longer considered a metabolite of risk concern. Canada has estab lished a maximum residue limit (MRL) of2 ppm for residues of 4-CPA in or on mung beans
. EPA's 0.2 ppm tolerance is based on updated residue data that has not been submitted to Canada. We did no t receive any comments on this disparity in MRLs and there are no trade barriers to U.S. growers. For more information please refer to 4-Ch/orophenoxyacetic Acid. Human Health Risk A ssessment in Support of Registration Review (Ju ly 17, 2014)
. Res idential and Occ upational E x

posure A residential hand ler and post-a pplication expo s ure assessment is not needed for registration review becau se there are no registered residential uses of 4

- CP A. For occupational use , the Agency believe s that the potential for exposure to 4

- C PA during pesticide handling operations exists, but is very low. Based on a conservative quantitative assessment of occupational handler exposure and risk, no ri sks of concern were identified. Occupational postapplication exposure was not quantitatively assessed. However, based on 4-CPA's use pattern and low exposure potent i al , the occupational handler assessment is expected to be protective of potential worker post-ap p lication exposure. Environmental Assessment EPA conducted a qualitative environmental fate and effects assessment for 4 -CPA and has determined that effe c ts to non -target species are unlikely. EPA considered potential 4-CPA exposure to non-target o rganisms, available information on the toxic ity of 4-CPA from ecological structure act ivity relationships, and annual usage information. Spent mun g bean soaking solution can be disposed of down mun icipal wastewater drains and represents a complete exposure pathway to downstream receiving waters. Ho wever , there is a low likelihood for significant toxicity to aquatic organisms , the taxa most likely to be exposed via a wastewater discharge scenario , bas ed on predictions from ecol o gical structure acti v ity relationships. 

### In addition , the 20 pound s of 4-C PA used annually is expected to be geographically disperse and greatly diluted before reaching receiving waters. Threatened and Endange red Species Based on the type and exte n t of use, the low expecte d toxic ity predicted by quantitative structure activity relationships , and the highly diffuse nature of the use site coup led with extremely low annual usage , the Agency concludes that effects on the environment are not reasonably expected to occur from the registered use of 4-CPA. Therefore , the EPA is making a " no effects" determination under the Endangered Species Act (ESA) for all listed species and no adverse modification of designated critical habitat for such species from the registered use of 4-CPA.

6Endocrine Disruptor Screening Program As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Co ll ectively , 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 eco l ogical hazard assessments, EPA evaluates acute tests and chronic stud ies t hat assess growth , develo pmental and reproductive effects in different taxonomic groups. As part of its most recent regist ration deci sio n for 4-CPA, EPA reviewed these data and s elected the most sensitive endpoints for relevant risk assessment scenar ios from the existing hazard database
. However , as required by FFDCA section 408(p), 4

-CP A is subject to the endocrine screening part of the Endocrine Disrupter Screening Program (EDSP). EPA has developed the EDSP to determine whether certain substances (including active pesticides and other ingredients) may have an effect in humans or w ildlife simi lar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDS P employs a two-tiered approach to making the statuto ril y required determinations. Tier I consists of a battery of 11 scree ning assays to identi fy 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 I screening and are found 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 ident ify any adverse endocrine-related effects caused by the substance, and establish a dose-respons e 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 February 20 I 0, EPA issued te st order s/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredient s and 9 inert ingredients. A second list of chemicals identified for EDS P screening was publi s hed on June 14, 2013 1 and includes some pesticides scheduled for Registration Review and chemicals found in water. For further information on the status of the EDSP, the polici es and procedures, the li sts of chemicals, future lists , the test guidelines a nd the Tier l screening bat tery , please visit our website. 2 In this Interim Registration Review Decision, EPA is making no human health or environmenta l safety findings associated with the EDS P screening of 4-CPA. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

1 See http: //www.regulations.gov /# !documentDetaii;D= EPA-HQ-OPPT-2009-0 477- 0074 for the final second list of chem icals
. 2 http: //www.epa.gov/ endo/ 7INTERIM REGISTRA T ION REVIEW DECISION In accordance with 40 CFR Sect i ons 155.50, 155 .56, and 155.58 , the Age n cy is issuing this Interim Re g i st ration Re v iew Dec ision. Except for the EDSP component of the 4-CP A registration review case, the Agency has made the following interim decision : (I) no additional data are required at thi s time; and (2) no changes to the affected registrations or their lab eling are needed at thi s time. EPA has not ide ntified any ri sks of co ncern to human health. C urrently registered uses of 4 -CPA are not exp ected to resu lt in adverse effects to li sted or non-listed species, or critical habitat. As such, EP A concludes "no effect" for all listed species and no adverse modification of designated critical habitat for such species for all c ur rently registered uses of 4-CP A. NEXT STEPS EPA wi ll make a final reg istration review decision for 4-CP A after an E DSP FFDCA section 408(p) determination has been made
.

8