July 21 , 2015 UN I TED S TATES EN V IR O NMENTA L PROTECTION AGENCY WASHINGTON , D .C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM SUBJECT: P C Code. 84400 I ; Acetic Acid; Human H ealth Risk Assessment and Ecological Effects Assess men t to Support Proposed Exemption from the Require ment of a Tolerance Wh e n Use d as an In ert In gred ie nt in Pesticide Formulations.


### All P C Code: 844001 

### DP Barcode: Deci sio n No.: Regulatory Acti o n : Inert Tolerance Exemption: 40 CFR 180.940 (b) 

### Petition No: lN -1 0766 

### All CAS No: 64-19-7
Inert Trackin g No: N/A



### FROM:

Throu gh:



### TO : Lisa Austin, Ph.D. , Toxicol og ist 

# L

**rA ~**  Chemistry, Jnert s and Toxic o logy Asse ss ment Branch (C ITAB) Registration Division (7505P) Kerry Leifer , Team Leader Chemistry, lnert s and Toxico R

eg istration Divi s ion (7505P) PV Shah, Ph.D
.. Branch Ch ief Chemistry , Inert s and Toxicology Assessment Branch (C IT AB) R eg istration Di vi s ion (7505P)EXECUTIVE SUMMARY The EPA (Agency) received a petition (IN -1 0766) from Technology Sciences Group, fn c., (1 150 18 1 h Street, S uite 1000 Washington, DC 20036) on behalf of West Agro, In c . (11100 Nort h Congress Avenue. Kansas Ci ty, MO 64153) requesting that the Agency amend a tolerance exemption for usc of acetic acid (CAS Reg No. 64-19-7) as an inert ingredient to include use as an active ingredient promoter on dairy and food-process in g equipment and utensils under 40 C FR Part 180.940(b)(c) limit ed to 1200 ppm in end-use co nc entration. This request seeks to increase the current lim i t from 686 ppm t o 1200 ppm for acetic acid under 40 CFR Part 180.940(b). Acetic acid is currently approved as an inert ingredient under 40 CFR Part 180.940(a) (limited to 290 ppm); l8 0.940(c) (limited to 686 ppm); 180.910 (no limitation); and 180.930 (l imit ed to 0.5% of pesticide formulations). A lso , it has an exemption f rom tolerance when used as a biochemical pesticide post-harvest on g rain s and hays for animal feed (40 CFR 180.1258(a)) and w hen used as an herbicide. unintentional residues of acetic acid in non-target plants are also exempt from the requirement of a tolerance (40 CFR 180.1258(b)). lt is approved as an active ingredient for use on rights of ways, go lf courses, open spaces, driveways and indu strial s ite s at co nc entrations similar to that in vinegar to desiccate (d ry out) plants. Further , it i s co n sidered Generally Recog ni zed as Safe (G RA S) by the F ood and Dru g Administration. EPA publ i shed the notice of filing for this petition in the Federal Register on March 4 , 2015 (80 FR 11611 ). No substantial comments were received in response to thi s notice.
In December 20 14 , the Agency iss ued a " Propos ed Interim Registration Review Decision·· for acetic acid. This document determined th at previous health assessments f or acetic acid were sufficient for registrati on review and no human health risks of concern were identified. Since. new data were not submitted for acetic acid , this deci s ion document r e li es on the previous assessments conducted by the Agency. These assessments were included in the subm itter's petition and were cited as such. They include: Acetic Acid and Sa lt s Summary Document Registration Review (2007) and the American Chemical Council (ACC) Acetic Acid and Acetate Panels High Production Volume (HPV) Challenge Program (2001). Ace tic acid is of lo w acute dermal and inhalation toxicity in rats. The acute dermal LD so was ::: 1.060 mg!kg and the acute inhalation LC so was :::11.4 mg/L (equivalent to 2956 mg!kg). Dermal irritation was observed at > I 00 mg/kg in mice and was corrosive at > 60% in rabbits. 

