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### Via Certified Mail April21, 2014 OPPT CDR Submission Coordinator Mailcode 7407M Attn: Inventory Update Reporting and Chemical DataReporting Office ofChemical Safety and Pollution Prevention Environmental Protection Agency 1200 PennsylvaniaAve., NW. Washington, DC 20460 Writer's DirectAccess Herbert Estreicher, J.D., Ph.D. (202) 434-4 334 estreich er@kh Iaw.com



### Re: REQUESTFOREXEMPTION OF CITRIC ACID, TRISODIUM CITRATEAND TRIPOTASSIUM CITRATE FROM TSCA CHEMICALDATAREPORTING (CDR) PROCESSING AND USE INFORMATIONREPORTING REQUIREMENTS IN 2016 Dear Sir or Madam: The ComRefiners Association (CRA) hereby requests the U.S. Environmental Protection Agency (EPA) to exempt citric acid (CASRN 77-92-9), trisodium citrate (CASRN 68-04-2) and tripotassium citrate (CASRN 866-84-2) from the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) processing and use reporting requirements (Part III ofthe reporting form, FormU) pursuantto 40 C.F.R. 711.15(b)(2)(iii). Citric acid and the corresponding citrates are predominantly used infood and are oflow risk to human health and the environment. 

### I BASIS FORPETITION EPA regulations at 40 C.F.R. 

### § 711.15(b)(2)(iii) permit any person to request that the EPA amend the list ofsubstances of "lowcurrent interest" that are partially exempt from CDR requirements, specifically from the processing and use reporting requirements contained in 40 C.F.R. § 711.15(b)(4). EPA states that inmaking the determination ofwhetherthis partial exemption should apply to a particular chemical substance, EPA will considerthe totality of information available for the chemical substance in question, including but not limited to, certain enumerated considerations at 40 C.F.R. § 711.15(b)(2)(ii). The supporting attachments to this petition address each ofthe six exemption considerations for citric acid and the citrates. Most importantly, ourpetition demonstrates that

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### KELLERAND HECKMANLLP OPPT CDR Submission Coordinator April21, 2014 Page 2
there is "low current interest" in CDRprocessing and use data for these products because they are oflowpotential human and environmental risk, are comprehensively regulated by other state and federal agencies, in particularthe U.S. Food and Drug Administration, have a long history of safe use in both food and non-food products, and offer great promise for environmentally beneficial and sustainable alternatives to traditional synthetic chemistry. Based onthese and the other considerations discussed below, we are confident that the EPA will conclude that these substances should be added to the list ofCDRpartially exempt substances. 

### II TSCA REGULATED USES According to the SIDS Initial Assessment Report (SIAR),the TSCA regulated uses of citric acid include "technical applications in various industries as a complex-forming agent, cleaning agent, softening agent, decalcifying agent, derusting agent, corrosive agent and synergist in antioxidant mixtures
...." The 2006 IURreport for trisodium citrate lists its use as a pH-regulating agent in paper mills and as a solvent in soap and cleaning compound manufacturing
. The 2006 IUR identifies tripotassium phosphate use as apH-regulating agent in paper mills. Even though the subject request is to partially exempt citric acid, trisodium citrate and tripotassium citrate for the 2016 CDRreporting cycle, the Coalitionrequests that the EPA provide its response to this petition within the 120 days contemplated under40 C.P.R. 711.15(b)(2)(iii)(A). The Coalitionhas a number ofother food related substances for which it intends to submit similarrequests and is anxious to receive the Agency's feedback on its general approach as reflected inthe subjectpetitions.Sincerely,



# &rei~ Partner Enclosures

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.CDR Petition for Certain Food-Use Substances 40 C.F.R. § 711.415(b)(2)(ii)(A) Criterion Information (Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in§ 711.15(b)(4)). Publicly available information on the 1986-2006 IUR and the 2012 CDR database was searched for citric acid, trisodium citrate and tripotassium citrate to determine whether the substances meet the criteria of"whetherthe chemical qualifies or has qualified in past IUR collections for the reporting ofinformation described in §711.15(b)(4)." See 40 C
.F.R. § 711.15(b)(2)(ii)(A). Citric acid, trisodium citrate and tripotassiurn citrate were reported in the 2006 IUR and the 2012 CDR. In 2012, processing and use data was provided by 41 companies for citric acid, 11 companies for trisodium citrate and 5 companies for tripotassium citrate. The 2012 CDR Volume was reported as 386,128,547lb/yrfor citric acid, 14,333,759lb/yrfor trisodium citrate and 1,903,962lb/yr for tripotassium citrate. Datareported to EPA for purposes ofiUR on a confidential basis is not necessarily reflected in this submission. The Agency is respectfully requested to review the IUR database for confidential datato supplement the data provided.

