         Review Report for Bentonite, Acid-Leached (CASRN 70131-50-9)
                                   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:  Supporting petition information for Oils, palm kernel (CASRN 8023-79-8) and 1,3-Propanediol (CASRN 504-63-2) 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 bentonite, acid-leached (hereinafter "acid-leached bentonite")(CASRN 70131-50-9).  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:  After the review of 2012 CDR data, EPA concludes that at least one site would have production volume above the 25,000 lb threshold that is the reporting threshold for processing and use information for 2016; 2) Consideration B: The U.S. Food and Drug Administration (FDA) lists bentonite (CASRN 1302-78-9) as "Generally Recognized As Safe" (GRAS), and EPA's Office of Pesticide Programs (OPP) exempts it from requiring a tolerance in pesticides and includes it on a list of inert ingredients permitted in minimum risk pesticides. EPA noted the human health and environmental concerns for acid-leached bentonite (CASRN 70131-50-9). Concerning environmental fate, acid-leached bentonite is not biodegradable, and based on its physical chemical properties, it will persist in the environment, but will not bioconcentrate or bioaccumulate;  3) Consideration C: There are no identified 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 for this chemical substance; 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 U.S.; and 6) Consideration F: The information provided by the petitioner did not sufficiently address whether the potential risks for acid-leached bentonite are adequately managed by EPA or another authority; however, EPA examined the Occupational Safety and Health Administration (OSHA) regulations in place to protect workers from inhalation, an exposure route not covered by the FDA GRAS determination.  

A direct final rule to add acid-leached bentonite 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, EPA will reevaluate the decision to include it in the partial exemption. 

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 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"), a coalition of trade associations (hereinafter the "Coalition") requesting that acid-leached bentonite (CASRN 70131-50-9) 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 711.52(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 amendment to the IUR 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 substance.  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 Background 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 substance 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 acid-leached bentonite 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, 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 EPA's Integrated Risk Information System (IRIS),  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; whether the substance is subject to other regulatory programs administered by EPA; and use, exposure, regulatory and other information researched by EPA to supplement the petition.

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 that acid-leached bentonite was reported in the 2006 IUR.  EPA reviewed the 2012 CDR data for acid-leached bentonite and found that five companies reported domestically manufacturing and/or importing acid-leached bentonite with a nationally-aggregated production volume of 10,000,000 to 50,000,000 lbs in 2011.     

EPA has concluded that at least one site would likely have an increased production volume above the  25,000 lb threshold that would lead to reporting the processing and use information for 2016.  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).
For acid-leached bentonite, the petitioner included a summary of the data from ECHA dissemination database for substances registered under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation.  This information comes from registration dossiers submitted by companies.  EPA reviewed the study summaries to inform its decision on Consideration B.  Because the summaries do not contain detailed studies for evaluating hazards, EPA also considered other sources of information to inform its decisions on human health and environmental toxicity.  
Human Health Effects.  The acute (oral, dermal and inhalation) toxicity data summaries submitted for acid-leached bentonite were not in accordance with laboratory practices.  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 test substance was not irritating to rabbit skin, nor a dermal sensitizer (species not specified).  This substance is reported as irritating to the eyes (species not specified). For human health, FDA considers bentonite (CASRN 1302-78-9) a GRAS substance when used as a processing aid with good manufacturing practices resulting in no significant residues in foods (21 CFR 184.1155).  Acid-leached bentonite has been processed to remove impurities that are in bentonite; therefore, the GRAS designation is considered sufficient for informing potential human health concerns for acid-leached bentonite (CASRN 70131-50-9).Taken together, EPA considers acid-leached bentonite a low hazard to human health.
Environmental Effects.  The ecotoxicity data in ECHA's dissemination database are limited and no fish study was submitted.  A 48-hour median effective concentration (EC)50 for water fleas and a 72-hour EC50 for green algae were both reported to be >100 milligrams per liter (mg/L); however, in both studies the concentration of acid-leached bentonite in test solution was not measured, because the acid-leached bentonite would not dissolve after 30 minutes of shaking.  Although the petitioner indicated that acid-leached bentonite is listed on the EPA's Office of Pesticide Programs' Inert List as 4B, meaning they are permitted for use in nonfood use pesticide products, this is an outdated listing. Upon additional research, EPA determined that OPP lists bentonite under 40 CFR 180.910 as having an exemption from the requirements of a tolerance for use as a solid diluent or carrier in both pre- and post-harvest pesticides on food crops. Section 408(c)(2)(A)(i) of  Federal Food Drug and Cosmetic Act (FFDCA) allows EPA's OPP 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. In its recent proposal to clarify the specific ingredients that are permitted in minimum risk pesticide products, EPA reiterated that the intent was to eliminate the need to regulate products that were deemed to be of minimum risk to human health and the environment (77 FR 76979, December 31, 2012).  The draft regulatory text at 40 CFR 152.25(2)(iv)  includes bentonite as one of the specific permitted inert ingredients, which will codify directly in the regulations bentonite's presence on the already existing list of inert ingredients eligible for FIFRA 25(b) pesticide products.  For this reason, EPA accepts that acid-leached bentonite would be considered to present a low hazard to the environment.  

