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.
2

Background: EPA received a petition1from 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”)2, 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”3 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. 

 

1

CDR Partial Exemption Petition (December 14, 2011) (Hereinafter “The Petition”); From: Herb Estreicher, Keller and Heckman LLP; To:

OPPT CDR Submission Control Coordinator, U.S. Environmental Protection Agency; Re: “Request for exemption of certain food-related 

chemical substances from TSCA chemical data reporting (CDR) processing and use information reporting requirements in 2016” (3 pp.), with 

attachment titled “CDR petition for certain food-use substances 40 C.F.R. § 711.15(b)(2)(ii)(A) criterion information”(34 pp.).

2 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”).

3

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 
3

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 ECHA4

dissemination database for substances registered under the Registration, Evaluation, 

Authorisation, and Restriction of Chemicals (REACH)5regulation. 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). Acidleached 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 

 

4

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

5

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 .
4

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.

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For this reason, EPA accepts that acidleached 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

 

6

Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products. 

http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf
5

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, 
6

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 search7, 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 

 

7

http://www.vulcascot.at/media/content/downloads/tonsil_bleaching.pdf
7

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.