     Review Report for 1,3-Propanediol (CASRN 504-63-2) Partial Exemption
                                       
                                   May 2014

Coalition of Corn Refiners Association ("CRA"), the National Oilseed Processors Association (NOPA), and the Institute of Shortening and Edible Oils (ISEO)
                   Docket Identifier:  EPA-HQ-OPPT-2012-0221

Note:  Two additional documents contain information for bentonite, acid-leached (CASRN 70131-50-9) and oils, palm kernel (CASRN 8023-79-8) which 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 1,3-propanediol (CASRN 504-63-2).  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 under the 2016 CDR (25,000 pound threshold); 2) Consideration B: While it had not made its own determination, the U.S. Food and Drug Administration (FDA) accepts the use of 1,3-propanediol (Generally Recognized As Safe GRAS Notice Inventory No. 302) to be used in place of 1,2-propanediol (as specified in 21 CFR 184.1666(c)) (GRAS listing for 1,2-propanediol) and EPA's Office of Pesticide Programs (OPP) exempts it from requiring a tolerance when used as an inert ingredient in food use pesticides. Concerning environmental fate, EPA determined from submitted data that 1,3-propanediol is readily biodegradable and will not persistent in the environment, and, EPA found data indicating that 1,3-propanediol has a low potential for bioconcentration and 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, for 1,3-propanediol, EPA recognized the assessment supporting OPP's recent tolerance exemption as providing complementary risk screening information; 5) Consideration E: Other recent 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 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 1,3-propanediol to the list of chemicals substances in 40 CFR 711.6(2)(b)(iv) will be published in the Federal Register.  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 decision and pursue amendment of the listing as appropriate. 

Persons submitting information in accordance with the CDR rule can still voluntarily report processing and use information even if a chemical substance is partially exempt, so that their chemicals substances may be considered for safer substitute analyses.

Background:  EPA received a petition from Keller and Heckman on behalf of a coalition of the Corn Refiners Association (CRA), the National Oilseed Processors Association (NOPA), and the Institute of Shortening and Edible Oils (ISEO) (hereinafter the "petitioner") requesting that 1,3-propanediol (CASRN 504-63-2) 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 ...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 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 1,3-propanediol are set forth below.

Discussion:  EPA considered information submitted with the petition, as well as other information including, but not limited to: whether the petition chemical substance is listed on the Emergency Planning and Community Right to Know Act, Section 313 list of Toxic Chemicals and thus is reportable to the Toxics Release Inventory (TRI); 2012 CDR submissions for this chemical substance;  evaluations available through EPA's Integrated Risk Information System (IRIS); evaluations by the International Agency for Research on Cancer (IARC), the Organisation for Economic Cooperation and Development's (OECD)'s High Production Volume ("HPV") Screening Information Data Set (SIDS) program, or the EPA's HPV Challenge Program; and other regulatory programs administered by EPA or other agencies.

The petitioner provided information concerning 1,3-propanediol from a variety of sources and linked the information to specific considerations cited in 40 CFR 711.6(b)(2)(ii).

Consideration A:  Whether the chemical substance qualifies or has qualified in past IUR collections for the reporting of the information described in §711.15(b)(4).

The petitioner provided information to show that 1,3-propanediol was reported in the 2006 IUR.  EPA reviewed the 2012 CDR data for 1,3-propanediol and found that in 2011, five companies reported an aggregate national production volume of 69,715,403 pounds.  

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 under the 2016 CDR (25,000 lb threshold). Thus, EPA concludes that the other considerations are ripe for evaluation.

Consideration B:  The substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together).

The petitioner submitted data summaries from the ECHA's dissemination database for substances registered under Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) regulation for 1,3-propanediol; however, these summaries may be used to give an indication of the hazards but are inadequate when used alone for purposes of evaluating hazards.    Notwithstanding the inadequate data summaries, EPA considered other sources of information to inform its decisions on human health and environmental toxicity. In response to a notice submitted by DuPont Tate & Lyle Bioproducts, the FDA indicated that while it had not made its own determination on the GRAS status of 1,3-propanediol, it had no questions about DuPont Tate & Lyle Bioproducts' conclusion that  1,3-propanediol is GRAS under the intended conditions of use. GRAS Notice Inventory GRN No. 302 indicates that 1,3-propanediol is intended to be used in place of 1,2-propanediol as specified in 21 CFR 184.666(c) at levels not to exceed good manufacturing practices. 