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### CDRPetition for Certain Food-Use Substances 40 C.F.R. 

### § 711.415(b)(2)(ii)(B) Criterion Information (The chemical substance's chemical and physical properties orpotential for persistence, bioaccumulation, health effects,'or environmental effects (considered independently or together). Extensive data are available to EPA for citric acid in the OECD SIDS Database (see http://webnet.oecd.org/HPV /UIISIDS Details.aspx?key==1a337636-fb4f -42e0-a9e7- a37fa7124cb2&idx=O). Data for trisodium citrate and tripotassium citrate are available in the U.S. High Production Volume (HPV) Chemical Challenge Program Robust Summaries for Carboxylic Food Acids and Salts Category provided to EPA by the American Chemistry Council's Acetic Acid and Salts Panel April16, 2003. The following provides a summary ofthe data from these databases. 

### Data Available on Citric Acid (CASRN 77-92-9) from the OECD SIAR 1) Substance identity profile
a. Substance identifiers IUPAC name: 2-Hydroxy-1,2,3-propanetricarboxylic CAS name: citric acid Other names: B-Hydroxytricarballylic acid 2-Hydroxypropanetricarboxylic acid CASRN: 77-92-9 EC number: 209-069-1 Molecular formula: C6H807 Molecular weight: 192.124 g/mol 

### b. Physical properties' Ap12_earance: white crystalline powder pH: 2.2 at 0.1 N,

**~**1.8 at 50 g/1 and Melting point: 152 to 159 degC Boilingpoint:

**~153** degC Relative density 1.665 at 20 degC Vapourpressure 7.3 X 1 

## o-/ Paat 25 degC (calculated ) Partition coefficient (log Kow) Log Pow= -1.72 at 20°C Solubility: 576- 771 g/L at 20 degC/room temperature, data from 4 sources Dissociation Constants pKa1 =3.3, pKa2 = 4.76,pKa3 =6.4 Henry's Law Constant Kh = 2.3 x 

### 10- 1Pam"'/mol (calculated)

This document was delivered electronically.c. Manufacturing According to the SIAR, worldwide, citric acid production is mainly through microbiological fermentation ofmolasses and sugar solutions, while extraction from lemonjuice or chemical synthesis is negligible. Dilute citric acid from filtered fermentation broths is precipitated with milk oflime (calcium hydroxide) as practically insoluble calcium citrate, which is thenreacted with sulfuric acid to form citric acid and calcium sulfate (gypsum) as a recoverable and valuable by-product. d. Uses According to the SIAR, approximately 50% ofthe production is estimatedto be used bythe beverage and soft drinks industry, another 20% in food processing industry and around I0% inpharmaceutical industry, where citric acid is used as an acidulant, buffering agent, taste enhancer and synergist in antioxidant mixtures. Thus, approximately four fifths ofthe production is destined for human consumption. The remainder is split betweentechnical applications in various industries as a complex-forming agent, cleaning agent, softening agent, decalcifying agent, derusting agent, corrosive agent and synergist in antioxidant mixtures. Last, small fractions are used in special applications such as citrate buffering ofwhole blood samples for transfusion. 2) Toxicological profile
a. Human Toxicity Information about the toxicology and environmental effects and fate ofcitric acid is summarized in the OECD SIDS Dossier. Also, additional information is presented inthe EPA Technical data sheet supporting the registration ofcitric acid based products as biopesticides under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"). The Office ofPesticide Programs (OPP) has waived the generic data requirements for citric acid, except for certaintechnical chemistry information, in light ofits lowtoxicity. They state that "citric acid is a well-known component ofcarbohydrate metabolism in living organisms, and is found naturally in soil and water. It degrades readily when in contact with a variety ofmicroorganisms that are found in soil, natural waters and sewage treatment systems. " Available literature indicates that this substance has low chronic toxicities. In addition, FDA has granted GRAS status to citric acid for use in human food
. Citric acid is an edible substance that is readily metabolized by humans. Citric acid is "generally recognized as safe," or GRAS (see 21 CFR 182.1033).

