
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Proposed Rules]
[Pages 3396-3403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01533]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2018-0682; FRL-9988-56]


Asbestos; TSCA Section 21 Petition; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This document provides the reasons for EPA's response to a 
September 27, 2018, petition it received under the Toxic Substances 
Control Act (TSCA) from the following organizations: Asbestos Disease 
Awareness Organization, American Public Health Association, Center for 
Environmental Health, Environmental Working Group, Environmental Health 
Strategy Center, and Safer Chemicals Healthy Families 
(``petitioners''). Generally, the petitioners requested that EPA make 
multiple amendments to the Chemical Data Reporting (CDR) rule under 
TSCA by January 1, 2019, in order to increase the reporting of 
asbestos. After careful consideration, EPA denied the petition for the 
reasons discussed in this document.

DATES: EPA's response to this TSCA section 21 petition was signed on 
December 21, 2018, and a copy is available in the docket.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Tyler Lloyd, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4016; email address: 
lloyd.tyler@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of particular interest to those persons who manufacture or 
process or may manufacture (which includes import) or process the 
chemical asbestos (CAS No. 1332-21-4). Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. How can I access information about this petition?

    The docket for this TSCA section 21 petition, identified by docket 
identification (ID) number EPA-HQ-OPPT-2018-0682, is available at 
https://www.regulations.gov or at the Office of Pollution Prevention 
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

II. TSCA Section 21

A. What is a TSCA section 21 petition?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA 
to initiate a rulemaking proceeding for the issuance, amendment, or 
repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA 
sections 4, 5(e), or (f). A TSCA section 21 petition must set forth the 
facts which it is claimed establish that it is necessary to initiate 
the action requested. EPA is required to grant or deny the petition 
with 90 days of its filing. If EPA grants the petition, the Agency must 
promptly commence an appropriate proceeding. If EPA denies the 
petition, the Agency must publish its reasons for the denial in the 
Federal Register. A petitioner may commence a civil action in a U.S. 
district court to compel initiation of the requested rulemaking 
proceeding either within 60 days of either a denial or, if EPA does not 
issue a decision, within 60 days of the expiration of the 90-day 
period.

[[Page 3397]]

B. What criteria apply to a decision on a TSCA section 21 petition?

    TSCA section 21(b)(1) requires that the petition ``set forth the 
facts which it is claimed establish that it is necessary to issue, 
amend or repeal a rule.'' 15 U.S.C. 2620(b)(1).
    TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate 
rules under which manufacturers (including importers) and processors of 
chemical substances must maintain such records and submit such 
information as the EPA Administrator may reasonably require (15 U.S.C. 
2607). TSCA section 8(a)(2) outlines the information that the EPA 
Administrator may require under TSCA section 8(a)(1), insofar as it is 
known to the person making the report or insofar as reasonably 
ascertainable. Under TSCA section 8(a), EPA has promulgated several 
data collection rules, including the Chemical Data Reporting (CDR) rule 
at 40 CFR part 711.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On September 27, 2018, the Asbestos Disease Awareness Organization, 
American Public Health Association, Center for Environmental Health, 
Environmental Working Group, Environmental Health Strategy Center, and 
Safer Chemicals Healthy Families (petitioners) petitioned EPA to amend 
the CDR rule under TSCA section 8(a), within 90 days of the petition 
being filed, in order to increase the reporting of asbestos under the 
CDR rule (Ref. 1).
    The petitioners requested the following specific amendments to the 
existing CDR rule in order to collect information for the ongoing 
asbestos risk evaluation being conducted under TSCA section 6(b), which 
is required to be completed by December 22, 2019, and, if necessary, 
any subsequent risk management decisions under TSCA section 6(a):
     Amend the CDR rule to require immediate submission, ``from 
January 1, 2019, to April 31, 2019,'' of reports on asbestos for the 
2016 reporting cycle (note: The petitioners incorrectly stated that 
there are 31 days in April. EPA has corrected this error throughout the 
remainder of this notice);
     Amend the naturally occurring chemical substance exemption 
at 40 CFR 711.6(a)(3) to make the exemption inapplicable to asbestos;
     Amend the articles exemption at 40 CFR 711.10(b) to 
require reporting pursuant to the CDR rule for all imported articles in 
which asbestos is present at detectable levels;
     Amend the CDR rule to exclude asbestos from the exemption 
at 40 CFR 711.10(c) to require the reporting of asbestos as a byproduct 
or impurity;
     Amend the reporting threshold for CDR at 40 CFR 711.8(b) 
to set a reporting threshold of 10 pounds for asbestos; and
     Amend 40 CFR 711.8 to add processors of asbestos and 
asbestos-containing articles as persons required to report under the 
CDR rule.
    In addition to these amendments to the CDR rule, the petitioners 
requested that EPA ``commit to making all reports submitted on asbestos 
publicly available notwithstanding any claims that these reports 
contain Confidential Business Information (CBI)'' (Ref. 1). To disclose 
CBI reported under the CDR rule, the petitioners requested that EPA use 
its authority under TSCA section 14(d)(3) or 14(d)(7).
    After submitting their petition on September 27, 2018, petitioners 
followed up with a subsequent email to Jeff Morris, Director of EPA's 
Office of Pollution Prevention and Toxics, on November 29, 2018, 
requesting to ``incorporate in the petition by reference all the 
materials in EPA-HQ-OPPT-2016-0736, the docket for the TSCA Review and 
Risk Evaluation for asbestos'' (Ref. 2). EPA has discretion (but not an 
obligation) to consider this type of request in this subsequent email 
when evaluating a petition submitted under TSCA section 21. In cases 
where the petitioners themselves attempt to enlarge the scope of 
materials under review while EPA's petition review is pending, EPA 
exercises its discretion to consider or not consider the additional 
material based on whether the material was submitted early enough in 
EPA's petition review process to allow adequate evaluation of the 
additional materials prior to the petition response deadline and the 
relation of the late materials to materials already submitted. In this 
instance, and as a threshold matter, EPA believes the petitioners have 
failed to set forth the facts contained in all those docket materials 
that they claim establish that it is necessary for EPA to amend the CDR 
rule in the manner requested. Indeed, they have made no showing at all 
in this regard. Thus, EPA believes that petitioners' attempt to 
supplement the petition record in this way does not fulfill the 
requirements of TSCA section 21(b)(1). Furthermore, EPA believes that 
through its evaluation of the petition, it already has, in fact, made 
use of the information in the docket for the TSCA Review and Risk 
Evaluation for asbestos, because, as discussed in Unit IV.A.i., that 
information informs much of EPA's understanding of the current uses of 
asbestos.