### It was also irritatin g in the eyes of rabbits. A 90-day oral toxicity study was available in rats admin istered acetic aci d in drinking water. A lth ough reduced body we ight was observed at 390 mg/kg/day, the reduction in weight gai n was likely attributed to reduced appetite and food cons umpti on observed in the study. Therefore , this was no t considered adverse effect. Rat s treated for 8 month s w ith 60 mg/kg bw / treatment (the only dose tested) of acetic acid (3 times/ week) via gavage. exhibited hyperplasia in the esophagus and forestomach but did not have tumors. Several de velop mental toxicity studies we r e available with acetic ac id. Fetal susceptibili ty was not observed in any of the stud ies. In rats, mic e and rabbits maternal and developmental toxicity was not observed up to 1600 mg/kg/day. Reproduction toxicity studies were not available with acetic acid. 2Tumors were not observed in rats treated for 8 months w ith 60 mg/ kg bw/ treatment of acetic ac id in d rinki ng water. Aceti c acid was not mutagenic in an Ames test nor was it clastogenic in a cytogenetic assay w i th Chinese hamster ovary K I cells. In a toxicity study via the inhalation rou t e of exposure , toxicity was manifested as decreased activity , behavioral changes and r educe d wo rk capacity following 22 days of treatment wi th 

### 15 ppm (equivalent to I 0 mg/k g/day) of acet ic acid in rat s and mice. The NOAEL vvas 11 ppm (equ i va lent to 7 mglkg/day). Neu rotoxicity stud i es for acet ic acid we r e not ava il ab le fo r r ev iew . Howeve r , ev idenc e of ne urotoxicity was not observed in the subm itte d studi es . Immunotoxicity studies for acetic acid were not available for review. Ho wever, increased sp lee n weig ht was o b ser ved at 23

- 3 1 ppm (e quivalent t o 

### 15 -19 mg/kg/ day) of ace ti c ac id in a toxicity s tud y in ra ts v ia th e inhalation route of exposure. However , th ese effects are not due to an immunotoxic response but due to red blood ce ll de s truction. The refore, there is no concern for potential immunotoxicity. ln addition , according to the American Co nferenc e of Governmenta l In dustrial Hygenis ts, In c. (ACG l H), the threshold limit val ue (TLV) for occ up ational ex pos ure to acet i c acid i s I 0 ppm via inh a lat ion
. Ba se d o n the req uested u se pattern , occupational inh a lat ion exposur e i s not expected. With regard to residential uses , inhalation exposure to acetic acid would be far less th an the estab li shed TL V and is therefore not of concern. Ace ti c acid undergoes dissociation to th e acetate an ion and th e 1 1 + cat ion s in aqueo u s media at pHs commonly found in the environment. A lso , it i s a naturally-occurring subs tance in p lants and animals. In aerobic metabolism , acetic acid (as ace tate) is a metabol ite that combines with Co-enzy me A to form acetyl Co-A which subsequ ent l y enters into the C itric Ac id Cyc le, a common metab o li c pathway in which food mo lec ul es a r e broken down to fonn e nergy. A major function ofthe Ci tri c Ac id Cyc le is the oxidat ion of acetate. In animals. acetate is obtai ned from the breakdown of glucose molecules. Based o n the widespread pr ese nce of ace tic ac id in human f oods, the fact th at it i s a normal metabolite in humans and animals , it s statu s as a s ub stance that is considere d Generally Reco g nized as Safe ( GRAS ) by the Food and Drug Administration , no toxicological endpoi n t of concern , its regulatory hi story and no new toxicologica l data to indicate concern r egar ding previous d ec isions a qua li tati ve assessme nt was appropriate of all pathways of human exposu r e (food , drinking water , and resident ia l )
. Occupatio na l exposure was qualitatively assessed based o n the re gulato ry hi story of acet ic acid and no new toxicological data to indicate concern regarding previous deci s ion s. Acet ic acid i s not expected t o be toxic to aquatic organisms, terre s trial m amma ls and birds. It does not persi st in the enviro n me n t.
3Taking into consideration all available infom1ation on acetic acid. EPA concludes that there is a reasonable certainty that no harm will result to the gene ral population or to infants and children from agg regate exposure to acetic ac id
. Therefo re, th e amendment of an exemptio n from to lerance under 40 CFR 1 80.940(b) and (c)for residues of acetic ac id as an inert in gredient in pesticide formulations used on dairy and food

- processing equipment and utensils to allow for a limitation of 1200 ppm in th e end

