Comments of the American Chemistry Council

on TSCA Section 21 Petition Concerning

Oil and Gas Exploration and Production Chemicals

October 20, 2011

Of Counsel: Christina Franz

Mark N. Duvall Senior Director, Regulatory & Technical Affairs

Beveridge & Diamond, P.C. American Chemistry Council

1350 I Street, N.W. 700 Second Street, N.E.

Washington, DC 20005 Washington, DC 20002

(202) 789-6090 (202) 249-6406

mduvall@bdlaw.com christina_franz@americanchemistry.com
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Table of Contents

Page

EXECUTIVE SUMMARY ..................................................................................................... 1

DISCUSSION.......................................................................................................................... 1

I. ACC Statement of Interest .......................................................................................... 1

II. Importance of Shale Gas to the Chemical Industry ..................................................... 2

III. The Actions Requested by the Petition Are Not Necessary ........................................ 3

A. Information Cited in the Petition ..................................................................... 3

B. EPA‘s Ongoing Study of Hydraulic Fracturing and Drinking Water.............. 5

C. Other Considerations About the Lack of Need for EPA Action...................... 9

D. Lack of Complete Information Does Not Justify TSCA Rulemaking........... 10

IV. Granting the Petition Would Distract EPA From Higher Priority Actions ............... 10

V. E&P Chemicals Is an Inappropriate Category........................................................... 11

VI. The Petition Is an Inappropriate Means for Obtaining Trade Secret Chemical

Identities..................................................................................................................... 12

VII. The Petition Fails to Meet the Criteria for EPA to Take Action Under TSCA ......... 13

A. Section 21 Puts the Burden of Proof on the Petitioners................................. 13

B. The Requested Section 4 Rule ....................................................................... 13

C. The Requested Section 8(a) Rule................................................................... 14

D. The Requested Section 8(c) Order................................................................. 15

E. The Requested Section 8(d) Rule .................................................................. 15

CONCLUSION...................................................................................................................... 16
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EXECUTIVE SUMMARY

The American Chemistry Council (ACC) urges EPA to deny the citizens‘ petition entitled 

―Citizen Petition under Toxic Substances Control Act Regarding the Chemical Substances and 

Mixtures Used in Oil and Gas Exploration or Production‖ (the Petition).

Initially, it should be noted that the Petition addresses an issue of considerable 

importance to America‘s chemical industry. The recent availability of commercial quantities of 

shale gas, obtained through technology such as hydraulic fracturing and horizontal drilling, has 

created the potential for a robust and growing chemical industry based on natural gas as a cheap 

and reliable feedstock. This in turn is creating jobs and generating economic growth for the 

country.

The Petition is largely a series of arguments against the development of shale gas in this 

country in the form of a petition for EPA actions under the Toxic Substances Control Act 

(TSCA). The actions it requests are not necessary. Many of the chemical substances covered by 

the Petition have robust information already available, while others are of low hazard. EPA is 

already reviewing the very issues raised by the Petition in a multi-year, Congressionallymandated study of hydraulic fracturing and drinking water supplies. EPA is already in the 

process of collecting much of the information requested by the Petition. 

The biocides referenced in the Petition are not subject to EPA‘s jurisdiction under TSCA, as they 

are pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

New chemical substances used in the oil and gas industry are reviewed in detail by EPA through 

the premanufacture notification (PMN) program. Information about the chemicals used in shale 

gas development is increasingly available to the public. The requested actions would 

undoubtedly divert EPA from higher priorities under TSCA. The requested actions would be a 

huge drain of EPA‘s resources, given the extraordinarily large number of chemicals and mixtures 

covered by the Petition. In short, there is simply no need for EPA to take the requested actions 

under TSCA.

Under section 21, the petitioner bears the burden of proving that taking the requested 

action meets the statutory requirements for action under each of the sections cited. The Petition 

has not shown that the requested test rule meets the various section 4 requirements. It fails to 

establish that rules under section 8(a) and section 8(d) would be reasonable or necessary. It asks 

for a section 8(c) call-in, relief which is not available under section 21.

Accordingly, EPA should deny the petition in its entirety...

DISCUSSION

I. ACC Statement of Interest

The American Chemistry Council (ACC) represents the leading companies engaged in 

the business of chemistry. A key feedstock for the chemical manufacturing industry in the 

United States is natural gas. The Petition challenges the safety of hydraulic fracturing and other 
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technologies and practices used in producing natural gas, particularly from shale. As shale gas is 

crucial to the economic future of the chemical industry, ACC and its member companies are 

affected by the Petition.

II. Importance of Shale Gas to the Chemical Industry

Section 2(c) of TSCA directs EPA to ―consider the environmental, economic, and social 

impact of any action‖ it takes or proposes to take under that statute. The Petition directly 

addresses aspects of shale gas production. Thus, in reviewing the Petition, EPA should consider 

the economic and social aspects of shale gas production as well as its environmental aspects.

The Energy Information Administration (EIA) has explained the importance of hydraulic 

fracturing and horizontal drilling to the production of shale gas, and the importance of shale gas 

to U.S. energy production:

Shale gas production in the United States grew at an average annual rate of 17 percent 

between 2000 and 2006 .... The combination of horizontal drilling and hydraulic 

fracturing technologies has made it possible to produce shale gas economically, leading 

to an average annual growth rate of 48 percent over the 2006-2010 period.

