TSCA Section 21 Petition To Initiate a Reporting Rule Under TSCA Section 8(a) for Asbestos; Reasons for Agency Response, 20062-20070 [2019-09335]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Proposed Rules]
[Pages 20062-20070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09335]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2019-0038; FRL-9992-67]


TSCA Section 21 Petition To Initiate a Reporting Rule Under TSCA 
Section 8(a) for Asbestos; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition for rulemaking; denial.

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SUMMARY: This document provides the reasons for EPA's response to a 
January 31, 2019, petition it received under section 21 of the Toxic 
Substances Control Act (TSCA) from the Attorneys General of 
Massachusetts, California, Connecticut, Hawaii, Maine, Maryland, 
Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, 
Vermont, Washington, and the District of Columbia (``petitioners''). 
Generally, the petitioners requested that EPA initiate a rulemaking 
proceeding under TSCA section 8(a) for the reporting of the manufacture 
(including import) and processing of asbestos. After careful 
consideration, EPA denied the petition for the reasons discussed in 
this document.

[[Page 20063]]


DATES: EPA's response to this TSCA section 21 petition was signed April 
30, 2019.

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 
(which includes import) or process or may manufacture or process the 
chemical asbestos (general 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-2019-0038, 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 5(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 within 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.

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), 
the section under which petitioners request the EPA to act here, 
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, 
such as the Chemical Data Reporting (CDR) rule at 40 CFR part 711, 
which covers asbestos.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On January 31, 2019, the Attorneys General of Massachusetts, 
California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New 
Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, 
Washington, and the District of Columbia (petitioners) petitioned EPA 
to initiate a rulemaking proceeding under TSCA section 8(a) for the 
reporting of the manufacture, import, and processing of asbestos (Ref. 
1).
    The petitioners requested specific TSCA section 8(a) reporting 
requirements for asbestos in order to collect information for the 
ongoing asbestos risk evaluation being conducted under TSCA section 
6(b), which is to be completed by December 22, 2019 (15 U.S.C. 
2605(b)(4)(G)(i)) and no later than June 22, 2020 if EPA exercises a 
six-month extension (15 U.S.C. 2605(b)(4)(G)(ii)), and, if necessary, 
for any subsequent risk management decisions under TSCA section 6(a). 
The petitioners specifically requested that EPA:
     Eliminate any applicability of the ``naturally occurring 
substance'' (NOCS) exemption in the CDR for asbestos reporting;
     Apply the CDR reporting requirements to processors of 
asbestos, as well as manufacturers (including importers) of the 
chemical substance;
     Eliminate any applicability of the impurities exemption in 
the CDR for asbestos reporting; and
     Eliminate any applicability of the articles exemption in 
the CDR with respect to imported articles that contain asbestos.

B. What support do the petitioners offer?

    The petitioners request that EPA initiate a rulemaking proceeding 
under TSCA section 8(a) ``to address infirmities in asbestos 
reporting'' under EPA's CDR rule at 40 CFR 711. In support of their 
request, the petitioners state that ``[r]obust reporting of the 
importation and use of asbestos in the U.S. is necessary for EPA to 
satisfy its statutory mandate under TSCA section 6(a) to establish 
requirements to ensure that asbestos does not present an unreasonable 
risk of injury to health or the environment and for states and the 
public to have access to data necessary to themselves evaluate such 
risks'' (Ref. 1).
    The petitioners present their views as to EPA's need for 
``comprehensive data with respect to the manufacture (including import) 
and use of asbestos in the U.S.'' when conducting the asbestos risk 
evaluation and undertaking any potential subsequent risk management 
actions. The petitioners conclude that such data are not being 
collected under the current CDR rule. Several times in their request, 
the petitioners cite EPA's response to a previous petition filed under 
TSCA section 21 by the Asbestos Disease Awareness Organization (ADAO) 
and five other non-governmental organizations. In that petition, which 
EPA received on September 27, 2018, ADAO and others requested that EPA 
initiate rulemaking proceedings under TSCA section 8(a) to amend the 
CDR rule to increase reporting of asbestos to CDR (Ref. 2). EPA denied 
the petition on December 21, 2018, on the grounds that the petitioners 
did not demonstrate that it is necessary to amend the CDR rule (84 FR 
3396, February 12, 2019) (FRL-9988-56). The petition from ADAO et al. 
and EPA's response are in Docket ID

[[Page 20064]]

