[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:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
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