B. What support do the petitioners offer?

    The petitioners state that TSCA section 8(a)(1) gives EPA broad 
authority to require manufacturers and processors of chemical 
substances to submit such reports as the ``Administrator may reasonably 
require.'' The CDR rule, which is one of several reporting rules 
promulgated under TSCA section 8, requires manufacturers (including 
importers) to provide EPA with information on the production and use of 
chemicals in commerce, generally 25,000 pounds or more of a chemical 
substance at any single site, with a reduced reporting threshold (2,500 
pounds) applying to chemical substances subject to certain TSCA 
actions, including, as applicable here, TSCA section 6. As the 
petitioners state, ``the CDR rule is EPA's primary tool under TSCA for 
obtaining basic information on the manufacture, importation, and use of 
chemicals and the nature and extent of exposure to these substances'' 
(Ref 1).
    While asbestos is already required to be reported under the CDR 
rule by manufacturers (including importers) meeting certain criteria, 
the petitioners request amendments to the CDR rule that they contend 
will increase the reporting of asbestos. Petitioners contend that these 
amendments could provide EPA with ``the comprehensive information on 
asbestos importation and use it needs for its ongoing risk evaluation'' 
(Ref. 1). The petitioners claim that ``the [CDR] rule has played no 
role in informing EPA about asbestos uses that could be addressed in 
the Agency's TSCA risk evaluation'' (Ref. 1). Petitioners add that 
their amendments would ``maximize EPA's ability to use the information 
reported to conduct the ongoing risk evaluation and the subsequent risk 
management rulemaking under TSCA section 6(a).''
    In their request, the petitioners state that ``asbestos is among 
the most dangerous chemicals ever produced, with expert bodies agreeing 
that there is no safe level of exposure.'' The petitioners cite 
research finding dangers from asbestos and provide a review of asbestos 
assessments and regulations under TSCA. In their petition, they state 
that in 1989, EPA determined that ``nearly all uses of asbestos 
presented an `unreasonable risk of injury' under section 6 of TSCA'' 
and assert that ``the basis for this conclusion is even more compelling 
today'' (Ref. 1).
    The petitioners state their belief that EPA ``lacks the basic 
information required for a complete and informed

[[Page 3398]]

risk evaluation that assures that unsafe asbestos uses are removed from 
commerce'' (Ref. 1). To support their assertion, the petitioners point 
to EPA's asbestos Problem Formulation (83 FR 26998, June 11, 2018) 
(FRL-9978-40), which, they say, ``attempts to identify the asbestos 
uses that EPA will address in its risk evaluation but its description 
of these uses is limited, vague and incomplete.'' Moreover, the 
petitioners cite language in the Problem Formulation that states that 
``the import volume of products containing asbestos is not known'' (Ref 
1).