No. EPA-HQ-OPPT-2018-0682 at https://www.regulations.gov.
    The CDR rule, which is one of several reporting rules promulgated 
under TSCA section 8(a), 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, actions taken under TSCA section 6.
    While asbestos is already required to be reported under the CDR 
rule by manufacturers (including importers) meeting certain criteria, 
the petitioners point out that CDR exempts from reporting chemicals, 
like asbestos, that are naturally occuring chemical substances, present 
as an impurity, or incorporated into an article. Additionally, the 
petitioners note that CDR does not require reporting from processors of 
chemical substances.
    The petitioners assert that ``[a]ny TSCA risk evaluation that EPA 
conducts without access to accurate and complete asbestos data cannot 
satisfy TSCA's risk evaluation criteria, including TSCA's requirement 
that EPA use the `best available science' in carrying out TSCA's 
mandate to eliminate unreasonable risk of injury to health or the 
environment presented by the manufacture (including importation), 
processing, distribution in commerce, use, or disposal of a toxic 
chemical substance'' (Ref. 1).
    Petitioners contend that the requested action under TSCA section 
8(a) ``would enable EPA to present and rely on a complete set of 
domestic data about the amount, and uses, of asbestos, is consistent 
with those goals and with the statute's requirements'' (Ref. 1).
    In their request, the petitioners state that ``[a]sbestos is a 
known human carcinogen and there is no safe level of exposure to this 
highly toxic material ubiquitous in our built environment'' (Ref. 1). 
The petitioners cite research finding dangers from asbestos and provide 
a review of asbestos assessments and regulations under federal and 
state law.
    In their petition, they state that in 1989, EPA concluded that 
``asbestos is a highly potent carcinogen regardless of the type of 
asbestos or the size of the fiber'' and assert that ``EPA has long 
possessed an abundance of information that supports aggressive 
regulatory actions to protect the public from asbestos disease risks'' 
(Ref. 1).
    The petitioners restate their belief that EPA has ``chos[en] to put 
on blinders and ignore some of the most meaningful data with respect to 
risks of exposure to the chemical substance'' (Ref. 1), a view which 
many of the petitioning Attorneys General first expressed in comments 
on EPA's Problem Formulation of the Risk Evaluation for Asbestos (83 FR 
26998, June 11, 2018) (FRL-9978-40). Moreover, the petitioners cite 
language in the Problem Formulation that states that ``import volumes 
of products containing asbestos is [sic] unknown'' (Ref 1). The 
petitioners assert that EPA's response to the ADAO Petition directly 
contradicts what EPA stated in the Problem Formulation.

IV. Background Considerations: 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, existing TSCA section 8(a) rules including the 
CDR rule, general exemptions for TSCA section 8(a) rules, and past 
reporting of asbestos under TSCA section 8(a). These details are 
explained in the following units.

A. Risk Evaluation of Asbestos

    On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 
21st Century Act (Pub. L. 114-182) amended TSCA (15 U.S.C. 2601 et 
seq.). The new law includes statutory requirements mandating that EPA 
conduct risk evaluations for existing chemicals. On December 19, 2016 
(81 FR 91927) (FRL-9956-47), EPA designated asbestos as one of the 
first 10 chemical substances subject to the Agency's initial chemical 
risk evaluations 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 in chemical 
manufacturing where extremely high temperatures are needed; brake 
blocks for oil drilling; aftermarket automotive brakes/linings; other 
vehicle friction products; and other gaskets (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 ID No. EPA-HQ-OPPT-2016-0736). EPA's review of these data 
sources served as the basis for the conditions of use of asbestos. 
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 ID No. 
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 (83 FR 26922; FRL-9978-76), EPA proposed a significant 
new use rule (SNUR) under TSCA section 5, 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 
products) and specifically 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 ID No. 
EPA-HQ-OPPT-2018-0159).
    In the Asbestos Problem Formulation document, based on the 
aforementioned outreach and research, EPA did not identify any 
conditions of use of

[[Page 20065]]

asbestos as an impurity. In EPA's Asbestos Problem Formulation for the 
Risk Evaluation (Ref. 3), the Agency identified the conditions of use 
as imported raw bulk chrysotile asbestos for the fabrication of 
diaphragms for use in chlorine and sodium hydroxide production; and 
several imported chrysotile asbestos-containing materials, including 
sheet gaskets; brake blocks for oil drilling, aftermarket automotive 
brakes, linings, and other vehicle friction products; and other 
gaskets.
    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 section 26 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, the deadline that Congress set in TSCA. EPA 
acknowledges the statute provides that EPA may extend the deadline to 
complete a risk evaluation by six months (15 U.S.C. 2605(b)(4)(G)(ii)). 
As discussed in Unit V.A., even if EPA were to exercise this extension 
authority in the case of the ongoing asbestos risk evaluation, that 
would not affect the Agency's reasons for denying this petition.