- product formulation can be considered safe under section 408 of the FFDCA.
1. BACKGROUND The EPA re ce ived a p etiti o n (IN-I 0766) f r om TechJ1ology Sciences Group, In c., (1150 18 111 Street. Suite 1000 Washington , DC 20036) on behalf of West Agro , Inc. ( 11100 North Cong ress Avenue, Kansas City , MO 64153) requesting a tolerance exemption for the use of acetic acid (CAS Reg No
. 64-19-7) as an inert ingredient to include use as an active in gredient promoter on dairy and food-p rocess ing equ ipm e nt and utensils under 40 CFR Part 180
. 940(b) an d (c) limited to 1200 ppm in end- u se concentration. This request seeks to incr ease the current limit from 686 ppm to 1200 ppm for acetic acid under 40 CFR Part 180. 940(b). EPA published the notice of filing for this petition in the Federal Register on March 4. 2015 (80 FR 11611). o substantial comments were received in response to this notice. Acetic acid is cu rrent ly approved as an inert ingredient under 40 CFR Part 180.940(a), limited to 290 ppm and 180.910 and 180.930. limited to 0.5%. It has an exemption from tolerance when used post-harvest on grains and hays (40 CFR 180.1258(a)) and unintentional residues of acetic ac id in non-target plants as a result of it s herbicid al use are a lso exempt from the requirement of a tolerance (40 CFR 1 80.1258(b)). It is approved as an active ingredient for use on rights of ways, golf courses , open spaces , driveways and industrial sites at concentrations similar to that in vinegar to desiccate (dry out) plants. 

### Jt is considered Generally Recognized as Safe (GRAS) by the Food and Drug Administration. Further, acetic acid can be found in num ero u s consumer p roducts at co ncent rat ions of 3-8%. This document provides an assessment of the risk to human health and the environment for acetic acid when used as an inert ingredient in in pesticide formulations used on dairy and foodprocessing equipment and ute n sils at 1200 ppm . Information from the s ubmitter's pet i tion is reproduced and refe r e nced in this assessment. They include EPA documents (2008. 20 I 0) , American Chemical Council (ACC) Acetic Acid and Acetate Panels Hi gh Production Volume (HPV) Challenge Pro gram (2001a and b). The Agency"s most recent document on acetic acid was also reprodu ced in this assessment (Pr oposed Interim Registration Review Decision). 2 . Inert Ingredient Profile Some of the physical and chemical characteristics of acetic acid along with its structure and nomenclature , are found in Table 1
. Tabl e 1. Ph ys ical and C he mical Pro pe rtie s of Ace tic A cid 4

### Parameter Value So urce 0 Structure 

# A OH

CAS # 64 -19-7 Molecu lar Wei g ht { g/mol) 60.05 Common N am es Acetic Acid

Physical State Liquid MRID 49 160501 Melting P o int ( 0 C) 16.7 Boilin?, Po int ( 0 C) 118.1 pH @.) 0 ° C 2.5 for 50 giL solution Vapor Pr essure ( mm Hg @ 11.4

20 ° C) Partition Coefficient (Log Kow) -0.17 W ater So lubili ty ( g/L at 23 ° C) 50


### 3. Hazard Assessme nt T h e following studies were rep roduc e d a nd refe re n ced f rom th e petition subm itted by the registrant , EPA docume nt , Acet ic Ac id and Sa lt s Summary D ocume nt Reg i strati on Review (2007 ) and American Chemical Co uncil (ACC) Acet ic Acid and Acetat e Panel s Hi gh Production Volume ( HPV ) C hallenge Pr og r a m (200 1 ).


### Ac ute Toxicity St udie s

Tabl e 2 Acute Toxicity Pro fil e o f Acetic Acid Guideline No. Stud y T y pe Resu l ts 870.1000 Ac ute - Oral-rat s LD50> 3. 3 10 mglkg 870
. 1000 Acute -Oral -m icc LD50 > 4.960 mg/ kg 870.1100 Acute -D em1a l-rat s LD50 > 1.060 mg/ kg 870.1 1 00 Acute -D em1al-mice > I00 mglkg in mice produced irrit ati o n 8 7 0.1200 Acute -Inh alation-rats LC 50 > 11.4 mg/ L( cquivalent to 29 5 6 m glkg) 870.2400 Acute-Eye Irrit ati on - Irrit ati n g rabbits 870 .2 500 Acute -D ermal Corro s iv e at > 60 % I rri tation-rabbit s 5

### Repeated Do se Toxicitv s tudie s 90-Dav oral

- Drinking Water-Rat A 90-day feeding study in rats was conducte d with acetic acid
. Rat s administered up to 390 mg acetic acid / kg/day in drinking water for 2 to 4 months had a LOAEL of 390 mg/ kg/day (based o n weight l oss) and a NOAEL of 195 mg/kg/day. ( Hum me l, S
.. 2/28/07. 0344771 )
. The reduction in weight gain was likely attributed to reduced appetite and food consumption observed in the study. Therefor e , this effec t was not considered adver se and the NOAEL is 390 mglkg/ da y . 