IV. Background Considerations

A. Review of EPA Actions, Activities, and Regulations

    To understand EPA's reasons for denying the petitioners' requests, 
it is important to first review the details of EPA's ongoing risk 
evaluation of asbestos, the CDR rule, exemptions under the CDR rule, 
and past reporting of asbestos under the CDR rule, which are explained 
in the following sections.
    i. Risk evaluation of asbestos. On June 22, 2016, Congress passed 
the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. 
L. 114-182), which amended TSCA (15 U.S.C. 2601 et seq.). The new law 
includes statutory requirements related to the risk evaluations of 
conditions of use for existing chemicals. On December 19, 2016, in the 
Federal Register, EPA designated asbestos as one of the first 10 
chemical substances subject to the Agency's initial chemical risk 
evaluations (81 FR 91927) (FRL-9956-47) pursuant to TSCA section 
6(b)(2)(A) (15 U.S.C. 2605(b)(2)(A)), which required EPA to identify 
the first 10 chemicals to be evaluated no later than 180 days after the 
date of enactment of the Act.
    EPA is currently evaluating the risks of asbestos under its 
conditions of use, pursuant to TSCA section 6(b)(4)(A). Through scoping 
and subsequent research for the asbestos risk evaluation, EPA 
identified the conditions of use of asbestos, including imported raw 
bulk chrysotile asbestos for the fabrication of diaphragms for use in 
chlorine and sodium hydroxide production; several imported chrysotile 
asbestos-containing materials, including sheet gaskets for production 
of titanium dioxide; brake blocks for oil drilling, aftermarket 
automotive brakes/linings, and other vehicle friction products; other 
gaskets and packing; cement products; and woven products (Ref. 3). In 
identifying the conditions of use for asbestos and the rest of the 
first 10 chemicals undergoing risk evaluation under amended TSCA, EPA 
included use information reported under the CDR rule. In addition to 
using CDR data to identify the current conditions of use of asbestos, 
EPA conducted extensive research and outreach. This included EPA's 
review of published literature and online databases including Safety 
Data Sheets (SDSs), the United States Geological Survey's Mineral 
Commodities Summary and Minerals Yearbook, the U.S. International Trade 
Commission's Dataweb, and government and commercial trade databases. 
(See Docket EPA-HQ-OPPT-2016-0736). Additionally, EPA worked with its 
federal partners, such as Customs and Border Protection, to enhance its 
understanding of import information on asbestos-containing products in 
support of the risk evaluation.
    EPA also reviewed company websites of potential manufacturers, 
importers, distributors, retailers, or other users of asbestos and 
received public comments (1) during the February 2017 public meeting on 
the scoping efforts for the risk evaluations for the first ten 
chemicals, (2) when EPA published the Scope of the Risk Evaluation for 
Asbestos in June 2017, and (3) when EPA published the Problem 
Formulation of the Risk Evaluation for Asbestos in June 2018, all of 
which were used to identify the conditions of use. (See Docket EPA-HQ-
OPPT-2016-0736). In addition, to inform EPA's understanding of the 
universe of conditions of use for asbestos for the scope document 
published in June 2017, EPA convened meetings with companies, industry 
groups, chemical users, and other stakeholders (Ref. 3). Lastly, on 
June 11, 2018, EPA proposed a significant new use rule (SNUR), in an 
administrative proposal separate and apart from the ongoing risk 
evaluation process under TSCA section 6, for certain uses of asbestos 
(including asbestos-containing goods) (83 FR 26922; FRL-9978-76) and 
asked for public comment or information on ongoing uses of asbestos. In 
the public comments submitted on the SNUR, EPA received no new 
information on any ongoing uses. (See Docket EPA-HQ-OPPT-2018-0159).
    In the Problem Formulation for asbestos, based on the 
aforementioned outreach and research, EPA did not identify any 
conditions of use of asbestos as a byproduct or as an impurity. As 
stated in EPA's Problem Formulation for asbestos (Ref. 3), EPA has 
identified the conditions of use as imported raw bulk chrysotile 
asbestos for the fabrication of diaphragms for use in chlorine and 
sodium hydroxide production; several imported chrysotile asbestos-
containing materials, including sheet gaskets for production of 
titanium dioxide; brake blocks for oil drilling, aftermarket automotive 
brakes, linings, and other vehicle friction products; other gaskets and 
packing; cement products; and woven products.
    The purpose of EPA's risk evaluation is to determine whether a 
chemical substance presents an unreasonable risk to health or the 
environment, under the conditions of use, including an unreasonable 
risk to a relevant potentially exposed or susceptible subpopulation (15 
U.S.C. 2605(b)(4)(A)). As part of this process, EPA must evaluate both 
hazard and exposure, excluding consideration of costs or other non-risk 
factors, use scientific information and approaches in a manner that is 
consistent with the requirements in TSCA for the best available 
science, and ensure decisions are based on the weight-of-scientific-
evidence. EPA intends to finalize the risk evaluation for asbestos by 
December 2019, as required by TSCA.
    ii. The CDR rule. The CDR rule requires U.S. manufacturers 
(including importers) of chemicals on the TSCA Inventory, with some 
exceptions, to report to EPA every four years the identity of chemical 
substances manufactured (including imported) for all years since the 
last principal reporting year (40 CFR 711.8(a)(2)). For example, for 
the 2020 submission period, the principal reporting year will be 2019; 
the principal reporting year for the 2016 submission period was 2015. 
Per the CDR rule at 40 CFR 711.20, the 2020 submission period will be 
from June 1, 2020, to September 30, 2020, followed by EPA review and 
validation of the reported data before it is released to the public. 
Reporting during the 2020 submission period will cover the manufacture 
of chemicals in 2016, 2017, 2018, and 2019. To reduce reporting burden, 
detailed information is required only for the principal reporting year 
(i.e., 2019), including a breakout of the production volume to provide 
separate volumes for domestically manufactured and imported amounts. 
Generally, reporting is required for substances with production volumes 
of 25,000 pounds or more at any single site during any of the calendar 
years since the last principal reporting year. However, a lower 
threshold applies for chemical substances that are the subject of 
certain TSCA actions (see 40 CFR 711.8(b)). The CDR regulation 
generally exempts several groups of chemical substances from its 
reporting requirements, e.g., polymers, microorganisms, naturally 
occurring chemical substances, certain

[[Page 3399]]

forms of natural gas, and water (see 40 CFR 711.5 and 711. 6).
    iii. Exemptions from reporting under the CDR rule. In addition to 
the exemption for naturally occurring chemical substances, if the 
chemical substance is imported solely as part of an article, the 
chemical substance is exempt from being reported under the CDR rule (40 
CFR 711.10(b)). An article is defined in 40 CFR 704.3 as ``a 
manufactured item (1) which is formed to a specific shape or design 
during manufacture, (2) which has end-use function(s) dependent in 
whole or in part upon its shape or design during end use, and (3) which 
has either no change of chemical composition during its end use or only 
those changes of composition which have no commercial purpose separate 
from that of the article, and that result from a chemical reaction that 
occurs upon end use of other chemical substances, mixtures, or 
articles; except that fluids and particles are not considered articles 
regardless of shape or design.''
    Under the CDR rule, a byproduct may be reportable when it is 
manufactured for a commercial purpose. The definition of manufacture 
for commercial purposes at 40 CFR 704.3 includes: ``. . . substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture, including both 
byproducts . . .'' Under 40 CFR 720.30(g) a byproduct is exempt from 
reporting if: `` . . . its only commercial purpose is for use by public 
or private organizations that (1) burn it as a fuel, (2) dispose of it 
as a waste, including in a landfill or for enriching soil, or (3) 
extract component chemical substances from it for commercial purposes. 
(This exclusion only applies to the byproduct; it does not apply to the 
component substances extracted from the byproduct.)''
    Impurities are exempt from CDR requirements. See 40 CFR 711.10(c) 
and 40 CFR 720.30(h)(1). An impurity is defined as a chemical substance 
unintentionally present with another chemical substance (40 CFR 704.3). 
Impurities are not manufactured for distribution in commerce as 
chemical substances per se and have no commercial purpose separate from 
the substance, mixture, or article of which they are a part.
    Furthermore, processors do not report under the CDR rule. 
Processing information is reported by the manufacturers: If a 
manufacturer reports a chemical under the CDR rule, it must also report 
processing and use information for the chemical substance unless it is 
exempted from this reporting by 40 CFR 711.6(b).
    iv. Asbestos reporting under the CDR rule. Two companies, both from 
the chlor-alkali industry, reported importing raw asbestos during the 
2016 CDR reporting cycle (Ref. 4) and did not claim the exemption for 
naturally occurring substances. Both companies claimed their reports as 
CBI. Because asbestos has not been mined or otherwise produced in the 
United States since 2002 (Ref. 5), all raw asbestos used in the U.S. is 
imported.

