Review Report for Corn, Steep Liquor (CASRN 66071-94-1) Partial Exemption

October 2014

The Corn Refiners Association (CRA)

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

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

Corn, steep liquor (CASRN 66071-94-1). 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: Based on the prior 

assessment letter by EPA’s High Production Volume (HPV) Challenge Program and EPA’s 

Office of Pesticide Program’s (OPP) Federal Insecticide, Fungicide and Rodenticide Act 

(FIFRA) minimal risk tolerance exemption under 40 CFR 180.950(b) for use as an inert 

ingredient in animal feed items, and confirmed by FDA’s listing of Corn, steep liquor under 21 

CFR 73.275 (also known as EAF Document 3073) as allowed in the color additive in dried algae 

meal used in chicken feed, EPA considers Corn, steep liquor to have a low hazard for human 

health and the environment. For environmental fate, EPA determined that Corn, steep liquor has 

a potential to biodegrade, will not persist in the environment, and has a low potential for 

bioconcentration or bioaccumulation in aquatic organisms; 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: EPA determined that, although the petitioner did 

not provide evidence that complementary risk screening information is available for Corn, steep

liquor in its discussion under Consideration D, EPA’s determination under the HPV Challenge 

Program that Corn, steep liquor has a low hazard concern and under OPP that Corn, steep liquor 

is of minimal risk for use in pesticides provide evidence of risk screening determinations in the 

United States for Corn, steep liquor; 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 is unaware of any specific actions 

that have already taken by other agencies or authorities to manage risks relating to this substance. 

A direct final rule to add Corn, steep liquor, 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. 
2

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 Corn, steep liquor 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 Corn, steep liquor 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 Organisation for 

Economic Co-operation and Development’s (OECD)’s HPV Screening Information Data Set 

(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 Corn, steep liquor 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).

 

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 Corn, steep liquor 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”(9 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.
3

The petitioner provided information to show that that Corn, steep liquor was reported for the 

2012 CDR. EPA reviewed the 2012 CDR data for Corn, steep liquor and found that 10 sites

reported domestically manufacturing and/or importing Corn, steep liquor with a nationally 

aggregated production volume of 250 million to 500 million 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 provided information on Corn, steep liquor from the CRA’s 2008 Revised 

Assessment Plan for Corn, steep Liquor,3 which was provided to EPA’s HPV Challenge Program 

along with the International Uniform Chemical Information Database (IUCLID) data set. In 

addition, the petitioner provided the Technical Evaluation Report, Compiled by the Technical 

Services Branch for the U.S. Department of Agriculture (USDA) National Organic Program. The 

submitted information are not adequate for assessing Corn, steep liquor’s potential hazards to the 

environment. 

In 2008, EPA reviewed CRA’s 2006 Assessment Plan for Corn, steep liquor submitted for the 

HPV Challenge Program and concluded that there is low concern for hazard for both ecotoxicity 

and human health endpoints4. Corn, steep liquor is listed under 40 CFR §180.950(b) as having a 

tolerance exemption as a minimal risk for use in animal feed items as either an inert or an active 

ingredient in pesticide chemical formulations, including antimicrobial pesticide chemicals 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 also considered other sources of information to confirm its decisions on human health,

environmental toxicity, and environmental fate including FDA’s listing of Corn, steep liquor 

under 21 CFR 73.275 (also known as EAF Document 3073) as allowed in the color additive in 

dried algae meal used in chicken feed in accordance with prescribed conditions and the European

Union’s (EU’s) Registration, Evaluation, and Authorization of Chemicals (REACH)

registration5.

Human Health Effects. Prior evaluation of Corn, steep liquor by EPA’s HPV Challenge Program

determined a low concern for human health hazards because the sponsored substance is about 

one-half water and the majority of the rest is lactic acid, protein and other nutritive substances.

While the crude protein component could contain low molecular weight proteins that could be 

 

3 Robust Summaries and Test Plan: Corn, steep Liquor. http://www.epa.gov/hpv/pubs/summaries/cornstlq/c16469tc.htm Accessed 18 June 2014 

4Letter from Mark Townsend, EPA, to Steve Lomax, Corn Refiners Association, EPA Comments on Corn, steep liquor Test Plan and Robust 

Summary Submission (January 24, 2008) http://www.epa.gov/hpv/pubs/summaries/cornstlq/c16469ct.pdf Accessed 18 June 2014.

5ECHA REACH registration for Corn, steep Liquor: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9fdcaf46-0f58-4e27-e044-

00144f67d031/DISS-9fdcaf46-0f58-4e27-e044-00144f67d031_DISS-9fdcaf46-0f58-4e27-e044-00144f67d031.html Accessed 18 June 2014
4

antigenic if isolated, these are not expected to pose a hazard as components of such an aqueous 

mixture. 

Environmental Effects. As noted above, under the HPV Challenge Program, EPA concluded 

there is “a low concern for hazard” for ecotoxicity as “the sponsored substance is about one-half 

water and the majority of the rest is lactic acid, protein and other nutritive substances.” This 

conclusion supports the petitioner’s assertion of low toxicity to aquatic organisms. There is a 

concern for eutrophication from multiple releases of Corn, steep liquor to freshwater over time. 

However, based on EPA’s conclusion under the HPV Challenge Program and the FIFRA inert 

ingredient tolerance exemption, EPA accepts that Corn, steep liquor would be considered to have 

a low hazard to the environment. 