### Developmenta l Toxicitv Study- Rabbit
In a developmental toxicity study in albino Wistar rats, mated female rats were admini stered acetic ac id (5%) via gavage at 0 , 16 , 74,345 and 1600 mg/ kg/ day on ges tation days 6-16
. On day 20 , Caesarean sections were performed. The number of implantation s ites. reso rption sites and li ve and dead fetuses were similar to the controls. Neither maternal nor fetal treatment related effects were observed up to 1600 mg/ kg/ day, the highest dose tested (HPV, 2001). In a developmental toxicity st udy in CO-l mice , mated female mice were administered acetic acid (5%) via gavage at 0 , 16 , 74. 345 and 1 600 mglkg/ day on gestation days 6-16. On day 17. Caesarean section s were perf01med. The number of implantation sites , resorption.sites and live and dead fetuses were similar to the controls. Neither maternal nor fetal treatment re lated effects were observed up to 1600 mg/kg/ day, the hi g hest dose t ested (HPV. 200 I). In a developmental toxicit y s tudy in Dutch-belted rabbits , artificially inseminated female rabbits were administered acetic acid (5%) via gavage at 0, 16 , 74 , 345 and 1600 mg/ kg/day on gestation days 6-19. On day 29, Caesarean sec tions were performed. The number of corpora lutea , implantation si tes, resorption sites and live and dead fetuses were similar to the control s . Neither maternal nor fetal treatment related effects we re observed up to 1600 m g/ k g/ day, the highe s t dose tested (HPV, 2001).


### 8-Month-Oral Toxicitv/Carcinogenicity S tudv-Rat In an 8

- month oral toxicity study in rats , the carcinogenic potential of acetic ac id was eval u ated
. In thi s s tudy , nin e outbred white male rat s were administered 0.5m l of 3% water so luti on of acetic ac id (equivalent to 60 mg/kg/treatment) vi a gavage three times per week for eight months. R ats were given N -nitrososarcosine ethyl ester (NSEE; a known carcinogen) alone and NSEE with an acetic acid solution, or the acetic acid solution alone. Rats treated with the carcinogen and NSEE had high in cidences of pre-neop l astic lesion s in the esophagus and forestomach as well as benign tumors, carcinomas and squamous cell cancer. Rats treated w ith acetic acid and NSEE had an increase in the number of benign and malignant tumors and
6carcin omas in the esophagus. Rats treated with acetic acid a lone had hyperplasia in the eso phag u s and forestomach but did not have tumors ( HPV , 2001).


### Ge n ot o xici tv S tudi es In a bacterial reverse mutati on assay 

### Salmonella typhimurium strai n s T A 98 , T A I 00 , T A 1535, TA 97 and TA 1537 were treated wi th acetic acid at conce ntrations of 100 , 333 , 1000 3333, 6666 and 10,000 !lg/plat e with and without m e tabolic activation. No revertant colonies were observed (HPV , 2001). In a cytogenetic assay, Chinese ham s te r ovary K I cells were treated with acetic ac id at concentrations up to l6mM. Acetic acid was not clastogenic ( HPV , 2001).


### Inh a l a ti o n T ox ic ity S tud v Rat s a nd mice were treated with 11-1 5 ppm (equ iva lent to7- 10 m g/ kg/day) of acet ic acid via the inhalation route of exposure for 3-35 days. Groups of I 0 rats and mice (sex unknown) were exposed to 15 ppm (e quivalent tolO mg/k g/ day) of ace tic acid for 22 da ys or more ex hibited decreased act ivity, behavioral changes and reduced work capacity. At 23

- 3 1 ppm (eq u ivalent to 15-19 mg/kg/day) , animals exhibited growth, increased spleen we i g ht. a n increase of the level of iron stored in the sp lee n , signs of kidney damage and increased kidn ey weights. The LOAEL was 

