### UNITED STATES ENVIRONMENT AL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF C H EM I CAL SAFETY AND POLL UT I ON PREV ENT I ON 

### MEMORANDUM DATE: June 4 , 2015 SUBJECT: 1- Naphtha leneacetic acid (NAA): Response to Comments on the HED Human Health Scoping Document. PC Code: 056001 , 056002, 056003 , 056004 , 056007 , DP Barcode: 0427651 056008 Decision No.: 505619 Registration No.: NA Petition No.: NA Regulatory Act i on: Regi s tration Review Risk Assessment Type: Single Chemical Aggregate Case No.: 0379 TXRNo.: NA CAS No.: 86-87-3 (NAA) MRID No.: NA 40 CFR: § 180. 155 

### FROM: Thurston Morton , Senior Chemist 

# (((**~** Abdallah Khasawinah , PhD. , Toxicologist

### ·**('"~** Ivan Nieves, Chemist Risk Assessment Branch IV Health Effects Di vision (7509P) THROUGH: Charles Smith , Branch Chie ....___ __ ---., Risk Assessment Branch IV

---- Health Effects Division (7509P) TO: Lata Venkateshwara , Chemical Review Manager (RM 53) Risk Management and Implementation Branch III Pesticide Re-Evaluation Division (7508P) 

# -

Attached is HED ' s Response to Comment on the hum an health risk assessment scoping document for NAA to support Registration Review. The HED NAA Risk Assessment team has received comments on the Registration Review Scoping Document (EPA Docket ID: EPA-HQ-OPP-2014-0773-0009)
. Comments relevant to HED's scoping document were provided by the Physicians Committee for Responsible Medicine AMVAC.

Page 1of4EPA'S RESPONSE TO COMMENTS FOR NAA I. Introduction 

### The following is EPA's respo n se t o public comments on the human-health assessment scop i ng document in support of Regist ration Rev iew for NAA. Some of the re s pon ses serve as c larifi cation o r a r es tatement of Agency policies and g uidance and it i s hoped th at this will provide a greater und e rstanding of the Age ncy's po s it ion and procedures o n the se matters . Comments concerning the rationa le behind Age ncy decisio ns, to x ic o logy, expos ur e assessment , and in t erp retati on of available data, were sub mitted. II . Comments 8 7 0.3-165 Subchronic inhalation study AMV AC Co mment : 

### AMY AC i s wi lli ng to accep t the additional 1 OX safe ty factor for thi s stu d y guideline data base om1ss 1on. H E D Response : 

### T he Age nc y acknow ledges the acceptance of the additional IOX for the lac k of the subchronic inh alation s tud y. If 

### in the future , the inh alation MO Es are of concern the inhalati on s tud y may be required. Physician s Co mmittee for R es ponsibl e Medicine Co mment: 

### With re s p ect to the s ubchron ic inhal atio n data requirem ent (870.3465), 

### we fo un d th e following data which may fulfill the Age n cy's needs without ad diti onal t est in g, or in a read-across assess ment. " CAS N umb e r 86-87

- 3: > 

### 0.45 

### mg/I ( 1- NAA , wh o le body, rat ) 0 CAS N umb er 61-31-4: 

### > 5.0 

### mg/ l ( 1-N AA

-Na, nose-o nl y, rat) 11 CAS N umb er 86-86

- 2: 

### > 2. 17 

### mg/I (w ho le bod y, rat) 1

1 European Food Safety Authority; Conclusion on the peer review of the pesticide risk asse ss ment of the active s ub s tance 1-naphthylacetic acid. EFSA Journal 20 11 ; 9(2):2019. Web accessed on February 11 , 2 015 at: http: // www.efsa.europa.eu/en/efsajou ma l/do c /20 19.pdf. HED Respon se: 

### The referenced material are ac ute inh alat io n LCs o va lu es and do no t satisfy th e r equi r eme nt for a s ubchronic inh a lation s tudy. The s ub chronic inhal ation study is requ ired
. Howeve r , in another com me nt from AMY AC th ey acce pt th e additi o na l I OX safe t y factor for thi s st udy gu id e lin e dat a base omission.

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### 860.1380 Storag e s tability data (p roc essed commodities of apples or c it rus and olives ) All six NAA compou nd s AMVA C C omm e nt: AMV AC is committing to conduct this study. Because of chemistry considerations , AMY AC intend s to demo n strate that NAA and its salts have a h igh leve l of c h e mi cal stab il ity at ca . -20 ° for a I -yea r period. On this basis , the st udy design w i ll entail fortification of the processe d matrice s at ca. 1 ppm using an eq ual-molar amount ofNAA and its salt s . The acetamide and e th y l es ter will be conducted se parately. Because of the high water so lubility ofNAA and it s sa lt s, there is no likelihood of residues in oils and AMY AC wou ld propose not including stability testing of olive oi l w ith in the program . Othe r w i se, the co mmodities t o be tested for a ll six NAA compounds wou ld incl ude app l e wet pomac e and appl e ju ice . H E D R es pon s e : The Agency look s forwar d to th e sub m itta l of the s torage s t a bili ty data
. A wa iv e r req uest mu s t be su bmitted for th e propo sa l for not conducting the olive oil storage s tability data along with rationale. The Age nc y w i ll rev ie w and utili ze them (if adequate) , during the Regi s tration Re v iew ofNAA.



### 860. 1520 Citrus Processing S tudy (dr i ed pulp , oil andjuice) All six NAA compound'i AMV AC C omm e nt : AMY AC inte nd s to registe r only the pota ss i um salt of naph thale ne acetic ac i d (NAA) fo r us e on citrus. For t h at rea so n , a proc ess ing study on ci trus wou ld o nl y emp loy the u se of this sal t as th e test s ub s tance . On this ba s i s, AMY AC is committing to pe rformin g a citrus process ing study for determining the p ote ntial for r es idue concentration in dried pulp , oil , and juice. We are also requesting waive r s for the citrus processin g s tudi es for NAA, its so dium and ammo n ium salts , the ethyl ester, and the acetarnide. HE D Res pon se: The Agency look s forward to the submitta l of the proce ss in g data for the potassium salt and waiver requests for NAA 's sod iu m and ammon i um sa lt s, the ethyl es t er , a nd th e acetamide. The Agency will review and utili ze them ( if adequate), durin g th e Re g is tration Revi ew ofNAA.

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### 860. 1650 Analyti cal Reference Standards PAI, all six NAA compounds AMV AC Co mment : AMVAC comm it s to fulfilling this requirement. H E D Respon se: Th e Agency looks forward to the submission of the analytica l standards. P lease submit them to the fo ll ow in g address: Analytical s tandard s and all res idu es of co ncern mu s t b e s ubmi tted and rep le nished as requested by the EPA Pes ticide Repository. The analytical reference stan dards must be sent to the Ana l ytical C hemi stry Lab , which is located at Fort Meade. Send them to the attention of e ith er The resa Co le or Thuy Ngygen at the following address: USE P A Na tional Pe s ticide Standards Repositor y / Analytical Chemistry Branch/OPP 70 I Mape s Road Fort George G. Meade , MD 20755

- 5350 The exte nd ed zi p code mu st be used or the mail will be returned.

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