B. TSCA Section 5(a) SNUR and Asbestos

    On April 17, 2019, EPA signed the SNUR for asbestos and asbestos-
containing products (84 FR 17345, April 25, 2019; FRL-9991-33). Section 
5(a)(2) of TSCA, as amended by the Frank R. Lautenberg Chemical Safety 
for the 21st Century Act, authorizes EPA to determine that a use of a 
chemical substance is a ``significant new use.'' Once EPA determines 
that a use of a chemical substance is a significant new use, TSCA 
section 5(a)(1) requires persons to submit a significant new use notice 
(SNUN) to EPA at least 90 days before they manufacture (including 
import) or process the chemical substance for that use (15 U.S.C. 
2604(a)(1)(B)(i)). TSCA prohibits the manufacturing (including 
importing) or processing from commencing until EPA has conducted a 
review of the notice, made an appropriate determination on the notice, 
and taken such actions as are required in association with that 
determination (15 U.S.C. 2604(a)(1)(B)(ii)). Those actions could 
include a prohibition on a use of that chemical substance.
    For that SNUR, the significant new use of asbestos is manufacturing 
(including importing) or processing for uses that are neither ongoing 
nor already prohibited under TSCA. The following uses are subject to 
the SNUR: Adhesives, sealants, and roof and non-roof coatings; arc 
chutes; beater-add gaskets; cement products; extruded sealant tape and 
other tape; filler for acetylene cylinders; friction materials (with 
certain exceptions); high-grade electrical paper; millboard; missile 
liner; packings; pipeline wrap; reinforced plastics; roofing felt; 
separators in fuel cells and batteries; vinyl-asbestos floor tile; 
woven products; any other building material; and any other use of 
asbestos that is neither ongoing nor already prohibited under TSCA.
    The asbestos SNUR prohibits these discontinued uses of asbestos 
from restarting without EPA having an opportunity to evaluate each 
intended use (i.e., significant new use) for potential risks to health 
and the environment and take any necessary regulatory action, which may 
include a prohibition. The SNUR ensures that the conditions of use that 
are in the scope of the risk evaluation and not subject to the SNUR are 
the only ongoing uses of asbestos and asbestos-containing products in 
the United States.

C. TSCA Section 8(a) Rules

    Section 8(a)(1) of TSCA authorizes the EPA Administrator to 
promulgate rules under which manufacturers 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. The 
Agency is prohibited by TSCA section 8(a)(5)(A) from requiring 
reporting that is ``unnecessary or duplicative'' and must apply the 
reporting obligations under TSCA section 8(a) to those persons who are 
likely to have the relevant information. 15 U.S.C. 2607(a)(5).
    EPA has promulgated several data reporting rules under TSCA section 
8(a); the CDR rule is the largest data collection rule, in terms of the 
number of entities subject to reporting under the rule.
    The CDR rule requires U.S. manufacturers (including importers) of 
chemicals on the TSCA Chemical Substance 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)). 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 
(2,500 pounds) 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 forms of natural gas, and water 
(see 40 CFR 711.5 and 711. 6). Asbestos is subject to the lower 
production volume reporting threshold of 2,500 pounds; thus, 
manufacturers and importers of asbestos are required to report asbestos 
under the CDR rule unless they qualify for an exemption.

D. Exemptions From Reporting Under the TSCA Section 8(a) Rules

    EPA has specified general reporting and recordkeeping provisions 
for TSCA section 8(a) information gathering rules at 40 CFR 704 and has 
promulgated general exemptions to reporting at 40 CFR 704.5 using the 
Agency's broad discretion in TSCA section 8(a) to fashion reporting 
schemes ``as the Administrator may reasonably require.'' (15 U.S.C. 
2607(a)(1)(A)). However, also utilizing this discretion, EPA can 
revise, remove, or add to these exemptions. The exemptions at 40 CFR 
704.5 are for articles, byproducts, impurities, non-isolated 
intermediates, research and development, and small manufacturers and 
importers.
    If the chemical substance is imported solely as part of an article, 
the chemical substance is generally exempt from being reported under 
TSCA section 8(a). 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.''

[[Page 20066]]

    Impurities are also generally exempt from reporting under rules 
promulgated pursuant to TSCA section 8(a). 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.
    The exemption from reporting naturally occurring chemical 
substances under the CDR rule, found at 40 CDR 711.6(b), is one example 
of an exemption that has been added to TSCA section 8(a) reporting 
requirements under EPA's broad discretion to fashion reporting schemes 
``as the Administrator may reasonably require''.
    While TSCA section 8(a) provides EPA with the authority to collect 
information from processors, EPA has used its discretion to not require 
processors to 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).

