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Review Report for Tripotassium Citrate (CASRN 866-84-2) Partial Exemption

October 2014

The Corn Refiners Association 

Docket Identifier: EPA-HQ-OPPT-2014-0347

Note: Supporting petition information for citric acid (CASRN 77-92-9) and trisodium citrate 

(CASRN 68-04-2) are addressed in separate review reports.

Summary of Decision: The U.S. Environmental Protection Agency (hereinafter “EPA” or the 

“Agency”) has determined that there is a low current interest in the processing and use 

information collected under the Chemical Data Reporting (CDR) rule (see 40 CFR Part 711) for 

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, potassium salt (1:3) (hereafter referred to as 

tripotassium citrate, CASRN 866-84-2). This determination is based on the totality of 

information on the chemical substance, including an evaluation of the considerations listed in 40 

CFR 7l1.6(b)(2)(ii): 1) Consideration A: Current CDR information suggests that at least one site 

would have a production volume sufficient to trigger the need to report processing and use 

information for the 2016 CDR (25,000 pound threshold); 2) Consideration B: The prior 

evaluation of tripotassium citrate by EPA’s High Production Volume (HPV) Challenge Program 

in conjunction with the Organisation of Economic and Co-operation Development’s (OECD)

Swiss-sponsored Screening Information Data Set (SIDS) Initial Assessment Report (SIAR), the 

U.S. Food and Drug Administration (FDA) treatment of tripotassium citrate as a prior sanctioned 

substance for use as a stabilizer when migrating from food packaging material (21 CFR 181.29), 

the similarity of tripotassium citrate to citric acid which FDA considers Generally Recognized 

As Safe (GRAS, 21 CFR 182 and 184) for use as a direct human food ingredient, and the 

Database of Select Committee on GRAS Substances (SCOGS) report for tripotassium citrate 

when used in reasonable amounts in accordance with prescribed tolerances and limitations, 

indicates a low concern for human health. Based on the available ecotoxicity data for citric acid 

and trisodium citrate from the HPV Challenge Program hazard assessment, the Swiss OECD 

SIAR, EPA’s Office of Pesticide Program’s (OPP) Federal Insecticide, Fungicide and 

Rodenticide Act (FIFRA) minimal risk tolerance exemption under 40 CFR 180.950(e), and 

OPP’s final Registration Review Decision for citric acid, tripotassium citrate appears to be of 

low toxicity to aquatic organisms. Concerning environmental fate, EPA determined that 

tripotassium citrate has the potential to biodegrade, will not persist in the environment, and has a 

low potential for bioconcentration or bioaccumulation; 3) Consideration C: EPA is not aware of 

any currently existing unmet information needs for CDR processing and use information for this 

chemical substance; 4) Consideration D: The availability of complementary risk screening 

information was not sufficiently characterized in the petition; however, EPA recognized that the 

data reviewed for the OECD SIAR, EPA’s HPV Challenge Program’s Risk Based Prioritization 

(RBP) and supporting Hazard Characterization (HC), OPP’s final Registration Review Decision, 

and OPP’s 40 CFR 180.950(e) minimal risk tolerance exemption provide evidence of 

complementary risk screening information for tripotassium citrate; 5) Consideration E: 

Comparable processing and use information is available in the European Chemical Agency’s 

(ECHA’s) database, and although it is for use of products in Europe and not the United States, it 

provides an indication of uses that may occur in the United States; and 6) Consideration F: EPA 
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is unaware of any specific actions that have already been taken by other agencies or authorities to 

manage risks relating to this substance. 

A direct final rule to add tripotassium citrate, using its TSCA Inventory name, 1,2,3-

Propanetricarboxylic acid, 2-hydroxy-, potassium salt (1:3) to the list of chemical substances

partially exempt from reporting CDR processing and use information in 40 CFR 711.6(2)(b)(iv) 

will be published in the Federal Register. The final listing is pending, based on possible adverse 

responses to the Federal Register notice. If the level of interest in the CDR processing and use 

information for this chemical substance were to change after final listing, EPA may reevaluate 

the listing and pursue amendment of the listing as appropriate. 

