Document ID: EPA-HQ-OPPT-2014-0347-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-11-10T05:00Z

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. 

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 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."   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).

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, 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 endpoints. 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) registration.

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 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.

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. 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 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 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.