V. Petition Response

A. What was EPA's response?

    After careful consideration, EPA has denied the petition. A copy of 
the Agency's response, which consists of a letter to the signatory 
petitioner from the Asbestos Disease Awareness Organization (Ref. 6), 
is available in the docket for this TSCA section 21 petition. In 
accordance with TSCA section 21, the reasons for the denial are set 
forth in this Federal Register document.

B. What are the details of the petitioners' requests and EPA's decision 
to deny each of the requests?

    This unit provides the reasons for EPA's decision to deny the 
petition asking EPA to amend the CDR rule and lift CBI protection for 
asbestos for all reports under the CDR rule.
    i. Require immediate reporting of asbestos to CDR for the 2016 
reporting cycle.
    a. Petitioners' request. The petitioners requested revisions to the 
CDR rule that would ``trigger immediate reporting on asbestos for the 
2012-2016 reporting cycle.'' To do this, the petitioners requested that 
EPA amend 40 CFR 711.20 to read: ``For asbestos, the 2016 CDR 
submission period is from January 1, 2019 to April [30], 2019'' (Ref. 
1). The petitioners believe that this information will be useful to EPA 
in support of the ongoing asbestos risk evaluation, which is required 
to be completed by December 22, 2019, and any subsequent risk 
management rulemakings under TSCA section 6(a).
    More specifically, the request for immediate reporting was made by 
the petitioners to ``make it possible for EPA to review and analyze the 
reports submitted while the risk evaluation is underway and to revise 
the draft evaluation on the basis of new information reported on 
asbestos importation and use'' (Ref. 1). Additionally, the petitioners 
suggested that EPA ``extend the completion date for the asbestos risk 
evaluation by six months under section 6(b)(4)(G)(ii)'' to allow the 
Agency time to receive the new data collected under the CDR rule as 
proposed (Ref. 1).
    b. Agency response. EPA does not believe that the requested 
amendments would result in the reporting of any information that is not 
already known to EPA. As noted in more detail in Unit IV, EPA conducted 
extensive research and outreach to develop its understanding of import 
information on asbestos-containing products in support of the ongoing 
asbestos risk evaluation. After more than a year of research and 
stakeholder outreach, EPA believes that the Agency is aware of all 
ongoing uses of asbestos and already has the information that EPA would 
receive if EPA were to amend the CDR requirements. As such, amending 
the CDR requirements would not provide the Agency with any additional 
information, and EPA does not believe it would collect information on 
any new ongoing uses by making the requested amendments to the CDR 
rule.
    Furthermore, even if EPA believed that the requested amendments 
would collect information on any new ongoing uses, EPA would not be 
able to finalize such amendments in time to inform the ongoing risk 
evaluation or, if needed, any subsequent risk management decision(s). 
The petitioners stated that their requested revisions should ``trigger 
immediate reporting on asbestos for the 2012-2016 reporting cycle'' 
(Ref. 1). Specifically, the petitioners asked that EPA amend 40 CFR 
711.20 to require reporting for the 2016 CDR submission period (i.e., 
2012-2015); they requested that this reporting be required to start on 
January 1, 2019, and to end on April 30, 2019.
    The petitioners, however, submitted their request on September 27, 
2018, less than 120 calendar days before they would like the submission 
period to begin. While EPA understands that petitioners desire prompt 
collection of the requested information under the CDR rule to inform 
the ongoing risk evaluation, this request does not factor in the 
necessary timeframes for any rulemaking processes that would be 
required to propose and then finalize such amendments. To allow for the 
notice and comment period for the public and regulated community 
required under the Administrative Procedure Act (5 U.S.C. 553) and for 
appropriate internal deliberation prior to proposal and after the close 
of the comment period, EPA typically needs at least 18 months to 
finalize a rulemaking. Furthermore, even if EPA were able to use 
expedited rulemaking procedures to quickly promulgate a requirement to

[[Page 3400]]

