Document ID: EPA-HQ-OPPT-2010-0446-0001
Agency: epa
Document Type: Notice
Title: Claims of Confidentiality: Certain Chemical Identities Contained in Health and Safety Studies and Data from Health and Safety Studies Submitted Under the Toxic Substances Control Act
Posted Date: 2010-05-27T04:00Z

[Federal Register: May 27, 2010 (Volume 75, Number 102)]
[Notices]               
[Page 29754-29757]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my10-52]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0446; FRL-8827-3]

 
Claims of Confidentiality of Certain Chemical Identities 
Contained in Health and Safety Studies and Data from Health and Safety 
Studies Submitted Under the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA will begin a general practice of reviewing confidentiality 
claims for chemical identities in health and safety studies, and in 
data from health and safety studies, submitted under the Toxic 
Substances Control Act (TSCA) in accordance with Agency regulations at 
40 CFR part 2, subpart B. Section 14(b) of TSCA does not extend 
confidential treatment to health and safety studies, or data from 
health and safety studies, which, if made public, would not disclose 
processes used in the manufacturing or processing of a chemical 
substance or mixture or, in the case of a mixture, the release of data 
disclosing the portion of the mixture comprised by any of the chemical 
substances in the mixture. Where a chemical identity does not 
explicitly contain process information or reveal portions of a mixture, 
EPA expects to find that the information would clearly not be entitled 
to confidential treatment. This builds on similar efforts regarding 
confidentiality of chemical identities listed on the public version of 
the TSCA Chemical Substances Inventory (TSCA Inventory) and submitted 
in notifications pursuant to TSCA section 8(e), discussed in the 
Federal Register of January 21, 2010.

DATES: EPA expects to begin reviews of confidentiality claims -- both 
newly submitted and existing claims -- in accordance with this guidance 
on August 25, 2010. Though EPA is not required to solicit comment for 
this action, comments received before this date will inform these 
reviews.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2010-0446, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
      Mail: Document Control Office (7407M), Office of 
Pollution Prevention and Toxics (OPPT), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
      Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2010-0446. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0446. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at

[[Page 29755]]

http://www.regulations.gov, or, if only available in hard copy, at the 
OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., 
Washington, DC. The EPA/DC Public Reading Room hours of operation are 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Scott M. Sherlock, Environmental Assistance Division, Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8257; e-mail address: sherlock.scott@epa.gov.
     For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This document is directed to the public in general, though it does 
not directly impose any binding requirements on parties outside the 
Agency. It may, however, be of particular interest to you if you 
manufacture (defined by statute to include import) and/or process 
chemical substances and mixtures subject to TSCA (15 U.S.C. 2601 et 
seq.). You may be identified by the North American Industrial 
Classification System (NAICS) codes 325 and 32411. Because this 
document is directed to the general public and other entities may also 
be interested, the Agency has not attempted to describe all the 
specific entities that may be interested in 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. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and 
then identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. What Action is the Agency Taking?

    The Agency expects to respond to certain confidentiality claims 
regarding chemical identities in health and safety studies and in data 
from health and safety studies with a determination letter under 40 CFR 
2.306(d), 40 CFR 2.204(d)(2), and 40 CFR 2.205(f) that such information 
is clearly not entitled to confidential treatment. This Federal 
Register document only serves to announce an impending general Agency 
practice, and this document does not constitute a final Agency action; 
rather, any determination letter issued by EPA will constitute the 
Agency's final determination that the chemical identity at issue is not 
entitled to confidential treatment under TSCA section 14 (15 U.S.C. 
2613), and the recipient of such a determination letter may seek 
judicial review under 5 U.S.C. 701 et seq.
    At this time, EPA expects to issue these determination letters when 
the chemical identity claimed as confidential:
    1. Was submitted as part of a health and safety study, or of data 
from a health and safety study, submitted under TSCA that is subject to 
TSCA section 14(b)(1).
     2. Does not explicitly contain process information.
     3. Does not reveal data disclosing the portion of the mixture 
comprised by any of the chemical substances in the mixture.
    Each determination letter will provide a contact person within the 
Agency whom the recipient of the letter can contact with any questions 
or concerns about the determination related to the submission.
    The TSCA Inventory is a list of chemical substances subject to TSCA 
that are in commerce in the United States, and the fact that a chemical 
substance is on the TSCA Inventory may be claimed as confidential. 
Release of a chemical identity under TSCA section 14(b) may 
correspondingly affect the validity of a confidentiality claim for 
presence on the TSCA Inventory. EPA expects to examine TSCA Inventory 
confidentiality claims for chemical identity at the time it makes 
determinations under TSCA section 14(b). EPA will issue determinations 
on confidential inventory status when appropriate.
    This action is part of a broader effort to increase transparency 
and provide more valuable information to the public by identifying data 
collections where information may have been claimed and treated as 
confidential in the past but is not in fact entitled to confidentiality 
under TSCA. For such information, EPA is considering what actions might 
be appropriate in accordance with its confidentiality regulations at 40 
CFR part 2, subpart B. EPA believes these actions will make more health 
and safety information available to the public and support an important 
mission of the Agency to promote public understanding of the potential 
risks posed by chemical substances in commerce.

