
[Federal Register Volume 78, Number 133 (Thursday, July 11, 2013)]
[Proposed Rules]
[Pages 41768-41771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16485]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2011-0683; FRL-9339-4]


Chemical Substances and Mixtures Used in Oil and Gas Exploration 
or Production; TSCA Section 21 Petition; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: On August 4, 2011, Earthjustice and 114 other organizations 
petitioned EPA under section 21 of the Toxic Substances Control Act 
(TSCA) to use: TSCA section 8(a) to require manufacturers and 
processors of oil and gas exploration and production (E&P) chemical 
substances and mixtures to maintain certain records and submit reports 
on those records; TSCA section 8(d) to require manufacturers, 
processors, and distributors to submit to EPA existing health and 
safety studies related to E&P chemical substances and mixtures; TSCA 
section 8(c) to request submission of copies of any information related 
to significant adverse reactions to human health or the environment 
alleged to have been caused by E&P chemical substances and mixtures; 
and TSCA section 4 to require manufacturers and processors of E&P 
chemical substances and mixtures to conduct toxicity testing of E&P 
chemical substances and mixtures. In a letter dated November 2, 2011, 
EPA informed petitioners that it denied the TSCA section 4 request and 
in a letter dated November 23, 2011, EPA informed petitioners that it 
granted in part the TSCA section 8(a) and 8(d) requests. This document 
sets forth EPA's reasons for denying in part the petitioners' requests. 
In addition, EPA has concluded that TSCA section 21 does not apply to 
requests for a TSCA section 8(c) data call-in.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Mark Seltzer, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-2901; fax number: (202) 564-4775; email address: 
seltzer.mark@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action, 
however, may be of interest to you if you manufacture (including 
import), process, or distribute chemical substances or mixtures used in 
hydraulic fracturing to create fractures in geologic formations, such 
as shale rock, allowing enhanced natural gas or oil recovery. Since 
other entities also may be interested, the Agency has not attempted to 
describe all the specific entities that may be affected by this action. 
If you have any questions regarding the applicability of this action to 
a particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.

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-2011-0683, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), EPA West 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 
http://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 5(e) or 6(b)(2). A TSCA section 21 petition must set forth the 
facts that are claimed to establish the necessity for 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 within 60 days 
of the denial, if the denial occurs prior to the expiration of the 90-
day period, or within 60 days after the expiration of the 90-day 
period.

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

    Section 21(b)(1) of TSCA requires that the petition ``set forth the 
facts which it is claimed establish that it is necessary'' to issue the 
rule or order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 
implicitly incorporates the statutory standards that apply to the 
requested actions. In addition, TSCA section 21 establishes standards a 
court must use to decide whether to order EPA to initiate rulemaking in 
the event of a lawsuit filed by the petitioner. 15 U.S.C. 
2620(b)(4)(B). Accordingly, EPA has relied on the standards in TSCA 
section 21 and in the provisions under which

[[Page 41769]]

actions have been requested to evaluate this petition. The standards 
that apply to actions under TSCA sections 4 and 8 (Ref. 1) are 
available in the docket established for this TCSA section 21 petition.

III. Summary of the TSCA Section 21 Petition

A. What Action Was Requested?

    On August 4, 2011, Earthjustice and several other organizations 
petitioned EPA to:
    1. Adopt a rule pursuant to TSCA section 4 to require manufacturers 
and processors of E&P chemical substances and mixtures to develop test 
data sufficient to evaluate the toxicity and potential for health and 
environmental impacts of all E&P chemical substances and mixtures that 
they manufacture and process. The petitioners request the rule include 
a requirement for the manufacturer or processor to identify any E&P 
chemical substance and mixture for which testing is required (Ref. 2).
    2. Adopt a rule pursuant to TSCA section 8(a) requiring 
manufacturers and processors of E&P chemical substances and mixtures to 
maintain records and submit reports to EPA disclosing the identities, 
categories, and quantities of E&P chemical substances and mixtures, 
descriptions of byproducts of E&P chemical substances and mixtures, all 
existing data on potential or demonstrated environmental and health 
effects of E&P chemical substances and mixtures, and the number of 
individuals potentially exposed to E&P chemical substances and mixtures 
(Ref. 2).
    3. Request call-in of all allegations of significant adverse 
reactions received and maintained by manufacturers, processors, and 
distributors of E&P chemical substances and mixtures pursuant to TSCA 
section 8(c) and 40 CFR part 717 (Ref. 2).
    4. Adopt a rule pursuant to TSCA section 8(d) to require submittal 
of all existing, not previously reported health and safety studies 
related to the health and/or environmental effects of all E&P chemical 
substances and mixtures (Ref. 2).

