        Review Report for Citric Acid (CASRN 77-92-9) Partial Exemption
                        
                                 October 2014

                      The Corn Refiners Association (CRA)
                   Docket Identifier:  EPA-HQ-OPPT-2014-0347
Note: Supporting petition information for trisodium citrate (CASRN 68-04-2) and tripotassium citrate (CASRN 866-84-2) are addressed in separate supporting 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 (hereafter referred to as citric acid, CASRN 77-92-9).  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 determinations that citric acid presents a low hazard concern for human health and the environment by EPA's High Production Volume Challenge Program  and EPA's Office of Pesticide Programs (OPP's) final Registration Review Decision is confirmed by the Organisation of Economic and Co-operation Development's (OECD) Swiss-sponsored Screening Information Data Set (SIDS) Initial Assessment Report (SIAR), and the U.S. Food and Drug Administration's (FDA) affirmation of citric acid as Generally Recognized As Safe (GRAS, 21 CFR 182.1 and 21 CFR 184.1033). Concerning environmental fate, EPA determined that citric acid 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 recognizes that the data reviewed for the OECD SIAR, EPA's HPV Challenge Program Risk Based Prioritization (RBP) and supporting documents, OPP's final Registration Review Decision, and EPA FIFRA 40 CFR 180.950(e) minimal risk tolerance exemption provide evidence of complementary risk screening information for citric acid; 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: Other than the pesticide and FDA regulations, EPA 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 citric acid, using its Toxic Substances Control Act (TSCA) Inventory name, 1,2,3-Propanetricarboxylic acid, 2-hydroxy- and CASRN 77-92-9, 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) (hereinafter the "petitioner"), requesting that citric acid 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."   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 citric acid 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 High Production Volume (HPV) SIDS program, or the EPA's HPVCP; 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 citric acid 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 citric acid was reported for the 2006 IUR and the 2012 CDR. EPA reviewed the 2012 CDR data for citric acid and found that 41 sites reported domestically manufacturing and/or importing citric acid with a nationally aggregated production volume of 386,128,547 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 indicated that extensive data are available for citric acid from the 2001 Swiss-sponsored OECD SIAR for citric acid and from data submitted to the U.S. High Production Volume Chemical Challenge Program for carboxylic acids and salts category by the American Chemistry Council's Acetic Acid and Salts Panel on April 16, 2003. The petitioner referred to data submitted to support the registration of citric acid products as biopesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and also indicated that EPA's OPP waived the generic data requirements for citric acid due to its low toxicity.  Additionally, the petitioner noted FDA's affirmation that citric acid is GRAS under 21 CFR 182.1 and 184.1033 for use as direct human food ingredients.  

EPA assessed citric acid and its salts 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. On December 15, 2009 (74 FR 66353), EPA's OPP published a registration review final decision; notice of availability for citric acid (case 4024).  Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without causing unreasonable adverse effects on human health or the environment.  Through registration review, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment. Additionally, citric acid is listed under 40 CFR 152.25(f)(1) as a pesticide not requiring registration if certain criteria are met and is also listed under 40 CFR 180.950(e) as having a tolerance exemption as a minimal risk active or inert ingredient in pesticides.  EPA reviewed hazard information during the development of the RBP and pesticide determinations.  EPA's conclusions are summarized in the sections below.

EPA also considered other sources of information to  confirm its decisions on human health, environmental toxicity, and environmental fate, including the 2001 Swiss-sponsored OECD SIAR for citric acid  and FDA's affirmation that citric acid is GRAS under 21 CFR 182.1  and 184.1033 for use as direct human food ingredients.  
 
Human Health Effects. EPA's Hazard Characterization (HC) supporting the RBP concluded that the acute oral toxicity of citric acid is low.  The acute oral toxicity of citric acid is low.  Citric acid is irritating to rabbit skin and severely irritating to rabbit eyes.  At high doses, the supporting chemical trisodium citrate showed no adverse effects in oral reproductive and developmental toxicity studies (species and sex not identified).  Citric acid did not show potential to induce genetic mutations; no data are available for chromosomal aberrations. During its registration review, EPA's OPP reviewed the hazard and exposure database for citric acid, and based on its low toxicity, determined that additional toxicity or exposure data were not needed.  