Persons submitting information in accordance with the CDR rule can still report processing and 

use information even if a chemical substance is partially exempt, so that their chemical

substances may be considered for safer substitute analyses.

Background: EPA received a petition from the Corn Refiners Association (CRA)1(hereinafter 

the “petitioner”), requesting that tripotassium citrate be added to the 40 CFR 711.6(b)(2)(iv) list 

of specific chemical substances that are exempt from the reporting requirements of 40 CFR 

711.15(b)(4) (i.e., exempt from requirements to report industrial processing and use and 

commercial/consumer use information). The chemical substances already included on this 

“partial exemption” list are substances for which EPA has previously determined that there is a 

low current interest in the CDR processing and use information. However, as stated in the 

preamble to the Inventory Update Reporting Amendments (IURA) rule promulgated on January 

7, 2003, “...the need for processing and use information under IURA changes over time. The 

inclusion of a chemical substance under this partial exemption is not based on the potential risks 

of a chemical. This partial exemption is solely intended to provide a tool to assist the Agency in 

better managing the collection of processing and use information...” and is also “...based on the 

Agency’s current assessment of the need for collecting IURA processing and use information.” 2 

Additionally, the preamble states, “[i]n determining whether there is low current interest in IUR 

processing and use information related to a specific chemical substance, EPA will look to the 

specific circumstances surrounding the chemical in question, and may use one or more of the 

considerations identified below, and/or considerations not identified below, to make an informed 

decision.” The considerations used by EPA in reviewing this petition and an analysis of how 

those considerations relate to tripotassium citrate are set forth below.

Discussion: EPA considered information submitted with the petition, as well as other 

information including, but not limited to: whether the petitioned chemical substance is listed on 

the Emergency Planning and Community Right to Know Act (EPCRA), Section 313 list of Toxic 

Chemicals and thus is reportable to the Toxics Release Inventory (TRI); 2012 CDR submissions 

for the chemical substance; evaluations available through the EPA’s Integrated Risk Information 

System (IRIS), the International Agency for Research on Cancer (IARC), the OECD’s HPV

 

1 CDR Partial Exemption Petition (April 21, 2014) (Hereinafter “The Petition”); From: Herb Estreicher, Keller and Heckman LLP; To: OPPT 

CDR Submission Coordinator, U.S. Environmental Protection Agency; Re: “Request for exemption of citric acid, trisodium citrate and 

tripotassium citrate from TSCA chemical data reporting (CDR) processing and use information reporting requirements in 2016” (2 pp.), with 

attachment titled “CDR petition for certain food-use substances 40 C.F.R. § 711.415(b)(2)(ii)(A) criterion information”(14 pp.).

2 Federal Register Volume 68, Issue 4 (January 7, 2003) p. 848 - 906. http://www.gpo.gov/fdsys/pkg/FR-2003-01-07/pdf/02-32909.pdf 

Accessed: 8/08/2013.
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SIDS program, or the EPA’s HPV Challenge Program; whether the substance is subject to other 

regulatory programs administered by EPA or other federal agencies; and other information 

researched by EPA to supplement the petition.

The petitioner provided information concerning tripotassium citrate from a variety of sources and 

linked it to specific considerations cited in 40 CFR 711.6(b)(2)(ii).

Consideration A: Whether the chemical qualifies or has qualified in past IUR collections for the 

reporting of the information described in 40 CFR 711.15(b)(4).

The petitioner indicated that tripotassium citrate (CASRN 866-84-2) was reported for the 2006

IUR and the 2012 CDR. EPA reviewed the 2012 CDR data for tripotassium citrate and found 

that 5 sites reported domestically manufacturing and/or importing tripotassium citrate with a 

nationally aggregated production volume of 1,903,962 pounds in 2011. 

EPA has concluded that at least one manufacturing site would likely have a production volume 

sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 

pound threshold). Thus, EPA concludes that the other considerations are ripe for evaluation.