### 15 ppm (equivalent tolO m g/ k g/ day) based on decreased ac tivity , b e havioral c h ange s and reduced work capacity. The NOAEL wa s II ppm (equ ival ent to7 m g/kg/day) ( HP V. 2001).
Me tab o li s m Acet i c ac id und e rgoes di ssoc iation to th e acetate a nion and the H + cations in aq ueo u s m ed ia at pHs commonly found in the e n v ironment. A l so , it is a natur a ll y - occurring substance in p la nt s and animals. In aerobic m e tab o li s m , acetic acid (as ace tate ) is a metab o lite that comb ine s with Co

- enzyme A to form acetyl Co-A wh ich subsequ e ntl y e nte rs into the Citric Acid Cycle, a common m e tabolic pathway in which food molecules are broken down to form e n ergy . A major fu nction of the Citri c Acid Cyc le is the oxidat ion of ace tate. In animals. ace tate is ob tained fro m the breakdown of gl u cose molecules.

T ab le 3. To x ico l ogy Profil e f o r Acetic Acid S tud y T y p e D oses R es ul ts 3-35 Day - inhalation -rat 11- 3 5 ppm ( equivalent to 7

- The OAEL = I I ppm ( 7 mg/ kg/ day) 23 mglkg/ day) Th e LOJ\EL = 15 ppm (equiv a le nt to I 0 m g/kg/ day) ba s ed on d ecrease d activity , behavioral c hanges an d reduced work capacity. 7T a bl e 3. Toxico logy Pr o fil e fo r Acetic Acid Stu dy T yp e Doses R es ults 90 day oral

- F344 rats- 195 a nd 390 mg/kg/day NOA EL = 390 mg/kg/day drinking water LOAEL was not established.8-Month60 m g/kg/ treatment The NOAEL was not established. Oral/ Ca rcinogenicity Toxicity Study-Rat-gavage LOAEL = 60 mg/kg/treatment based on hyperplasia in the (equi valent to96 days) esophagus and forestomach. No tumors were observed. Deve lopme nta l toxicity-rat 0. 16, 74. 345 and 1600 The NOAEL = 1600 mglkg/ day. mglkg bw / day The LOAEL was not established. Deve lopme nt a l toxicity- 0, 16, 74 , 345 and 1600 Th e NOAE L = 1600 mg/kg/ day. mou se rnglkg/day The LOAEL was not established. Deve lopme nta l toxicity- 0, 16 , 74 , 345 and 1600 Th e NOAEL = 1 600 mg/kg/day. rabbit mglkg/ day The LOAEL was not established. Ames assay I00. 333, I 000 3333, 6666 Negative and I0,000 !Jg/plate Cytogenetic assay :;: 16mM Negative



### 5. T o xici ty E ndp o int Selecti on B ased o n the widespread presence of acetic acid in human food s, th e fact that it i s a normal metabolite in humans and ani m a l s, its status as a subs tance that is considered Generally Recognized as Safe (GRAS) by th e Food and Dru g Administration, no toxicological e ndp o int of co nc ern, it s reg ulatory hi story and no n ew toxicol og ical data t o ind icate co nc ern regardin g prev ious decisions a qualitative assessment was appropriate of all pathways of human exposure (foo d , drinking water, and residential).


### 6. S p ecial C on s id er at ion s fo r I nfant s a nd C hildren
As part of its qua lit at ive assessme nt , the Age n cy d id not use safety facto r s for assessing risk , and no add itional safety factor is needed for assessing risk to infants and children. Based on the lack of toxicity of acetic acid in th e available s tudi es a nd its c he mical propertie s, EPA ha s concluded that th ere are no to xico logic a l en dpoint s of concern for the U.S
. population , includin g infants and childr en. 8

### 7. Exposure Assessment Di etary Exposure In evaluating dietary exposure to acetic acid. EPA considered exposure under the petitioned for exemptions from the requirement of a tolerance. Since no endpoint of concern was identified for the acute and chronic dietary exposure assessment and short and intermediate dermal and inhalation expos ure, a quantitat ive risk assessment for acetic acid is not necessary. Cancer. Acetic acid is not expected to be carcinogenic since there was no evidence of carc inogenic ity in an o r al toxicity study in rats and there was a negativ e re spo n se for mutagenicity. Since the Agency has not identified any concerns for carcinogenicity relating to acetic acid a cancer dietary exposure assessment was not performed.