On June 12, 2013 (78 FR 35143), EPA's OPP published an exemption from the requirement of a tolerance for 1,3-propanediol.  DuPont Tate & Lyle Bioproducts submitted a petition to EPA under the Federal, Food, Drug and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. Section 408(c)(2)(A)(i) of  FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food), only  if EPA determines that the tolerance is "safe."  Under FFDCA, "safe" is defined to mean that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all exposures for which there is reliable information. In concluding that the tolerance is safe, EPA conducts a human health risk assessment and ecological effects assessment and makes a determination of safety for the pesticide chemical residue. EPA conducted such a determination prior to publishing the regulation at 40 CFR 180.940, which establishes exemptions from the requirement of a tolerance for residues of 1,3-propanediol when used as an inert ingredient solvent, co-solvent, diluent, or freeze-point depressant in pesticide formulations applied to growing crops and to raw agricultural crops after harvest and in antimicrobial pesticide formulations applied to food contact surfaces in public eating places, dairy-processing equipment, and food processing equipment and utensils. 

Human Health Effects.  The acute oral toxicity of 1,3-propanediol in rats is moderate.  Signs of toxicity included ataxia within hours of exposure and frequent unconsciousness which preceded death. The altered lethal concentration (ALC)50 of 1,3-propanediol via inhalation is moderate in rats after one hour of exposure and the dermal toxicity is low in rabbits. Sufficient data were not submitted to determine the validity of the no observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) for repeated-dose (systemic), reproductive, developmental and genetic toxicity endpoints.  The substance did not induce gene mutations in mammalian cells in vitro, but induced cytotoxicity at the highest concentration tested without metabolic activation.  The test substance is irritating to the skin and eye of rabbits.   Based on information provided in the petition and EPA's recent assessment in support of a tolerance exemption, taken together, EPA has determined that 1,3-propanediol is of low hazard to human health.
 
Environmental Effects.  For ecological toxicity, three ECHA test summaries for 1,3-propanediol were reviewed.  In a static acute fish test with no test guideline information, there was no mortality or sublethal effects observed at any test concentration and the 96-hour lethal concentration (LC)50, based on mean measured concentrations, was > 9,720 milligrams per liter (mg/L). In a static acute water flea test with no test guideline information or measured concentrations, the 48-hour effective concentration (EC)50 was 7,417 mg/L (nominal). Finally, in a green algae test following OECD test guideline 201, the algal biomass effective growth inhibition concentration (EbC)50 was 1,600 mg/L and the algal effective growth rate inhibition concentration (ErC)50 was > 10,000 mg/L.  Based on information provided in the petition, which is supported by EPA's recent assessment in support of a tolerance exemption, EPA has determined that 1,3-propanediol is of low hazard to the environment.

Environmental Fate.  The results of a ready biodegradability study showed 71 % biodegradation in 28 days with 58.5 % biodegradation occurring in the first 7 days.  Therefore, the substance is classified as readily biodegradable and not expected to persist in the aquatic or soil environment. EPA estimated an atmospheric half life of 1.1 days for 1,3-propanediol using Estimation Programs Interface for Windows (EPIWIN) (v 3.11) Atmospheric Oxidation Rates for Windows (AOPWIN) Submodel (v 1.91) 2006. Therefore, the substance is not expected to persist in the atmosphere. No measured bioconcentration or bioaccumulation data were submitted by the petitioner, but EPA found, in data submitted under the U.S. chemical industry's Extended HPV (EHPV) program, measured octanol/water partition coefficients ranging from -1.3 to -1.4 suggest a low potential for bioconcentration and bioaccumulation.  
EPA believes FDA's acceptance of the GRAS designation and EPA's tolerance exemption provide sufficient evidence to address human health and environmental toxicity concerns.  EPA accepts the submitted data showing that 1,3-propanediol is readily biodegradable and will not persist in the environment, and the EHPV data indicating that 1,3-propanediol has a low potential for bioconcentration and bioaccumulation as sufficient evidence to address environmental fate concerns.  Taken together, this information is sufficient to weigh in favor of partially exempting 1,3-propanediol 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 1,3-propanediol has not been the subject of or considered for information collection requirements by EPA under TSCA (other than the TSCA IUR), the Interagency Testing Committee (ITC) or the U.S. Agency for Toxic Substances and Disease Registry (ATSDR).  1,3-Propanediol has not been nor is it the subject of any proposed or final regulation by the EPA.  The petitioner is not aware of any unmet information needs of the EPA, other federal agencies, tribes, states, local governments or members of the public in light of FDA regulatory clearances currently available for 1,3-propanediol, which maintain that its use in certain food applications is safe; and the extensive data on 1,3-propanediol published on the ECHA website.