report additional information on asbestos for the 2016 CDR cycle, it is 
important to note that potential reporters have had no prior notice or 
expectation of a need to retain the records necessary to report on past 
chemical manufacturing. Therefore, EPA has no reason to expect that 
potential reporters subject to such a rule amendment would have 
information that could be reasonably ascertainable for submission.
    Additionally, the January through April 2019 submission period that 
the petitioners requested would not, in fact, provide timely 
information for the ongoing risk evaluation on asbestos. While the 
petitioners suggest that EPA ``should extend the completion date for 
the asbestos risk evaluation by six months under section 
6(b)(4)(G)(ii)'' (Ref. 1), such an extension would not allow time for 
EPA to (1) conduct a data collection effort under the CDR rule and (2) 
incorporate this data into the ongoing risk evaluation prior to public 
comment and peer review.
    Petitioners' request to extend the completion date of the final 
risk evaluation for asbestos by six months would move the completion 
from December 2019 to June 2020. Yet, any changes to the CDR rule would 
need to be made by notice-and-comment rulemaking that would involve, at 
a minimum, five to eight months to develop the proposed rule, a 30 to 
60-day comment period, and five to eight months to complete the final 
rule. Under this hypothetical rulemaking scenario outlined, even if the 
rulemaking process began in December 2018, the data elements requested 
by the petitioners would not result in available data until, at the 
very earliest, March 2020 (only three months prior to completion of the 
six-month deferred risk evaluation). Petitioners' request ignores the 
fact that the draft risk evaluation must undergo public comment and 
peer review, which is a four to eight-month process (see 15 U.S.C. 
2605(b)(4)(H); 40 CFR 702.45; 40 CFR 702.49).
    Moreover, even if the regulations were amended and, in response to 
the finalized amendments, chemical manufacturers could reasonably 
ascertain and provide the newly-required information, EPA would be 
receiving information on manufacturing, import, and processing for 
conditions of use that may no longer be ongoing conditions of use. As 
an example, in comparing the 2012 and 2016 United States Geological 
Survey Minerals Yearbook for asbestos (Refs. 7 and 5), EPA has observed 
that a number of importers of raw asbestos and asbestos-containing 
articles are exiting or have already exited the market. As a result, 
all or a significant part of the information they would report for 
activities undertaken during the 2016 CDR submission period (i.e., 
2012-2015) would likely consist of conditions of use that are no longer 
ongoing, and, thus, uninformative for the risk evaluation.
    In sum, EPA believes--based on the extensive research and data 
gathering already conducted during the asbestos risk evaluation 
process--that the requested amendments to the CDR rule would not lead 
to the reporting of new information that would contribute to EPA's 
ongoing asbestos risk evaluation or, if needed, subsequent risk 
management decision(s). Based on outreach and research, EPA believes 
that the Agency already has the information that would be collected, 
without amending the CDR rule. Furthermore, and, as previously 
discussed, EPA would not be able to promulgate a rulemaking to require 
the reporting by the submission period (beginning January 1, 2019) the 
petitioners requested, nor would the rulemaking amendments discussed 
above allow EPA to receive any new information in time to inform the 
ongoing asbestos risk evaluation.
    EPA finds that petitioners have failed to set forth sufficient 
facts to establish that it is necessary to issue the requested 
amendment to require immediate past reporting of the manufacturing and 
use of asbestos under the CDR rule for the 2016 reporting cycle.
    ii. Lift exemption for naturally occurring chemical substances for 
asbestos.
    a. Petitioners' request. Several times in the petition, the 
petitioners requested that EPA either add asbestos to the CDR rule or 
close what they referred to as a ``reporting loophole'' for asbestos 
under the CDR rule. Under the exemption for naturally occurring 
chemical substances at 40 CFR 711.6(a)(3), manufacturers (including 
importers) do not have to report a chemical substance when the 
substance is manufactured as described at 40 CFR 710.4(b).
    As support for the petitioners' claim of a reporting loophole for 
asbestos, the petitioners cited EPA's letter to Occidental Chemical 
Corporation (Occidental), dated July 28, 2017, wherein EPA stated that 
it did not believe Occidental was required to report its imports of 
asbestos under the CDR rule because Occidental's operations satisfied 
the criteria of the naturally occurring chemical substances exemption 
(Ref. 1). EPA issued this letter in response to the Asbestos Disease 
Awareness Organization's notice of intent to sue Occidental for what 
the Organization believed to be a CDR violation. In reaction to EPA's 
letter to Occidental, the petitioners stated that ``EPA's 
interpretation of the CDR rule means that no manufacturers or importers 
of asbestos or asbestos-containing products were required to report on 
their activities'' (Ref. 1). The petitioners further posited that 
``this loophole in the rule has resulted in a troubling--and wholly 
avoidable--lack of reliable information about who is importing asbestos 
and in what quantities, where and how asbestos is being used in the 
U.S., and who is being exposed and how that exposure is occurring'' 
(Ref. 1).
    b. Agency response. EPA emphasizes that manufacturers and importers 
of asbestos are already required to report asbestos under the CDR rule 
if they meet the production volume threshold of 2,500 pounds and do not 
qualify for an exemption (including the naturally occurring substances 
exemption). As noted above, during the last reporting cycle, two 
companies reported under the CDR rule the import of asbestos for use in 
the chloro-alkali industry to make asbestos diaphragms. After extensive 
research and outreach, including with Customs and Border Protection, 
EPA believes that the chloroalkali industry is the only importer of raw 
bulk asbestos, and the Agency has sufficient volume, import, use, and 
hazard data from the industry to conduct the risk evaluation.
    Petitioners mistakenly seem to believe that no domestically 
manufactured or imported asbestos is currently required to be reported 
under the CDR rule as a result of the exemption for naturally occurring 
substances. EPA's letter to Occidental, however, found that the 
exemption for naturally occurring substances applied under the specific 
circumstances described in the letter. EPA did not find that the 
exemption applied for all ``manufacturers or importers of asbestos or 
asbestos-containing products'' as claimed by petitioners.
    In general, the petitioners, misunderstand the naturally occurring 
substances exemption's specific definition. As defined by 40 CFR 
711.6(a)(3), a naturally occurring chemical substance is:

    Any naturally occurring chemical substance, as described in 40 
CFR 710.4(b). The applicability of this exclusion is determined in 
each case by the specific activities of the person who manufactures 
the chemical substance in question. Some chemical substances can be 
manufactured both as described in 40 CFR 710.4(b) and by

[[Page 3401]]

means other than those described in 40 CFR 710.4(b). If a person 
described in Sec.  711.8 manufactures a chemical substance by means 
other than those described in 40 CFR 710.4(b), the person must 
report regardless of whether the chemical substance also could have 
been produced as described in 40 CFR 710.4(b). Any chemical 
substance that is produced from such a naturally occurring chemical 
substance described in 40 CFR 710.4(b) is reportable unless 
otherwise excluded.