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### The conclusion ofthe SIDS Initial Assessment Report (SIAR) is that: "Based on many experimental data in animals and on human experience, citric acid is oflow acute toxicity. The NOAEL for repeated dose toxicity for rats is 1200 mg/kg/d. The major, reversible (sub)chronic toxic effects seem to be limited to changes in blood chemistry and metal absorption/excretion kinetics. Citric acid is not suspected ofbeing a carcinogen nor a reprotoxic or teratogenic agent. The NOAEL for reproductive toxicity for rats is 2500 mg/kg/d. Further, it is not mutagenic in vitro and in vivo. Also, the sensitising potential is seen as low. In contrast, irritation, inparticular ofthe eyes but also ofthe respiratory pathways and the skin, is the major toxicological hazard presented by citric acid; this conclusion is confirmed by a series ofreports relating to eye and skin irritation. " b. Ecological Toxicity: 

### Numerous metabolic studies on the dietary effects and metabolism ofcitric acid in birds, mammals, and fish are reported in the SIDS Dossier. In summary, the conclusion ofthe SIAR is that: "Due to its physico -chemical characteristics citric acid is highly mobile in the environment and will partitionto the aquatic compartment. Citric acid is rapidly degraded in both sewage works and surface waters and in soil. Citric acid is of low acute toxicity to freshwater fish, daphnia and algae and also to the few marine species tested; longer -term tests show comparable effect values. Similarly, citric acid has no obvious toxic potential against protozoans and many specie s or strains ofbacteria including activated sludge micro-organisms. Based on the available data, citric acid is notjudgedto be a substance that presents a hazard to the environment."
c. Exposure 

### The SIAR summarizes exposure as follows: "Citric acid is a water soluble organic solid. It

### is a natural substance that appears as an intermediate in the basic physiological citric acid orKrebs cycle in every eukaryote cell. Citric acid has beenproduced for many years in high volumes, current global production is estimated to approach 1,000,000 t/a. It

### has wide dispersive use, being added to processed food and beverages, used in pharmaceutical preparations and in household cleaners as well as in special technical applications." 3) Other information 

### The SIDS Initial Assessment Report is attached to this document. It 

### concludes that no further work is recommended on citric acid. The SIAR includes detailed data and references supporting the conclusion.

This document was delivered electronically.Data Available on Trisodium Citrate (CASRN 68-04-2) 1) Substance identity profile

a. Substance identifiers IUPAC name: Trisodium citrate CAS name: Citric acid, trisodium salt Othernames: Sodium citrate I,2,3-Propanetricarboxylic acid, 2- hydroxy-, sodium salt (1 :3) CASRN: 68-04-2 EC number: 209-069-1 Molecularformula: Na3C6Hs07 Molecular weight: 258
.06g/mol b. Physical properties' Appearance: white crystalline powder pH:

**~8** Meltingpoint: 150 degC Boiling point: Decomposes at red heat Relative density 1.7 Vapourpressure (calculated) 2.79 X 

### 10-u hPa (2.09 X 

### 10-t.,;mm Partition coefficient (log Kow) Log Pow= -0.28 (calculated) Solubility:

**~425** g/L at 25 degC

c. Manufacturing Accordingto information from manufacturers, trisodium citrate is manufactured byneutralizing citric acid derived from a submerged fermentation process. d. Uses Trisodium citrate is chiefly used as a food additive E331, usually for flavor or as a preservative
. It is also used as a pH-regulating agent in papermills and as a solvent in soap and cleaning compound manufacturing. A small amount is used in blood collection tubes and for the preservation ofblood inblood banks and for other medical uses. 2) Toxicological profile
a. Human Toxicity Information about the toxicology and environmental ef fects and fate oftrisodium citrate is U.S. High Production Volume (HPV) Chemical Challenge Program