E. Recent Asbestos Reporting Under TSCA Section 8(a)

    Two companies, both from the chloro-alkali industry, reported 
importing raw asbestos during the 2016 CDR reporting cycle (Ref. 4) and 
did not claim the exemption for naturally occurring chemical 
substances. Both companies claimed their reports as confidential 
business information. Because asbestos has not been mined or otherwise 
produced in the United States since 2002 (Ref. 5), all raw asbestos 
currently in commerce 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 State of California (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.
    EPA agrees that knowledge of which entities are importing and using 
asbestos and asbestos-containing products, where and how these 
activities occur, and the quantities of asbestos involved is important 
for identifying exposed populations, and characterizing pathways of 
exposure. EPA already has this information, which it has obtained 
through reporting, voluntary submission, and modeling. EPA has used 
information currently reported under the CDR rule and other sources of 
data to identify and characterize the conditions of use for asbestos, 
and is using this information as part of the ongoing risk evaluation 
for asbestos under TSCA section 6(b).
    EPA does not believe that petitioners have demonstrated that it is 
necessary to initiate a rulemaking proceeding under TSCA section 8(a) 
to obtain additional information in order to conduct its risk 
evaluation on asbestos and any potential subsequent risk management. 
While the petitioners assert that EPA's response to the ADAO Petition 
directly contradicts what EPA stated in the Problem Formulation 
regarding EPA's acknowledgement of a lack of certain data, EPA 
disagrees. EPA believes that the Agency is aware of all ongoing uses of 
asbestos and already has the essential information that EPA would 
receive if EPA were to grant the petition. Since asbestos was announced 
in December 2016 as one of the first ten chemicals for evaluation under 
TSCA, the Agency has conducted market research, public outreach, 
voluntary data collection, collaborative work with other Federal and 
State agencies, and stakeholder engagement. Given EPA's understanding 
of asbestos and reporting under TSCA section 8(a), as a result of 
implementation of the CDR rule and other TSCA section 8(a) rules, EPA 
does not believe that the requested reporting requirements would 
collect the data the petitioners believe the Agency lacks. Where EPA 
lacks information, the Agency has relied on models. This use of modeled 
data is in line with EPA's final Risk Evaluation Rule (Ref. 7) and 
EPA's risk assessment guidelines. Furthermore, EPA will provide 
opportunity for peer and public review of the draft Asbestos Risk 
Evaluation, which EPA will use to refine the risk evaluation of 
asbestos.
    Further, even if EPA believed that the requested reporting 
requirements would collect new and useful information, EPA would not 
complete the rulemaking proceeding in time to collect data to inform 
the ongoing risk evaluation. The petitioners' request does not factor 
in the necessary timeframes for any rulemaking proceeding 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 the promulgation, amendment, or repeal of a rule. EPA would 
then need to provide time for implementation, data collection, and data 
review prior to making use of the reported information. EPA intends to 
finalize the risk evaluation for asbestos in December 2019, but EPA 
notes that it has statutory authority to extend that deadline by up to 
six months. If EPA finds unreasonable risk for a condition of use, risk 
management must promptly be initiated with a proposed rule issued one 
year after EPA makes such a determination.
    While it is possible that the requested rulemaking proceeding 
itself could be completed prior to any potential subsequent risk 
management decision(s) being finalized, EPA does not believe that the 
requested section 8(a) reporting requirements on asbestos would collect 
information useful for any necessary risk management, for the reasons 
explained in Unit V.B. Given the statutorily required timing for 
finalizing the asbestos risk evaluation and initiating risk management, 
if unreasonable risk exists for a condition of use, the requested TSCA 
section 8(a) reporting requirements on asbestos would not provide 
timely or useful information to inform either the ongoing asbestos risk 
evaluation or any potential subsequent risk management action. EPA 
believes that this would still be the case even were it to exercise its 
statutory authority to extend the deadline to complete the asbestos 
risk evaluation for six months, because the requested section 8(a) 
reporting requirements would likely not collect that would further 
inform the risk evaluation beyond the information EPA already has, as 
explained in Unit V.B.