Neither is EPA aware of any currently existing, unmet information needs respecting the processing and use of 1,3 propanediol.  EPA notes that recent processing and use information for 1,3-propanediol is 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.

With respect to future information needs, EPA recognizes that there are now two processes for the conversion of ethylene oxide into 1,3-propanediol, one of which is newly developed and uses bio-based materials. Because of the substantial change in the manufacturing process of this chemical, EPA expects that companies are exploring new markets.  This may eventually affect the currency of existing information sources respecting processing and use of the substance (e.g., 1,3-propanediol manufactured using the bio-based materials might be used in new products). It is also possible that the information needs of agencies and the public may evolve as the market expands.  

In light of the recent change in manufacturing process, the relevance of Consideration C to the rulemaking process was mixed.  However, 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 did not regard the recent change in manufacturing process as sufficiently weighty to alter the overall weight of evidence in favor of establishing a partial reporting exemption.


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

The petition included a table which provides the status of the petitioned substances 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.  No discussion was provided linking the status to the availability of recent 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 lack of inclusion of 1,3-propanediol in the HPV Challenge Program means that no screening information data would be available from that program for the chemical.  

However, EPA used data on 1,3-propanediol submitted to EPA under the EHPV program to supplement information provided in the petition under Consideration B.  Also, EPA published an exemption from the requirement of a tolerance for residues of 1,3-propanediol when it is used as an inert ingredient in pesticides used in food (78 FR 35143, June 12, 2013).  While this exemption only applies to the substance when it is used as an inert ingredient in pesticides used in food, EPA prepared a Human Health Risk Assessment and Ecological Effects Assessment to support the exemption which was considered in this analysis. 

EPA determined that, although not included in the petition, the recent risk assessment supporting the Agency's tolerance exemption for 1,3-propanediol and the data submitted under the EHPV Program serve as complementary risk screening information for 1,3-propanediol.   

Overall, EPA concluded that the availability of information relevant to Consideration D weighs in favor of partially exempting 1,3-propanediol from CDR reporting.

Consideration E:  The availability of comparable processing and use information

While the petitioner indicated that 1,3-propanediol is predominantly used in food (which is not a use subject to TSCA), the information 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."  Citing the ECHA database, the petitioner indicated that 1,3-propanediol is mainly used as a monomer for the production of polytrimetnyleneterephthalate (PTT).  It also listed the variety of industrial preparations in which 1,3-propanediol can be formulated.  

Although the uses in the ECHA database are for the European Union, comparison with data from the non-confidential 2012 CDR database indicates that similar uses were reported for industrial, commercial and consumer activities in the United States.  The following industrial sectors were reported to the 2012 CDR for 1,3-propanediol uses:  basic organic chemical manufacturing; plastics material and resin manufacturing; pharmaceutical and medicine manufacturing; other chemical product and preparation manufacturing; soap, cleaning compound, and toilet preparation manufacturing; and paint and coating manufacturing. The following commercial and consumer uses were reported to the 2012 CDR:  anti-freeze and de-icing products; personal care products; ink toner, and colorant products; floor coverings; laundry and dish washing products, building/construction materials; and apparel and footwear care products.   

Overall, the relevance of Consideration E to the rulemaking was mixed.  EPA agrees that other recent processing and use information, available from ECHA, is sufficiently comparable to CDR processing and use information to favor 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 1,3-propanediol 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 sufficiently weighty to alter its overall decision to establish a partial reporting exemption for the chemical substance.

Consideration F:  Whether the potential risks for the chemical substance are adequately managed by EPA or another agency or authority.

The petitioner claims that 1,3-propanediol is comprehensively regulated by other state and federal agencies, in particular by the FDA. The petitioner claims that 1,3-propanediol has a long history of safe use in adhesives, anti-freezing agents, toners, and waxes, as well as in cosmetics, personal care products, and fragrances. The petitioner generally indicated that the manufacturing and use of 1,3-propanediol primarily falls within the jurisdiction and authority of the FDA.  The petitioner also stated that EPA, 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 1,3-propanediol.  

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, nor how such risk management actions should bear on EPA's level of current interest in processing and use information.

EPA is unaware of any specific actions that have already 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 therefore assume that this substance would likely be the subject of a risk management action 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.