Shale gas production continues to increase strongly through 2035 in the [Annual Energy 

Outlook 2011] Reference case, growing almost fourfold from 2009 to 2035. While total 

domestic natural gas production grows from 21.0 trillion cubic feet in 2009 to 26.3 

trillion cubic feet in 2035, shale gas production grows to 12.2 trillion cubic feet in 2035, 

when it makes up 47 percent of total U.S. production—up considerably from the 16-

percent share in 2009.1

Commercial shale gas production in the United States is proving to be the key to renewed 

growth in the domestic chemical industry. ACC recently analyzed the impact of a hypothetical, 

but realistic, 25 percent increase in ethane supply from shale gas on growth in the petrochemical 

sector,

2

and found that the increase would generate: 

 17,000 new knowledge-intensive, high-paying jobs in the U.S. chemical industry 

 395,000 additional jobs outside the chemical industry (165,000 jobs in other industries 

that are related to the increase in U.S. chemical production and 230,000 jobs from new 

capital investment by the chemical industry) 

 $4.4 billion more in federal, state, and local tax revenue annually ($43.9 billion over 10 

years) 

 A $32.8 billion increase in U.S. chemical production 

 $16.2 billion in capital investment by the chemical industry to build new petrochemical 

and derivatives capacity 

 

1 EIA, Annual Energy Outlook 2011 with Projections to 2035 (2011), DOE/EIA-0383(2011), available at 

http://www.eia.gov/forecasts/aeo/pdf/0383(2011).pdf, at 2.

2 ACC, Shale Gas and New Petrochemicals Investment: Benefits for the Economy, Jobs, and US Manufacturing 

(2011), available at http://www.americanchemistry.com/ACC-Shale-Report. 
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 $132.4 billion in U.S. economic output ($83.4 billion related to increased chemical 

production (including additional supplier and induced impacts) plus $49.0 billion related 

to capital investment by the U.S. chemical industry) 

The scenario outlined in ACC‘s report is corroborated by trends in the chemical industry. 

ACC member companies, including The Dow Chemical Company, Shell Chemical, 

LyondellBasell, Bayer MaterialScience, and others have announced new investments in U.S. 

petrochemical capacity to benefit from available resources and grow their chemical businesses.3

Accordingly, as EPA reviews the Petition, it should do so with recognition that continued and 

expanded shale gas production is extremely important to the U.S. economy and to the chemical 

industry in particular. 

III. The Actions Requested by the Petition Are Not Necessary

The Petition asks EPA to require the development of new information and submission of 

existing information about what it calls ―E&P Chemicals,‖ a term it defines as ―chemical 

substances and mixtures used in oil and gas exploration or production.‖ It is not clear what 

chemicals and mixtures qualify as E&P Chemicals, but it is clear that much information is 

available about many chemicals used in the oil and gas industry. At best, the Petition is 

overbroad and fails to establish that the actions requested of EPA are necessary.

A. Information Cited in the Petition

The principal source cited in the Petition as supporting the need for EPA action under 

TSCA is a list of 980 products containing 649 chemicals compiled by the Endocrine Exchange, 

an NGO with no known expertise in oil and gas issues (Petition pp. 9-11).

4

 The list includes 

well-studied chemicals such as ammonia, carbon black, chlorine, crystalline silica, ethylene 

glycol, formaldehyde, and hydrochloric acid. There is no need for EPA to require the generation 

or reporting of information on these and other chemicals to supplement the already considerable 

data available on them.

The list also includes many low hazard chemicals, such as cellulose, citric acid, deionized 

water, and guar gum. Indeed, multiple listed chemicals are generally recognized as safe (GRAS)

for direct use in food per FDA regulations, including the following, among others:

 Acetic acid, 21 C.F.R. § 184.1005

 Aluminum sodium sulfate, 21 C.F.R. § 182.1131

 Ammonium chloride, 21 C.F.R. § 184.1138

 Ammonium sulfate, 21 C.F.R. § 184.1143

 Boric acid, 21 C.F.R. § 181.30

 Calcium carbonate, 21 C.F.R. § 184.1191

 

3

See, e.g., J. Kaskey, Cheap Shale Gas Means Record U.S. Chemical Industry Growth (Aug. 10, 2011), available at 

http://www.bloomberg.com/news/2011-08-10/cheap-shale-gas-means-record-u-s-chemical-industry-expansion.html. 

4 The list is available at http://www.endocrinedisruption.com/files/MultistateSpreadsheet3-29-11States.xls. 
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 Calcium chloride, 21 C.F.R. § 184.1193

 Calcium hydroxide, 21 C.F.R. § 184.1205

 Calcium sulfate, 21 C.F.R. § 184.1230

 Calcium oxide, 21 C.F.R. § 184.1210

 Citric acid, 21 C.F.R. § 184.1033

 Guar gum, 21 C.F.R. § 184.1339

 Magnesium chloride, 21 C.F.R. § 184.1426

 Sodium carbonate, 21 C.F.R. § 184.1742

 Sodium hydroxide, 21 C.F.R. § 184.1763

 Sodium metasilicate, 21 C.F.R. § 184.1769a

 Sodium nitrate, 21 C.F.R. § 181.33

 Sodium sulfite, 21 C.F.R. § 182.3798

 Sucrose, 21 C.F.R. § 184.1854

 Sulfuric acid, 21 C.F.R. §184.1095

 Tricalcium silicate, 21 C.F.R. § 182.2906

Although the chemicals listed above as GRAS may not meet the FDA specifications noted in the 

regulations or be of a quality appropriate for use in food when used in the oil and gas industry, 

the point is that they are recognized as very low hazard chemicals, particularly at the extremely 

low concentrations used in hydraulic fracturing, where the formulations are predominantly water. 