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 initiate rulemaking proceedings under TSCA 
section 8(a) for the reporting of the manufacture, import, and 
processing of asbestos.
1. Eliminate Exemption for Naturally Occurring Chemical Substances for 
Asbestos
    a. Petitioners' request. The petitioners ask that the requested 
TSCA section 8(a) reporting requirements for asbestos remove any 
exemption for naturally occurring chemical substances. The petitioners 
state that the import of raw asbestos represents ``pathways of

[[Page 20067]]

exposure that present risks to health and the environment that EPA must 
consider in conducting its risk evaluation and regulating asbestos'' 
(Ref. 1). In support of this request, the petitioners question EPA's 
prior assertion that the Agency has sufficient information about 
asbestos use and exposure, as obtained through CDR and other 
``voluntary disclosures'' (Ref. 1). The petitioners believe that EPA 
contradicted itself in that in the response to the earlier ADAO 
petition the Agency stated it has sufficient information for the risk 
evaluation, while in the Problem Formulation EPA said ``[i]t is 
important to note that the import volumes of products containing 
asbestos is [sic] unknown'' (Ref. 1).
    b. Agency response. Raw asbestos is the only type of asbestos to 
which the naturally occurring substance exemption could apply. As 
defined by the CDR-specific rules in 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 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)). Articles containing asbestos would not be considered 
a naturally occurring chemical substance, given the processing required 
to create the article.
    EPA does not believe that the requested elimination of the 
exemption for naturally occurring chemical substances would result in 
the reporting of any information that is not already known to EPA, for 
several reasons. EPA's understanding is that the chloro-alkali industry 
is the only importer of raw bulk asbestos, and the Agency has 
sufficient volume, import, use, and hazard data from that industry to 
conduct the risk evaluation. EPA has no reason to believe there are 
other importers of raw asbestos. Raw asbestos generally refers to 
asbestos as a naturally occuring chemical substance. Implementing TSCA 
section 8(a) asbestos reporting requirements for manufacturers 
(including importers) of asbestos as a naturally occuring chemical 
substance, therefore, would not provide any additional useful or timely 
information to EPA on the use of raw asbestos.
    Because the purpose of domestic manufacturing or importing of raw 
asbestos is to make asbestos diaphragms, for which EPA already has use 
and exposure information, the request to require 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.), and the Agency is 
prohibited by TSCA section 8(a)(5)(A) from requiring reporting that is 
unnecessary or duplicative.
    EPA disagrees that there is a contradiction between what EPA stated 
in the Asbestos Problem Formulation and what EPA stated in the petition 
response to ADAO. While EPA did state in the problem formulation that 
the imported volumes of products containing asbestos are unknown, the 
requested reporting of naturally occurring substances would not provide 
imported volumes of products containing asbestos, given that articles 
are not considered naturally occurring substances. As used in the 
asbestos Problem Formulation, the term ``products containing asbestos'' 
refers to asbestos articles. For more information on the data 
availability and evaluation of asbestos in articles, see Unit V.B.iii. 
for EPA's response to the request for reporting of imported asbestos 
articles.
    EPA finds that petitioners have failed to set forth sufficient 
facts to establish that it is necessary for the Agency to use its 
discretion to no longer exempt naturally occurring asbestos from 
reporting requirements under TSCA section 8(a).
2. Apply the CDR Reporting Requirements to Processors of Asbestos
    a. Petitioners' request. The petitioners note that EPA has the 
authority to require that processors report under TSCA section 8(a), 
but EPA does not require processors to report to CDR. The petitioners 
believe a rulemaking proceeding to subject CDR reporting requirements 
on the processing of asbestos is needed in order ``to enable EPA to 
carry out its responsibility to impose requirements on processors to 
eliminate unreasonable risks of injury to health or the environment 
arising from exposures to asbestos'' (Ref. 1). In support of their 
request, the petitioners cite the U.S. Geological Survey (USGS) 
Minerals Yearbook for 2016 (Ref. 5) and state that ``U.S. firms 
exported and reexported $35.4 million of manufactured asbestos products 
in 2016, including asbestos based friction products like brake linings, 
clutch linings, and disk pads, and gaskets, packing, and seals, in the 
amount of 2,710 metric tons'' (Ref.1).
    b. Agency response. EPA knows of 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 sheets. Information on these uses is well understood by EPA 
as a result of direct communication with these processors (see Problem 
Formulation of the Risk Evaluation for Asbestos (Ref. 3, pg. 25)).
    To support a claim that there is ongoing processing of articles 
that EPA is unaware of, the petitioners cite the export and reexport of 
articles described in the USGS Minerals Yearbook for 2016 (Ref. 5). The 
petitioners, however, neglect to note that the same report states that 
these shipments were likely misclassified and that ``[s]hipments 
reported under these categories may have been reexports and (or) 
exports of products that were similar but did not contain asbestos.'' 
In identifying the conditions of use for asbestos during the TSCA risk 
evaluation process, EPA reviewed the U.S. International Trade 
Commission's Dataweb and other government and commercial trade 
databases. EPA was unable to confirm any processing of asbestos beyond 
processing of raw asbestos into diaphragms and the fabrication of 
gaskets from imported asbestos-containing sheets.
    Since asbestos is not mined in the United States, raw asbestos is 
imported solely by the chlor-alkali industry; because sheet gaskets are 
the only imported asbestos-containing products that may involve 
processing, EPA does not believe there are additional, unknown 
processors of asbestos in the United States. Accordingly, EPA does not 
believe that requiring reporting from processors of asbestos under TSCA 
section 8(a) 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 section 8(a) and the Agency is prohibited by 
TSCA section 8(a)(5)(A) from requiring