### 8. Re s id enti a l (No n -Occ up a ti o nal) Exposure/Risk C haracteriz a tion Acetic acid ma y be used in pesticide and nonpesticide products that may be u sed around the home. It is registered as a 6% active ingredient liquid formulation for consumer use as a home garden non-selective herbicide in non-food crop areas. Also , the homeowner use p roduct contains 6% acet ic acid, which is approximately the same concentration as household vinegar. Therefore , based on the w idespread pre se nc e of acetic acid in human foods , the fact that it is a normal metabolite in humans and animals , its status as a substance that is considered Generally Recognized as Safe (GRAS) by the Food and Dru g Administration, no toxicological endpoint of concern, its r egu latory hi s to ry a nd no new toxicological data to indicat e concern regarding previous decisions a qua litative assessment was conducted for residential exposure. 

### 9. Occupational Exposure/Risk Pathw ay The Agency believes that increasing the limit from 686 ppm to 1200 ppm for acetic acid under 40 CFR Part 180.940(b) and (c) wil l not significantly / measurably increase occupational exposure. In view of the regu latory history of acet ic acid, i.e. , approved use Lmder 40 CFR 

### § 180.940 (a) , 

### § 180.910 and 

### § 18 0.930 and no new toxicological information to indicate otherwise , it is not necessary to quantitatively assess occupational exposure . 

### 10. C umulative Ex po s ure : Section 408(b)(2)(D)(v) ofFFDCA requires that when considering whether to establish. modify , or revoke a tolerance. the EPA consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Unlike other p est ic ides for which EP 1\ has followed a cumulative risk approach based on a common mechanism of toxicity. EPA has not made a common mechanism
9of toxicity findi n g as to acetic ac id and any other substances and , this material does not appear to produce a toxic metabolite produ ced by other s ub stances. For the pu rp oses of this tolerance action , therefore , EPA has not ass wned that acetic acid has a common mechani s m of tox icity with other s ubsta nces. For info rm at ion re gardi ng EPA' s efforts t o d e termine which chemical s have a common mechan i sm of toxicity and to evaluate the cumulative effec ts of suc h chemicals. see the policy stateme nts rel eased by EPA's Office of P est ic ide Pr og ram s concerning common mechanism determinations an d procedures for cumulating effects fro m substances fou nd to have a common mechani s m on EP A's website at ht tp: //www.epa.gov/p es ticides/ cumulative/
. 11 . E c o t oxi c ity a nd E nv iro nm e nta l F a te Based on th e "Acetic Acid and Sod ium Diacetate Pr oposed Inte ri m R egist r at io n Rev iew D ec is ion ( D ocket N wnber E PA-HQ

- OPP- 200 8

- 001 6), acetic acid is not expected to be t ox ic to aquat ic o rgan isms , terrestrial mammals and bird s . It d oes not per sist in the e n viron ment. 12. Env ironmental Ju s tice Potential areas of environmental justice co ncern s . to the extent possible, were co n sidered in this hum an health risk assessment, in accordance w ith U.S. Exec uti ve Order 1 2898 , " F ederal Actions to Address Environme ntal Justic e in Minority Populations a nd Low-I nc o me P opu lations," http: //www .e h .doe.gov/oepa/guidance/ ju s t ice/eo 12898.pdf)
. As a part of eve ry pe sticid e risk assessment , OPP consider s a large vari e ty of consumer s ub gro up s according to we ll -es tabli s hed procedures. In line w ith OPP policy , HED estimates risks to popu l at io n s ubgroup s from pe sticid e exposures that are ba sed on pattern s of that s ub g rou p 's food and water consumpti on , and act ivities in and around the home th at invol ve pesticide use in a resi denti a l sett ing. Extensive data on f ood consumption patterns are compiled by the US D A under the Continuing Survey of Food Intake by Indi viduals (CSF U ) and are used in pesticide risk assess ment s for all regi stered food u ses of a pe s ticid e. These data are analy zed and categorized by s ubgroup s ba se d on a ge , se ason of the year, ethnic g roup , and re g ion of th e country. Additionally , O PP is able to assess dietary expos ure to sma ll e r, specialized s ub g roups and expos ure assessments are performed when conditions or circumstances war rant. Whenever approp ri ate, non-dietary expos ures based on home use of pesticide products and assoc iated risks fo r ad ult app li cators and for todd l ers, youths , a nd adult s e ntering or play ing on treated areas postapp li cation a r e eva luate d. Further conside rations are currently in development as OPP has committed re so urces and expertise to the development of s peciali zed software and models that co nsider exposure t o bystanders and farm wo rkers as we ll as lifestyle and trad itional dietary patterns an1on g s pecific subgroups
. 13 . Ri s k C hara cte riz ati on The EPA (Age nc y) rec e ive d a petition (TN