    A chemical substance qualifies as naturally occurring only if it 
is: (1)(i) Unprocessed or (ii) processed only by manual, mechanical, or 
gravitational means; by dissolution in water; by flotation; or by 
heating solely to remove water; or (2) extracted from air by any means 
(40 CFR 710.4(b)). Mined materials such as metal ores, minerals, and 
clays that are separated from the natural environment by only physical 
means are examples of chemical substances that are considered naturally 
occurring for TSCA purposes and are exempt from reporting under the CDR 
rule. If this specifically defined exemption does not apply (and if no 
other exemption applies), then a manufacturer or importer of asbestos 
must report under the CDR rule.
    In addition, given that the purpose of domestic manufacturing or 
importing of raw asbestos is to make asbestos diaphragms, for which EPA 
already has use and exposure information, removing the exemption for 
reporting on naturally occurring substances for asbestos would not 
provide any additional data to EPA. EPA already has this information 
obtained through extensive outreach and research (as described in Unit 
IV.A.i.).
    EPA finds that petitioners have failed to set forth sufficient 
facts to establish that it is necessary to issue the requested 
amendment to lift the naturally occurring chemical substances exemption 
for asbestos under the CDR rule.
    iii. Require reporting of imported articles containing asbestos.
    a. Petitioners' request. As noted by the petitioners, 40 CFR 
711.10(b) exempts from reporting persons who import a reportable 
substance as part of an article. Additionally, the petitioners asserted 
that ``since a large number of the asbestos-containing products 
historically in use are articles, this exemption would prevent EPA from 
obtaining a considerable amount of useful information about asbestos 
use and exposure in the U.S.'' As such, the petitioners requested that 
EPA make the articles exemption at 40 CFR 711.10 inapplicable to 
asbestos. Furthermore, they requested that reporting be required for 
``all imported articles in which asbestos is present at detectable 
levels'' (Ref. 1).
    b. Agency response. Import of a chemical substance as part of an 
article is not subject to reporting under the CDR rule (40 CFR 
711.10(b)). A chemical substance is considered to be imported ``as part 
of an article'' if the substance is not intended to be removed from 
that article and has no end use or commercial purpose separate from the 
article of which it is a part (Ref. 8).
    While the petitioners correctly pointed out that ``a large number 
of the asbestos-containing products historically in use [were] 
articles'' (Ref. 1), these uses, along with most uses of asbestos, have 
ceased and thus are not being evaluated as part of the ongoing asbestos 
risk evaluation (Ref. 3). As identified in the Problem Formulation of 
the Risk Evaluation for Asbestos, currently imported articles include 
asbestos-containing sheet gaskets, other gaskets and packing, 
aftermarket automotive brakes/linings, other vehicle friction products, 
brake blocks, asbestos cement products, and woven products. EPA has 
relied on extensive outreach and research, including sources other than 
the CDR rule, to determine the conditions of use of asbestos, as 
described in Unit IV.A.i. The Agency does not believe amending the CDR 
rule would be helpful in collecting additional import information on 
articles. EPA has sufficient information on imported articles 
containing asbestos to conduct the risk evaluation and inform 
subsequent risk management decisions based the risk determination.
    Though the petitioners suggested that there may be import of 
additional articles containing asbestos that EPA is unaware of, they 
provide no examples of any such known or ongoing imports of asbestos 
articles and provide no reason to believe that there may be any of 
which EPA is unaware. Considering the extensive outreach and research 
that has been conducted since December 2016, EPA has no reason to 
believe there are ongoing imports of articles containing asbestos that 
are unknown to EPA.
    While the petitioners requested that EPA require reporting for 
``all imported articles in which asbestos is present at detectable 
levels'' (Ref. 1), the information that manufacturers are required to 
report under the CDR rule is limited to information ``known to or 
reasonably ascertainable'' by the reporter (40 CFR 704.3). EPA could 
not require manufacturers to test these products for the purposes of 
CDR reporting under TSCA section 8. Therefore, EPA would not be able to 
require CDR reporters to report articles in which the potential 
presence of asbestos could be determined only through testing.
    Additionally, because information reported under the CDR rule is 
limited to that which is ``known to or reasonably ascertainable'' by 
the reporter, even if EPA were to require the reporting of asbestos-
containing articles under the CDR rule, importers would rely on 
information readily available to them, such as Safety Data Sheets or 
other documentation provided by their foreign supplier. EPA does not 
believe that making the requested amendment to the CDR rule would 
result in importers reporting articles that are not already known to 
EPA because the Agency has conducted its own research to analyze Safety 
Data Sheets and other evidence in order to determine the conditions of 
use of asbestos for the risk evaluation. EPA believes that lifting the 
articles exemption for the reporting of asbestos under the CDR rule 
would not provide any new use information that would inform the ongoing 
risk evaluation or any subsequent risk management decisions, if needed.
    For these reasons, EPA believes that the petitioners have failed to 
set forth sufficient facts to establish that it is necessary to issue 
the requested amendment to lift the articles exemption for asbestos 
under the CDR rule.
    iv. Lift the byproduct and impurity exemption for asbestos.
    a. Petitioners' request. The petitioners cited 40 CFR 711.10(c), 
which exempts from CDR reporting activities described in 40 CFR 
720.30(g) and (h). Under this exemption, manufacturers (including 
importers) do not have to report a chemical substance when the 
substance is an impurity or a byproduct not used for commercial 
purposes. The petitioners requested that these exemptions be made 
inapplicable to asbestos, ``since the low levels of asbestos that have 
been found in makeup and crayons may be unintended contaminants that 
comprise byproducts and impurities'' (Ref. 1). Moreover, the 
petitioners stated that, ``EPA needs information about asbestos-
contaminated consumer products to conduct a complete and protective 
risk evaluation'' (Ref. 1)
    b. Agency response. Under 40 CFR 720.30(g), a byproduct is exempt 
from reporting if: ``. . . its only commercial purpose is for use by 
public or private organizations that (1) burn it as a fuel, (2) dispose 
of it as a waste, including in a landfill or for enriching soil, or (3) 
extract component chemical substances from it for commercial 
purposes.''