FDA requires the same quantity and quality of scientific evidence for GRAS classification as it 

requires for approval of a food additive application,5so it is reasonable to conclude that these are 

well-studied chemicals.

Of the 649 chemicals on the Endocrine Exchange list, 432 (66%) were reported to have

appeared in only 1 of the 980 products, and 9 (1%) were reported to have appeared in 0 products. 

Thus, while the list may include 649 chemicals, most appear to be in extremely limited usage in 

the oil and gas industry, and thus are of little relevance in this context. Only the following 

chemicals on the list were reported to have appeared in 10 or more of the 980 products (with the 

number of products in which they were apparently reported):

 2-BE (ethylene glycol monobutyl ether) – 23

 Aluminum oxide – 17

 Barite (BaSO4) – 15

 Bentonite – 20

 Crystalline silica, cristobalite – 14

 Crystalline silica, quartz – 124

 Crystalline silica, tridymite – 13

 Deionized water – 32

 Diesel 2 – 20

 Ethylene glycol – 18

 Glutaraldehyde – 11

 

5

21 C.F.R. § 170.30(b).
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 Guar gum – 11

 Heavy aromatic petroleum naphtha (aromatic solvent) – 15

 Hydrochloric acid (HCl) – 13

 Iron oxide (Fe203, Diiron trioxide) – 10

 Isopropanol (Propan-2-OL) – 50

 Methanol – 76

 Mica – 14

 Napthalene – 19

 Petroleum distillate hydrotreated light – 24

 Potassium chloride – 10

 Potassium hydroxide – 10

 Proprietary – 34

 Sodium chloride – 15

 Sodium hydroxide – 17

 Unknown – 45

 Xanthan gum – 10

 Xylene – 12

This is hardly a list of exotic or understudied chemicals for which EPA must postpone its other 

activities under TSCA and collect information. 

In denying an earlier section 21 petition involving air fresheners by some of the same 

petitioners, EPA concluded:

In sum, the NRDC report indicates that some phthalate esters are present in some air 

fresheners at generally low concentrations. This information is not surprising and does 

not provide a basis to suspect that the presence of the phthalate esters at the 

concentrations detected presents a significant public health risk.6

Similarly, the mere presence of certain chemicals in products used in the oil and gas industry 

does not provide a basis to suspect that those chemicals present a significant health risk, 

particularly in light of their low concentrations in hydraulic fracturing, where by far most of the 

fluid is water.

B. EPA’s Ongoing Study of Hydraulic Fracturing and Drinking Water

The Petition recognizes (Petition pp. 3-4), then disregards, that EPA is currently 

undertaking a large study of the very issues for which the Petition asks EPA to collect 

information under TSCA. The House of Representatives Appropriations Conference Committee, 

in connection with EPA‘s Fiscal Year 2010 appropriation, directed EPA to undertake the study:

Hydraulic Fracturing Study.—The conferees urge the Agency to carry out a study on the 

relationship between hydraulic fracturing and drinking water, using a credible approach 

 

6

72 Fed. Reg. 72886, 72889 (Dec. 21, 2007).
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that relies on the best available science, as well as independent sources of information.

The conferees expect the study to be conducted through a transparent, peer-reviewed 

process that will ensure the validity and accuracy of the data. The Agency shall consult 

with other Federal agencies as well as appropriate State and interstate regulatory agencies 

in carrying out the study, which should be prepared in accordance with the Agency‘s 

quality assurance principles.7

Since announcing in March 2010 that it would undertake the study, EPA has prepared a draft 

study plan.

8

The Science Advisory Board (SAB) has reviewed the draft study plan,

9

and EPA is 

revising the draft in light of the SAB comments.10 EPA has identified seven case studies to be 

undertaken as part of the overall study.11 EPA expects to issue a first report of results by the end 

of 2012, with an additional report in 2014.12

This massive project includes the collection of information on the identities, hazards, and 

risks of chemicals used in hydraulic fracturing, the key request of the Petition. The section 8(a) 

rule requested in the Petition will be substantially addressed by the study:

EPA is concerned with assessing the toxicity and potential human health effects 

associated with these possible drinking water contaminants. In order to do this, EPA will 

first obtain an inventory of the chemicals associated with hydraulic fracturing activities 

(and their estimated concentrations of occurrence), including chemicals used in hydraulic 

fracturing fluid and naturally occurring substances that may be released from subsurface 

formations during the hydraulic fracturing process. EPA will also need to identify the 

relevant reaction and degradation products of these substances, which may have different 

toxicity and human health effects than their parent compounds, in addition to the fate and 

transport characteristics of the chemicals.

13

The section 8(d) rule requested in the Petition will also be effectively addressed:

 

7 H.R. Rep. 111-316 (2009) at 109 (conference report for Pub. L. 111-88), available at 

http://www.gpo.gov/fdsys/pkg/CRPT-111hrpt316/pdf/CRPT-111hrpt316.pdf.