[[Page 29756]]

III. What is the Agency's Authority for Taking this Action?

Under TSCA section 3(6) (15 U.S.C. 2602(6)):

    The term ``health and safety study'' means any study of any 
effect of a chemical substance or mixture on health or the 
environment or on both, including underlying data and 
epidemiological studies, studies of occupational exposure to a 
chemical substance or mixture, toxicological, clinical, and 
ecological studies of a chemical substance or mixture, and any test 
performed pursuant to this chapter.

    Health and safety studies may be submitted under various sections 
of TSCA, such as TSCA section 8(d) rules explicitly requiring 
submission of health and safety studies, notices of substantial risk 
under TSCA section 8(e), and TSCA section 4 rules requiring persons to 
perform testing. (15 U.S.C. 2603, 2607(d), and 2607(e)) Premanufacture 
notices submitted under TSCA section 5 must include test data in the 
possession or control of the person submitting the notice. (15 U.S.C. 
2605(d)(1)(B)) Chemical identity is part of a health and safety study. 
See, e.g., 40 CFR 716.3 and 40 CFR 720.3(k).
    Section 14(b)(1) of TSCA provides that health and safety studies 
and data from health and safety studies are not entitled to 
confidential treatment unless such information, if made public, would 
disclose processes used in the manufacturing or processing of a 
chemical substance or mixture or in the case of a mixture, the portion 
of the mixture comprised by any of the chemical substances in the 
mixture. (15 U.S.C. 2613(b)(1)) This document discusses the disclosure 
of process information element only, and does not deal with the portion 
of a mixture information element, which pertains to the concentrations 
of the components of a mixture.
    Section 14(b)(1) of TSCA is limited to health and safety studies 
and data submitted with respect to chemical substances or mixtures that 
have been offered for commercial distribution and those for which 
testing is required under TSCA section 4 or for which notification is 
required under TSCA section 5.
    Until recently, EPA has not announced the Agency's views regarding 
when disclosure of chemical identities may in turn disclose process 
information. In the Federal Register issue of January 21, 2010 (75 FR 
3462) (FRL-8807-9), EPA announced that ``[w]here a health and safety 
study submitted under section 8(e) of TSCA involves a chemical identity 
that is already listed on the public portion of the TSCA Chemical 
Substances Inventory, EPA expects to find that the chemical identity 
clearly is not entitled to confidential treatment.''
    In that January 21, 2010 Federal Register document the Agency 
stated that:

``Where the identity of a chemical substance is already contained on 
the public portion of the TSCA Chemical Substances Inventory, which 
is publicly available from the National Technical Information 
Service and other sources, EPA believes that the identity itself, 
even assuming it might otherwise be CBI, as well as any information 
that might be derived from it about processes or portions, has 
already been disclosed.''
Id.