[[Page 3402]]

Under 40 CFR 720.30(h), any (1) impurity or (2) any byproduct that is 
not used for a commercial purpose is not subject to reporting. Based on 
the extensive outreach and research undertaken by EPA in connection 
with developing the ongoing asbestos risk evaluation, EPA is unaware of 
any examples of asbestos as a byproduct. Thus, EPA anticipates there 
would be no new information reported if the Agency were to lift the 
byproduct exemption for asbestos.
    With regard to the impurity exemption, the petitioners requested 
that these exemptions be made inapplicable to asbestos ``since the low 
levels of asbestos that have been found in makeup and crayons may be 
unintended contaminants that comprise byproducts and impurities'' 
(emphasis added). However, these findings were made only after 
independent laboratory testing of final consumer products, and 
petitioners make no attempt to explain why they believe these findings 
are the result of the manufacture of asbestos as a byproduct or 
impurity such that it would be reportable under the CDR rule if the 
Agency required such reporting. Indeed, the CDR rule does not require 
submitters to perform chemical analyses of products containing the 
chemicals they manufacture. Instead, the information required when 
reporting on a chemical is limited to information that is ``known to or 
reasonably ascertainable'' by the manufacturer. This standard is 
applicable to all information reported in accordance with 40 CFR 
711.15(b) as required by TSCA section 8(a)(2). Thus, it is unlikely 
that EPA would receive new information that would change its 
understanding of the conditions of use for asbestos that can be 
addressed under TSCA.
    EPA does not believe that making the requested amendment to the CDR 
rule would result in reporting of asbestos as an impurity or a 
byproduct, for uses that are known or reasonably ascertainable, and the 
petitioners have not provided evidence that there are such known uses 
that are ongoing but remain outside the scope of the asbestos risk 
evaluation. EPA finds that the petitioners have failed to set forth 
sufficient facts to establish that it is necessary to issue the 
requested amendment to lift the byproducts and impurities exemptions 
for asbestos under the CDR rule.
    v. Lower asbestos reporting threshold to 10 pounds.
    a. Petitioners' request. Manufacturers (including importers) are 
required to report under the CDR rule if they meet certain production 
volume thresholds, generally 25,000 pounds or more of a chemical 
substance at any single site. However, a reduced reporting threshold of 
2,500 pounds applies to chemical substances subject to certain TSCA 
actions (40 CFR 711.8). The petitioners correctly point out that 
because asbestos is subject to a TSCA section 6 action (40 CFR 763, 
subpart I), it is subject to the lower reporting threshold of 2,500 
pounds. The petitioners believe that even the reduced reporting 
threshold ``is too high in view of the absence of any safe level of 
exposure to asbestos and the need for comprehensive use and exposure 
information for the ongoing risk evaluation'' (Ref. 1). The petitioners 
therefore request that the reporting threshold for asbestos be lowered 
to 10 pounds for any year in the CDR reporting period.
    b. Agency response. Since asbestos is no longer mined in the United 
States and the only importation of raw asbestos is for production of 
asbestos diaphragms, for which yearly imports for each site well exceed 
the threshold of 2,500 pounds, lowering the reporting threshold would 
not provide additional information to EPA. As a result, EPA believes 
that it already sufficient import data from the chloralkali industry to 
support conducting the risk evaluation.
    While the petitioners believe that the current reporting threshold 
``is too high in view of the absence of any safe level of exposure to 
asbestos and the need for comprehensive use and exposure information 
for the ongoing risk evaluation,'' they fail to show that lowering the 
reporting threshold would provide any new information to EPA. 
Therefore, EPA finds that the petitioners have failed to set sufficient 
facts to establish that it is necessary to issue the requested 
amendment to lower the CDR reporting threshold for asbestos.
    vi. Add processors of asbestos to CDR.
    a. Petitioners' request. The petitioners pointed out that, while 
EPA has the authority to require that processors report under the CDR 
rule, processors are not currently subject to CDR reporting 
requirements. The petitioners requested that EPA amend the CDR rule to 
require reporting from asbestos processors asserting that, while 
manufacturers (including importers) of a chemical substance are 
required to report downstream processing and use information under the 
CDR rule, ``in many cases, importers will be unable to provide the 
detailed information about use and exposure necessary for full 
understanding of the risks posed by these products. Therefore, the 
additional information available to processors will be essential'' 
(Ref. 1).
    b. Agency response. Currently, the CDR rule does not require 
processors of any chemical substances to report. However, EPA knows of 
only two ongoing uses of asbestos that constitute processing: (1) The 
processing of raw asbestos into diaphragms and (2) the fabrication of 
gaskets from imported asbestos-containing sheet gaskets. Information on 
these uses is well understood by EPA as a result of direct 
communication with these processors (see Problem Formulation for 
asbestos (Ref. 3)). Accordingly, EPA does not believe that requiring 
processors of asbestos under the CDR rule will provide useful 
information not already in the Agency's possession. The petitioners 
have failed to indicate what additional information EPA would collect 
by requiring asbestos processors to report under the CDR rule. 
Therefore, EPA finds that the petitioners have failed to set forth 
sufficient facts to establish that it is necessary to issue the 
requested amendment to require processors of asbestos to report under 
the CDR rule.
    vii. Lift CBI claims for all reports to CDR for asbestos.
    a. Petitioners' request. In addition to the requests made under 
TSCA section 8, the petitioners requested that EPA use its authority 
under TSCA sections 14(d)(3) and 14(d)(7) to lift CBI claims on 
asbestos information reported under the CDR rule.
    TSCA section 14(d)(3) states that CBI ``shall be disclosed if the 
Administrator determines that disclosure is necessary to protect health 
or the environment against an unreasonable risk of injury to health or 
the environment, without consideration of costs or other nonrisk 
factors, including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by the Administrator 
under the conditions of use'' (15 U.S.C. 2613(d)(3)). The petitioners 
requested that EPA use its authority under TSCA section 14(d)(3) to 
lift CBI claims on information reported under the CDR rule, ``given the 
significant risk of harm that asbestos presents at any level of 
exposure, knowledge of how, where and in what quantities asbestos and 
asbestos-containing products are being imported and used is clearly 
necessary to protect against unreasonable risks and EPA would have an 
ample basis to make a determination to that effect'' (Ref. 1).
    TSCA section 14(d)(7) states that CBI ``may be disclosed if the 
Administrator determines that disclosure is relevant in a proceeding 
under this Act, subject to the condition that the disclosure is made in 
such a manner as to preserve confidentiality to the extent practicable 
without impairing the proceeding'' (15 U.S.C. 2613(d)(7)). For EPA's 
authority under TSCA section 14(d)(7), the