8 EPA, Draft Plan to Study the Potential Impacts of Hydraulic Fracturing on Drinking Water Resources, 

EPA/600/D-11/001 (2011), available at 

http://water.epa.gov/type/groundwater/uic/class2/hydraulicfracturing/upload/HFStudyPlanDraft_SAB_020711-

08.pdf.

9 The SAB comments on the draft study plan, dated August 4, 2011, are available at 

http://yosemite.epa.gov/sab/sabproduct.nsf/0/2BC3CD632FCC0E99852578E2006DF890/$File/EPA-SAB-11-012-

unsigned.pdf. 

10 EPA‘s response to the SAB comments, dated September 27, 2011, is available at 

http://yosemite.epa.gov/sab/sabproduct.nsf/2BC3CD632FCC0E99852578E2006DF890/$File/EPA-SAB-11-

012_Response_09-27-2011.pdf

11 EPA, Case Study Locations for Hydraulic Fracturing Study, available at 

http://water.epa.gov/type/groundwater/uic/class2/hydraulicfracturing/case_studies.cfm.

12 EPA, Questions and Answers About EPA‘s Hydraulic Fracturing Study, available at 

http://water.epa.gov/type/groundwater/uic/class2/hydraulicfracturing/faqs.cfm#generalthree.

13 Draft Study Plan at 47-48,
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In the first phase of this work, EPA will conduct an initial screen for known toxicity and 

human health effects information (including existing toxicity values such as reference 

doses and cancer slope factors) by searching existing databases.14

Finally, even the section 4 rule requested in the Petition will be addressed:

The second phase of this work will focus on additional testing and/or assessment of highpriority chemicals. High-priority chemicals may be subjected to a battery of tests used in 

the ToxCast program, a high-throughput screening tool that can identify toxic responses 

.... ToxCast may also be used to establish the level of toxicity or dose-response 

relationships for chemicals where some existing information on toxicity or mode of 

action is available. For chemicals that QSAR analysis and high-throughput screening 

identify as having a high priority for assessing risk in a semi-quantitative or quantitative 

mode, EPA will initially apply computational modeling (e.g., ToxPi and computation 

dose-response analysis) to determine a relative estimate of toxicity. Based on these 

assessments, additional testing of the highest-priority chemicals may be conducted using 

medium-throughput cellular and alternative animal models (e.g., C. elegans, zebra fish, 

and stress response cellular assays) together with targeted laboratory animal assays. The 

latter will be targeted to the specific mode of action indicated by high- and mediumthroughput assays and computational modeling.15

The ultimate purpose of the actions requested by the Petition is assessment of the risk of

E&P Chemicals. The ongoing EPA study will assess the risk of both individual chemicals and 

relevant mixtures used in hydraulic fracturing:

EPA may also develop chemical-specific Provisional Peer Reviewed Toxicity Values 

(PPRTVs) for high-priority chemicals for which there are no existing toxicity values. 

PPRTVs summarize the available scientific information about the adverse effects of a 

chemical and the quality of the evidence, then ultimately derive toxicity values, such as 

reference doses and cancer slope factors, that can be used in conjunction with exposure 

and other information to develop a risk assessment. In addition to single chemical 

assessments, further information may be obtained for mixtures of chemicals based on 

which components occur most frequently together and their relevant proportions as 

identified from exposure information. EPA may also assess how changes in source water 

characteristics impact treated drinking water and associated disinfection by products .... 

When combined with exposure and other relevant data, this information will help EPA 

characterize the potential public health impacts of hydraulic fracturing on drinking water 

resources.16

 

14 Id. at 48.

15 Id. at 48-49.

16 Id. at 49.
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EPA has already begun data collection from companies involved with hydraulic 

fracturing,17 including issuing a subpoena to one company.18 The Petition‘s requested section 

8(a) and section 8(d) rules duplicate this data collection, despite the Petition‘s attempt to show 

otherwise (Petition p. 4). For example, the 2010 EPA data collection request addressed to the 

nine companies includes the following information, similar to the provisions of sections 8(a) and 

8(d) as applied to this context: 

1. Provide the name of each hydraulic fracturing fluid formulation/mixture distributed or 

utilized by the Company within the past five years from the date of this letter. For 

each formulation/mixture, provide the following information for each constituent of 

such product ....

2. Provide all data and studies in the Company‘s possession relating to the human health 

and environmental impacts and effects of all products and constituents identified in 

Question 1.

3. For all hydraulic fracturing operations for natural gas extraction involving any of the 

products and constituents identified in the response to Question 1, describe the 

process including the following: ....

4. a. Identify all sites where, and all persons to whom, the Company:

i. provided hydraulic fracturing fluid services that involve the use of hydraulic 

fracturing fluids for the year prior to the date of this letter, and

ii. plans to provide hydraulic fracturing fluid services that involve the use of 

hydraulic fracturing fluids during one year after the date of this letter.

b. Describe the specific hydraulic fracturing fluid services provided or to be 

provided for each of the sites in Question 4.a.i. and ii., including the identity of 

any contractor that the Company has hired or will hire to provide any portion of 

such services.

For each site identified in response to Question 4, please provide all information 

specified in the enclosed electronic spreadsheet.

 

17 The EPA letter sent to 9 hydraulic fracturing service providers in September 2010 requesting certain information 

is available at 

http://water.epa.gov/type/groundwater/uic/class2/hydraulicfracturing/upload/HFvoluntaryinformationrequest.pdf. 