- I 0766) from Technology Sciences Group, Inc . , (1150 18 111 Street, S uite 1 000 W as hington , DC 20036) o n behalf of Wes t Agro, In c. (111 00 No rth Congress Aven ue . Kansas City , MO 64153) requestin g a t o leran ce exempt ion for use of acet ic acid (CAS Reg No. 64 -1 9

- 7) as an i nert in g red ie nt limited to 1200 ppm in pesticide formulations 1 0used on dairy and food-processing equipment and utensils under 40 CFR Part 180.940 (b) and (c)
. This request seeks to increase the current limit from 686 ppm to 1200 ppm for acetic acid under 40 CFR Part 180.940(b)(c). Acetic acid is currently approved as an inert ingredient under 40 CFRPart 180.940 (a) , 180.910 , 180.9 30,40CFR 1 80.1258(aandb). Itisapprovedasanactive in gredient. Further, it is considered Gen e rall y Recognized as Safe (GRAS) by the Food and Drug Administration. Acetic acid is of low acute dermal and inhalation toxicity in rats. It causes dermal irritation in mice and is corrosive in rabbits. It was also irritating in the eyes of rabbit s. Toxicity was not observed up to 390 mglkg/day in a 90 -day oral toxicity study. Fetal susceptibility was not observed in developmental studies in rats , mice and rabbits. It is not gcnotoxic or mutagenic. lt is not carci no genic, neurotoxic or immunotoxic. Acetic acid Lmdergo es dissociation to the acetate anion and the H+ cation s in aqueous media at pHs commonly found in the env ironm ent. Also, it is a naturally-occurring s ubstance in plant s and animals. Ba se d on the widespread presence of acetic acid in human foods , the fac t that it is a nom1al me tabolite in human s and animals, its status as a s ub s tance that is considered Generally Recognized as Safe (GRAS) by the Food and Drug Administration, no toxicological endpoint of co ncern, its regulatory hi sto r y and no new toxicological data to indicate concern regarding previous decisions a qualitat ive assessment was appropriate of all pathways of human exposure (food, drinking water , and residential). Ne ither aggregate expos ure nor occupat ional ex po s ure is of concern. Acetic acid is not expected to be toxic to aquatic organisms, terrestri a l m a mmals and bird s. It does not persist in th e environment. Taking into consideration all available information on acetic acid , EPA conc lud es that there is a reasonable certainty th at no harm will r es ult to the general population o r to infants and children from aggregate exposure to acetic acid. T herefore, the amendment of an exemption from tolerance under 40 CFR 180 .940 (b) and (c) f o r residues of acetic acid as an inert ingredient in pesticide formulation s used on dairy and food-processing equipment and uten s ils to allow fo r a limitation of 1200 ppm in the end -product formulation can be considered safe under section 408 of the FFDCA.

11

### RE FE R ENCES American Chemistry Council Acetic Acid and Salts Panel. 20Q I, U .S. High Production Volume (HPV) Chemical Challenge Program: Robust summaries for Acet i c acid and sa l ts category. EPA. Hummel , S. (2007) Memorandum: Acetic Acid Registration Review Case No. 400 I.DP Barcode D344 771. November 28. 2007. U
. S. Environmental Protect ion Agency (EPA), 2008. Acetic acid and salts summary document. Reg istrat ion R eview: In iti a l Docket, E P A- HQ-EPA- O P P-2008-00 1 6. Case #4 00 

### I. www.regu lations.gov. U .S. Environmental Protecti o n Agency (EP A). 20 14. Acetic Acid and Sodium Diacetate Propo sed Interim Registration Review Decision. Regi s tration Review: Initial Docket , EPA-HQ-EPA- OPP2008

- 00 16. Case #400 I , www.regulations.gov
.

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