[[Page 20068]]

reporting that is unnecessary or duplicative. Therefore, EPA finds that 
petitioners have failed to set forth sufficient facts to establish that 
it is necessary for the Agency to use its discretion to require TSCA 
section 8(a) reporting for processors of asbestos.
3. Eliminate Exemption for Reporting of Imported Articles Containing 
Asbestos
    a. Petitioners' request. In support of their request to eliminate 
the reporting exemption for imported articles containing asbestos, the 
petitioners state that ``the Asbestos Problem Formulation provides 
virtually no information about the amount of asbestos in any of these 
products, the quantities in which they may be imported, and where they 
may be used, let alone any information about the extent to which the 
public may be exposed to these asbestos-containing products'' (Ref. 1). 
Furthermore, the petitioners state that ``EPA simply throws up its 
hands, stating that `[c]onsumer exposures will be difficult to evaluate 
since the quantities of these products that still might be imported 
into the United States is not known' '' (Ref. 1).
    b. Agency response. EPA has relied on extensive outreach and 
research to determine the conditions of use of asbestos (as described 
in Unit IV.A.). The Agency does not believe that requiring TSCA section 
8(a) reporting on imported articles for asbestos would be helpful in 
collecting additional import information on asbestos-containing 
articles because the Agency has identified the articles that are 
imported into the United States and promulgated a significant new use 
rule under TSCA section 5 to require notification to the Agency of any 
new uses, including different or new articles. The Agency is prohibited 
by TSCA section 8(a)(5)(A) from requiring reporting that is unnecessary 
or duplicative. Even if EPA were to require reporting on imported 
articles for asbestos, EPA does not believe that potentially useful 
information for EPA's ongoing asbestos risk evaluation would be 
``reasonably ascertainable'' by importers and thus EPA could not 
require this information to be reported under TSCA section 8(a). Nor 
would EPA be able to collect new data in time to inform the risk 
evaluation, which EPA intends to complete in December 2019. EPA, 
however, acknowledges the statute provides that EPA may extend the 
deadline to complete a risk evaluation by six months (15 U.S.C. 
2605(b)(4)(G)(ii)). As discussed in Unit V.A., even if EPA were to 
exercise this extension authority in the case of the ongoing asbestos 
risk evaluation, that would not affect the Agency's reasons for denying 
this petition. If EPA finds unreasonable risk for a condition of use, 
risk management must promptly be initiated with a proposed rule issued 
one year after EPA makes such a determination.
    EPA has sufficient information on imported articles containing 
asbestos to conduct the risk evaluation and inform any potential risk 
management decisions based on the risk determination. The only 
asbestos-containing articles that EPA has identified that are currently 
imported into the United States are asbestos-containing sheet gaskets, 
other gaskets, aftermarket automotive brakes/linings, other vehicle 
friction products, and brake blocks. Furthermore, the final Asbestos 
SNUR, published on April 25, 2019, ensures that no significant new uses 
of asbestos, including as an article, can begin without EPA first 
evaluating the significant new use and then, if necessary, taking 
action to prohibit or limit the activity.
    The petitioners state that EPA lacks information on the quantity of 
asbestos contained in articles and assert that the Agency ``lack[s] 
this information despite'' communication with Chemours, a company that 
uses asbestos-containing gaskets, and Branham Corporation, the gasket 
supplier to Chemours (Ref. 1). Yet, as stated in the Asbestos Problem 
Formulation, Chemours notified EPA of their current use of imported 
gaskets from China (Comment identified by Document ID No. EPA-HQ-OPPT-
2016-0736-0067). Chemours stated that these sheet gaskets are composed 
of 80% (minimum) chrysotile asbestos, encapsulated in Styrene Butadiene 
Rubber, and used to create tight chemical containment seals during the 
production of titanium dioxide. Furthermore, as stated in the Asbestos 
Problem Formulation, on October 30, 2017, EPA met with Chemours and 
Branham Corporation, who provided EPA with additional information on 
the fabrication and use of the gaskets (Ref. 3).
    Similarly, the petitioners stated that EPA lacks information on 
asbestos-containing brake blocks, even though a domestic brake block 
manufacturer confirmed the continued import of these products (Ref. 1). 
However, EPA believes that it is able to conduct scientifically 
rigorous risk evaluations even without the information to which 
petitioners refer. For the asbestos risk evaluation, in instances where 
the specific use information on asbestos is unknown, EPA has made use 
of best available science. EPA's assumptions, uncertainty factors, and 
models or screening methodologies used when assessing risks associated 
with the conditions of use of asbestos-containing articles will be peer 
and publicly reviewed. It is standard practice for EPA to make 
conservative assumptions in the absence of complete information. 
Considering the extensive outreach and research conducted since 
December 2016, EPA has no reason to believe there are ongoing imports 
of articles containing asbestos that are unknown to EPA.
    Additionally, information reported under TSCA section 8(a) is 
limited to that which is ``known to or reasonably ascertainable'' by 
the reporter. Thus, even if EPA were to require the reporting of 
asbestos-containing articles under TSCA section 8(a), importers would 
rely on information readily available to them, such as Safety Data 
Sheets or other documentation provided by their foreign supplier. As a 
result, EPA does not believe that the requested reporting requirement 
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. Requiring 
importers of asbestos-containing articles to report under TSCA section 
8(a), therefore, would not provide any new use information that would 
inform the ongoing risk evaluation or any subsequent risk management 
decisions, if needed, and the Agency is prohibited by TSCA section 
8(a)(5)(A) from requiring reporting that is unnecessary or duplicative.
    For these reasons, EPA believes that the petitioners have failed to 
set forth sufficient facts to establish that it is necessary for the 
Agency to use its discretion to require reporting from importers of 
asbestos-containing articles under section 8(a).
4. Eliminate Impurities Exemption for Asbestos.
    a. Petitioners' request. In support of their request eliminate the 
impurities exemption for asbestos, the petitioners state that 
``contamination of talc with asbestos is well-known, having been 
discovered as impurities in cosmetics, baby powder, and crayons'' (Ref. 
1). As such, the petitioners assert that the ``presence of asbestos in 
such consumer products, whether unintentional ``impurities'' or as an 
unintended ingredient in the article, dictates that these exemptions 
cannot apply with respect to the reporting requirements for asbestos in 
commerce'' (Ref. 1).