Consideration B: The chemical substance’s chemical and physical properties or potential for 

persistence, bioaccumulation, health effects, or environmental effects (considered independently 

or together).

The petitioner submitted summary information from EPA’s HPV Challenge Program for 

carboxylic acids and salts category that was submitted by the American Chemistry Council’s 

Acetic Acid and Salts Panel on April 16, 2003. EPA published an Initial RBP document3and 

supporting HC4in August 2008. The petitioner noted that FDA affirms the use of tripotassium 

citrate as Generally Recognized As Safe (GRAS, 21 CFR 184.1625) for use as direct human 

food ingredients. The safety of these ingredients have been evaluated under the comprehensive 

safety review conducted by the agency (as specified in 21 CFR parts 182 and 184). 

EPA assessed tripotassium citrate along with citric acid and trisodium citrate as a subcategory of 

the carboxylic food acids and salts category based on structural, functional and toxicological 

properties and published a Risk-Based Prioritization (RBP) document in August 2008.

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Additionally, tripotassium citrate is also listed under 40 CFR 180.950(e) as having a tolerance 

exemption as a minimal risk active or inert ingredient in pesticides. In a 2002 Decision Memo, 

reassessing the tolerance exemption, EPA’s hazard characterization concluded that there is no 

available information indicative of a hazard, significant adverse effects to the general public or 

any population for tripotassium citrate.

4 EPA reviewed hazard information during the 

development of the RBP and pesticide determinations. EPA’s conclusions are summarized in the

sections below.

 

3

Initial RBP of Carboxylic Food Acids and Salts Category. 

http://www.epa.gov/chemrtk/hpvis/rbp/CAT_Carboxylic%20Food%20Acids_Web_RBP_August%202008.pdf. Accessed 8 July 2014

4 Supporting Documents for Initial RBP of Carboxylic Food Acids and Salts Category. 

http://www.epa.gov/chemrtk/hpvis/rbp/CAT_Carboxylic%20Food%20Acids_Web_SuppDocs_August%202008.pdf
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EPA also considered other sources of information to inform its decisions on human health and 

environmental toxicity, and environmental fate, including the 2001 Swiss-sponsored OECD 

SIAR for citric acid,5and FDA’s affirmation of tripotassium citrate as Generally Recognized As 

Safe (GRAS, 21 CFR 184.1625) for use as direct human food ingredients. 

Human Health Effects. EPA’s Hazard Characterization (HC) supporting the RBP concluded that 

the acute oral toxicity for the supporting chemical citric acid is low. The supporting chemical 

citric acid is irritating to rabbit skin and severely irritating to the rabbit eye. At high doses, the 

supporting chemical trisodium citrate showed no adverse effects in oral reproductive and 

developmental toxicity studies (species and sex not identified). The supporting chemical citric 

acid did not show potential to induce genetic mutations; no data are available for chromosomal 

aberrations.

Environmental Effects. Tripotassium citrate has a low potential hazard to aquatic organisms. 

Based on the available ecotoxicity data for citric acid and trisodium citrate from the HPV 

Challenge Program HC, the Swiss OECD SIAR, and the OPP decision memo, tripotassium 

citrate appears to be of low toxicity to aquatic organisms.

Environmental Fate. Tripotassium citrate is expected to have high mobility in soil, and is 

expected to partition primarily to water and soil if released to the environment. Based on 

experimental data for citric acid and trisodium citrate from several biodegradation tests, 

tripotassium citrate is expected to be readily biodegradable. EPA ran the Estimation Programs 

Interface Suite (v. 3.20) modeling software to support the HPV Program Risk-based 

prioritization screening assessment and determined that tripotassium citrate has a low potential to 

bioaccumulate.

EPA believes that the Agency’s HPV Challenge Program’s RBP and supporting HC, OPP 

FIFRA tolerance exemptions, and the OPP decision memo are supported by the OECD SIAR 

and provide sufficient evidence to address human health and environmental toxicity concerns for 

tripotassium citrate. Taken together, this information is sufficient to weigh in favor of partially 

exempting tripotassium citrate from CDR reporting based on human health and environmental

concerns covered under Consideration B. 