Environmental Effects. EPA's Hazard Characterization supporting the RBP concluded that the evaluation of available data on aquatic organisms indicates the potential hazard of the carboxylic food acids and subcategories for fish, aquatic invertebrates, and aquatic plants is low.  

Environmental Fate. EPA's Hazard Characterization supporting the RBP indicated that citric acid 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 from several biodegradation tests using alternate methodology, citric acid 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 citric acid has a low potential to bioaccumulate.
EPA believes that its decisions on citric acid made in the RBP, the FIFRA minimal risk pesticide exemption and tolerance exemption and the OPP Registration review decision of low hazard are supported by FDA's acceptance of the GRAS designation and the OECD SIAR. Taken together, this information is sufficient to weigh in favor of partially exempting citric acid 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 citric acid in food applications and the extensive data published on the ECHA website.  The petitioner also noted that citric acid 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.

In 2006, EPA denied an earlier petition for partial exemption for citric acid, indicating that because citric acid was part of EPA's HPVCP, EPA needed IUR processing and use information to put the hazard data received under the HPVCP in context in a risk screening assessment.  In 2009, EPA completed a RBP document for citric acid as part of the carboxylic food acids and salts category, using 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 citric acid 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 noted in ECHA information 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 HPVCP, and safety determinations for low toxicity pesticide inerts.  No discussion was provided linking the status to the availability of risk screening information.  Therefore, it is unclear how this table relates to Consideration D, the availability of other complementary risk screening information.  The significance of the chemical not being listed on the two European lists was not explained.  The fact that citric acid was sponsored under the HPV program does not mean that risk screening data is necessarily available.  In this case, the petitioner should have noted that there is an OECD SIAR and an EPA RBP document available based on HPV data, both of which conclude that citric acid presents a low concern.  The identification of citric acid as a 4A pesticide inert does not provide information about risk screening. 

It is more useful to  note that citric acid is listed under 40 CFR 152.25(f)(1) as a minimum risk pesticide not requiring registration if certain criteria are met and is also 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 Final Registration Review Decision for Citric Acid in December, 2009 (74 FR 66353) concluding that there are not likely to be any unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, or to non-target organisms or the environment from the use of registered pesticide products containing citric acid when currently required label instructions are followed.

EPA finds that the petitioner did not provide evidence that complementary risk screening information is available for citric acid in its discussion under Consideration D.  However, the data reviewed for the OECD SIAR, EPA's RBP and supporting HC, OPP's final Registration Review Decision, and 40 CFR 180.950(e) minimal risk tolerance exemption provide evidence of complementary risk screening information for citric acid.  Overall, EPA concluded that the availability of information relevant to Consideration D weighs in favor of partially exempting citric acid from CDR reporting.

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

The petitioner did not provide specifics, but simply indicated that processing and use is well characterized and is included under information submitted for Consideration B.  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."  Under Consideration B, the petitioner asserted that while most of the citric acid produced is used in the food and pharmaceutical industries, a small amount of citric acid has certain industrial uses, but the source of this information was not provided.  

Although the petitioner did not reference it under this Consideration, the ECHA database contains recent processing and use information.  The uses in the ECHA database are for the European Union and indicate that citric acid may have broader use in Europe than in the United States.  Data from the non-confidential 2012 CDR database identified the following industrial uses: adhesives and sealant chemicals, agricultural chemicals (non-pesticidal), bleaching agents, corrosion inhibitors and anti-scaling agents, finishing agents, intermediates, laboratory chemicals, lubricants and lubricant additives, oxidizing/reducing agents, plating and surface treating agents, process regulators, processing aids, processing aids specific to petroleum production, propellants and blowing agents, solids separation agents, solvents (for cleaning or degreasing), solvents (which become part of product formulation or mixture), surface active agents, and viscosity adjustors.  The following consumer and commercial uses were also identified: agricultural products (non-pesticidal), cleaning and furnishing care products, fuels and related products, ink, toner, and colorant products, laundry and dishwashing products, non-TSCA use, and water treatment products.  

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 citric acid 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 citric acid 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 citric acid.  However, the petitioner did not specifically identify which uses of citric acid are regulated by the foregoing governmental bodies or regulations, except for FDA regulations covering the use of citric acid as a food additive in a variety of products.  

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, citric acid is exempt from pesticide registration as a minimal risk pesticide and is approved for use as a minimal risk active or inert ingredient in pesticides.  EPA is unaware of any specific actions that have been 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 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.