[[Page 20069]]

    b. Agency response. Even if EPA were to eliminate the impurities 
exemption for asbestos, it is unlikely that requiring this reporting 
would yield any new information because rules under TSCA section 8(a) 
do not require submitters to perform chemical analyses of products 
containing the chemicals they manufacture. Instead, the standard for 
all information required to be reported under TSCA section 8(a)(2) is 
that it be ``known or reasonably ascertainable.'' EPA is aware that 
testing by a small number of importers of talc or products such as 
crayons has shown that some of these products are contaminated with 
asbestos as an impurity. However, EPA cannot compel importers who have 
not tested their imports to conduct this kind of testing under TSCA 
section 8(a). EPA can only compel reporting of testing information that 
is known or reasonably ascertainable to the reporter. While the 
petitioners ``believe that it is reasonable to expect that importers of 
talc [. . . will . . .] test it for asbestos and that the results of 
such testing constitute `reasonably ascertainable' information for 
reporting purposes'' (Ref. 1), the petitioners provide no support for 
the belief that importers are testing for asbestos. EPA is not aware of 
routine testing of imports for impurities of asbestos. 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 issuing the requested TSCA section 8(a) 
reporting requirements would result in reporting of asbestos as an 
impurity, to the extent that the presence of asbestos as an impurity in 
these articles generally is not known or reasonably ascertainable to 
the importer. EPA finds that the petitioners have failed to set forth 
sufficient facts to establish that it is necessary for the Agency to 
use its discretion to require manufacturers (including importers) of 
asbestos as an impurity to report under section 8(a).
5. Enable EPA To Satisfy Requirements for Best Available Science
    a. Petitioners' request. As overall support for their petition, the 
petitioners state that EPA must grant their request to satisfy its 
statutory obligation under TSCA section 26 to consider the information 
``reasonably available'' to it. Additionally, since the petitioners 
believe that if EPA were to require reporting on asbestos as a 
naturally occurring chemical substance, asbestos-containing articles, 
asbestos as an impurity, and from asbestos processors, that this data 
is ``reasonably available to the agency'' and thus ``needed for EPA to 
be able to make informed technically complex decisions regarding the 
regulation of asbestos'' (Ref. 1).
    b. Agency response. TSCA section 26 requires that, to the extent 
that EPA makes a decision based on science under TSCA sections 4, 5, or 
6, EPA must use scientific standards and base those decisions on the 
best available science and on the weight of the scientific evidence. 15 
U.S.C. 2625(h) and (i). In the final Risk Evaluation Rule (Ref. 7), EPA 
defined ``best available science'' as science that is reliable and 
unbiased. This involves the use of supporting studies conducted in 
accordance with sound and objective science practices, including, when 
available, peer reviewed science and supporting studies and data 
collected by accepted methods or best available methods (if the 
reliability of the method and the nature of the decision justifies use 
of the data).
    Additionally, in the final Risk Evaluation Rule, EPA defined weight 
of scientific evidence as a systematic review method, applied in a 
manner suited to the nature of the evidence or decision, that uses a 
pre-established protocol to comprehensively, objectively, 
transparently, and consistently, identify and evaluate each stream of 
evidence, including strengths, limitations, and relevance of each study 
and to integrate evidence as necessary and appropriate based upon 
strengths, limitations, and relevance (Ref. 7 at pg. 33733). EPA sees 
weight of the scientific evidence approach as an interrelated part of 