The EPA letter to those service providers in August 2011 requesting additional information is available at 

http://water.epa.gov/type/groundwater/uic/class2/hydraulicfracturing/upload/LetterTo9HFCompanies_August2011.p

df. 

18 The subpoena to Halliburton is available at 

http://water.epa.gov/type/groundwater/uic/class2/hydraulicfracturing/upload/hydrofrac_halliburton_subpoena_11-9-

2010.pdf.
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In light of this ongoing study and its focus on the very issues underlying the Petition, the 

actions requested in the Petition are unnecessary.

The Petition seeks (Petition p. 3) to discount the relevance of the EPA study, which 

focuses on the potential effects of hydraulic fracturing to drinking water, by asserting that E&P 

Chemicals may also have adverse effects on air quality. EPA is addressing air issues in oil and 

natural gas production separately through a proposed rulemaking under the Clean Air Act. It is 

obligated by a consent decree to take final action on that rulemaking by February 28, 2012. The 

preamble explains, ―[w]e are proposing operational standards for completions of hydraulically 

fractured gas wells.‖19 Thus, EPA has already proposed to take action on a subject for which the 

Petition merely requests that it collect information.

C. Other Considerations About the Lack of Need for EPA Action

The Petition refers (Petition pp. 2, 12) to ―bactericides,‖ ―biocides,‖ and ―microbicides‖ 

[sic] as being among the E&P Chemicals for which the petitioners have concerns. As EPA is 

well aware, biocides are regulated under FIFRA and are excluded from the scope of TSCA 

through the definition of ―chemical substance‖ in section 3(2)(B)(ii). There is no authority for 

EPA to require information about biocides under TSCA. Moreover, there is no need for EPA to 

do so, since oilfield use of biocides must be specifically supported and reviewed by EPA before 

that use can be added to a biocide‘s FIFRA label.

The Petition says (Petition p. 20) that EPA should include ―new substances‖ in its section 

8(a) rulemaking for E&P Chemicals. New chemical substances must be reviewed by EPA under 

TSCA section 5 before they are used for non-exempt commercial purposes, such as oil and gas 

exploration and development. .

The Petition also states (p. 20) that all new mixtures must be included in the requested 

section 8(a) rule. Such a requirement would be burdensome and pose an impediment to 

innovation, as it would slow down the introduction of new products, even those which may 

reduce the environmental footprint of oil and gas exploration and production. This request is 

similar to that in the 2010 House bill to amend TSCA, which would have required a declaration 

under section 8(a) for any use of a mixture which had not previously been reported to EPA.20 

This request would put EPA in the business of reviewing each new formulation used in the oil 

and gas industry, for no apparent purpose. 

Information about the chemicals used in hydraulic fracturing is now widely available 

through such sources as the FracFocus website, as the Petition concedes (pp. 4-5). These sources 

may not satisfy the petitioners, either because they do not disclose trade secret chemical 

identities or because they are largely voluntary. (Reporting for the FracFocus website is now 

mandatory in Texas.21) Those objections, however, do not undermine the Petition‘s own 

 

19 76 Fed. Reg. 52738, 52745 (Aug. 23, 2011).

20 The Toxic Chemicals Safety Act of 2010, H.R. 5820 (2010), § 5(2).

21 Texas Natural Resources Code § 91,851(a)(1).
- 10 -

evidence that there is no need at this point for EPA to duplicate such websites through 

rulemaking under TSCA.

D. Lack of Complete Information Does Not Justify TSCA Rulemaking

The Petition does ask for some information not already available in public databases or to 

be included in the ongoing EPA study. For example, EPA asked some, but not all, companies 

involved in hydraulic fracturing to provide detailed information (Petition p. 5). The testing that 

EPA anticipates in the course of the study may be narrower than the virtually unlimited testing 

requested in the Petition. This lack of exact duplication of the Petition does not establish that 

additional information is necessary to be developed under TSCA.

It is abundantly clear that EPA must balance the need for additional information about 

any chemical or category of chemicals against the need to make decisions in a timely manner and 

the costs of obtaining additional information. In this case, EPA plans to work through 2014 on 

the study which it launched in 2010. EPA reasonably concluded that its draft study plan was 

sufficiently broad in scope to meet its needs and the Congressional mandate. The Petition 

attempts to second-guess that conclusion and should be denied.

IV. Granting the Petition Would Distract EPA From Higher Priority Actions

The effect of a successful section 21 petition is to disrupt EPA‘s established priorities so 

that EPA redirects its limited resources to the subject matter addressed by the petition, even if 

EPA does not consider that subject matter to be a priority. Section 21(b)(4)(B) recognizes that 

EPA‘s priorities are a relevant factor in its review of a petition.

EPA is already addressing the potential impact of hydraulic fracturing on drinking water 

as a priority matter, as evidenced by the ongoing study discussed above. Beyond that, EPA has 

important priorities under TSCA reflected in its chemical action plans, its long-range plan, and 

other documents.

EPA has struggled to establish clear priorities and stick with them. In a 1987 report, EPA 

Administrator Lee Thomas called for risk-based prioritization: 

Although EPA‘s mission enjoys broad public support, our agency nonetheless must 

operate on finite resources. Therefore, we must choose our priorities carefully so that we 

apply those resources as effectively as possible ....