B. What Support Do the Petitioners Offer?

    The petitioners believe that there are potential risks to human 
health, terrestrial and aquatic life, and the environment from E&P 
chemical substances and mixtures, and that there is currently 
insufficient information about these potential risks. The petitioners 
believe rulemakings under TSCA section 4 and section 8 are necessary to 
fill information gaps so that Federal and State regulators can 
appropriately assess and regulate E&P chemical substances and mixtures 
and provide information to the public about E&P chemical substances and 
mixtures. To support their requests, the petitioners discussed the 
following information sources which focus mostly on hydraulic 
fracturing chemical substances and mixtures, and assert the limitations 
of these sources:
     EPA's current study to examine the relationship between 
hydraulic fracturing and drinking water resources (Ref. 3).
     FracFocus.org (http://fracfocus.org), a Web site (operated 
jointly by the Ground Water Protection Council (GWPC) and the 
Interstate Oil and Gas Compact Commission (IOGCC)) that serves as a 
voluntary chemical substance registry for companies to report 
publically available information on chemicals used in hydraulic 
fracturing operations.
     Current Federal and State regulations requiring the 
disclosure of E&P chemical substances and mixtures.
     Two reports published by The Endocrine Disruption Exchange 
(TEDX) (Ref. 4) and the New York State Department of Environmental 
Conservation (NYSDEC) (Ref. 5) that analyze the health effects of 
chemical substances and mixtures for which TEDX and NYSDEC could locate 
a Chemical Abstracts Service Registry Number (CASRN).
     Reports of potential harm to human and environmental 
health from exposure to E&P chemical substances and mixtures.

IV. Disposition of TSCA Section 21 Petition

    For the purpose of making its decision, EPA evaluated the 
information presented or referenced in the petition and the Agency's 
authority and requirements under TSCA sections 4, 8, and 21. EPA has 
also evaluated the comments in response to the petition received from 
the American Petroleum Institute (Ref. 6), the American Chemistry 
Council (Ref. 7), and Halliburton Energy Services (Ref. 8). After 
careful consideration, EPA has granted in part and denied in part the 
petition. In a letter dated November 2, 2011 (Ref. 9), EPA informed 
petitioners that it denied the TSCA section 4 request. In a subsequent 
letter dated November 23, 2011 (Ref. 10), EPA informed petitioners that 
it granted in part the TSCA section 8(a) and 8(d) requests.
    By virtue of partially granting the TSCA section 8(a) and 8(d) 
requests, EPA plans to initiate rulemaking under TSCA sections 8(a) and 
8(d) to obtain data on chemical substances and mixtures used in 
hydraulic fracturing. Although EPA has partially granted the TSCA 
section 8(a) and 8(d) requests, the Agency is not committing to a 
specific rulemaking outcome. EPA's response to the petition describes a 
principle that will guide EPA's efforts: ``given efforts underway [in 
states, industry and other federal agencies], our expectation is that 
the TSCA proposal would focus on providing aggregate pictures of the 
chemical substances and mixtures used in hydraulic fracturing. This 
would not duplicate, but instead complement, the well-by-well 
disclosure programs of states'' (Ref. 10).
    EPA plans first to develop an Advance Notice of Proposed Rulemaking 
(ANPRM) and initiate a stakeholder process to provide input on the 
design and scope of the TSCA reporting requirements that would be 
included in a proposed rule. EPA anticipates that States, industry, 
public interest groups, and members of the public will be participants 
in the process. The stakeholder process will bring stakeholders 
together to discuss the information needs and help EPA to ensure any 
reporting burdens and costs are minimized, ensuring information already 
available is considered in order to avoid duplication of efforts. The 
dialogue will also assist EPA in determining how information that is 
claimed Confidential Business Information could be aggregated and 
disclosed to maximize transparency and public understanding.
    Section 9(d) of TSCA provides that the EPA Administrator shall 
consult and cooperate with other Federal agencies ``for the purpose of 
achieving the maximum enforcement of [TSCA] while imposing the least 
burdens of duplicative requirements.'' 15 U.S.C. 2608(d). Consistent 
with TSCA section 9(d), in the development of these actions, EPA will 
consult and cooperate with other agencies (e.g., Bureau of Land 
Management (BLM) and the U.S Department of Energy (DOE)). Consistent 
with TSCA section 9(b), EPA will consult and cooperate with multiple 
offices within the Agency.
    Regarding the TSCA section 4 request, EPA has concluded that the 
petition does not set forth sufficient facts to support the 
petitioners' assertion that it is necessary to initiate the requested 
rulemaking under TSCA section 4. The discussion in this unit provides 
the reasons for EPA's decisions to deny the petition in part.