This document was delivered electronically.Robust Summaries for Carboxylic Food Acids and Salts. In addition, FDA has granted GRAS status to trisodium citrate for use in human food (see sodium citrate, 21 CFR 184.1751). Trisodium citrate is an edible substance that is readily metabolized by humans. Studies cited in the Robust summaries gave the following LD5ovalues when trisodium citrate was administered by IV:

Species LDso, mg/kg-bw Rat 1,548 and 1,364 Mouse 170 Rabbit 449
b. Ecological Toxicity: Trisodium citrate showed very low ecotoxicity in the following tests:

Species Result Poecilia reticu/ata (Guppy) LC50 (96 h) >18,000-32,000 mg/L and Oryzias latipes (medaka) Daphnia magna EC50 (48 h)= 5,600- 10,000 mg/L Chiarella vulgaris biomass EC50 (96 h) > 18,000

- 32,000 mg/L
Trisodium citrate is readily biodegradable.
c. Exposure As with citric acid, trisodium citrate is a water soluble organic solid. Ithas been produced for many years in high volumes, is added to processed food and beverages, and used in pharmaceutical preparations and in household cleaners
. 3) Other information U.S. High Production Volume (HPV) Chemical Challenge Program Robust Summaries for Carboxylic Food Acids and Salts Category are attached to this document. Data referenced above for trisodium citrate was reported in the summaries.

This document was delivered electronically.Data Available on Tripotassium Citrate (CASRN 68-04-2) 1) Substance identity profile
a. Substance identifiers IUPAC name: Tripotassium citrate CAS name: Citric acid, tripotassium salt Other names: Potassium citrate 1,2,3-Propanetricarboxylic acid, 2- hydroxy-, potassium salt (1 :3) CASRN: 866-84-2 EC number: 212-755-5 Molecular formula: C6HsK307 Molecular weight: 306.395 g/mol b. Physical properties' Appearance: white crystalline powder pH: 8.5 Melting point: 211 degC Boiling point: Decomposes at 230 degC Relative density 1.98 Vapourpressure (calculated) 2.79 x 10- 1..: hPa (2.09 x 10- 1..:mm Partition coefficient (log Kow) Log Pow= -0.28 (calculated) Solubility (calculated) 63 g/L at 25 degC

c. Manufacturing According to information from manufacturers, tripotassium citrate is produced by adding potassium bicarbonate orpotassium carbonate to a solution ofcitric acid until effervescence ceases, filtering the solution and evaporating to granulation. d. Uses Tripotassium citrate is chiefly used as a food additive E332, usually to regulate acidity. Itis also used as apH-regulating agent in paper mills. A small amount is used to reduce the frequency ofkidney stones and for othermedical uses. 2) Toxicological profile
a. Human Toxicity FDA has granted GRAS status to tripotassium citrate for use in human food (see potassium citrate, 21 CPR 184.1625). Tripotassium citrate is an edible substance

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.that is readily metabolized by humans. It is also used in medical treatment to diminish the frequency ofkidney stones. Tripotassium citrate also has a negative Ames Test. 

### b. Ecological Toxicity: There were no studies that directly address the ecological toxicity oftripotassium citrate, but data developed for citric acid and trisodium citrate reported above should also be applicable to tripotassium citrate. Tripotassium citrate is expected to be readily biodegradable.


### c. Exposure As with citric acid, tripotassium citrate is a water soluble organic solid. Ithas been produced for many years in high volumes, and has wide dispersive use, being added to processed food and beverages, used in pharmaceutical preparations. 

### 3) Other information U.S. High Production Volume (HPV) Chemical Challenge Program Robust Summaries for Carboxylic Food Acids and Salts Category are attached to this document. Data referenced above for tripotassium citrate was reported in the summaries.

This document was delivered electronically.CDRPetition for Certain Food-Use Substances 40 C.F.R. 