In a world of limited resources, it may be wise to give priority attention to those 

pollutants and problems that pose the greatest risks to our society.22

 

22 EPA, ―Unfinished Business: A Comparative Assessment of Environmental Problems - Overview Report‖ (1987) 

at i, ii, available at http://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=2001635G.TXT. 
- 11 -

EPA is already working to identify priorities under TSCA. As announced in August 2011, 

―EPA intends to identify priority chemicals for review and possible risk management action 

under TSCA,‖ in part through a webinar and discussion forum in September 2011.23

In effect, the Petition asks EPA to drop its other priorities and redirect its broad TSCA 

resources to promulgate regulations under section 4, section 8(a), and section 8(d) and issue orders 

under section 8(c) on substances used in oil and gas exploration and production, and then review and 

evaluate the resulting information. The Petition applies to hundreds – potentially thousands -- of 

individual chemicals and mixtures. The resulting rules, orders, reviews, and analyses would consume 

substantial amounts of EPA‘s limited resources, precluding work on many higher priority activities, 

including those priorities that may be identified in EPA‘s current effort. In denying a section 21 

petition on air fresheners, EPA noted that it had higher priorities:

EPA has a number of high priority chemical assessment and risk management projects and 

actions already underway that are requiring a substantial amount of OPPT resources. EPA 

views many of these projects as being more broadly applicable, and as having greater 

potential to result in the understanding and reduction of possible chemical risks, than the 

actions suggested by the petitioners.24

Simply put, the need for this Petition has not been established, and EPA should deny it in its entirety.

V. E&P Chemicals Is an Inappropriate Category

The Petition defines (Petition p. 1) E&P Chemicals as ―chemical substances and mixtures 

used in the oil and gas exploration or production.‖ Thus, it is a category consisting of both 

individual chemicals and mixtures of chemicals related only by the industry in which they are 

used. Section 26(c) of TSCA authorizes EPA to take action with respect to categories rather than 

with respect to individual chemicals, but only if the members of the proposed categories are 

―suitable for classification as such for purposes of this Act.‖ The Petition‘s proffered category is

not suitable for regulatory purposes under TSCA.

In denying a section 21 petition on air fresheners, EPA concluded that it ―does not 

believe that it would be appropriate at this time to treat the vast array of air freshener products as

a category.‖25 Similarly, it is not appropriate to classify the vast array of chemicals and mixtures 

used in the exploration and production of oil and gas as one or more categories, the members of 

which are unrelated in terms of chemical structure, toxicity, or exposure.

This is an issue clearly committed to EPA‘s discretion. As noted in its denial of the air 

freshener petition:

 

23 EPA, Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and 

Assessment (Aug. 2011), available at 

http://www.epa.gov/opptintr/existingchemicals/pubs/Chem.Priorization.August2011.DiscussionGuideOnly.pdf. For 

additional information regarding EPA‘s ongoing prioritization activities under TSCA, see 

http://www.epa.gov/oppt/existingchemicals/pubs/chemprioritizations.html.

24 72 Fed. Reg. 72886, 72890 (Dec. 21, 2007).

25 Id. at 72891.
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EPA has broad discretion to determine whether to regulate by category under TSCA 

section 26(c). Beyond the language of TSCA section 26(c), this discretion is evidenced 

by the fact that TSCA section 21(b)(4)(B)(i) provides an opportunity for a de novo

hearing with respect to petitions for testing of chemical substances, but not for categories 

of chemicals or mixtures. As with mixtures, Congress left the complex issues associated 

with regulation by category to the Administrator‘s discretion. Congress intended this 

authority to ―facilitate the efficient and effective administration‖ of TSCA. Senate 

Report No. 94–698 at p. 31.26

EPA has already exercised considerable discretion in planning and executing its study of 

hydraulic fracturing and drinking water supplies. EPA should exercise its discretion as it did in 

denying the air freshener petition and conclude that the category suggested is not suitable, 

because its use would not facilitate the efficient and effective administration of TSCA.

VI. The Petition Is an Inappropriate Means for Obtaining Trade Secret Chemical 

Identities

The Petition seems motivated largely because trade secret identities are not disclosed 

publicly. This may be seen from the following excerpts from the Petition:

 ―At present, EPA and the public lack adequate data about the identity of E&P 

Chemicals.‖ (Petition p. 3)

 ―This exemption, commonly known as the  ̳Halliburton loophole,‘ allows the oil and gas 

industry to conceal chemical formulas.‖ (Petition p. 5)

 ―the oil and gas industry is resistant to disclosure of E&P Chemicals.‖ (Petition p. 9)

 ―manufacturers and processors rarely disclose the complete chemical composition of their 

products.‖ (Petition p. 10)

 ―the [requested section 4] rule must require the identification of each chemical substance 

or mixture for which testing is performed.‖ (Petition p. 19)

 ―Petitioners request that this [section 8(d)] rulemaking encompass all health and safety 

studies related to any substance or mixture used in oil and gas exploration or production, 

including ... the identity of the chemical substances and mixtures.‖ (Petition p. 21)

EPA has recognized that using section 14(b) as a means of obtaining trade secret 

chemical identities is inappropriate. In denying the section 21 air freshener petition, EPA 

explained:

Petitioners request EPA to use a TSCA section 8(d) rule to obtain ingredient information. 