[[Page 41770]]

A. Partial Denial of the TSCA Section 8(a) Request

    Although EPA is granting the TSCA section 8(a) request in part, the 
petitioners' request is overly broad, and they have not demonstrated 
that the broad rule they requested is necessary. The petitioners 
request that for all chemical substances and mixtures used throughout 
all E&P operations, EPA require by rule submission of essentially all 
of the information identified in TSCA section 8(a) for rules under that 
section. (The petitioners request all information for the chemical 
substances and mixtures generally, even beyond their use in the E&P 
industry.) The E&P industry is a large industry involving a range of 
varied operations and classes of chemical substances and mixtures 
(Refs. 11 and 12). EPA, other Federal agencies, and States, have 
focused attention on hydraulic fracturing due to specific concerns 
raised about this practice, and most of the incidents and information 
sources referenced in the petition pertain to hydraulic fracturing. EPA 
believes information collection under TSCA could significantly advance 
the Federal Government's understanding of potential risks associated 
with this practice. EPA notes that it already has broad regulations 
under TSCA section 8(a) requiring periodic reporting of extensive 
information with respect to chemical substances (Ref. 1) including 
chemical substances used in the E&P industry. Before proposing a TSCA 
section 8(a) rule specific to the E&P industry as a whole, EPA would 
want a better understanding of the incremental value of individual 
information elements.

B. Partial Denial of TSCA Section 8(d) Request

    EPA is partially granting the TSCA section 8(d) request in this 
petition. EPA intends first to issue an ANPRM regarding the submission 
of unpublished health and safety studies and lists of ongoing and 
initiated studies from companies manufacturing (including importing), 
processing, and distributing certain chemical substances and mixtures, 
used in hydraulic fracturing. As part of the stakeholder process 
discussed in Unit IV., EPA plans to seek input on the range of chemical 
substances and mixtures that may be subject to the TSCA section 8(d) 
rulemaking. For the reasons set out in Unit IV.A., EPA does not believe 
a broader TSCA section 8(d) rule is needed or appropriate at this time.