Environmental Fate. Corn, steep liquor consists of water and water soluble nutrients. It is 

expected to partition to water when released to the environment. No measured biodegradation, 

bioconcentration, or bioaccumulation data were submitted by the petitioner, but EPA found, in 

data submitted under the EU REACH registration, an OECD test guideline 310 Ready 

Biodegradability test summary. In the 28-day ready biodegradability test, > 80% biodegradation 

occurred within the first 7 days. Therefore, the substance is considered to be readily 

biodegradable and not expected to persist in the aquatic or soil environment. The petitioner 

asserted that Corn, steep liquor is not expected to bioaccumulate based on its composition of 

water soluble components derived from soaking corn in water. EPA determined that the HPV

Challenge Program submission adequately addressed the physical-chemical and environmental 

fate endpoints. 

EPA believes that the review under the HPV Challenge Program and OPP tolerance exemption 

provide sufficient evidence to address human health, environmental toxicity, and environmental 

fate concerns for Corn, steep liquor. EPA accepts that the OPPT comments document, along with 

the Ready Biodegradability test summary, indicating that Corn, steep liquor is readily 

biodegradable, will not persist in the environment, and has a low potential for bioconcentration 

and bioaccumulation, are sufficient evidence to address environmental fate concerns. Taken 

together, this information is sufficient to weigh in favor of partially exempting Corn, steep liquor 

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 Corn, steep liquor in food applications and the extensive data published 

on the ECHA website. The petitioner also noted that Corn, steep liquor 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

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

and use of Corn, steep liquor and agrees that 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 (for a detailed summary of specific uses see Consideration E). 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 under the 

REACH registration program, status under the voluntary EPA HPV Challenge Program, and 

status as a pesticide inert. However, no discussion was provided linking the status to the 

availability of recent risk screening information. Therefore, it is unclear how this table relates to 

Consideration D, the availability of other complementary risk screening information. The fact 

that Corn, steep liquor is not exempt from REACH and is the subject of a full REACH 

registration is not sufficient information. The petitioner indicated that Corn, steep liquor has an 

HPV status of 4, indicating that a company wished to sponsor it; however, the petitioner 

neglected to mention the more relevant point that not only had the substance been sponsored, but 

robust summaries and a test plan had been submitted to EPA, and the Agency had concluded that 

there is low concern for hazard for both ecotoxicity and human health endpoints.

6 Additionally, 

the listing of Corn, steep liquor as a 4B pesticide inert is outdated. Under 40 CFR 180.950(b), 

animal feed items have tolerance exemptions as minimal risk active or inert ingredients in 

pesticides. As the petitioner indicated, the primary use of Corn, steep liquor is as a nutrient 

supplement in animal feed. This is based on a determination that safety concerns would have 

been addressed during the long history of safe use of animals consuming the feed items and then 

producing products that are in turn consumed by humans (67 FR 1928, January 15, 2002). FDA 

listed Corn, steep liquor under 21 CFR 73.275 (also known as EAF Document 3073) as allowed 

in the color additive in dried algae meal used in chicken feed in accordance with prescribed 

conditions, with the same considerations as for the FIFRA minimal risk tolerance exemption.

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

information is available for Corn, steep liquor in its discussion under Consideration D. 

However, EPA’s determinations under the HPV Challenge Program that Corn, steep liquor has a 

low hazard concern, and under the Pesticides Program that Corn, steep liquor is of minimal risk 

for use in pesticides provide evidence of risk screening determinations in the United States for 

Corn, steep liquor. Overall, EPA concluded that the availability of information relevant to 

Consideration D weighs in favor of partially exempting Corn, steep liquor from CDR reporting.

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

The petitioner stated that the processing and use of Corn, steep liquor is well characterized and 

asserted that TSCA-regulated exposures are comparable to, or less significant than, the food-use 

 

6 Letter from Mark Townsend, EPA, to Steve Lomax, Corn Refiners Association, EPA Comments on Corn, steep Liquor Test Plan and Robust 

Summary Submission (January 24, 2008) http://www.epa.gov/hpv/pubs/summaries/cornstlq/c16469ct.pdf Accessed 18 June 2014
6

exposures associated with these substances, which have already been shown to be “safe”. While 

it is true that Corn, steep liquor’s predominant use in animal food is well characterized, this is 

not a use subject to TSCA. Under Consideration B, the petitioner also noted that Corn, steep

liquor is used in the chemical industry in the production of acetic acids, food acids and in 

fermentation, which would be uses subject to TSCA. Under Consideration C, the petitioner 

referenced the extensive data available on the ECHA website. 

The uses in the ECHA database are for the EU and indicate that Corn, steep liquor is used in 

Europe in fertilizers and products such as pH-regulators, flocculants, precipitants, and 

neutralization agents. Data from the non-confidential 2012 CDR database identified the 

following industrial uses: non-pesticidal agricultural chemicals, fillers, functional fluids, 

intermediates, and processing aids. The following consumer and commercial uses were also 

identified: non-pesticidal agricultural products, anti-freeze and de-icing products. 

On balance, 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 Corn, steep liquor 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 Corn, steep liquor 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 Corn, steep liquor. However, the petitioner did not specifically identify 

which uses of Corn, steep liquor are regulated by the foregoing governmental bodies or 

regulations, except for the FDA regulation at 21 CFR 73.275, which allows Corn, steep liquor to

be in dried algae meal that is used as a color additive in chicken feed.

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, or how such risk 

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

information.

As noted above, EPA has determined that Corn, steep liquor is a minimal risk active or inert 

pesticide ingredient. 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 
7

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.