[[Page 3403]]

petitioners posited that ``the ongoing asbestos risk evaluation is such 
a `proceeding' and information on asbestos importation and use is 
clearly `relevant' because it has a direct bearing on EPA's 
determinations of exposure and risk and the ability of the public to 
comment on these elements of the risk evaluation'' (Ref. 1).
    b. Agency response. Petitioners' request is not appropriate for a 
TSCA section 21 petition. Under TSCA section 21 (15 U.S.C. 2620(a)), 
any person can petition EPA to initiate a rulemaking proceeding for the 
issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 
8, or an order under TSCA sections 4 or 5(e) or (f). Under this express 
statutory language, therefore, a TSCA section 21 petition is not a 
vehicle to petition EPA to initiate an action under TSCA section 14.
    Moreover, even if petitioners could use the TSCA section 21 
mechanism to request an action under TSCA section 14, the petitioners 
have not made a sufficient case for lifting CBI protections as 
described by either TSCA section 14(d)(3) or section 14(d)(7). TSCA 
section 14(d)(3) states that CBI ``shall be disclosed if the 
Administrator determines that disclosure is necessary to protect health 
or the environment against an unreasonable risk of injury to health or 
the environment. . . .'' The asbestos risk evaluation is ongoing for 
the uses reported under the CDR rule, and EPA has yet to determine if 
these uses pose an unreasonable risk. In the absence of an unreasonable 
risk finding for a condition of use, EPA cannot make a determination 
whether disclosure is necessary under TSCA section 14(d)(3). TSCA 
section 14(d)(7) states that CBI ``may be disclosed if the 
Administrator determines that disclosure is relevant in a proceeding 
under this Act, subject to the condition that the disclosure is made in 
such a manner as to preserve confidentiality to the extent practicable 
without impairing the proceeding.'' However, EPA believes that 
disclosure of CBI would have no practical relevance to the risk 
evaluation or risk determination as the CBI claims are limited and EPA 
retains the ability to characterize the information without revealing 
the actual protected data. Accordingly, EPA denies this request.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Asbestos Disease Awareness Organization, American Public Health 
Association, Center for Environmental Health, Environmental Working 
Group, Environmental Health Strategy Center, and Safer Chemicals 
Healthy Families to Andrew Wheeler, Acting Administrator, 
Environmental Protection Agency. Re: Petition under TSCA Section 21 
to Require Reporting on Asbestos Manufacture, Importation and Use 
under TSCA Section 8(a). Received September 27, 2018.
2. Bob Sussman email to Jeff Morris, Director of EPA's Office of 
Pollution Prevention and Toxics. RE: TSCA Section 21 Petition. 
Received November 29, 2018.
3. EPA. Problem Formulation of the Risk Evaluation for Asbestos. May 
2018. Washington, DC: US Environmental Protection Agency, Office of 
Pollution Prevention and Toxics. https://www.epa.gov/sites/production/files/2018-06/documents/asbestos_problem_formulation_05-31-18.pdf.
4. EPA. Public database 2016 chemical data reporting (May 2017 
release). Washington, DC: US Environmental Protection Agency, Office 
of Pollution Prevention and Toxics. Retrieved from https://www.epa.gov/chemical-data-reporting.
5. Flanagan, DM. (2016). 2015 Minerals yearbook. Asbestos [advance 
release]. In US Geological Survey 2015 Minerals Yearbook. Reston, 
VA: U.S. Geological Survey. https://minerals.usgs.gov/minerals/pubs/commodity/asbestos/myb1-2015-asbes.pdf.
6. EPA. Response to Petition to Require Reporting on Asbestos 
Manufacture, Importation and Use under TSCA Section 8(a). Letter. 
2018.
7. Virta, Robert. (2012). 2012 Minerals yearbook. Asbestos. In US 
Geological Survey 2015 Minerals Yearbook. Reston, VA: U.S. 
Geological Survey. https://minerals.usgs.gov/minerals/pubs/commodity/asbestos/myb1-2012-asbes.pdf.
8. EPA. TSCA Chemical Data Reporting. Fact Sheet: Articles. August 
3, 2012. https://www.epa.gov/sites/production/files/documents/articlesfactsheetforcdr_reporting_080312.pdf.

List of Subjects in 40 CFR Chapter I

    Environmental protection, Asbestos, Flame retardants, Chemicals, 
Confidential business information, Hazardous substances, Reporting and 
recordkeeping requirements.

    Dated: December 21, 2018.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and 
Pollution Prevention.
[FR Doc. 2019-01533 Filed 2-11-19; 8:45 am]
BILLING CODE 6560-50-P