While information on air freshener ingredients could be a useful starting point for 

assessing whether air fresheners present any significant health risk, TSCA section 8(d) 

does not provide an efficient or effective way to obtain ingredient information because a 

TSCA section 8(d) rule would only obtain the ingredient information that was part of

a health or safety study. Section 8(d) of TSCA is not designed for, and is not an

 

26 Id.
- 13 -

efficient or effective means of obtaining general or comprehensive ingredient information 

on air fresheners.27

The same point can be made even more effectively for the identities of all chemicals and 

mixtures used in oil and gas exploration and production. A section 4 test rule for hundreds or 

thousands of chemicals and mixtures, at a potential cost to industry of hundreds of millions of 

dollars, is a grossly inefficient and ineffective means of obtaining ingredient information on 

those chemicals and mixtures, and a section 8(d) rule would also be costly and inefficient.

VII. The Petition Fails to Meet the Criteria for EPA to Take Action Under TSCA

A. Section 21 Puts the Burden of Proof on the Petitioners

Section 21(b)(3) mandates that EPA either agree to initiate actions requested in a petition 

or deny the petition within 90 days of receipt. During that time EPA may hold a public hearing,

conduct an investigation, or complete a proceeding, per section 21(b)(2), but the time available is 

very limited. 

Accordingly, section 21 puts the burden of proof on the petitioner to provide sufficient 

information to enable EPA to make a decision, including a demonstration that the requested 

actions meet the applicable requirements. As discussed above, the petitioners failed to carry 

their burden of proof that the requested actions are reasonable and appropriate, and otherwise 

meet the TSCA criteria for taking action.

B. The Requested Section 4 Rule

Section 21(b)(4)(B)(i) requires the petitioner to demonstrate that information available to 

EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of a 

chemical, and that in the absence of such information, the chemical may pose an unreasonable 

risk or that the chemical is produced in substantial quantities and it enters or may enter the 

environment in substantial quantities, or that there is or may be substantial or significant human 

exposure. In addition, EPA has determined that the petitioner must establish that the requested 

testing is necessary to develop the data.

28

As noted earlier, the Petition has not provided sufficient information for EPA to make 

any of these findings. Instead, the Petition has outlined (Petition pp. 13-18) a set of unsupported 

allegations that some unspecified chemicals and some unspecified mixtures used in oil and gas 

exploration and production may at some time have caused some adverse effects in a handful of 

alleged incidents. For context, over a million wells have been hydraulically fractured. This is 

exactly what the court had in mind when it concluded that:

 

27 72 Fed. Reg. 72886, 72892 (Dec. 21, 2007) (air fresheners petition denial).

28 Id. at 72887. See also 55 Fed. Reg. 17404, 17405 (Apr. 24, 1990) (new carpet emissions petition denial).
- 14 -

Congress did not intend EPA to direct expensive experimentation based on mere 

speculation .... [T]he statute prevents a testing rule based on little more than scientific 

curiosity ....29

The Petition has not shown that there is more than a ―theoretical possibility‖ of harm,30 and for 

that reason the request for a section 4 rule must be denied.

The Petition asks that every mixture of E&P Chemicals be tested. In the case of 

mixtures, section 4(a)(2) establishes a heavy burden for those seeking the testing of mixtures; 

EPA must find that:

in the case of a mixture, the effects which the mixture‘s manufacture, distribution in 

commerce, processing, use, or disposal or any combination of such activities may have 

on health or the environment may not be reasonably and more efficiently determined or 

predicted by testing the chemical substances which comprise the mixture ....

The Petition has offered nothing which would support such a finding. The legislative history 

explains the reasoning behind this additional requirement:

The assessment of safety of a mixture may well be based upon the toxicity of particular 

components, and tests of the entire mixture with its varying component ratios may be 

unnecessary or unrewarding.31

In this case, testing of hundreds or thousands of mixtures is simply unnecessary. 

Citing section 4(a)(2), EPA has denied petitions for the testing of mixtures in similar 

situations,32 and it should do so here as well. EPA‘s denial of the Petition on this basis would be 

within EPA‘s unreviewable discretion, as section 21(b)(4)(B)(i) does not provide for judicial 

review of a denial of a petition for a test rule on mixtures.33

C. The Requested Section 8(a) Rule

Under section 21(b)(4)(B)(ii), the petitioner seeking a rule under section 8(a) must 

establish that ―there is a reasonable basis to conclude that the issuance of [the requested rule] is 

necessary to protect health or the environment against an unreasonable risk of injury to health or 

the environment.‖ EPA has previously denied petitions for section 8(a) rules on the basis that 

the petitioner failed to establish that the requested rule was necessary,34 and it should do so here 

as well. 

 

29 Ausimont U.S.A., Inc. v. EPA, 838 F.2d 93, 96-97 (3d Cir. 1988).

30 See Chemical Manufacturers Ass‘n v. EPA, 859 F.2d 977, 988 (D.C. Cir. 1988).

31 H.R. Rep. 94-1341 (1976) at 18, Legislative History of the Toxic Substances Control Act (1976) at 425.

32 72 Fed. Reg. at 72893-94 (testing of air fresheners as such); 72 Fed. Reg. 50954, 50957 (Sept. 5, 2007) (testing of 

unspecified mixtures of nonylphenol and nonylphenol ethoxylates).

33 EPA made this point in connection with the air fresheners petition at 72 Fed. Reg. 72886, 72887 (Dec. 21, 2007).

34 65 Fed. Reg. 18097, 18098-101 (Apr. 6, 2000) (HPV chemicals petition denial); 55 Fed. Reg. 17404, 17407 (Apr. 