### § 711.15(b)(2)(ii)(C) Criterion Information (The information needs ofEPA, otherfederal agencies, tribes, states, and local governments, as well as members ofthe public). None ofthe petitioned substances have been the subject ofor considered for information collectionrequirements by EPA under TSCA (other than the TSCA IUR), the Interagency Testing Committee (ITC), or the Agency for Toxic Substances and Disease Registry (ATSDR). No petitioned substance has been or is the subject ofany proposed or final regulation bythe EPA under the following programs: TSCA 4 Test Rules TSCA 4(F) Required Actions TSCA 5(A)(2) Chemicals Subject to Significant NewUse Rules (SNURS) TSCA 5(B) Data Gathering Requirements TSCA 5(E) Testing Consent Order Chemicals TSCA 5(F) Immediately Effective Rules TSCA 6(A) Hazardous Chemical Control Rules TSCA 8(A) Toxic Substances Subjectto Reporting Rules on Production TSCA 8(A) CAIR Comprehensive Assessment Information Rules TSCA 8(A) Pair Preliminary Assessment Information Rules TSCA 8(C) Records ofAllegations ofSignificant Adverse Reactions TSCA 8(D) Health and Safety Reporting Rules TSCA 8(D) Health and Safety Reporting Rules Termination TSCA 12(B) Notices ofExport SARA 313 Chemicals Regulated Under §313 ofEPCRA See http://www.epa.gov/opptintr/CORR/index.htm. The petitioning associations are not aware ofany unmet information needs ofthe EPA, other federal agencies, tribes, states, local governments, or members ofthe public in light of: D FDA regulatory clearances currently available for these petitioned substances which acknowledge that their use in food applications is safe; D The extensive data on the substances published on the ECHA website. See http://apps
.echa.europa.eu/registered/data/dossiers/DISS-9d9b878d-05c8-56aa-e044- 00 144f67d249/DISS-9d9b878d-05c8-56aa-e044-00144f67d249 DISS-9d9b878d-05c8-56aae044-00144f67d249.html The petitioning associations would like the opportunity to respond and submit additional information needs identified by EPA during the petitionprocess, ifany, prior to EPA's final action on the petition request.

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.CDRPetition for Certain Food-Use Substances 40 C.F.R. § 711.15(b)(4)(ii)(D) Criterion Information (The availability ofother complementary riskscreening information). The following table provides the status ofthe petitioned substances on the Annex IV exemption determinations by the European Union for the REACHprogram, the REACH registration process, and the voluntary EPA HighProduction Volume (HPV) Chemical Challenge Program, as well as EPA safety determinations for lowtoxicitypesticide inerts. 

### BU Lew 

### Risk 

## CAS E Ahaex 

### RE.A:CH 1Numb€r Ch mical**Ind~ ~arne** **'** II Exempti 

## E**~~@H** HPV List inert**Registrati~rl** 

### L"sting en
;;; 77-92-9 1,2,3- No No Yes 2,4- 4A

.Propanetricarboxylic sponsored Iacid, 2-hydroxy- (Citric Acid) 68-04-2 1,2,3- No !No Yes 0- 4A Propanetricarboxylic sponsored acid, 2-hydroxy-, trisodium salt I (Sodium Citrate) I 866-84-2 1,2,3- INo No Yes 

## lo- 4A Propanetricarboxylic sponsored acid, 2-hydroxy-, I tripotassium salt (Potassium Citrate) •


### ·- The categorization for the 1990 and 1994 HPV lists are as follows: 0 

### = Chemical is within the scope ofthe HPV Challenge Program and may be sponsored. 1

### =Chemical is not considered a candidate for testing under the HPV Challenge Program, based onpreliminary EPA review indicatingthat testing using the SIDS base set would not further EPA's understanding ofthe chemical's properties. 2 = Chemical is otherwise being handled underthe Organization for Economic Co-operation and Development (OECD) Screening Information Data Set (SIDS) Program. 3 = Chemical is not subjectto the HPV ChallengeProgrambecause it is a polymer or inorganic substance. 4 = A company or consortium has clearly indicated to and has had confirmed by ICCA its sponsorship ofthis chemical inthe Global HPV Initiative ofthe International Council of Chemical Associations, and all information essentially equivalent to a Full Commitment under the HPV Challenge Program (i.e., chemical name, CAS number, start year for each chemical, technical contact person and telephone number) has beenprovided to EPA.