Environmental Fate.  The petitioner did not provide biodegradation, or bioconcentration fate testing results for acid-leached bentonite; however, fate testing for clay, such as the acid-leached bentonite, would not be expected to yield useful or new information.  Clays are known to undergo slow abiotic transformation over geologic time. These reactions are not expected to result in destruction of the substance. Because they do not contain organic carbon they do not undergo the sometimes extensive oxidative or reductive carbonaceous biodegradation typically measured in standard biodegradation tests for organic chemicals. As a mineral with a complex multilayered structure and relatively large size, acid-leached bentonite would not be expected to diffuse or undergo active transport through cell membranes into cells, therefore bioconcentration testing would not be expected to be informative.  Testing for other fate endpoints such as photolysis, hydrolysis, and partitioning is not expected to yield useful information.	

EPA accepts that the GRAS determination for bentonite by FDA and the EPA tolerance exemption and inclusion of bentonite in a list of inert ingredients that may be included in minimum risk pesticides provide sufficient evidence to address human health and environmental toxicity concerns (e.g., the evidence that the potential human health effects and/or environmental effects would be low),.  EPA recognizes that acid-leached bentonite is not biodegradable, and that based on its physical chemical properties, it will persist in the environment.  But evidence that it will not bioconcentrate or bioaccumulate is sufficient to address environmental fate concerns.  Taken together, this information is sufficient to weigh in favor of partially exempting acid-leached bentonite 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, which acknowledge that use of acid-leached bentonite in food applications is safe, and the extensive data published on the ECHA website.  The petitioner also noted that acid-leached bentonite has not been the subject of information collection requirement by EPA under TSCA (other than CDR), the Interagency Testing Committee (ITC), or the Agency for Toxic Substances and Disease Registry (ATSDR). 

EPA is not aware of any unmet information needs and agrees that recent processing and use information for acid-leached bentonite 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, 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 acid-leached bentonite 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 High Production Volume (HPV) Challenge Program and safety determinations for low toxicity pesticide inerts; 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 acid-leached bentonite 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 chemical substances not being listed on the two European lists.  The lack of inclusion of acid-leached bentonite in the HPV Challenge Program means that no screening information data would be available from that program for acid-leached bentonite because the HPV Challenge Program did not include inorganic chemical substances. As discussed under Consideration B, the listing of acid-leached bentonite as a 4B Inert Ingredient has been superseded. While EPA found that bentonite is listed for a tolerance exemption on food crops at 40 CFR 180.910 and is listed as an inert ingredient that may be used in minimum risk pesticides for food and nonfood uses, no risk screening information was found in association with those determinations. 

EPA finds that the petitioner has not provided evidence of the availability of other complementary risk screening information.  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 this consideration as sufficiently weighty to alter the overall weight of evidence in favor of establishing a partial reporting exemption.

Consideration E:  The availability of comparable processing and use information
While the petitioner indicated that acid-leached bentonite 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 stated 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."  

The petitioner included a list of uses obtained from ECHA's database.  The uses in the ECHA database are for the European Union and indicate that acid-leached bentonite may have broader use in Europe than in the United States.  Data from the non-confidential 2012 CDR database identified the primary industrial processing and use activities as adsorbents and absorbents primarily in petroleum sectors and use as fillers in paper manufacturing.  No consumer uses were reported and one commercial use in paper products was reported.  
Based on an internet search, EPA found that acid-leached bentonite is also used in dry cleaning applications for cleaning spent solvent.  On July 25, 2012, at EPA's request, the petitioner sent information stating that "Acid-leached bentonite is used in the vegetable oil refining step termed `bleaching,' which is used to remove color substances through adsorption.  Used acid-leached bentonite can be sold for use as a fertilizer depending on nutrient content.  According to publically available information, acid-leached bentonite is used as an absorbing media for technical applications, in the production of carbonless copy paper, and as a desiccant in packaging applications to protect against moisture."

Overall, the relevance of Consideration E to the disposition of the petition 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 acid-leached bentonite 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 this substance.

Consideration F:  Whether the potential risks for the chemical substance are adequately managed by EPA or another agency or authority.
The petitioner indicated that the manufacturing and use of acid-leached bentonite primarily falls within the jurisdiction and authority of the FDA.  The petition also stated that EPA, OSHA, the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC) regulate the manufacture and use of acid-leached bentonite.  Other than FDA regulations addressed in 21 CFR that list multiple uses [175.105, 175.300, 176.170, 178.3297, and 184.1155 (for bentonite CASRN 1302-78-9)], the petition did not specifically identify the regulations applicable to the uses of acid-leached bentonite.  The petition also did not explain why the downstream processing and use information should be of low current interest in light of these regulatory actions.  The petitioner stated that extensive information on the substance submitted as part of the REACH registration process, showed no identifiable hazards for acid-leached bentonite.  The petitioner also acknowledged that state regulations govern fertilizer products, volatile organic compound (VOC) content of paints and coatings, and phosphate and other chemical substances in detergents, and that "none of the existing federal or state regulation imposes restrictions on acid-leached bentonite and no restrictions are needed because, as already noted, the substance does not pose a hazard."  

Based on the toxicological profile, the route of exposure not specifically addressed by the information in the petition would be via inhalation of acid-leached bentonite in a powder form.  As noted above, the only references to regulations provided by the petitioner were to certain FDA regulations which cover use of bentonite in paper and paperboard products used in food packing with consideration for ingestion.  References to specific OSHA regulations for occupational exposure to acid-leached bentonite powder through inhalation were not provided.  EPA reviewed information on occupational controls that would be needed and regulations that are in place to protect workers from exposure with respect to the particle size of the powder and is satisfied that the chemical is adequately regulated.

EPA believes that the evidence of existing occupational controls for acid-leached bentonite is sufficient that Consideration F weighs in favor of establishing a partial exemption from reporting.   