24, 1990) (new carpets petition denial).
- 15 -

Moreover, under section 8(a)(2), ―to the extent feasible,‖ EPA may not adopt a section 

8(a) rule that is ―unnecessary or duplicative.‖ States already collect much of the information that 

the Petition seeks. EPA is already collecting much of the information requested in the section 

8(a) rule from multiple companies in the oil and gas industry, as noted above. Further, the 

Chemical Data Reporting (CDR) rule already collects detailed information on E&P Chemicals.35 

Thus, the requested section 8(a) rule would be unnecessary and duplicative. It is noteworthy that 

the CDR rule exempts from processing and use information requirements most petroleum 

distillates,36 which the Petition cites (Petition p. 12) as being of particular concern. EPA has 

already determined that collection of processing and use information on petroleum distillates is 

unnecessary.

D. The Requested Section 8(c) Order

The Petition asks EPA to issue an order under 40 C.F.R. § 717.17(c) requiring nine 

named companies to submit their section 8(c) allegations relating to E&P Chemicals to EPA. 

The expected value of this requested action is not explained. More significantly, section 21 does 

not permit such a request, and for that reason alone, EPA should deny the Petition.

Section 21(a) authorizes citizens‘ petitions for ―a rule under section 4, 6, or 8 or an order 

under section 5(e) or (6) (b) (2).‖ An order under section 8(c) is not included. EPA has 

previously concluded that a request for a call-in under section 8(c) is ―not a petitionable matter 

under TSCA section 21,‖ explaining:

EPA interprets section 21 to apply only to the enumerated actions. EPA believes the 

Congress reasonably chose to extend TSCA section 21 only to the specific rules and 

orders identified under section 21 .... Congress chose not to extend TSCA section 21 to 

other kinds of agency implementation actions.37

Accordingly, EPA should deny the request for a call-in of section 8(c) allegations.

It is particularly concerning that the request for a non-petitionable section 8(c) call-in 

order is made here, since two of the petitioners here, the Sierra Club and the Natural Resources 

Defense Fund (NRDC), were also petitioners for the 2007 air freshener petition. Yet the Petition 

fails even to acknowledge that EPA has previously determined that requests for section 8(c) callin orders are not petitionable.

E. The Requested Section 8(d) Rule

As with section 8(a), under section 21(b)(4)(B)(ii), the petitioner seeking a rule under 

section 8(d) must establish that ―there is a reasonable basis to conclude that the issuance of [the 

 

35 40 C.F.R. Part 711, 76 Fed. Reg. 50816 (Aug. 16, 2011), corrected, 76 Fed. Reg. 54932 (Sept. 6, 2011).

36 40 C.F.R. § 711.6(b)(1).

37 72 Fed. Reg. 72886, 72891 (Dec. 21, 2007) (air fresheners petition denial). See also 71 Fed. Reg. 42640 (July 27, 

2006) (lead in toy jewelry petition denial) (―The other two requests, for actions under TSCA sections 5(a) and 9, are 

not petitionable under section 21.‖).
- 16 -

requested rule] is necessary to protect health or the environment against an unreasonable risk of 

injury to health or the environment.‖ EPA may exclude studies if it finds that they are 

―unnecessary,‖ per section 8(d)(1). The legislative history emphasized that ―the Administrator is 

to avoid imposing unnecessary or overly burdensome reporting requirements‖ under section 

8(d).38

This situation resembles the air freshener petition, where EPA found that the request for a 

section 8(d) rule on hundreds of products was unnecessary: ―Petitioners have not set forth 

sufficient facts to establish that it is necessary to initiate the requested section 8(d) 

rulemaking.‖39 In addition to the inadequate factual presentation in the petition itself, EPA found 

that:

The cost of this TSCA section 8(d) rule would be substantial for both the industry and the 

Agency. Although such a rule would not require industry to perform new testing, the 

scope of studies covered by the requested rule would be very broad. It is not clear

whether the ―manufacturers and processors‖ that would to be subject to the rule 

petitioners request are intended to include manufacturers and processors of air freshener 

ingredients as well as products. Such a rule would potentially cover a very large group of 

entities, products, and ingredients.

In addition, this rulemaking would require substantial Agency resources to develop, and 

significant Agency resources would also be required to analyze submitted studies on air

fresheners.40

The Petition has failed to provide an adequate factual predicate of establishing that a section 8(d) 

rule is ―necessary to protect health and the environment against an unreasonable risk of injury to 

health or the environment,‖ and the requested rule would be unduly costly to both industry and 

EPA. Like with the air freshener petition, the requested section 8(d) rule would cover hundreds 

or thousands of chemicals and hundreds or thousands of mixtures. There is simply no basis for 

requiring the immense cost involved with industry compliance and EPA time in reviewing and 

analyzing those studies.

CONCLUSION

EPA should deny the Petition in all its aspects.

 

38 H.R. Rep. 94-1679 (1976) at 81, Legislative History of the Toxic Substances Control Act (1976) at 694.

39 72 Fed. Reg. 72886, 72891 (Dec. 21, 2007). EPA has also denied requests for section 8(d) rules in other section 

21 petitions as well, including 71 Fed. Reg. 42640, 42641 (July 27, 2006) (lead in toy jewelry); 65 Fed. Reg. 18097, 

18098-100 (Apr. 6, 2000) (HPV chemicals); 55 Fed. Reg. 17404, 17407 (Apr. 24, 1990) (new carpets). 

40 Id. at 72892.