    The January 21, 2010 Federal Register document did not, however, 
address chemical substances not on the public TSCA Inventory. With 
respect to such chemical substances, EPA is aware that some companies 
believe their competitors are sufficiently knowledgeable that if EPA 
were to disclose the chemical identity, the competitors would be 
capable of ascertaining on their own how the chemical substance might 
be manufactured or processed, and therefore this would in effect 
disclose process information.
    EPA, however, questions the assertion that when disclosing a 
chemical identity of a chemical substance inspires a competitor to 
ascertain a process for manufacturing the chemical substance, such 
disclosure is equivalent to disclosing the process itself. Disclosing 
the end product of a process (i.e., a chemical identity) is not the 
same thing as disclosing the process to make that end product. The 
process information would come from the competitor's expertise, 
research, or publicly available sources, not from EPA. Although some 
companies might find such use of a chemical identity undesirable, EPA 
does not believe that TSCA section 14(b) was intended to limit the uses 
of information from a health and safety study.
    Interpreting TSCA section 14(b)(1) otherwise might for all intents 
and purposes exclude chemical identities in health and safety studies 
from the disclosure provisions of TSCA section 14(b). Carried to its 
logical conclusion, the argument that the manufacturing process for 
chemical substances can be figured out by someone knowledgeable in the 
area and for that reason disclosure of chemical identities is 
considered equivalent to disclosing process information, would yield 
the perverse result that chemical identities would rarely, if ever be 
subject to TSCA section 14(b) disclosure.
     Chemical identify has been claimed as confidential in a 
significant number of health and safety submissions. The result, in the 
context of substantial risk notices under TSCA section 8(e) for 
example, has been that the public is able to see that some unidentified 
chemical substance might present a substantial risk of injury to health 
or the environment. EPA believes that Congress generally intended for 
the public to be able to know the identities of chemical substances for 
which health and safety studies have been submitted. Congress did not 
specifically exempt chemical identities from TSCA section 14(b), and 
EPA believes that interpreting TSCA section 14(b) in such a manner 
would be inconsistent with the intent of Congress in enacting the 
provision.
    It is EPA's view that as a general matter disclosure of a chemical 
identity does not disclose process information except where the 
identity explicitly contains process information. For example, a name 
such as ``formaldehyde'' (Chemical Abstracts Service (CAS) No. 50-00-0) 
reveals nothing about the process to make the chemical substance, even 
if any chemist could figure out independently that formaldehyde can be 
generated by oxidizing methanol.
    In contrast, the names of some chemical substances -- especially 
polymers and chemical substances of unknown or variable composition, 
complex reaction products and biological materials (known as UVCB 
substances) -- do explicitly contain process information. An 
illustrative UVCB example is CAS No. 64742-28-5, specific chemical 
substance's name ``Distillates (petroleum), chemically neutralized 
light paraffinic.'' A polymer example is CAS No. 68474-52-2, safflower 
oil, polymer with adipic acid, glycerol and phthalic anhydride. The 
monomers adipic acid, glycerol and phthalic anhydride are reactants, 
information pertaining to manufacture of the polymer. EPA expects that 
such names would not be subject to TSCA section 14(b) disclosure in 
those instances where the chemical substances' name were claimed as 
confidential in a study.
    EPA intends to begin review of confidentiality claims for 
identities of chemical substances in health and safety studies, and 
data from health and safety studies, as described in this guidance, on 
August 18, 2010. The Agency solicits comments prior to that date 
regarding classes of chemical substances and attributes of chemical 
identities that do or do not disclose process information. Such 
comments will inform the Agency's reviews. Where process information in 
the chemical identity is unnecessary to

[[Page 29757]]

characterize the chemical substance or mixture, EPA may release a 
version of the chemical identity with the process information removed.
    EPA premanufacture notification regulations at 40 CFR 720.90(c) 
state that EPA will deny a confidentiality claim for chemical identity 
in a health and safety study submitted as part of a premanufacture 
notice unless:
     1. The information in turn discloses process information,
     2. The information discloses portions of a mixture, or
     3. ``[t]he specific chemical identity is not necessary to 
interpret a health and safety study'' (see also 40 CFR 725.92(c) 
regarding microbial commercial activity notices). Consistent with the 
intent of TSCA section 14(b) to allow broad public availability of 
health and safety data, with limited exceptions, EPA intends to 
interpret paragraph 3. narrowly.

IV. Why is EPA Taking this Action?

    Part of the Agency's mission is to promote public understanding of 
potential risks by providing understandable, accessible, and complete 
information on potential chemical risks to the broadest audience 
possible. In support of this mission, EPA posts useful information 
about chemical substances regulated under TSCA for the public on its 
website (http://www.epa.gov/oppt/index.htm). One important source of 
this information is health and safety studies submitted to the Agency. 
The TSCA section 14(b) exclusion from confidential protection for 
information from health and safety studies indicates the importance 
attributed by Congress to making such information available to the 
public. Chemical identities in particular constitute basic information 
that helps the public to place risk information in context. Making 
public chemical identities in health and safety studies whose 
confidentiality is precluded by TSCA will support the Agency's mission.

List of Subjects

    Environmental protection, Chemicals, Confidential Business 
Information, Health and safety, Reporting and recordkeeping.

    Dated: May 20, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

[FR Doc. 2010-12646 Filed 5-26-10; 8:45 am]
BILLING CODE 6560-50-S