Consideration C: The information needs of EPA, other federal agencies, tribes, states, and local 

governments, as well as members of the public.

The petitioner stated that it was unaware of any unmet information needs of EPA, other federal 

agencies, tribes, states, local governments, or members of the public in light of FDA regulatory 

clearances available for tripotassium citrate in food applications and the extensive data published 

on the ECHA website. The petitioner also noted that tripotassium citrate has not been the subject 

of information collection requirement by EPA under the Toxic Substances Control Act (TSCA)

(other than CDR), the Interagency Testing Committee (ITC), or the Agency for Toxic 

Substances and Disease Registry (ATSDR). The petitioner asserts that there is sufficient 

information available, and there have been no previous information requests.

 

5 Swiss sponsored 2001 SIDS Initial Assessment Report published by UNEP. http://www.inchem.org/documents/sids/sids/77929.pdf Accessed 08 

July 2014
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In 2006, EPA denied an earlier petition for partial exemption for tripotassium citrate, indicating 

that there was no basis to believe that the 300,000 pound threshold volume for reporting 

processing and use information would be met for tripotassium citrate.

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 Since then, the 

nationally aggregated production volume for tripotassium citrate has increased and the threshold

volume for reporting processing and use in 2016 will be 25,000 pounds. As noted under 

Consideration A, EPA has concluded that at least one manufacturing site would likely have a 

production volume sufficient to trigger the need to report processing and use information for the 

2016 CDR. Additionally, in 2009, EPA completed a RBP document for tripotassium citrate as 

part of the carboxylic food acids and salts category,7using processing and use information from 

the 2006 IUR. 

EPA is not aware of any currently existing unmet information needs respecting the processing 

and use of tripotassium citrate and agrees that recent processing and use information for this 

chemical is otherwise available to government agencies and the public on the ECHA website. 

Although the uses in Europe may not be exactly the same as the uses in the United States, EPA 

believes they can provide an indication of potential uses on which to base further analysis, 

should the chemical substance be of interest. Overall, EPA regards Consideration C as weighing 

in favor of establishing a partial exemption for this chemical substance.

Consideration D: The availability of other complementary risk screening information.

The petitioner included a table which provided the status of the petitioned substance on the 

European Commission Annex II list of low risk substances, exemption determinations by the 

European Union for the REACH program, status under the voluntary EPA HPV Challenge 

Program and safety determinations for low toxicity pesticide inerts. However, no discussion was 

provided linking the status to the availability of risk screening information. Therefore, it is 

unclear why the petitioner believes this table relates to Consideration D, the availability of other 

complementary risk screening information. EPA notes that the fact that the petitioned substance 

was not present on most of these lists provided no evidence of the availability of risk screening 

information nor were explanations given of the significance of the chemicals not being listed on 

the two European lists. The significance of the chemical not being listed on the two European 

lists was not explained. The fact that tripotassium citrate could be sponsored under the HPV 

program does not mean that risk screening data is necessarily available and that entry is outdated 

anyway. The petitioner did not note the availability of an OECD SIAR for citric acid (which is a 

suitable analog for tripotassium citrate) and an EPA RBP document (which included tripotassium 

citrate, which had been sponsored in the HPV program), both of which conclude that citric acid

and its salts present a low concern. The identification of tripotassium citrate as a 4A pesticide 

inert does not provide information about risk screening. It is more useful to note that 

Tripotassium citrate is listed under 40 CFR 180.950(e) as having a tolerance exemption as a 

minimal risk active or inert ingredient in pesticides. Additionally, upon review of all available 

information, EPA issued a Decision Memo in March 2008 reassessing the tolerance exemption 

and concluding that there are not likely to be any unreasonable adverse effects to the U.S. 