C. Denial of TSCA Section 4 Request

    The petitioners requested a TSCA section 4 test rule covering all 
chemical substances and mixtures used in oil and gas E&P. Specifically, 
the petitioners requested that EPA promulgate a rule under TSCA section 
4 requiring ``manufacturers and processors of E&P [chemical substances 
and mixtures] to develop test data to evaluate the toxicity and 
potential for health and environmental impacts of all chemical 
substances and mixtures they manufacture and process'' and that the 
TSCA section 4 rule require the manufacturers and processors to 
identify all chemical substances and mixtures tested (Ref. 2). EPA is 
denying this request as the petitioners have not set forth sufficient 
facts to support their assertion that it is necessary to issue a TSCA 
section 4 rule requiring testing of all chemical substances and 
mixtures used in all oil and gas E&P, as required by TSCA section 
21(b)(1). Further, to the extent that the petition could be read to 
articulate a somewhat narrower request (that only some chemical 
substances and mixtures should be tested, as necessary to evaluate the 
potential impacts of those chemical substances and mixtures), this is 
not a request for an identifiable rule under TSCA section 4, as 
required by TSCA section 21 (e.g., the petition does not identify 
specific chemical substances or mixtures for which inadequate data 
exist, or the data gaps or endpoints for which testing is necessary).
    The petitioners have not set forth sufficient facts for EPA to find 
that information available to the EPA Administrator is insufficient to 
permit a reasoned evaluation of the health and environmental effects of 
all E&P chemical substances and mixtures, or that testing is necessary 
to develop such information. The petitioners identified two reports 
that discuss health effects from some chemical substances and mixtures 
used during oil and gas operations with some specific discussion on 
hydraulic fracturing. The reports are an information source that EPA 
might review in developing a TSCA section 4 rulemaking to determine 
whether data are lacking for specific health end points for specific 
chemical substances. However, EPA believes the analysis conducted for 
the reports are not comprehensive because not all E&P chemical 
substances and mixtures were reviewed in either report (Ref. 2). 
Therefore, the petitioners do not demonstrate that data are 
insufficient for all E&P chemical substances and mixtures.
    The petitioners also failed to show it is necessary to issue a TSCA 
section 4 rule by failing to support the other findings under TSCA 
section 4. 15 U.S.C. 2603(a)(1)(A)(i) and (B)(i). The petitioners made 
a minimal attempt to show that any individual E&P chemical substance is 
produced in ``substantial quantities'' and provided no production 
volume information for any individual chemical substance. While the 
petitioners do make general statements that E&P chemical substances and 
mixtures are used in large quantities (Ref. 2), this does not provide a 
basis for EPA to conclude that all E&P chemical substances and mixtures 
are produced in substantial quantities. The term ``substantial 
quantities'' has been interpreted by EPA to generally be one million 
pounds or more per year (Ref. 13). Nor have the petitioners shown that 
any specific chemical substance or mixture enters or may reasonably be 
anticipated to enter the environment in substantial quantities or that 
there is or may be significant or substantial human exposure to any 
specific chemical substance or mixture. Individual chemical substances 
and mixtures used in E&P operations may well be produced and released 
in small volumes.
    Furthermore, the petitioners have not shown that all E&P chemical 
substances and mixtures may present an unreasonable risk (Refs. 4 and 
5). The oil and gas E&P industry is broad and engages in a wide variety 
of activities and uses many different chemical substances and mixtures 
depending on site characteristics. Although petitioners provided 
examples of spills and releases and cited existing databases collecting 
health effects data, they did not show that any individual chemical 
substance or mixture, or the entire class of chemical substances and 
mixtures used in all phases of the E&P industry, may present an 
unreasonable risk. While it is possible that such a finding could be 
made for some chemical substances and mixtures used in some operations, 
it is also likely that many are benign, and petitioners did not provide 
sufficient information for the broad finding they request. For these 
reasons, the petitioners have not demonstrated that it is necessary to 
issue the requested TSCA section 4 rule.
    With respect to E&P mixtures, petitioners have not made any attempt 
to show that evaluating the effects of mixtures would be reasonable and 
more efficient than testing chemical substances in the mixtures. 15 
U.S.C. 2603(a)(2). EPA is not prepared to make this finding without 
more complete information regarding the chemical

[[Page 41771]]

substances and mixtures currently in use and the existing available 
information regarding potential health effects. EPA understands that 
mixtures can change frequently in hydraulic fracturing operations, and 
in the E&P industry more broadly, and the petition does not provide 
sufficient information to enable EPA to effectively identify what 
mixtures, or classes of mixtures, if any, might most efficiently be 
tested. Any existing mixture tested might not still be in use once 
testing has been completed, and additional mixtures might be in use at 
that point. A requirement to test certain representative mixtures might 
be reasonable and more efficient than testing individual chemical 
substances, but petitioners did not provide sufficient information to 
support such a finding.
    EPA is in the process of evaluating information in its possession 
and plans to request additional information as described in this 
document. While EPA agrees with petitioners that the Office of Research 
and Development (ORD) study focuses on the potential impacts on 
drinking water resources and does not require companies to conduct 
testing or to develop health and safety data, EPA plans to summarize 
the available data (including data the Agency may already have 
collected) on the toxicity of chemical substances and mixtures used in 
hydraulic fracturing, and to identify and prioritize data gaps for 
further investigation. This information will aid in EPA's understanding 
of potential effects beyond drinking water impacts. EPA also plans to 
review the results from the Agency's other activities and those from 
other Federal agencies (Ref. 3).

