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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. 
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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”)1requesting 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.”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 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).

 

1 The petition indicates that the Coalition consists of: the Corn Refiners Association (“CRA”), the National Oilseed Processors Association 

(“NOPA”), and the Institute of Shortening and Edible Oils (“ISEO”).

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
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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’s3dissemination database for 

substances registered under Registration, Evaluation, Authorisation and restriction of Chemicals 

(REACH)4regulation 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.5 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 

 

3 Registered Substances, European Chemicals Agency, available at http://echa.europa.eu/web/guest/information-on-chemicals/registeredsubstances (Accessed August 8, 2013).

4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, 

Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and 

repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and 

Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, Official Journal of the European Union, L396, Vol. 49, 849 pp., 

available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF .

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 FDA. Agency Response Letter GRAS Notice No. GRN 003002, March 5, 2010. 

http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm207980.htm 
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contact surfaces in public eating places, dairy-processing equipment, and food processing 

equipment and utensils.6

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 bioaccumulation7. 

 

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Federal Register Volume 78, No. 113 for 1,3-Propanediol (CASRN 504-63-2); Exemptions From the Requirement of a Tolerance, 

http://www.gpo.gov/fdsys/pkg/FR-2013-06-12/pdf/2013-13823.pdf [pp. 35143 - 35147] 12 June 2013; See also: 40 CFR Part 180.

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504-63-2 1,3-Propanediol EHPV IUCLID1-2-08 - Final USEPA HPVIS 2012; 

http://iaspub.epa.gov/oppthpv/public_search.publiclist?wChemicalName=504-63-2&programFlags= . 
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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.
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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 
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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.