systematic review, and further believes that integrating systematic 
review into the TSCA risk evaluations is critical to meet the statutory 
requirements of TSCA.
    TSCA section 26(k) (15 U.S.C. 2625(k)) states that in carrying out 
risk evaluations, EPA shall consider information that is ``reasonably 
available,'' but the statute does not further define this phrase. In 
the final Risk Evaluation Rule (Ref. 7), EPA defined ``reasonably 
available information'' to mean information that EPA possesses, or can 
reasonably obtain and synthesize for use in risk evaluations, 
considering the deadlines for completing the evaluation. While EPA 
prefers high quality data, where available, EPA recognized in the Risk 
Evaluation Rule that data is not always necessary to reach a 
scientifically grounded conclusion on the potential risks of a chemical 
substance, within the timeframes dictated by the statute (Ref. 7 at pg. 
33739).
    As outlined in the previous units, EPA does not believe that the 
requested asbestos reporting requirements would collect information 
that is either new or useful in informing the ongoing asbestos risk 
evaluation. EPA believes that it already has sufficient information to 
conduct the risk evaluation. Moreover, even if EPA were to initiate the 
requested action, EPA would not collect information in a timely manner 
to inform the ongoing risk evaluation nor any potentially subsequent 
risk management activities, if unreasonable risk for the asbestos uses 
being evaluated is determined. EPA intends to finalize the risk 
evaluation for asbestos no later than December 2019, EPA acknowledges 
the statute provides that EPA may extend the deadline to complete a 
risk evaluation by six months (15 U.S.C. 2605(b)(4)(G)(ii)). As 
discussed in Unit V.A., even if EPA were to exercise this extension 
authority in the case of the ongoing asbestos risk evaluation, that 
would not affect the Agency's reasons for denying this petition. If EPA 
finds unreasonable risk for a condition of use, risk management must 
promptly be initiated with a proposed rule issued one year after EPA 
makes such a determination.
    Thus, EPA finds that the petitioners have failed to set forth 
sufficient facts to establish that it is necessary to grant their 
request in order to meet its obligations under TSCA section 26 to make 
its decision under TSCA section 6 based on the weight of the scientific 
evidence, using reasonably available information, and using the best 
available science.

VI. 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. The Attorneys General of Massachusetts, California, Connecticut, 
Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, 
Pennsylvania, Rhode Island, Vermont, Washington, and the District of 
Columbia to Andrew Wheeler, Acting Administrator, U.S. Environmental 
Protection Agency. Re: Petition of the Commonwealths of 
Massachusetts and Pennsylvania, the States of California, 
Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New 
York, Oregon, Rhode Island, Vermont, and Washington, and the 
District of Columbia under Section 21(a) of TSCA, 15 U.S.C. 2620(a), 
for EPA to

[[Page 20070]]

Issue an Asbestos Reporting Rule to Require Reporting under TSCA 
Section 8(a), 15 U.S.C. 2607(a), of Information Necessary for EPA to 
Administer TSCA as to the Manufacture (including Importation), 
Processing, Distribution in Commerce, Use, and Disposal of Asbestos. 
Received January 31, 2019.
2. 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.
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 Initiate Rulemaking Under Section 
8(a) of TSCA for the Reporting of the Manufacture, Import, and 
Processing of Asbestos. Letter. 2019.
7. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register. 82 FR 
33726, July 20, 2017 (FRL-9963-38).

List of Subjects in 40 CFR Chapter I

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

    Dated: April 30, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2019-09335 Filed 5-7-19; 8:45 am]
 BILLING CODE 6560-50-P