 

6 Letter from Charles M. Auer, EPA, to Herbert Estreicher, Esq. and Martha E. Marrapese, Esq., “Petition for Partial Exemption from Inventory 

Update Reporting Requirements, Docket No. EPA-HQ-OPPT-2004-0071”, January 31, 2006. 

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Initial RBP of Carboxylic Food Acids and Salts Category. 

http://www.epa.gov/chemrtk/hpvis/rbp/CAT_Carboxylic%20Food%20Acids_Web_RBP_August%202008.pdf Accessed 7 July 2014
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population in general, and to infants and children in particular, or to non-target organisms or the 

environment from the use of the tolerance exemption.

EPA determined that the petitioner did not provide evidence that complementary risk screening 

information is available for tripotassium citrate in its discussion under Consideration D. 

However, the data reviewed for the OECD SIAR, EPA’s RBP and supporting HC, EPA’s FIFRA 

40 CFR 180.950(e) minimal risk tolerance exemption and the decision memo affirming it 

provide evidence of complementary risk screening information for tripotassium citrate. Overall, 

EPA concluded that the availability of information relevant to Consideration D weighs in favor 

of partially exempting tripotassium citrate from CDR reporting.

Consideration E: The availability of comparable processing and use information.

While the petitioner indicated that tripotassium citrate is predominantly used in food (which is 

not a use subject to TSCA), the information they provided from the ECHA database indicated a 

broader range of uses. The petitioner asserted that TSCA-regulated exposures are comparable to, 

or less significant than, the food-use exposures associated with these substances, which have 

already been shown to be “safe.” The petitioner included a list of uses obtained from ECHA’s 

database. 

The uses in the ECHA database are for the European Union and indicate that tripotassium citrate

may have broader use in Europe than in the United States. Data from the non-confidential 2012 

CDR database identified the following industrial use: flame retardants. The following consumer 

and commercial use was also identified: non-TSCA use. 

EPA agrees that other recent processing and use information, available from ECHA is 

sufficiently comparable to CDR processing and use information to weigh in favor of granting a 

partial reporting exemption for this chemical substance. While the ECHA information may not 

be completely representative of use in the United States, EPA concluded in this case (in view of 

all relevant considerations) that the ECHA information is a reasonable surrogate indicator of 

possible United States processing and use. EPA also recognizes that the ECHA database does 

not specify the amounts of tripotassium citrate to each use. But when considered in combination 

with the other substance-specific factors that weigh in favor of granting a partial reporting 

exemption (e.g., the evidence that the potential human health effects and/or environmental 

effects would be low) EPA does not regard the lack of use-by-use volume information as 

sufficient to affect the decision.

Consideration F: Whether the potential risks of the chemical substance are adequately managed 

by EPA or another agency or authority.

The petitioner generally indicated that the manufacturing and use of tripotassium citrate

primarily falls within the jurisdiction and authority of the FDA. The petitioner also stated that 

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 of tripotassium citrate. However, the petitioner did not 

specifically identify which uses of tripotassium citrate are regulated by the foregoing 
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governmental bodies or regulations, except for the FDA regulation at 21 CFR 175.105, which 

covers uses of substances as components of adhesives used in food packaging. This citation is 

not useful as it does not specifically mention the substance. More to the point is the fact that 

tripotassium citrate is listed as a prior sanctioned substance for use as a stabilizer under 21 CFR 

181.29.

Overall, although the petition included the general claim that this substance is already 

“controlled adequately under other regulatory regimes,” it did not identify how any particular 

agency or authority was managing any particular risk relating to this substance, let alone how 

such risk management actions should bear on EPA’s level of current interest in processing and 

use information.

As noted above, tripotassium citrate is approved for use as a minimal risk active or inert 

ingredient in pesticides. EPA is unaware of any specific actions that have already taken by other 

agencies or authorities to manage risks relating to this substance. However, given the evidence 

that the potential human health effects and/or environmental effects would be low, EPA does not 

therefore assume that this substance would likely be the subject of risk management actions in 

the future. Thus, in this case, EPA believes this consideration weighs neither in favor of nor 

against adding the substance to the CDR partial exemption list.