V. References

    The following is a list of the documents that are specifically 
referenced in this document and placed in the docket that was 
established under docket ID number EPA-HQ-OPPT-2011-0683. For 
information on accessing the docket, refer to Unit I.B.

    1. Legal Standards on TSCA Section 4, 8(a), 8(c), 8(d) and 
Applicability to a Section 21 Petition. May 24, 2012.
    2. Earthjustice and 114 other organizations. Letter from Deborah 
Goldberg, Earthjustice to Wendy Cleland-Hamnett, Director, Office of 
Pollution Prevention and Toxics (OPPT), EPA. ``Re: Citizen Petition 
Under Toxic Substances Control Act Regarding the Chemical Substances 
and Mixtures Used in Oil and Gas Exploration or Production.'' August 
4, 2011.
    3. EPA, ORD. EPA's Study of Hydraulic Fracturing and Its 
Potential Impact on Drinking Water Resources. Available online at: 
http://www.epa.gov/hfstudy.
    4. TEDX. Health Effects Spreadsheet and Summary. Summary 
Statement. January 27, 2011. Available online at: http://www.endocrinedisruption.com/chemicals.multistate.php.
    5. NYSDEC. Draft Supplemental SGEIS [Generic Environmental 
Impact Statement] on the Oil, Gas and Solution Mining Regulatory 
Program. September 30, 2009. Available online at: http://www.dec.ny.gov/energy/58440.html.
    6. Letter from Erik Milito, Group Director Upstream and Industry 
Operations, American Petroleum Institute (API) to Wendy Cleland-
Hamnett, Director OPPT, EPA: ``Comments on August 4, 2011 Citizen 
Petition under Toxic Substances Control Act Regarding the Chemical 
Substances and Mixtures Used in Oil and Gas Exploration or 
Production.'' October 13, 2011.
    7. Letter from Christina Franz, Senior Director, Regulatory & 
Technical Affairs, American Chemistry Council (ACC) to Wendy 
Cleland-Hamnett, Director OPPT, EPA: ``Comments of the American 
Chemistry Council on the TSCA Section 21 Petition Concerning Oil and 
Gas Exploration and Production Chemicals.'' October 20, 2011.
    8. Letter from Mark N. Duvall, Council for Halliburton Energy 
Services, Inc., to Wendy Cleland-Hamnett, Director OPPT, EPA: ``TSCA 
Section 21 Petition Regarding Oil and Gas Exploration and Production 
Chemicals; Comments of Halliburton Energy Services, Inc.'' October 
26, 2011.
    9. Letter from Stephen A. Owens, Office of Chemical Safety and 
Pollution Prevention (OCSPP), Assistant Administrator, EPA: ``TSCA 
Section 21 Petition Concerning Chemical Substances and Mixtures Used 
in Oil and Gas Exploration or Production.'' November 2, 2011. 
Available online at: http://www.epa.gov/oppt/chemtest/pubs/SO.Earthjustice.Response.11.2.pdf.
    10. Letter from Stephen A. Owens, OCSPP Assistant Administrator, 
EPA: ``TSCA Section 21 Petition Concerning Chemical Substances and 
Mixtures Used in Oil and Gas Exploration or Production.'' November 
23, 2011. Available online at: http://www.epa.gov/oppt/chemtest/pubs/EPA_Letter_to_Earthjustice_on_TSCA_Petition.pdf.
    11. North American Industry Classification System. 2007 NAICS 
Definition. August 2011. Available online at: http://www.census.gov/eos/www/naics/index.html.
    12. API Energy. About Oil and Natural Gas. Industry Sectors. 
September 14, 2011.
    13. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; 
Criteria for Evaluating Substantial Production, Substantial Release, 
and Substantial or Significant Human Exposure; Final Statement of 
Policy. Federal Register (58 FR 28736, May 14, 1993) (FRL-4059-9).

List of Subjects in Chapter I

    Environmental protection, Exploration and production (E&P), 
Hydraulic fracturing, Oil and gas, Toxic Substances Control Act (TSCA).

    Dated: July 3, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2013-16485 Filed 7-10-13; 8:45 am]
BILLING CODE 6560-50-P