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### The key to EPA's Pesticide and Inert listings are as follows: 1 = Inert Ingredients ofToxicological Concern 2 = Potentially Toxic Inert Ingredients/High Priority for Testing Inerts 3 = Inerts ofUnknownToxicity 4A =MinimalRisk Inert Ingredients 4B = Inerts which have sufficient data to substantiate they canbe used safely inpesticide products

This document was delivered electronically.CDRPetition for Certain Food-Use Substances 40 C.F.R. § 711.15(b)(2)(ii)(E) Criterion Information (The availability ofcomparable processing and use information) Processing and use ofthese substances is well characterized. TSCA-regulated exposures associated with these substances are comparable to, or less significant than, the food-use exposures associated with these substances which have already been shown to be "safe". More specific processing and use information is included in the data summaries at that section ofthis petitionthat discusses (B) Criterion Information.

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.CDR Petition for Certain Food-Use Substances 40 C.F.R. § 711.15(b)(2)(ii)(F) Criteria Information (Whether the potential risks ofthe chemical substance are adequately managed by EPA or another agency or authority) CRA is not aware ofany information to suggest that these agencies are inadequately managing the safe use ofthe petitioned substances. The manufacturing and use ofthese substances primarily fall within thejurisdiction and authority ofthe FDA. However, the EPA, the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC) regulate the manufacture and use ofthe petitioned substances as well. In addition, state environmental protection agencies have authority over facilities within theirjurisdictions. As previously indicated, food uses ofthe petitioned components far exceed TSCA-regulated uses. Activities related to TSCA-regulated processing and use ofthe petitioned substances will also result from food-processing activities. Indeed, the same production equipment, processing techniques, and feed stocks may be used. These activities and their resulting environmental effects are already controlled adequately under otherregulatory regimes. With respect to EPA programs specifically, human and environmental exposures are adequately controlled through existing regulatory programs such as the Clean Water Act, the Clean Air Act, and the Resource, Conservation and Recovery Act, and the Spill Prevention, Control and Countermeasures (SPCC) Program. Relevant FDA regulations for the petitioned substances are provided below. p . . d 

## s b



### etltwne u stance CASRN FDAR I

. egu at:IOn at 21 CFR


### .. 1,2,3-Propanetricarboxylic 77-92-9 73.85- Caramel acid, 2-hydroxy- 131.111

- Acidified milk (citric acid) 131.112- Cultured milk 133.123- Cold-pack and club cheese 133.124- Cold-pack cheese food 133.129- Dry curd cottage cheese 133.169

- Pasteurized process cheese 133.173- Pasteurized process cheese food 133.17 8 - Pasteurized neufchatel cheese spread with other foods 133.179

- Pasteurized process cheese spread 145.134- Canned preserved figs 145.145- Canned grapefruit 146.187

- Canned prunejuice 150.161- Artificially sweetened fruit preserves andjams 150.141 -Artificially sweetened fruit jelly

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.155.130- Canned com 161.190

- Canned tuna 163.110- Cacao nibs 163.111

- Chocolate liquor 163.112

- Breakfast cocoa 169.115

- French dressing 169.140

- Mayonnaise 169.150- Salad dressing 172.755

- Stearyl monoglyceridyl citrate 172.861

- Cocoa butter substitute from coconut oil, palm kernel oil, or both oils 173.165

- Candida lipolytica 173.160

- Candida guilliermondii 173.280

- Solvent extractionprocess for citric acid 178.1010- Sanitizing solutions 184.1033

- Citric acid food use
1,2,3-Propanetricarboxylic 68-04-2 131.111

- Acidified milk add, 2-hydroxy-, trisodium salt 131.112- Cultured milk 131.160- Sour cream 131.185- Sour halfand half 133.179 -Pasteurizedprocess cheese spread 133.169

- Pasteurized process cheese and Jams 133.173

- Pasteurized process cheese food 150.141- Artificially sweetened fruit jelly 150.161 -Artificially sweetened fruit preserves 175.300 -Resinous and polymeric coatings 179.45

- Packaging materials for use during the irradiation ofprepackaged foods 181.29

- Stabilizers 184.1751

- Sodium citrate food use 1,2,3-Propanetricarboxylic 866-84-2 175.105 -Adhesives acid, 2-hydroxy, tripotassium salt

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